chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Blood pressure measurement, Breast pain, Chest pain
Clinical narrative: heart pain was severe, right around the breast area; heart pain was severe, right around the breast area; felt "something" going through arms; BP went up to 151/95/Her blood pressure was 155 on the top and 97 on the bottom; HR 108; felt weak; felt real bad; pain in chest; fingers were cold/fingers, hands and toes got really cold/cold feet; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient felt weak and was getting pain in chest on 15Jul2021. Her BP went up to 151/95 and HR 108 on 15Jul2021, her fingers were cold, felt "something" going through arms, and had cold feet. On 15Jul2021 about 3 o'clock, she felt real bad and real weak and she started getting pains in her chest. Her fingers, hands and toes got really cold and her chest was hurting terrible. The patient took half of a BP medication in the morning and in the evening; took it and things calmed down about an hour later. She said the "heart pain" was severe, right around the breast area, and she could feel her heart beating. She described the "skipping" as "go go, stop stop, go". She said that sometimes it would be strong and other times, not. On 15Jul2021, her blood pressure was 155 on the top and 97 on the bottom and her heart rate was 108 and she could feel it beating in her chest. She was wondering if she should get another one on 04Aug2021 based on her side effects. Outcome of the events was unknown.   The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Hypertension, Limb discomfort
Clinical narrative: heart pain was severe, right around the breast area; heart pain was severe, right around the breast area; felt "something" going through arms; BP went up to 151/95/Her blood pressure was 155 on the top and 97 on the bottom; HR 108; felt weak; felt real bad; pain in chest; fingers were cold/fingers, hands and toes got really cold/cold feet; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient felt weak and was getting pain in chest on 15Jul2021. Her BP went up to 151/95 and HR 108 on 15Jul2021, her fingers were cold, felt "something" going through arms, and had cold feet. On 15Jul2021 about 3 o'clock, she felt real bad and real weak and she started getting pains in her chest. Her fingers, hands and toes got really cold and her chest was hurting terrible. The patient took half of a BP medication in the morning and in the evening; took it and things calmed down about an hour later. She said the "heart pain" was severe, right around the breast area, and she could feel her heart beating. She described the "skipping" as "go go, stop stop, go". She said that sometimes it would be strong and other times, not. On 15Jul2021, her blood pressure was 155 on the top and 97 on the bottom and her heart rate was 108 and she could feel it beating in her chest. She was wondering if she should get another one on 04Aug2021 based on her side effects. Outcome of the events was unknown.   The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: heart pain was severe, right around the breast area; heart pain was severe, right around the breast area; felt "something" going through arms; BP went up to 151/95/Her blood pressure was 155 on the top and 97 on the bottom; HR 108; felt weak; felt real bad; pain in chest; fingers were cold/fingers, hands and toes got really cold/cold feet; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient felt weak and was getting pain in chest on 15Jul2021. Her BP went up to 151/95 and HR 108 on 15Jul2021, her fingers were cold, felt "something" going through arms, and had cold feet. On 15Jul2021 about 3 o'clock, she felt real bad and real weak and she started getting pains in her chest. Her fingers, hands and toes got really cold and her chest was hurting terrible. The patient took half of a BP medication in the morning and in the evening; took it and things calmed down about an hour later. She said the "heart pain" was severe, right around the breast area, and she could feel her heart beating. She described the "skipping" as "go go, stop stop, go". She said that sometimes it would be strong and other times, not. On 15Jul2021, her blood pressure was 155 on the top and 97 on the bottom and her heart rate was 108 and she could feel it beating in her chest. She was wondering if she should get another one on 04Aug2021 based on her side effects. Outcome of the events was unknown.   The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Facial paralysis, Fall, Hallucination, Loss of consciousness
Clinical narrative: passed out/She was out; she later told him that he was a big blue octopus and she couldn't understand anything that he was saying; her face was drooping a bit; twitching of the arms/legs; she couldn't understand anything that he was saying; fell over in the chair; This is a spontaneous report from a contactable consumer received via Medical Information Team. A 15-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced twitching of the arms/legs and passed out. The reported stated that: he took his niece (patient) to get a COVID vaccine shot. When she got the shot, she was fine. He was holding her hand and everything, she sat there for the wait period and were waiting for 10 minutes. Suddenly, she fell over in the chair, her legs were twitching, her arms were twitching a bit and her face was drooping a bit. She was out. He quickly ran over there by her and shook her, not violently, but just like waking someone up. He shook her and was calling out her name and telling her that he loved her if she could hear him and come to. After a while she started coming to and he put his hand in front of her and moved it back and forth and she had no movement in her eyes or anything. He asked her after she started coming back to if she could see his hand, she later told him that he was a big blue octopus and she couldn't understand anything that he was saying. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: passed out/She was out; she later told him that he was a big blue octopus and she couldn't understand anything that he was saying; her face was drooping a bit; twitching of the arms/legs; she couldn't understand anything that he was saying; fell over in the chair; This is a spontaneous report from a contactable consumer received via Medical Information Team. A 15-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced twitching of the arms/legs and passed out. The reported stated that: he took his niece (patient) to get a COVID vaccine shot. When she got the shot, she was fine. He was holding her hand and everything, she sat there for the wait period and were waiting for 10 minutes. Suddenly, she fell over in the chair, her legs were twitching, her arms were twitching a bit and her face was drooping a bit. She was out. He quickly ran over there by her and shook her, not violently, but just like waking someone up. He shook her and was calling out her name and telling her that he loved her if she could hear him and come to. After a while she started coming to and he put his hand in front of her and moved it back and forth and she had no movement in her eyes or anything. He asked her after she started coming back to if she could see his hand, she later told him that he was a big blue octopus and she couldn't understand anything that he was saying. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Melanocytic naevus
Clinical narrative: gotten a bunch of mole on arms now on legs/moles showing up on her legs/on her shoulders/on her back; a cyst on right arm; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 09Apr2021 at age of 56 years old as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received the first dose of the Pfizer 09Apr2021 and the second dose on 07May2021 in her right arm (Lot # EW0182) and since 1st dose had gotten a bunch of mole on arms currently on legs. She got a bunch of moles on her arms and they were spreading to her legs after she received the Covid 19 vaccine. She was seen by her family doctor and her doctor said they were moles and cysts.  MD told her they were harmless but also noticed a cyst on right arm. She felt like the moles were going overtake her body and looked like crap, more mole were going to keep appearing. She was going to see a dermatologist in a month.The patient was looking information on reports of moles and cysts. She had asked her doctor for a referral to a dermatologist and she knew her doctor was concerned also. She started to notice the moles and cysts about 3 to 3.5 months ago and that corresponded with the first vaccine. When probing medical history and concomitant medications she reports nothing was relevant. She wasn't taking any new medications. She can't remember exactly when she saw her doctor. She had seen her doctor a couple of times. Both times she's asked her doctor about the moles because they were concerning her. The last time she saw her doctor was 12Jul2021 and that was a follow up so she saw her doctor a month before that maybe around 12Jun2021. She would have mentioned the moles to her doctor at that first appointment in Jun2021. The moles appeared first on her arms and she didn't think it was one arm more than the other. She felt like the moles could end up overtaking her body, she looked like crap. The doctor said they were moles and one was a cyst. The moles were still showing up, showing up on her legs and shoulders, and back as far as she can tell. Her cyst was on her right arm. Her doctor looked at the moles and said there was nothing wrong. Event required visit to Physician Office. Outcome of the events was not recovered.   The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Renal failure, Renal function test
Clinical narrative: Kidney failure; She said that she can barely get around now.; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of BNT162B2 for Covid-19 Immunization in Mar2021. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced kidney failure (medically significant and life-threatening). The doctor called the patient and told her she cannot have a kidney transplant and that she is not eligible for dialysis either. She only has 5-15 percent function left in her kidneys, all because she took the shots. She would never have taken it. She can't get any medical help. The patient reported that she can barely get around now. They told her she maybe has 6 months to live. The patient underwent lab tests and procedures which included renal function test: failure on 2021 She only has 5-15 percent function left in her kidneys. The outcome of the events was unknown.   Information on the Batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Psoriasis, Psoriatic arthropathy
Clinical narrative: Psoriasis and psoriatic arthritis flare; Psoriasis and psoriatic arthritis flare; Period with iud for 3 months which is abnormal; This is spontaneous report from a contactable consumer (Patient). A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the left arm on 23Apr2021 11:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. The patient medical history included psoriasis, psoriatic arthritis, rheumatoid arthritis,depression and iud (Intra-uterine contraceptive device). The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. The patient concomitant medication taken in two weeks included citalopram and leunomide. The patient did not receive any other vaccines within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on 02Apr2021 10:30 (at the age of 44-years-old) at single dose for covid-19 immunisation. On 03May2021, the patient experienced psoriasis and psoriatic arthritis flare, period with iud for 3 months which was abnormal. Treatment was received for the events with estrogen pills and steroid added to infusions. The patient had not tested positive for COVID-19 since the vaccination. The outcome of events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Nail disorder, Psoriasis
