chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Temperature 35.6 F; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 24-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1637651 with expiration date 09-JUN-2022, dose detail and route were not reported) for prophylaxis.  The vaccine was stored at 35.6 Fahrenheit degrees (F) for 3 hours and 15 minutes (product storage error). There was a previous temperature excursion and the call was because of a data logger involved.   This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA003213:
Sex: F
Vaccine: FLUX
Symptoms: Eye movement disorder, Infantile spasms
Clinical narrative: hypsarrhythmia; had a lot of rapid eye movements; This case was reported by a consumer via other manufacturer and described the occurrence of hypsarrhythmia in a 22-month-old female 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, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hypsarrhythmia (serious criteria GSK medically significant) and eye movement disorder. On an unknown date, the outcome of the hypsarrhythmia and eye movement disorder were unknown.   It was unknown if the reporter considered the hypsarrhythmia and eye movement disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received Flu shot and experienced eye movement disorder and hypsarrthymia.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Quarter-sized area at injection site that is swollen; Quarter-sized area at the injection site that is swollen, hard; Quarter-sized area at the injection site that is swollen, hard and tender; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 10-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 5X5J2, expiry date 30th June 2021) for prophylaxis.   On 4th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 5th October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site swelling, injection site induration and injection site tenderness. On an unknown date, the outcome of the injection site swelling, injection site induration and injection site tenderness were not recovered/not resolved.   The reporter considered the injection site swelling, injection site induration and injection site tenderness to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient was vaccinated wth FluLaval shot. Next day after vaccination patient had Quarter-sized area at the injection site that was swollen, hard and tender. Till the time of reporting symptoms were not recovered. The reporter did not consent to follow up.
Sex: M
Vaccine: UNK
Symptoms: Seizure
Clinical narrative: experienced seizures following the administration / had two seizures 10-15 minutes after being administered; This case was reported by a nurse via sales rep and described the occurrence of seizure in a 23-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   In October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In October 2020, less than an hour after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: Age at vaccination was not reported. The vaccine was administered to the patient and the patient experienced seizures following the administration. It was reported that the patient had two seizures 10-15 minutes after being administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200826:same reporter
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Cyanosis, Dyspnoea, Fatigue, Headache
Clinical narrative: severe stomach pain; she became nauseated; she could not breathe / doctor prescribed oxygen; her face turned gray; her lips turned blue; Headache; body rash; fever; Fatigue; Body Trembing; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 12-year-old female patient who received FluLaval Tetra 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 7th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor. The patient was treated with oxygen. On an unknown date, the outcome of the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, generalized rash and tremor were recovered/resolved and the outcome of the headache, fever and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The reporter was the mother of the patient. The reporter stated that her daughter received the vaccine and immediately the patient complained of severe stomach pain, her face turned gray, her lips turned blue, she stated she could not breathe, and she became nauseated. The physician saw the patient while she was in the office that day for the injection. The physician prescribed oxygen for the patient and after one hour allowed the patient to go home. The patient also complained of a headache, had a body rash and a fever between 99 degrees to 106 degrees. The patient had recovered except for the headache, fever and fatigue. The reporter wanted to know if the patient should receive the FluLaval injection next year. The reporter was provided with the Medical Disclaimer and gave her the number to our MI department for her health care provider. The reporter also read the information from the PI in content. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Nausea, Oxygen therapy, Pallor, Pyrexia
Clinical narrative: severe stomach pain; she became nauseated; she could not breathe / doctor prescribed oxygen; her face turned gray; her lips turned blue; Headache; body rash; fever; Fatigue; Body Trembing; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 12-year-old female patient who received FluLaval Tetra 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 7th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor. The patient was treated with oxygen. On an unknown date, the outcome of the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, generalized rash and tremor were recovered/resolved and the outcome of the headache, fever and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The reporter was the mother of the patient. The reporter stated that her daughter received the vaccine and immediately the patient complained of severe stomach pain, her face turned gray, her lips turned blue, she stated she could not breathe, and she became nauseated. The physician saw the patient while she was in the office that day for the injection. The physician prescribed oxygen for the patient and after one hour allowed the patient to go home. The patient also complained of a headache, had a body rash and a fever between 99 degrees to 106 degrees. The patient had recovered except for the headache, fever and fatigue. The reporter wanted to know if the patient should receive the FluLaval injection next year. The reporter was provided with the Medical Disclaimer and gave her the number to our MI department for her health care provider. The reporter also read the information from the PI in content. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Tremor
