chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Heavy menstrual bleeding
Clinical narrative: anemia; Severe menstrual bleeding that lasted for several weeks after the first dose; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 47-years-old) via an unspecified route of administration, administered in Arm Left on 17Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient has no known allergies and no covid-19 prior to vaccination. The patient had no other vaccine in four weeks. The patient experienced severe menstrual bleeding that lasted for several weeks after the first dose on 21Jun2021. The patient's cycle is extremely regular otherwise. The event resulted in doctor or other healthcare professional office/clinic visit and was treated with "iron and progesterone, fixed anemia". The patient was not tested for covid-19 post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Neuropathy peripheral
Clinical narrative: neuropathy in both feet; I had muscle aches; tired; This is a spontaneous report from contactable consumer (patient).   A female patient of unspecified age received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included patient had COVID-19, prior to vaccination and received the vaccine 3 months after COVID. Concomitant medication was not reported. On an unspecified date, patient had muscle aches and tired and one week after vaccination, started with neuropathy in both feet. The outcome of events was resolving.  Information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Condition aggravated, Pemphigoid
Clinical narrative: Bullous Pemphigoid; condition aggravated; little blisters all over her body; This is a spontaneous report from a contactable consumer (patient)   An 85 years old male patient receivedfirst dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EY0584) on 03Aug2021 at 11:30 at single dose via an unspecified route of administration  for COVID-19 immunization. Patients Medical History (included Thyroid disorder, Bullous Pemphigoid and acid reflux. In 2015 patient had kidney stones and she was taking 8 Advils and 1 Hydrocodone every 8 hours at the advice of physician. She had a drug reaction from that and it caused Bullous Pemphigoid which were blisters, a skin problem (as such). She had this for 6 years. The Bullous Pemphigoid was supposed to be gone after 5 years but she still had. (as reported). She stated about every 5 years she gets the pneumonia vaccine and has never had any problems with it.  Concomitant medications included SYNTHROID (levothyroxine sodium). Patient informed Her last flare of Bullous Pemphigoid was last May/June this year and after she got the 1st dose of the vaccine, she broke out again in a big flare of Bullous Pemphigoid. d. It was nasty. The doctor gave her cortisone cream and wanted to prescribe a Prednisone Pack for 12 days to take before she gets her second Covid 19 vaccine. She was leery to do this. How can she take a chance in getting the second Covid 19 vaccine. She wants to get the second Covid 19 vaccine but doesn't want to get another flare. Patient  went to her doctor regarding her Bullous Pemphigoid flare. He could see her rash and didn't know what to do, no one knows what to do. No one was familiar with this skin disease, it's a very rare autoimmune skin disease. It causes little blisters all over her body. She fortunately had a very mild case so her blisters look like little pimples. She had to put Cortisone, a lot of Cortisone on her legs and thighs and bra line. Patient was also concerning  if there is any information on Pfizer Covid vaccine and Prednisone pack interaction and if there is guidance whether she should receive the 2nd dose given that she had a flare with the Bullous Pemphigoid. At the time of the reporting events outcome was unknown.  Follow-up attempts are completed. No further information is expected
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dyspnoea exertional, Electrocardiogram
Clinical narrative: Right big toe pain; Heart palpitations; Tightness in the chest; Blood pressure increased; Gets out of breath quicker when walking; This is a spontaneous report from a contactable consumer (patient). An 78 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 (age at vaccination: 78 year old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received her first dose of the Pfizer-Biontech Covid19 vaccine 27Jul2021. The patient experiencing "heart palpitations, tightness in the chest, right big toe pain, blood pressure increased, and gets out of breath quicker when walking in 2021". Her HCP did an EKG and chest X-ray in 2021 with unknown results. He has prescribed prednisone, which she would still be on during her second dose scheduled for 17Aug2021. She reported that she has been on prednisone from the toe situation, and now HCP put her on prednisone again saying she might have asthma, which she have never had asthma problems." She was very nervous about getting the second dose, stating "With the vaccine you can still get the virus or be a carrier and you still have to wear a mask. So that's kind of a scary thing, plus its not been FDA approved yet. The patient was really scared, at her age and she keep hearing horror stories everywhere that somebody'll get the second dose and die." She's looking for guidance on how to proceed saying "she don't know which way to go with it". The event right big toe pain was considered as serious (medically significant) by health authority. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, X-ray
