chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The patient had rash all over his chest; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number and Expiry Date: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. Patient also took lisinopril (manufacturer, start and stop dates, NDC number and Expiry Date: unknown) as an ACE Inhibitor. Patient's medical history and concomitant medications were not reported. Patient had rash all over his chest after his first dose of the Pfizer COVID Vaccine. According to the doctor, the rash might be due to the Lisinopril. Outcome of the event was unknown. Investigation Assessment: Not Provided.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: I got pneumonia; I got pneumonia; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as 1st dose, single and 2nd dose, single, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got pneumonia after 30 days of vaccination in Apr2021. Patient was taking many mediations. Patient was fine before the vaccine. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller received first dose, then tested positive for covid; Caller received first dose, then tested positive for covid; This is a spontaneous report received from a non-contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 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 medical history and concomitant medications were not reported. The patient received first dose, then tested positive for COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient received first covax, then contracted Covid-19; patient received first covax, then contracted Covid-19; This is a spontaneous report from a contactable other healthcare professional via the Pfizer Sponsored Program.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received first covax, then contracted Covid-19, was treated with antibodies, asked if safe for patient to receive 2nd CoVax. The outcome of the events was unknown.  Information about batch/lot number is not available. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Drug ineffective, Lethargy, Pyrexia
Clinical narrative: had extreme Covid like symptoms/ those side effects seem to be what it looks like, possible Covid; had extreme Covid like symptoms/ those side effects seem to be what it looks like, possible Covid; dry cough; fever; she has been laying in bed; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dry cough, fever, had extreme covid like symptoms/ those side effects seem to be what it looks like, possible covid and "she has been laying in bed." It was reported that patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and afterwards, she had extreme Covid-like symptoms, which included dry cough, and fever. Reporter (patient's husband) informed that the patient's temperature yesterday was at 102.4 F and today the fever is low. Reporter said his wife does not feel like taking her regular vitamins and medications so he is worried. He said she has been laying in bed. Reporter wants to know if this is a common side effect reported with the vaccine, or if his wife actually has Covid. If so, reporter wants to know if his wife should get tested for Covid. The reporter was informed that there is no information about dry cough was associated with the vaccine and he was referred to his HCP for further guidance.The patient underwent lab tests and procedures which included body temperature: 100, 102.4 degree fahrenheit. She has had extreme Covid like symptoms, fever over 100 degrees, that spiked over 102 degrees. She didn't appear to have a fever this morning, but is laying in bed. He wonders if this is something that happens as a side effect or if she could actually have Covid since those side effects seem to be what it looks like, possible Covid. The outcome of the events was unknown.  Follow up attempts are needed; information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: had extreme Covid like symptoms/ those side effects seem to be what it looks like, possible Covid; had extreme Covid like symptoms/ those side effects seem to be what it looks like, possible Covid; dry cough; fever; she has been laying in bed; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dry cough, fever, had extreme covid like symptoms/ those side effects seem to be what it looks like, possible covid and "she has been laying in bed." It was reported that patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and afterwards, she had extreme Covid-like symptoms, which included dry cough, and fever. Reporter (patient's husband) informed that the patient's temperature yesterday was at 102.4 F and today the fever is low. Reporter said his wife does not feel like taking her regular vitamins and medications so he is worried. He said she has been laying in bed. Reporter wants to know if this is a common side effect reported with the vaccine, or if his wife actually has Covid. If so, reporter wants to know if his wife should get tested for Covid. The reporter was informed that there is no information about dry cough was associated with the vaccine and he was referred to his HCP for further guidance.The patient underwent lab tests and procedures which included body temperature: 100, 102.4 degree fahrenheit. She has had extreme Covid like symptoms, fever over 100 degrees, that spiked over 102 degrees. She didn't appear to have a fever this morning, but is laying in bed. He wonders if this is something that happens as a side effect or if she could actually have Covid since those side effects seem to be what it looks like, possible Covid. The outcome of the events was unknown.  Follow up attempts are needed; information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: The freezerdidn't get below regular freezingtemp, which should be -25 to -15.; This case has been considered invalid as there is no indication that the patient experienced an event under suspect product BNT162B2.  This is a spontaneous report received from a contactable consumer via Pfizer- sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Powder for solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller says their Ultra-Low temperature freezer went out of range this weekend and it's come back into range. The freezer did not get below regular freezing temp, which should be -25 to -15. As she put it back at the ultra-low temp it will still be good until it's actual manufacture expiration date? The outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.  Amendment :This follow-up report was being submitted to amend previously reported information: the case is invalid as it was unknown if the patient received the incorrectly stored vaccine per Vaccine guidance.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She became infected with COVID19 more than 2 weeks after her 2nd Pfizer vaccination; She became infected with COVID19 more than 2 weeks after her 2nd Pfizer vaccination; This is spontaneous report received from a contactable consumer. A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) (at 50-year-old) at 2nd dose, single in arm left for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It's unknown if other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) (at 50-year-old) at 1st dose, single for COVID-19 immunisation. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient became infected with COVID19 more than 2 weeks after her 2nd Pfizer vaccination. The event was confirmed (test positive) to have been reported to the (Name withheld) was not hospitalized and appeared to have recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Malaise, Migraine, Neuropathy peripheral
