chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: vision went blurry; Dizzy/Light-headed; weird sensations in different parts of her head; hands and legs went weak; vision was so bad.; left eye twitching; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, solution for injection, lot number: EW0176) via unknown route of administration on 30Apr2021 at dose 1 single in deltoid left (left shoulder as reported) for COVID-19 immunisation. Medical history included lyme disease (since she was young, weakened immune system), bartonella (since she was young, weakened immune system), anaemia (several years), vitamin D low (several years), interstitial cystitis (10 years) all are ongoing. Concomitant medications were not reported. Then 1-2 min after her vision went blurry. She was dizzy, and light-headed. She felt weird in different parts of her head. She was like having weird sensations in different parts of her head. One second it would be in her forehead and then in the back of her head. It was weird. That occurred on 30Apr2021 but went away that same day. Her hands and legs went weak. That happened on 30Apr2021, just that day and she recovered. All the side effects subsided after several hours except for the blurred vision. Her vision was still blurry. Her left eye was also twitching which has started since the vaccine in 2021. She didn't have eye twitching before, but she thinks that was less frequent now. She went to the Ophthalmologist, and he did an eye exam with unknown results. That was 3 weeks ago in 2021. Her last eye exam was 8 years ago with unknown results. But he said that her vision change since that exam was extremely significant. It was now illegal for her to drive her vision was so bad in 2021. Her doctor was not sure what happened either. Her doctor was now referring her to a Neuro-ophthalmologist.  She has been taking Vitamins to try to help. She has been taking Vitamin D3 and iron. She does have chronic Lyme disease and Bartonella because of that she does have a weakened immune system. She has had both of those since she was little. She was a lot better now. She was not as sick anymore from those. She was not going to get the second dose. She was wondering if she can reverse the blurry vision. she asked her doctor about the Lyme disease, and her vision change. The doctor said she needed to report this to Pfizer. If it was because of the Lyme disease it would have happened before the vaccine. The outcome of event vision blurred was not recovered, vision abnormal was unknown, eyelid twitching was recovering and remaining were recovered on 30Apr2021.   Information on the batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain, Product temperature excursion issue, Pyrexia
Clinical narrative: had classic symptoms after the second dose/fever and body aches; had classic symptoms after the second dose/fever and body aches; the vaccine she received has been deemed invalid due to record keeping practice and temperature.; the vaccine she received has been deemed invalid due to record keeping practice and temperature.; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0153), via an unspecified route of administration, administered in Arm Left on 08Apr2021 09:00 (Age at Time of Vaccination 56 Years) as single dose for COVID-19 immunisation. The medical history was none. Concomitant medication included vitamins nos. Historical vaccine includes first dose of bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP6955), dose 1 via an unspecified route of administration, administered in Arm Left 19Mar2021 09:00 as single dose for COVID-19 immunisation. No prior vaccinations within 4 weeks. On Apr2021 the patient experienced the vaccine she received has been deemed invalid due to record keeping practice and temperature, on 09Apr2021 had classic symptoms after the second dose/fever and body aches. No emergency Room or Physician Office. No relevant Tests done. She was already received advice from her doctor to get an antibody test, She reached out on her own to the owner of the clinic and was told that the owner felt the caller did get the vaccine. It is explained that she wants to fly to withheld in August but that government is very strict and she will have to show proof vaccination. When she went online it does, in fact say, her vaccine is invalid. She spoke to a doctor who encouraged her to get antibody test, which she has scheduled on Friday. The caller is nervous about doing a repeat of the vaccine. If the antibodies are positive she doesn't want to get the vaccine again as she is worried it will cause her body to react in a way. This was heard through a friend, that the place had been shut down, on the news. A week after the second dose she reached out to the department of health who finally called her back and explained it was true and that about 7000 people were affected and they should redo the vaccines, get both doses again. They couldn't provide any medical information which really upset her regarding this situation. Caller has no information or product details for the 7000 mentioned during this report but explains it was all on the news. The outcome for even the vaccine she received has been deemed invalid due to record keeping practice and temperature was not recovered, other events was recovered on 10Apr2021.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Head discomfort, Presyncope
