chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: arm that I got the shot in is reddened and swollen and there is pain; arm that I got the shot in is reddened and swollen and there is pain; tiny little red spots; tiny little bit of aching; a little itchy all over too; arm was really sore and hurting and I noticed it had turned red; my arm is very uncomfortable; This is a spontaneous report from a contactable nurse (patient).  A 58-Year-Old female patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Aug2021 single dose in left arm for COVID-19 immunisation. Lot number was FA7484. Medical history and concomitant medications were unknown. On 14Jul2021, the patient received first dose of BNT162 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and she experienced sore in arm (lot number FA6780). On unknown date, the patient received a flu shot for immunization (inflamed, painful). The patient experienced arm that got the shot in was reddened and swollen and there was pain, tiny little red spots; tiny little bit of aching, a little itchy all over too, arm was really sore and hurting and it had turned red, arm was very uncomfortable. Little spots treated with antibiotics cream; the patient also received Benadryl and a Claritin, Ibuprofen 200 milligram. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Electrocardiogram, Fall
Clinical narrative: vertigo; Blood pressure went up so high; Nausea; terrible brain fog; anxiety so bad couldn't leave the house; sick; caller topples over all the time; hasn't been able to work; tunnel vision; feeling like half dead; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in right arm on 08Jun2021 as single dose for COVID-19 immunisation. The patient's medical history included tachycardia (has had tachycardia for probably 20 years), she was tested for red measles when pregnant and had no antibodies and was not protected, as soon as delivered child had to get that vaccine. The patient's concomitant medications were not reported. The patient previously received measles vaccination for immunization and smallpox vaccine for immunization (The caller also states when she received the smallpox vaccine and it never left an indentation on the caller's arm.). Vaccine was not administered at military facility. The patient experienced tunnel vision on Jun2021, feeling like half dead on Jun2021, vertigo on 09Jun2021, topples over all the time on Jun2021, hasn't been able to work on Jun2021, blood pressure went up so high on 08Jun2021, nausea on 08Jun2021, terrible brain fog on 08Jun2021, anxiety so bad couldn't leave the house on 08Jun2021, sick on Jun2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure: 110/80 (blood pressure was taken prior to receiving the first dose Pfizer Covid Vaccine and it was 110/80) on 08Jun2021 and 146/80 (The caller was released from the emergency room when the blood pressure went down to 146/80 something) on Jun2021; EKG: heart attack and enzymes were tested and stuff (The caller was monitored, given an EKG and of course because of high blood pressure thought the caller may have a heart attack and enzymes were tested and stuff) on 08Jun2021. The outcome of the events tunnel vision, nausea and terrible brain fog was recovering, and the outcome of the other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Loss of personal independence in daily activities, Nausea, Near death experience
Clinical narrative: vertigo; Blood pressure went up so high; Nausea; terrible brain fog; anxiety so bad couldn't leave the house; sick; caller topples over all the time; hasn't been able to work; tunnel vision; feeling like half dead; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in right arm on 08Jun2021 as single dose for COVID-19 immunisation. The patient's medical history included tachycardia (has had tachycardia for probably 20 years), she was tested for red measles when pregnant and had no antibodies and was not protected, as soon as delivered child had to get that vaccine. The patient's concomitant medications were not reported. The patient previously received measles vaccination for immunization and smallpox vaccine for immunization (The caller also states when she received the smallpox vaccine and it never left an indentation on the caller's arm.). Vaccine was not administered at military facility. The patient experienced tunnel vision on Jun2021, feeling like half dead on Jun2021, vertigo on 09Jun2021, topples over all the time on Jun2021, hasn't been able to work on Jun2021, blood pressure went up so high on 08Jun2021, nausea on 08Jun2021, terrible brain fog on 08Jun2021, anxiety so bad couldn't leave the house on 08Jun2021, sick on Jun2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure: 110/80 (blood pressure was taken prior to receiving the first dose Pfizer Covid Vaccine and it was 110/80) on 08Jun2021 and 146/80 (The caller was released from the emergency room when the blood pressure went down to 146/80 something) on Jun2021; EKG: heart attack and enzymes were tested and stuff (The caller was monitored, given an EKG and of course because of high blood pressure thought the caller may have a heart attack and enzymes were tested and stuff) on 08Jun2021. The outcome of the events tunnel vision, nausea and terrible brain fog was recovering, and the outcome of the other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision, Vertigo