Clinical narrative: severe stomach pain; she became nauseated; she could not breathe / doctor prescribed oxygen; her face turned gray; her lips turned blue; Headache; body rash; fever; Fatigue; Body Trembing; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 12-year-old female patient who received FluLaval Tetra 2020-2021 season) for prophylaxis.   On 7th October 2020, the patient received FluLaval Tetra 2020-2021 season. On 7th October 2020, immediately after receiving FluLaval Tetra 2020-2021 season, the patient experienced stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor. The patient was treated with oxygen. On an unknown date, the outcome of the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, generalized rash and tremor were recovered/resolved and the outcome of the headache, fever and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, nausea, difficulty breathing, pallor facial, blue lips, headache, generalized rash, fever, fatigue and tremor to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The reporter was the mother of the patient. The reporter stated that her daughter received the vaccine and immediately the patient complained of severe stomach pain, her face turned gray, her lips turned blue, she stated she could not breathe, and she became nauseated. The physician saw the patient while she was in the office that day for the injection. The physician prescribed oxygen for the patient and after one hour allowed the patient to go home. The patient also complained of a headache, had a body rash and a fever between 99 degrees to 106 degrees. The patient had recovered except for the headache, fever and fatigue. The reporter wanted to know if the patient should receive the FluLaval injection next year. The reporter was provided with the Medical Disclaimer and gave her the number to our MI department for her health care provider. The reporter also read the information from the PI in content. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 8th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix  and experienced sore arm which led to pan in arm. The patient states that she does not have fever. The reporter did not consented to follow up.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: allergy to vaccine; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a female patient (age no reported) who experienced allergy to vaccine, while she received vaccine TETANUS TOXOID.  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing hip dysplasia (right hip) from 16-Jan-1942, obesity from 01-Jan-1973 and allergy to penicillin-hives from 01-Jan-1980.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On 01-Jan-1982, the patient developed an allergy to vaccine (unknown latency) following the administration of TETANUS TOXOID.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from allergy to vaccine.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: shingles; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown demographics) who had shingles (herpes zoster) when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date (several years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in the unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious shingles (herpes zoster) (unknown latency, intensity: mild) following the administration of INFLUENZA VACCINE.  She did not think that first shot protects people forever. Her plan was to get 2 new shots which would probably prevent her from getting shingles at all.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had flu after receiving flu shot; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient's wife) via social media.  This case involves a male patient (age not reported) who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE.  Vaccination(s) included influenza vaccine for prophylactic vaccination. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign, it was assumed that consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Made me sick never having another.; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp from social media.  This case involves a patient (unknown demography) who was sick and never having another (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickness (malaise), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that the patient was sick after the vaccination so he/she never had another dose.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a female patient (age unspecified) who had a flu (Influenza), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (20 years ago), the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient was sick after receiving the vaccine twice; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional via social media.  This case involves a patient(age, gender not reported) who was sick (malaise) , while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. Patient had not had another vaccine over 25 years.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sick (malaise) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign it had been assumed the consumer was referring to the Sanofi flu vaccine  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: M
Vaccine: RAB, UNK, RAB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: patient received of IMOVAX RABIES vaccine 45 minutes to 1 hour after reconstitution/ NO AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient who received vaccine  in rabies series first dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] and IMMUNOGLOBULIN ANTI-RABIES on 16-Sep-2020, second dose of suspect RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] and third dose of suspect IMOVAX RABIES (administered 45 minutes to 1 hour after reconstitution on 23-Sep-2020) (wrong technique in product usage process) batch number, expiry date not reported via an unknown route at an unknown administration site for post-exposure immunization.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong technique in product usage process (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.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: RAB, UNK, RAB
Symptoms: Product preparation issue
Clinical narrative: patient received of IMOVAX RABIES vaccine 45 minutes to 1 hour after reconstitution/ NO AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves male patient who received vaccine  in rabies series first dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] and IMMUNOGLOBULIN ANTI-RABIES on 16-Sep-2020, second dose of suspect RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] and third dose of suspect IMOVAX RABIES (administered 45 minutes to 1 hour after reconstitution on 23-Sep-2020) (wrong technique in product usage process) batch number, expiry date not reported via an unknown route at an unknown administration site for post-exposure immunization.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong technique in product usage process (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.  There will be no information available on the batch number for this case.
