chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Presyncope, Pyrexia, Respiratory disorder
Clinical narrative: Recurring Fever; chills; nausea; severe body aches; severe exhaustion; not clear headed; chest pressure; almost fainted right after the infections 2 & 3; respiratory issues; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 10:00 (Lot number: Fj8762) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "covid", start date: 10Dec2020 (unspecified if ongoing), notes: Had covid 10Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 15Apr2021, prev dose administration time: 04:00 PM, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 15Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 18Mar2021, prev dose administration time: 09:00 PM, prev dose number: 1), administration date: 18Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted".  The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 10:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "recovering", described as "Recurring Fever"; CHILLS (non-serious), outcome "recovering", described as "chills"; NAUSEA (non-serious), outcome "recovering", described as "nausea"; PAIN (non-serious), outcome "recovering", described as "severe body aches"; FATIGUE (non-serious), outcome "recovering", described as "severe exhaustion"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "not clear headed"; CHEST DISCOMFORT (non-serious), outcome "recovering", described as "chest pressure"; PRESYNCOPE (non-serious), outcome "recovering", described as "almost fainted right after the infections 2 & 3"; RESPIRATORY DISORDER (non-serious), outcome "recovering", described as "respiratory issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, nausea, pain, fatigue, feeling abnormal, chest discomfort, presyncope. Therapeutic measures were taken as a result of respiratory disorder.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Recurring Fever; chills; nausea; severe body aches; severe exhaustion; not clear headed; chest pressure; almost fainted right after the infections 2 & 3; respiratory issues; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 10:00 (Lot number: Fj8762) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "covid", start date: 10Dec2020 (unspecified if ongoing), notes: Had covid 10Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 15Apr2021, prev dose administration time: 04:00 PM, prev dose number: 2, prev dose vaccine location: Left arm), administration date: 15Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted"; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: Er2613, prev dose lot unknown: False, prev dose administration date: 18Mar2021, prev dose administration time: 09:00 PM, prev dose number: 1), administration date: 18Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Exhausted".  The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 10:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "recovering", described as "Recurring Fever"; CHILLS (non-serious), outcome "recovering", described as "chills"; NAUSEA (non-serious), outcome "recovering", described as "nausea"; PAIN (non-serious), outcome "recovering", described as "severe body aches"; FATIGUE (non-serious), outcome "recovering", described as "severe exhaustion"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "not clear headed"; CHEST DISCOMFORT (non-serious), outcome "recovering", described as "chest pressure"; PRESYNCOPE (non-serious), outcome "recovering", described as "almost fainted right after the infections 2 & 3"; RESPIRATORY DISORDER (non-serious), outcome "recovering", described as "respiratory issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, nausea, pain, fatigue, feeling abnormal, chest discomfort, presyncope. Therapeutic measures were taken as a result of respiratory disorder.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 72 year-old male patient received BNT162b2 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no history of COVID-19 prior vaccination. Vaccination history included: BNT162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, life threatening) with onset Nov2021, outcome "unknown", described as "stroke". After receiving the second dose of the vaccine, patient suffered a stroke. Adverse event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: stroke;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4191475-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single and intramuscular, administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab, subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. Relevant medical history included: "Non-smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Oct2021, outcome "unknown", described as "stroke". The action taken for adalimumab was unknown.  Clinical course: It was reported that in Oct2021 the patient had minor stroke. No effects as of now showing. Added unknown medication but patient was doing well. Patient feels the vaccination caused it. He did not have high blood pressure and was not diabetic. It was unknown if he was enrolled in a Covid-19 Vaccine Trial. The action taken for adalimumab was unknown.  The reporter considered "stroke" related to bnt162b2. The reporter's causality for the event(s) of STROKE was not provided. opinion is that the event of STROKE is not assessable.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Rash
