chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 13Mar2021 (Lot number: unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, on 18Mar2021, the patient tested positive for COVID. She completed the 10 days of quarantine. She returned for her COVID test on 29Mar2021, it was positive. She was told that she could keep testing positive for 2-3 weeks even without any symptoms. She was concerned that she will have to restart the whole COVID vaccine series after having tested positive for COVID. The patient would like to know if she can get the 2nd dose of the COVID vaccine after having tested positive for COVID although she no longer had symptoms. Event outcome was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; Tested positive for covid-19; This is a spontaneous report from a contactable consumer (patient) via female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via unspecified route of administration on 14Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on 29Mar2021.There was no PQC reported. On 06Apr2021, patient was scheduled for 2nd dose. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: he was experiencing side effects such as headache and fever; effects such as headache and fever; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program.   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 24Mar2021 as SINGLE DOSE for COVID-19 immunisation. It was reported that the patient received his first dose before 3 weeks the 2nd dose. The patient medical history and the concomitant medications were not reported. After the second dose, the patient experienced side effects such as headache and fever. Patient wants to know which medicine he can take. At the time of this report the event outcome was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Pain
Clinical narrative: she is experiencing heart pain around the heart; she is experiencing heart pain around the heart and body; This is a spontaneous report from consumer (patient) reported for herself via Pfizer sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 21Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced heart pain around the heart and body after taking the first dose of Covid-19 vaccine last 21Mar2021. She was scheduled to take the 2nd dose on 12Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Pruritus, Throat irritation, Throat tightness, Tongue pruritus
Clinical narrative: experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; throat feels very tight; she feels itchiness in different parts of her body; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (Patient herself) reported that a female of an unspecified age received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced throat feels very tight, experiencing itchy throat, eyes and tongue, she feels itchiness in different parts of her body. She stated received her first dose today and she is experiencing itchy throat, eyes and tongue. She said that her throat feels very tight and she feels itchiness in different parts of her body. She was asking if she can take Benadryl. The outcome of events was unknown.  No follow-up attempts are possible. Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Paraesthesia oral, Pruritus, Throat tightness
Clinical narrative: experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; throat feels very tight; she feels itchiness in different parts of her body; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (Patient herself) reported that a female of an unspecified age received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced throat feels very tight, experiencing itchy throat, eyes and tongue, she feels itchiness in different parts of her body. She stated received her first dose today and she is experiencing itchy throat, eyes and tongue. She said that her throat feels very tight and she feels itchiness in different parts of her body. She was asking if she can take Benadryl. The outcome of events was unknown.  No follow-up attempts are possible. Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; experiencing itchy throat, eyes and tongue; throat feels very tight; she feels itchiness in different parts of her body; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (Patient herself) reported that a female of an unspecified age received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced throat feels very tight, experiencing itchy throat, eyes and tongue, she feels itchiness in different parts of her body. She stated received her first dose today and she is experiencing itchy throat, eyes and tongue. She said that her throat feels very tight and she feels itchiness in different parts of her body. She was asking if she can take Benadryl. The outcome of events was unknown.  No follow-up attempts are possible. Information related to batch/Lot number could not be requested.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: after the 2nd shot, my platelets were lower to 369 which was normal for me; This is a spontaneous report received from a contactable (reporting for self). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. Medical history included polycythaemia vera, essential thrombocythaemia. The historical vaccine included first dose of BNT162B2 received on Jan2021 for COVID-19 immunization. The patient's concomitant medications were not reported. The patient previously took jakafi for polycythaemia vera and experienced skin lesion. It was reported that patient received her/his two BNT162B2 Covid 19 vaccine back in Jan2021 and 03Feb2021. After her/his 2nd shot of BNT162B2, her/his platelet dropped down around 400. Patient was using medication Jakafi up until Dec2020. But patient had skin lesions and he/she dropped it. So, at the time patient received the vaccines, he/she was not on any medication. Patient was asking that can you look into if BNT162B2 or similar medication can possibly be produced to drop down the platelet level and hemoglobin for the patients who have Polycythemia Vera and Essential Thrombocythemia. Patient wrote to Pfizer because the BNT162B2 could be a way to find a medication for Polycythemia Vera and Essential Thrombosis. Because right after the 2nd shot, "my platelets were lower to 369 which was normal for me". Pa-tients platelets were over 1000 when he/she started the Jakafi medication. It did drop to 500-600 but not lower than that. Patient not sure if it was the vaccine that helped to lower platelet but, patient was trying to see if it can be studied to find a medication for the referenced diseases. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Facial paralysis, Swelling face
