chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest discomfort, Dizziness, Nausea, Syncope
Clinical narrative: -Head jerking  -not responding  -confusion  -lost understanding of where and what was happening  - I called for help, while my husband (patient) stood up and started moaning and swearing in pain  -grabbed heart while groaning, ?ahhh my heart?  -technician came out and instructed him to lay on ground and raise legs -said he was dizzy and sick to his stomach  -raised legs for 15 min before deciding to leave and go home - while driving home, he asked me to pull over  -  he vomited in a parking lot  -arrived home, (30 min drive) he went straight to the bathroom said he needed to vomit again  -laid on bedroom floor with feet propped up as instructed  -couldn?t walk much  -by 8:00 pm he was well enough to move locations and crawl in bed  -did not want to walk -fell asleep -woke up the next day feeling fatigued color in face was a little better  -rested more than usual the next day -complained of headache and fatigue
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: -Head jerking  -not responding  -confusion  -lost understanding of where and what was happening  - I called for help, while my husband (patient) stood up and started moaning and swearing in pain  -grabbed heart while groaning, ?ahhh my heart?  -technician came out and instructed him to lay on ground and raise legs -said he was dizzy and sick to his stomach  -raised legs for 15 min before deciding to leave and go home - while driving home, he asked me to pull over  -  he vomited in a parking lot  -arrived home, (30 min drive) he went straight to the bathroom said he needed to vomit again  -laid on bedroom floor with feet propped up as instructed  -couldn?t walk much  -by 8:00 pm he was well enough to move locations and crawl in bed  -did not want to walk -fell asleep -woke up the next day feeling fatigued color in face was a little better  -rested more than usual the next day -complained of headache and fatigue
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Confusional state, Dizziness, Dyskinesia, Fatigue
Clinical narrative: -Head jerking  -not responding  -confusion  -lost understanding of where and what was happening  - I called for help, while my husband (patient) stood up and started moaning and swearing in pain  -grabbed heart while groaning, ?ahhh my heart?  -technician came out and instructed him to lay on ground and raise legs -said he was dizzy and sick to his stomach  -raised legs for 15 min before deciding to leave and go home - while driving home, he asked me to pull over  -  he vomited in a parking lot  -arrived home, (30 min drive) he went straight to the bathroom said he needed to vomit again  -laid on bedroom floor with feet propped up as instructed  -couldn?t walk much  -by 8:00 pm he was well enough to move locations and crawl in bed  -did not want to walk -fell asleep -woke up the next day feeling fatigued color in face was a little better  -rested more than usual the next day -complained of headache and fatigue
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Moaning, Unresponsive to stimuli, Vomiting
Clinical narrative: -Head jerking  -not responding  -confusion  -lost understanding of where and what was happening  - I called for help, while my husband (patient) stood up and started moaning and swearing in pain  -grabbed heart while groaning, ?ahhh my heart?  -technician came out and instructed him to lay on ground and raise legs -said he was dizzy and sick to his stomach  -raised legs for 15 min before deciding to leave and go home - while driving home, he asked me to pull over  -  he vomited in a parking lot  -arrived home, (30 min drive) he went straight to the bathroom said he needed to vomit again  -laid on bedroom floor with feet propped up as instructed  -couldn?t walk much  -by 8:00 pm he was well enough to move locations and crawl in bed  -did not want to walk -fell asleep -woke up the next day feeling fatigued color in face was a little better  -rested more than usual the next day -complained of headache and fatigue
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia
Clinical narrative: 101-102°fever; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The patient was in bed with 101 to 102 degree fever for 3 days after shingrix shot. The patient reported that, he or she should not have listened to the pharmacist and a nurse who said it was fine to get the Shingrix shot one day and flu vaccine the next.  The patient  got the 2nd dose with no ill effects. For tolerance refer linked case US2021AMR202746, same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202746:same patient US-GLAXOSMITHKLINE-US2021AMR202852:same patient
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: administered a pediatric dose instead of a Adult dose; patient vaccinated with an expired dose; administered a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number KC57F, expiry date 16th September 2021) for prophylaxis.   On 28th September 2021, the patient received Engerix B pediatric. On 28th September 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose, expired vaccine used and adult use of a child product. On an unknown date, the outcome of the underdose, expired vaccine used and adult use of a child product were unknown.  Additional details were reported as follows: Nurse reported a female patient vaccinated with an expired pediatric dose of Engerix-B, which got expired on 16th September 2021, which led to expired vaccine used, adult use of a child product and underdose. Health care professional administered a pediatric dose instead of an adult dose of Engerix-B . The reporter consented to follow up.  Health care professional gave consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203772:same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: somewhat of a rash; 100 F temperature; extreme fatigue; pain at arthritis point; This spontaneous case was reported by a patient and describes the occurrence of RASH (somewhat of a rash), PYREXIA (100 F temperature), FATIGUE (extreme fatigue) and ARTHRALGIA (pain at arthritis point) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIAZEPAM (VALIUM) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, ASCORBIC ACID (VITAMIIN C), VITAMIN D NOS, CALCIUM and ZINC for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (somewhat of a rash), PYREXIA (100 F temperature), FATIGUE (extreme fatigue) and ARTHRALGIA (pain at arthritis point). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (somewhat of a rash), PYREXIA (100 F temperature), FATIGUE (extreme fatigue) and ARTHRALGIA (pain at arthritis point) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100 F temperature.         Patient reports that she has a genetic defect called MThfr compound heterozygous. It means sometimes she methylates, or absorb medications very quickly, and there are other times where she absorbs medications very slowly. They are not quite sure what will happen in either situation. Concomitant includes Thyroid medication.      This case was linked to MOD-2021-329852, MOD-2021-329883 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (healthcare worker left a voicemail stating they gave an expired vaccine to a patient) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Sep 25, 2021, patient administered expired product (healthcare worker left a voicemail stating they gave an expired vaccine to a patient). At the time of the report, administered expired product (healthcare worker left a voicemail stating they gave an expired vaccine to a patient) resolved. The reporter did not provide any causality assessments. The  expiration date for the 1st dose: Sep 18, 2021. Date the vial was initially stored in the refrigerator: Friday, Sep 24, 2021. They didn't know how much time the vial was exposed to room temperature, or whether the vial had undergone any temperature excursions. No concomitant medications or treatment information reported. Most recent follow-up information incorporated: On Sep 27, 2021: Follow-up  received on Sep 27, 2021: Reporter information, vaccine start date, event date and details updated.
Age: 90.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death, Localised infection
Clinical narrative: Deceased; Toe infection; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Deceased) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) capsule for Prostate cancer.    Concurrent medical conditions included Prostate cancer (Received enzalutamide).   On 24-Sep-2020, the patient started ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) (Oral) 160 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2020, the patient experienced LOCALISED INFECTION (Toe infection). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOCALISED INFECTION (Toe infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection. The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Sender's Comments: This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection.  The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Reported Cause(s) of Death: Deceased
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: gotten sicker; Initial information received on 27-Sep-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non healthcare professional.  This case involves a patient (unknown age and gender) who had gotten sicker (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past 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 INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had gotten sicker (illness, non-serious) (unknown latency) following the administration of vaccine.  It was reported "I didn't think the flu existed anymore. No one seemed to get it last year. Only Covid. So weird. I don't get the flu shot. Every time I have, I've gotten sicker than a dog. Stopped about 10 years ago despite teaching and being around all the germs. And seriously flu was down 99% last year."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant patient was administered Menactra, with no reported adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 25 year old female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] during pregnancy (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The pregnant patient was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], and was exposed to MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE during first pregnancy trimester.  The date of last menstrual period was reported as 27-Jul-2020.  The estimated due date was 17-Mar-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 24-Sep-2020, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: 46952AA; expiry date: 09-Jul-2022; form: Solution for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency same day).  No adverse events were reported at the time of this report.  The outcome of the reported event was unknown.  At time of reporting, the outcome of the pregnancy was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sick; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious received from a consumer/non-healthcare professional.  This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past 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 INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) [unknown latency] following the administration of vaccine.  It was reported "Had a flu shot 30 years ago. Sick for about a year. Had the flu ONCE about 25 years ago. Never had it since nor do I take the vaccine. My immune system has done me well."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.   It was not reported if the patient received a corrective treatment.   At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: get a flu shot twice. Both years I caught the flu a few months later.; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involved an unknown age and gender patient who experienced get a flu shot twice both years i caught the flu a few months later (influenza) while receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious caught the flu (influenza) few months later get a flu shot twice both years following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Hard pass! I wish you'd stick to your old content that was just fun and funny."  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, 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: No adverse event, Product administration error