Clinical narrative: vertigo; Blood pressure went up so high; Nausea; terrible brain fog; anxiety so bad couldn't leave the house; sick; caller topples over all the time; hasn't been able to work; tunnel vision; feeling like half dead; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in right arm on 08Jun2021 as single dose for COVID-19 immunisation. The patient's medical history included tachycardia (has had tachycardia for probably 20 years), she was tested for red measles when pregnant and had no antibodies and was not protected, as soon as delivered child had to get that vaccine. The patient's concomitant medications were not reported. The patient previously received measles vaccination for immunization and smallpox vaccine for immunization (The caller also states when she received the smallpox vaccine and it never left an indentation on the caller's arm.). Vaccine was not administered at military facility. The patient experienced tunnel vision on Jun2021, feeling like half dead on Jun2021, vertigo on 09Jun2021, topples over all the time on Jun2021, hasn't been able to work on Jun2021, blood pressure went up so high on 08Jun2021, nausea on 08Jun2021, terrible brain fog on 08Jun2021, anxiety so bad couldn't leave the house on 08Jun2021, sick on Jun2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure: 110/80 (blood pressure was taken prior to receiving the first dose Pfizer Covid Vaccine and it was 110/80) on 08Jun2021 and 146/80 (The caller was released from the emergency room when the blood pressure went down to 146/80 something) on Jun2021; EKG: heart attack and enzymes were tested and stuff (The caller was monitored, given an EKG and of course because of high blood pressure thought the caller may have a heart attack and enzymes were tested and stuff) on 08Jun2021. The outcome of the events tunnel vision, nausea and terrible brain fog was recovering, and the outcome of the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Deafness
Clinical narrative: Hearing loss in right ear; Feeling of losing equilibrium; This is a spontaneous report from a contactable consumer (patient) via a company representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number not reported), as dose number unknown, single, for COVID-19 immunisation. On an unspecified date, the patient experienced a feeling of losing equilibrium and hearing loss in right ear occurred shortly after receiving the COVID vaccine. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke two weeks after he received his second Covid vaccination; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer sponsored program. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The patient had a stroke two weeks after he received his second covid vaccination on an unspecified date. He did not have any underlining conditions that could contribute to his stroke. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cytokine storm, Inflammation, Myocardial infarction
Clinical narrative: heart attack; cytokine storm; inflammation; This is a spontaneous report from a contactable consumer reporting for a friend. A 61-years-old female patient received bnt162b2 (BNT162B2) at the age of 61-years-old, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization at the age of 61 years. After the second dose, the patient had inflammation, a cytokine storm, a heart attack and then died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attack; cytokine storm; inflammation
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure measurement, Electrocardiogram, Enzyme level test, Fall
Clinical narrative: vertigo; topples over all the time; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0187), via an unspecified route of administration, administered in the right arm on 16Jul2021 (at the age of 58 years old; as reported) as dose 2, single for COVID-19 immunization. Medical history included tachycardia from an unknown date (for probably 20 years) and unknown if ongoing. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0178, expiry date: 21Aug2021), via an unspecified route of administration, administered in the right arm (near rotator cuff) on 08Jun2021 (at the age of 58 years old; as reported) as dose 1, single for COVID-19 immunization and experienced vertigo, blood pressure went up so high, terrible brain fog, nausea, anxiety so bad and tunnel vision; measles vaccination for immunization (this was so long ago, the caller's child is now 25 years old); and small pox vaccination for immunization (in the 4th grade). The patient experienced vertigo and topples over all the time on an unspecified date in Jul2021. It was reported that the patient received both doses Pfizer Covid vaccine and has been left with vertigo. The vertigo was horrible, and she toppled over all the time. She has accrued so many medical bills. She had to have her brain looked at. It was also reported that the patient visited the emergency room and was discharged from the emergency room each time. She has never had Covid. But her father died of Covid and her husband had Covid. The patient underwent lab tests and procedures which included antibodies: 100 % (just after receiving the first dose Pfizer Covid vaccine) in Jun2021, blood pressure: 110/80 (prior to receiving the first dose) in 2021, blood pressure: 146/80 in Jun2021, EKG: unknown results in Jun2021, enzymes: unknown results in Jun2021, tested for red measles: no antibodies on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Measles antibody, Vertigo
