chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm r a little sore; had a fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The patient took the 2nd shot for shingles in right arm, little sore and had a fever. The patient asked how long should it last.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis, Product administered to patient of inappropriate age
Clinical narrative: developed bells palsy.; in their late 40s received shingrix; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the bell's palsy and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, the patient in 40's received dose of Shingrix, which led to inappropriate age at vaccine administration. The reporter stated hat, about 1 year ago the patient received Shingrix and had bell's palsy.
Sex: F
Vaccine: RAB
Symptoms: Malaise, Product administered at inappropriate site
Clinical narrative: Did not feel well; Receiving Rabavert in her tendon rather than deltoid; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Rabavert with an associated reaction of therapeutic response decreased (for tolerance to the past dose, refer case US2020AMR232591). Concurrent medical conditions included animal bite (possible bat bite). Concomitant products included Rabies NVS (RabAvert).   On 9th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 9th November 2020, less than a day after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced feeling unwell and vaccine administered at inappropriate site. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   Additional details were provided as follows: The age at the vaccination was not reported. The patient received RabAvert was post exposure prophylaxis. Possible bat bite on 28th October 2020. The patient received  Rabavert in her tendon rather than deltoid and said she did not feel well afterwards, which led to vaccine administered at inappropriate site. The nurse said there was no blood after the shot. It took 30 minutes for the nurse to get the doctor's signature. Once she got the vaccine the patient thought she should start feeling bad, like it could mimic rabies, but was still feeling well. The reporter declined to provide contact information and further details for adverse event report.  It was unknown if the reporter considered the feeling unwell to be related to RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232591:same patient
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Renal failure
Clinical narrative: high temperature; Renal Failure; This case was reported by a physician via call center representative and described the occurrence of renal failure in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   On 12th November 2020, the patient received Shingrix (intramuscular). In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced renal failure (serious criteria GSK medically significant) and fever. In November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the renal failure was unknown.   It was unknown if the reporter considered the renal failure and fever to be related to Shingrix.  Additional details were received as follows: The age at onset could be 62 or 63 year old. The patient had renal failure and high temperature post dose 2 of Shingrix. The patient went to the hospital on 24th November 2020. The fever resolved. The patient was in the Doctors office today 25th November 2020 (date of report) still searching for questions about the renal failure The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the third dose of RECOMBIVAX HB 4 days early; No adverse effect reported; This spontaneous report has been received from a consumer referring to herself as a female patient of an unspecified age. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not provided.   On an unknown date, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, formulation, vaccination scheme frequency, route of administration were not provided; lot number and expiration date were unknown by the reporter).   It was stated that on an unspecified date, the patient reported that she received the third dose of vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 4 days early (inappropriate schedule of product administration). No adverse effect was reported.  Follow up information has been received from the consumer on 16-NOV-2020.  The patient historical vaccine included an unspecified hepatitis B vaccine, which never worked and she was never immune.  The patient stated that she received six doses (reported as "shots") of an unspecified hepatitis B vaccine, but did not disclose which one it was. The reporter additionally stated that the doctor switched her to the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route of administration, lot number and expiration date continued reported as unknown), and received three shots that worked for her. The patient also reported that later after nine shots of the unspecified hepatitis B vaccine and hepatitis b vaccine (recombinant) (RECOMBIVAX HB), she was finally immune to Hepatitis B.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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 an unknown route at an 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.  It was reported as the patient quit taking the shots after retirement. At least for 10 years later got the flu, hence started taking shots without getting the flu because of new and improved vaccine  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise, Vaccination complication
Clinical narrative: sick; got a reaction to it; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was sick (illness) and got a reaction to it (vaccination complication), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) and got a reaction to vaccine (vaccination complication) (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE.  It was reported that the patient was so sick that couldn't even go to Thanksgiving dinner. So the patient will not pass this year.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the lot number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: can get an awful bad cold.; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a male patient who experienced awful bad cold (nasopharyngitis), while he received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient developed a non-serious awful bad cold (nasopharyngitis), (unknown latency) following the administration of INFLUENZA VACCINE. The intensity was severe for the event.  Laboratory data was not reported.   It was not reported if the patients 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: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Every time I get a shot I get sick within a week; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient with unknown demography who got sick within a week (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick within a week (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patients 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: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Every year received flu shot and was so soo sick; Initial information was received on 16-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case is linked to case 2020SA302659.  