Clinical narrative: person who gave the shot gave it way too high with no adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from via other health professional (under reference number: US-SA-SAC20211001000464).  This case involves Adult and unknown gender patient who was administered  INFLUENZA VACCINE (product administration error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   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.  It is unknown if the patient experienced any additional symptoms/ event.   It is unknown if there were lab data/results available.  It was case of an actual medication error due to product administration error (latency: same day).  At the time of reporting, no adverse event was reported.  There will be no further information on the lot number for this case.  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 the 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: FLUR4
Symptoms: Back pain, Burning sensation, Cough, Gait disturbance, Herpes zoster
Clinical narrative: shingles on her face/ shingles spreading to her eye.; runny nose; cough; 10 pustules on her forehead and they are crusting over; could hardly walk or move" and could barley do her PT exercises.; severe pain; burning" in her back, and down her right leg to the top of her ankle/ felt like her body was on fire/felt like her body was "inflamed"; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00632994).  This case involves a 66-year-old female patient who experienced severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation), shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough, 10 pustules on her forehead and they are crusting over (pustule) and could hardly walk or move and could barley do her pt exercises (gait disturbance) after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, vaccinations, concomitant medication and family history were not provided. Patient has had a knee surgery in the past without further detail.  On 13-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 15-SEP-2021 the patient developed a non-serious severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation) and could hardly walk or move and could barley do her pt exercises (gait disturbance) 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 19-SEP-2021 the patient developed a non-serious shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough and 10 pustules on her forehead and they are crusting over (pustule) 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "She went to her regularly scheduled physical therapy appointment (she is post-knee surgery)."  Laboratory details were not reported.  An anti-viral oral medication and eye drops was received for the events (herpes zoster) as a treatment.  It was not reported if the patient received a corrective treatment for the events (Pain, burning sensation, back pain and pain in extremity, rhinorrhoea, cough, pustule, inflammation and gait disturbance).   On an unknown date, the patient recovered from rhinorrhoea.  At the time of this report, outcome of the event cough was not recovered.  The event outcome was unknown for the other events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Inflammation, Mobility decreased, Ophthalmic herpes zoster, Pain, Pain in extremity
Clinical narrative: shingles on her face/ shingles spreading to her eye.; runny nose; cough; 10 pustules on her forehead and they are crusting over; could hardly walk or move" and could barley do her PT exercises.; severe pain; burning" in her back, and down her right leg to the top of her ankle/ felt like her body was on fire/felt like her body was "inflamed"; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00632994).  This case involves a 66-year-old female patient who experienced severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation), shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough, 10 pustules on her forehead and they are crusting over (pustule) and could hardly walk or move and could barley do her pt exercises (gait disturbance) after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, vaccinations, concomitant medication and family history were not provided. Patient has had a knee surgery in the past without further detail.  On 13-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 15-SEP-2021 the patient developed a non-serious severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation) and could hardly walk or move and could barley do her pt exercises (gait disturbance) 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 19-SEP-2021 the patient developed a non-serious shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough and 10 pustules on her forehead and they are crusting over (pustule) 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "She went to her regularly scheduled physical therapy appointment (she is post-knee surgery)."  Laboratory details were not reported.  An anti-viral oral medication and eye drops was received for the events (herpes zoster) as a treatment.  It was not reported if the patient received a corrective treatment for the events (Pain, burning sensation, back pain and pain in extremity, rhinorrhoea, cough, pustule, inflammation and gait disturbance).   On an unknown date, the patient recovered from rhinorrhoea.  At the time of this report, outcome of the event cough was not recovered.  The event outcome was unknown for the other events.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Pustule, Rhinorrhoea
