chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: vaccination failure; mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 13 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM and RT-PCR at buccal. The results were postive for mumps at bilateral buccal. It was considered probable mumps parotitis. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Sex: F
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: vaccination failure; mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 16 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested RT-PCR at buccal. The results were postive for mumps at bilateral buccal. It was confirmed that the patient experienced mumps parotitis. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).   This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Sex: M
Vaccine: MMR
Symptoms: Incomplete course of vaccination, Mumps, Mumps antibody test positive
Clinical narrative: vaccination failure; incompletely immunized; Probable mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 7 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided) (Incomplete course of vaccination).   In 2015, the patient was tested mumps IgM. The results were postive for mumps. It was considered probable mumps parotitis. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Sex: M
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: vaccination failure; mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare  emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 7 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2014, the patient was tested mumps IgM. The results were postive for mumps at right site. It was cnsidered probable mumps parotitis. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Sex: M
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive, Vaccination failure
Clinical narrative: mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 15 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2014, the patient was tested mumps IgM. The results were postive for mumps at bilateral site. It was considered probable mumps parotitis. The patient required admission to the ward. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience. Literature report:  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Nasal discomfort
Clinical narrative: NOSE BURNING; STUFFY NOSE ON ONE SIDE; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown    No concomitant products were reported.    On an unknown date, the patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for an unknown indication.     On an unknown date, the patient experienced nose burning (preferred term: Nasal discomfort) and stuffy nose on one side (preferred term: Nasal congestion).     The outcome of the events of nose burning and stuffy nose on one side was unknown.     The company physician considered events nose burning and stuffy nose on one side to be non-serious.
Sex: F
Vaccine: FLUN3
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Malaise
Clinical narrative: GUILLAIN BARRE SYNDROME; SICK; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown    No concomitant products were reported.    On an unknown date, the patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for an unknown indication.     Reporter stated that patient developed Guillain Barre syndrome (preferred term: Guillain-Barre syndrome) immediately after shot also she got sick (preferred term: Illness) after your shot.    At the time of the report, the outcome of the events of guillain barre syndrome and sick was unknown.    The company physician assessed the event guillain barre syndrome as serious due to important medical event criterion.    The company physician assessed the event sick to be non-serious.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Contraindicated product administered, Documented hypersensitivity to administered product, Nonspecific reaction
Clinical narrative: Got the Flu Shot had reaction- (egg allergy ); Documented allergy to administered drug; This case was reported by a consumer via interactive digital media and described the occurrence of contraindicated product administered in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included pneumonia shot for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and pneumonia shot at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced contraindicated product administered and documented allergy to administered drug. On an unknown date, the outcome of the contraindicated product administered and documented allergy to administered drug were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was allergic to egg and vaccinated with Flu shot led to contraindicated product administered and documented allergy to administered drug. The patient was also got the Pneumonia shot and had a reaction too. Now patient was questioning about  the Covid vaccine. No further information was available
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: my temperature keeps rising; This case was reported by a consumer via interactive digital media and described the occurrence of body temperature increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient received the 2nd dose of Shingrix vaccine last night and the patient's temperature keeps rising.  The patient ask what was a normal range of fever with the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea ever since; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 2nd dose of Shingrix, the patient experienced diarrhea. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pain in extremity
Clinical narrative: Sore arm; Erythema; This case was reported by a other health professional 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.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. The other health professional mentioned she had received a few complaints on sore arm and redness after receiving a dose of Bexsero. The reporter did not agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt terrible; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Customer reported that her friend had the Shingrix vaccine and felt terrible. The reporter did not consent to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Local reaction, Swelling
Clinical narrative: local reaction; swelling; patient received two flu shots accidentally (one on 18Sep2020 and one on 01Oct2020); patient received two doses of Fluzone Quadrivalent total (one on 18Sep2020 and one on 01Oct2020); Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (reference number: 00298451) was received from a nurse and transmitted to Sanofi 02-Oct-2020.  This case involved a 5 years old male patient who experienced local reaction, swelling after accidentally receiving two flu shots of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Extra dose administered and Inappropriate schedule of product administration).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On 01-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7041NA via intramuscular route in the left thigh (Extra dose administered and Inappropriate schedule of product administration).   On an unknown date, the patient is having more of a local reaction and swelling, unknown latency, following the administration of INFLUENZA QUADRIVAL A-B VACCINE that he received on 01-Oct-2020 (Extra dose administered and Inappropriate schedule of product administration).  Relevant laboratory test result was not reported.  Final diagnosis was Not Applicable patient received two flu shots accidentally, Not Applicable patient received two flu shots accidentally, swelling and local reaction.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events, local reaction and swelling.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310708, 2020SA310768, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310708, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Tenivac expired on 12-Oct-2020 and the patient received the on 16-Oct-2020/no AE; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from other health care professional via call center.  This case involved a 40-year-old male patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which expired on 12-Oct-2020 and received a 0.5 mL dose once on 16-Oct-2020 (Expired product administered) (lot U6091AA) via an intramuscular route at left deltoid for prophylactic vaccination.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: M
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: body achiness; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 49 year old male patient who had body achiness (pain), while he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 23-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the upper left arm for prophylactic vaccinations.  On 26-Oct-2020, the patient developed a non-serious body achiness (pain) 3 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided   No corrective treatment was received.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 10.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 10 year old patient was administered the flublok, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (MI) (Reference number- 00333645) and transmitted to Sanofi on 27-Oct-2020.   This case involves a 10 years old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2039, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 05-Oct-2020 (product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given that day.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Syringe issue
Clinical narrative: Used a 5/8" needle instead of of a 1"
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Colectomy total, Colitis ulcerative
Clinical narrative: Ulcerative colitis with an eventual full colectomy
Age: 49.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain, Pain
Clinical narrative: After rec flu vax, started experiencing soreness at site. After a few days, soreness did not go away, some days a little better, some days more aching and tenderness with pushing with pain and any movement. Still have spot on arm that is sore and hurt when try to move arm up or down, left or right.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Chills, headache, body aches, fever, flu like symptoms, tired
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, headache, body aches, fever, flu like symptoms, tired
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Ocular hyperaemia
Clinical narrative: lots of blood in eye.  Still have almost a week later...not better.  Chills malaise and sick feeling for 2 days
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: I had severe chills and body shakes then fever and sweating. Injection sight soreness and weakness in that arm. The next day the area around the injection site went red and warm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pyrexia, Tremor
Clinical narrative: I had severe chills and body shakes then fever and sweating. Injection sight soreness and weakness in that arm. The next day the area around the injection site went red and warm.
Sex: M
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: patient convulsing; This case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In August 2019, the patient received Boostrix. On an unknown date, less than 9 months after receiving Boostrix, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion was not recovered/not resolved.   The reporter considered the convulsion to be related to Boostrix.  Additional details were provided as follows: The patient received one doseof boostrix and experienced convulsion. The patient is having prolonged side effects and includes a video of the patient convulsing. The patient was still suffering from the vaccine injury he sustained in August 2019. The batch and lot number were unknown. The reporter consented to follow up. No further information was available.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Laboratory test, Rash, Vaccination failure
Clinical narrative: two doses of Shingrix in 2019 / diagnosed with Shingles; two doses of Shingrix in 2019 / diagnosed with Shingles; started developing a rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9JG52, expiry date unknown) for prophylaxis.   The patient's past medical history included cancer (Twice).   On 12th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2020, 399 days after receiving Shingrix and 488 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: On 14th November 2020,Saturday, the patient started developing a rash and on 15th November 2020, Sunday, she was diagnosed with shingles. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown. The reporter did not consent to follow up.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Patient immediatly broke out in a full body rash with administration.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dysuria, Fatigue
Clinical narrative: Evening of 11/14/2020 started to experience malaise. Patient 11/15/2020 had extreme fatigue, body chills, loose stools, stomach cramping, tightness during urination. 11/17/2020 body chills, extreme fatigue, loose stools, ongoing cramping, and pain urination. Did have minor pain in arm.  By 11/20/2020 patient went to urgent care  due to ongoing loose stools, cloudy urine. Symptoms persisted till 11/22/2020. Cramping was described as a 'muscle spasm' such as 'labor contractions at the beginning'. Confirmation for UTI and administered antibiotics. Patient describes self as a 'very healthy' individual.   This was the second dose of shingrix.