Clinical narrative: itching got really annoying; rash spread to different parts of my body; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Nov2021 12:00 (Lot number: fh8030) at the age of 74 years as dose 3(booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=pfizer, prev dose brand unknown=False, prev dose lot number=fl9262, prev dose lot unknown=False, prev dose administration date=17Mar2021, prev dose administration time=03:00PM , prev dose  dose number=2, after 2nd shot got minor itching), administration date: 17Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "got minor itching", "some minor rash,mostly on back of"; Bnt162b2 (prev dose product=COVID 19, prev dose brand=pfizer, prev dose brand unknown=False, prev dose lot number=en6201, prev dose lot unknown=False, prev dose administration date=24Feb2021, prev dose administration time=02:00PM , prev dose vaccine location= Left arm, prev dose  dose number=1), administration date: 24Feb2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:00, outcome "not recovered", described as "Booster"; PRURITUS (non-serious), outcome "not recovered", described as "itching got really annoying"; RASH (non-serious), outcome "not recovered", described as "rash spread to different parts of my body". The events "booster", "itching got really annoying" and "rash spread to different parts of my body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of immunisation, pruritus, rash.  Additional Information:It was reported that patient did not had any other vaccine in four weeks. And  The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination. And had no known allergies. Other medical history: none After 2nd shot got minor itching and some minor rash, mostly on back of arms, After 3rd shot itching got really annoying and rash spread to different parts of my body. Using anti itching creams. seems to help, but problem is still intermitant.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Deep vein thrombosis, Foot fracture, Near death experience, Thrombosis
Clinical narrative: developed 3 DVT's (deep vein thrombosis) on my legs; I almost died; blood clots; broke her foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; tamoxifen (TAMOXIFEN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant) with onset 27Mar2021, outcome "unknown", described as "developed 3 DVT's (deep vein thrombosis) on my legs"; NEAR DEATH EXPERIENCE (medically significant) with onset 2021, outcome "unknown", described as "I almost died"; THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; FOOT FRACTURE (medically significant) with onset 2021, outcome "unknown", described as "broke her foot". Patient got in a knee high boot from 05Jan2021 to 24Mar2021. She was not supposed to be walking in the boot but she did. During this time she was also on tamoxifen. She should've gotten off this medication immediately, but her oncologist did not let her know she should have done so and she had received the second dose, while she was on the knee high boot and taking tamoxifen. On 27Mar2021, patient developed 3 DVT's (deep vein thrombosis) on her legs. She was scheduled on 14Dec2021 to receive booster dose. She spoke to a pharmacist and he told her she could develop blood cloths from this vaccine two weeks after vaccination, other people had told her the same (that there was information that could develop blood cloths after vaccination). Her doctor told her she should get the booster dose and she was scared about developing blood cloths again. She almost died. Patient broke her foot and was on tamoxifen at the time. The doctor told her that she should have been off the tamoxifen because if a person wasn't moving around that product could cause blood clots and he thought that was why she got the blood clot, not because of the vaccine. It was noted that after this happened within 2 weeks of the second dose that was given 19Mar2021. It was also told to her that after the second dose, it was rare, but a person could get a blood clot, which was what happened to her. Her doctor said that probably this was from the tamoxifen, the blood clot. The events "developed 3 dvt's (deep vein thrombosis) on my legs" and "blood clots" were evaluated at the physician office visit. The action taken for tamoxifen was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasal discomfort, Nausea, Spinal pain, Vision blurred
Clinical narrative: Burning Nostrils; Severe migraines; nausea; spine pain; blurred vision in right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: NASAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning Nostrils"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Severe migraines"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; SPINAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "spine pain"; VISION BLURRED (non-serious) with onset 2021, outcome "unknown", described as "blurred vision in right eye".  Additional information: It was reported that, the patient was not on any Medications prior to receiving the Pfizer vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: double-vaxxed and boosted; Took a COVID PCR test this afternoon and she came back POSITIVE./double-vaxxed and boosted/zero symptoms; Took a COVID PCR test this afternoon and she came back POSITIVE./double-vaxxed and boosted/zero symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 13Dec2021, outcome "unknown" and all described as "Took a COVID PCR test this afternoon and she came back POSITIVE./double-vaxxed and boosted/zero symptoms"; IMMUNISATION (medically significant), outcome "unknown", described as "double-vaxxed and boosted". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) positive; (Dec2021) negative. Clinical course: The patient had COVID PCR test this afternoon (13Dec2021) and she came back POSITIVE. She is double-vaxxed and boosted. And she has ZERO symptoms. She tested negative on all of last week's tests.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Febrile convulsion