Clinical narrative: face drooping; face swelling; face pain; This is a spontaneous report from contactable consumer (caregiver reported regarding his mom). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient previously received the first dose of BNT162B2 on unknown date. The patient received concomitant drug, however, drug name was unspecified. 4 days after receiving vaccine (on 28Mar2021), the patient experienced face swelling and pain, drooping. Caller reports giving his mom tylenol for the pain. Today the swelling has went down some, but there is still pain and drooping. Caller would like to know it this is a possible side effect and what to do. The outcome of face swelling was recovering. The outcome of the other events was unknown.   Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness when it rains; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 74-year-old female patient received both doses of BNT162B2 (Formulation: Solution for injection, lot number; unknown) via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient takes XELJANZ XR TAB 11MG from 08Jul2020 and stop date is unknown. On an unknown date, patient experienced stiffness when it rains. The patient said that she was told by provider she can have up to 4 Tylenols per day if needed. The outcome of the event was unknown.  No follow attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Seizure
Clinical narrative: seizure; fell out of bed; bruises; This is a spontaneous report from a contactable consumer. A female 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 a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who received the vaccine experienced and similar seizure same day she feel out of bed/ bruises/spent night on an unspecified date. The outcome of the events was unknown.   Additional information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chills
Clinical narrative: heart flutters; chills; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date in Mar2021 as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unknown date, the patient reported that she was fine yesterday but today she was experiencing chills and what feels like heart flutters that come and go. The patient experienced heart flutters and chills. The outcome of the events was unknown.  Information about batch/lot no has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Vaccination site pain
Clinical narrative: has injection site pain; swelling in left ankle; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored study. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain and swelling in left ankle. The patient was unsure if it was normal side effects. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, at the age of 72 years, administered in left arm on 11Mar2021 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization.  Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 23Mar2021, patient tested positive for COVID-19 infection. Patient was wondering if she should still take the second shot which was scheduled on 01Apr2021. The event was considered as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Confusional state, Decreased appetite, Fatigue
Clinical narrative: hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pain; started having confusion; This is a spontaneous report from a contactable physician.  A 88-years-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), second dose via an unspecified route of administration on 24Mar2021,single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , pulmonary hypertension, allergies to medications, food, or other products: clindamycin, levofloxacin, sulfa drugs, penicillin from an unknown date and unknown if ongoing. Patient started having fatigue immediately after 2nd dose vaccination. 3 days later (27Mar2021), patient had very poor appetite, abdominal pain and started having confusion. 6 days later (30Mar2021), patient was hospitalized for acute pancreatitis and acute renal failure. Events resulted in going to the emergency room/department or urgent care. Treatment received for the adverse event was IV rehydration, levophed, vasopressin, dobutamine, cefepime and flagyl. The outcome of the events was unknown. No COVID prior vaccination. Patient had COVID test post vaccination (nasal swab) on 31Mar2021 with result of negative.  No follow-up attempts are possible.; Sender's Comments: By close temporal relationship, the company cannot completely exclude a contributory role of BNT162b2 in the development of the reported diagnosis of acute pancreatitis and acute renal failure. Medical history including  chronic kidney disease in the setting of elderly age, cannot be also excluded as confounding factors.  The impacts 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: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis acute, SARS-CoV-2 test negative
Clinical narrative: hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pain; started having confusion; This is a spontaneous report from a contactable physician.  A 88-years-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), second dose via an unspecified route of administration on 24Mar2021,single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , pulmonary hypertension, allergies to medications, food, or other products: clindamycin, levofloxacin, sulfa drugs, penicillin from an unknown date and unknown if ongoing. Patient started having fatigue immediately after 2nd dose vaccination. 3 days later (27Mar2021), patient had very poor appetite, abdominal pain and started having confusion. 6 days later (30Mar2021), patient was hospitalized for acute pancreatitis and acute renal failure. Events resulted in going to the emergency room/department or urgent care. Treatment received for the adverse event was IV rehydration, levophed, vasopressin, dobutamine, cefepime and flagyl. The outcome of the events was unknown. No COVID prior vaccination. Patient had COVID test post vaccination (nasal swab) on 31Mar2021 with result of negative.  No follow-up attempts are possible.; Sender's Comments: By close temporal relationship, the company cannot completely exclude a contributory role of BNT162b2 in the development of the reported diagnosis of acute pancreatitis and acute renal failure. Medical history including  chronic kidney disease in the setting of elderly age, cannot be also excluded as confounding factors.  The impacts 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: Thrombosis