Age: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 year old received the Flubok vaccine, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 12 years old patient who was vaccinated with a dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QSAA2009 and expiration date:30-Jun-2021) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date (PT: product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).  No adverse event reported at the time of reporting.  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: 11.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was vaccinated with expired Fluzone Quadrivalent syringe from the 2019-2020 season, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11 years old female patient who was vaccinated with once 0.5 ml dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ304AB and expiration date: 30-Jun-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine syringe used was from the 2019-2020 season (PT: expired product administered).  Medical history was not reported.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (same day latency).  No adverse event reported at the time of reporting.  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: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm sore; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involved a 72 years old female patient whose arm was sore (Pain in extremity), while she received INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient arm was sore (pain in extremity) (non-serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that caller would like to know if the Fluzone High Dose (HD) contained mercury or preservatives and also would like to know if there were other preservatives in Fluzone HD. Stated that a friend got the flushot and her arm was sore. She did not know which flushot she received but a assumes that it was Fluzone because they used the same doctor.  No relevant laboratory test was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event arm sore, at the time of reporting.  There will be no information on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: No adverse event, Underdose
Clinical narrative: 4 year old female patient recieved a 0.25 mL FLUZONE Quad dose, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a four year old female patient who received 0.25 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (PT: underdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 30-Sep-2020, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ452AC and expiry date: 20-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to vaccine underdose (latency on 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: FLU3
Symptoms: Expired product administered, Extra dose administered, Myelitis
Clinical narrative: myelitis; a patient received FLUZONE HIGH DOSE vaccine twice in a month; a patient received an expired dose of FLUZONE HIGH DOSE vaccine; Initial information received on 02-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a male patient (age not reported) who experienced myelitis, while he received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 17-Sep-2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI6848E and expiry date: 30-Jun-2017) via an unknown route at an unknown administration site for prophylactic vaccination and also a dose of same vaccine on 17-Oct-2017 (lot number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination from a hospital when he was in vaccine recovery program.  On an unknown date, the patient developed a serious myelitis unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  It is also a case of medication error due to extra dose administered and expired vaccine used. A patient received an expired dose of FLUZONE HIGH DOSE vaccine twice in a month.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for myelitis.  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.; Sender's Comments: An elderly male patient presented with myelitis following the overdose vaccination with expired FLUZONE HIGH DOSE. Time to onset is not clearly defined. Medical history, concomitant medication, and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 15.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 year old female patient inadvertently administered Flublok Quadrivalent rather than Fluzone Quadrivalent, no AE; 15 year old female patient inadvertently administered Flublok Quadrivalent, no AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 year old female patient who inadvertently administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered and Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.   No other vaccines were administered concomitantly.  On 01-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ446AA and expiry date: 18-Mar-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on 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: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 68 years old female patient who experienced flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Lung disorder.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for influenza at the time of reporting.  There will be no information available on lot number for this case.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Tinnitus
