chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Adenovirus test, Blood culture, Blood thyroid stimulating hormone, Borrelia test, Brain natriuretic peptide increased
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest X-ray abnormal, Chest pain, Cough, Coxsackie virus test
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Echocardiogram normal, Electrocardiogram ST segment elevation, Enterovirus test, Epstein-Barr virus antibody
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test negative, Painful respiration, Parvovirus B19 test, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test negative, Respiratory tract congestion, Respiratory viral panel, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Thyroxine free, Troponin I increased, Urine analysis, Vomiting
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: received pfizer 2nd vaccine at PCP office on 1/19/2022. The following day (1/20/2022), developed fever (t max 102) and then progressively worsening chest pain on 1/21/2022. Chest pain worse when breathing and not with palpitation (6/10 severity). +cough, +rhinorrhea, +congestion. +emesis. With motrin given for fever, there was improvement, but the chest pain persisted which prompted ED evaluation 1/21/2022. tylenol given in ED with no improvement in chest pain.
Age: 76.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site reaction, Pain in extremity, X-ray normal
Clinical narrative: patient called pharmacy and reported a severe site reaction, she can not move her arm and the arm is very soar. patient went to doctor and did x-ray but not damage was showing in the x-ray. patient said that she had tried topical cream to relieve the pain but no success.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got extremely sick; Initial information received on 10-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who got extremely sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for  prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got extremely sick" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Got a flu shot one time in my life and got extremely sick. So no I won't be doing that again."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got extremely sick).  At time of reporting, the outcome was Unknown for the event got extremely sick.
Age: 22.0
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: son experiencing seizures after DTP vaccine series; Initial information received on 31-Dec-2021 regarding an unsolicited valid serious courtesy case received from a consumer/non-hcp.  This case involves a 22 years old male patient who reported son experiencing seizures after dtp(Diphtheria, Tetanus And Acellular Pertussis Vaccine).  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect Diphtheria, Tetanus and Acellular Pertussis Vaccine produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date were unknown) for prophylactic vaccination.  It was reported that patient had seizures after dtp vaccine series (seizure, onset and latency was unknown). This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   Outcome: unknown  Reporter causality: related; Sender's Comments: Sanofi company comment dated 31-Dec-2021: This case concerns 22 years old male patient who had seizures after Diphtheria, Tetanus And Acellular Pertussis Vaccine (produced by unknown manufacturer). The time to onset is not reported with the role of the vaccine. Further information regarding medically history, concurrent condition during vaccination, previous vaccination, concomitant medication 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: Malaise
Clinical narrative: always got sick after shot; Initial information received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp from.  This case involves an unknown age and unknown gender patient who always got sick after shot while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, (strength, formulation, dose, frequency, route and  lot number:  not reported) in unknown administration site for prophylactic vaccination (flu).   On an unknown date the patient developed a non-serious event of "always got sick after shot"  (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Always got sick after shot for 2 wks felt fine before because of my age was told I needed too No more I try to do what's right to stay healthy ."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (always got sick after shot).  At time of reporting, the outcome was recovered for the event always got sick after shot.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got flu; Initial information was received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), 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 (formulation, dosage, strength, lot number and expiration date: unknown) via unknown route in unknown administration site as prophylactic vaccination. There will be no information available on the batch number for this case.  On an unknown date the patient developed a non-serious event "got flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "Reported Adverse Event Information: The case received from Social media Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I got the flu shot and got flu. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got flu).  At time of reporting, the outcome was Unknown for the event got flu.
