chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: double vision after the second dose of the Pfizer covid vaccine; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: ER8730; Expiration Date: Jul2021) via an unspecified route of administration, administered in arm left on 28Apr2021 13:18 (at the age of 37-year-old) at dose 2, 0.3 ml single for covid-19 immunisation. Medical history included high blood pressure (He clarifies that on the patients profile he sees the patient is on blood pressure medication). Confirms she has the patient's paper only has high blood pressure and she doesn't see any other conditions on there. Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. Patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: ER8730; Expiration Date: Jul2021, via an unspecified route of administration on 31Mar2021 (at the age of 37-year-old) at dose 1, single for covid-19 immunisation. On an unspecified date in Apr2021 the patient experienced double vision after the second dose of the Pfizer covid vaccine. Reporter stated they have a 37-year-old female patient who reported of double vision after the second dose of the Pfizer covid vaccine yesterday. caller wanted to know about any reports of it. Reporter stated he is a pharmacist calling from . He has a customer who got the second dose yesterday and the customer called back saying she has double vision. Caller is wondering if there any reports on that. Reporter states he tried to check on the website, clarified as the CDC website, but did not see that. Reporter asks are there on any reports on double vision. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cardiac disorder, Chills, Feeling cold, Heart rate
Clinical narrative: typical flu symptoms; My Fever still went to 103; heart rate was 183; pouring sweat; my teeth were chattering; I was wrapped in a heating blanket on high and so cold; My heart felt like it was going to beat out of my chest; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 59267-1000-2), via an unspecified route of administration, administrated in Left arm on 24Apr2021 17:30 (age at the time of vaccination 36-years-old), as a single dose for COVID-19 immunization. The patient's medical history Lymphoma, complete recovery and patient took other vaccine in four weeks (name unspecified). The patient's concomitant medications included Multi vitamins. Patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 59267-1000-2), via an unspecified route of administration, administrated in Left arm on 27Mar2021 18:45 (age at the time of vaccination 36-years-old), as a single dose for COVID-19 immunization. On 25Apr2021 16:30, the patient experienced typical flu symptoms, My Fever still went to 103, heart rate was 183, pouring sweat, my teeth were chattering, I was wrapped in a heating blanket on high and so cold, and My heart felt like it was going to beat out of my chest. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 103, My Fever still went to 103; and heart rate: 183. Patient had been taking Tylenol as a treatment received for adverse events. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible: No further information is excepted.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Influenza, Pyrexia
Clinical narrative: typical flu symptoms; My Fever still went to 103; heart rate was 183; pouring sweat; my teeth were chattering; I was wrapped in a heating blanket on high and so cold; My heart felt like it was going to beat out of my chest; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 59267-1000-2), via an unspecified route of administration, administrated in Left arm on 24Apr2021 17:30 (age at the time of vaccination 36-years-old), as a single dose for COVID-19 immunization. The patient's medical history Lymphoma, complete recovery and patient took other vaccine in four weeks (name unspecified). The patient's concomitant medications included Multi vitamins. Patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: 59267-1000-2), via an unspecified route of administration, administrated in Left arm on 27Mar2021 18:45 (age at the time of vaccination 36-years-old), as a single dose for COVID-19 immunization. On 25Apr2021 16:30, the patient experienced typical flu symptoms, My Fever still went to 103, heart rate was 183, pouring sweat, my teeth were chattering, I was wrapped in a heating blanket on high and so cold, and My heart felt like it was going to beat out of my chest. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 103, My Fever still went to 103; and heart rate: 183. Patient had been taking Tylenol as a treatment received for adverse events. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible: No further information is excepted.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diplopia, Fatigue, Muscular weakness