Clinical narrative: Did not loose consciousness but patient reported he felt like he would if he stood up; A severe pressure in his head; He felt a loss of equilibrium; Patients grandma did walk with him and he was able to walk of the store about hour after receiving with her assistance.; This is a spontaneous report from a contactable pharmacist .   A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 Immunization. Patient medical history and concomitant medications not reported. Caller is a pharmacist calling on behalf of a patient experiencing an adverse event after receiving the first dose of the Pfizer Covid 19 vaccine. The patient received his first dose of the vaccine at 1:20/1:30pm. Within ten minutes, the patient said he experienced a severe pressure in his head; patient did not loose consciousness but patient reported he felt like he would if he stood up on unspecified date. He felt a loss of equilibrium. Caller reports the patient did not experience any blood pressure changes. Patients grandma did walk with him and he was able to walk of the store about hour after receiving with her assistance. EMTs determined consumer was okay without a hospital trip. Family was okay with that decision. Caller asking if this specific symptom has been reported before (severe pressure in head with loss of equilibrium). The Outcome of all the events were unknow.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Was diagnosed with Covid-19; Was diagnosed with Covid-19; sick; This is a spontaneous report from a contactable pharmacist via medical information team. This pharmacist reported for a female patient.  A female patient of unknown age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date in Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller stated that the patient got sick and was diagnosed with Covid-19 on Mar2021. The caller was asking on how to proceed with second dose. The caller was asking whether the second dose can be given earlier than 3 weeks. The patient laboratory data Covid-19 was positive in mar2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid !9. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Feeling abnormal, Rash
Clinical narrative: the rash was on the torso, back, chest, stomach, buttocks, under arm, shoulder and neck area.; miserable; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 92-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as dose 2, single for COVID-19 immunization. Medical history included measles from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiry date: Unknown was not reported) on middle of Feb2021 Covid-19 immunization. On an unspecified date Apr2021 the patient experienced the rash was on the torso, back, chest, stomach, buttocks, under arm, shoulder and neck area, drug reaction, miserable. The patient underwent lab tests and procedures which included biopsy: drug reaction on biopsy of the rash done by the dermatologist came back as a drug reaction. Therapeutic measures were taken as a result of the rash was on the torso, back, chest, stomach, buttocks, under arm, shoulder and neck area, miserable rash did not go away and not gone away treatment included with steroid shots and prescription creams. The outcome of events was unknown.  Additional information has been requested and will be provided as it becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles-like rash appeared 12 days post first COVID vaccination; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles-like rash, 12 days post first COVID vaccination. The outcome of the event was unknown.  Information about lot/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pain, Pyrexia
Clinical narrative: generalized body ache which was worse in pelvis and knees; sick as a dog; her temperature went up to 101 degrees; This is a spontaneous case from a contactable consumer. A 63-year-old female patient receive dose 2 of COVID-19 vaccine (UNSPECIFIED TRADE NAME) via an unspecified route of administration in 2021 as a single dose for COVID-19 immunization. Medical history included ankylosing spondylitis. Concomitant medications included etanercept (ENBREL; Solution for injection in pre-filled pen; lot number 1124377) via an unspecified route of administration from Feb2021 at 50 mg frequency unknown for ankylosing spondylitis. The patient previously received dose 1 of COVID-19 vaccine on an unknown date. In 2021 after the second COVID-19 vaccine, the patient was sick as a dog . Her temperature went up to 101 degrees and stayed high for 12 hours. The patient had generalized body ache which was worse in pelvis and knees and had difficulty performing everyday tasks. The outcomes of sick, temperature went up, and generalized body ache were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache is really bother her; Head is hurting pretty bad; Nausea little bit; Fever; This is a spontaneous report from a contactable consumer (grandparent). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number:EW0169, and expiration date was not reported), via an unspecified route of administration on 23Jun2021, as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), DOSE 1, SINGLE for covid-19 immunization. On 23Jun2021, the patient started feeling some side effects, she had a headache, little bit of nausea, and fever. At the morning of report, the patient still had a headache and it really bother her and her head was hurting pretty bad. The reporter would like to know what patient can take for her headache. The outcome of the event Headache was not recovered and of Nausea and pyrexia was unknown at the time of report.
Sex: M
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis, Myelitis transverse
Clinical narrative: he developed Acute Disseminated Encephalomyelitis; He is also diagnosed with Transverse myelitis; This is a spontaneous report from a Pfizer sponsored program. A contactable Consumer reported for a male patient (reporter son).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included acute disseminated encephalomyelitis, myelitis transverse. Concomitant medications were not reported. The patient experienced he developed acute disseminated encephalomyelitis; he was also diagnosed with transverse myelitis. her doctor confirmed the vaccine can cause demyelination in adults post vaccination. she has also read some thin like this NORD rare diseases document online. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. they may not have the list of all the possible potential side effect associated with the vaccine. she wants to know if you have any information on minors developing ADEM and transverse myelitis after receiving the vaccine. She was just looking for any data on youth that have had the vaccine with any medical history, but there wasn't any. The outcome of events was unknown.  Information on the lot/batch number has been requested
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Two weeks after 2nd shot, extreme vertigo..and it is ongoing.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 02Jun2021 11:00 (Lot Number: EW0178) as dose 2, single at the age of 47-year-old for covid-19 immunization. The patient was not pregnant. Medical history included known allergies: Penicillin from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other medications the patient received within 2 weeks of vaccination. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in left arm on 11May2021 14:30 (Lot Number: ew0167) as dose 1, single at the age of 47-year-old for covid-19 immunization. Two weeks after 2nd shot, the patient experienced extreme vertigo..and it was ongoing on 17Jun2021 23:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of event. The outcome of event was not recovered.    No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I'm almost afraid I would die from the second shot and My reaction was so bad; This is a spontaneous report from a contactable consumer (patient).  A male patient (age and unit not reported) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on an unspecified date, as dose 2, single for covid-19 immunization. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided) as dose 1, single for COVID-19 Immunization (Pneumonia). On unspecified date, patient reported that he was almost afraid he would die from the second shot and his reaction was so bad. Patient was praying for his life that night. The outcome of event was unknown.  Follow-up attempts are possible. Information regarding the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Echoencephalogram, Hepatic failure, Life support, Myocardial infarction, Renal failure
Clinical narrative: Heart attack; he is in the hospital, fully on life support; he has his kidneys and liver are failing; he has his kidneys and liver are failing; This is a spontaneous report from a contactable consumer or other non hcp.  A 34-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. Medical history included Anxiety, depression. Concomitant medication included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccine within 4 weeks Prior to Vaccine. Reporter stated, is it possible for heart attack to happen 8 days after the vaccine. reporter want to report a reaction, because reporter think it was vaccine reporter wanted to make sure, repoters brother is 34 and he had a heart attack yesterday and he received his vaccine (Confirmed as Pfizer Covid 19 vaccine) 8 days ago, he received his vaccine before his heart attack. Reporter stated, patient has his kidneys and liver are failing, he said they did the lab work really done, he is still waiting to get echo that for his heart. Patient is completely on life support, he still in the hospital. The patient underwent lab tests and procedures which included echoencephalogram: unknown results, Therapeutic measures were taken as a result of heart attack. The outcome for the events he has his kidneys and liver are failing was reported as unknown and for remaining events outcome was reported as not resolved.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Headache, Vision blurred
Clinical narrative: shooting (Left) eye pain/more into the corner of her eye, whole head hurting; Could not even focus out of her left eye; irritating; shooting (Left) eye pain/more into the corner of her eye, whole head hurting; This is a spontaneous report from a contactable consumer via Pfizer. (Patient, reported for self).  A 64-years-old female patient received first dose of BNT162B2 (Pfizer-BioNTech mRNA Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0175, Expiration date: 31Aug2021), via an unspecified route of administration on 06May2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications includes: clopidogrel bisulfate (PLAVIX) taken at 75 mg, 1x/day (one time a day by mouth) and  acetylsalicylic acid (ASPIRIN (E.C.) taken at 81 mg, 1x/day (one time a day by mouth) both from unspecified dates for indication: Stents and ongoing. It was reported that after receiving the first dose of Covid vaccine the patient's eye has had shooting pain every now and then since the vaccine, her whole head was hurting, has been to multiple healthcare providers, wants to report and wants to know if other people have experienced this as well, also wants to know whether to take second dose or not as well. It was reported that the patient has seen her primary for this event, two ER (Emergency Room), two urgent care doctors and an eye doctor and no one knows what was going on. The patient stated that the extreme eye pain started between the 13th and the 19Jun2021, exact date unknown, clarifies the pain was in the left eye, felt like someone was just stabbing her in the eye, it would come when it wanted, the pain would shoot into her eye. Her doctor numbed her eye and pain kept shooting through her eye, it is unbearable. Could not even focus out of her left eye, noticed the pain is a little better but keeps getting the shooting pains into the eye, more into the corner of her eye, it is so irritating. Patient clarified that she received the vaccine on 06May2021 and has not received second dose yet. No investigation Assessment was reported. Patient enquired how long symptoms should last after the vaccine, has anyone else reported this symptom, should she get the second dose. The clinical outcome of the events shooting (Left) eye pain/more into the corner of her eye, whole head hurting had not recovered, and the outcome of other events were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in the arm that I got vaccination in; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient had both of the vaccine doses and now the arm was starting like getting numb now (arm that got vaccination) and wondering if numbness in the arm was one of the side effects. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sensory disturbance, Vaccination site pain