Clinical narrative: My nerves are stuck; My memory is lost; Feeling sick.; I have vomited again yesterday; I am tired; I have been having pains throughout my body; I had a migraine headache all day yesterday; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received unknown dose bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Lot number: was not reported; Expiration date was not reported), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got confirmed as Pfizer BioNTech Covid19 Vaccine about a month ago and patient still feeling sick, vomited again yesterday, tired, nerves are stuck, memory was lost. Patient has been having pains throughout his body, migraine headache all day yesterday and patient didn't have any of these symptoms before took the vaccine. Right after the vaccine patient immediately felt pretty sick like within the same couple days and he hasn't felt right since then. Consumer was informed about the Pfizer Medical Information Department for the concern and was provided and timings as 8am to 8pm Monday to Friday and 9am to 3pm Saturday and Sunday as per Eastern Standard Timings. When informed the role of Pfizer Drug Safety, consumer stated, Okay. This is a safety report. The clinical outcome of the events was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: My nerves are stuck; My memory is lost; Feeling sick.; I have vomited again yesterday; I am tired; I have been having pains throughout my body; I had a migraine headache all day yesterday; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received unknown dose bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Lot number: was not reported; Expiration date was not reported), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got confirmed as Pfizer BioNTech Covid19 Vaccine about a month ago and patient still feeling sick, vomited again yesterday, tired, nerves are stuck, memory was lost. Patient has been having pains throughout his body, migraine headache all day yesterday and patient didn't have any of these symptoms before took the vaccine. Right after the vaccine patient immediately felt pretty sick like within the same couple days and he hasn't felt right since then. Consumer was informed about the Pfizer Medical Information Department for the concern and was provided and timings as 8am to 8pm Monday to Friday and 9am to 3pm Saturday and Sunday as per Eastern Standard Timings. When informed the role of Pfizer Drug Safety, consumer stated, Okay. This is a safety report. The clinical outcome of the events was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Pulmonary embolism
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital.  Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported.  The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization.  The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital.  Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported.  The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization.  The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Muscular weakness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient wife) or other non hcp. A 44-years-old male patient received BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiration date was not reported), dose 1 via an unspecified route of administration on 26May2021 (at the age of 44-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. concomitant medications were not reported. on 27 May 2021 the patient experienced severe chills, muscle weakness, fever/he is having a temperature, nothing crazy. it was 99.9. the patient underwent lab tests and procedures which included body temperature: 99.9 on 27May2021. The outcome of event severe chills was not recovered, while outcome of other events was unknown. Follow-up (27May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (wife) reported for a 44-year-old male patient new information included event detail was updated. Follow-up (27May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (wife) reported for a 44-year-old male patient Limited information available over the call. Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site swelling
Clinical narrative: swelling on her right arm; half an inch long with some pink there on the surface of the skin; This is a spontaneous report from a contactable consumer. Follow-up (27May2021) received from same reporter was processed together along with initial information.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in upper Arm Right on 26May2021 10:46 (at the age of 57-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was none. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 05May2021 at 10:53 AM (batch/lot number: ER8733). No additional vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. On 26May2021, the patient experienced swelling on her right arm and half an inch long with some pink color on the surface of the skin. It was reported that, the swelling on her right arm is weirdly shaped and is described as a scratch mark. The reporter said that it started just a few hours afterwards vaccination and was same by the time of the report. Reporter asked if she could put rubbing alcohol or ice on the site and asked if she had to skip any food items. The patient was not treated for the event. The event did not require a visit to emergency room and physician office. Outcome of the events was not resolved.  Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site haemorrhage, Wrong technique in product usage process
Clinical narrative: patient bled more than usual after administration; 14 year old male patient; not sure if she hit something; This is a spontaneous report from a contactable pharmacist. A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as Unknown single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced bled more than usual after administration in which the circle bandage was immediately filled up. reporter states that patient utilized a 1inch needle. The patient does not take any medications. Reporter queried never seen this before in her three years of administering vaccines. not sure if hit something or what caused him to bleed more than normal. Caller was asking if the patient needs to be revaccinated due to the patient bleeding more than normal after vaccination. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.  Follow up (01Jun2021): This is a follow up spontaneous report from a contactable pharmacist. This Pharmacist reported for 14-years-old male patient, no lot number, no expiry date and no new  adverse event was added.  Information on the lot/ batch number has been requested.  .
