chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: A person took the first dose of Pfizer and has some fast heartbeat; This is a spontaneous report from consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number, expiration date was unknown) via unspecified route of administration on unspecified date. The patient's medical history and concomitant medications were not reported. The patient experienced some fast heartbeat on unspecified date. Additional information: Reporter wonders if a person took the first dose of Pfizer and has some fast heartbeat, can that person take the second dose. Reporter seriousness for A person took the first dose of Pfizer and has some fast heartbeat was unspecified. The outcome of the event was unknown.  No follow-up attempts are possible, Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for PCR; Tested positive for PCR; This is a spontaneous report from contactable reporter. This reporter reporting for a 36-year-old female patient (reporters friend) that:  A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on Jun2021 (Age at vaccination 36 years) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for pcr on 23Jun2021. Reporter stated, her friend had the vaccine on Friday and now she tested positive for PCR. Reporter does not know if it is normal because of the vaccine. It is just the Pfizer vaccine. Her friend tested positive today 23Jun2021 and she doesn't know if it is from the vaccine. Her friend tested positive an hour ago, and they are concerned. She has been in contact with her friend. She doesn't know what Pfizer vaccine it was or what it was for. She just knows her friend received the Pfizer vaccine. She is not sure if her friend received the vaccine on Thursday or Friday of last week. She does not have an NDC, lot number, or expiration date. She thinks her friend had it in her left arm. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 23Jun2021.The outcome of events was unknown.  Information about lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I do feel little bit pressure when I am breathing; This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself that:  The patient of an unspecified age and gender received second dose of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: unknown) via an unspecified route of administration on 23Jun2021 at 11:00 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history included asthma and Obesity. Its not severe asthma but had asthma.(Further not clarified hence not captured in tab).  The concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Patient reported that received second dose of vaccine this morning about 10 hours ago. Patient was mostly being trying but he was also asthmatic and obese so patient had been experiencing some shortness of breath nothing too severe, but patient was just concerned about what time it would be a concern. Patient reported that from the last 2 hours or so patient had been little short of breath nothing too bad, patient could breath fine, but patient felt little bit pressure when breathing on 23Jun2021. The patient was asking was that a concern and should patient go to the ER. The outcome of the event was unknown.  Information on Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she was told that 9 players and the coaches of the baseball team all came down with covid; she was told that 9 players and the coaches of the baseball team all came down with covid; This is a spontaneous report from Pfizer sponsored Program . A contactable consumer reported on behalf of multiple patients. This report was for player2 out of 9 players and coach.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller was told that 9 players and the coaches of the baseball team all came down with covid. The caller wanted to know why this has happened. The caller was asking whether the vaccine was not supposed to save you from getting covid. The outcome of the events was unknown.  Information about Lot/Batch number were requested
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was told that 9 players and the coaches of the baseball team all came down with covid; she was told that 9 players and the coaches of the baseball team all came down with covid; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program . This case is for a patient (Player #6). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced "she was told that 9 players and the coaches of the baseball team all came down with covid". It was reported that Player #6 of the baseball team came down with covid. The reporter wanted to know why this happened and she stressed that the vaccine is supposed to save you from getting covid. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on this specific patient. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events were unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Movement disorder, Pain in extremity, Vaccination site pain
Clinical narrative: left arm which is where I received both of the shot started hurting on the site of the vaccination; sore arm and like a kind of heavy that cannot be lifted; sore arm and like a kind of heavy that cannot be lifted; sore arm and like a kind of heavy that cannot be lifted; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient left arm which is where patient received both of the shot started hurting on the site of the vaccination, sore arm and like a kind of heavy that cannot be lifted on an unspecified date. Reporter queried I didn't know who to call. So, I got my two vaccine already, I am fully vaccinated. The second shot I received it in May 4th so it's been over a month and half and today all of sudden on my left arm which is where I received both of the shot started hurting on the site of the vaccination and I feel the same thing when I felt when I got vaccinated what's like the sore arm and like a kind of heavy that cannot be lifted and I don't know if that is normal. I have been googling it and I know there's people that have had sore arm for weeks but I had sore arm for one night and then now it came back and I don't want to have later. So I don't know if this is normal or I should be concerned or got to the hospital. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Neck pain
Clinical narrative: I have serious joint stiffness and soreness; I am 48 hours out from getting the vaccine and my neck still really hurts; I have serious joint stiffness and soreness; I am 48 hours out from getting the vaccine and my neck still really hurts; I have serious joint stiffness and soreness; I am 48 hours out from getting the vaccine and my neck still really hurts; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 24-years-old female patient received BNT162B2 (Batch/Lot Number: EW0187), dose 2 via an unspecified route of administration, administered in Arm Left on 21Jun2021 17:00 as dose 2, single for covid-19 immunization, first dose was taken on 31May2021 (LOT# EW0177) (Expiration Date: unknown). The patient medical history and concomitant medications were not reported. Patient reported family medical history and confirmed there were no other vaccinations 4 weeks prior to vaccination. On 23Jun2021 at 17:00 (48 hours after getting vaccine) patient experienced serious joint stiffness and soreness; neck hurts (neck pain) (joint stiffness), (arthralgia). Clinical course of events includes; " I am calling to report a reaction with the Pfizer vaccine, so I have serious joint stiffness and soreness and I am 48 hours out from getting the vaccine and my neck still really hurts". Patient reported that no treatment was taken for the events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Echocardiogram, Headache, Pain
Clinical narrative: First dose: Hives; First dose: Body aches; First dose: Headache; First dose: Body had no energy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown and expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing AFib (Her Afib started like 5 years and 5 or 6 months ago), ongoing Water on her heart and lungs (She started having water on her heart and lungs about 17 years ago. If she had anything abnormal, she was supposed to go to emergency. Every year they do an echocardiogram and X-rays for her lungs to control it and make sure it had not increased). She was very allergic to a lot of stuff. The patient's concomitant medications were not reported (Other Products: No). Patient reported that she was taking some unspecified medications for Afib that include high blood pressure medicines.On an unspecified date in 2021, patient experienced first dose: hives, first dose: body aches, first dose: headache, first dose: body had no energy. Patient reported, due to the fact that she had Afib, today she was going to see her cardiologist. She happened to have an appointment from last year. He sees her twice a year, so she was hoping that he will find out what was wrong with her. She didn't remember her physician's phone number. She did not have contact information available for her physician. Her doctor told her that if she was completely short of breath due to the Afib she needs to go to the emergency room. Patient reported, with her first dose the reaction she had was very low. She had her vaccine on Wednesday, and her symptoms completely went away by Thursday mid-morning. She had body aches, hives, a headache, and her body had no energy. She had the vaccine on Wednesday, and by noonish the next day it was gone. Again stated, she had her first dose of the vaccine on Wednesday. She thinks it was 2 or 3 weeks prior to the second dose. She doesn't remember the exact date she had it. They took her card, and she has no NDC, lot, or expiration date for the first dose. They took that one and gave her the one she has. She takes medications for Afib that include high blood pressure medicines. The patient underwent lab tests and procedures which included X-rays for her lungs and echocardiogram: unknown results. There was no investigation assessment. The outcome of events was recovered on an unspecified date in 2021.  Additional information has been requested and will be provided as it becomes available
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: First dose: Hives; First dose: Body aches; First dose: Headache; First dose: Body had no energy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown and expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing AFib (Her Afib started like 5 years and 5 or 6 months ago), ongoing Water on her heart and lungs (She started having water on her heart and lungs about 17 years ago. If she had anything abnormal, she was supposed to go to emergency. Every year they do an echocardiogram and X-rays for her lungs to control it and make sure it had not increased). She was very allergic to a lot of stuff. The patient's concomitant medications were not reported (Other Products: No). Patient reported that she was taking some unspecified medications for Afib that include high blood pressure medicines.On an unspecified date in 2021, patient experienced first dose: hives, first dose: body aches, first dose: headache, first dose: body had no energy. Patient reported, due to the fact that