chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: not feeling well for a day or two and needing to rest.; urine was dark; got really sick; She is progressively ill.; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 06Jun2021 (Lot Number: Unknown) (at the age of 69-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. AE(s) following prior vaccinations was none. The Patient Medical History (including any illness at time of vaccination) was none. No Family Medical History Relevant to AE(s). The patient concomitant medications were not reported. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. The patient experienced not feeling well for a day or two and needing to rest and urine was dark (in morning) on an unspecified date in Jun2021. She got really sick and was progressively ill on an unspecified date in 2021. The clinical details of the events as follows: About two weeks following her first injection, she had typical reactions. She was not feeling well for a day or two and needing to rest. Two weeks after that, she did not connect the two events. Her urine was dark and two weeks following the injection to It continued on until she got really sick. It was an ongoing, progressive state of getting worse. She has been diagnosed with a medical condition as a result of receiving the vaccine. She was progressively ill. The AE(s) did not require a visit to emergency Room. The patient visited Physician Office. On an unknown date, she received heart tests, lab tests, and ultrasound for all the result was unknown. Relevant Tests were none. She wanted to report a severe side effect. She feels like it needs to be brought to our attention. She was not sure her doctor was going to send it in. Her urine was no longer brown. The patient outcome of the event urine was dark was resolved on an unspecified date in 2021 and the outcome of the other events 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: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Illness, Pyrexia
Clinical narrative: Feeling so sick right now, I can't even think straight; Feeling so sick right now, I can't even think straight; Full body chills; Fever of 102; Feel bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 09Aug2021 16:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Then evening started to have really bad adverse effects, had full body chills, a fever of 102, on 17Aug2021, feeling so sick right now, patient could not even think straight and Feel bad. The patient underwent lab tests and procedures which included body temperature: 102 degree centigrade on 17Aug2021. The patient was suggested to reach out to nearest Physician in case of emergency room in case of any medical emergency. The outcome of the event feel bad was unknown and other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Feeling so sick right now, I can't even think straight; Feeling so sick right now, I can't even think straight; Full body chills; Fever of 102; Feel bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 09Aug2021 16:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Then evening started to have really bad adverse effects, had full body chills, a fever of 102, on 17Aug2021, feeling so sick right now, patient could not even think straight and Feel bad. The patient underwent lab tests and procedures which included body temperature: 102 degree centigrade on 17Aug2021. The patient was suggested to reach out to nearest Physician in case of emergency room in case of any medical emergency. The outcome of the event feel bad was unknown and other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was hurting and still continues to hurt; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. On an unspecified date in 2021, a couple days later patient arm was hurting and still continues to hurt when the air hits, like the air conditioning. Consumer stated that she has an old scar on her arm where nobody usually gives her a shot in there, but the nurse gave the second shot of the Pfizer COVID-19 Vaccine in there and she can see where the needle went in. Consumer stated that she put alcohol on it, "I don't think that would hurt". Caller added that it does not hurt all the time, only when she was close to an air conditioning. She did not have any medical condition. Consumer asked if it was okay that the vaccination provider administered the shot in that scar. The outcome of 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-202101064375 same reporter/vaccine/AE different patient.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in my legs and hands and arms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration on 17Aug2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated that patient got second Pfizer vaccine today (17Aug2021) and patient guessed after 20 minutes (10:20) patient got the vaccine, patient had like numbness in the legs and hands and arms and patient just wanted to know if that was normal. The clinical outcome for the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass
Clinical narrative: There is a lump on my left breast like armpit as well; There is a lump on my left breast like armpit as well; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a lump on left breast like armpit as well. The patient stated that got the Pfizer vaccine on Wednesday the 11th, the last week. And knows it has the side effects like headache or tiredness or dizziness. And asked if a lump on left breast like armpit as well is one of the side effects of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura
Clinical narrative: IGA vasculitis; This is a spontaneous report from a contactable consumer. This consumer (patient's father) reported for a 40-year-old male patient (reporter's son).  A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: unknown, Expire Date: Unknown), via an unspecified route of administration on Apr2021 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. Patient's concomitant medications were not reported. Patient's report was not related to a study or Programme. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect. Patient had no additional Vaccines administered on same date of the Pfizer Suspect. Patient had no adverse event following prior vaccinations. Caller stated a year ago from Apr2021, so about 18 months ago, his son had what they all thought may have been Covid, but he could not get a test and he went to the hospital a couple of times, but they still never tested him for Covid, that was when tests were hard to get. Caller stated the doctors now were suggesting he might have had Covid last Apr2021. Caller stated they are saying he probably did have it. The patient experienced IGA vasculitis on 25Apr2021. It was reported that the patient got his first dose of the Pfizer BioNTech Covid-19 vaccine in Apr2021. Within 6 days, he got IGA vasculitis and was told not to get the second dose because of the vasculitis. Caller stated it went undiagnosed for a good couple of weeks. Caller stated this was back in Apr2021, and it had not gone away yet, it was better, but had not gone away. He was asking if there was any relation between vasculitis and the vaccine. Caller felt like the question of whether or not to get the second dose should had been asked by his son's doctors back in May2021 when he was finally diagnosed, which took a long time. His concern was that his son and his wife have a 2-week-old infant, and he was walking around with only one dose of the vaccine, so he was concerned about his son, his wife, and the baby. He had not received the second dose, greater than 21 days. Caller states 2 weeks ago, him and his wife had a baby. Caller stated so now his son was caring for his newborn grandchild, and he was only half vaccine. Caller stated his son sent him a picture of his leg on 01May2021, and it is hard to look at. Caller stated so this happened in Apr2021. Caller stated the injection was in the first or second week of Apr2021. Patient received Prednisone for the treatment of event. The outcome of the event was resolving.  The lot number for BNT162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive; This is a spontaneous report from a contactable consumer (wife) received via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0170), via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that, she and her husband (patient) got their first dose of the Pfizer COVID-19 vaccine on 02Aug2021, then they both tested positive on Aug 12th. Reporter further stated that her husband had no symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Aug2021 tested positive. The clinical outcome for the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder
Clinical narrative: Rash on inner right arm, upper right arm, side of right breast and a couple of spots on abdomen; a couple spots on the  right side of her stomach; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3180) via an unspecified route of administration, administered in Arm Left on 17Aug2021 as DOSE 1, SINGLE (at the age of 53-year-old) for covid-19 immunisation. The patient's medical history included guillain-barre syndrome from 1992 to an unknown date History of GB syndrome in 1992. The patient's concomitant medications were not reported. It was reported that, patient got vaccine in left arm and right side has the rash on 19Aug2021. The rash was on her inner, upper right arm and on the outer side of her right breast. Patient also has a couple spots on the right side of her stomach. Patient  was currently taking Allegra twice/day for symptoms. Therapeutic measures were taken as a result of events. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia, Malaise, Pain in extremity
Clinical narrative: Sore arm; blurry vision; numbness and tingling in hands and feet; numbness and tingling in hands and feet; shortness of breath; heart palpitation; anxiety; feeling of not being well; This is a spontaneous report from two contactable consumers. A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 12Aug2021 at 16:30 (age at vaccination: 21 years) as dose number unknown single for covid-19 immunisation. Medical history was repoted as None. Patient had Pertussis vaccine allergy. There were no concomitant medications. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vacccinations. Since the vaccination the patient was not tested for COVID-19. The patient experienced sore arm, blurry vision, numbness and tingling in hands and feet, shortness of breath, heart palpitation, anxiety, feeling of not being well on 14Aug2021.Patient received unspecified treatment for the events. The outcome of the events was no recovered.  Device Date was 20Aug2021.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Vision blurred