Age: 56.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Malaise, Pain in extremity, Urinary tract infection, Urine abnormality, Urine analysis
Clinical narrative: Evening of 11/14/2020 started to experience malaise. Patient 11/15/2020 had extreme fatigue, body chills, loose stools, stomach cramping, tightness during urination. 11/17/2020 body chills, extreme fatigue, loose stools, ongoing cramping, and pain urination. Did have minor pain in arm.  By 11/20/2020 patient went to urgent care  due to ongoing loose stools, cloudy urine. Symptoms persisted till 11/22/2020. Cramping was described as a 'muscle spasm' such as 'labor contractions at the beginning'. Confirmation for UTI and administered antibiotics. Patient describes self as a 'very healthy' individual.   This was the second dose of shingrix.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling abnormal, Pyrexia
Clinical narrative: Patient reported that the day after vaccination she felt "loopy and out of it" and that all the joints in her body were aching. She also reported low grade fever and chills. The joint pain lasted approximately 24 hours then subsided.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient developed rash/hives over body. Areas include wrist, waist, face, and neck
Age: 55.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash macular
Clinical narrative: Patient received Shingrix in left deltoid area on 11/2/2020. That night, patient developed a rash. It started in acromioclavicular joint area and then she noticed some rash on the left side of the neck, biceps and axillary areas. There was no pain but some minimal burning. She denied any discharge, fevers, chills. No similar rashes in the past. Patient denied taking any new medications, supplements, traveling or sick contacts.  Skin exam showed erythematosus macular rash about 1-1/2 inch by half inch in size on the left side of the neck just below occipital area. Patient also had multiple raised lesions in the anterior part of deltoid upper biceps and axillary area.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After rec vax, left arm started swelling a lot, was hot to touch, red and painful. Lasted several days. Took ibprophen for pain. Pain left, but swelling and hot to touch continued. Redness in the entire upper arm appeared. Hot painful and swollen were symptoms
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pt reports persistent proximal left arm pain with movement at site of injection (ab-duction, internal rotation, flexion, extension >90 degrees)
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: HepA adult dose given to 16 year old instead of intended HepA pediatric/adol dose.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pain, Swelling
Clinical narrative: She had some redness, pain and mild swelling.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Angiogram, Chest X-ray, Chest discomfort, Chest pain, Echocardiogram
Clinical narrative: Within 20 minutes of vaccine I developed heavy, pulsing, constant chest pain. I went to the emergency room where they performed an EKG and chest x-ray and admitted me to the cardiac unit.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram, Stress cardiomyopathy
Clinical narrative: Within 20 minutes of vaccine I developed heavy, pulsing, constant chest pain. I went to the emergency room where they performed an EKG and chest x-ray and admitted me to the cardiac unit.
Age: 55.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Rash erythematous, Skin exfoliation
Clinical narrative: Red Rash, burning, blistering and skin peeling. Symptoms returned 11/16/2020 Red Rash, burning, blistering and skin peeling. Patient had flu vaccine same day, intramuscular on L side. Flu vaccine type give unknown.