Clinical narrative: Right big toe pain; Heart palpitations; Tightness in the chest; Blood pressure increased; Gets out of breath quicker when walking; This is a spontaneous report from a contactable consumer (patient). An 78 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection and Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 (age at vaccination: 78 year old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received her first dose of the Pfizer-Biontech Covid19 vaccine 27Jul2021. The patient experiencing "heart palpitations, tightness in the chest, right big toe pain, blood pressure increased, and gets out of breath quicker when walking in 2021". Her HCP did an EKG and chest X-ray in 2021 with unknown results. He has prescribed prednisone, which she would still be on during her second dose scheduled for 17Aug2021. She reported that she has been on prednisone from the toe situation, and now HCP put her on prednisone again saying she might have asthma, which she have never had asthma problems." She was very nervous about getting the second dose, stating "With the vaccine you can still get the virus or be a carrier and you still have to wear a mask. So that's kind of a scary thing, plus its not been FDA approved yet. The patient was really scared, at her age and she keep hearing horror stories everywhere that somebody'll get the second dose and die." She's looking for guidance on how to proceed saying "she don't know which way to go with it". The event right big toe pain was considered as serious (medically significant) by health authority. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: little fever with a temperature of 99.1F; not feeling good; pulse rate of 97 that she feels is a little high; This is a spontaneous report from a contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/ Lot number was not reported), via an unspecified route of administration on 11Aug2021, as a dose 2, single for COVID-19 immunisation. The patient medical history included COVID-19 (on an unspecified date in Apr2021 to unknown if ongoing). She had COVID on Apr20201 treated with monoclonal antibodies. Historical vaccination included that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as a dose 1, single for COVID-19 immunization. The patient concomitant medications were not reported. On 12Aug2021 (Today, on the day of this report), the patient experienced little fever with a temperature of 99.1 F, not feeling good and pulse rate of 97 that she feels is a little high. She felt like she had COVID again. All the events were non-serious. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Pharyngeal swelling, Throat irritation, Vaccination site pain
Clinical narrative: throat feels swollen; really scratchy; hard time to swallow; injection site (right arm) was itchy and with pain; injection site (right arm) was itchy and with pain; experienced tiredness; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Aug2021 in the right arm as a single dose for COVID-19 immunisation. Medical history included systemic lupus from an unknown date. Concomitant medications were not reported. The patient reported she received the first dose of BNT162B2 on 04Aug2021 and experienced tiredness, injection site (right arm) was itchy and with pain. She further reported that her throat felt swollen, really scratchy and she was having a hard time to swallow. The patient inquired when the side effects would start to clear up. The clinical outcomes of the events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: throat feels swollen; really scratchy; hard time to swallow; injection site (right arm) was itchy and with pain; injection site (right arm) was itchy and with pain; experienced tiredness; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 04Aug2021 in the right arm as a single dose for COVID-19 immunisation. Medical history included systemic lupus from an unknown date. Concomitant medications were not reported. The patient reported she received the first dose of BNT162B2 on 04Aug2021 and experienced tiredness, injection site (right arm) was itchy and with pain. She further reported that her throat felt swollen, really scratchy and she was having a hard time to swallow. The patient inquired when the side effects would start to clear up. The clinical outcomes of the events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Paraesthesia
Clinical narrative: He began experiencing "pins and needles in his feet and legs."; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not provided) as single dose for COVID-19 immunization. Medical history included COVID-19 infection from Feb2021 (6 Months ago). The patient's concomitant medications were not reported. The patient stated he received his first dose of the Pfizer BioNTech Covid-19 Vaccine on Saturday 07Aug2021. Patient stated he did not have anything immediate or serious occur after vaccination, "just a sore arm and some fatigue the next day (08Aug2021) and also stated that by day four post vaccination on 10Aug2021 and he began experiencing pins and needles in his feet and legs. The patient stated "it seems like it's getting a little bit better and spoke with his primary care physician and they did not provide much insight for him. The patient stated he had Covid-19 infection six months ago and he has heard that some people who have had Covid-19 infection and later were vaccinated seemed to have worse side effects after their first dose. The patient asking if these side effects he experienced are considered severe and how long they may last and also if, given his side effects after the first dose, he should still receive the second dose of the Pfizer BioNTech Covid-19 Vaccine. The outcome of the events was recovering.   Information regarding Lot/Batch number not available.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, SARS-CoV-2 test