This case involves a patient with unknown demography who was soo sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient who was soo sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patients 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: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Based on information received on 23-Nov-2020, the report previously considered as non-valid became valid: [suspect vaccine clearly identified follow-up].  Initial information received on 24-Oct-2020 regarding an unsolicited non-valid serious case received from a consumer (patient) via social media.  This case involves male patient (unknown age) who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE. Medical history, medical treatment, vaccination, 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 expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on the batch number was requested.  Follow-up information received on 23-Nov-2020 regarding an unsolicited non-valid serious case received from a consumer (patient) via social media.  Suspect was updated.; Sender's Comments: Follow-up information was received on 23-Nov-2020 changes the previous assessment of the case: This case involves a male patient of an unknown age who had influenza, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. However, patient's medical condition at time of vaccination, received concomitant medication, laboratory data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got sick; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient (age not reported) who got sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, 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 and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  The patient developed a non-serious got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not known if patient received any treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUR4
Symptoms: Erythema, Swelling
Clinical narrative: redness; swelling; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer via sales representative.  This case involves a patient of unknown age who experienced redness (erythema) and swelling, when received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [batch number and expiration date not reported] via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced redness (erythema) and swelling unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovered from both the events on an unknown date.  There will be no information available regarding batch number in this case.
Sex: F
Vaccine: FLUR4
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on left side of neck; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or nurse.  This case involves a female patient (unknown age) who experienced swollen lymph node on left side of neck (lymphadenopathy), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in the right arm for prophylactic vaccination.  On 21-Oct-2020, the patient developed non-serious swollen lymph node on left side of neck (lymphadenopathy) 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT 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: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to get FLUZONE HIGH-DOSE QUADRIVALENT but got FLUBLOK QIV/No AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient's daughter) via call center via Medical Information (Reference number- 00356636) and transmitted to Sanofi on 12-Nov-2020.  This case is linked to case 2020SA322320 (same reporter).  This case involves an 87 years old female patient who supposed to get INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] but got INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: QFAA2054 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination [wrong product administered].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered (latency: at the time of vaccination).  At the time of report no adverse event was reported.  Caller asked is there any booster available.  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.
Sex: M
Vaccine: FLUR4
Symptoms: Allergy to vaccine, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: received Flublok quadrivalent in years past and it "makes him feel like he has the flu; severe allergies to vaccine; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (patient) via phone at call center agency inquiry (reference number: 00360035). Related case ID for TUBERSOL was not found.   This case involved a male patient of an unknown age who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in years past and it made him feel like he had the flu (Influenza like illness) and developed severe allergies (Allergy to vaccine).  Medical history, medical treatment(s), vaccination(s), family history and concomitant medication(s) were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that the vaccine made patient feel like he had the flu (Influenza like illness). On an unknown date,, unknown latency, the patient also enquired if the vaccine contained corn or corn derivatives or sulfa due to severe allergies (Allergy to vaccine).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the both adverse events was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: flu that has turned into pneumonia; patient had flu after taking flu shot; Initial information was received on 21-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case involves a male patient (age unspecified) who experienced flu that had turned into pneumonia (influenza), (pneumonia), after he received INFLUENZA VACCINE.  The patient's past vaccination included influenza vaccine as prophylactic vaccination.  The patient's medical history, past medical treatments, concomitant therapy, 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 flu that had turned into pneumonia (influenza), (pneumonia) (Unknown latency) following the administration of INFLUENZA VACCINE. Event pneumonia was assessed as medically significant.  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 events were unknown.  There will be no information available on lot number for this case.; Sender's Comments: This case involves a male patient (age unspecified) who experienced influenza and pneumonia after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: get the flu; Initial information was received on 25-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer (Patient).  This case involves patient of unknown demographics who got flu (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, 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 expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got flu (influenza) every time unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.      