chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection was painful; usual sore shoulder; feeling tired; groggy; Caller received the Pfizer COVID-19 vaccine; he is afraid that the ingredients in the hand sanitizer entered the muscle through the skin; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2, on an unspecified date for covid-19 immunization. The patient states that while he was waiting for the pharmacist to assemble and prepare the vaccine, the patient saw a jar of disinfecting alcohol wipes. The patient wiped both of his shoulders with the wipes. The sanitizer dried. Then the vaccine administrator rubbed the injection site area with an alcohol swab and gave him the injection. The patient specified that she did a light rub and gave the injection. The patient was afraid that the ingredients in the hand sanitizer entered the muscle through the skin. The patient mentioned that the ingredients that were found in the sanitizer besides alcohol were: aloe Vera juice, glycerin, a food thickener (which the patient was not sure of the name) and a few other things like vitamin E, an antioxidant. The patient was worried that they could had entered the muscle along with the needle. The patient would like to know if any of these ingredients would be in risk of interacting with the vaccine and affecting the effectiveness of it. The patient also mentioned that the injection was painful. There had been no problem, except usual sore shoulder, feeling tired, groggy. The patient stated that he was doing better today. The patient wants to know when the dosage of the booster shot was injected into the muscle and how long did it take to disperse in the blood. The patient received his booster dose and while the patient was waiting to get his booster dose the patient saw that there were hand sanitizer wipes (further clarification unknown hence, captured as Unspecified Product) and so, the patient thought the patient would wipe down his shoulder before receiving the vaccine and when the patient went to get the booster he did not think that hand sanitizer was dry all the way and so, the patient was wondering if some of the chemicals in that hand sanitizer could had gotten into the injection site from getting the booster and so, the patient was just wanting to know if there would be any interaction but because of this the patient wanted him to speak with Drug and safety first in case you have additional questions for him. The outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Pain in extremity
Clinical narrative: severe period cramps; arm hurts; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 3 via an unspecified route of administration on 28Oct2021 (Batch/Lot number was not reported) at the age of 33-years-old as dose 3 (booster), single for covid-19 immunisation. Medical history included endometriosis and patient is allergic to shrimp (patient is still getting tested) from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from Sep2021 to Sep2021; levonorgestrel (KYLEENA) taken for an unspecified indication, start and stop date were not reported, paracetamol (TYLENOL) and vitamins taken for an unspecified indication, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 on 11Jan2021 and dose 2 on 01Feb2021 both at the age of 32-years-old for Covid-19 immunization. On 28Oct2021, the patient experienced severe period cramps an hour after getting the shot and arm hurts. The patient did not receive treatment for the events. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101479859 same patient, suspect drug and event; different dose
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Parkinsonism
Clinical narrative: increased symptoms in 7 months which was not horrible but was progressing; diagnosed with Tentative Parkinson's Syndrome; This is a spontaneous report from a contactable consumer (patient) or other non healthcare professional. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Lot Number: EN6203), via an unspecified route of administration on 03Mar2021 as DOSE 1, SINGLE (age at the vaccination was 69-year-old) and the patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Lot Number: ER2613) via an unspecified route of administration on 24Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient was not if the reaction was to the first or second, but it started 2 weeks after the second. The patient stated that he started to develop what he thought was Parkinson's syndrome. The patient had the vaccine in Mar2021 and was diagnosed with tentative Parkinson's Syndrome on an unknown date Apr2021. The patient had an appointment with a respected hospital. The patient saw his primary care physician, a neurologist, and a rheumatologist. His question to everyone, some of the appointments were on an unknown dated June or July, was when the booster was available is it recommended to get the booster with the tentative Parkinson's Diagnosis in on an unknown dated Apr2021 It had gotten worse. It has progressed over the 7 months. The patient was in a high-risk category. The patient was 7 months past the second shot. The patient doesn't want to stay hibernated in his house. The patient would like to be able to see his children. The patient stated that he had seen doctors over the last 7 months and had been in contact with them through email and asked them specifically about his condition as he had increased symptoms in 7 months which was not horrible but was progressing. The patient wanted to know if this was a reported side effect with the vaccine and how it progresses as his doctors had no data and referred him to call Pfizer. The events outcome was reported as not recovered.  These adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it was not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cholecystitis, Drug ineffective, Illness
