chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Chronic obstructive pulmonary disease, Near death experience
Clinical narrative: shots were nearly killing him; COPD; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and chronic obstructive pulmonary disease. On an unknown date, the outcome of the near death experience and chronic obstructive pulmonary disease were unknown.   The reporter considered the near death experience and chronic obstructive pulmonary disease to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient was working in a hospital so the shots were mandatory. He now had an exemption from his physician because the shots were nearly killing him.. The case had been linked with US2020214862, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020214862:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: first dose was bad; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccination and experienced awful and dad For tolerance to 2nd dose refer linked case US2020AMR215955, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215955:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received Shingrix. On 30th October 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix vaccine and not feeling well at time of reporting.  The reporter asked whether he/she needs to be isolated or quarantined.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: outbreak of genital herpes/second outbreak of genital herpes; injection site reaction on her right arm. It was sore; injection site reaction on her right arm,. It was sore and itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes. Concomitant products included valaciclovir hydrochloride (Valacyclovir) and ethanol (Alcohol).   On 16th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 16th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site itching. On 17th October 2020, the patient experienced genital herpes. On an unknown date, the outcome of the injection site pain and injection site itching were recovered/resolved and the outcome of the genital herpes was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site itching and genital herpes to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site reaction on her right arm, it was sore and itching and had resolved.  On 17th October 2020, the patient had an outbreak of genital herpes.  The first outbreak of genital herpes resolved but on 26th October 2020 second outbreak occurred and was not resolved. The reporter did not consent to follow up.
Age: 12.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Fatigue, Hypersomnia, Lethargy, Myalgia, Peripheral swelling
Clinical narrative: he slept/ Increased sleep; arm was swollen; muscle pain like falling off a bike; Fever; really lethargic; threw up dinner first couple days; was very tired; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 12-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID + TETANUS TOXOID (ADACEL) for prophylaxis and MENACTRA for prophylaxis.   On 15th March 2017, the patient received Bexsero, ADACEL (intramuscular) and MENACTRA (intramuscular). On an unknown date, unknown after receiving Bexsero, the patient experienced swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive. On an unknown date, the outcome of the swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive to be related to Bexsero.  Additional details were provided as follows: The patient's mother reported that the patient received Bexsero, Menactra and Adacel all on 15th March 2017. Two vaccines were received in one arm, and one shot in the other arm. The reporter stated the patient's arm was swollen, he slept, was very tired, he threw up dinner first couple days, he was really lethargic, fever, and he had muscle pain like falling off a bike. The mother reported that it took her son a week to recover.
Age: 12.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: he slept/ Increased sleep; arm was swollen; muscle pain like falling off a bike; Fever; really lethargic; threw up dinner first couple days; was very tired; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 12-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID + TETANUS TOXOID (ADACEL) for prophylaxis and MENACTRA for prophylaxis.   On 15th March 2017, the patient received Bexsero, ADACEL (intramuscular) and MENACTRA (intramuscular). On an unknown date, unknown after receiving Bexsero, the patient experienced swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive. On an unknown date, the outcome of the swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the swelling arm, muscle pain, fever, lethargy, vomiting, tiredness and sleep excessive to be related to Bexsero.  Additional details were provided as follows: The patient's mother reported that the patient received Bexsero, Menactra and Adacel all on 15th March 2017. Two vaccines were received in one arm, and one shot in the other arm. The reporter stated the patient's arm was swollen, he slept, was very tired, he threw up dinner first couple days, he was really lethargic, fever, and he had muscle pain like falling off a bike. The mother reported that it took her son a week to recover.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Malaise, Musculoskeletal stiffness, Myalgia
Clinical narrative: stiff neck; Muscle pain across the back; muscle pain spreading; Patient is feeling worst; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknwon date.).   On 24th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 25th October 2020, 1 days after receiving Shingrix, the patient experienced stiff neck, muscular back pain, muscle pain and feeling unwell. On an unknown date, the outcome of the stiff neck, muscular back pain, muscle pain and feeling unwell were unknown.   It was unknown if the reporter considered the stiff neck, muscular back pain, muscle pain and feeling unwell to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. On 28th October,2020 pharamcist reported that patient received the 2nd dose of Shingrix on sunday 24th October,2020 and on monday morning patient woke up with with a stiff neck and muscle pain across the back. It was also reported that symptoms were spreading and patient was feeling worst. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever; Fatigue; Chills; She felt really sick; Muscle pain; This case was reported by a physician via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced fever, fatigue, chills, malaise and muscle pain. On an unknown date, the outcome of the fever, fatigue, chills, malaise and muscle pain were unknown.   It was unknown if the reporter considered the fever, fatigue, chills, malaise and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and couple of days later experienced fever, fatigue for a few days, chills, muscle pain and she felt really sick. The reporter did not provide vaccine details and said the patient got it in a drugstore and though the patient might had received the vaccine by the IM route. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019197557:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness in the injection site; It was also hot to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 8th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and patient did not present symptoms after 1st dose).   On 27th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that a patient received the 2nd dose of Shingrix on 27th October 2020 and started to experienced redness in the injection site and it was also hot to touch.  Pharmacist said that patient did not present symptoms after the 1st dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: was thought he was having a stroke; acutely aphasic / patient remained aphasic for 48 hours /Patient was hospitalized; This case was reported by a physician via call center representative and described the occurrence of aphasia in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced aphasia (serious criteria hospitalization) and stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the aphasia was recovered/resolved and the outcome of the stroke was unknown.   It was unknown if the reporter considered the aphasia and stroke to be related to Shingrix.  Additional case details were reported as follows: The patient was reporter's friend. The age at vaccination was not reported. The reporter stated that the patient who received a Shingrix vaccine was not a personal patient. A week after the first dose of Shingrix vaccine patient became acutely aphasic and was thought he was having a stroke. The patient hospitalized. The reporter stated the patient remained aphasic for 48 hours. Gradually improving after 36 to 48 hours. Patient was still in the hospital. The reporter consented to follow up. This case has been link with case US2020AMR217355, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR217355:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pulmonary fibrosis
Clinical narrative: January 2020 the 1st dose of Shingrix / she has pulmonary fibrosis; This case was reported by a pharmacist via call center representative and described the occurrence of pulmonary fibrosis in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Cellcept.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pulmonary fibrosis (serious criteria GSK medically significant). On an unknown date, the outcome of the pulmonary fibrosis was unknown.   It was unknown if the reporter considered the pulmonary fibrosis to be related to Shingrix.  Additional case details were reported as follows: After vaccination patient started taking Cellcept to received a transplant because she had pulmonary fibrosis. The reporter consented to follow up.
Age: 7.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 7 year old patient received a dose of Flublok instead of Fluzone with no adverse event; 7 year old 1 day; Flublok and Fluzone do look very similar with no adverse event; Initial information regarding this unsolicited valid non-serious case from a pharmacist was received and transmitted to Sanofi on 12-Oct-2020.  This case is linked to case 2020SA283692.  This case involved a 7-years-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date was unknown for both) via an unknown route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product administered to patient of inappropriate age) and (Wrong product administered) on an unknown date.  It was a case of an actual medication due to inappropriate age at vaccine administration and wrong vaccine administered (Latency: Same day).  The reporter also reported that both the vaccines looks very similar (Product confusion)  (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.
Sex: M
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: patient got the flu and died; Initial information received on 29-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves male patient of unknown age who got the flu and died (influenza), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date (reported as in September of 88), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (reported as in December 88), the patient got the flu and died (influenza) (serious event), approximately 3 months (exact latency unknown) following the administration of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient was receiving any corrective treatment.  It was unknown at the time of reporting if an autopsy was done and the cause of death was captured as influenza.  Information on the batch number to be requested.; Sender's Comments: This poorly documented social media case concerns a male patient of unknown age who had influenza and died after receiving INFLUENZA VACCINE. Time to onset is compatible. Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient got flu and died
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 15 years old patient was given Flublok inadvertently/ No AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to 2020SA273791.  This case involves a 15 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2005, expiry date: 21-May-2021), via an unknown route and administration site inadvertently, on 25-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was a case of an actual medication error due to the inappropriate age at vaccine administration (latency same day).  At the time of reporting, the patient had no 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.