Clinical narrative: Sore arm; blurry vision; numbness and tingling in hands and feet; numbness and tingling in hands and feet; shortness of breath; heart palpitation; anxiety; feeling of not being well; This is a spontaneous report from two contactable consumers. A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 12Aug2021 at 16:30 (age at vaccination: 21 years) as dose number unknown single for covid-19 immunisation. Medical history was repoted as None. Patient had Pertussis vaccine allergy. There were no concomitant medications. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vacccinations. Since the vaccination the patient was not tested for COVID-19. The patient experienced sore arm, blurry vision, numbness and tingling in hands and feet, shortness of breath, heart palpitation, anxiety, feeling of not being well on 14Aug2021.Patient received unspecified treatment for the events. The outcome of the events was no recovered.  Device Date was 20Aug2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Electric shock sensation, Fatigue, Feeling abnormal, Muscle spasms
Clinical narrative: seizures; Muscle jerking; muscle twitching; pain; external & internal tremors; electric shock feeling; brain fog; cramps; stomach issues; blurry vision; fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 02Mar2021 at 12:00 PM (at the age of 39 years old) as single 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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 21:00, patient experienced muscle jerking, seizures, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Therapeutic measures were taken as a result of seizures, muscle jerking, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events treatment included numerous doctor's visits. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myoclonus, Pain, Seizure, Tremor
Clinical narrative: seizures; Muscle jerking; muscle twitching; pain; external & internal tremors; electric shock feeling; brain fog; cramps; stomach issues; blurry vision; fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 02Mar2021 at 12:00 PM (at the age of 39 years old) as single 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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 21:00, patient experienced muscle jerking, seizures, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Therapeutic measures were taken as a result of seizures, muscle jerking, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events treatment included numerous doctor's visits. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: seizures; Muscle jerking; muscle twitching; pain; external & internal tremors; electric shock feeling; brain fog; cramps; stomach issues; blurry vision; fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 02Mar2021 at 12:00 PM (at the age of 39 years old) as single 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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 21:00, patient experienced muscle jerking, seizures, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Therapeutic measures were taken as a result of seizures, muscle jerking, muscle twitching, pain, external and internal tremors, electric shock feeling, brain fog, cramps, stomach issues, blurry vision, and fatigue. The events treatment included numerous doctor's visits. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Palpitations, Supraventricular tachycardia
Clinical narrative: Sudden high heart rate 64-153 taking several minutes to subside, chest pounding; Sudden high heart rate 64-153 taking several minutes to subside, chest pounding; lightheaded; appears to be an episode of SVT; This is a spontaneous report from a contactable other hcp. A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Aug2021 13:30 (at the age of 39-years-old) as DOSE 1, SINGLE for covid-19 immunisation at other facility. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included omeprazole (OMEPRAZOLE); loratadine (CLARITINE); montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. The patient previously took Sulfa and experienced allergies. Other vaccine in four weeks included none. No COVID prior vaccination and COVID was not tested post vaccination. The patient experienced sudden high heart rate 64-153 taking several minutes to subside, chest pounding, lightheaded, gradually subsided, appeared to be an episode of SVT on 21Aug2021 21:15. The patient underwent lab tests and procedures which included heart rate: high on an unspecified date. No treatment was received for the events. The event appeared to be an episode of SVT was recovered with sequel on an unspecified date, while the other events were recovering at the time of this report.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dysphagia, Dyspnoea, Laryngeal pain
Clinical narrative: tightness was mixed with the pain; worst part of symptoms occurred around the larynx or trachea; worst part of symptoms occurred around the larynx or trachea; tightness was mixed with the pain; felt tight between the lower neck and upper chest area; felt tight between the lower neck and upper chest area; caused difficulty for me to breathe (inhale); caused difficulty for me to breathe (inhale), drink water, and swallow; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE- solution for injection; lot number- FA7485, expiry date not reported) via an unspecified route of administration into right arm, at the age of 33-year-old ,on 20Aug2021,16:30,at dose 2 single for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes allergic to soft-shell crab and giant river prawn. The patient didn't had any concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EW0191, expiry date not reported) via an unspecified route of administration, at the right arm, on 29Jul2021,16:30 at age of 32-year-old at dose 1, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On the night of Aug 21 22:00, he felt tight between the lower neck and upper chest area. It caused difficulty for him to breathe (inhale), drink water, and swallow. On the morning of Aug 22, those symptoms were more severe. The tightness was mixed with the pain. It was very hard to drink and swallow. During that moment, he noticed the worst part of symptoms occurred around the larynx or trachea. On Aug 23, 1:00 AM, the symptoms were getting better, but not fully normal. The patient did not receive treatment in response to the events. The outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat tightness, Tracheal pain