Clinical narrative: got an inflamed gallbladder; The patients were immunocompromised and got sick after taking the vaccine, and got COIVD; The patients were immunocompromised and got sick after taking the vaccine, and got COIVD; The patients were immunocompromised and got sick after taking the vaccine, and got COIVD; This is a spontaneous report from Pfizer via a contactable healthcare professional reporting different events under the same suspect product for 2 patients. This is one of 2 reports. A 76-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included immunocompromised. The patient's concomitant medications were not reported. The patient got sick after taking the vaccine and got COIVD. Patient got an inflamed gallbladder and the doctor wanted to remove it, that she did not agree with it was necessary organ. Outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Inappropriate schedule of product administration
Clinical narrative: 1st dose: 01Feb2021, 2nd dose: 18Feb2021; Cyst developed on head; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 41 years old) (Batch/Lot Number: EL8982) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported and statins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took the first dose of BNT162B2 on 01Feb2021 (at the age of 40 years old) Batch/Lot No: EL8982, administered to Arm Left for Covid-19 immunization. On an unspecified date in 2021, the patient had a Cyst developed on head. The event resulted in a Doctor or other healthcare professional office/clinic visit. Therapeutic measures of Steroid injection in the cyst location and antibiotics were taken as a result of the event. The outcome of the event was recovered on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Lip swelling, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Strong allergic reaction; hives; swelling hand; Swelling lips; Swelling other places; dose 3, single (booster dose); This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: Ff2593 and expiry sate: not reported), via an unspecified route of administration into right arm on 26Oct2021 at 01:00 PM as dose 3, single (booster dose) (Age at vaccination: 70-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concurrent conditions were none. Concomitant medications (within 2 weeks of vaccination) included: Amoxicillin and patient had competed 10-day course 28Oct2021. The patient had no Known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: En6208), on 16Mar2021 at 11:00 AM as dose 1, single; Second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: Er8729), on 09Apr2021 at 11:00 AM as dose 2, single, both doses via an unspecified route of administration into right arm for COVID-19 immunization (The patients age at both first and dose of vaccination was 69-year-old). On 29Oct2021 at 06:00 AM, the patient had Strong allergic reaction, hives, swelling on hand, lips, and other places. Therefore, the patient had visited Emergency room/department or urgent care (Doctor or other healthcare professional office/clinic visit). The patient was not diagnosed with COVID-19 prior to vaccination but was tested for COVID-19 Since the vaccination. The laboratory tests included PCR test (Nasal Swab) on 29Oct2021, and results were pending. The patient was treated with Prednisone for all events. All events were considered serious. Outcome of events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Strong allergic reaction; hives; swelling hand; Swelling lips; Swelling other places; dose 3, single (booster dose); This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: Ff2593 and expiry sate: not reported), via an unspecified route of administration into right arm on 26Oct2021 at 01:00 PM as dose 3, single (booster dose) (Age at vaccination: 70-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concurrent conditions were none. Concomitant medications (within 2 weeks of vaccination) included: Amoxicillin and patient had competed 10-day course 28Oct2021. The patient had no Known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: En6208), on 16Mar2021 at 11:00 AM as dose 1, single; Second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: Er8729), on 09Apr2021 at 11:00 AM as dose 2, single, both doses via an unspecified route of administration into right arm for COVID-19 immunization (The patients age at both first and dose of vaccination was 69-year-old). On 29Oct2021 at 06:00 AM, the patient had Strong allergic reaction, hives, swelling on hand, lips, and other places. Therefore, the patient had visited Emergency room/department or urgent care (Doctor or other healthcare professional office/clinic visit). The patient was not diagnosed with COVID-19 prior to vaccination but was tested for COVID-19 Since the vaccination. The laboratory tests included PCR test (Nasal Swab) on 29Oct2021, and results were pending. The patient was treated with Prednisone for all events. All events were considered serious. Outcome of events was recovering at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chest discomfort, Contusion, Gait inability, Head discomfort