Clinical narrative: she had developed what she believes is a blood clot in her leg; This is a spontaneous report from a contactable other healthcare professional (nurse) via medical information team. The contactable consumer reported for her mother that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) intramuscularly on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took her first dose of bnt162b2, on an unspecified date for covid-19 immunisation. The patient's mother received the second dose of the covid vaccine yesterday morning. When the caller saw her mother last night, she had developed what she believes is a blood clot in her leg on an unknown date. The reporter would like to know whether a blood clot is a possible side effect from the covid vaccine. The patient did not receive any type of treatment for the adverse event. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Thrombosis leg   due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this elderly patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including venous doppler of lower extremities and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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: Systemic lupus erythematosus
Clinical narrative: his wife has Lupus; This is a spontaneous report received from a contactable consumer (patient husband) via medical information team. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unknown route of administration on an unknown date in 2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that he and his wife received the first dose of the Pfizer COVID vaccine three weeks ago. Reporter stated they are scheduled for the second dose tomorrow. Reporter stated that his wife has Lupus and she was prescribed a Medrol steroid dose pack three days ago. Reporter would like to know if it would be okay for his wife to receive the second dose of the vaccine after taking the Medrol steroid dose pack. The outcome of the event was unknown.  Follow-up needed. Further information was requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site warmth
Clinical narrative: Sore arm; Warmth at injection site; Fatigued; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced sore arm, warmth at injection site and fatigued on 30Mar2021. Outcome of the events was not reported.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Loss of control of legs, Mobility decreased
Clinical narrative: could not navigate her legs; She was not able to stand up on her own; could not move her legs; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on 23Mar2021 as a single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on 23Mar2021 and at night she could not move her legs. She was not able to stand up on her own and could not navigate her legs. She rushed to the emergency. The patient was scheduled to take the second dose of the vaccine on 13Apr2021. She was worried that maybe she would experience the same effects of the vaccine. The clinical outcome of the events, could not move her legs, was not able to stand up on her own and could not navigate her legs, was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: could not navigate her legs; She was not able to stand up on her own; could not move her legs; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on 23Mar2021 as a single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 on 23Mar2021 and at night she could not move her legs. She was not able to stand up on her own and could not navigate her legs. She rushed to the emergency. The patient was scheduled to take the second dose of the vaccine on 13Apr2021. She was worried that maybe she would experience the same effects of the vaccine. The clinical outcome of the events, could not move her legs, was not able to stand up on her own and could not navigate her legs, was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Inappropriate schedule of product administration, Overdose
Clinical narrative: Sudden Death; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6199) and second dose (lot: ER8730); both via an unspecified route of administration into the right arm on 28Mar2021 12:00 for COVID-19 immunization. Medical history included coronary artery disease (CAD), hypertension, parkinson's disease, abdominal aortic aneurysm, cerebral aneurysm and arthritis. Concomitant medications included paracetamol (TYLENOL) taken for arthritis and a pill for his hypertension. It was reported that the first and second dose of vaccine was administered on 28Mar2021 12:00 PM. The patient's sudden death on 30Mar2021 15:30 was also reported. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination.  Further information has been requested.; Reported Cause(s) of Death: Sudden Death
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Myalgia, Pain in extremity
Clinical narrative: she can't walk; her ankle, arms, muscles are in pain; her ankle, arms, muscles are in pain; her ankle, arms, muscles are in pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing urinary tract infection. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021 for COVID-19 immunization and experienced pain and nausea. In Mar2021, the patient can't walk because her ankle, arms, muscles were in pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive in between doses; This is a spontaneous report received from Pfizer sponsored patient support program. A contactable consumer (patient) reported that a female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on 16Mar2021, as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was scheduled for her second dose on 06Apr2021. On 22Mar2021, she was tested positive in between doses. She called to inquire about getting the second dose. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller received first dose- got covid shortly after; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN; Expiry date: not reported) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose and got COVID shortly after that, on an unspecified date in Mar2021. He still in quarantine and symptoms were gone. Second dose scheduled on 06Apr2021. He asked whether he was able to go, if not what was the time frame- Cold transferred to D and S. The outcome of event was recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid 19 positive on 28MAR2021; This is a spontaneous report. A contactable female consumer non- healthcare professional(patient) via measurable supplier other. A female patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, (solution for injection/Batch/lot number: unknown) via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications were unknown. It was reported that the patients had taken COVID-vaccine on 23Mar2021 and the patient had experienced covid 19 positive on 28Mar2021. Patient second dose was scheduled on 13Apr2021. Outcome of the event was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360085 Diffferent patient, same drug and event