she had Afib, today she was going to see her cardiologist. She happened to have an appointment from last year. He sees her twice a year, so she was hoping that he will find out what was wrong with her. She didn't remember her physician's phone number. She did not have contact information available for her physician. Her doctor told her that if she was completely short of breath due to the Afib she needs to go to the emergency room. Patient reported, with her first dose the reaction she had was very low. She had her vaccine on Wednesday, and her symptoms completely went away by Thursday mid-morning. She had body aches, hives, a headache, and her body had no energy. She had the vaccine on Wednesday, and by noonish the next day it was gone. Again stated, she had her first dose of the vaccine on Wednesday. She thinks it was 2 or 3 weeks prior to the second dose. She doesn't remember the exact date she had it. They took her card, and she has no NDC, lot, or expiration date for the first dose. They took that one and gave her the one she has. She takes medications for Afib that include high blood pressure medicines. The patient underwent lab tests and procedures which included X-rays for her lungs and echocardiogram: unknown results. There was no investigation assessment. The outcome of events was recovered on an unspecified date in 2021.  Additional information has been requested and will be provided as it becomes available
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Headache, Nausea
Clinical narrative: disoriented; unsteady; very sick to my stomach; Headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number EW0162 and expiry date not reported), via an unspecified route of administration, administered in Arm Left in May2021 (also reported as 14May2021 at 11:00 (pending clarification)) (at the age of  62-year-old), as dose 1, single for covid-19 immunisation. Patient had no medical history. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEBREX) and lisinopril. The patient had no other vaccine in four weeks. The patient has not been tested for COVID-19 prior to vaccination and post vaccination. Patient had no known allergies. In May2021 (also reported as 04May2021 at 12:00 (pending clarification)), approximate 12 hours after the first dose, the patient became disoriented, unsteady, had bad headache and the patient felt very sick to her stomach. It was reported that bad headache persisted for days and it was notified to the Doctor. The patient visited physician office and therapeutic measures were taken as a result of the events. The outcome for the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable other HCP via Pfizer sponsored program. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Mar2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. No patient identifiers were provided- it was unknown if the reporter had a specific patient in mind. It was reported that patient received first Pfizer on 03Mar2021, 21 days after that the patient tested positive for COVID-19 in Mar2021, patient was advised to wait 3 months for 2nd dose. HCP asked how to proceed. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective with the suspect drug BNT162B2.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nightmare
Clinical narrative: The second dose brought nightly terrifying dreams; I also have experienced bad cramps in both calves; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0175 and expiration date: not reported), via an unspecified route of administration, on left arm, on 14May2021 (at the age of 62-years-old), as dose 2, single for COVID-19 immunization at a Hospital. Medical history included ongoing hypertension and ongoing adenomatous polyposis coli. Patient did not have any allergies. Concomitant medications included lisinopril taken for hypertension, and celecoxib (CELEBREX) taken for adenomatous polyposis coli. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EW0162 and expiration date: not reported) on Left arm, in May2021 11:00 (at the age of 62-year-old; pending clarification) as dose 1, single for COVID-19 immunization and patient became disoriented, unsteady, very sick to stomach, and had a bad headache persisted for days. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at time of vaccination. On an unspecified date in 2021, the patient reported that the second dose brought nightly terrifying dreams. She had very bad dreams practically every night, typically around 4am-5am since having the second dose. They were unlike any dreams that she has ever experienced. They were filled with carnage, chaos, and always ended with her being terrified when she woke up from them. They were not normal dreams; she was usually being hunted or pursued by unknown people and it never ended well. The patient would like to find out when these dreams might stop as they were very disturbing. The patient also experienced bad cramps in both calves, mostly on the right. Zanaflex was taken as a therapeutic measure for the event bad cramps in both calves (muscle spasms). It was reported that events result in doctor or other healthcare professional office/clinic visit. After the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Myalgia, Pain in extremity