Age: 9.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 year-old patient inadvertently received a dose of Flublok quadrivalent/no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9 year-old patient who was inadvertently vaccinated with a dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number UJ448AA and expiry date 22-Mar-2021) via unknown route in unknown administration site on 05-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (Latency was on same day).  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: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 year old patient inadvertently received a dose of Flublok quadrivalent with no AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9 years old female patient who received 0.5 ml once dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ448AA, expiry date: 22-Mar-2020) via intramuscular route on left deltoid on 05-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  No laboratory data was reported.  Action taken was not applicable.   It was not reported if the patient received any corrective treatment.  Event outcome was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further information was reported.  No further information was reported.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient was inadvertently given FLUBLOK QUADRIVALENT, no AE; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from the pharmacist.  This case involves a 11-year-old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2044 and expiration date 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive any other vaccine concomitantly.  This was an actual medication error case due to inappropriate age at vaccine administration (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  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: 67.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine was not suitable for use because it was in transit too long, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00303610) and transmitted to Sanofi on 06-Oct-2020.  This case involves a 67 years old male patient who was administered 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ518AA, expiry date: 30-Jun-2021, form: prefilled syringe) once via unknown route in the right deltoid for prophylactic vaccination on 06-Oct-2020 (product storage error)   Medical history, medical treatment(s), past vaccination and family history were not provided.  The patient had not received concomitant medication.  It was a case of an actual medication error due to incorrect product storage.  The pharmacy became aware from Pasteur Customer Service that the dose was not suitable for use because it was in transit too long (due to it arriving 1 day late)  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: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Flublok vaccine was administered to a 13 years old patient/ No adverse event; Initial information regarding this valid unsolicited non-serious case from Medical Information (Reference number- 00303684) was received from pharmacist and transmitted to Sanofi on 06-Oct-2020.  This case involved a 13 years old female patient received a standard dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2015, expiration date- 30-Jun-2021) (Product administered to patient of inappropriate age) via intramuscular route in the left arm for prophylactic vaccination on 29-Sep-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.  It was a case of actual medication error due to inappropriate age at vaccine administration. (Latency: Same day).  At the time of reporting it was not reported that the patient had experienced any adverse event.  Reporter wanted to know that if the patient should revaccinated or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok has been administered to a 13 year old patient with no AE; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 13 years old male patient who received 0.5 ml dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: unknown, expiry date: unknown, Pre-filled syringe) via un unknown route and site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  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: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Flublok Quadrivalent vaccine was administered to 13 year old patient, No AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case was linked to the case 2020SA279481 (same reporter).  This case involves a 13-years-old male patient who received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2047, expiry date-30-Jun-2021) via an unknown route in left upper arm for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  This was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported that, no other medications or vaccinations were administered at that visit.   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 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.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 17 years old patient received a dose of Flubok with no adverse event; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA287443 (13 years old, same reporter).  This case involved a 17 years old male patient who received a 0.5 Ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number-QFAA2047, expiration date unknown) via an unknown route and administration site for prophylactic vaccination on 06-Oct-2020 (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.   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: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient received Flublok instead of the Fluzone High Dose with no adverse event; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved a 65 years old female received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2028, Expiration date- 30-Jun-2021) via an unknown route in unknown administration site for prophylactic vaccination on 03-Oct-2020 instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered (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: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 17 year old was given Flublok by accident due to grabbing the wrong vaccine/no AE; 17 year old was given Flublok by accident due to grabbing the wrong vaccine/no AE; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot QFAA2042, expiry date not reported] via an intramuscular at the left arm for prophylactic vaccination by accident due to grabbing the wrong vaccine (product administered to patient of inappropriate age, wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. (latency: at the same time of vaccination)  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: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: pain with any movements of vaccinated deltoid which causes in arm lift; patient still has pain at the injection site; Initial information regarding this valid unsolicited non-serious case from the via the agency (reference number- 00305801) was received from physician and transmitted to Sanofi on 07-Oct-2020.  