Clinical narrative: having nosebleeds all over the place; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number: Unknown, as single dose for COVID-19 immunization. Medical history included travel to foreign country. The patient's concomitant medications were not reported. The patient experienced having nosebleeds all over the place on an unspecified date in 2021. The clinical course was described as follows: On 11Aug2021, the patient's mother reported that her son (the patient) told her what happened to him after he had gotten the vaccine. She clarified that her son was put on programs doing (Place withheld) Cricket and had been out of the country so he was vaccinated at the place he went to. People were coming from (Place withheld) for a tournament. Therefore, every week or so, when he went to different Islands, he was tested by being swabbed in his nostril. He just came back home about 3 or so weeks ago. He was having nosebleeds all over the place. He previously has never had a nosebleed in his life. They had to rush him to a specialist who had to put a camera up his nose and burn it and close it and seal it up. He said it hurt. The specialist gave her son a card that said no one is to swab him until Pfizer tells them what is in the swab as well as the vaccination. The doctor said he is not allowed to have anyone swab his nose again. Therapeutic measure was received for the nosebleeds. The clinical outcome of the event, nosebleeds, was not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for the Covid virus, after both vaccines; Tested positive for the Covid virus, after both vaccines; This is a spontaneous report from a contactable consumer patient mother), received via the Pfizer-sponsored program.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  Medical history included exposure to SARS-COV-2 (patient was at a school event and a woman, at the event, was Covid positive). The patient's concomitant medications were not reported.  The patient was tested positive for the COVID virus, after both vaccines. It was reported that patient had two young children (5 and almost 2 years old) and a husband, who were exposed, and they were in quarantine. Children were tested negative for COVID, they had to continue to quarantine. Only the patient got COVID.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date.    The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : 202101041383 Same reporter, different patient
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthma
Clinical narrative: did find but a friend of theirs has a son with a history of high anaphylaxis and asthma, male, aged 14, who is now in the hospital after receiving the vaccine; did find but a friend of theirs has a son with a history of high anaphylaxis and asthma, male, aged 14, who is now in the hospital after receiving the vaccine; This is a spontaneous report from a contactable consumer.  A 14-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose (dose unknown) for COVID-19 immunisation. Medical history and concomitant medications were unknown. At the time of report, the patient with a history of high anaphylaxis and asthma was in the hospital after receiving the vaccine. The outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Menstruation delayed, Ultrasound scan
Clinical narrative: maybe miscarriage; 2 months after my second vaccine shot - 17 days late period; after delay whole month heavier flows with big clots; This is a spontaneous report from a contactable consumer (patient).     A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration in Arm Left on 10Apr2021 at 15:00 (at 40 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  No known allergies. Not pregnant at vaccination time. Previously on 20Mar2021 at 15:00 patient received first dose of bnt162b2 (BNT162B2; Lot Number: EP7534, at 40 years), in Arm Left for covid-19 immunisation.On 19Jun2021, 2 months after the second vaccine shot, she had 17 days late period, which was unusual, maybe miscarriage, and after delay whole month heavier flows with big clots. Events caused doctor or other healthcare professional office/clinic visit. Ultrasound was done on an unspecified date in 2021, no result reported. Treatment included birth control pills (as reported). Outcome of the events was not recovered