Clinical narrative: Patient is very angry due to his left leg got paralyzed after receiving the 2nd dose of Pfizer COVID 19 vaccine; He has been experiencing extreme pain on left leg; Severe muscle pain on the back of his thigh; This is a spontaneous report received from a Pfizer sponsored program A male contactable consumer (patient) reported for himself that:  A male patient of an unspecified age received 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 second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunization. Patient was very angry due to his left leg got paralyzed on an unspecified date after receiving the 2nd dose of Pfizer COVID 19 vaccine. He mentioned that next week will be the 7th week from the time he received the 2nd dose. He had been experiencing extreme pain on left leg, severe muscle pain on the back of his thigh. He always used heat pad to ease the pain. Prior to vaccination he could do 7000 steps, now it was just 4000 steps. He also mentioned that he already went to (withheld) and his doctor and told him that there were numerous complaints about Pfizer COVID 19 vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: I was diagnosed with a pulmonary embolism in each lobe of my right lung on 24May2021; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration in left arm on 25Feb2021 (at the age of 33 years old) as single for covid-19 immunisation. Medical history included brain tumor, chronic migraine, premature ovarian failure. The patient had known allergies to codene, dust, tree pollen. The patient received other concomitant medications in the past two weeks. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab sars-cov-2 test: negative on 24May2021. On 24May2021, patient was diagnosed with a pulmonary embolism in each lobe of right lung. The event resulted in: Emergency room/department or urgent care, hospitalization. The patient was hospitalized for 9 days. The patient received treatment due to the event with placed on heprin, evaluated for additional clots. The reporter considered events as serious. Since the vaccination, the patient tested for COVID-19. The outcome of event was resolving.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Dyspnoea, Epistaxis, Headache
Clinical narrative: Blooding from the nose for 3weeks unable to stop the bleeding; Bad headaches; Muscle pain; Pain all over; Chest pain; Difficulties breathing; Blood clots every where in my body; Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 14:00 (54-year-old at time of vaccination) as single dose for COVID-19 immunization.  Medical history included protein C deficiency (protein C and S deficiencies), protein S deficiency (protein C and S deficiencies), PE.s (I've had PE.s in the pasted), allergies (I will need to provide a list I have several). Concomitant medications that the patient received within 2 weeks of vaccination included blood clot meds and a list of other meds daily (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Apr2021, the patient experienced "Blooding from the nose for 3weeks unable to stop the bleeding", bad headaches, muscle pain, pain all over, chest pains, difficulties breathing, "blood clots every where in my body" (medically significant), and stomach pains. The events were serious with criteria of life threatening. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "blooding from the nose for 3weeks unable to stop the bleeding" and included surgery to stop the bleeding. The outcome of the events was recovering.  Information on lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Thrombosis
Clinical narrative: Blooding from the nose for 3weeks unable to stop the bleeding; Bad headaches; Muscle pain; Pain all over; Chest pain; Difficulties breathing; Blood clots every where in my body; Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 14:00 (54-year-old at time of vaccination) as single dose for COVID-19 immunization.  Medical history included protein C deficiency (protein C and S deficiencies), protein S deficiency (protein C and S deficiencies), PE.s (I've had PE.s in the pasted), allergies (I will need to provide a list I have several). Concomitant medications that the patient received within 2 weeks of vaccination included blood clot meds and a list of other meds daily (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Apr2021, the patient experienced "Blooding from the nose for 3weeks unable to stop the bleeding", bad headaches, muscle pain, pain all over, chest pains, difficulties breathing, "blood clots every where in my body" (medically significant), and stomach pains. The events were serious with criteria of life threatening. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of "blooding from the nose for 3weeks unable to stop the bleeding" and included surgery to stop the bleeding. The outcome of the events was recovering.  Information on lot/batch number has been requested.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 3 year-old girl received expired third ACTHIB vaccine/ NO AE; Initial information received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via call center via Medical Information (reference number- 00655008).  This case involves a 3-years-old female patient who was vaccinated with an expired 0.5 mL third dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, lot number : UJ318ABA and expiry date : 18-Jun-2021 ) via an intramuscular route in left thigh(expired product administered) on 23-Jun-2021 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  Caller wanted to know if the product was still active or should the patient be re-vaccinated.  