Clinical narrative: loud ringing in both ears; left arm sore at the injection site and down the elbow; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 74 year old female patient who had a loud ringing in both ears (tinnitus) and left arm was sore at the injection site and down the elbow (vaccination site pain), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 29-Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) once via unknown route in unknown administration site for prophylactic vaccination.  On 29-Sep-2020, the patient developed a non-serious loud ringing in both ears (tinnitus) and left arm was sore at the injection site and down the elbow (vaccination site pain) within 2 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   She and her husband received the fluzone high dose vaccine at the local pharmacy. Her husband did not have a reaction and they have not had one in the past. The ringing in her ears did not stop.   No laboratory data was provided.  The patient did nothing to treat herself  At the time of reporting, the outcome of event vaccination site pain was unknown while the event tinnitus was not recovered.  There will be no information available on the batch number for this case.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Grip strength decreased, Hypersensitivity, Rash, Skin lesion
Clinical narrative: Breaking out on her upper thighs/ big lesions then spread to arms, chest and whole body; Having trouble picking things; Fatigued; 2 different types of eruptions; Hyper reaction to flu vaccine; This spontaneous case was received on 05-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-02890) and concerned a 76-year-old female patient.  The patient's concurrent conditions included allergy to sulfa which caused her muscle paralysis, and meloxicam allergy. The patient was not taking any concomitant medications and stated she was very healthy.   On 08-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml; anatomical location: deltoid; route of administration: not reported) for influenza prophylaxis. The batch number and expiry date were not reported. The patient had no problem at the time of administration.  On 10-Sep-2020, two days after receiving Afluria Quadrivalent, the patient was fatigued, had trouble picking things up and started breaking out on her upper thighs, it was tiny at first, then by the second week had developed into big lesions then spread to arms, chest and whole body.  On an unknown date in 2020, the patient saw dermatologist that reported the patient had two different types of eruptions and diagnosed her with hyper reaction to flu vaccine. She was prescribed prednisone, at dose of 40 mg, for two weeks and a return appointment on 29-Oct-2020.  On 02-Oct-2020, the patient started treatment with prednisone, at dose of 40 mg.   At the time of initial reporting on 05-Oct-2020, the patient had not recovered from events 'fatigue' 'hypersensitivity reaction' and 'movement disorder' but was recovering from events 'skin lesion' and 'skin eruption', as it was reported that the rash was much improved.  The events 'hypersensitivity reaction', 'skin lesion' and 'skin eruption' were considered to be medically significant by a Physician within Seqirus's Department.  The reporter assessed the event of 'hypersensitivity reaction', 'skin lesion' and 'skin eruption' to be related to Afluria Quadrivalent. The reporter did not provide a causality assessment for other events.  Company comment: Hypersensitivity, skin lesion, rash, movement disorder and fatigue were associated with the use of the suspect product - Afluria Quadrivalent. Causality was assessed as possibly related  for all events due to plausible chronology and absence of any other confounding factor.; Reporter's Comments: The patient saw dermatologist that reported the patient had two different types of eruptions and diagnosed her with hyper reaction to flu vaccine.; Sender's Comments: Hypersensitivity, skin lesion, rash, movement disorder and fatigue were associated with the use of the suspect product - Afluria Quadrivalent. Causality was assessed as possibly related  for all events due to plausible chronology and absence of any other confounding factor.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyskinesia, Fatigue, Headache, Mood altered, Muscle spasms
Clinical narrative: Seizure-like activity; Incontrollable muscle movement; Mood change; Muscle weakness; Cramps; Tired; Nausea; Headache; This spontaneous case from the was received on 05-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-02860) and concerned a 51-year-old, male patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 27-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 287096 and expiry date was not reported.   On 01-Oct-2020, four days after receiving Flucelvax QIV, the patient experienced seizure-like activity, incontrollable muscle movement, mood change, muscle weakness, cramps, nausea, headache and was tired.   At the time of initial reporting on 05-Oct-2020, the patient had not recovered from the events, as it was reported that the symptoms were still ongoing.   The reporter assessed the events as non-serious.   The event of 'seizure' was considered to be serious due to the criterion of medical significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  This case is linked to cases 202004934 (the corresponding spouse case) and 202004935 (the corresponding daughter case).  Company comment: A 51-year-old, male patient experienced seizure (seizure like symptoms), dyskinesia, mood altered, muscular weakness, muscle cramps, nausea, headache and fatigue four days after receiving Flucelvax QIV vaccine. The patient had no relevant medical history and was not taking any concomitant medications. More information regarding diagnostic findings is needed. Causality is assessed as possibly related for all events due to plausible chronology and no alternative aetiology provided. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.; Sender's Comments: A 51-year-old, male patient experienced seizure (seizure like symptoms), dyskinesia, mood altered, muscular weakness, muscle cramps, nausea, headache and fatigue four days after receiving Flucelvax QIV vaccine. The patient had no relevant medical history and was not taking any concomitant medications. More information regarding diagnostic findings is needed. Causality is assessed as possibly related for all events due to plausible chronology and no alternative aetiology provided. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Muscular weakness, Nausea, Seizure like phenomena
Clinical narrative: Seizure-like activity; Incontrollable muscle movement; Mood change; Muscle weakness; Cramps; Tired; Nausea; Headache; This spontaneous case from the was received on 05-Oct-2020 from other non-health professional via Med Communications (reference number: SEQW20-02860) and concerned a 51-year-old, male patient.   The patient had no relevant medical history and was not taking any concomitant medications.  On 27-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 287096 and expiry date was not reported.   On 01-Oct-2020, four days after receiving Flucelvax QIV, the patient experienced seizure-like activity, incontrollable muscle movement, mood change, muscle weakness, cramps, nausea, headache and was tired.   At the time of initial reporting on 05-Oct-2020, the patient had not recovered from the events, as it was reported that the symptoms were still ongoing.   The reporter assessed the events as non-serious.   The event of 'seizure' was considered to be serious due to the criterion of medical significance by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  This case is linked to cases 202004934 (the corresponding spouse case) and 202004935 (the corresponding daughter case).  Company comment: A 51-year-old, male patient experienced seizure (seizure like symptoms), dyskinesia, mood altered, muscular weakness, muscle cramps, nausea, headache and fatigue four days after receiving Flucelvax QIV vaccine. The patient had no relevant medical history and was not taking any concomitant medications. More information regarding diagnostic findings is needed. Causality is assessed as possibly related for all events due to plausible chronology and no alternative aetiology provided. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.; Sender's Comments: A 51-year-old, male patient experienced seizure (seizure like symptoms), dyskinesia, mood altered, muscular weakness, muscle cramps, nausea, headache and fatigue four days after receiving Flucelvax QIV vaccine. The patient had no relevant medical history and was not taking any concomitant medications. More information regarding diagnostic findings is needed. Causality is assessed as possibly related for all events due to plausible chronology and no alternative aetiology provided. Brighton Collaboration criteria for generalised tonic-clonic seizure could not be assessed due to insufficient information.
Sex: F
Vaccine: UNK
Symptoms: Adverse event, Chills, Fatigue, Influenza
Clinical narrative: Flu symptoms; Chills; Fatigue; Usual side effects; This spontaneous case was received on 05-Oct-2020 with additional document (being processed together) received on 07-Oct-2020 from other non-health professional (consumer) via agency and concerned a female patient. At the time of this report the patient was 70-year-old.  The patient's medical history and concomitant medications details were not reported.  On unknown dates, for many years (as reported) the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On unknown dates, unknown amount of time after vaccination, the patient developed mild flu symptoms, chills, fatigue and suffer from usual side effects.   The outcome of the events was not reported.  The reporter did not provide causality assessment.  This case is linked with the case 202004938 (same patient).  Company comment: A female patient was administered influenza virus vaccine polyvalent. On unknown dates, unknown amount of time after vaccination, the patient developed influenza, chills, fatigue and adverse event (reported as usual side effects). The patient's medical history and concomitant medications details were not reported. Due to insufficient information regarding temporal relationship and patient's medical history, causality is unassessable for all events.; Sender's Comments: A female patient was administered influenza virus vaccine polyvalent. On unknown dates, unknown amount of time after vaccination, the patient developed influenza, chills, fatigue and adverse event (reported as usual side effects). The patient's medical history and concomitant medications details were not reported. Due to insufficient information regarding temporal relationship and patient's medical history, causality is unassessable for all events.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: PATIENT REPORTED CLASSIC SYMPTOMS OF BRUSITIS - UNABLE TO LIFT LEFT ARM & SHOULDER ABOVE HEAD FOR ABOUT 5-7 DAYS AFTER IMMUNIZATION. HAS BETTER RANGE OF  MOVEMENT NOW BUT STILL SORE AT SHOULDER