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: can't get a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in 2021, the patient experienced can't get a deep breath. The outcome of the event was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, COVID-19, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: COVID test: PCR showed positive; COVID test: PCR showed positive; High blood pressure; dose 1 on 16Jun2021 and dose 2 on 29Jun2021; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2, dose 2 via an unspecified route of administration, administered in arm left on 29Jun2021 15:00 as single dose, dose 1 via an unspecified route of administration, administered in arm left on 16Jun2021 15:00 as single dose, both at the age of 32-year-old for COVID-19 immunisation. Medical history reported as none. No Known allergies. There were no concomitant medications. There was no other vaccine in four weeks. The patient was not diagnosed COVID prior vaccination. The patient experienced high blood pressure (life threatening) on 01Jul2021 16:00 with outcome of recovered in 2021, the event (high blood pressure) resulted in physician office visit. No treatment received for the event (high blood pressure). The patient had COVID test: PCR showed positive on 28Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure: high on 01Jul2021 16:00, COVID test: PCR: positive (Nasal Swab) on 28Jul2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: COVID test: PCR showed positive; COVID test: PCR showed positive; High blood pressure; dose 1 on 16Jun2021 and dose 2 on 29Jun2021; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2, dose 2 via an unspecified route of administration, administered in arm left on 29Jun2021 15:00 as single dose, dose 1 via an unspecified route of administration, administered in arm left on 16Jun2021 15:00 as single dose, both at the age of 32-year-old for COVID-19 immunisation. Medical history reported as none. No Known allergies. There were no concomitant medications. There was no other vaccine in four weeks. The patient was not diagnosed COVID prior vaccination. The patient experienced high blood pressure (life threatening) on 01Jul2021 16:00 with outcome of recovered in 2021, the event (high blood pressure) resulted in physician office visit. No treatment received for the event (high blood pressure). The patient had COVID test: PCR showed positive on 28Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure: high on 01Jul2021 16:00, COVID test: PCR: positive (Nasal Swab) on 28Jul2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Can't walk or move too much without my heart rate accelerating making faint or passing out; Can't walk or move too much without my heart rate accelerating making faint or passing out; Heart was constantly at 120 to 130 /can't walk or move too much without her heart rate accelerating; Low blood pressure; Shortness of breath; Tired all the time; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0167), via an unspecified route of administration in Arm Right on 29Apr2021 at 15:00 (at 32 years) as single dose for covid-19 immunisation. Prior to vaccination patient was diagnosed with COVID-19 (positive) and had allergy to sulfa. Concomitant medications were not reported.  On 03May2021 at 04:00 patient experienced heart was constantly at 120 to 130, low blood pressure, shortness of breath, tired all the time, can't walk or move too much without her heart rate accelerating making faint or passing out.  No treatment given. Events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Patient took second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0178), on 20May2021 at 15:00 (at 32 years) for covid-19 immunisation.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness, SARS-CoV-2 test, Syncope
Clinical narrative: Can't walk or move too much without my heart rate accelerating making faint or passing out; Can't walk or move too much without my heart rate accelerating making faint or passing out; Heart was constantly at 120 to 130 /can't walk or move too much without her heart rate accelerating; Low blood pressure; Shortness of breath; Tired all the time; This is a spontaneous report from a contactable consumer (patient).   A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Ew0167), via an unspecified route of administration in Arm Right on 29Apr2021 at 15:00 (at 32 years) as single dose for covid-19 immunisation. Prior to vaccination patient was diagnosed with COVID-19 (positive) and had allergy to sulfa. Concomitant medications were not reported.  On 03May2021 at 04:00 patient experienced heart was constantly at 120 to 130, low blood pressure, shortness of breath, tired all the time, can't walk or move too much without her heart rate accelerating making faint or passing out.  No treatment given. Events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Patient took second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0178), on 20May2021 at 15:00 (at 32 years) for covid-19 immunisation.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, COVID-19, Drug ineffective, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer (reported himself). A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on an unknown date 2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on 25Apr2021 as dose 1, single for covid-19 immunisation. Medical history included Known allergies, penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 30Jul2021, the patient experienced symptoms included mild/moderate fever, chills, body aches, fatigue, head cold-cough, moderate-elevated bp (blood pressure), high resting heart rate, anxiety, and mild loss of smell and taste. The patient was tested positive covid on 01Aug2021. The events resulted in emergency room/department or urgent care visit. On 30Jul2021, the patient lab test includes moderate-elevated blood pressure, high resting heart rate. On 01Aug2021, the patient lab test included post vaccination the patient was test for covid-19 with COVID test was positive (nasal swab). The patient did not receive any treatment for the events. The outcome of the events COVID-19, moderate-elevated bp, high resting heart rate, and anxiety was resolving.