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Condition aggravated, Inflammation, Lymphadenopathy, Nerve compression
Clinical narrative: heart swelling or inflammation; heart swelling or inflammation; maybe she has a swollen lymph node that is putting pressure on a nerve.; arm pain in the opposite arm of vaccination/ left arm pain that has progressively gotten worse; get worse/ left arm pain that has progressively gotten worse; swollen lymph node; excruciating pain all the way down to her hand; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 13-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8736; Expiration Date: Jul2021) via an unspecified route of administration in right arm on 13May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient did not receive any vaccination within 4 weeks prior to covid vaccine. The reporter stated that the day the vaccine was approved [for her age group] she got her initial vaccine. She received her first vaccine dose on May 13th in her right arm, several hours later she began having left arm pain that has progressively gotten worse. She reported that after running her arm was in excruciating pain all the way down to her hand. She further enquired if left arm pain a common symptom of the heart swelling or inflammation of the heart following vaccination or is left arm pain something people have when they had heart swelling or inflammation. She further stated that hadn't happened the exact same day she wouldn't connect it so much. The vaccine was given in the right arm, but it is her left arm that is hurting. she called her pediatrician, and he is thinking it is coincidental or thinking maybe she hurt herself, but caller states she doesn't know but maybe she has a swollen lymph node that is putting pressure on a nerve. The patient took Tylenol for the reported events. Outcome of the events was reported as unknown at the time of reporting.  Information on Lot/Batch number was available. Additional information has been requested
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: heart swelling or inflammation; heart swelling or inflammation; maybe she has a swollen lymph node that is putting pressure on a nerve.; arm pain in the opposite arm of vaccination/ left arm pain that has progressively gotten worse; get worse/ left arm pain that has progressively gotten worse; swollen lymph node; excruciating pain all the way down to her hand; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 13-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8736; Expiration Date: Jul2021) via an unspecified route of administration in right arm on 13May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient did not receive any vaccination within 4 weeks prior to covid vaccine. The reporter stated that the day the vaccine was approved [for her age group] she got her initial vaccine. She received her first vaccine dose on May 13th in her right arm, several hours later she began having left arm pain that has progressively gotten worse. She reported that after running her arm was in excruciating pain all the way down to her hand. She further enquired if left arm pain a common symptom of the heart swelling or inflammation of the heart following vaccination or is left arm pain something people have when they had heart swelling or inflammation. She further stated that hadn't happened the exact same day she wouldn't connect it so much. The vaccine was given in the right arm, but it is her left arm that is hurting. she called her pediatrician, and he is thinking it is coincidental or thinking maybe she hurt herself, but caller states she doesn't know but maybe she has a swollen lymph node that is putting pressure on a nerve. The patient took Tylenol for the reported events. Outcome of the events was reported as unknown at the time of reporting.  Information on Lot/Batch number was available. Additional information has been requested
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Blood potassium increased, Contusion, Eye haemorrhage, Thrombosis
Clinical narrative: she is bleeding into the eye and that to her is just, it keeps getting worse; thrombo; elevated potassium; had bruising in the other leg; doctor did PTT, confirmed as PTT, and it was elevated; This is a spontaneous report from a contactable consumer (patient).   An 81-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on an unknown date in Feb2021 (at the age of 81 years old) as a single dose for COVID 19 immunisation. Medical history was not reported. The patient received the medications within 2 weeks of vaccination was Asperin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 experienced adverse events such as large bruising on one leg, after the next dose, bruising on the other leg. She has bruising on both lower limbs, a bleeding disorder. She bled from her eye at the ophthalmologists office. On an unspecified date patient second one, then had bruising in the other leg. She went to the hematologist, and to the doctor. The doctor did PTT, confirmed as PTT, and it was elevated. Reported added that patient also had an elevated potassium. She states this was like what you would get if patient were taking warfarin. it was very concerning now, not only does she have bruising in the leg, but she was bleeding into the eye and that to her was just, it keeps getting worse. She has nothing else to add to that report except that her mom has an elevated PTT, TPTT and states she does not know, it was thrombo. At 81, her mom walks around an hour a day, does aerobics. She was not seeing a hematologist and she was concerned. If she cut herself, she would bleed out. The fact she was bleeding into the eyeball, she has to google the acronym but it was basically clotting issues it was resulting in. No additional details provided; Reporter did not know the name of the elevated test.  