Clinical narrative: tightness was mixed with the pain; worst part of symptoms occurred around the larynx or trachea; worst part of symptoms occurred around the larynx or trachea; tightness was mixed with the pain; felt tight between the lower neck and upper chest area; felt tight between the lower neck and upper chest area; caused difficulty for me to breathe (inhale); caused difficulty for me to breathe (inhale), drink water, and swallow; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE- solution for injection; lot number- FA7485, expiry date not reported) via an unspecified route of administration into right arm, at the age of 33-year-old ,on 20Aug2021,16:30,at dose 2 single for covid-19 immunisation in a pharmacy or drug store. The patient's medical history includes allergic to soft-shell crab and giant river prawn. The patient didn't had any concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EW0191, expiry date not reported) via an unspecified route of administration, at the right arm, on 29Jul2021,16:30 at age of 32-year-old at dose 1, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On the night of Aug 21 22:00, he felt tight between the lower neck and upper chest area. It caused difficulty for him to breathe (inhale), drink water, and swallow. On the morning of Aug 22, those symptoms were more severe. The tightness was mixed with the pain. It was very hard to drink and swallow. During that moment, he noticed the worst part of symptoms occurred around the larynx or trachea. On Aug 23, 1:00 AM, the symptoms were getting better, but not fully normal. The patient did not receive treatment in response to the events. The outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dehydration, Dizziness, Feeling abnormal, Lymphadenopathy
Clinical narrative: for almost 2 months Dozens of Lymph nodes on left chest and left arm; dizzy spells; migraines; dazed,; nauseous; all I wanted was to sleep; drugged; Blindness; dehydration; This is a spontaneous report from a contactable consumer (patient). A (Age: 66 unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history included restless legs syndrome (RLS) and known allergies: Penicillin. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID prior to vaccination. It was unknown if the patient was tested for COVID post vaccination. On 29Mar2021, the patient experienced "for almost 2 months Dozens of Lymph nodes on left chest and left arm", dizzy spells, blindness, migraines, dazed, drugged, nauseous, "all I wanted was to sleep", going back to school and she barely made it on zoom sessions. She had to lie down to appear on zoom, lived at Doctor's offices, emergencies (Doctor or other healthcare professional office clinic visit, Emergency room department or urgent care) and still not out of it. The patient additionally experienced dehydration. The patient received "Ivy" for dehydration. The patient underwent lab tests and procedures which included magnetic resonance (MRI) brain: unknown result and magnetic resonance imaging (MRI) chest (chest scans): unknown result, as treatment for events. The outcome of the other events was reported as recovered with sequelae. The outcome of the event dehydration was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging thoracic, Migraine, Nausea, Sedation
Clinical narrative: for almost 2 months Dozens of Lymph nodes on left chest and left arm; dizzy spells; migraines; dazed,; nauseous; all I wanted was to sleep; drugged; Blindness; dehydration; This is a spontaneous report from a contactable consumer (patient). A (Age: 66 unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history included restless legs syndrome (RLS) and known allergies: Penicillin. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID prior to vaccination. It was unknown if the patient was tested for COVID post vaccination. On 29Mar2021, the patient experienced "for almost 2 months Dozens of Lymph nodes on left chest and left arm", dizzy spells, blindness, migraines, dazed, drugged, nauseous, "all I wanted was to sleep", going back to school and she barely made it on zoom sessions. She had to lie down to appear on zoom, lived at Doctor's offices, emergencies (Doctor or other healthcare professional office clinic visit, Emergency room department or urgent care) and still not out of it. The patient additionally experienced dehydration. The patient received "Ivy" for dehydration. The patient underwent lab tests and procedures which included magnetic resonance (MRI) brain: unknown result and magnetic resonance imaging (MRI) chest (chest scans): unknown result, as treatment for events. The outcome of the other events was reported as recovered with sequelae. The outcome of the event dehydration was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: for almost 2 months Dozens of Lymph nodes on left chest and left arm; dizzy spells; migraines; dazed,; nauseous; all I wanted was to sleep; drugged; Blindness; dehydration; This is a spontaneous report from a contactable consumer (patient). A (Age: 66 unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history included restless legs syndrome (RLS) and known allergies: Penicillin. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient received no other vaccine in 4 weeks. The patient was not diagnosed with COVID prior to vaccination. It was unknown if the patient was tested for COVID post vaccination. On 29Mar2021, the patient experienced "for almost 2 months Dozens of Lymph nodes on left chest and left arm", dizzy spells, blindness, migraines, dazed, drugged, nauseous, "all I wanted was to sleep", going back to school and she barely made it on zoom sessions. She had to lie down to appear on zoom, lived at Doctor's offices, emergencies (Doctor or other healthcare professional office clinic visit, Emergency room department or urgent care) and still not out of it. The patient additionally experienced dehydration. The patient received "Ivy" for dehydration. The patient underwent lab tests and procedures which included magnetic resonance (MRI) brain: unknown result and magnetic resonance imaging (MRI) chest (chest scans): unknown result, as treatment for events. The outcome of the other events was reported as recovered with sequelae. The outcome of the event dehydration was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient was tested positive on the virus and after quarantine she went back to the doctor and doctor told her to take the second dose of a vaccine after 3 months; This is a spontaneous report from a contactable patient (reported for herself) from Pfizer sponsered program Pfizer covax US Support.  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was unknown), via unspecified route of administration, on 12Jun2021, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the first dose of Pfizer Biotech covid-19 vaccine on 12Jun2021. On 21Jun2021, Patient was tested positive on the virus and after quarantine she went back to the doctor and doctor told her to take the second dose of a vaccine after 3 months. Patient was supposed to be schedule for the second dose on 02Jul2021 for the second schedule but wasn't able to take it because of the virus that patient was tested positive. Patient was calling to ask if she can take second dose already even without the 3 months or taking in 3 month time after being infected by the virus. The patient underwent the lab tests and procedure which included the COVID-19 test result was positive on 21Jun2021. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Feeling like throat was closing up; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8448), via an unspecified route of administration on 21Aug2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just had the vaccine and he/she have an allergic reaction. It was reported that the patient was sitting in front of the pharmacy right now (21Aug2021). The patient got the shot a little bit before 4 o' clock and he/she have been little bit stopped in the store and he/she just feeling like his/her throat was closing up. The pharmacist gave him/her a Benadryl as treatment. He/She have been so afraid to take this shot and now he/she have take the shot and this was what's happening. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Both of them are positive (confirmed as COVID positive); Both of them are positive (confirmed as COVID positive); This is a spontaneous report from a contactable consumer (Parent) reported for her daughter. This is report received from a Pfizer-sponsored program regulatory authority Support.  A female patient of an unspecified age 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 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced both of them are positive. The patient underwent lab tests and procedures which included COVID positive: positive on unspecified date, Both of them are positive (confirmed as COVID positive). This was the second case out of 2 cases (For daughter). Today (unspecified date) was her second dose she had asked as if she could take it. By the way it was for her and her daughter. The clinical outcome of events was unknown.   Follow up attempts are needed. Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Nephrolithiasis, Pain
Clinical narrative: Kidney stones; Fever 103; Rigors; Severe body aches; Malaise; This is a spontaneous report from a contactable nurse (patient), this nurse reported events for different dose, this is for the second dose. A 35-year-old female (pregnant: no) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9262) at age of 35-year-old, as dose 2, single for covid-19 immunisation in Hospital. Medical history included asthma, Known allergies: Laundry. Concomitant medication included fish oil; vitamin d nos; cyanocobalamin (B 12); paracetamol (TYLENOL); ibuprofen (IBUPROFEN) and Multivitamin. Patient previously received first dose of bnt162b2 (Batch/Lot number was EL1284), first dose on right arm via intramuscular on 27Dec2020 at dose 1, single for COVID-19 immunization and experienced kidney stones. It was reported patient experienced fever 103, rigors, severe body aches, malaise, kidney stones (she got kidney stones approx. 2 weeks after each shot), all on unspecified date, event resulted in doctor or other healthcare professional office/clinic visit. Covid test post vaccination included Nasal Swab with test result of Negative. No treatment received for the events. Outcome of the event was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Nephrolithiasis cannot be totally 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Kidney stones; Fever 103; Rigors; Severe body aches; Malaise; This is a spontaneous report from a contactable nurse (patient), this nurse reported events for different dose, this is for the second dose. A 35-year-old female (pregnant: no) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9262) at age of 35-year-old, as dose 2, single for covid-19 immunisation in Hospital. Medical history included asthma, Known allergies: Laundry. Concomitant medication included fish oil; vitamin d nos; cyanocobalamin (B 12); paracetamol (TYLENOL); ibuprofen (IBUPROFEN) and Multivitamin. Patient previously received first dose of bnt162b2 (Batch/Lot number was EL1284), first dose on right arm via intramuscular on 27Dec2020 at dose 1, single for COVID-19 immunization and experienced kidney stones. It was reported patient experienced fever 103, rigors, severe body aches, malaise, kidney stones (she got kidney stones approx. 