Clinical narrative: double vision; muscle weakness; very tired and weak; very tired and weak; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8731; Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 79-year) in right arm on 16Apr2021 at 12:00 as dose 1, single for COVID-19 immunization. Medical history included ongoing cataract in left eye, ongoing neuropathy in his feet, stroke from Sep2020 and ongoing, coronary bypass surgery from 2005 to an unknown date. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) the patient was not administered with any other vaccinations. On 18Apr2021 the patient experienced very tired and weak, on an unspecified date the patient experienced double vision and muscle weakness. The patient was not hospitalized for the adverse events. It was not provided if AEs required a visit to Emergency Room/Physician Office. It was reported that "Caller was 79 y/o male. Caller received his first dose of the Pfizer Covid vaccine on 16Apr2021. His second dose was due tomorrow 06May2021 and he wanted to know if he should get it based off of his side effects. He stated he developed double vision after his vaccine dose, which had now resolved, and he had on-going fatigue and muscle weakness since the vaccine. He stated he had been in rehab for a stroke that occurred in Sep2020 and now his rehab stay had been extended for 6 weeks due to his muscle weakness. Caller stated he had the first dose of the Pfizer Covid vaccine on 16Apr2021, stated he had a reaction to it. Stated about 3 hours after the vaccine he started to feel very tired and weak, stated it started to get better and then got worse again, stated the past 3 days it had been really bad. Stated he had been going to rehab for a stroke and he was about to get discharged, then he got this vaccine and these symptoms had put him back about 2-3 months. Today he woke up and was more tired than he had ever been. Scheduled to have the second shot tomorrow, wanted to know should he get the second dose. The last few days it had gone downhill. Caller also stated he had taken 4-15 pills a day, had coronary bypass surgery in 2005, takes blood pressure, blood thinner, neuropathy medication, no further information provided." The clinical outcome of the event double vision was resolved on an unspecified date; outcome of muscle weakness was unknown; while, the outcome of other events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diplopia, Dizziness, Fatigue
Clinical narrative: Swollen lymph nodes; Injection site pain; Tiredness; Insomnia; Double vision; Joint pain; Muscle pain; Nausea; Chills; Sweating; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 35-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on an unspecified date, as single dose for COVID-19 immunization and experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first 30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hous. It was reported that after receiving the second dose of vaccine on an unspecified the patient experienced injection site pain, tiredness, insomnia, muscle pain, joint pain chills, nausea, swollen lymph nodes, double vision and dizziness within the first 4 hrs and also experienced sweating. Caller mentioned that she had side effects after getting the first and second dose of the vaccine and stated that she had experienced way more severe and longer than usual side effects during the first dose compared to that of the second dose. Caller would like to know if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Swollen lymph nodes; Injection site pain; Tiredness; Insomnia; Double vision; Joint pain; Muscle pain; Nausea; Chills; Sweating; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 35-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on an unspecified date, as single dose for COVID-19 immunization and experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first 30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hous. It was reported that after receiving the second dose of vaccine on an unspecified the patient experienced injection site pain, tiredness, insomnia, muscle pain, joint pain chills, nausea, swollen lymph nodes, double vision and dizziness within the first 4 hrs and also experienced sweating. Caller mentioned that she had side effects after getting the first and second dose of the vaccine and stated that she had experienced way more severe and longer than usual side effects during the first dose compared to that of the second dose. Caller would like to know if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swollen lymph nodes; Injection site pain; Tiredness; Insomnia; Double vision; Joint pain; Muscle pain; Nausea; Chills; Sweating; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization (at the age of 35-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on an unspecified date, as single dose for COVID-19 immunization and experienced injection site pain, tiredness, insomnia, headache within the first 4 hours, muscle and joint pain, nausea, feeling unwell, cough for the first 30 minutes, accelerated heartbeat for the first 30 minutes but did not last, dizziness and weakness for the first 4hous. It was reported that after receiving the second dose of vaccine on an unspecified the patient experienced injection site pain, tiredness, insomnia, muscle pain, joint pain chills, nausea, swollen lymph nodes, double vision and dizziness within the first 4 hrs and also experienced sweating. Caller mentioned that she had side effects after getting the first and second dose of the vaccine and stated that she had experienced way more severe and longer than usual side effects during the first dose compared to that of the second dose. Caller would like to know if there are currently any antibody test used for detecting the COVID19 virus accurately post vaccination that might not give a false positive result. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diplopia, Gait disturbance, Impaired driving ability