Sex: F
Vaccine: FLUR4
Symptoms: Muscle atrophy
Clinical narrative: muscle atrophy; Initial information received on 12-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced muscle atrophy ,while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (dose, formulation, lot number not reported via unknown route in arm)  as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event " muscle atrophy" (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported"I have a question with regards to a potential event that I would like to discuss and potential report if it falls into this category. My wife went to the doctor yesterday about an issue with her arm. The doctor said it was likely caused by the way the a vaccine was administrated. The last vaccine she received was Flublok and they said it was given to high in her arm and has caused muscle atrophy. She was given the vaccine at a sanofi clinic. She also received covid vaccines but that was before she received her flu shot and the doctor said if it was administered where the atrophy occurred it was given way to high and was the cause. I would like to talk through this as I am not sure it qualifies or not but I wanted to report it once becoming aware and I also have a few other questions."  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (muscle atrophy).  At time of reporting, the outcome was Unknown for the event muscle atrophy.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got sick every year; Initial information was received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who got sick every year after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), 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 (dosage, formulation, strength, lot number and expiration date: Unknown) via unknown route in unknown administration site as prophylactic vaccination. There will be no information available on the batch number for this case.  On an unknown date the patient developed a non-serious event "got sick every year" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Reported Adverse Event Information: The case received from Social media Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I used to get a flu shot every year and I got sick every year. I stopped getting the shot and never got sick again. Take Ivermectin. It cures Covid and the Flu. Oh, and so does HCQ (Hydroxychlororquine). Oh, but the vaccine companies don't make billions off of vaccines if people take therapeutics to cure them, right? "  It is unknown if there were lab data/results available  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick every year).  At time of reporting, the outcome was Unknown for the event got sick every year.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got sick; Initial information was received on 13-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown demographics patient who got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), 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 (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "got sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "patient used to get free flu shots at work and got sick anyway. So patient had stopped."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
Sex: F
Vaccine: FLUX
Symptoms: Death, Illness, Malaise
Clinical narrative: got sick and two months later she was gone; Initial information received on 13-Jan-2022 regarding an unsolicited valid serious case was received from a consumer via social media.  This case involves a 96 years old female patient who got sick and two months later she was gone while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Respiratory disorder.   On an unknown date the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick and two months later she was gone (sickness) (unknown latency) following the administration of INFLUENZA VACCINE.  "It was reported that the patient got respiratory problems, they talked her into getting it anyways , we both got sick and two months later she was gone."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick and two months later she was gone).  At time of reporting, the outcome was Unknown for the event "got sick and two months later she was gone ".; Sender's Comments: Sanofi Company Comment dated 19-Jan-2022:  This case involves a 96 years old female patient who got sick and two months later she died. Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.; Reported Cause(s) of Death: got sick and two months later she was gone
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 13-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown demographics patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2005, (17 years ago) the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (flu).  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "The only time I ever got the flu was a few days after the one time I was forced to get the flu shot if I wanted a job at a school for a year. After getting the flu vaccine I got the flu. That was about 17 years ago. The only time I've ever had the flu on the forty-four years I've been Macrobiotic and vegan since 1978 and I don't think I ever had the flu as a kid either. My parents got the flu shot every year and then got the flu shortly after getting the vaccine."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: Every time I get a flu shot I get the flu; Initial information received  from on 13-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via digital media.  This case involves patient of unknown demographics who reported every time he/she get a flu shot he/she get the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation,route administration site, frequency, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event " every time i get a flu shot i get the flu "(influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Every time I get a flu shot I get the flu).  At time of reporting, the outcome was Unknown for the event every time i get a flu shot i get the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu virus; Initial information was received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown demographics patient who experienced flu virus while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2008 (14 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  In 2008 the patient developed a non-serious event "flu virus" (influenza) (latency: 3 months) following the administration of INFLUENZA VACCINE.  It was reported " I once got the flu shot about 14 years ago (which most Drs do agree are only about 30% effective based upon which flu/viruses actually become active in any given year). Â  That year, within 3 months after getting the flu shot, I got a flu virus. Then, the following month, I got another flu/virus. Then, within a couple of weeks after recovering from that, I got a flu/virus again. Â  I've never got another flu shot since. Â  And, since then, I've had a flu/virus only just a few times over the course of 14 years. And, the 15 years prior to getting that flu shot, I'd only caught a flu/virus just a handful of times. Â  My worst year for getting a flu/virus (other than when I was a kid) was the year I got the flu shot."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu virus).  At time of reporting, the outcome was Unknown for the event flu virus.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion which occurred from 19Dec2021 to 22Dec2021, the temperature dropped to 33.98 degrees Fahrenheit for (27) hours, due to an unknown cause, with no adverse event; Initial information received on 11-Jan-2022 regarding an unsolicited valid non-serious case was received from the health professional.  This case involves an unknown age and unknown gender patient who had temperature excursion which occurred from 19dec2021 to 22dec2021, the temperature dropped to 33.98 degrees fahrenheit for (27) hours, due to an unknown cause, with no adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past 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 INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose 0.7 ml (strength and form: unknown; lot number: UJ715AC and expiry date: 30-Jun-2022) via unknown route in unknown administration site for flu vaccine.  On 19-DEC-2021, the patient developed a non-serious event 'temperature excursion which occurred from 19dec2021 to 22dec2021, the temperature dropped to 33.98 degrees fahrenheit for (27) hours, due to an unknown cause, with no adverse event' (product temperature excursion issue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported 'RN reporting a temperature excursion which occurred from 19Dec2021 to 22Dec2021, the temperature dropped to 33.98 degrees Fahrenheit for (27) hours, due to an unknown cause, on the product FLUZONE HIGH-DOSE QUADRIVALENT, RN states that this occurred at one of their satellite offices and suspects the temperature dropped outside and the heat was never adjusted, this is reported as a potential AE because of temperature excursion. To be evaluated by PV. No further information provided by the reporter. First time product used : No Still using product : Yes'  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event 'temperature excursion which occurred from 19dec2021 to 22dec2021, the temperature dropped to 33.98 degrees fahrenheit for (27) hours, due to an unknown cause, with no adverse event'.