Clinical narrative: soreness at the injection site; the thumb feels funny; the thumb feels numb; This is a spontaneous report from a contactable consumer (caregiver). A 49-year-old female patient (Caller's wife) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05May2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in left arm on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received first covid vaccine in Apr2021 and received the second one on 05May2021. Since then she had soreness at the injection site and the thumb feels funny, numb in 2021. The soreness isn't debilitating. Caller asked "have you had other reports of this and will it go away? What light can you shed?". The case is reported as non-serious. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: redness around the injection site; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Regulatory Authority (Reference number- 00636207) and transmitted to Sanofi on 10-Jun-2021.  This case involves a patient (unknown demographics) who had redness around the injection site (vaccination site erythema) while receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical treatment(s), vaccination(s), 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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious redness around the injection site (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  This event affected 3 patients.  It is unknown if the patient experienced any additional symptoms/events.   It is 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: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of vaccine/no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a nurse via Regulatory Authority (Reference number- 00655131).  This case is linked to case 2021SA212366 (same reporter).  This case involves a patient of unknown age and gender who was vaccinated with 0.5 mL [once; standard] expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number R2A301M and expiry date 31-May-2021) via an intramuscular route at the right deltoid on 23-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  It was reported that "Wanted to know what to do and what recommendations were".  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: No adverse event, Off label use
Clinical narrative: Using Pentacel off Label with Pediarix on both VFC and Private; Initial information was received on 21-Jun-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210628000362).  It was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was used off Label with DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIADRIX] on both VFC and Private on an unknown date for prophylactic vaccination (off label use).  It was a case of actual medication error due to off label use.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 66.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 66 years old patient received MENACTRA vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Regulatory Authority (Reference number- 00644060) and transmitted to Sanofi on 16-Jun-2021.  This case involves a 66 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX); and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for prophylactic vaccination.  On 14-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6878BA and expiry date:02-Mar-2022] via an intramuscular route at right deltoid prophylactic vaccination.  It was as of actual medication error due to product administered to patient of inappropriate age [Latency: on the same day].   It was reported that, medical Assistant (MA) asks for information regarding administration of MENACTRA to patients older than 55 years-old; what are the risks, any benefits that may exist, and whether there was a risk of interaction with concomitantly administered vaccines.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment for the 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: accidentally give the diluent from Pentacel to a baby, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00646006) and transmitted to Sanofi on 17-Jun-2021.  This case involves an unknown age and unknown gender patient who accidentally give the diluent from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (other dosing details unknown) (batch number and expiry date unknown) for prophylactic vaccination (product preparation issue) on an unknown date  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  Additionally laboratory tech reported: they wanted to know if it is possible to get a vial of diluent for ActHib to complete the Pentacel dose.  At the time of report, no adverse event was reported.  At the time of reporting, the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 2.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Alopecia, Autoimmune disorder
Clinical narrative: exacerbate autoimmune issues with hair loss; exacerbate autoimmune issues with hair loss; alopecia/ hair loss; Initial information was received on 21-Jun-2021 regarding an unsolicited valid serious case from a physician.  This case involves a two-year-old female patient who had a exacerbate autoimmune issues with hair loss (autoimmune disorder with symptom of alopecia), after she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and YELLOW FEVER VACCINE - US [YF-VAX].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEFLOQUINE HYDROCHLORIDE (LARIAM) (1/4 tab weekly) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) was administered via arm.  On 18-May-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 10-Jun-2021, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US [lot number: UJ372AA, expiry date not reported] via subcutaneous route at right thigh for prophylactic vaccination.  On 10-Jun-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot number: T1A671M, expiry date not reported] via subcutaneous route at right thigh for prophylactic vaccination.  On an unknown date the patient had a serious exacerbate a potential autoimmune issue with hair loss (autoimmune disorder, condition aggravated with symptom of alopecia), (unknown latency) following the administration of YELLOW FEVER VACCINE - US, TYPHOID VI POLYSACCHARIDE VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These event was assessed as medically significant.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the patient's father was asking if theses vaccines could exacerbate a potential autoimmune issue with hair loss that his daughter is experiencing.  At the time of reporting, the event outcomes were unknown.; Sender's Comments: This case involves a two-year-old female patient who experienced exacerbated autoimmune issues with hair loss after vaccination with MENACTRA, TYPHIM VI and YF-VAX. The time to onset was unknown. Concomitant medications included LARIAM and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination 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 the suspect vaccines cannot be assessed.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of ACT-HIB  inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00649513) and transmitted to Sanofi on 21-Jun-2021.  This case involves a 15 months old male patient who inadvertently administered with a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ318AB and expiry date: 18-Jun-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 21-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) via intramuscular route for immunization.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced 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.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received both IPOL and PENTACEL and they were both expired doses, no adverse event; Initial information received on 22-Jun-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professional and physician via Information (under reference 00651487).  This case involves a 3 years old male patient who was vaccinated with an expired dose of both 0.5 ml IPV (VERO) [IPOL] (lot number and expiration date not reported) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (total, lot UJ228AA (HIB)/ UJ315AA and expiration date: 04-Apr-2021) via intramuscular route in an unknown administration site for prophylactic vaccination on 21-Jun-2021 (expired product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included a dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (lot number and expiration date not reported) via unknown route and site of administration for prophylactic vaccination on 21-Jun-2021.  It was a case of an actual medication error due to expired vaccine used (same day latency).  Reported that the caller was with a question on whether dose needs repeating and on adverse effects to expect due to patient receiving IPOL as well as PENTACEL.   At time of reporting, the outcome was unknown for the reported 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 on the batch number for IPOL.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: TENIVAC was administered to a patient and it was a few days expired with no AE; Initial information regarding an unsolicited valid non-serious case was received from the physician and a consumer/non-health care professional via Regulatory Authority (Reference number- 00651546) and transmitted to Sanofi on 22-JUN-2021.  This case involves a 22 year old male patient who received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot number: C5638AA, expiry date: 17-Jun-2021] via an intramuscular route at the right deltoid on 22-Jun-2021 for prophylactic vaccination (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided.  At the time of report, list of concomitants was reported as no other vaccines.    It was case of actual medication error due to expired vaccine used (Latency: on the same day).  At the time of report, it was reported that, the TENIVAC was administered to a patient and it was a few days expired and reporter was wanted to know if the vaccine was good even if the vaccine was a few days expired or did the patient need to be revaccinated.   At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event 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 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: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Menactra/ NO AE; Initial information received on 22-Jun-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Agency (Reference number- 00651603).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and expiry date not reported) via an unknown route in unknown administration site a month ago (expired product administered) on an unknown date for prophylactic vaccination.  The patient's past medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion information needed for a maximum temperature of 49 degree F for a duration of 10 hours out of range reason for the excursion was a problem with the refrigerator door with no reported adverse event; Initial information received on 22-Jun-2021 regarding an unsolicited valid  non-serious case received from from a pharmacist.  This case involves a patient of an unknown demographics whose temperature excursion information needed for a maximum temperature of 49 degree, F for a duration of 10 hours out of range and reason for the excursion was a problem with the refrigerator door with no reported adverse event while receiving vaccines meningococcal a-c-y-w135 (D conj) vaccine [Menactra] and diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] and while treated with dupilumab [Dupixent] via device not known, insulin lispro [Admelog] via device not known, insulin glargine [Lantus] via device not known and insulin glargine [Toujeo] via device not known.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking meningococcal a-c-y-w135 vaccine, diphtheria-2/tetanus/5 ac pertussis vaccine ,dupilumab via device not known, insulin lispro via device not known, insulin glargine via device not known and insulin glargine via device not known. All with an unknowj other dosing details for an unknown indication.   Reportedly, temperature excursion information needed for a maximum temperature of 49-degree F for a duration of 10 hours out of range for the following suspect products. The reason for the excursion was a problem with the refrigerator door (Product temperature excursion issue, onset, and latency: unknown). The pharmacy's refrigerator door got stuck and did not seal itself. The pharmacist stated, the door got stuck on something and not sealed all the way.  No laboratory tests data were provided  Action taken :Not applicable  Outcome :Not applicable
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB was administered with no adverse event; Initial information regarding an unsolicited valid non-serious case from a nurse via Agency (Reference number- 00651749) and transmitted to Sanofi on 21-Jun-2021.  This case involves a patient of unknown age for whom  it was reported that expired HIB (PRP/T) VACCINE [ACT-HIB] was administered (expired product administered) on 21-Jun-2021 [lot number: unknown and expiration date: unknown] at 0.5 ml once (total) dose via unknown route in an unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to incorrect expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  Outcome of the event was unknown.  It was reported that " expired ACTHIB was administered to a patient yesterday. She has questions about next steps and if the patient needs to be re-vaccinated "  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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 regarding batch number in this case.