Clinical narrative: Angioedema; Urticaria; I developed urticarial vasculitis; I started having tremors; Spasms; Nerve pain on my right side down my shoulder; Heart palpitations; chest pressure; Head pressure; I have inflammation all over my body; numbness in my feet; I am unable to walk at times; Bruising from head to toe; passing blood clots from my vagina; passing blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid patient from an unknown date and unknown if ongoing; and uterine ablation from an unknown date reported as 11 years ago. Prior to vaccination, the patient had no known allergies, had not received any other vaccines in 4 weeks and was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of the vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6203) in the left arm on 18Mar2021 at 11:00 (at 41-years-old) for COVID-19 immunisation. The patient reported that 14 days after her second dose on 22Apr2021 at 05:30, she developed angioedema and urticaria. Then she developed urticarial vasculitis. She started having tremors, spasms, nerve pain on her right side down her shoulder, heart palpitations, and chest pressure. She had developed head pressure with nerve pain and had inflammation all over her body that was causing numbness in her feet where she was unable to walk at times. She had bruising from head to toe that no doctor could explain. She was passing blood clots from her vagina that had a uterine ablation 11 years ago. The events were reported as serious for disabling. The events required a physician office visit, and the patient was treated with " medicines, supplements, HBOT, EBO2, etc." The clinical outcomes of the events were not recovered. On 01Sep2021 the patient had a blood test for SARS-COV-2 Total Antibody Interpretation which was negative.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypoaesthesia, Inflammation, Muscle spasms, Neuralgia
Clinical narrative: Angioedema; Urticaria; I developed urticarial vasculitis; I started having tremors; Spasms; Nerve pain on my right side down my shoulder; Heart palpitations; chest pressure; Head pressure; I have inflammation all over my body; numbness in my feet; I am unable to walk at times; Bruising from head to toe; passing blood clots from my vagina; passing blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid patient from an unknown date and unknown if ongoing; and uterine ablation from an unknown date reported as 11 years ago. Prior to vaccination, the patient had no known allergies, had not received any other vaccines in 4 weeks and was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of the vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6203) in the left arm on 18Mar2021 at 11:00 (at 41-years-old) for COVID-19 immunisation. The patient reported that 14 days after her second dose on 22Apr2021 at 05:30, she developed angioedema and urticaria. Then she developed urticarial vasculitis. She started having tremors, spasms, nerve pain on her right side down her shoulder, heart palpitations, and chest pressure. She had developed head pressure with nerve pain and had inflammation all over her body that was causing numbness in her feet where she was unable to walk at times. She had bruising from head to toe that no doctor could explain. She was passing blood clots from her vagina that had a uterine ablation 11 years ago. The events were reported as serious for disabling. The events required a physician office visit, and the patient was treated with " medicines, supplements, HBOT, EBO2, etc." The clinical outcomes of the events were not recovered. On 01Sep2021 the patient had a blood test for SARS-COV-2 Total Antibody Interpretation which was negative.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test, Tremor, Urticaria, Urticarial vasculitis
Clinical narrative: Angioedema; Urticaria; I developed urticarial vasculitis; I started having tremors; Spasms; Nerve pain on my right side down my shoulder; Heart palpitations; chest pressure; Head pressure; I have inflammation all over my body; numbness in my feet; I am unable to walk at times; Bruising from head to toe; passing blood clots from my vagina; passing blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid patient from an unknown date and unknown if ongoing; and uterine ablation from an unknown date reported as 11 years ago. Prior to vaccination, the patient had no known allergies, had not received any other vaccines in 4 weeks and was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of the vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6203) in the left arm on 18Mar2021 at 11:00 (at 41-years-old) for COVID-19 immunisation. The patient reported that 14 days after her second dose on 22Apr2021 at 05:30, she developed angioedema and urticaria. Then she developed urticarial vasculitis. She started having tremors, spasms, nerve pain on her right side down her shoulder, heart palpitations, and chest pressure. She had developed head pressure with nerve pain and had inflammation all over her body that was causing numbness in her feet where she was unable to walk at times. She had bruising from head to toe that no doctor could explain. She was passing blood clots from her vagina that had a uterine ablation 11 years ago. The events were reported as serious for disabling. The events required a physician office visit, and the patient was treated with " medicines, supplements, HBOT, EBO2, etc." The clinical outcomes of the events were not recovered. On 01Sep2021 the patient had a blood test for SARS-COV-2 Total Antibody Interpretation which was negative.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Angioedema; Urticaria; I developed urticarial vasculitis; I started having tremors; Spasms; Nerve pain on my right side down my shoulder; Heart palpitations; chest pressure; Head pressure; I have inflammation all over my body; numbness in my feet; I am unable to walk at times; Bruising from head to toe; passing blood clots from my vagina; passing blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid patient from an unknown date and unknown if ongoing; and uterine ablation from an unknown date reported as 11 years ago. Prior to vaccination, the patient had no known allergies, had not received any other vaccines in 4 weeks and was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of the vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6203) in the left arm on 18Mar2021 at 11:00 (at 41-years-old) for COVID-19 immunisation. The patient reported that 14 days after her second dose on 22Apr2021 at 05:30, she developed angioedema and urticaria. Then she developed urticarial vasculitis. She started having tremors, spasms, nerve pain on her right side down her shoulder, heart palpitations, and chest pressure. She had developed head pressure with nerve pain and had inflammation all over her body that was causing numbness in her feet where she was unable to walk at times. She had bruising from head to toe that no doctor could explain. She was passing blood clots from her vagina that had a uterine ablation 11 years ago. The events were reported as serious for disabling. The events required a physician office visit, and the patient was treated with " medicines, supplements, HBOT, EBO2, etc." The clinical outcomes of the events were not recovered. On 01Sep2021 the patient had a blood test for SARS-COV-2 Total Antibody Interpretation which was negative.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Major Seizure; This is a spontaneous report from a contactable Consumer or other non-HCP (parent). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FE3590, Expiration date: Unknown), via an unspecified route of administration in right arm on 22Oct2021 at 14:00 (at the age of 18-year-old), as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history included allergy. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the past drugs BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: Unknown), via an unspecified route of administration in right arm on 15Jan2021, as dose 1, single and then BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810, Expiration date: Unknown), via an unspecified route of administration in right arm on 05Feb2021, as dose 2, single for COVID-19 immunization. On 28Oct2021 at 07:00, the patient experienced major seizure. The adverse events resulted in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care visit. Therapeutic measures were taken as a result of major seizure. The case was reported as non-serious and the event did not result death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The outcome of the event was unknown at the time of this report.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Hypertension
Clinical narrative: high blood pressure; Immense chest pain; This is a spontaneous report from a contactable consumer reported for himself (Patient). A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: 30135BA, Expiration date: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Oct2021 06:00 (age at vaccination was 27 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included covid-19 from an unknown date. Patient experienced covid prior to the vaccination. Concomitant medication within two weeks of vaccination included Creatine, Magnesium, Vitamin D3, Turkesterone, rhod taken for an unspecified indication, The patient did not have any known allergy. Patient did not receive any other vaccine in four weeks. The patient experienced high blood pressure and immense chest pain on 18Oct2021 10:30PM. The patient underwent lab tests and procedures which included blood pressure measurement as high. Event leads the patient to visit emergency room. Patient did not receive any treatment. Vaccination facility was Pharmacy or Drug Store. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Severe stomach pains; headaches; fatigue; graying of the skin; brain fog; sinuses; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 21Sep2021 12:30 (at the age of 52 years old) (Batch/Lot Number: FE3592) as dose 1, single for COVID-19 immunisation.  Medical history included known allergies to Penicillin, erythromycin and eggs. The patient was not pregnant at the time of vaccination. It was unknown if patient had COVID prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 21Sep2021 15:00, the patient experienced Severe stomach pains, headaches, fatigue, graying of the skin, brain fog and sinuses. Treatment for the events was yes, acupuncture. The events resulted in a doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. (Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No). The outcome of the events was recovering. Post vaccination COVID test type nasal swab on 15Oct2021, result: negative.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Skin discolouration
Clinical narrative: Severe stomach pains; headaches; fatigue; graying of the skin; brain fog; sinuses; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 21Sep2021 12:30 (at the age of 52 years old) (Batch/Lot Number: FE3592) as dose 1, single for COVID-19 immunisation.  Medical history included known allergies to Penicillin, erythromycin and eggs. The patient was not pregnant at the time of vaccination. It was unknown if patient had COVID prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 21Sep2021 15:00, the patient experienced Severe stomach pains, headaches, fatigue, graying of the skin, brain fog and sinuses. Treatment for the events was yes, acupuncture. The events resulted in a doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. (Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No). The outcome of the events was recovering. Post vaccination COVID test type nasal swab on 15Oct2021, result: negative.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vertigo
Clinical narrative: Vertigo; booster; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female non-pregnant patient received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 30135BA), via an unspecified route of administration, administered in left arm on 01Oct2021 16:15 (50-year-old at time of vaccination) as dose 3 (booster), single for COVID-19 immunisation. Medical history included GERD, high blood pressure, high cholesterol, and hypothyroidism. Concomitant medications (patient received within 2 weeks of vaccination) included benazepril (BENAZEPRIL); escitalopram oxalate (LEXAPRO); trazodone (TRAZODONE); omeprazole (PRILOSEC); estradiol (ESTRADIOL). The patient previously received the first dose of bnt162b2 (Lot Number: EL9265) administered in left arm on 29Jan2021 (49-year-old at time of vaccination) for COVID-19 immunization; previously received the second dose of bnt162b2 (Lot Number: EN6198) administered in left arm on 26Feb2020 09:30 (49-year-old at time of vaccination) for COVID-19 immunization; previously received promethazine (PHENERGAN) and experienced allergy: phenergan. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced vertigo on 24Oct2021 04:00. The event was assessed as non-serious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient has been diagnosed with vertigo that will not go away. She has been suffering for 6 days now. Therapeutic measures were taken as a result of vertigo and included Meclizine and Zofran. The outcome of the event vertigo was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal, Hepatic failure, Immunisation, Multiple organ dysfunction syndrome
Clinical narrative: Booster; Booster; Multi organ failure; Liver; Renal; Pancreatitis; A-fib; Feeling pretty crappy like he had the flu or virus; This is a spontaneous report from a contactable physician reporting for himself. A 62-years-old male patient received bnt162b2 (BNT162B2), dose 3 (booster) intramuscular, administered in arm on 10Sep2021 (Batch/Lot Number: FC3183) as a single dose for COVID-19 immunisation. The first dose of the Pfizer COVID Vaccine was given on 05Jan2021, with Lot EL0142 expiration Mar2021. The 2nd dose was given on 26Jan2021 with Lot EL9262, expiration May2021. Prior vaccinations (within 4 weeks) prior to the first administration date of the COVID vaccine was none. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol from an unknown date and unknown if ongoing, iodine allergy from an unknown date and unknown if ongoing allergy to iodine diagnosed 10-15 years ago, rubber sensitivity from an unknown date and unknown if ongoing allergy to latex diagnosed 10-15 years ago. There were no concomitant medications. On an unspecified date in 2021, the patient experienced multi-organ failure, feeling pretty crappy like he had the flu or virus, liver (hepatic failure), renal (renal failure), pancreatitis, a-fib (atrial fibrillation), and hemodialysis. The patient was hospitalized for a-fib, multi organ failure, liver (hepatic failure) renal (renal failure), and pancreatitis (pancreatitis) from 04Oct2021 to 19Oct2021. The physician described the clinical course of the events as follows: He had booster shot and about 3 weeks later started feeling pretty crappy like he had the flu or virus.  He went to the doctor who sent him to the ER and he ended up in multi organ failure including: renal, liver, pancreatitis, A-fib and hemodialysis for about a week and a half. His Creat, Bili, and Lipase is still high, but trending better.  He is not on dialysis anymore. The patient underwent lab tests and procedures which included blood bilirubin: 14 on 04Oct2021, blood creatinine: 8's on 04Oct2021, blood urea: 80's on 04Oct2021, lipase: 900 on 04Oct2021. The patient received hemodialysis as treatment for renal failure. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pancreatitis, Renal failure
Clinical narrative: Booster; Booster; Multi organ failure; Liver; Renal; Pancreatitis; A-fib; Feeling pretty crappy like he had the flu or virus; This is a spontaneous report from a contactable physician reporting for himself. A 62-years-old male patient received bnt162b2 (BNT162B2), dose 3 (booster) intramuscular, administered in arm on 10Sep2021 (Batch/Lot Number: FC3183) as a single dose for COVID-19 immunisation. The first dose of the Pfizer COVID Vaccine was given on 05Jan2021, with Lot EL0142 expiration Mar2021. The 2nd dose was given on 26Jan2021 with Lot EL9262, expiration May2021. Prior vaccinations (within 4 weeks) prior to the first administration date of the COVID vaccine was none. Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol from an unknown date and unknown if ongoing, iodine allergy from an unknown date and unknown if ongoing allergy to iodine diagnosed 10-15 years ago, rubber sensitivity from an unknown date and unknown if ongoing allergy to latex diagnosed 10-15 years ago. There were no concomitant medications. On an unspecified date in 2021, the patient experienced multi-organ failure, feeling pretty crappy like he had the flu or virus, liver (hepatic failure), renal (renal failure), pancreatitis, a-fib (atrial fibrillation), and hemodialysis. The patient was hospitalized for a-fib, multi organ failure, liver (hepatic failure) renal (renal failure), and pancreatitis (pancreatitis) from 04Oct2021 to 19Oct2021. The physician described the clinical course of the events as follows: He had booster shot and about 3 weeks later started feeling pretty crappy like he had the flu or virus.  He went to the doctor who sent him to the ER and he ended up in multi organ failure including: renal, liver, pancreatitis, A-fib and hemodialysis for about a week and a half. His Creat, Bili, and Lipase is still high, but trending better.  He is not on dialysis anymore. The patient underwent lab tests and procedures which included blood bilirubin: 14 on 04Oct2021, blood creatinine: 8's on 04Oct2021, blood urea: 80's on 04Oct2021, lipase: 900 on 04Oct2021. The patient received hemodialysis as treatment for renal failure. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Musculoskeletal stiffness, Pain, Pain in extremity, Swelling
Clinical narrative: hand became stiff and sore and within a week settled in index and thumb; severe pain; Swelling; A cellulitis developed in the hand of the arm that received the vaccine in; hand became stiff and sore and within a week settled in index and thumb; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in the left arm in Jan2021 at 12:00 (at the age of 37-year-old), dose 1, single for COVID-19 immunisation. Medical history included allergy. The patient did not receive concomitant medications. The patient previously took unspecified medication and had allergy. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 19Jan2021, a cellulitis developed in the hand of the arm that the patient received the vaccine in. The hand became stiff and sore and within a week settled in the index and thumb. The patient also had swelling and severe pain. The events were reported as serious (medically significant) and resulted in doctor or other healthcare professional office/clinic visit. The patient received Augmentin and Bactrim for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Arthralgia, Diarrhoea, Fatigue
Clinical narrative: anaphylactic reaction; lung producing bloody phlegm (when waking up in morning); sore muscle (deltoid) / muscle pain; abdomen pain (lower left); diarrhea; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received dose 3 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Oct2021 10:00 (Batch/Lot Number: FF2590) (at the age of 50 years old) as dose 3 (booster), single for Covid-19 immunisation. Medical history included asthma, hypertension, degenerative disc degeneration (DDD), attention deficit hyperactivity disorder (ADHD), and bee sting allergy. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunization, start and stop date were not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 16Mar2021 10:00am in left arm (Batch/Lot No: GN6206) (at the age of 50 years old); and second dose on 06Apr2021 10:00am in left arm (Batch/Lot No: FR8730) (at the age of 50 years old); for COVID-19 immunization. The patient previously took metformin and levothyroxine and experienced allergy. After the third dose, on 29Oct2021 at 16:00, the patient experienced anaphylactic reaction, lung producing bloody phlegm, sore muscle (deltoid), abdomen pain (lower left), diarrhea, fatigue, and muscle and joint pain. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis, Myalgia
Clinical narrative: anaphylactic reaction; lung producing bloody phlegm (when waking up in morning); sore muscle (deltoid) / muscle pain; abdomen pain (lower left); diarrhea; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received dose 3 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Oct2021 10:00 (Batch/Lot Number: FF2590) (at the age of 50 years old) as dose 3 (booster), single for Covid-19 immunisation. Medical history included asthma, hypertension, degenerative disc degeneration (DDD), attention deficit hyperactivity disorder (ADHD), and bee sting allergy. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for immunization, start and stop date were not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 16Mar2021 10:00am in left arm (Batch/Lot No: GN6206) (at the age of 50 years old); and second dose on 06Apr2021 10:00am in left arm (Batch/Lot No: FR8730) (at the age of 50 years old); for COVID-19 immunization. The patient previously took metformin and levothyroxine and experienced allergy. After the third dose, on 29Oct2021 at 16:00, the patient experienced anaphylactic reaction, lung producing bloody phlegm, sore muscle (deltoid), abdomen pain (lower left), diarrhea, fatigue, and muscle and joint pain. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Syncope
Clinical narrative: Faint; diarrhea; a bit dizzy not followed by positional vertigo; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 05Oct2021 at 13:00 (at the age of 65-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 26Feb2021 at 10:00 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunization and upset stomach until 2nd shot then  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6208 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 20Mar2021 at 02:00 PM (at the age of 64-year-old) as DOSE 2, SINGLE for covid-19 immunization and almost blacked out, diarrhea, dizzy, followed by a week of positional vertigo. The patient previously had Compazine for vomiting and had Drug hypersensitivity and allergic to tyramine also. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The patient didn't receive any other medications within 2 weeks of vaccination.  Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. On 05Oct2021, 21 days after 3rd shot, patient experienced same symptoms but less severe as 2nd shot. Faint, diarrhea, a bit dizzy not followed by positional vertigo. No treatment was received for adverse events. Events required doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering at time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.