Sex: F
Vaccine: MNQ
Symptoms: Amnesia, Blood test normal, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: short term memory loss for three days; headache; fatigue; Initial information received on 11-Jan-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves an unknown age female patient who experienced short term memory loss for three days, headache and fatigue while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U6821AA, expiry date: 27-Jun-2023, anatomical location: unknown) as prophylactic vaccination.  On an unknown date the patient developed a non-serious "short term memory loss for three days (amnesia)" (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. On an unknown date the patient developed a non-serious "headache" (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. On an unknown date the patient developed a non-serious "fatigue" (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. Relevant laboratory test results included: Blood test - On an unknown date:  [normal]  It was reported "She states that the patient is reporting that she had short term memory loss for three days. She states that she also had the normal side effects like headache and fatigue right after the injection but she also doesn't remember the three days after the shot. She states that she "saw psych and is seeing neuro" and her blood work has been normal. She states that she is in between patients so she declined to provide additional AE information. No additional information from primary intake; caller refused to respond to questions and has accepted follow-up"  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the events (short term memory loss for three days, headache, fatigue).  At time of reporting, the outcome was Unknown for the event short term memory loss for three days, was Unknown for the event headache and was Unknown for the event fatigue.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: partial dose of the Pentacel was given with no reported adverse event; only received the liquid part, the DTaP-IPV, and they didn't mix it with the other part the Hib component with no reported adverse event; Initial information received on 12-Jan-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-month-old and 6-month-old of unknown gender patients who had partial dose of the Pentacel was given and only received the liquid part, the DTAP-IPV, and they didn't mix it with the other part the Hib component with no reported adverse event while receiving 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.   On an unknown date, the patients received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number; formulation; strength: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious events "partial dose of the pentacel was given with no reported adverse event" (incorrect dose administered), "only received the liquid part, the dtap-ipv, and they didn't mix it with the other part the hib component with no reported adverse event" (product preparation issue) (unknown latency).  It was reported "caller states that the patients only received the liquid part, the DTaP-IPV, and they didn't mix it with the other part the Hib component. She would like to request two of the proper diluents, the 0.4% NaCl (Sodium chloride) saline solution. She would like to know if they can call the patient and have them come in to get the Hib component now or do they have to wait until they get the diluent."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event partial dose of the pentacel was given with no reported adverse event and for the event only received the liquid part, the dtap-ipv, and they didn't mix it with the other part the hib component with no reported 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 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.; Sender's Comments:  US-SA-2022SA014669:
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product preparation issue
Clinical narrative: Patient received only the liquid DTaP/IPV portion of PENTACEL with no reported adverse event; Initial information received on 12-Jan-2022 regarding an unsolicited valid non-serious case from was received from the health professional.  This case involves a 7 months old male patient who received only the liquid dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 29-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dosage: 0.5 ml once (Third in the series); lot number: U6940AA and expiry date: 21-May-2022) via intramuscular route in the left leg for Immunisation.  On 29-Dec-2021, the patient developed a non-serious event "patient received only the liquid dtap/ipv portion of pentacel with no reported adverse event" (incorrect dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "Caller states that a patient received only the DTaP/IPV portion of the product and would like to know how to proceed? Additional Description of event Adverse events : Patient received only the liquid DTaP/IPV portion of PENTACEL. Dosage Information o Frequency = once o Therapy Date: 29Dec2021 o Route = IM Left Leg o Dose = 0.5mL o Strength = standard o Indications = Immunization  Event Information - Treatment - Dose: Third in the series "  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event patient received only the liquid dtap/ipv portion of pentacel with no reported 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 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Accidental exposure to product, Medication error
Clinical narrative: 2 month old was accidentally given only the liquid portion with no reported adverse event; Initial information received on 13-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old of unknown gender patient who was accidentally given only the liquid portion with no reported adverse event, while receiving 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.   On 13-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On 13-JAN-2022, the patient developed a non-serious event "2 month old was accidentally given only the liquid portion with no reported adverse event "(accidental exposure to product) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (2 month old was accidentally given only the liquid portion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 2 month old was accidentally given only the liquid portion with no reported 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 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.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Balance disorder, Cataplexy, Disability, Eye movement disorder, Fall
Clinical narrative: Narcolepsy with Cataplexy; cannot work and is on disability; Narcolepsy with Cataplexy; weakness in her legs; loses bodily control and drops to the floor with her eyes rolled back into her head; loses bodily control and drops to the floor with her eyes rolled back into her head; had changes in her body after receiving the vaccine; Initial information received on 13-Jan-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who had narcolepsy with cataplexy, cannot work and is on disability, narcolepsy with cataplexy, weakness in her legs, loses bodily control and drops to the floor with her eyes rolled back into her head, loses bodily control and drops to the floor with her eyes rolled back into her head and had changes in her body after receiving the vaccine while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2010, the patient received an unknown dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (strength, formulation, frequency, route, administration site was unknown, lot UH214AB and expiry date was unknown) for prophylactic vaccination.  It was reported by patient that adverse reactions that have existed for 11 years that her world-renowned sleep physician, states it stems from that vaccine. Patient stated that she had changes in her body after receiving the vaccine (unevaluable event), she had experienced weakness in her legs (Muscular weakness) and had been diagnosed with Narcolepsy with Cataplexy (Narcolepsy, cataplexy) (onset and latency: unknown). Reportedly stated that she loses bodily control (Balance disorder) and drops to the floor with her eyes rolled back into her head (eye movement disorder) (onset and latency: unknown). Patient had a letter from her doctor describing the events, she states she cannot work and was on disability (impaired work ability) (onset and latency: unknown). Patient wonders what the company would do to compensate her for her struggles  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown for unevaluable event and not recovered for other events  Seriousness criteria: Medically significant for event narcolepsy, cataplexy and disability for impaired work ability; Sender's Comments: Sanofi company comment dated 13-Jan-2022: This case involves female patient of unknown age who had Narcolepsy, Impaired work ability and Cataplexy after receiving INFLUENZA VACCINE (QUADRIVALENT). (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Impaired work ability, Muscular weakness, Narcolepsy
Clinical narrative: Narcolepsy with Cataplexy; cannot work and is on disability; Narcolepsy with Cataplexy; weakness in her legs; loses bodily control and drops to the floor with her eyes rolled back into her head; loses bodily control and drops to the floor with her eyes rolled back into her head; had changes in her body after receiving the vaccine; Initial information received on 13-Jan-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who had narcolepsy with cataplexy, cannot work and is on disability, narcolepsy with cataplexy, weakness in her legs, loses bodily control and drops to the floor with her eyes rolled back into her head, loses bodily control and drops to the floor with her eyes rolled back into her head and had changes in her body after receiving the vaccine while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2010, the patient received an unknown dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (strength, formulation, frequency, route, administration site was unknown, lot UH214AB and expiry date was unknown) for prophylactic vaccination.  It was reported by patient that adverse reactions that have existed for 11 years that her world-renowned sleep physician, states it stems from that vaccine. Patient stated that she had changes in her body after receiving the vaccine (unevaluable event), she had experienced weakness in her legs (Muscular weakness) and had been diagnosed with Narcolepsy with Cataplexy (Narcolepsy, cataplexy) (onset and latency: unknown). Reportedly stated that she loses bodily control (Balance disorder) and drops to the floor with her eyes rolled back into her head (eye movement disorder) (onset and latency: unknown). Patient had a letter from her doctor describing the events, she states she cannot work and was on disability (impaired work ability) (onset and latency: unknown). Patient wonders what the company would do to compensate her for her struggles  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown for unevaluable event and not recovered for other events  Seriousness criteria: Medically significant for event narcolepsy, cataplexy and disability for impaired work ability; Sender's Comments: Sanofi company comment dated 13-Jan-2022: This case involves female patient of unknown age who had Narcolepsy, Impaired work ability and Cataplexy after receiving INFLUENZA VACCINE (QUADRIVALENT). (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Narcolepsy, Sleep paralysis, Sleep study abnormal, Somnolence, Syncope