Clinical narrative: Psoriasis and psoriatic arthritis flare; Psoriasis and psoriatic arthritis flare; Period with iud for 3 months which is abnormal; This is spontaneous report from a contactable consumer (Patient). A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the left arm on 23Apr2021 11:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. The patient medical history included psoriasis, psoriatic arthritis, rheumatoid arthritis,depression and iud (Intra-uterine contraceptive device). The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. The patient concomitant medication taken in two weeks included citalopram and leunomide. The patient did not receive any other vaccines within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on 02Apr2021 10:30 (at the age of 44-years-old) at single dose for covid-19 immunisation. On 03May2021, the patient experienced psoriasis and psoriatic arthritis flare, period with iud for 3 months which was abnormal. Treatment was received for the events with estrogen pills and steroid added to infusions. The patient had not tested positive for COVID-19 since the vaccination. The outcome of events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: I'm not diabetic and it raised my sugar dramatically to 289 for numerous days; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jul2021 (Batch/Lot Number: FA6780) at age of 42-years-old as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Patient was not diabetic and it raised her sugar dramatically to 289 for numerous days on 15Jul2021 with outcome of recovering. Treatment received included Insulin. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of blood sugar increased cannot be excluded.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, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: dizzy; a fast heart rate; Dose Number:1/ Date of start of drug: 02May2021 / Dose Number:2/ Date of start of drug: 16May2021; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16May2021 12:30 (Batch/Lot Number: Ew0171) at age of 31-years-old as single dose for COVID-19 immunisation. Medical history included known allergies: sulfa drug and have allergic reaction to some foods nothing life treating, both from an unknown date and unknown if ongoing. Concomitant medication included omeprazole. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 02May2021 12:30 (Batch/Lot Number: Ew0185) at age of 31-years-old for COVID-19 immunisation. Patient was not pregnant. Facility type vaccine was Clinic/ facility. No other vaccine in four weeks. The patient experienced dizzy and a fast heart rate on 22May2021 22:00 with outcome of not recovered. Clinical course reported as follow: Patient was very dizzy 5 days after and several times she got very dizzy over the last month and now she has been having a fast heart rate for about 3 weeks. She is having tests done now. AE resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Patient is being tested now to receive treatment. No COVID prior vaccination. No COVID tested post vaccination.
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Pyrexia
Clinical narrative: fever; Initial information received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via call center via Regulatory Authority (Reference number- 00690406).  This case involves male patient who experienced fever (pyrexia) when received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and HPV VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  Stated he did receive a COVID vaccine at another time and only had a fever for two days.  On an unknown date, 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 an unknown date the patient developed a non-serious fever (pyrexia) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  The event outcome was unknown for pyrexia.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: F
Vaccine: YF
Symptoms: Expired product administered, Medication error
Clinical narrative: administration of an expired diluent with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via  Medical Information  (Reference number- 00690445) and transmitted to Sanofi on 20-Jul-2021.  This case involves a 36 year old female patient who had administration of an expired diluent with no reported adverse event at the time of receiving YELLOW FEVER VACCINE - [YF-VAX] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) and HEPATITIS B VACCINE RHBSAG (YEAST) (HEPLISAV B) for prophylactic vaccination.  On 19-Jul-2021, the patient received a dose (0.5ml) of suspect YELLOW FEVER VACCINE - (lot number: UJ371AB; expiry date: 21-JUL-2022; expiry date of diluent: 21-Jun-2021) via subcutaneous route in the left arm for prophylactic vaccination.  It was case of actual medication error due to expired product administered (latency: same day).  The outcome of the event was unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: medical assistant gave an expired vaccine to a patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional and a physician via Medical Information (MI) (Reference number- 00691414) and transmitted to Sanofi on 21-Jul-2021.  This case involves a 01-year-old male patient for whom it was reported that medical assistant gave an expired vaccine to the patient (expired product administered) for HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ353AAA and expiration date: 16-Jul-2021) via intramuscular route for prophylactic vaccination on 20-Jul-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and HEPATITIS A VACCINE INACT (HAVRIX).  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 t in the Directive requirements set ou2001/83/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: 35.0
Sex: F
Vaccine: DTAPIPV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they accidently gave a patient QUADRACEL instead of ADACEL /No AE; they accidently gave a 35 years old patient QUADRACEL instead of ADACEL /No AE; Initial information was received on 21-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via phone Inquiry Number: 00692015).     This case involves a 35 years old female patient who was accidently given DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) [QUADRACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) [QUADRACEL] lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "Caller said that they accidently gave a 35 year old patient QUADRACEL instead of ADACEL. Is there any side effective and does she need to get an Adacel vaccine. No agent was available at the time of call."  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.  There will be no information on the lot number for this case.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass, Rash