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity, Abnormal dreams, Blood pressure measurement, Breath sounds abnormal, Cardiospasm
Clinical narrative: glaucoma; stool turned black; constipation; clay like stool; heart spasm; chest and abdomen feels hard; movement under skin; euphoria; Looking at things looked so far away. Had no thought in her head.; dryness behind her eyeballs; sensitive to light; teeth felt weak; vivid dreams; heart beating on top of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; felt like getting hemorrhoids; high blood pressure; pupils are very large; horrid dreams; whistling in her chest; chest and abdomen feels hard; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of 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. The patient had the first dose of vaccine. Side effects reported included stool turned black, constipation, clay like stool, heart spasm, heart beating on top of chest, chest and abdomen feels hard, feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest and felt like getting hemorrhoids. Next day, the patient has feeling of euphoria, like on drugs; looking at things looked so far away and had no thought in her head, like taken Vallum but she never took vallum but that's what she thinks it would be. The patient has high blood pressure and takes beta blocker. On the day of vaccine, pulse went to 79, like it reversed medication. The patient has glaucoma, felt dryness behind her eyeballs, the socket, pupils are very large and sensitive to light. Her teeth felt weak, 1 tooth broke from tortilla chip. In sleep, she had horrid and vivid dreams. All stress went into her dreams. 3 days she had no thoughts or stress but would have in dreams. Also, when waking up she had whistling in her chest and feeling like having heart spasm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Constipation, Daydreaming, Dry eye, Euphoric mood
Clinical narrative: glaucoma; stool turned black; constipation; clay like stool; heart spasm; chest and abdomen feels hard; movement under skin; euphoria; Looking at things looked so far away. Had no thought in her head.; dryness behind her eyeballs; sensitive to light; teeth felt weak; vivid dreams; heart beating on top of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; felt like getting hemorrhoids; high blood pressure; pupils are very large; horrid dreams; whistling in her chest; chest and abdomen feels hard; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of 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. The patient had the first dose of vaccine. Side effects reported included stool turned black, constipation, clay like stool, heart spasm, heart beating on top of chest, chest and abdomen feels hard, feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest and felt like getting hemorrhoids. Next day, the patient has feeling of euphoria, like on drugs; looking at things looked so far away and had no thought in her head, like taken Vallum but she never took vallum but that's what she thinks it would be. The patient has high blood pressure and takes beta blocker. On the day of vaccine, pulse went to 79, like it reversed medication. The patient has glaucoma, felt dryness behind her eyeballs, the socket, pupils are very large and sensitive to light. Her teeth felt weak, 1 tooth broke from tortilla chip. In sleep, she had horrid and vivid dreams. All stress went into her dreams. 3 days she had no thoughts or stress but would have in dreams. Also, when waking up she had whistling in her chest and feeling like having heart spasm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Faeces pale, Glaucoma, Haemorrhoids, Heart rate
Clinical narrative: glaucoma; stool turned black; constipation; clay like stool; heart spasm; chest and abdomen feels hard; movement under skin; euphoria; Looking at things looked so far away. Had no thought in her head.; dryness behind her eyeballs; sensitive to light; teeth felt weak; vivid dreams; heart beating on top of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; felt like getting hemorrhoids; high blood pressure; pupils are very large; horrid dreams; whistling in her chest; chest and abdomen feels hard; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of 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. The patient had the first dose of vaccine. Side effects reported included stool turned black, constipation, clay like stool, heart spasm, heart beating on top of chest, chest and abdomen feels hard, feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest and felt like getting hemorrhoids. Next day, the patient has feeling of euphoria, like on drugs; looking at things looked so far away and had no thought in her head, like taken Vallum but she never took vallum but that's what she thinks it would be. The patient has high blood pressure and takes beta blocker. On the day of vaccine, pulse went to 79, like it reversed medication. The patient has glaucoma, felt dryness behind her eyeballs, the socket, pupils are very large and sensitive to light. Her teeth felt weak, 1 tooth broke from tortilla chip. In sleep, she had horrid and vivid dreams. All stress went into her dreams. 3 days she had no thoughts or stress but would have in dreams. Also, when waking up she had whistling in her chest and feeling like having heart spasm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Herpes virus infection, Herpes zoster, Hypertension, Mydriasis