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (reported himself). A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on an unknown date 2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on 25Apr2021 as dose 1, single for covid-19 immunisation. Medical history included Known allergies, penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 30Jul2021, the patient experienced symptoms included mild/moderate fever, chills, body aches, fatigue, head cold-cough, moderate-elevated bp (blood pressure), high resting heart rate, anxiety, and mild loss of smell and taste. The patient was tested positive covid on 01Aug2021. The events resulted in emergency room/department or urgent care visit. On 30Jul2021, the patient lab test includes moderate-elevated blood pressure, high resting heart rate. On 01Aug2021, the patient lab test included post vaccination the patient was test for covid-19 with COVID test was positive (nasal swab). The patient did not receive any treatment for the events. The outcome of the events COVID-19, moderate-elevated bp, high resting heart rate, and anxiety was resolving.    Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Hyperkalaemia, Hyperparathyroidism, Proteinuria, Renal disorder
Clinical narrative: Hyperparathyroidism; Proteinuria; Hyperkalemia; I am having Hyperparathyroidism, Proteinuria, and Hyperkalemia, in other words, kidney issues; After my vaccination, I got blood work exams, showing that my creatinine level was very high risk; his kidney was at 15% capacity; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 (Lot Number: EW0173) as single dose (at age of 43-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Jun2021 12:00 patient experienced hyperparathyroidism, proteinuria, and hyperkalemia, in other words, kidney issues. After his vaccination, patient got blood work exams, showing that his creatinine level was very high risk. Patient went to the hospital. As a result, his kidney was at 15% capacity. The patient was hospitalized for the events for 2 days, admission dates not provided. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No treatment was received for the events. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination. The patient underwent laboratory tests and procedures which included COVID-19 nasal swab test PCR negative on 04Nov2020. Patient had not recovered from the events, at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Renal impairment, SARS-CoV-2 test
Clinical narrative: Hyperparathyroidism; Proteinuria; Hyperkalemia; I am having Hyperparathyroidism, Proteinuria, and Hyperkalemia, in other words, kidney issues; After my vaccination, I got blood work exams, showing that my creatinine level was very high risk; his kidney was at 15% capacity; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 (Lot Number: EW0173) as single dose (at age of 43-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 21Jun2021 12:00 patient experienced hyperparathyroidism, proteinuria, and hyperkalemia, in other words, kidney issues. After his vaccination, patient got blood work exams, showing that his creatinine level was very high risk. Patient went to the hospital. As a result, his kidney was at 15% capacity. The patient was hospitalized for the events for 2 days, admission dates not provided. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. No treatment was received for the events. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination. The patient underwent laboratory tests and procedures which included COVID-19 nasal swab test PCR negative on 04Nov2020. Patient had not recovered from the events, at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Muscle twitching
Clinical narrative: Left Eye twitching for 2 week; Taste of metal in money for a few hours; This is a spontaneous report from a contactable consumer (patient) via a Covid-19 program.   A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Jul2021 14:00 (lot number: ew0198; expiry date: unknown) at the age of 37-years-old, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a pharmacy/drug store. On 23Jul2021 at 14:00, the patient experienced left eye twitching for 2 weeks and taste of metal in money for a few hours. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was recovered on unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood test, Chest discomfort, Chest pain, Computerised tomogram
Clinical narrative: Neurologist said I'm having an autoimmune response to the vaccine; Shortness of breath started one month after the second shot; followed by chest tightness (ER visit 1); A slew of other neurological symptoms began (apx 30) including sharp chest pain; neurological symptoms; This was followed by muscles seizing up in my back and neck to the point where I could not turn my head and it was affecting my tongue and speech (ER visit 3); This was followed by muscles seizing up in my back and neck to the point where I could not turn my head and it was affecting my tongue and speech (ER visit 3); This is a spontaneous report from a contactable consumer (patient) via a Covid-19 program  A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Apr2021 07:45 (lot number: EW0165; expiry date: unknown) as dose 2, single, for COVID-19 immunisation. Medical history included COVID and pneumonia. She possibly had a long COVID starting with all of the COVID symptoms on 02Dec2019. She had to take 6 weeks of medical leave from work to recover from pneumonia, symptoms lasted 4-6 months. Concomitant medications included ibuprofen (ADVIL), ethinylestradiol, etonogestrel (NUVARING), and nasal sprays for allergies. The patient previously received first dose of BNT162B2 on 05Apr2021 at 07:45 AM (lot number: EW0151; expiry date: unknown) at the age of 40-years-old, in left arm for COVID-19 immunisation.The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 28May2021, the patient experienced shortness of breath that started one month after the second shot, followed by chest tightness (ER visit 1). Did chest X-ray and CT chest scan. A slew of other neurological symptoms began (apx 30) including sharp chest pain to go with the shortness of breath (ER visit 2). Did chest X-ray and follow up CT scan. This was followed by muscles seizing up in my back and neck to the point where she could not turn her head and it was affecting her tongue and speech (ER visit 3). At this point, it had been two months of rotating neurological symptoms, so the doctor admitted her to the hospital to run a CT scan on her carotid artery and MRI of the brain. Through all of these she had tons of blood tests done and an echocardiogram done looking for autoimmune diseases. None were found. Spoke to a rheumatologist who referred her to pulmonologist and neurologist. Pulmonologist will test her for asthma this fall, but nothing was clear. Neurologist said she was having an autoimmune response to the vaccine. The patient was hospitalized due to the events for one day. Outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Magnetic resonance imaging head, Muscle disorder, Neurological symptom
Clinical narrative: Neurologist said I'm having an autoimmune response to the vaccine; Shortness of breath started one month after the second shot; followed by chest tightness (ER visit 1); A slew of other neurological symptoms began (apx 30) including sharp chest pain; neurological symptoms; This was followed by muscles seizing up in my back and neck to the point where I could not turn my head and it was affecting my tongue and speech (ER visit 3); This was followed by muscles seizing up in my back and neck to the point where I could not turn my head and it was affecting my tongue and speech (ER visit 3); This is a spontaneous report from a contactable consumer (patient) via a Covid-19 program  A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Apr2021 07:45 (lot number: EW0165; expiry date: unknown) as dose 2, single, for COVID-19 immunisation. Medical history included COVID and pneumonia. She possibly had a long COVID starting with all of the COVID symptoms on 02Dec2019. She had to take 6 weeks of medical leave from work to recover from pneumonia, symptoms lasted 4-6 months. Concomitant medications included ibuprofen (ADVIL), ethinylestradiol, etonogestrel (NUVARING), and nasal sprays for allergies. The patient previously received first dose of BNT162B2 on 05Apr2021 at 07:45 AM (lot number: EW0151; expiry date: unknown) at the age of 40-years-old, in left arm for COVID-19 immunisation.The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 28May2021, the patient experienced shortness of breath that started one month after the second shot, followed by chest tightness (ER visit 1). Did chest X-ray and CT chest scan. A slew of other neurological symptoms began (apx 30) including sharp chest pain to go with the shortness of breath (ER visit 2). Did chest X-ray and follow up CT scan. This was followed by muscles seizing up in my back and neck to the point where she could not turn her head and it was affecting her tongue and speech (ER visit 3). At this point, it had been two months of rotating neurological symptoms, so the doctor admitted her to the hospital to run a CT scan on her carotid artery and MRI of the brain. Through all of these she had tons of blood tests done and an echocardiogram done looking for autoimmune diseases. None were found. Spoke to a rheumatologist who referred her to pulmonologist and neurologist. Pulmonologist will test her for asthma this fall, but nothing was clear. Neurologist said she was having an autoimmune response to the vaccine. The patient was hospitalized due to the events for one day. Outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Speech disorder, X-ray
Clinical narrative: Neurologist said I'm having an autoimmune response to the vaccine; Shortness of breath started one month after the second shot; followed by chest tightness (ER visit 1); A slew of other neurological symptoms began (apx 30) including sharp chest pain; neurological symptoms; This was followed by muscles seizing up in my back and neck to the point where I could not turn my head and it was affecting my tongue and speech (ER visit 3); This was followed by muscles seizing up in my back and neck to the point where I could not turn my head and it was affecting my tongue and speech (ER visit 3); This is a spontaneous report from a contactable consumer (patient) via a Covid-19 program  A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Apr2021 07:45 (lot number: EW0165; expiry date: unknown) as dose 2, single, for COVID-19 immunisation. Medical history included COVID and pneumonia. She possibly had a long COVID starting with all of the COVID symptoms on 02Dec2019. She had to take 6 weeks of medical leave from work to recover from pneumonia, symptoms lasted 4-6 months. Concomitant medications included ibuprofen (ADVIL), ethinylestradiol, etonogestrel (NUVARING), and nasal sprays for allergies. The patient previously received first dose of BNT162B2 on 05Apr2021 at 07:45 AM (lot number: EW0151; expiry date: unknown) at the age of 40-years-old, in left arm for COVID-19 immunisation.The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 28May2021, the patient experienced shortness of breath that started one month after the second shot, followed by chest tightness (ER visit 1). Did chest X-ray and CT chest scan. A slew of other neurological symptoms began (apx 30) including sharp chest pain to go with the shortness of breath (ER visit 2). Did chest X-ray and follow up CT scan. This was followed by muscles seizing up in my back and neck to the point where she could not turn her head and it was affecting her tongue and speech (ER visit 3). At this point, it had been two months of rotating neurological symptoms, so the doctor admitted her to the hospital to run a CT scan on her carotid artery and MRI of the brain. Through all of these she had tons of blood tests done and an echocardiogram done looking for autoimmune diseases. None were found. Spoke to a rheumatologist who referred her to pulmonologist and neurologist. Pulmonologist will test her for asthma this fall, but nothing was clear. Neurologist said she was having an autoimmune response to the vaccine. The patient was hospitalized due to the events for one day. Outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Chills, Heart rate, Hypoaesthesia
Clinical narrative: heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; chills and numbness down entire left side of body.; chills and numbness down entire left side of body.; constant goosebumps since the injection date; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (non-pregnant) received the first dose of BNT162B2 at the age of 43-year-old via an unspecified route of administration, administered in arm left in Aug2021 (Lot Number: AF7484) as single dose for COVID-19 immunisation. Medical history reported as none. No known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced heart palpitations/flutter, sharp chest pains since the date of the injection in Aug2021, chills and numbness down entire left side of body in Aug2021, constant goosebumps since the injection date in Aug2021. Heart rate in Aug2021 showed heart palpitations/flutter. Seriousness criteria of the events was reported as disabling/incapacitating and life threatening. Events resulted in emergency room/department or urgent care. Treatment received for the events that included anti-imflammatory and aspirin. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Piloerection
Clinical narrative: heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; chills and numbness down entire left side of body.; chills and numbness down entire left side of body.; constant goosebumps since the injection date; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (non-pregnant) received the first dose of BNT162B2 at the age of 43-year-old via an unspecified route of administration, administered in arm left in Aug2021 (Lot Number: AF7484) as single dose for COVID-19 immunisation. Medical history reported as none. No known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced heart palpitations/flutter, sharp chest pains since the date of the injection in Aug2021, chills and numbness down entire left side of body in Aug2021, constant goosebumps since the injection date in Aug2021. Heart rate in Aug2021 showed heart palpitations/flutter. Seriousness criteria of the events was reported as disabling/incapacitating and life threatening. Events resulted in emergency room/department or urgent care. Treatment received for the events that included anti-imflammatory and aspirin. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, SARS-CoV-2 antibody test
Clinical narrative: Stage 4 lung disease; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 72 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced stage 4 lung disease on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test with negative result on Jul2021 and sars-cov-2 antibody test with negative result on 09Aug2021  Follow-up (12Aug2021): This is a Follow up spontaneous report from a Health Authority. A contactable 72-years-old male consumer reported for himself (patient) that: he received the Pfizer Covid19 vaccines in March both doses and he was in a clinical trail where they tested him for antibodies and the result was negative. He took another antibody test at Withheld and that result was also negative.   No follow-up attempts are possible. No further information is expected.