2 weeks after each shot), all on unspecified date, event resulted in doctor or other healthcare professional office/clinic visit. Covid test post vaccination included Nasal Swab with test result of Negative. No treatment received for the events. Outcome of the event was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Nephrolithiasis cannot be totally 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Loss of consciousness, Pain in extremity
Clinical narrative: passed out 2 days after the shot; Fever of 102+; severe chills; severe fatigue; soreness of arm; slept almost two full days; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 71-year-old administered in arm left on 20Aug2021 08:30 at single dose for covid-19 immunisation. Medical history included completed chemo for splenic lymphoma 2 months prior to this report. No covid prior vaccination and no covid tested post vaccination. There were no known allergies. Concomitant medications included gabapentin, pantoprazole and hydrochlorothiazide in two weeks. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced Fever of 102+, severe chills, severe fatigue (slept almost two full days, soreness of arm, and passed out 2 days after the shot (which also happened after my second dose) on 20Aug2021 16:00. Facility type vaccine was reported as in pharmacy or drug store. The patient underwent lab tests included body temperature: 102+ on 20Aug2021.There was no treatment received. The outcome of event was recovering.   The lot number for [BNT162B2], was not provided and will be requested during follow up
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: passed out 2 days after the shot; Fever of 102+; severe chills; severe fatigue; soreness of arm; slept almost two full days; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 71-year-old administered in arm left on 20Aug2021 08:30 at single dose for covid-19 immunisation. Medical history included completed chemo for splenic lymphoma 2 months prior to this report. No covid prior vaccination and no covid tested post vaccination. There were no known allergies. Concomitant medications included gabapentin, pantoprazole and hydrochlorothiazide in two weeks. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced Fever of 102+, severe chills, severe fatigue (slept almost two full days, soreness of arm, and passed out 2 days after the shot (which also happened after my second dose) on 20Aug2021 16:00. Facility type vaccine was reported as in pharmacy or drug store. The patient underwent lab tests included body temperature: 102+ on 20Aug2021.There was no treatment received. The outcome of event was recovering.   The lot number for [BNT162B2], was not provided and will be requested during follow up
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, Chills, Condition aggravated
Clinical narrative: Chills; Joint pain; Fever actually its getting worse. Last time I checked it was 100.8 and now it's 103; Fever actually its getting worse. Last time I checked it was 100.8 and now it's 103; I am calling to report the side effects. I took the booster shot yesterday. Chills, joint pain and fever and fever actually its getting worse. Last time I checked it was 100.8 and now it's 103."; I am calling to report the side effects. I took the booster shot yesterday. Chills, joint pain and fever and fever actually its getting worse. Last time I checked it was 100.8 and now it's 103."; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FD8448, NDC number, UPC number and Expiry Date are unknown), via an unspecified route of administration on 21Aug2021 at the age of 50-years-old as dose 3, single (Booster dose) for covid-19 immunisation. The patient's relevant medical history and concurrent conditions included Immune disease  and fever from an unknown date. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported; rituximab (RITUXIMAB) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534) on 19Mar2021 at the age of 50-years-old as single dose and second dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW958) on 19Apr2021 at the age of 50-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccine prior to Covid-19 Vaccine in four weeks of vaccination. There was investigation Assessment. The reporter stated that she was calling to report the side effects. She took the booster shot the previous day. On an unspecified date, the patient experienced Chills, joint pain and fever and fever actually its getting worse. Last time she checked it was 100.8 and then it was 103. It was reported that morning, she had fever. she had chills last night. Treatment for adverse events included Tylenol. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date in 2021, body temperature: 100.8 on an unspecified date, body temperature: 103 on an unspecified date, investigation: unknown results on an unspecified date in 2021. She stated, "Yeah, well I had the toxin within past two weeks, its 'fusion of toxin or toxin map' (further not clarified) and in blood work we had within the past 3 weeks." (further not clarified). The outcome of events was unknown.