Clinical narrative: Narcolepsy with Cataplexy; cannot work and is on disability; Narcolepsy with Cataplexy; weakness in her legs; loses bodily control and drops to the floor with her eyes rolled back into her head; loses bodily control and drops to the floor with her eyes rolled back into her head; had changes in her body after receiving the vaccine; Initial information received on 13-Jan-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who had narcolepsy with cataplexy, cannot work and is on disability, narcolepsy with cataplexy, weakness in her legs, loses bodily control and drops to the floor with her eyes rolled back into her head, loses bodily control and drops to the floor with her eyes rolled back into her head and had changes in her body after receiving the vaccine while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2010, the patient received an unknown dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (strength, formulation, frequency, route, administration site was unknown, lot UH214AB and expiry date was unknown) for prophylactic vaccination.  It was reported by patient that adverse reactions that have existed for 11 years that her world-renowned sleep physician, states it stems from that vaccine. Patient stated that she had changes in her body after receiving the vaccine (unevaluable event), she had experienced weakness in her legs (Muscular weakness) and had been diagnosed with Narcolepsy with Cataplexy (Narcolepsy, cataplexy) (onset and latency: unknown). Reportedly stated that she loses bodily control (Balance disorder) and drops to the floor with her eyes rolled back into her head (eye movement disorder) (onset and latency: unknown). Patient had a letter from her doctor describing the events, she states she cannot work and was on disability (impaired work ability) (onset and latency: unknown). Patient wonders what the company would do to compensate her for her struggles  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown for unevaluable event and not recovered for other events  Seriousness criteria: Medically significant for event narcolepsy, cataplexy and disability for impaired work ability; Sender's Comments: Sanofi company comment dated 13-Jan-2022: This case involves female patient of unknown age who had Narcolepsy, Impaired work ability and Cataplexy after receiving INFLUENZA VACCINE (QUADRIVALENT). (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia
Clinical narrative: Tecchydardia; This spontaneous case was received on 05-Jan-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-00052) and concerned a 47-year-old, female patient.  The patient's concurrent condition included Mast cell activation syndrome. The patient's concomitant medications included Zyrtec (cetirizine hydrochloride) and cromolyn sodium, both used for an unreported indication.  On 12-Dec-2021, the patient was vaccinated at a Pharmacy with Afluria Quadrivalent (influenza vaccine; dose, route of administration, anatomical location: not reported) to prevent influenza. The batch number was not reported.   On 13-Dec-2021, reported as the next morning, after receiving Afluria Quadrivalent, the patient experienced tachycardia. The patient went to the emergency room (ER) in the late afternoon. She was treated with Metoprolol (metoprolol succinate) at an unspecified dose and was sent home.  On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 47-year-old female patient experienced tachycardia within one day after vaccination with Afluria Quadrivalent. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.; Sender's Comments: A 47-year-old female patient experienced tachycardia within one day after vaccination with Afluria Quadrivalent. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Allergic reaction to excipient, Urticaria
Clinical narrative: Broke out in hives; The specific ingredient in the flu vaccine to which I am allergic to; This spontaneous case was received on 13-Jan-2022 from other non-healthcare professional (consumer) via the Agency (reference number: SEQW22-00191) and concerned a 62-year-old, female patient.  The patient's concurrent condition included type 2 diabetes which the patient controlled with exercise and diet. The patient was not taking any concomitant medications. The patient's historical vaccine included Fluarix QIV in 2019 without any adverse reaction.  On 25-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On the same day, in the evening after receiving Flucelvax Quadrivalent, the patient broke out in hives. The patient was allergic to unknown ingredient in the flu vaccine. It was also reported that the patient had not had a reaction to any other vaccine than flu.  On 26-Se-2020, the next day, she took Benadryl (diphenhydramine hydrochloride) as corrective treatment. She was also treated with ice packs.  On an unspecified date in Sep-2020, reported as 2-3 days later, the patient recovered from the event.  The reporter assessed the events as related to Flucelvax Quadrivalent.  The events were assessed as non-serious.  Company comment: The events of  hives and 'allergic reaction to excipient' are assessed as related to Flucelvax Quadrivalent.; Reporter's Comments: I am working with an allergist to figure out the specific ingredient in the flu vaccine to which I am allergic; Sender's Comments: The events of  hives and 'allergic reaction to excipient' are assessed as related to Flucelvax Quadrivalent.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient had received 2 prior doses of Pfizer vaccine and requested the booster be Moderna. I failed to note that Moderna was not approved  yet at  Patients age. Patient is fine and had no adverse effects.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Dizziness , fever, sorethroat, runny nose and a positive covid test