Clinical narrative: fever spiked (103.5), triggering seizure; This is a spontaneous report received from contactable healthcare professional from a representative.  An 8 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as second, single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included BNT162B2 (dose 1, single), for Covid-19 immunization.  The following information was reported Febrile convulsion (non-serious), outcome unknown, triggering seizure. Relevant laboratory tests and procedures are available in the appropriate section.  After the second dose, the 8 year had fever spiked (103.5), triggering seizure. The patient was taken to a hospital.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: The caller's buddy also has blurry vision now after the covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "The caller's buddy also has blurry vision now after the covid vaccine". Additional information: The patient was calling about the covid shot regarding side effects. The patient has a letter, in which they could not find the reference number, but the reporter had spoken to someone about this event previously. The patient's eyes are fuzzy or blurry. The patient stated that they got the shot at 04:30 at store, but the paper states 04:45. The patient's buddy also had blurry vision now after the covid vaccine. The caller did not provide any patient identifiers for his buddy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypersensitivity, Wrong technique in product usage process
Clinical narrative: when vaccine was administered, an artery was hit; heart was affected; severe allergic reaction; This is a spontaneous report received from a contactable reporter consumer or other non HCP.  A 60 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date Mar2021 (batch/lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient had other vaccine in four weeks.  The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (hospitalization) with onset Mar2021, outcome "unknown", described as "when vaccine was administered, an artery was hit"; CARDIAC DISORDER (hospitalization) with onset Mar2021, outcome "recovered" (2021), described as "heart was affected"; HYPERSENSITIVITY (hospitalization) with onset Mar2021, outcome "recovered" (2021), described as "severe allergic reaction". The events "heart was affected" and "severe allergic reaction" were evaluated at the emergency room visit. It was unknown if patient was covid tested post vaccination. Therapeutic measures were taken as a result of cardiac disorder, hypersensitivity. The AE treatment was unsure.  Additional information: The reporter informed that when vaccine was administered, an artery was hit and the patient's heart was affected. A severe allergic reaction was reported as well.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Muscle spasms
Clinical narrative: booster; had severe cramping in his feet and legs.; This is a spontaneous report received from a non-contactable reporter. Other Case identifier(s): MOD21-170944. A male patient received bnt162b2  (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: immunization and muscle spasms, outcome unknown. Additional information: Patient thought this was the PFIZER line of reporting AE and said his father got the Pfizer booster and had severe cramping in his feet and legs. Agent let the patient know that this was the Moderna line. Call ended as the patient will call the PFizer line. Product complaint: there is no product complaint associated with this case. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had a breakthrough with the COVID Shots; I had a breakthrough with the COVID Shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a breakthrough with the COVID Shots".  Medical Information Were any medical questions addressed by this program forwarded/referred to Medical Information? (Live Operators Only): N/A: Customer's questions addressed or no medical questions asked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Balance disorder, Coma, Fall, Gait disturbance
Clinical narrative: He was in medical care for months and now he is in the an assisted care facility because he is still in the wheelchair, he still can not walk; Coma for two months; Guillain-Barre syndrome; Paralysis; He passed out, he fell down; dysthyroid; He passed out, he fell down; He had lost his balance; He couldn't walk; His weight at the time was about a 100, 280 pounds somewhere in that range and knock down to 158; arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72 year-old (it's like between 72 and 73) male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. The patient took concomitant medications. He was taking stuff now, kind of stuff, now but back then now, he was in pretty good health other than diabetes. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. He had problem after the first shot. The following information was reported: GAIT INABILITY (disability), outcome "unknown", described as "He was in medical care for months and now he is in the an assisted care facility because he is still in the wheelchair, he still can not walk"; COMA (medically significant), outcome "unknown", described as "Coma for two months"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome"; PARALYSIS (medically significant), outcome "unknown", described as "Paralysis"; SYNCOPE (medically significant), FALL (non-serious), outcome "unknown" and all described as "He passed out, he fell down"; THYROID DISORDER (non-serious), outcome "unknown", described as "dysthyroid"; BALANCE DISORDER (non-serious), outcome "unknown", described as "He had lost his balance"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "He couldn't walk"; WEIGHT FLUCTUATION (non-serious), outcome "unknown", described as "His weight at the time was about a 100, 280 pounds somewhere in that range and knock down to 158"; ARTHRITIS (non-serious), outcome "unknown", described as "arthritis". It was not really right but when he took the second shot that's when everything went to heck in a handbasket. He had lost his balance. He passed out, he fell down. He couldn't walk and then he, the last time he passed out, he didn't wake up for two months. The patient was in a coma for two months and then had to be reflect to take it twice for the dysthyroid and now was in a care facility because he was still in the wheelchair, he still cannot walk. He was in paralysis and dysthyroid had to be brought back then arthritis and he was in medical care for months. The patient underwent the following laboratory tests and procedures: weight: 100 lbs; 280 lbs; 158 lbs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Paralysis, Syncope, Thyroid disorder
Clinical narrative: He was in medical care for months and now he is in the an assisted care facility because he is still in the wheelchair, he still can not walk; Coma for two months; Guillain-Barre syndrome; Paralysis; He passed out, he fell down; dysthyroid; He passed out, he fell down; He had lost his balance; He couldn't walk; His weight at the time was about a 100, 280 pounds somewhere in that range and knock down to 158; arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72 year-old (it's like between 72 and 73) male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. The patient took concomitant medications. He was taking stuff now, kind of stuff, now but back then now, he was in pretty good health other than diabetes. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. He had problem after the first shot. The following information was reported: GAIT INABILITY (disability), outcome "unknown", described as "He was in medical care for months and now he is in the an assisted care facility because he is still in the wheelchair, he still can not walk"; COMA (medically significant), outcome "unknown", described as "Coma for two months"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome"; PARALYSIS (medically significant), outcome "unknown", described as "Paralysis"; SYNCOPE (medically significant), FALL (non-serious), outcome "unknown" and all described as "He passed out, he fell down"; THYROID DISORDER (non-serious), outcome "unknown", described as "dysthyroid"; BALANCE DISORDER (non-serious), outcome "unknown", described as "He had lost his balance"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "He couldn't walk"; WEIGHT FLUCTUATION (non-serious), outcome "unknown", described as "His weight at the time was about a 100, 280 pounds somewhere in that range and knock down to 158"; ARTHRITIS (non-serious), outcome "unknown", described as "arthritis". It was not really right but when he took the second shot that's when everything went to heck in a handbasket. He had lost his balance. He passed out, he fell down. He couldn't walk and then he, the last time he passed out, he didn't wake up for two months. The patient was in a coma for two months and then had to be reflect to take it twice for the dysthyroid and now was in a care facility because he was still in the wheelchair, he still cannot walk. He was in paralysis and dysthyroid had to be brought back then arthritis and he was in medical care for months. The patient underwent the following laboratory tests and procedures: weight: 100 lbs; 280 lbs; 158 lbs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight fluctuation
Clinical narrative: He was in medical care for months and now he is in the an assisted care facility because he is still in the wheelchair, he still can not walk; Coma for two months; Guillain-Barre syndrome; Paralysis; He passed out, he fell down; dysthyroid; He passed out, he fell down; He had lost his balance; He couldn't walk; His weight at the time was about a 100, 280 pounds somewhere in that range and knock down to 158; arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72 year-old (it's like between 72 and 73) male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. The patient took concomitant medications. He was taking stuff now, kind of stuff, now but back then now, he was in pretty good health other than diabetes. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. He had problem after the first shot. The following information was reported: GAIT INABILITY (disability), outcome "unknown", described as "He was in medical care for months and now he is in the an assisted care facility because he is still in the wheelchair, he still can not walk"; COMA (medically significant), outcome "unknown", described as "Coma for two months"; GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome"; PARALYSIS (medically significant), outcome "unknown", described as "Paralysis"; SYNCOPE (medically significant), FALL (non-serious), outcome "unknown" and all described as "He passed out, he fell down"; THYROID DISORDER (non-serious), outcome "unknown", described as "dysthyroid"; BALANCE DISORDER (non-serious), outcome "unknown", described as "He had lost his balance"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "He couldn't walk"; WEIGHT FLUCTUATION (non-serious), outcome "unknown", described as "His weight at the time was about a 100, 280 pounds somewhere in that range and knock down to 158"; ARTHRITIS (non-serious), outcome "unknown", described as "arthritis". It was not really right but when he took the second shot that's when everything went to heck in a handbasket. He had lost his balance. He passed out, he fell down. He couldn't walk and then he, the last time he passed out, he didn't wake up for two months. The patient was in a coma for two months and then had to be reflect to take it twice for the dysthyroid and now was in a care facility because he was still in the wheelchair, he still cannot walk. He was in paralysis and dysthyroid had to be brought back then arthritis and he was in medical care for months. The patient underwent the following laboratory tests and procedures: weight: 100 lbs; 280 lbs; 158 lbs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: booster; Positive rapid test followed by a positive PCR test; Positive rapid test followed by a positive PCR test/Runny nose, dry cough, tired; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single, administration date Apr2021 (Lot number: Unknown) at the age of 26 years as dose 2, single and administration date Mar2021 (Lot number: Unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies, no covid prior vaccination.  The patient's concomitant medications were not reported. No other vaccine if four weeks. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021, outcome "recovering", described as "booster"; DRUG INEFFECTIVE (medically significant) with onset 15Dec2021, outcome "unknown", described as "Positive rapid test followed by a positive PCR test"; COVID-19 (medically significant) with onset 15Dec2021, outcome "recovering", described as "Positive rapid test followed by a positive PCR test/Runny nose, dry cough, tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (15Dec2021) positive, notes: Nasal Swab; sars-cov-2 test: (15Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, COVID-19, Fatigue, Oedema
Clinical narrative: covid test date=17Aug2021 / covid test result=Positive; covid test date=17Aug2021 / covid test result=Positive; I was spilling protein into my urine; kidney issues; edema issues; high cholesterol; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:30 (Lot number: Ew0161) at the age of 33 years as dose 2, single and administered in arm left, administration date 16Mar2021 12:45 (Lot number: En6208) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. it was reported that No other vaccine was taken in for weeks, In the month of April reporter was informed by a nurse for a place of hiring that patient was spilling protein into his urine. She recommended that I check with patients primary care physician to see what the deal was. Fast forward to December patient was having kidney issues that is causing edema issues high cholesterol and fatigue. Patient was healthy 34 year old male. With no smoking history, With No drinking or illicit drug history. No kidney problems in patient family tree and just out of the blue this is happening. It began in April and has progressed to me seeing a nephrologists for treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2021, outcome "unknown" and all described as "covid test date=17Aug2021 / covid test result=Positive"; PROTEIN URINE PRESENT (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "I was spilling protein into my urine"; RENAL DISORDER (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "kidney issues"; OEDEMA (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "edema issues"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "high cholesterol"; FATIGUE (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "fatigue". The events "i was spilling protein into my urine", "kidney issues", "edema issues", "high cholesterol" and "fatigue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood cholesterol: (22Apr2021) high; protein urine: (22Apr2021) spilling protein into my urine; sars-cov-2 test: (17Aug2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of protein urine present, renal disorder, oedema, blood cholesterol increased, fatigue. No follow-up attempts are possible no further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Protein urine, Protein urine present, Renal disorder, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date=17Aug2021 / covid test result=Positive; covid test date=17Aug2021 / covid test result=Positive; I was spilling protein into my urine; kidney issues; edema issues; high cholesterol; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 13:30 (Lot number: Ew0161) at the age of 33 years as dose 2, single and administered in arm left, administration date 16Mar2021 12:45 (Lot number: En6208) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. it was reported that No other vaccine was taken in for weeks, In the month of April reporter was informed by a nurse for a place of hiring that patient was spilling protein into his urine. She recommended that I check with patients primary care physician to see what the deal was. Fast forward to December patient was having kidney issues that is causing edema issues high cholesterol and fatigue. Patient was healthy 34 year old male. With no smoking history, With No drinking or illicit drug history. No kidney problems in patient family tree and just out of the blue this is happening. It began in April and has progressed to me seeing a nephrologists for treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2021, outcome "unknown" and all described as "covid test date=17Aug2021 / covid test result=Positive"; PROTEIN URINE PRESENT (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "I was spilling protein into my urine"; RENAL DISORDER (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "kidney issues"; OEDEMA (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "edema issues"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "high cholesterol"; FATIGUE (non-serious) with onset 22Apr2021 12:00, outcome "not recovered", described as "fatigue". The events "i was spilling protein into my urine", "kidney issues", "edema issues", "high cholesterol" and "fatigue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood cholesterol: (22Apr2021) high; protein urine: (22Apr2021) spilling protein into my urine; sars-cov-2 test: (17Aug2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of protein urine present, renal disorder, oedema, blood cholesterol increased, fatigue. No follow-up attempts are possible no further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Vaccination site pain
Clinical narrative: Pain in the injection area; Swollen lymph nodes; dose number=3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 at 14:30 (Lot number: FH8027) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot Number: EP6955 Anatomical site: Left Arm Administration time: 10:15 Route of administration: Intramuscular), administration date: 30Mar2021, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot Number: EL3247 Anatomical site: Left Arm Administration time: 10:00 Route of administration: Intramuscular), administration date: 09Mar2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 14:30, outcome "unknown", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "Pain in the injection area"; LYMPHADENOPATHY (non-serious) with onset 16Dec2021, outcome "unknown", described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of vaccination site pain and lymphadenopathy.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 22 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Apr2021 11:00 (Lot number: EP6955) at the age of 21 years as dose 2, single and intramuscular, administered in arm left, administration date 23Mar2021 11:00 (Lot number: EP6955) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. The patient's concomitant medications received within 2 weeks of vaccination was reported as unknown. It was unknown whether the patient was pregnant at time of vaccination. 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. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 14Dec2021, outcome "recovering" and all described as "Patient tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) positive. The reporter seriousness was reported as non-serious. Therapeutic measures were not taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Immunisation, Lymphadenopathy
Clinical narrative: Moderate cellulitis; right axillary lymphadenopathy; COVID booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 16:30 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (COVID 19 Pfizer , 31Mar2021 Given by pharmacy clinic, administration time=12:00 PM, dose number=2, vaccine location=Right arm.), administration date: 31Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (COVID 19, Pfizer, 08Mar2021 Given by CVS, administration time=12:00 PM, dose number=1, vaccine location=Right arm.), administration date: 08Mar2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant) with onset 17Dec2021 08:00, outcome "not recovered", described as "Moderate cellulitis"; IMMUNISATION (non-serious) with onset 15Dec2021 16:30, outcome "unknown", described as "COVID booster"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021 08:00, outcome "not recovered", described as "right axillary lymphadenopathy". The events "moderate cellulitis" and "right axillary lymphadenopathy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of cellulitis, lymphadenopathy.  Other vaccine in four-weeks was No. Adverse event: Moderate cellulitis and right axillary lymphadenopathy on same side as COVID booster given. Covid prior vaccination was No. Covid tested post vaccination was No. No Known allergies. No other medical history. The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization and cellulitis and BNT162B2.  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.