Clinical narrative: shingles on her face/ shingles spreading to her eye.; runny nose; cough; 10 pustules on her forehead and they are crusting over; could hardly walk or move" and could barley do her PT exercises.; severe pain; burning" in her back, and down her right leg to the top of her ankle/ felt like her body was on fire/felt like her body was "inflamed"; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00632994).  This case involves a 66-year-old female patient who experienced severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation), shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough, 10 pustules on her forehead and they are crusting over (pustule) and could hardly walk or move and could barley do her pt exercises (gait disturbance) after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, vaccinations, concomitant medication and family history were not provided. Patient has had a knee surgery in the past without further detail.  On 13-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  On 15-SEP-2021 the patient developed a non-serious severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation) and could hardly walk or move and could barley do her pt exercises (gait disturbance) 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On 19-SEP-2021 the patient developed a non-serious shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough and 10 pustules on her forehead and they are crusting over (pustule) 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "She went to her regularly scheduled physical therapy appointment (she is post-knee surgery)."  Laboratory details were not reported.  An anti-viral oral medication and eye drops was received for the events (herpes zoster) as a treatment.  It was not reported if the patient received a corrective treatment for the events (Pain, burning sensation, back pain and pain in extremity, rhinorrhoea, cough, pustule, inflammation and gait disturbance).   On an unknown date, the patient recovered from rhinorrhoea.  At the time of this report, outcome of the event cough was not recovered.  The event outcome was unknown for the other events.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A two month old patient accidentally received two injections of Fluzone QIV NP that were intended for family members instead of 2 month vaccine, no AE; A two month old patient accidentally received two injections of Fluzone QIV NP that were intended for family members instead of 2 month vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via consumer/non-health care professional via Agency (Reference number- 00786864) and transmitted to Sanofi on 27-Sep-2021.  This case involves a 2 month old male patient who accidentally received two injections of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that were intended for family members instead of 2 month vaccine (Wrong product administered and Product administered to patient of inappropriate age)  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 27-Sep-2021, the patient received a 0.5 ml (dose 1 and 2) of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7325LA, expiry date: 30-Jun-2022, Solution for injection in pre-filled syringe) via intramuscular route in the left thigh for prophylactic vaccination twice.  It was a case of an actual medication error due to Wrong product administered and Inappropriate age at vaccine administration (latency same day).  It was reported "Doctor states that a two-month-old patient accidentally received two injections of FLUZONE QIV NP (no preservative) that were intended for his family members instead of his 2 month vaccines that were scheduled on 27SEP2021. Doctor asked if there was any information regarding FLUZONE QIV NP in patients of this age and also asked if she should report this to the Vaccine Adverse Event Reporting System (VAERS) as well. Doctor asked if she should hold off on the patient's intended vaccinations so that it could be determined if the FLUZONE QIV NP were responsible if the patient developed any adverse events. Doctor states that patient is still in her office and has not experienced any adverse events thus far"  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Extra dose administered, Medication error, Wrong product administered
Clinical narrative: inadvertently received a two dose of FLUZONE QUADRIVALENT vaccines instead of PENTACEL (VERO) with no adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a physician and non-healthcare professional via Medical information (under reference number - 00786957).  This case involves a patient of (unknown demographics) who inadvertently received a two dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] vaccines instead of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (extra dose administered).  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment, vaccination, family history and concomitant medications were not reported.  On 27-Sep-2021, the patient received a two dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of actual medication error due to extra dose administered.  At the time of report, no adverse event was reported.  There were no laboratory data/results available.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: U
Vaccine: DTAP
Symptoms: Product dose omission issue
Clinical narrative: patient never received the 5th dose, with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and consumer/ non-healthcare professional via Media Information (under reference 00787054).   This case involves a 7 years old patient (unknown gender) who never received the 5th dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [product dose omission issue].  The patient had received DAPTACEL for the first four dose in the past.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DAPTACEL (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Missed dose (same day latency).  It was reported "Is it okay to give them ADACEL for the 5th dose? A clinic wanting to know how to help get a consumer caught up due to having a 7-year old that has not gotten their 5th dose of DAPTACEL. The caller reported that the last dose of DAPTACEL was at the age of 4-years-old."  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. 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 lot number for this case.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired polio vaccine that was given, of the 10 patients we gave this lot, 6 had this expiration date charted as 7/20/15, others had an expiration of 3/28/15 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number-00788547) and transmitted to Sanofi on 24-Sep-2021.  This case involves six patients of unknown demographics to whom an expired IPV (VERO) [IPOL] was given, of the 10 patients that were given this lot, 6 had this expiration date charted as 7/20/15, others had an expiration of 3/28/15 (expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history of the patients were not provided.  Concomitant medications were not reported.  On an unknown date, six patients received a dose of suspect IPV (VERO) (lot number: J1406; expiry date: 20-Jul-2015) via unknown route in unknown administration site for prophylactic vaccination.  It was the case of actual medication error due to expired vaccine used (latency: same day).  It was reported "I have a random question. We received a call from a school nurse about and expired polio vaccine that was given here. Our records show it expired 7/20/15. Can you verify when the lot # J1406 of IPV expired? Of the 10 patients we gave this lot # to, 6 had this expiration date charted. Others had an expiration of 3/28/15."  No adverse events were reported at the time of this report.  The outcome of the event was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 58.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered Fluzone High Dose to a patient who is 58 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 58 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer or non-health professional via Information (Reference number: 00789359) and transmitted to Sanofi on 28-Sep-2021.  This case involved a 58-year-old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported. [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, strength: 0.5 mL, lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter ''pharmacist states that the patient administered FLUZONE HIGH DOSE to a patient who was 58 years old. Pharmacist asks if this was okay and if it would cause any problems. Pharmacist states the patient did not have time to complete an adverse event or safety report at time of call. Pharmacist was given case reference number; stated the patient would try to call back to complete adverse event or safety report at a better time.''  no other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had 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: F
Vaccine: FLU4
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: chills; low grade fever; cough; aches; Initial information regarding an unsolicited valid non-serious case from the Agency (Reference number- 00790611) was received from a consumer and transmitted to Sanofi on 29-Sep-2021.  This case involved a 71-year-old female patient who experienced chills, low grade fever (pyrexia), cough and aches (pain) while receiving 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.   On 23-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ716AA (expiry date not provided) via intramuscular route in the left deltoid.  On 23-SEP-2021 the patient developed a non-serious chills, low grade fever (pyrexia), cough and aches (pain) following the administration of vaccine.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was resolved for the event chills, low grade fever, and pain and was not resolved for the event cough.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Patient was administered an expired dose of FLUZONE QIV from last year with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Agency (Reference number- 00791011) and transmitted to Sanofi on 29-Sep-2021.  This case involved an unknown age and gender patient was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from last year (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date in September 2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: not reported and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported "Pharmacy student calling for information regarding the FLUZONE QIV and the caller would like to know if the patient requires revaccination? Caller does not have information on the patient of the event. Caller was unable to provide a lot number, but was able to provide an expiration date for the product".  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUZONE QUADRIVALENT vaccine that was given in error with No reported adverse event; Initial information regarding an unsolicited valid non-serious case from United states was received from other health professional via call centre General medical inquiry inbound (reference number-00791319) and transmitted to Sanofi on 29-Sep-2021.  This case involved a 67-year old female patient when received fluzone quadrivalent vaccine that was given in error with no reported adverse event (Wrong product administered) while receiving vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] and influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing immunosuppression.  On 28-Sep-2021, the patient received a 0.5 ml of suspect influenza quadrival a-b vaccine (lot number not reported and expiry date-30-Jun-2022) via intramuscular route in the deltoid not otherwise specified for prophylactic vaccination.  On an unknown date, the patient received an of suspect influenza quadrival a-b high dose hv vaccine (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 28-Sep-2021, 1 day following the administration of influenza quadrival a-b vaccine the patient developed a non-serious event "fluzone quadrivalent vaccine that was given in error with no reported adverse event" (Wrong product administered).  It was reported "HCP (health care professional) states that a patient, over 65, who is immunosuppressed, requested a fluzone high dose quadrivalent vaccine, however the HCP accidentally pulled the flu vaccine from the wrong box and gave the fluzone quadrivalent vaccine instead. The HCP asks if she can give the patient a fluzone high dose quadrivalent vaccine in addition to the fluzone quadrivalent vaccine since she is over 65 and is immunosuppressed".  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event wrong product administered.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.  No further information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Pain, Pruritus, Rash
Clinical narrative: Moderna COVID-19 Vaccine  Rash developed around 7-9 days after shot. Extends from torso to arms and legs, around a pimple/square inch. Some painful, many itchy. Prescribed triamcinolone 0.1% cream - not effective. Antihistamines, standard dose - somewhat helpful. No overall reduction in symptoms at time of reporting (10/4/2021).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fatigue
Clinical narrative: fatigue then death
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram thorax abnormal, Echocardiogram, Pulmonary embolism, Sinus tachycardia
Clinical narrative: Developed three pulmonary embolisms and sinus tachycardia