Information about lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: she is bleeding into the eye and that to her is just, it keeps getting worse; thrombo; elevated potassium; had bruising in the other leg; doctor did PTT, confirmed as PTT, and it was elevated; This is a spontaneous report from a contactable consumer (patient).   An 81-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on an unknown date in Feb2021 (at the age of 81 years old) as a single dose for COVID 19 immunisation. Medical history was not reported. The patient received the medications within 2 weeks of vaccination was Asperin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 experienced adverse events such as large bruising on one leg, after the next dose, bruising on the other leg. She has bruising on both lower limbs, a bleeding disorder. She bled from her eye at the ophthalmologists office. On an unspecified date patient second one, then had bruising in the other leg. She went to the hematologist, and to the doctor. The doctor did PTT, confirmed as PTT, and it was elevated. Reported added that patient also had an elevated potassium. She states this was like what you would get if patient were taking warfarin. it was very concerning now, not only does she have bruising in the leg, but she was bleeding into the eye and that to her was just, it keeps getting worse. She has nothing else to add to that report except that her mom has an elevated PTT, TPTT and states she does not know, it was thrombo. At 81, her mom walks around an hour a day, does aerobics. She was not seeing a hematologist and she was concerned. If she cut herself, she would bleed out. The fact she was bleeding into the eyeball, she has to google the acronym but it was basically clotting issues it was resulting in. No additional details provided; Reporter did not know the name of the elevated test.  Information about lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Eye haemorrhage
Clinical narrative: Bleeding of eyes; Bruising of leg; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient daughter) reported that a 81-year-old (same age at vaccination) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on Feb2021 as single dose for COVID-19 immunization. Caller stated that her mother received the first Pfizer covid vaccine in February and had large bruising that showed up on one leg, then she received the second dose and large bruising showed up on her other leg. while her mother was at her eye appointment, she started bleeding from her eye. Caller stated her mother was now being seen by a haematologist for a bleeding disorder. Caller stated her mother was very active and doesn't take medication for anything, no blood thinners, no heart medications. Outcome of both the events was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nonspecific reaction
Clinical narrative: Muscle pain; Neck and shoulder are stiff; His body "rejects vaccine"; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain, neck and shoulder are stiff and his body "rejects vaccine" on an unspecified date. The patient confirmed he was scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 vaccine tomorrow. He asked what is the efficacy of the vaccine after a single dose. He then explained his body "rejects vaccine" and stated he was still experiencing muscle pain from the first shot. He added his neck and shoulder are stiff.  He expressed he was trying to determine if he should get the second dose of the vaccine. The patient stated he was due to take the second shot for Covid. He did not know if he needed it. He asked if he was protected with the first shot. The patient said his body tended to reject shots. He is scheduled for second shot tomorrow. Outcome of the event (his body "rejects vaccine", neck and shoulder are stiff) was unknown and muscle pain was not recovered.  Information on batch/lot number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her 31 year old boyfriend got his first vaccine dose on April 12 and shortly after he got covid; her 31 year old boyfriend got his first vaccine dose on April 12 and shortly after he got covid; This is a spontaneous report from a contactable consumer (Caregiver). A 31-year-old male patient (reporter's boyfriend) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown, NDC number, UPC number, Expiry Date: Unknown), intramuscularly on 12Apr2021 as 1st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter mentioned that, on an unspecified date in Apr2021, patient got Covid shortly after his first vaccine dose. After he was better his doctor said he could go to get the second dose but when he went to the pharmacy the pharmacist told him that because he was outside the 3 weeks recommended timing, he would have to repeat the series. Reporter seriousness for event was unspecified. Patient was unable to take the 2nd dose of the vaccine scheduled on 04May2021 because he tested positive with the Covid-19 virus. Reporter was advised that patient can't take the 2nd dose because it's already passed the scheduled date and that she needs to schedule an appointment for patient to start the 1st dose again. Reporter wanted to know if that is true because her doctor said that once patients Covid-19 gone, he can proceed in taking the 2nd dose. Outcome of the events were unknown.  No follow-up attempts are required; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Lymphadenopathy, Thrombosis