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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a 11 years old patient has erroneously received a second dose of MENACTRA within a 7 month timeframe with no adverse event; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 11 years old female patient has erroneously received a 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Injection batch number: U6827BA, expiry date: 18-FEB-2022 via intramuscular route in the left deltoid on 09-Nov-2020 and a 0.5 ml second dose batch number not reported, expiry date: 09-JAN-2022 via intramuscular route in the right deltoid on 22-Jun-2021 within a 7 month time frame for prophylactic vaccination (inappropriate schedule of product administration).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) batch number: U6827BA on 09-Nov-2020 for Prophylactic vaccination.  It was an actual medication error due to drug dose administration interval too short (latency: same day).  It was reported that "The caller stated that an 11 years old patient has erroneously received a second dose of MENACTRA within a 7 months timeframe. Please see the Event Information, additional description of event for further details. Nurse asks if there are adverse effects that they should monitor for and should the child still receive a booster dose at 16 or so. On 09-Nov-2020, the patient received a dose of Menactra. On 22-Jun-2021, the patient reported to the doctor office for a routine annual exam where she was administered Menactra again in error. The caller would like to know if there will be any adverse events as a result of this error. The caller also wants to know if the patient should still receive another dose of Menactra at 16 year of age. Dosage Information Frequency: once, Strength: standard. No adverse events reported. Product used: Used".  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: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a patient only received the DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV (DTAP-IPV) portion and not the HIB portion of Pentacel vaccine, due to the two components not being mixed, No AE; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old female patient who received the Diphtheria, Tetanus, AC Pertussis, IPV (DTAP-IPV) portion and not the HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], due to the two components not being mixed (lot number: UJ496ABA, expiry date: 29-MAY-2022), dose: 0.5 ml, frequency: once, strength: standard via intramuscular route in left thigh for prophylactic vaccination on 21-Jun-2021 (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  List concomitant: No other vaccines.   It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  Potential Product Technique Complain: No, Treatment: The clinic calling the manufacturer and  Product used.  At the time of reporting on 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: 73.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was administered expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00659835) and transmitted to Sanofi on 28-Jun-2021.   This case involves a 73-year-old female patient who received  0.5 mL of expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via an intramuscular route in the left arm for prophylactic vaccination on 28-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was reported that "Caller would like to know if this dose is considered a valid dose or whether the dose needs to be repeated."  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, no adverse events were 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Missed miscarriage. Expected due date 01/20/22. Fourth pregnancy. One termination, One live birth, two miscarriages. This is a second missed miscarriage in a row first one being in January 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injected limb mobility decreased, Pain in extremity
Clinical narrative: A few hours after receiving my first shot my right arm started to hurt. It was difficult to raise my arm. I also experienced fatigue. I went to bed that night at 7:00pm due to be so tired. I took Tylenol for the arm pain. I woke up the next morning with my arm still hurting and still feeling tired. The tiredness continued throughout the day. The arm pain subsided by that evening (7/1/2021 around 7:00 pm).  The tiredness is getting better, but I?m not yet back to my energetic self as of this morning (7/3/2021)
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Wheals, lip swelling, tongue swelling (vaccine given 10 am symptom onset 6pm, worsened 10pm)
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic ketoacidosis, Intensive care, Laboratory test, Type 1 diabetes mellitus
Clinical narrative: I developed Type I Diabetes shortly after being fully vaccinated.  Earliest symptoms began on May 21, 2021.  Confirmed diagnoses on June 23, 2021 with visit to Emergency Room and diagnosed with diabetic ketoacidosis.  I do not know if the Type I Diabetes diagnosis is a direct symptom of receiving the vaccine, but I am reporting in case others are seeing the same side effect.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: rash on right leg
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dizziness, Fatigue
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 8 minutes after pt received Moderna vaccine, pt's mother yelled for help because the pt had passed out for a duration of 5-10 seconds then woke up. Pt was administered 1 dose of adult epipen and 911 was called. Once EMT arrived they took him to the hospital to be evaluated. He appeared to recover by demonstrating the ability to stand up walk around and respond to questions asked by the EMT.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypertension, Injection site pain, Lethargy
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 8 minutes after pt received Moderna vaccine, pt's mother yelled for help because the pt had passed out for a duration of 5-10 seconds then woke up. Pt was administered 1 dose of adult epipen and 911 was called. Once EMT arrived they took him to the hospital to be evaluated. He appeared to recover by demonstrating the ability to stand up walk around and respond to questions asked by the EMT.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Paraesthesia, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 8 minutes after pt received Moderna vaccine, pt's mother yelled for help because the pt had passed out for a duration of 5-10 seconds then woke up. Pt was administered 1 dose of adult epipen and 911 was called. Once EMT arrived they took him to the hospital to be evaluated. He appeared to recover by demonstrating the ability to stand up walk around and respond to questions asked by the EMT.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Respiration abnormal, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10-15 mins after vaccine, pt stated he was feeling dizzy. RPh went to take pt's BP, but pt fainted. called 911. pt woke up after 5 mins, no trouble breathing, but sweating. BP was 167/93 & pulse 78. First responders came and took BP and blood sugar. pt fainted again for 5-10 mins, stopped beathing few mins and decided to transport him to nearest ER. RPh called next day 6/29 & 7/1 but no response and left message.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10-15 mins after vaccine, pt stated he was feeling dizzy. RPh went to take pt's BP, but pt fainted. called 911. pt woke up after 5 mins, no trouble breathing, but sweating. BP was 167/93 & pulse 78. First responders came and took BP and blood sugar. pt fainted again for 5-10 mins, stopped beathing few mins and decided to transport him to nearest ER. RPh called next day 6/29 & 7/1 but no response and left message.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: NUMBNESS IN LEFT ARM
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was well during the 15 minute observation period and has no comorbidities according to health questionnaire. As she was exiting the store she felt faint and lost consciousness for 30 seconds and recovered consciousness. She fell backwards and bumped her head against the ground. Paramedics were called and patient BP and blood glucose was within normal limits. Patient was alert and sitting upright when paramedics arrived.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was well during the 15 minute observation period and has no comorbidities according to health questionnaire. As she was exiting the store she felt faint and lost consciousness for 30 seconds and recovered consciousness. She fell backwards and bumped her head against the ground. Paramedics were called and patient BP and blood glucose was within normal limits. Patient was alert and sitting upright when paramedics arrived.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Eye swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Paraesthesia, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Gait disturbance, Hypoaesthesia, Panic attack, Tachycardia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient had panic attack after the dose. She felt numbness and stated it was difficult to walk. She insisted Son (pharmacist) to call emergency number. However, once she was feeling better, Son cancelled the emergency number call. However, later, her husband called emergency number. The firefighters stated ptn is fine as she was feeling better was able to go home with her husband.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: upon administration of vaccine patient appeared to be okay. 2 minutes after administration, patient sat on floor and started report feeling sweaty, lightheaded, dizzy. had patient lay down and called 911. patient became unresponsive but pulse was still present. ambulance took patient via stretcher to hospital
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: upon administration of vaccine patient appeared to be okay. 2 minutes after administration, patient sat on floor and started report feeling sweaty, lightheaded, dizzy. had patient lay down and called 911. patient became unresponsive but pulse was still present. ambulance took patient via stretcher to hospital
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Paraesthesia, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Anxiety-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Malaise, Nausea, Syncope
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Rph noticed pt didn't look well as she waited after the shot. pt said she was not feeling well and rested head on RPH shoulder & passsed out. Rph with assistance of another Rph lower pt to floor. pt regained consciousness but still seemed out of it. We called 911. kept her feet elevated, covered her with blanket since body temp dec to 93.2, she was able to answer questions. paramedics took bp & bs and said bs low. pt had had smoothie before shot . Went to hosp in ambulance
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Rph noticed pt didn't look well as she waited after the shot. pt said she was not feeling well and rested head on RPH shoulder & passsed out. Rph with assistance of another Rph lower pt to floor. pt regained consciousness but still seemed out of it. We called 911. kept her feet elevated, covered her with blanket since body temp dec to 93.2, she was able to answer questions. paramedics took bp & bs and said bs low. pt had had smoothie before shot . Went to hosp in ambulance
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe