chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested COVID-19 positive after receiving her Pfizer-BioNTech COVID-19 vaccination; Tested COVID-19 positive after receiving her Pfizer-BioNTech COVID-19 vaccination; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0140; Expiration Date: 31Mar2021), via an unspecified route of administration, administered in arm on 27Jan2021 (Age at the vaccination: 56-year-old) as dose 2, single and also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL0140; Expiration Date: 31Mar2021), via an unspecified route of administration on 06Jan2021 (Age at the vaccination: 56-year-old) as dose 1, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took her daily medications but declined to provide that information at the time of reporting. Patient stated she was advised by her husband who was a Pfizer employee, to report to Pfizer that she tested COVID-19 positive on 03Aug2021 after receiving her Pfizer BioNTech COVID-19 vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Aug2021. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL0140. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The outcome of events was unknown.   Lot/ batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Body started to feel tingling and numb; Body started to feel tingling and numb; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Aug2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), polycarbophil calcium (FIBER), ascorbic acid, vaccinium spp (CRANBERRY), ginkgo biloba (GINKGO) and D all for unknown indications, from an unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Aug2021 about 10 minutes after injection the patient experienced body started to feel tingling and numb (like patient was given novicane at the dentist). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event body started to feel tingling and numb was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Meningitis
Clinical narrative: Meningitis; Difficulty breathing; This is a spontaneous report from a Pfizer-sponsored Program. This is the second of 2 reports. A contactable consumer reported a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 16Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: Unknown), dose 1, via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects.On an unspecified date, the patient experienced difficulty breathing. It was mentioned the patient had meningitis on an unspecified date. Clinical outcome of the events meningitis and difficulty breathing was unknown.   Information on lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mouth swelling, Musculoskeletal stiffness, Night sweats
Clinical narrative: Face and mouth swollen; Face and mouth swollen; Chills; Soak and wet in the night; Tired; Fever sores; Mouth was sore; Fever; Aches, pains; Stiff neck; Soreness of the arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (Patient's parent). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 31Jul2021 10:30 (at 22 years old) as dose 2, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 in right arm, on 10Jul2021 10:30 (at 22 years old), for COVID-19 immunization. The patient's parent reported that her son received the second dose of the vaccine on Saturday, 31Jul2021 and had reactions. The patient had a fever. He also had aches, pains, stiff neck, and soreness of the arm where the vaccine was administered. The patient also woke up in the morning of 04Aug2021 with his face and mouth swollen. He had an appointment with the doctor. He had a fever and chills and was soak and wet in the night of 31Jul2021. The stiff neck was not ongoing, but the patient still felt like tired. The patient's parent was wondering if the fever the patient had was so high that it caused the outbreak of the face and everything to swell. The patient's parent stated the patient had fever sores from one side of lip to other. The patient was saying his mouth was sore and woke up and the patient's parent gave him an ice pack and called the doctor. The outcome of the events "face and mouth swollen", and "tired" was not recovered, "aches, pains" was recovering, and unknown outcome for other events.   Information on the batch/lot number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Oral pain, Pain, Pyrexia, Swelling face
Clinical narrative: Face and mouth swollen; Face and mouth swollen; Chills; Soak and wet in the night; Tired; Fever sores; Mouth was sore; Fever; Aches, pains; Stiff neck; Soreness of the arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (Patient's parent). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 31Jul2021 10:30 (at 22 years old) as dose 2, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 in right arm, on 10Jul2021 10:30 (at 22 years old), for COVID-19 immunization. The patient's parent reported that her son received the second dose of the vaccine on Saturday, 31Jul2021 and had reactions. The patient had a fever. He also had aches, pains, stiff neck, and soreness of the arm where the vaccine was administered. The patient also woke up in the morning of 04Aug2021 with his face and mouth swollen. He had an appointment with the doctor. He had a fever and chills and was soak and wet in the night of 31Jul2021. The stiff neck was not ongoing, but the patient still felt like tired. The patient's parent was wondering if the fever the patient had was so high that it caused the outbreak of the face and everything to swell. The patient's parent stated the patient had fever sores from one side of lip to other. The patient was saying his mouth was sore and woke up and the patient's parent gave him an ice pack and called the doctor. The outcome of the events "face and mouth swollen", and "tired" was not recovered, "aches, pains" was recovering, and unknown outcome for other events.   Information on the batch/lot number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Face and mouth swollen; Face and mouth swollen; Chills; Soak and wet in the night; Tired; Fever sores; Mouth was sore; Fever; Aches, pains; Stiff neck; Soreness of the arm where the vaccine was administered; This is a spontaneous report from a contactable consumer (Patient's parent). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 31Jul2021 10:30 (at 22 years old) as dose 2, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 in right arm, on 10Jul2021 10:30 (at 22 years old), for COVID-19 immunization. The patient's parent reported that her son received the second dose of the vaccine on Saturday, 31Jul2021 and had reactions. The patient had a fever. He also had aches, pains, stiff neck, and soreness of the arm where the vaccine was administered. The patient also woke up in the morning of 04Aug2021 with his face and mouth swollen. He had an appointment with the doctor. He had a fever and chills and was soak and wet in the night of 31Jul2021. The stiff neck was not ongoing, but the patient still felt like tired. The patient's parent was wondering if the fever the patient had was so high that it caused the outbreak of the face and everything to swell. The patient's parent stated the patient had fever sores from one side of lip to other. The patient was saying his mouth was sore and woke up and the patient's parent gave him an ice pack and called the doctor. The outcome of the events "face and mouth swollen", and "tired" was not recovered, "aches, pains" was recovering, and unknown outcome for other events.   Information on the batch/lot number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore left Arm; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, eczema and allergic to fish, grass and oak pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included loratadine (CLARITIN) and salbutamol (ALBUTEROL INHALER); both for an unknown indication from an unknown date. On 04Aug2021 at 12:15, the patient experienced sore left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient gave nasal swab for SARS-CoV-2 test and the result was negative. The clinical outcome of the event sore left arm was recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dizziness, Drug ineffective, Headache
Clinical narrative: covid_test_result = Positive; covid_test_result = Positive; Weakness feeling in body lingers after second shot.; Headache slightly comes and goes.; Light headed Des.; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 23Jun2021 at 16:30 as dose 1, single and second of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Aug2021 11:15 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. Concomitant medications included aspirin (ACETYLSALICYLIC ACID) and nasal spray taken for an unspecified indication. The patient previously took phenobarbital and experienced drug hypersensitivity. Patient had not taken any treatment for reported events. Patient was diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient had covid test result positive (drug ineffective), covid test result positive (covid-19). On 04Aug2021 (at 11:30 AM), the patient experienced weakness feeling in body lingers after second shot, headache slightly comes and goes, light headedness. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on an unspecified date. At the time of this report event COVID-19 was unknown and other event outcome was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid_test_result = Positive; covid_test_result = Positive; Weakness feeling in body lingers after second shot.; Headache slightly comes and goes.; Light headed Des.; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 23Jun2021 at 16:30 as dose 1, single and second of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Aug2021 11:15 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. Concomitant medications included aspirin (ACETYLSALICYLIC ACID) and nasal spray taken for an unspecified indication. The patient previously took phenobarbital and experienced drug hypersensitivity. Patient had not taken any treatment for reported events. Patient was diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient had covid test result positive (drug ineffective), covid test result positive (covid-19). On 04Aug2021 (at 11:30 AM), the patient experienced weakness feeling in body lingers after second shot, headache slightly comes and goes, light headedness. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on an unspecified date. At the time of this report event COVID-19 was unknown and other event outcome was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Chills, Cold sweat, Hyperhidrosis
Clinical narrative: Pulmonary hypertension; Cold sweats; Chills; Bones and back ache; Bones and back ache; Sweating; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, solution for injection, batch/lot number: not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing COVID-19 from 2020. She was a long term COVID patient for the last year and a few months. She was still on medication. Concomitant medications were not reported. The patient experienced pulmonary hypertension on an unspecified date, cold sweats, chills, bones and back ache, sweating on an unspecified date in 2021. The patient stated that, I was okay for 14 days. On the 15 day of my first dose which was last night I started to experience cold sweats, chills, bones and back ache. It just woke me up. I was sweating and I had chills. I had a horrible aching around my back. I had to sit for quite a lot of time maybe until 3 in the morning. It started to feel better, but It was horrible last night. I have the long term COVID. I am still on medication. Caller wants to know if the second dose is required for people with previous COVID-19 history. She was really concerned with getting the second. The patient underwent lab tests and procedures which included investigation: pulmonary hypertension on an unspecified date, SARS-COV-2 test: positive on an unknown date in 2020. Therapeutic measures taken as a result of pulmonary hypertension included blood thinners. The outcome of pulmonary hypertension was unknown. The outcome of the rest of the events was recovering at the time of this report.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pulmonary hypertension, SARS-CoV-2 test
Clinical narrative: Pulmonary hypertension; Cold sweats; Chills; Bones and back ache; Bones and back ache; Sweating; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, solution for injection, batch/lot number: not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing COVID-19 from 2020. She was a long term COVID patient for the last year and a few months. She was still on medication. Concomitant medications were not reported. The patient experienced pulmonary hypertension on an unspecified date, cold sweats, chills, bones and back ache, sweating on an unspecified date in 2021. The patient stated that, I was okay for 14 days. On the 15 day of my first dose which was last night I started to experience cold sweats, chills, bones and back ache. It just woke me up. I was sweating and I had chills. I had a horrible aching around my back. I had to sit for quite a lot of time maybe until 3 in the morning. It started to feel better, but It was horrible last night. I have the long term COVID. I am still on medication. Caller wants to know if the second dose is required for people with previous COVID-19 history. She was really concerned with getting the second. The patient underwent lab tests and procedures which included investigation: pulmonary hypertension on an unspecified date, SARS-COV-2 test: positive on an unknown date in 2020. Therapeutic measures taken as a result of pulmonary hypertension included blood thinners. The outcome of pulmonary hypertension was unknown. The outcome of the rest of the events was recovering at the time of this report.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel well after vaccine; This is a spontaneous report from a non-contactable consumer. A male patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. On an unknown date, the patient did not feel well after he received the vaccine. The clinical outcome of the event did not feel well after vaccine was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: Sore arm; Metallic taste in mouth; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm and metallic taste in the mouth after the shot. The clinical outcome for the events sore arm and metallic taste in mouth were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: 1st Dose 19Feb2021/2nd Dose 04Mar2021; COVID-19 positive test results; COVID-19 positive test results; This is a spontaneous report from a contactable consumer.A 58-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EI9269), via an unspecified route of administration, administered in Arm Left on 04Mar2021 as dose 2, single and first dose via unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: EL9262) as dose1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not had covid-19 prior to vaccination. Post vaccination the patient was tested for COVID-19. On 01Aug2021, the patient had COVID-19 positive test result and on an unspecified date, there was Inappropriate schedule of vaccine administered. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests which included rapid result antigen test: positive on 01Aug2021 nasal Swab. The patient had not yet recovered from COVID-19 positive test results.   Follow-up attempts are completed. No further information is expected
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Positive Test Results; COVID-19 Positive Test Results; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9269, Expiry date: Unknown) via intramuscularly administered in Arm Left on 02Mar2021 (at the age of 58-years-old) as dose 2, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EM9809, Expiry date: Unknown) intramuscularly administered in Arm Left arm on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 31Jul2021 the patient experienced COVID-19 positive test results. On 02Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Antigen Test) as positive for nasal Swab. Patient did not receive other vaccine in four weeks. Patient has no covid prior vaccination, He tested for covid post vaccination. The events resulted in doctor or other healthcare professional office or clinic visit. No treatment received for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Hot flush, Nausea
Clinical narrative: Tired; Weak; Nauseous; Hot flash; Dizzy; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 03Aug2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Aug2021 at 11:45, the patient felt tired, weak, nauseous, hot flash, dizzy and had arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, weak, nauseous, hot flash, dizzy and arm pain were unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Tired; Weak; Nauseous; Hot flash; Dizzy; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 03Aug2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04Aug2021 at 11:45, the patient felt tired, weak, nauseous, hot flash, dizzy and had arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, weak, nauseous, hot flash, dizzy and arm pain were unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Skin burning sensation
Clinical narrative: pins and needles on the skin; itching on the skin/itching all over her body; burning sensation on the skin; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 23Jul2021 (Batch/Lot Number: ER8729) as dose 1, single for covid-19 immunization (at the age of 61-years-old). Medical history included asthma (controlled and nothing has flared up), Porphyria cutanea tarda (it was formally diagnosed last year but she has had issues on and off her whole life but didn't notice) and allergic to sulfa based drugs all from an unknown date and unknown if ongoing. The patient previously took penicillin [penicillin nos] and was allergic to Penicillin. The patient stated that she received the first dose of vaccine on 23Jul2021 and within 4 hours she was experiencing burning, pins and needles, and itching all over her body but there was no visible rash or redness on her skin. She further explained that she has a history of PCT which was Porphyria Cutanea Tarda, which was a condition she has with her skin. She rarely has break outs, like 1 break out in her whole life. It was now 2 weeks out today and she was still experiencing the symptoms, it has gone down a little bit in the last couple days but her next shot was schedule on 13Aug2021 on Wednesday and would like to know what should be done in regards to the second dose. She stated that she doesn't know if this was a coincidence or an allergic reaction, but if it were an allergic reaction what should be the protocol for the second dose. The burning sensation, itching, and pins and needles sensation was all ongoing, and has all improved in the last 2 days. Her Second dose is schedule for 13Aug2021. As a treatment She can't take antihistamines because it can set off PCT, but she follows a protocol trying to eat really clean and taking vitamins, no alcohol Kind of like a detox. The adverse event did not result into the emergency room or physician office visit. She did not seek any medical attention because it didn't affect her breathing, it was just a constant burning and itching. The outcome of all the event was recovering at the time of report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Apr2021 09:00 (at the age of 31-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization. The patient had no past drug event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 03Jun2021, the patient experienced Blood clot in right arm. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with prescription for Xarelto. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovered with lasting effects in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Flushing
Clinical narrative: face was flushed, its red; face was flushed, its red; doesn't feel bad he just doesn't want to do anything; This is a spontaneous report from a contactable consumer (patient's wife). A 7-decade-old (in their 80's) male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 02Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 02Aug2021 and 03Aug2021, noticed that patient and his wife were both doing good but patient face was flushed on Aug2021. Wife was wondering if it was connected to the shot, it was red. Patient works out in the yard. Patient had not been outside or in the sun. Patient does not feel bad he just does not want to do anything. Patient otherwise were doing well with no other concerns. Patient was advised to consult with his doctor/healthcare provider about for what patient experienced, as his doctor/healthcare provider was most familiar with his medical condition, clinical history, how his treatment has been conducted and any relevant information to his specific case, his doctor/healthcare provider was in the best position to advise him about the appropriate action to take. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A 17-years-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EP7534), via intramuscularly, in Left arm on Mar2021 as single dose (at the age of 17-year-old) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that, on Apr2021 at 08:00 AM 2 weeks after the 1st COVID vaccine dose, patient developed COVID symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on Apr2021 Nasal Swab. Patient waited for the symptoms to go for 2 weeks and then we scheduled her 2nd shot until 26May2021 (2 months after her 1st dose). No treatment was received. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pruritus, Rash, Vaccination site pain
Clinical narrative: rash/a rash all over his body; chest pain; pain at the injections site; itchy; This is a spontaneous report from a contactable nurse. A 12-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced rash/a rash all over his body, chest pain, pain at the injections site and itchy. The outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: he passed away within 48 hours; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 (Batch/Lot Number: em9809) as dose 1, single for covid-19 immunisation. The patient has no medical history. Concomitant medication included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021, 12:00, the patient passed away within 48 hours. The patient received defibrillation as treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient died on 11Feb2021 due to cardiac disorder. An autopsy was not performed.; Reported Cause(s) of Death: Cardiac
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Autoimmune disorder, Diarrhoea, Irritable bowel syndrome
Clinical narrative: stomach pain; very concerned, worried, scared/ crying and scared; had more diarrhea; IBS flare up; symptoms that seem to be flaring, auto immune system stuff; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 22Jul2021 as dose 1, single for COVID-19 immunization. Medical history included IBS. The patient's concomitant medications were not reported. Patient got her first dose of the Pfizer BioNTech Covid-19 vaccine on 22Jul2021 and was scheduled for her second dose on 12Aug2021. Since the first dose, she has had stomach pain, and was very concerned, worried, scared. She was asking if others have experienced it and how long it lasted for them. Stated she has heard of Covid doing this to people, and knows everyone is different and that she is sensitive to things. She was calling regarding the Pfizer Covid vaccine. She just wanted to get a little bit of comfort. She was late at getting it because she does have some auto immune issues and some significant gastrointestinal things. She was originally on the side of not getting the vaccine but recently decided that she should just go and do it. She was one of those people who were really on the fence because of her underlying stuff. She had the first shot 22Jul2021 and it wasn't even 2 weeks out. Thursday, it will be 2 weeks. Her biggest concern was that she got some symptoms that seem to be flaring, auto immune system stuff. The biggest was stomach pain. She had more diarrhea and she has IBS but has the other kind of IBS. Everything she keeps reading says that it is going away in 3 days. For her, she was usually the exception, hers was usually 5 to 7 days. The severity kind of comes and goes. She didn't need to go to the ER or anything, not to be alarming but, it did feel a lot like an IBS flare up. She was concerned because her next shot is 12Aug2021 and she does not want to not get it and not be protected. She has other side effects and then would not be protected from that either. She has so much going on in her whole life. She was just worried, and has been crying and scared. Her stomach hurts a lot, since 22Jul2021. She thought things would be a little better by now. There were some other things but, this was the biggest. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headaches; This is a spontaneous report from a contactable consumer (patient's father) through a Pfizer-sponsored program.. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 2, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had dizziness and headaches. The events were assessed as serious (medically significant). The patient had been to specialists (physician office visit), and was unable to work because of the reported events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from program. A non-contactable female consumer (patient) of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced tested positive for covid. The patient underwent lab tests which included sars-cov-2 test: positive on an unspecified date. She was asking what would happen if a certain person took the 1st dose of the Pfizer COVID-19 vaccine and tested positive for COVID after. She was asking how long she needs to wait to get the 2nd dose. The outcome of both events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic
Clinical narrative: metastatic breast cancer; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient herself) reported that A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection. Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and second dose via an unspecified route of administration on 19Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced metastatic breast cancer (breast cancer metastatic) on an unspecified date. The clinical course as follows, it reported as Caller 65-years-old with metastatic breast cancer had both doses of the Pfizer covid-19 vaccine, with the second dose on 19Feb21. Caller has been watching (news channel name) and read a quarterly report and on page 25 read about Pfizer making a booster shot. Caller inquiring on third booster and how vaccines are recorded. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vitreous floaters
Clinical narrative: Floaters in both eyes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on 26Apr2021(at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On 05May2021, two weeks after the first dose of vaccination, the patient experienced floaters in both eyes and it was still ongoing and was getting worse. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of floaters in both eyes which included treatment with eye drops (MANUFACTURER UNKNOWN). On an unknown date, the patient underwent SARS-CoV-2 test and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event floaters in both eyes was not resolved at the time of this report.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Potential COVID infection based upon symptoms and my spouse's positive COVID test; Potential COVID infection based upon symptoms and my spouse's positive COVID test; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP7534), via an unspecified route of administration on 26Mar2021 (at the age of 49-years-old) as dose 2, single; and received first dose of BNT162B2 (Lot Number: EN6205), via an unspecified route of administration on 05Mar2021 (at the age of 48-years-old) as dose 1, single; both for COVID-19 immunization at other. Medical history included asthma and high blood pressure. Family history included positive COVID-19 test of spouse (wife) on 01Aug2021. Concomitant medication was not reported and had no relevant past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, patient not been tested for COVID-19. On 01Aug2021, Patient experienced potential COVID-19 infection based upon symptoms and spouse's positive COVID-19 test. Reporter assessed the events as non-serious. No hospitalization prolonged reported and no treatment received. The outcome of the events were not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dizziness, Dysmenorrhoea, Fatigue
Clinical narrative: Seizures around 7 pm the same day; Cough; Severe congestion; Freezing cold all the time; Muscle spasms; Heart palpitations; Numbness of my hands and feet; Severe tremors in my hands; Dizziness; Weight loss; Menstrual cramps; Has affected my menstrual cycle severely; Loss of appetite; Headaches; Had extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0175), via an unspecified route of administration in the left arm on 10Jun2021 at 11:40 as a dose 2, single for COVID-19 immunization (at the age of 31-years-old). Medical history included Known allergies: Soy from an unknown date and unknown if ongoing.There were no concomitant medications. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173), via an unspecified route of administration in the left arm on 20May2021 at 12:00 as a dose 1, single for COVID-19 immunization (at the age of 31-years-old). The patient did not receive any medication within 2 weeks of vaccination. 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 had not been tested for COVID-19. The patient stated that she had two seizures around 7 pm the same day (10Jun2021 19:00). Since her second dose of Pfizer, 10Jun2021 13:00, she have had extreme fatigue, cough, severe congestion, freezing cold all the time, muscle spasms, heart palpitations, numbness of my hands and feet, severe tremors in my hands, headaches, dizziness, loss of appetite, weight loss, menstrual cramps every day and has affected her menstrual cycle severely. The patient did not receive any treatment. The clinical outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected