chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Her cycle was suppose to start one week after she got her first dose of the vaccine but she didn't.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Lot number: ER8731) via an unspecified route of administration in right arm on 18Apr2021 at 10:30 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Lot number: unknown) via an unspecified route of administration on 06May2021 at around 9am in right arm as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that the history of all previous immunization with the Pfizer vaccine and additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks) and events following prior vaccinations, family medical history and relevant tests were reported as none. On an unspecified date in Apr2021, it was reported that the patient's cycle was supposed to start one week after she got her first dose of the vaccine but she did not. No therapeutic measures were taken. The patient did not require emergency room and physician office visit. Caller wanted to know what information was available regarding menstrual changes and if this had been reported or is a know side effect. They responded that the authorized  Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine did not list menstrual changes as adverse reaction from clinical studies and post authorization experience. We might not have the list of all the possible side effects related to the vaccine. The event outcome was unknown.   Follow-up attempts were needed. Further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Pain in extremity
Clinical narrative: Abdominal cramp; Had sore arm; This is a spontaneous report from contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, Yesterday evening patient received second dose Pfizer vaccine and patient was just concerned about some of the symptoms patient was experiencing when patient received first vaccine and all had was a sore arm, it was a little sore for two days and that was it like, said patient received second dose last night and patient arm got a little sore few hours later and now experiencing a little bit of abdominal cramp patient did not experience that last time and patient was looking on the list of side effects and patient did not necessarily see that and patient just wanted to make sure was that a normal reaction. Consumer stated, his/her vaccination card did not have it and it did not have any barcode on it. On an unspecified date, patient experienced abdominal cramp and had sore arm. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Having 100 degree fever, 101 degree fever at night every night since I got it and I got in on Thursday; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient stated that she had a question about the second Covid vaccine which she received from Pfizer. The patient was having 100-degree fever, 101-degree fever at night every night since she got it and got on Thursday (further clarification not provided) on an unspecified date and she just wanted to know if that was normal or that something to worried about. The patient underwent lab test which included Body Temperature (Fever): 100-101 degrees on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Pain in extremity
Clinical narrative: Had sore arm; Abdominal cramp; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Solution for Injection, Lot/Batch number and expiration date: unknown), via an unspecified route on an unknown date, as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot/Batch number and expiration date: unknown) for covid-19 immunization and experienced I had was a sore arm. On an unknown date, the patient experienced had sore arm and abdominal cramp. The patient reported that, received second dose last night and my arm got a little sore few hours later and now experiencing a little bit of abdominal cramp I didn't experience that last time and I was looking on the list of side effects and I didn't necessarily see that and I just wanted to make sure is that a normal reaction. The clinical outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives; High fever; This is a spontaneous report from a contactable consumer. This Consumer reported for a unknown(male) patient that.  A male patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives, and high fever on an unspecified date. It was reported that reporter need to know the side effects of the Pfizer shot because his boyfriend has the shot the other day, 2 days ago, he has broken out with all hives and he is running a high fever. Reporter wanted to know "Are those any side effects of this medication (Intent: Pfizer shot) or does he need to seek medical attention". Reporter stated, "Then it should be 24 hours because they are going around, giving shot which is not approved and people are getting sick of getting the vaccine (Further clarification was unknown) so, your advice is, you are telling me that, the best way, is go to the doctor, is what you are saying, because you are saying I cannot talk to nobody until it's 8 am in the morning. I noticed it is not even approved, you guys don't understand just hold in the phone." Reporter seriousness for events: Unspecified. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: Pain/hurting; Burning so bad; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional via. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration in Apr2021 as dose 1, single for covid-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient experienced pain/hurting and burning so bad on an unspecified date. Patient reported that since she got the shot, she can't do the insulin injection all because it was hurting and burning so bad. she got the second shot she was started feeling better, but she was still can't do her injections because she said it hurts and feels so bad and she has recently bad nose with shingles and she says she had believed that it was because of the Covid vaccine and she was calling to report those events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Muscle twitching
Clinical narrative: Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Keeping me up at night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old female (Non-pregnant) patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FR28744), via an unspecified route of administration, administered in am left on 01May2021 at 12:00 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Known allergies from Aleve, and prior to vaccination, the patient diagnosed with COVID-19. The patient's concomitant medication included losartan (LOSARTAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced started with 1st dose, muscle twitches in lower legs, in the last 2 months, after second dose, increasing; and keeping me up at night. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the upper arm where he got the shot after the first dose; This is a spontaneous report received from a contactable consumer. A contactable consumer reported that, a 59-year-old male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 01Apr2021), dose 1 via an unspecified route of administration, administered in right upper arm deltoid area on 01Apr2021 at 10:30 (at the age of 59-year-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included neck surgery from an unknown date and unknown if ongoing he has had surgery on his neck, but this was before the shots and related to his disability. It was done on C5, C6, C7, he had a discectomy done in either 2017-2018. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination) were none. The patient experienced pain in the upper arm where he got the shot after the first dose on an unspecified date in Apr2021. It was reported that, he received 2 doses of the COVID Vaccine in Apr2021 and is still having pain in the upper arm with numbness and tingling. The patient confirmed it is the Pfizer COVID Vaccine. he was disable but use to work as a medical tech. Reporter wanted to know what he should do, where does he go from here. No treatments were reported for the event. Events did not require a visit to the Emergency Room or Physician Office (his next step would be to call his primary care). Relevant Tests done were none. Reporter seriousness for the event was Unspecified. Outcome of the event was not recovered.  Follow-up actions are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Nasal discomfort
Clinical narrative: Bad nose with shingles; Bad nose with shingles; This is a spontaneous report from a contactable consumer (patient) or other non health care professional.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in 2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced bad nose with shingles in 2021. She was calling because she said she had the first dose of the shot in April and she started having pain and she said she was the diabetic (Intent of medical history) and she said ever since she got the shot she can't do the insulin injection (Further clarification unknown hence captured suspect as Unspecified medication) all because it was hurting and burning so bad but she said after she got the second shot she was started feeling better but she was still can't do her injections because she said it hurts and feels so bad and she has recently bad nose with shingles and she says she had believes that it is because of the Covid vaccine and she was calling to report those events. The outcome of the events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her sister's left foot had swelled after getting the vaccine; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (owner's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration on an unspecified date, at unknown dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. When the reporter was at a consignment store and was talking to the owner about the vaccine her sisters left foot had swelled after getting the vaccine (unknown date). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jun2021 (Age at vaccination:60 years) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient medical history was penicillin allergy and concomitant medications were not reported. The patient previously took allergyx. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient had not received other medications in two weeks. On an unspecified date, after the 1st shot she experienced mild side effects of sore arm. The event outcome was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram, SARS-CoV-2 test, Vaccination failure
Clinical narrative: For after being vaccinated against Covid-19/Patient got tested for covid on 09Jul2021/he was positive for covid; For after being vaccinated against Covid-19; This is a spontaneous report from a contactable consumer. This contactable consumer (patient's wife) reported for a 78-year-old male patient.   A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8736; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Arm on 30Apr2021 10:30 (age at the time of vaccination was 78-year-old) as single dose for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Jan2021 (Patient had covid in late Dec 2020 to early Jan 2021). There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151; Expiration Date: on an unspecified date in Jul2021), dose 1 via an unspecified route of administration, administered in Arm on 09Apr2021 10:30 as single dose for COVID-19 immunization. The reporter reported that she and her husband both had COVID in late Dec2020 to early Jan2021. she stated she and her husband both received both doses of the Pfizer covid vaccine. Reporter's husband is the patient. Patient was now tested positive for COVID again. Because it was a mild case of COVID, the CDC does not care. Reporter was very aggravated because they had their grandkids over that past weekend and exposed them to COVID. Reporter and patient thought they were safe to have family over because they received the COVID vaccine. Now patient has tested positive for COVID. The patient got tested for COVID on 09Jul2021. The hospital called yesterday, 11Jul2021, and told patient he was positive for COVID and cancelled his surgery. The patient was supposed to have a total knee replacement on 12Jul2021. Prior to patient's knee replacement, patient had got a big check-up. The doctors did an EKG, and everything was fine. The doctor told patient he was in the best health out of anyone his age. The reporter stated she was going to go get tested for COVID. The patient underwent lab tests and procedures which included electrocardiogram: fine on 09Jul2021, sars-cov-2 test: positive on 09Jul2021. Outcome of the events was reported as unknown.   Follow-up attempts are needed. Further information is requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021(at the age of 38 years old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated he got the COVID-19 shot yesterday, has a slight fever of 100 stated he is not sick just having COVID shot symptoms. The patient underwent lab tests and procedures which included body temperature:100 on an unspecified date on Jul2021 (slight fever of 100). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: I have had migraines every single day since my first, which worsened with the second.; This is a spontaneous report received from a Pfizer Sponsored Program Pfizer.com - General Company Information. A contactable consumer reported that a patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and second dose via an unspecified route of administration on an unspecified date (BNT162B2, solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient have had migraines every single day since first, which worsened with the second on an unspecified date in 2021. The outcome of event was unknown.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: Blood clot in her legs; This is a spontaneous report from a contactable other healthcare professional. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), oral from 2020 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to 2021, at 11 mg, 1x/day for psoriatic arthritis. It was unknown if the patient was pregnant. The patient medical history was not reported. Concomitant medications included metoprolol succinate, rivaroxaban (XARELTO) (20 mg tablet) and paracetamol (TYLENOL) (325 mg tablet). On an unspecified date in May2021, the patient experienced blood clot in her legs. The patient reported that she developed blood clots in her legs, went to the emergency room in early Jun2021. She further stated that she has been followed by vascular MD that currently have her off all her prescription medications except the anticoagulants. She also stated that the doctor said it was hard to tell what caused the clots since she was taking birth control, xeljanz and also had her covid vaccine around the same time. She was off xeljanz until cleared by vascular MD. Prescribing MD aware. The clinical outcome of the event was reported as not recovered.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pruritus, Erythema, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer or other non hcp reported that a female patient (reporter's sister) of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right ear itching and burning and then the skin started to crack, her other ear was burning, red, felt hot and started cracking again. The outcomes of events were unknown.  Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. This 69-year-old Female consumer (patient) reported for herself that: received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot Number: ER8736 expiry date was not reported) via an unspecified route of administration at arm Left on 27Apr2021 (at the age of 69-years-old) as a single dose, dose 2 (Lot Number and expiry date was not reported) via an unspecified route of administration on 19May2021 as a single dose, for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient received vaccine on 19May2021 and got shingles on 27May2021 or 28May2021 (conflictingly reported). The patient reported that It pretty much went away she still has some tingling. The patient received treatment with the prescription she gave her and over the counter ibuprofen. Prescription includes gabapentin 300 mg, capsule, she took it whenever she needed. It was not helping she said she could start taking it every four hours. Outcome of the event was recovering.  Follow-up attempts are needed. Information on Lot/Batch number can be requested
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his arm; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported) via an unspecified route of administration on Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced rash on his arm on Jul2021. The patient unsure if this has something to do with the vaccine or not and want to clarify if rashes on the arm is a common side effect. Patient also wanted to know, is still safe to get a second dose of BNT162B2. The outcome of the events was unknown.   No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer (patient daughter) received via a sales representative. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient experienced shingles after second dose of COVID vaccine on an unspecified date. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasal congestion
Clinical narrative: Experiencing headache; Super congestion; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age 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 consumer stated that the patient was supposed to get his second dose of vaccine on Monday (12Jul2021) but he had been experiencing headache and super congestion since an unspecified day. On 15Jul2021, the patient did not have fever and his temperature was 98.7 in the morning. The consumer wanted to know if congestion was part of the side effects of the COVID vaccine. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: her SED rate went from 30 to 130; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Jun2021 as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Jul2021, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a blood test done before she received the vaccine. On an unspecified date of 2021, patient had another blood test done after she received the vaccine, and her erythrocyte sedimentation rate (SED) went from 30 to 130. Patient questioned that, has this happened before and was informed that there was no information regarding a change in lab results with the Pfizer Covid-19 vaccine, Survey offered. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: seizure; Initial information received on 12-Jul-2021 regarding an unsolicited valid serious case received from a pharmacist via call center via Regulatory Authority (Reference number- 00676744).  This case involves an female patient (unknown demographics) who experienced seizure when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, vaccination, concomitant and family history were not provided.  Past vaccination include ADACEL 10 years ago for prophylactic vaccination and did not have any side effect or seizures attack related to the vaccine for the past 10 years.  On an unknown date, the patient received a booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious seizure (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  It was reported that ''what to advise patient after informing her medical provider? does patient have to undergo tests through provider to rule out any adverse reaction from the vaccine due to her current seizure disorder. If Pharmacist calls in verify if asking of drug interactions between Adacel and Keppra.''  The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) 500 mg for her seizures.  The event outcome was unknown for seizure.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a unknown age old female patient who presented with seizure after vaccination with ADACEL. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: A child received an expired dose of ACTHIB yesterday with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via regulatory authority (Reference number- 00678904) and transmitted to Sanofi on 12-Jul-2021.  This case involves a 2 months old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] yesterday (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination.  On 12-Jul-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ359AA, expiry date: 11-Jul-2021) (Diluent- Lot: U6872AA, Expiration date: 01-Feb-2022, dose of diluent 0.6 ml) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported that "Nurse called to report that an expired dose of a vaccine had been administered today (12JUL2021). The vaccine expired 11-Jul-2021. The caller would like to know if this dose is valid or if the child should be revaccinated?"  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: male patient was accidently given Tenivac instead of TDap with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an adult male patient in his 40's who was accidently given DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 12-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) (Frequency: once) instead of TDAP not produced by Sanofi Pasteur via an unknown route at an unknown administration site (Wrong product administered) for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (latency on same day).  It was reported that "Practitioner reported that a patient was accidently given TD instead of TDap on yesterday. Caller would like to know when can TDap now be administered to this patient. The Practitioner reported that the patient that received the Tenivac and not the ordered Tdap is in their 40s and is a male and that the dose of TDap was ordered was to be able to be near a newborn. The Practitioner was not able to provide any more information for this report due to not being in the clinic".   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 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: 40.0
Sex: M
Vaccine: YF
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 40 year old male patient administered expired diluent with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 40 year old male patient who was vaccinated with an expired diluent dose of suspect YELLOW FEVER VACCINE - US [YF-VAX].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 13-Jul-2021, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ386AA and expiry date: 22-Aug-2022, Diluent Lot number: U6309AA and expiry date: 30-Jun-2021) (Frequency: once) via an subcutaneous route in the left arm (Expired product administered) for prophylactic vaccination.  It was an actual medication error case due to Expired medical agent used (latency on 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 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: 17 year old male patient was inadvertently administered an expired dose of Menactra with no reported AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer in the United States.   This case involves a 17 year old male patient who was inadvertently administered an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Patient received no concomitant vaccines. Medical history, medical treatment, concomitant medication, and family history were not provided.   On 16-Jun-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6365AA and expiry date: 24-Sep-2020) via an intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "Caller stated the vaccine is expired and they administered it to a patient. Caller wants to know how effective the vaccine is, if they needed to give the vaccine to the patient again, or would they need to wait. Reported stated that as of today (14 Jul 2021) the patient has not reported any adverse effects from having received the expired vaccine."  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 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: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: IMOVAX for pre-exposure, incorrect schedule, dose on day 0, day 3, and day 7, no AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid  non-serious case from a pharmacist via Global Media Information (under reference number: 00681667).  This case involves a patient of unknown age and gender patient who received RABIES (HDC) VACCINE [IMOVAX RABIES]'s incorrect schedule; that is on day 0, day 3, and day 7.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   The patient received first, second and third dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for pre-exposure immunization on day 0, day 3 and day 7 respectively (dates unknown) (inappropriate schedule of product administration).  It was an actual medication error case due to inappropriate schedule  vaccine administered.  It was reported: "Pharmacist asked about the dosing series of IMOVAX for pre-exposure. An incorrect schedule was given to a patient. Patient was given a dose on day 0, day 3, and day 7. They are wondering if a 4th dose should be given, or would the patient be fully protected already. Pharmacist does not have the patient information at the moment."  At time of reporting, it was unknown whether the patient had any adverse event or not.  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 this case.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old female patient inadvertently given DAPTACEL instead of a TDAP vaccine with no reported adverse event; 11 year old female patient inadvertently given DAPTACEL vaccine with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 13-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5774AA and expiry date: 18-Sep-2022) (Frequency: once) via an intramuscular route in the right arm instead of TDAP not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site (Wrong product administered and Product administered to patient of inappropriate age) for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered and inappropriate age at vaccine administration (latency on same day).  It was reported that "Patient age greater than one year enter as two month, four month, etc. Many pediatric vaccines need month for age. Pregnancy: not applicable, Last menstrual period, Due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement. Reporter relationship: HCP (health care professional) Product used: Used First time product used: Yes".  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, Immunoglobulin therapy, No adverse event
Clinical narrative: inadvertently given an expired dose of Imovax Rabies with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age female patient who was inadvertently given an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  The patient's past medical history included cat bite. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received an expired dose of suspect RABIES (HDC) VACCINE (lot number not reported via unknown route in unknown administration site for post exposure immunization (expired product administered).  It was reported that, "A patient was bitten by a cat and presented at the clinic on June 30th. She was inadvertently given an expired dose of Imovax Rabies. My colleague called, the patient was re-vaccinated with unexpired vaccine, on the same day. She also received immunoglobulin on that day. Today, she is back, 14 days later. How should I proceed with the series? Should I start over or give the day 3 dose?"  It was a case of actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired PENTACEL was administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00682124) and transmitted to Sanofi on 14-Jul-2021.  This case involved 4 month old female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (reported as ROTOTECK) for prophylactic vaccination.  On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ341AAA and expiry date: 22-jun-2021) (Frequency: one) (strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  It was reported that, "RMA (Registered Medical Assistant) stated that she accidentally gave an expired Pentacel injection to a patient today because she looked at the Pentacel wrong. Caller asked what she should do".  It was an actual medication error case (expired vaccine used) (latency same day)  At time of reporting, no adverse event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.