Clinical narrative: vertigo; topples over all the time; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0187), via an unspecified route of administration, administered in the right arm on 16Jul2021 (at the age of 58 years old; as reported) as dose 2, single for COVID-19 immunization. Medical history included tachycardia from an unknown date (for probably 20 years) and unknown if ongoing. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0178, expiry date: 21Aug2021), via an unspecified route of administration, administered in the right arm (near rotator cuff) on 08Jun2021 (at the age of 58 years old; as reported) as dose 1, single for COVID-19 immunization and experienced vertigo, blood pressure went up so high, terrible brain fog, nausea, anxiety so bad and tunnel vision; measles vaccination for immunization (this was so long ago, the caller's child is now 25 years old); and small pox vaccination for immunization (in the 4th grade). The patient experienced vertigo and topples over all the time on an unspecified date in Jul2021. It was reported that the patient received both doses Pfizer Covid vaccine and has been left with vertigo. The vertigo was horrible, and she toppled over all the time. She has accrued so many medical bills. She had to have her brain looked at. It was also reported that the patient visited the emergency room and was discharged from the emergency room each time. She has never had Covid. But her father died of Covid and her husband had Covid. The patient underwent lab tests and procedures which included antibodies: 100 % (just after receiving the first dose Pfizer Covid vaccine) in Jun2021, blood pressure: 110/80 (prior to receiving the first dose) in 2021, blood pressure: 146/80 in Jun2021, EKG: unknown results in Jun2021, enzymes: unknown results in Jun2021, tested for red measles: no antibodies on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: killed my roommate; This is a spontaneous report from a Pfizer- sponsored program. A Non-contactable consumer reported for a patient (reporters friend) that a patient of unspecified age and gender received bnt162b2 (BNT162B2, the Pfizer COVID Vaccination), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that "you killed my roommate, My friends death is worth nothing to you" on an unspecified date. The patient died on an unspecified date.  The outcome of the event was fatal. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed my roommate
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 Fever, congestion and chest; tested positive for covid-19 Fever, congestion and chest; This is a spontaneous report from a contactable consumer (patient) reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8729) as dose 1, single and dose 2 via an unspecified route of administration on 14May2021 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient is tested positive for covid-19 Fever, congestion and chest on 08Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Aug2021. The seriousness criteria was medically significant for the event covid-19. The event outcome was Unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Heart rate, Loss of consciousness, Seizure, Tremor
Clinical narrative: Passed out for about a minute or less; Seizure; fell; Shaking; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2, intramuscular, administered in left arm on 09Aug2021 14:57 (Batch/Lot Number: FC3181; Expiration Date: Oct2021; NDC number: 59267-1000-01) at the age of 30 years old as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included rheumatoid arthritis and had a history of passing out. Family medical history relevant to adverse event was unknown. There were no concomitant medications. The patient previously took whooping cough vaccine in 2010. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). On 09Aug2021, about 5 minutes after she was got the shot, the patient passed out for about a minute or less. She was in the waiting room. They had to call an ambulance. Upon the minute, the caller was awake, responding, had a good pulse. She was breathing, talking after passing out. The reporter explained that as far as what she witnessed, it was not serious. She was okay. When asked if event required a visit to - answered, "Emergency Room?" The patient was taken by ambulance, but she was not sure where it went. She is not sure if it was to the ER, but they took the patient out. The patient did mention she had not eaten all day. The caller didn't move the patient from where she passed out and fell. While she was on the ground, the patient mentioned she had a history of passing out. However, on the form she filled out, the patient responded 'no' to the question of "have you had any reaction to any previous vaccination including fainting or dizziness." A witness said she also thought the patient had a seizure because the patient was shaking. It's all subjective though. Outcome of events passed out was recovered on 09Aug2021, while other events was unknown. The reporter assessed the report as not serious and considered the relatedness of COVID-19 vaccine with passed out for about a minute or less as unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events seizures, passed out and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable Nurse. A 57-years-old male patient received first does 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 received second 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 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. On an unspecified date, the patient experienced covid. Patient was hospitalized in ICU with COVID after receiving Pfizer COVID vaccine. The clinical outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events DI and Covid 19 and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It was reported that patient received the first dose of vaccine last 22Jul2021 and tested positive for Covid last 30Jul2021. Patient asked when her schedule was to receive the second dose. Outcome of 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: Arthralgia, Gait disturbance, Limb discomfort