It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was never so sick; Initial information was received on 25-Nov-2020 regarding an unsolicited valid non-serious case received from the patient.  This case involved a male patient of unknown age who was never so sick (malaise) in his life, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   The patient was ok till sitting in the hospital for vaccination.   On an unknown date (some years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient was sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, it was 10 weeks before had strength and felt like himself again and was debating to get this vaccine in 2020.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: died from flu shot; Initial information received on 28-Nov-2020 regarding an unsolicited valid serious case received from a consumer/ non- healthcare professional via social media.  This case involves a female patient (unknown age) who died (death) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), family history and concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was also reported that just follow good hygiene, common sense and reporter haven't had the flu for a long time.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  Date of death was not reported. It was unknown at the time of reporting if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: A case was reported from social media, which involved a female patient of an unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset was unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination, concomitant medication and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: died from flu shot
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu within hours of shot both times; Initial information was received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer (Patient).  This case involves patient of unknown demographics who got flu within hours of shot both times (influenza), while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, 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 expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu both times (influenza) (within hours) following the administration of INFLUENZA VACCINE.  It was reported that, patient take flu shot twice.   Details of laboratory data not reported.      It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 yrs old child was by mistake given FluBlok /no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via Medical Information (MI) (Reference number- 00332565) and transmitted to Sanofi on 26-Oct-2020.  This case involved a 4 year old female patient who by mistake received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (frequency- once, standard dose, batch number-UJ448AB, UJ448A expiration date- 22-Mar-2021) via intramuscular route at right deltoid for prophylactic vaccination on 26-Oct-2020 (Product administered to patient of inappropriate age)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Patient did not received any concomitant vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency- same day).  No adverse event was reported.  Reporter asked about expected reaction and if any death was reported due to this error.  Disclaimer- 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 Disclaimer: 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: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Extraocular muscle disorder, Eye pain, Malaise
Clinical narrative: eyes crossed/muscles in eyes are stiff; hideous eye pain; loss of balance; dizzy and keeps falling over side ways and is off balance because she is cross eyed; patient is sick even now; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 84 years old female patient who developed eyes crossed/muscles in eyes are stiff (Strabismus), hideous eye pain (Eye pain), loss of balance (Balance disorder), dizzy and keeps falling over side ways and is off balance because she is cross eyed (Dizziness )and patient is sick even now (Malaise), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].    The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included vitamins. Patient said she only takes vitamins and no other medications and is very healthy otherwise.     On 25-Sep-2020, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiration date unknown] via unknown route in the left arm for prophylactic vaccination.  On 19-OCT-2020 (latency 24 days) after administration of suspect the patient had developed eyes crossed/muscles in eyes are stiff (Strabismus), hideous eye pain (Eye pain), loss of balance (Balance disorder), dizzy and keeps falling over side ways and is off balance because she is cross eyed (Dizziness )and patient is sick even now (Malaise).  Patient said the paper that the pharmacy gave her says that Fluzone HD can cause motor problems and trouble controlling body movements and vision changes. Patient said the muscles in her eyes are stiff. Caller was very agitated and she said she is exasperated by all this and did not wish to provide more information.    Patient said she will never take this vaccine again.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.   At the time of reporting, outcome was not recovered for all the events.  There will be no information available on the batch number for this case.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Strabismus
Clinical narrative: eyes crossed/muscles in eyes are stiff; hideous eye pain; loss of balance; dizzy and keeps falling over side ways and is off balance because she is cross eyed; patient is sick even now; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 84 years old female patient who developed eyes crossed/muscles in eyes are stiff (Strabismus), hideous eye pain (Eye pain), loss of balance (Balance disorder), dizzy and keeps falling over side ways and is off balance because she is cross eyed (Dizziness )and patient is sick even now (Malaise), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].    The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included vitamins. Patient said she only takes vitamins and no other medications and is very healthy otherwise.     On 25-Sep-2020, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiration date unknown] via unknown route in the left arm for prophylactic vaccination.  On 19-OCT-2020 (latency 24 days) after administration of suspect the patient had developed eyes crossed/muscles in eyes are stiff (Strabismus), hideous eye pain (Eye pain), loss of balance (Balance disorder), dizzy and keeps falling over side ways and is off balance because she is cross eyed (Dizziness )and patient is sick even now (Malaise).  Patient said the paper that the pharmacy gave her says that Fluzone HD can cause motor problems and trouble controlling body movements and vision changes. Patient said the muscles in her eyes are stiff. Caller was very agitated and she said she is exasperated by all this and did not wish to provide more information.    Patient said she will never take this vaccine again.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.   At the time of reporting, outcome was not recovered for all the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Product quality issue