Clinical narrative: She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient).   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. Patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypertension, Therapeutic response unexpected
Clinical narrative: Very high blood pressure; Feeling tired; Other effect: Was gluten intolerant - rash and hives disappeared after vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2  (lot number: ER8737) via an unspecified route of administration in right arm on 01Apr2021 02:00 PM at 2nd dose single for COVID-19 immunization. The patient was not pregnant. The patient had known allergies gluten intolerance (rash and hives disappeared after vaccine). The historic vaccine was bnt162b2 (lot number: EN6199) via an unspecified route of administration in right arm on 11Mar2021 01:00 PM at 63 years old at 1st dose single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination included: levothyroxine and liothyronine, all for an unknown indication, start/stop date not reported. The patient experienced feeling tired, very high blood pressure, and gluten intolerant: rash and hives disappeared after vaccine on 25May2021 10:45 AM. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included blood pressure high on 25May2021. Therapeutic measures were taken as a result of very high blood pressure and included treatment with blood pressure medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: runny nose; Coughing; now has a cold; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: not and expiry dates were not reported), via an unspecified route of administration, on an unspecified date, in May2021 as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first dose two weeks ago (in May2021) and now had a cold and wanted to know if he needed to wait to get his second dose. The patient was scheduled for his second dose on today (on 27May2021) at 2pm and he had mostly a runny nose and was coughing: Events were occurred to patient on an unknown date in May2021. The outcome of the events was unknown. Information on Lot/Batch Number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Swelling
Clinical narrative: armpit swelling; broke out a month later in a herpes simplex on her chest and back; This is a spontaneous report from a contactable consumer (patient's mother). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient had some armpit swelling and she broke out a month later in a herpes simplex on her chest and back. She asked if Pfizer would probably want her to call even if it shows a month out and she never had that either. Consumer stated that she declines to complete a report for her daughter stated her daughter has all the timelines of all the breakouts and she does not want to give the wrong information about when she started having symptoms. Reporter did not specify seriousness for reported events. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I end up getting shingles; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration on 05May2021 (at the age of 59-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. Patient stated, patient was just calling you know just to, report a side effect of the Pfizer vaccine that patient had done 05May2021, patient had second dose of it and this week patient end up getting shingles on 22May2021. Patient was almost 60-year-old woman and patient looked it up when its, sometime people do end up getting shingles after getting the Covid vaccine and patient just want you guys would be aware that, of course she was treating it right now, to aware research and just you know, take a quick look at the vaccine. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back disorder, COVID-19, Drug ineffective, Dyspnoea
Clinical narrative: Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years,  as single dose for covid-19 immunisation.  Medical history included back disorder from an unknown date and unknown if ongoing.   The patient's concomitant medications were not reported.  Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown.  Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date.  Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator).  The patient died on 16Apr2021.  An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Pneumonia, Respiratory failure, SARS-CoV-2 test
Clinical narrative: Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years,  as single dose for covid-19 immunisation.  Medical history included back disorder from an unknown date and unknown if ongoing.   The patient's concomitant medications were not reported.  Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown.  Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date.  Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator).  The patient died on 16Apr2021.  An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: All died within the 5 weeks after there first shot; This is spontaneous report from a contactable consumer. This the second case out of six cases.   An elderly male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed. The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter, same vaccine, same adverse event, different patient.; Reported Cause(s) of Death: Unknown cause of death