Clinical narrative: Pain on the left side of the hip; it is preventing her from walking; she said felt heavy; This is a spontaneous report from a contactable pharmacist. A 12-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2021 the patient experienced pain on the left side of the hip, it is preventing her from walking, she said felt heavy lot number and expiration date of the suspected medication were not provided limited information was available from the reporter. The outcome of the events arthralgia, gait disturbance, limb discomfort was unknown.  Information on lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, Rash
Clinical narrative: leg had a deep infection in it; I broke out in the really bad all over my body rash. I mean it was on my legs, my chest my, stomach my face and all over me; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old (also the age at time of vaccination) male patient received bnt162b2 (BNT162B2), via an unspecified route of administration administered in Arm Left on 25Mar2021 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for COVID-19 immunization.  The patient had blood pressure abnormal (reported as blood pressure) and he took medication to keep it under control. Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) taken for an unspecified indication and therapy dates and unspecified medication for blood pressure. Three to four days after he received the first dose (Mar2021), he broke out that was really bad all over his body rash. It was on his legs, chest, stomach, face and all over him.  He did not got his second vaccination as nobody can really tell him what caused this. He was afraid as he was not sure what's crazy thing will go again on him. It was also reported that he had to go to the hospital for a night and it was noted that he had a deep infection in his leg. He was on antibiotics and was discharged instantly. He was also on different kind of creams as he went to the dermatologist. Outcome of deep infection in his leg while recovering from the remaining event.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction post-vaccination; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included cancer and cancer surgery. The patient's concomitant medications were not reported. The patient experienced severe allergic reaction post-vaccination on an unspecified date. The event was reported as serious, medically significant and resulted in emergency room visit. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia Areta; This is a spontaneous report from a contactable consumer reporting for a male patient (son). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced "alopecia areta". The reporter stated that after COVID Vaccine the son developed Alopecia Areta. Just want to hear from Pfizer all about that. The reporter was also asking whether the vaccine trigger auto immune response. The outcome of the event was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy
Clinical narrative: arm was sore on Sunday; swollen lymph nodes on the left arm; This is a spontaneous report from a contactable consumer and from a sponsored program Support. This 45-year-old female Consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Jul2021 (at the age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 09Aug2021 after the second dose of vaccination, the patient experienced swollen lymph nodes on the left arm and on an unspecified date arm was sore on Sunday. It was reported that after got second dose of vaccine, patient was experienced swollen lymph nodes on the left arm (side of injection) that began yesterday and became worse last night. Patient also reported that her arm was sore on Sunday.  Her question was, was that normal because she needs to know if she needs to go to urgent care.  After information provided, patient stated that she will watch and if it did get better, she will reach out to her Healthcare Professional. Patient asked if she can took Tylenol for her symptoms. Patient provided PMI number and HOO. While talking to the agent and providing the caller's demographics, the call got disconnected. Created AE form. The outcome of events were unknown.  Unknown if reporter was a Healthcare Professional (HCP). Unknown if reporter's contact information available to you or a sub-contracted party. The reporter was not the prescribing Healthcare professional Medical Information: Yes, Customer and/or medical inquiry forwarded or referred to   Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other health care professional. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose (lot number EL3248) on Jan2021 05:45, 2nd dose (lot number EL3248, as reported) on 04Feb2021 06:00, both at 61-year-old intramuscular in left arm for Covid-19 immunization. Medical history was not provided. There was no other medications in two weeks. There was no other vaccine in four weeks. It was unknown if patient had covid prior vaccination. There was no known allergies. Patient experienced symptoms of covid starting on 01Aug2021, and was tested positive for covid PCR Nasal swab on 05Aug2021. Treatment was unknown. Outcome of the event was not resolved.; Sender's Comments: The possibility of Covid19,  being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chest discomfort, Cough, Dyspnoea, Pulmonary congestion