This case involved a 61 years old female patient who experienced pain at the injection site (vaccination site pain) and pain with any movements of vaccinated deltoid which causes in arm lift (pain), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 31-August (year unspecified), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection [Lot UJ442AA, expiry date: 30-Jun-2021] via an intramuscular route at the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious pain at the injection site (vaccination site pain) and pain with any movements of vaccinated deltoid which causes in arm lift (pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  At the time of reporting it was reported that, patient still has pain at the injection site. It is not red, swollen or warm.   Details of laboratory data not reported.  It was reported that, anti-inflammatories have been given to patient and they do work temporarily but when they wear off the pain come back.  At the time of reporting, the patient was not recovered from the reported events.  follow-up information was received regarding this valid unsolicited non-serious case from the the agency (reference number- 00305801) was received from physician and transmitted to Sanofi on 09-Oct-2020.  Pain event and formulation of suspect vaccine added and narrative updated accordingly.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK Quadrivalent that was administered to a 12 year old patient with no adverse event; Initial information regarding the valid unsolicited non-serious case received from pharmacist on 08-Oct-2020.  This case involved a 12 years old female who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age) with no adverse event.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug was not reported. No other vaccines were administered.  On 06-Oct-2020, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Lot number-UJ448AB, expiration date unknown) via intramuscular route in the left arm for prophylactic vaccination.  This was a case of actual medication error due to Inappropriate age at vaccine administration. (latency: at the same time of vaccination)  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: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: redness and pain at the injection site; pain at the injection site; redness at the injection site; administered Flublok to a female patient who is 16 years and 10 months old; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone.  This case involves a 16 years and 10 months old female patient who experienced redness and pain at the injection site (vaccination site inflammation with vaccination site pain and vaccination site erythema), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not reported.   The patient did not receive other vaccine concomitantly.  On 07-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2047 and expiration date 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed non-serious redness and pain at the injection site (vaccination site inflammation with vaccination site pain and vaccination site erythema), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Also, this was an actual medication error case due to inappropriate age at vaccine administration (latency was same day at the time of vaccination).  The pharmacist wanted to know if patient need to be revaccinated.  Details of laboratory data were not reported.  The patient was treated with IBUPROFEN for vaccination site inflammation .  At the time of reporting, outcome of the events was unknown.  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: 6.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 6 years-old child patient received Flublok with no AE; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old male patient who received an 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ448AA, expiry date: 22-Mar-2020) via intramuscular route in right arm site on 26-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy was given.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  No adverse effects have been 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: 9.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 9 years old patient was administered FLUBLOK QUADRIVALENT with no adverse event; Initial information regarding this unsolicited valid non-serious case from a nurse was received and transmitted to Sanofi on 12-Oct-2020.  This case involved a 9-years-old male patient received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2042, expiration date- 30-Jun-2021) via intramuscular route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 09-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. No other concomitant drug was given.  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: 8.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: patient received a dose of Flublok instead of Fluzone with no adverse event; 8 year old patient received a dose of Flublok with no adverse event; the packaging for Flublok and Fluzone is very similar which creates confusion with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 12-Oct-2020. This case is linked to case 2020SA284931.  This case involved an 8-year-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2027, expiration date unknown) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (Lot number and expiration date unknown) via unknown route in unknown administration site (Product administered to patient of inappropriate age) and (Wrong product administered) for prophylactic vaccination on an unknown date. The reporter also reported that the packaging for Flublok and Fluzone was very similar and believed this caused confusion to nurse (Product packaging confusion).  The patient's medical history, medical treatments, vaccinations and family history were not provided. No concomitant drug was reported.  This was a case of actual medication error as Inappropriate age at vaccine administration and Wrong vaccine administered due to Look alike packaging (Latency: Same day).  At the time of reporting 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.