Clinical narrative: the vaccine was very hard to draw/no AE; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involved adult patient for whom the vaccine was very hard to draw/no ae (Product quality issue) was reported, while patient received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number- UJ355AA and expiration date- 24-Jul-2021) via unknown route at unknown administration site.  On an unknown date, the vaccine was very hard to draw/no ae (Product quality issue) was reported for the patient.  At the time of reporting no adverse event was reported.  No relevant laboratory data was reported.    It was not reported if the patient received a corrective treatment.  The event outcome was not applicable at the time of reporting.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient got FluBlok on 01Oct2020 and by mistake a 2nd dose of FluBlok on 09Oct2020 with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via the agency (Reference number- 00353266) and transmitted to Sanofi on 10-Nov-2020.  This case is linked to case 2020SA317927 (same reporter) (male patient).  This case involves a 59 years old female patient who got  first dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on 01-Oct-2020 (lot number and expiration date was not reported) and by mistake got the 0.5 mL second dose of same vaccine (lot QFAA2009 and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid (extra dose administered) on 09-Oct-2020.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to extra dose administered (latency on the 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 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.  There will be no information on the batch number for this case.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: accidentally given a Pentacel and an ActHIB vaccine on the same day with no adverse event; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case from  a other health professional.  This case is linked to case 2020SA317690.  This case involves a 1 years old male patient who experienced accidentally given a pentacel and an acthib vaccine on the same day (extra dose administered), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not provided.  On 10-Nov-2020, the patient received a 4  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ160AAA via intramuscular route in the left thigh for prophylactic vaccination.  On 10-Nov-2020, the patient developed a non-serious accidentally given a pentacel and an acthib vaccine on the same day (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE..  No laboratory data was provided.  No corrective treatment was received.  The event outcome was reported as not applicable for extra dose administered, 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 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: 36.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: TENIVAC was administered to 36 year old pregnant women/ NO AE; patient received TENIVAC instead of prescribed ADACEL/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency via call-center (Reference number- 00359588) and transmitted to Sanofi on 16-Nov-2020.  This case involves a 36-years-old female patient who received once 0.5 mL DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (strength: standard, batch number: U6603AA, expiry date: 05-Mar-2022 via an intramuscular route at an unknown administration site) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date not reported) (wrong product administered) on 02-Nov-2020 for prophylactic vaccination while she was pregnant (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported.  The estimated due date was not reported.  The medical history, medical treatment, vaccination and family history were not provided.  No other concomitant vaccines were used.   It was the case of actual medication error due to wrong vaccine administered and also involve vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received TENIVAC vaccine.  No adverse effects reported so far.  Pregnancy outcome was unknown at the time of report.   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: FLU4
Symptoms: Vasculitis
Clinical narrative: severe reaction (vasculitis); Initial information received on 20-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via call center.  This case involves female patient (unknown age) who experienced severe reaction (vasculitis), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious severe reaction (vasculitis) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient wanted to know if FLUBLOK is a better alternative.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the event vasculitis.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves female patient (unknown age) who presented with vasculitis, after vaccination with  FLUZONE QUADRIVALENT. Time to onset is unknown. Moreover, concomitant medication, family history, patient medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Horrible flu; This spontaneous case retrieved on 24-Nov-2020 from Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 885811-1), reported by other non-health professional (consumer) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for prophylaxis. The batch number was not reported.  On an unknown date, less than a year after receiving influenza virus vaccine polyvalent, the patient got a horrible flu.  The outcome of the event was unknown.  The reporter did not provide a causality assessment influenza virus vaccine polyvalent.  The event of 'flu' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment:The patient developed influenza unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.; Sender's Comments: The patient developed influenza unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: 100.3 fever, headache, moderate arm pain,  fatigue
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Woke up with chills, muscle pain, slight fever.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Full blood count, Laboratory test, Metabolic function test, Platelet count
Clinical narrative: Oct 8 in the morning I noticed tiny red dots all over her arms,legs, face, and feet. She also had MULTIPLE bruises on her legs, hips, arms and I know she had not been injured
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash macular
Clinical narrative: Oct 8 in the morning I noticed tiny red dots all over her arms,legs, face, and feet. She also had MULTIPLE bruises on her legs, hips, arms and I know she had not been injured
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain
Clinical narrative: Patient reports having a bruise and soreness after over a month has passed. No signs of infection.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: very sore arm, extreme swelling and redness  in hand; patient says it "looks like a lobster"; advised patient to contact physician