Clinical narrative: very congested; hard for me to breathe; cant taste food was reported as worsened.; Tightness in chest; heavy cough was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 06Aug2021 11:00 (at the age of 37-year-old) (Batch/Lot Number: EW0164) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on the same date as the bnt162b2. On an unspecified date, the patient was very congested and hard for her to breathe. On 07Aug2021, the patient experienced heavy cough. On 09Aug2021, the patient had tightness in her chest. On 10Aug2021, the patient had can't taste her food was reported as worsened. The patient reported that she could taste her food yesterday but not today. The events did not required a visit to emergency room and physician office. Patient was referred to a healthcare provider (HCP) for medical evaluation. The patient asked if she were to be tested again for Covid, would the vaccine cause her to have a false positive. Prior vaccinations (within 4 weeks) was none and no events following prior vaccinations. Outcome of events heavy cough was reported as worsened, cant taste food was reported as worsened was not recovered; tightness in chest was recovering; and outcome of the rest of events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high; tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 02Apr2021 as dose 2, single (at the age of 62-years-old) for covid-19 immunisation. Medical history included high blood pressure (under control with medicine before), supraventricular tachycardia (under control with medicine before) and allergies to almonds (all from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 at 13:30 hours as dose 1, single (at the age of 62-years-old) for covid-19 immunisation and patient blood pressure (BP) had been quite high and hard to control. Patient had now added Lisinopril and actually tried an anxiety pill because of the stress of the high BP. Patient was also wearing an event monitor now. Concomitant medication(s) within 2 weeks of vaccination included metoprolol tartrate taken for high blood pressure and supraventricular tachycardia, start and stop date were not reported and multivitamin for unknown indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 03Apr2021, the day after the second shot, patient tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high, and patient could not get her heart rate (HR) back to normal after her workout. Events were assessed as non-serious by the reporter. The outcome of both the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fell; This is a spontaneous report. from a non-contactable consumer (reporter's uncle)  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient shortly thereafter fell on an unspecified date with outcome of unknown and was hospitalized. Caller would like to knowhow long he can go between shots or if he needs to start the series again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives 24 hours later; This is a spontaneous report from a contactable other healthcare professional (nurse). A 12-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date, NDC and UPC number was unknown), 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, 24 hours later/the next day, patient experienced full body hives. Patient do not know if he should get the second dose. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac aneurysm, Diabetes mellitus
Clinical narrative: I have got a aneurysm on the valve of my heart and I have got diabetes; I have got a aneurysm on the valve of my heart and I have got diabetes; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: FG7484) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that "I have got a aneurysm on the valve of my heart and I have got diabetes. I took the first dose and now I am kind of little skeptic about taking the second. The patient added that he is thinking if he can take the second dose of the vaccine and he is currently on a medication for the diabetes. The patient may not take the second dose. The outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received her initial COVID vaccine and she ended up developing COVID after that; Received her initial COVID vaccine and she ended up developing COVID after that; This is a spontaneous report from a contactable consumer.   A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: EW0191; Expiration Date: 01Sep2021) as DOSE 1, SINGLE (at the age of 63 years) for covid-19 immunisation.  The patient medical history included hypertension. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported.  The patient received her initial COVID vaccine and she ended up developing COVID after that (medically significant) on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957591 similar report from same reporter, second dose