Age: 55.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Burning sensation, Oral mucosal blistering, Rash erythematous, Skin exfoliation
Clinical narrative: Red Rash, burning, blistering and skin peeling. Symptoms returned 11/16/2020 Red Rash, burning, blistering and skin peeling. Patient had flu vaccine same day, intramuscular on L side. Flu vaccine type give unknown.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Injection site rash, Night sweats
Clinical narrative: Day 1: fever (100.4), body aches, chills, sweats occurred throughout day. Swelling and soreness where injection was administered. Took Tylenol to help with side effect throughout day. Also drank green tea to help. Day 2: fever (100.4), chills during day, heavy night sweats. Swelling and intense pain where injected was administered. Arm could not go higher that 45 degrees. Painful to apply any pressure. Arm now is hot to touch. Took Tylenol to help with side effects throughout day. Alternate between Tylenol and Motrin to assist with pain and swelling in arm. Alternate between heat and ice to assist with pain and soreness. Day 3: fever (100.4), night sweats. Woke to a rash on bicep directly below where shot was administered. Arm continues to be hot where shot was administered and swelling has moved into bicep location as well. Arm cannot be lifted higher than 45 degrees. Alternate between Tylenol and Motrin to assist with pain and swelling in arm. Applied ice to arm to assist with swelling and pain.  Day 4: No fever. Mild night sweats. Swelling is in bicep of arm. Arm is hot to touch. Applied benedryl cream to outside of arm to assist with the mild rash. Applied cold compress to arm to assist with swelling. Motrin has been used to assist with swelling and pain. Arm can move to a 90 degree angle without assistance today.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Day 1: fever (100.4), body aches, chills, sweats occurred throughout day. Swelling and soreness where injection was administered. Took Tylenol to help with side effect throughout day. Also drank green tea to help. Day 2: fever (100.4), chills during day, heavy night sweats. Swelling and intense pain where injected was administered. Arm could not go higher that 45 degrees. Painful to apply any pressure. Arm now is hot to touch. Took Tylenol to help with side effects throughout day. Alternate between Tylenol and Motrin to assist with pain and swelling in arm. Alternate between heat and ice to assist with pain and soreness. Day 3: fever (100.4), night sweats. Woke to a rash on bicep directly below where shot was administered. Arm continues to be hot where shot was administered and swelling has moved into bicep location as well. Arm cannot be lifted higher than 45 degrees. Alternate between Tylenol and Motrin to assist with pain and swelling in arm. Applied ice to arm to assist with swelling and pain.  Day 4: No fever. Mild night sweats. Swelling is in bicep of arm. Arm is hot to touch. Applied benedryl cream to outside of arm to assist with the mild rash. Applied cold compress to arm to assist with swelling. Motrin has been used to assist with swelling and pain. Arm can move to a 90 degree angle without assistance today.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I have a 99.98 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 13th November 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter asked how long would fever last after getting the shot. The patient had no fever this morning but the patient had a 99.98 degree F fever at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/small patches of shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several weeks 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 patient received Shingrix two years before the date of reporting and then had shingles a few weeks later. The patient still had small patches of shingles (outbreak) if she get stressed. The doctor advised not to take second shot. The patient asked if she should receive the 2nd shot.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Erythema, Feeling hot, Joint dislocation, Mobility decreased
Clinical narrative: barely move her arm / lot of difficulty moving normally; reaction that was hot and red; reaction that was hot and red; got shoulder pain; right thumb is clicking and moving out of its position; is painful; neck pain; neck pain and its stiff; This case was reported by a consumer via patient support programs and described the occurrence of mobility decreased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck. On an unknown date, the outcome of the mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck were unknown.   It was unknown if the reporter considered the mobility decreased, erythema, feeling hot, shoulder pain, dislocated thumb, pain, neck pain and stiff neck to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot a month after the Shingrix shot. The patient experienced hot and red. Then she got shoulder pain and she can barely move her arm.  The patient had been treating with heat and creams. Her right thumb was clicking and moving out of position and she has to put it back in place and is painful and not feeling right. She was having neck pain and it is stiff. The patient was having a lot of difficulty moving normally.