Clinical narrative: having diplopia; cannot drive; cannot walk; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient stated having diplopia for a month and "nothing patient took to resolve it had worked patient still had double vision, cannot drive, cannot walk really patient can barely function. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Injection site muscle weakness, Muscular weakness
Clinical narrative: 2 days after 2nd vaccination, felt dizzy; Short of breath; Fatigue; Right arm weakness; Picking up or opening anything feel weakness and shoots up to where shot was given; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 27Apr2021 at 15:00 (at the age of 52-year-old) as dose 2, single for COVID-19 immunisation. Medical history included hemiparesis (left) and spasticity. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and botulinum toxin type a (BOTOX) from unknown date for unspecified indication. The patient has taken AVELOX on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date for COVID-19 immunisation. On 29Apr2021 at 12:00, 2 days after vaccination, the patient felt dizzy, short of breath, fatigue, right arm weak. While picking up or opening anything, the patient felt weakness and shoots up to where shot was given, the symptoms were ongoing at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with steroids. The outcome of the events 2 days after 2nd vaccination, felt dizzy, short of breath, fatigue, right arm weakness, picking up or opening anything feel weakness and shoots up to where shot was given was not recovered at the time of this report.  Information on the lot/batch number not available, despite of follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the body, which started a month after the vaccination series; This is a spontaneous report received from a contactable nurse, the patient. A 48-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: not reported), via an unspecified route of administration in arm left on 10Feb2021 at 10:30 AM (at the age of 48-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 00:00, the patient experienced hives all over the body, which started a month after the vaccination series. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was not received for the event. On 25May2021, the patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 test), resulted as negative. The outcome of the event was recovering.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vertigo
Clinical narrative: Vaccine location: Right buttocks; Started feeling moderate to severe vertigo; This is a spontaneous report from a contactable nurse (patient). A 48 years old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via intramuscular route, administered in the gluteus medius right (right buttock) on 26May2021 at 12:00 (at the age of 48-year-old) as a Dose 2, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included depression, anxiety and IV iodine allergy. The patient's concomitant medications included bupropion hydrochloride (WELLBUTRIN) 150 mg and escitalopram oxalate (LEXAPRO) 20 mg; both since unknown dates for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Unknown) via an unspecified route of administration on unknown date as a dose 1, single for COVID-19 immunization. On 26May2021 at 16:00, the patient experienced feeling moderate to severe vertigo in afternoon and better the next day but the vertigo was still there, although it was somewhat less severe, and this was upon her second dose of the vaccine. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event moderate to severe vertigo was recovering.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: experienced cramps but cycle has still not come. As of sending this notification cycle is now 13 days late. Cycle has never been late - regular; experienced cramps but cycle has still not come. As of sending this notification cycle is now 13 days late. Cycle has never been late - regular; This is a spontaneous report from a contactable consumer. A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0175) via an unspecified route of administration on 18May2021 18:00 PM administered in left arm as DOSE 1, SINGLE for covid-19 immunization (age of 14 years). The patient medical history included asthma - seasonal and food allergies of cashews and pistachios. The patient concomitant medications were none. It was reported that patient did not took any vaccination in four weeks and did not experienced COVID prior to vaccination. On 31May2021, the patient had experienced cramps but cycle has still not come. As of sending this notification cycle is now 13 days late. Cycle has never been late - regular. The patient did not undergo any lab test for COVID -19 after vaccination. The patient had received unknown therapeutic measure of the adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Started period on 22May2021. Still on it as of 08Jul2021. Non stop.; Started period on 22May2021. Still on it as of 08Jul2021. Non stop.; This is a spontaneous report from a contactable consumer (patient). A 15-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 12:00 (at the age of 15-years-old) (Batch/Lot Number: CP7533) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have any medical history. There were no concomitant medications. The patient's period had started on 22May2021 12:00 PM and was still on it as of 08Jul2021 non stop. The patient had not received any other vaccine within four weeks and other medications in two weeks. Patient did not have any known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that patient did not have pregnancy at time of vaccination. Patient did not receive any treatment for adverse events. Outcome of events were not recovered.   No follow up attempts are possible. No further information is expected.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Candida infection, Chills, Cough, Diarrhoea