Clinical narrative: glaucoma; stool turned black; constipation; clay like stool; heart spasm; chest and abdomen feels hard; movement under skin; euphoria; Looking at things looked so far away. Had no thought in her head.; dryness behind her eyeballs; sensitive to light; teeth felt weak; vivid dreams; heart beating on top of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; felt like getting hemorrhoids; high blood pressure; pupils are very large; horrid dreams; whistling in her chest; chest and abdomen feels hard; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of 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. The patient had the first dose of vaccine. Side effects reported included stool turned black, constipation, clay like stool, heart spasm, heart beating on top of chest, chest and abdomen feels hard, feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest and felt like getting hemorrhoids. Next day, the patient has feeling of euphoria, like on drugs; looking at things looked so far away and had no thought in her head, like taken Vallum but she never took vallum but that's what she thinks it would be. The patient has high blood pressure and takes beta blocker. On the day of vaccine, pulse went to 79, like it reversed medication. The patient has glaucoma, felt dryness behind her eyeballs, the socket, pupils are very large and sensitive to light. Her teeth felt weak, 1 tooth broke from tortilla chip. In sleep, she had horrid and vivid dreams. All stress went into her dreams. 3 days she had no thoughts or stress but would have in dreams. Also, when waking up she had whistling in her chest and feeling like having heart spasm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Paraesthesia, Photophobia, Teeth brittle
Clinical narrative: glaucoma; stool turned black; constipation; clay like stool; heart spasm; chest and abdomen feels hard; movement under skin; euphoria; Looking at things looked so far away. Had no thought in her head.; dryness behind her eyeballs; sensitive to light; teeth felt weak; vivid dreams; heart beating on top of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; Feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest; felt like getting hemorrhoids; high blood pressure; pupils are very large; horrid dreams; whistling in her chest; chest and abdomen feels hard; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of 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. The patient had the first dose of vaccine. Side effects reported included stool turned black, constipation, clay like stool, heart spasm, heart beating on top of chest, chest and abdomen feels hard, feels movement under skin, like getting shingles or herpes in different places, face, arms, right side of chest and felt like getting hemorrhoids. Next day, the patient has feeling of euphoria, like on drugs; looking at things looked so far away and had no thought in her head, like taken Vallum but she never took vallum but that's what she thinks it would be. The patient has high blood pressure and takes beta blocker. On the day of vaccine, pulse went to 79, like it reversed medication. The patient has glaucoma, felt dryness behind her eyeballs, the socket, pupils are very large and sensitive to light. Her teeth felt weak, 1 tooth broke from tortilla chip. In sleep, she had horrid and vivid dreams. All stress went into her dreams. 3 days she had no thoughts or stress but would have in dreams. Also, when waking up she had whistling in her chest and feeling like having heart spasm. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Gingival bleeding, Immune thrombocytopenia, Platelet count, Platelet count decreased
Clinical narrative: Immune thrombocytopenia purpuria; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; platelet count of 1000; This is a spontaneous report from a contactable nurse reported for herself.  This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number  ELU266), via an unspecified route of administration at single dose in left arm on 20Feb2021 12:45 for COVID-19 immunisation. Medical history included allergies to medications penicillins, ceclor, statins, environmental; diabetes; hypertension; asthma; gastrooesophageal reflux disease. The vaccine was administered at Health Clinic. Concomitant medications included rabeprazole, clonazepam, montelukast, venlafaxine hydrochloride. On 22Feb2021, the patient experienced immune thrombocytopenia purpuria, bleeding of gums, nose, skin pricks, platelet count of 1000. Therapeutic measures were taken as a result of the events included steroids, IVGM, platelets, PRBC, iron, antibiotics. The outcome of the events was recovering. The patient was hospitalized and condition was life threatening. The patient underwent lab tests and procedures which included platelet count: 1000 on 22Feb2021, SARS-CoV-2 test: negative on 07Mar2021.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be excluded based on plausible temporal relationship and lack of alternate explanation at this time. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin haemorrhage
Clinical narrative: Immune thrombocytopenia purpuria; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; platelet count of 1000; This is a spontaneous report from a contactable nurse reported for herself.  This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number  ELU266), via an unspecified route of administration at single dose in left arm on 20Feb2021 12:45 for COVID-19 immunisation. Medical history included allergies to medications penicillins, ceclor, statins, environmental; diabetes; hypertension; asthma; gastrooesophageal reflux disease. The vaccine was administered at Health Clinic. Concomitant medications included rabeprazole, clonazepam, montelukast, venlafaxine hydrochloride. On 22Feb2021, the patient experienced immune thrombocytopenia purpuria, bleeding of gums, nose, skin pricks, platelet count of 1000. Therapeutic measures were taken as a result of the events included steroids, IVGM, platelets, PRBC, iron, antibiotics. The outcome of the events was recovering. The patient was hospitalized and condition was life threatening. The patient underwent lab tests and procedures which included platelet count: 1000 on 22Feb2021, SARS-CoV-2 test: negative on 07Mar2021.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be excluded based on plausible temporal relationship and lack of alternate explanation at this time. 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.