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A little fever; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 19Jul2021 13:45 (at age of 23-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 28Jun2021 11:00 as dose 1, single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. On 21Jul2021 at 11:30, the patient experienced a little fever. Therapeutic measures were taken as a result of a little fever (pyrexia). The outcome of event was recovered.  Information on batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted at laboratory. Patient displayed mild symptoms including loss of smel; Breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6205), via intramuscular route of administration in the right arm, on 25Feb2021 (age at the time of vaccination was 38-year-old), as dose 1, single and dose 2 received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6207), via intramuscular route of administration in the right arm, on 17Mar2021, as dose 2, single for COVID-19 Immunization. Medical history was not reported. Concomitant medications included emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and alprazolam (XANAX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had tested for COVID-19 and the result was positive. The patient was breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted at laboratory. Patient displayed mild symptoms including loss of smell and sinus pressure. On 06Aug2021, the patient underwent lab tests which included positive PCR covid-19 detection test (also reported as: Nasal swab test) conducted at laboratory and the result was obtained as positive. The patient received unspecified treatment by consulting with doctor via phone. The outcome of the event was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Poor quality product administered, Product quality issue, Product use issue
Clinical narrative: They administered the second dose at that point of second. I got very ill. I ended up in emergency room; They seemed to think in the emergency room that I was administered the double dose; They administered the first dose. It was pharmacy and then I was told that dose was empty, that syringe was empty; They administered the first dose. It was pharmacy and then I was told that dose was empty, that syringe was empty; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. It was reported that patient received first dose of vaccine on Wednesday, 04Aug2021. Patient stated they administered the first dose, It was pharmacy and then patient was told that dose was empty, that syringe was empty, and they administered the second dose at that point of second. patient got very ill and ended up in emergency room and not sure, they seemed to think in the emergency room that patient was administered the double dose. Patient need to know that if patient going to require the actual second dose. Patient was hospitalized due to got very ill and ended up in emergency room. Outcome of the events was Unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Drug ineffective, Fatigue
Clinical narrative: Had COVID positive result.; Had COVID positive result.; Cough; Fatigue; Sore throat; Headache; Loss of smell; Muscle body aches; Inability to stay awake; congestion; runny nose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee).  A 35-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 02Feb2021 (at the age of 35-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included known allergies maybe Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had no COVID prior vaccination. On 26Jul2021, the patient experienced cough, fatigue, sore throat, headache, loss of smell, muscle body aches, inability to stay awake, congestion or runny nose. The patient was COVID tested post vaccination on 29Jul2021, nasal swab taken, and the polymerase chain reaction (PCR) test done which showed COVID positive result. As a result of events the patient visited to doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Oropharyngeal pain, Polymerase chain reaction
Clinical narrative: Had COVID positive result.; Had COVID positive result.; Cough; Fatigue; Sore throat; Headache; Loss of smell; Muscle body aches; Inability to stay awake; congestion; runny nose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee).  A 35-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 02Feb2021 (at the age of 35-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included known allergies maybe Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had no COVID prior vaccination. On 26Jul2021, the patient experienced cough, fatigue, sore throat, headache, loss of smell, muscle body aches, inability to stay awake, congestion or runny nose. The patient was COVID tested post vaccination on 29Jul2021, nasal swab taken, and the polymerase chain reaction (PCR) test done which showed COVID positive result. As a result of events the patient visited to doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: Had COVID positive result.; Had COVID positive result.; Cough; Fatigue; Sore throat; Headache; Loss of smell; Muscle body aches; Inability to stay awake; congestion; runny nose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee).  A 35-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 02Feb2021 (at the age of 35-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included known allergies maybe Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had no COVID prior vaccination. On 26Jul2021, the patient experienced cough, fatigue, sore throat, headache, loss of smell, muscle body aches, inability to stay awake, congestion or runny nose. The patient was COVID tested post vaccination on 29Jul2021, nasal swab taken, and the polymerase chain reaction (PCR) test done which showed COVID positive result. As a result of events the patient visited to doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.