Clinical narrative: liver enzymes were high; URI/Flu like symptoms; Flu like symptoms; Diarrhea; chills; fever; weird taste; weird smell; thrush; lesions in my mouth; persistent cough; dizziness; nausea; runny nose; extreme fatigue; upper abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), intramuscular, administered in Arm Left on 01Jun2021 14:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunisation. Medical history included Diabetes from 2001 and ongoing, POTS from almost 2 years and ongoing, Mild asthma, diabetic autonomic neuropathy, possible unknown autoimmune, Glaucoma from 5 plus years and ongoing, Gastric patient from 7 years and ongoing (Sleeve then revision to RNY 2018), Upper Respiratory thrush, mouth lesions thrush. Family medical history relevant to AE(S) included Possible unknown auto immune disorder. Known allergies included PCN, Topamax, Imitex, Vancomycin, Benzoyl peroxide. Concomitant medication(s) included azithromycin (Z-PAK) taken for Upper Respiratory thrush by oral route from 21Jun2021 to 26Jun2021; Nystatin oral wash for mouth lesions thrush by Oral route from 13Jul2021 to 19Jul2021; Nystatin tablets for mouth lesions by oral route from 30Jun2021 to 12Jul2021. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as yes, too many to list. Patient did not have Covid prior vaccination. Covid was tested post vaccination using: Nasal Swab method (Patient had the rapid and the regular nasal). The reported that her first symptom was fatigue which progressed to URI/Flu like symptoms. The patient experienced flu like symptoms, diarrhea, chills, fever, weird taste, weird smell, thrush, lesions in my mouth, persistent cough, dizziness, nausea, runny nose, extreme fatigue, upper abdominal pain on 02Jun2021 10:00. The patient stated that her liver enzymes were high as well. The patient underwent lab tests and procedures which included Liver magnetic resonance imaging: Abnormal on 26Jul2021, sars-cov-2 test: negative on 25Jun2021 Nasal Swab, ultrasound scan: abnormal on 26Jul2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was advised not to get the second dose. Patient received treatment for adverse events which included two courses of antibiotics, steroids, antivirals. The outcome of fatigue was recovering, for liver enzymes were high it was unknown, and all other events was not recovered. The Pfizer product had a causal effect to the adverse event was reported as probably.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hepatic enzyme increased, Influenza like illness, Magnetic resonance imaging
Clinical narrative: liver enzymes were high; URI/Flu like symptoms; Flu like symptoms; Diarrhea; chills; fever; weird taste; weird smell; thrush; lesions in my mouth; persistent cough; dizziness; nausea; runny nose; extreme fatigue; upper abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), intramuscular, administered in Arm Left on 01Jun2021 14:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunisation. Medical history included Diabetes from 2001 and ongoing, POTS from almost 2 years and ongoing, Mild asthma, diabetic autonomic neuropathy, possible unknown autoimmune, Glaucoma from 5 plus years and ongoing, Gastric patient from 7 years and ongoing (Sleeve then revision to RNY 2018), Upper Respiratory thrush, mouth lesions thrush. Family medical history relevant to AE(S) included Possible unknown auto immune disorder. Known allergies included PCN, Topamax, Imitex, Vancomycin, Benzoyl peroxide. Concomitant medication(s) included azithromycin (Z-PAK) taken for Upper Respiratory thrush by oral route from 21Jun2021 to 26Jun2021; Nystatin oral wash for mouth lesions thrush by Oral route from 13Jul2021 to 19Jul2021; Nystatin tablets for mouth lesions by oral route from 30Jun2021 to 12Jul2021. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as yes, too many to list. Patient did not have Covid prior vaccination. Covid was tested post vaccination using: Nasal Swab method (Patient had the rapid and the regular nasal). The reported that her first symptom was fatigue which progressed to URI/Flu like symptoms. The patient experienced flu like symptoms, diarrhea, chills, fever, weird taste, weird smell, thrush, lesions in my mouth, persistent cough, dizziness, nausea, runny nose, extreme fatigue, upper abdominal pain on 02Jun2021 10:00. The patient stated that her liver enzymes were high as well. The patient underwent lab tests and procedures which included Liver magnetic resonance imaging: Abnormal on 26Jul2021, sars-cov-2 test: negative on 25Jun2021 Nasal Swab, ultrasound scan: abnormal on 26Jul2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was advised not to get the second dose. Patient received treatment for adverse events which included two courses of antibiotics, steroids, antivirals. The outcome of fatigue was recovering, for liver enzymes were high it was unknown, and all other events was not recovered. The Pfizer product had a causal effect to the adverse event was reported as probably.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral disorder, Parosmia, Pyrexia, Rhinorrhoea
Clinical narrative: liver enzymes were high; URI/Flu like symptoms; Flu like symptoms; Diarrhea; chills; fever; weird taste; weird smell; thrush; lesions in my mouth; persistent cough; dizziness; nausea; runny nose; extreme fatigue; upper abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), intramuscular, administered in Arm Left on 01Jun2021 14:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunisation. Medical history included Diabetes from 2001 and ongoing, POTS from almost 2 years and ongoing, Mild asthma, diabetic autonomic neuropathy, possible unknown autoimmune, Glaucoma from 5 plus years and ongoing, Gastric patient from 7 years and ongoing (Sleeve then revision to RNY 2018), Upper Respiratory thrush, mouth lesions thrush. Family medical history relevant to AE(S) included Possible unknown auto immune disorder. Known allergies included PCN, Topamax, Imitex, Vancomycin, Benzoyl peroxide. Concomitant medication(s) included azithromycin (Z-PAK) taken for Upper Respiratory thrush by oral route from 21Jun2021 to 26Jun2021; Nystatin oral wash for mouth lesions thrush by Oral route from 13Jul2021 to 19Jul2021; Nystatin tablets for mouth lesions by oral route from 30Jun2021 to 12Jul2021. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as yes, too many to list. Patient did not have Covid prior vaccination. Covid was tested post vaccination using: Nasal Swab method (Patient had the rapid and the regular nasal). The reported that her first symptom was fatigue which progressed to URI/Flu like symptoms. The patient experienced flu like symptoms, diarrhea, chills, fever, weird taste, weird smell, thrush, lesions in my mouth, persistent cough, dizziness, nausea, runny nose, extreme fatigue, upper abdominal pain on 02Jun2021 10:00. The patient stated that her liver enzymes were high as well. The patient underwent lab tests and procedures which included Liver magnetic resonance imaging: Abnormal on 26Jul2021, sars-cov-2 test: negative on 25Jun2021 Nasal Swab, ultrasound scan: abnormal on 26Jul2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was advised not to get the second dose. Patient received treatment for adverse events which included two courses of antibiotics, steroids, antivirals. The outcome of fatigue was recovering, for liver enzymes were high it was unknown, and all other events was not recovered. The Pfizer product had a causal effect to the adverse event was reported as probably.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder, Ultrasound scan, Upper respiratory tract infection
Clinical narrative: liver enzymes were high; URI/Flu like symptoms; Flu like symptoms; Diarrhea; chills; fever; weird taste; weird smell; thrush; lesions in my mouth; persistent cough; dizziness; nausea; runny nose; extreme fatigue; upper abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186), intramuscular, administered in Arm Left on 01Jun2021 14:30 (at the age of 47-year-old) as dose 1, single for covid-19 immunisation. Medical history included Diabetes from 2001 and ongoing, POTS from almost 2 years and ongoing, Mild asthma, diabetic autonomic neuropathy, possible unknown autoimmune, Glaucoma from 5 plus years and ongoing, Gastric patient from 7 years and ongoing (Sleeve then revision to RNY 2018), Upper Respiratory thrush, mouth lesions thrush. Family medical history relevant to AE(S) included Possible unknown auto immune disorder. Known allergies included PCN, Topamax, Imitex, Vancomycin, Benzoyl peroxide. Concomitant medication(s) included azithromycin (Z-PAK) taken for Upper Respiratory thrush by oral route from 21Jun2021 to 26Jun2021; Nystatin oral wash for mouth lesions thrush by Oral route from 13Jul2021 to 19Jul2021; Nystatin tablets for mouth lesions by oral route from 30Jun2021 to 12Jul2021. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as yes, too many to list. Patient did not have Covid prior vaccination. Covid was tested post vaccination using: Nasal Swab method (Patient had the rapid and the regular nasal). The reported that her first symptom was fatigue which progressed to URI/Flu like symptoms. The patient experienced flu like symptoms, diarrhea, chills, fever, weird taste, weird smell, thrush, lesions in my mouth, persistent cough, dizziness, nausea, runny nose, extreme fatigue, upper abdominal pain on 02Jun2021 10:00. The patient stated that her liver enzymes were high as well. The patient underwent lab tests and procedures which included Liver magnetic resonance imaging: Abnormal on 26Jul2021, sars-cov-2 test: negative on 25Jun2021 Nasal Swab, ultrasound scan: abnormal on 26Jul2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was advised not to get the second dose. Patient received treatment for adverse events which included two courses of antibiotics, steroids, antivirals. The outcome of fatigue was recovering, for liver enzymes were high it was unknown, and all other events was not recovered. The Pfizer product had a causal effect to the adverse event was reported as probably.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was administered without reconstitution of the HIB component approximately 2 weeks ago with no reported adverse event; Initial information received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown demographic patient who vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstitution of the HIB component approximately 2 weeks ago (lot number and expiry date not reported) via unknown route at an unknown administration site on 30-Aug-2021 for prophylactic vaccination (product preparation error).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to product preparation error (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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 batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient given PENTACEL instead of DAPTACELwith no reported adverse event; given an extra IPOL dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00759904) and transmitted to Sanofi on 08-Sep-2021.  This case involved 4 year-5-month-old male patient given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and given an extra IPV (VERO) [IPOL] dose (wrong product administered and extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE; MUMPS VACCINE; RUBELLA VACCINE; VARICELLA ZOSTER VACCINE in the right for prophylactic vaccination.   On 08-Sep-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number: UJ473AAA and expiry date: 09-Jul-2022) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and given an extra 0.5ml dose of suspect IPV (VERO) [IPOL] (lot number: T1E871M and expiry date: 10-Oct-2022) (Frequency = once) (Strength = standard) via subcutaneous route in the left thigh for prophylactic vaccination.  It was reported, "What should they do now? The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. The patient is doing fine and the provider is aware".   This case was an actual medication error due to wrong vaccine administered and extra dose administered.  At the time of reporting, no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Vaccine was exposed to 34.7 degree Fahrenheit for 5 hours and 36 minutes/ no AE; Initial information was received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from an Other health professional via Medical Information (Reference number- 00763952) and transmitted to Sanofi on 10-Sep-2021.  This case involves a five-year-old female patient reported that DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] was exposed to 34.7-degree Fahrenheit for 5 hours and 36 minutes with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml (total) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5772BA and expiry date 17-Sep-2022] via intramuscular route in the right deltoid for prophylactic vaccination.  It was reported, "They had a temperature excursion of unknown cause. Caller stated it was a total of 5 hours and 36 minutes. Caller stated the refrigerator temperature reached 34.7 degrees Fahrenheit. Caller also stated 5 children received vaccines after the excursion occurred."  Product used: Used. First time product used: Yes. Still using product: No. HCP can be contacted Yes/No: No.  It was a case of actual medication error due to incorrect product storage (latency was on same day).  At the time of reporting, patient had 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: The rash spreading out from the injection site extends down to her elbow; The injection site was swollen and red; The injection site was swollen; The injection site was red; Initial information received on 13-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00766539).   This case involves an unknown age female patient who had injection site was swollen and red (vaccination site inflammation, vaccination site swelling and vaccination site erythema) and the rash spreading out from the injection site extends down to her elbow (rash), after receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 09-Sep-2021 at 14:00, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (total, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 12-Sep-2021, the patient developed a non-serious injection site was swollen and red (vaccination site inflammation, vaccination site swelling and vaccination site erythema) and the rash spreading out from the injection site extends down to her elbow (rash),3 days following the administration of vaccine.  It was reported "Pharmacist states that he provided the MENQUADFI to a patient on Thursday but on Sunday, the patient reported that the area of injection was swollen and red. There's now a rash down to her elbow, do we have any information on that? Email declined.Received from MIA (medical information agency). Do you have any information about a rash spreading out from the injection site? Is this common, or should we be concerned about possible cellulitis? The pharmacist declined to provide additional details, saying that he is very busy at the moment."  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the patient did not recover from the reported events.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given Pentacel instead of Quadracel, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (Reference number- 00766758) and transmitted to Sanofi on 13-Sep-2021.  This case involves a 4 years old and unknown gender patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 13-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry dates were not reported) via unknown route at an unknown administration site for prophylactic vaccination (wrong product administered).  It was reported "do they need to re-boost with Quadracel or is the patient ok with just the Pentacel?"  It was an actual medication error case due to wrong vaccine administered (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.  There will be no information on the batch number for this case.