Clinical narrative: rash that went up her neck and around to her back and then up the back of her neck and then to her hair; red, hard bump at the injection site; bump that turned into a bruise at the injection site; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (GMI Inquiry number: 00694400).  This case involves a 51-year-old female patient who experienced rash that went up her neck and around to her back and then up the back of her neck and then to her hair (rash), red, hard bump at the injection site (vaccination site mass) and bump that turned into a bruise at the injection site (vaccination site bruising) after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 15-Jul-2021, the patient received a 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 15-Jul-2021 the patient developed a non-serious red, hard bump at the injection site (vaccination site mass) and bump that turned into a bruise at the injection site (vaccination site bruising) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 16-Jul-2021, the patient developed a non-serious rash that went up her neck and around to her back and then up the back of her neck and then to her hair (rash) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovering from rash, and the event outcomes for vaccination site mass and vaccination site bruising were unknown.  There will be no information on batch number for this case.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Rash follicular
Clinical narrative: rash that went up her neck and around to her back and then up the back of her neck and then to her hair; red, hard bump at the injection site; bump that turned into a bruise at the injection site; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (GMI Inquiry number: 00694400).  This case involves a 51-year-old female patient who experienced rash that went up her neck and around to her back and then up the back of her neck and then to her hair (rash), red, hard bump at the injection site (vaccination site mass) and bump that turned into a bruise at the injection site (vaccination site bruising) after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 15-Jul-2021, the patient received a 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 15-Jul-2021 the patient developed a non-serious red, hard bump at the injection site (vaccination site mass) and bump that turned into a bruise at the injection site (vaccination site bruising) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 16-Jul-2021, the patient developed a non-serious rash that went up her neck and around to her back and then up the back of her neck and then to her hair (rash) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovering from rash, and the event outcomes for vaccination site mass and vaccination site bruising were unknown.  There will be no information on batch number for this case.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a over 55 years old patient received first dose of Menactra/ No AE; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via phone (under Medical Information (MI) Inquiry Number: 00694452) in.  This case involves over 55 years old female patient who had her first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Product administered to patient of inappropriate age).  The patient's medical history included Splenectomy.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a first dose of suspect MENACTRA VACCINE lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported Caller says that she had her first dose of Menactra and then had a splenectomy. She was due for her second dose of Menactra soon as well as chemo treatment next week. Caller wants to find out how long she can delay her second dose of Menactra. The caller states that she was over 55 years of age. She would like to know if it was safe for her to get chemotherapy if she has only had one dose of Menactra and she does not have a spleen. She states that this was not a booster dose and that she was told that she needed a 8 week interval with a second dose of Menactra. She states that it had taken her an hour to get, she was not asked for additional Adverse Event information.   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.   There will be no information on the lot number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of PENTACEL/no AE; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Regulatory Authority (Reference number- 00694634).  This case involves a 2-month-old male patient who was vaccinated with an expired dose of suspect IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 20-Jul-2021, the patient received a 0.5mL of first dose of suspect IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number : UJ323ABA and expiry date : 13-Jun-2021) via an intramuscular route in the right thigh administration site for prophylactic vaccination.  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.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired dose of Pentacel administered with no reported adverse event; Initial information received on 23-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional and physician via Global Media information (under reference 00694720).  This case is linked to cases 2021SA247614 and 2021SA247618 (Cluster).  This case involved a 4 months old male patient who received an expired dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE  [PENTACEL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) and PNEUMOCOCCAL VACCINE 13V [Lot number and expiration date were not reported] for prophylactic vaccination.  On 19-Jul-2021, the patient received a dose of suspect PENTACEL (lot UJ342AAA and expiration date: 22-JUN-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "patient Information patient age lees than one year enter as 2 month, 4month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, Strength standard for Fluzone HD-STANDARD. 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 drug administration) requirement". It was not reported if the patient received a corrective treatment.  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.
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: Product was out of range at 75 fahrenheit for 960 hours with no reported adverse event; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Global Medical Information under reference -00694728.  This case involves a 79 year-old female patient who was vaccinated with DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which was out of range at 75 fahrenheit for 960 hours because product was left out of refrigeration (Product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given.   On an unknown date, the patient received 0.5 mL once dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported that "Pharmacist is requesting to know if the patient needs to be revaccinated".  It was a case of a potential medication error due to incorrect product storage.  At the time of reporting, no adverse event reported.  Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: an expired dose of ActHIB was given with no adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional via Regulatory Authority (Reference number- 00697016) and transmitted to Sanofi on 26-Jul-2021.  This case involves a 01-year-old female patient for whom it was reported that an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was given (expired product administered) to her (lot number: UJ352AAA and expiration date: 13-Jul-2022) at a dose of 0.5 ml via intramuscular route in the right thigh for prophylactic vaccination on 23-Jul-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications were not reported.  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: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose of ACTHIB was inadvertently administered, with no reported adverse event; Initial information received on 26-Jul-2021 regarding an unsolicited valid  non-serious case received from a nurse and physician via Regulatory Authority (under reference 00697020).  This case involved a 2 years old female patient who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) inadvertently (expired product administered),   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A) [not produced by Sanofi Pasteur] (Lot number and expiration date were not reported) via unknown route in an unknown route for prophylactic vaccination.   On 26-Jul-2021, the patient received a 0.5mL dose of suspect ACT-HIB (lot UJ355AAA and expiration date: 24-JUL-2021; lot number (diluent) U6825AA and expiration date: 05-Dec-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that " what actions need to be taken."  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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired daptacel was administer to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 26-Jul-2021 from pharmacist via global medical information (GMI) (Reference number- 00697188) and transmitted to Sanofi on 26-Jul-2021.  This case involves a patient of unknown demographics who was vaccinated with an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, past medical treatment, vaccination, family history and concomitant medications were not reported.  On an unknown date in Jul-2021, the patient received a 0.5 mL (once) [total] dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date 17-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "pharmacist is looking for information regarding precautions on administration of an expired product".   It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event was reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This spontaneous case was received on 22-Jul-2021 from a pharmacist via Med Communication (reference number: SEQW21-01510) and concerned a 69-year-old female patient.  The patient's medical history and concomitant medications were unknown.  On 16-Oct-2013, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported. The vaccine might have been Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) or Flucelvax (influenza vaccine, subunit influenza virus vaccine polyvalent) vaccine, but the reporter was not entirely sure.  On the same day, after receiving influenza virus vaccine polyvalent, the patient experienced severe anaphylactic reaction.   The reporter stated that the patient was hospitalized, but was not sure. The reporter did not provide any further information regarding the adverse event.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of anaphylactic reaction was considered to be serious due to hospitalization and medical significance.  Company comment: A 69-year-old female patient developed anaphylactic reaction on the same day after vaccination with the suspect product influenza virus vaccine polyvalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on suggestive time relationship, causality for the reported events is assessed as possibly related. With limited information present Brighton Collaboration criteria for anaphylaxis could not be assessed.; Sender's Comments: A 69-year-old female patient developed anaphylactic reaction on the same day after vaccination with the suspect product influenza virus vaccine polyvalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on suggestive time relationship, causality for the reported events is assessed as possibly related. With limited information present Brighton Collaboration criteria for anaphylaxis could not be assessed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash, Rash pruritic
Clinical narrative: Eczema type reaction on the left side of my neck. Very itchy.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Burning sensation, Pain
Clinical narrative: About 10 days following 3nd vaccination, I felt a strangely ominous burning ache in a larger region of my left shoulder; the pain increased with arm movement, but dissipated within about 1/3 to 1/2 minute.  There have been at least 4-6 similar events, usually somewhat longer, since that first concerning event.