chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt a very strong pain in the heart; felt a very strong pain in the heartand then pain in the middle of my chest as is I had something in my heart.; I'm still not feeling well; My body hurts; I'm very worried.; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination. Medical history included Penicillin allergy, iodine, several antibiotics from an unspecified date. Patient received first dose of BNT162B2 on 15Jan2021 for covid-19 immunisation. The patient's concomitant medications were not reported. Patient got the Pfizer Covid-19 vaccine, the first dose on January 15th and the second dose on February 21st. She was having some really bad symptoms and she was really worried because it has been a while and she was still not feeling well. On 23Feb2021, reported as two days after the vaccine she felt a very strong pain in the heart, and then pain in the middle of her chest (unspecified date in 2021) as if she had something in her heart. She went to the doctor, he did an ECG and told me she didn't had a heart attack; then she went to a cardiologist and he cannot find anything that could cause her symptoms. On an unspecified date in 2021, her body hurts, she was still not feeling well and she was very worried. She would like to know if Pfizer has something to make the symptoms go away, she feels very bad and it's been awhile since she got vaccinated. She was really scared and wanted to report this. Events required physician office visit. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Myalgia, SARS-CoV-2 test
Clinical narrative: severe pain in her upper middle part to the right portion of her back; pain is in the muscles; she couldn't take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 13:45 (69-year-old at time of vaccination) (Batch/Lot Number: EN6204) at a single dose for covid-19 immunisation.  Medical history included ongoing blood cholesterol d and thinks she was diagnosed about 3 years ago.  Patient was taking unspecified statins 5 mg, once a day, by mouth.    Patient got the first dose of the Pfizer COVID-19 vaccine on 10Mar2021 (Sunday). On 14Mar2021 at 10AM, she experienced a localized severe pain in her upper middle part to the right portion of her back. She said that it is a pain in the muscle where her scapula pulls and maybe the muscle that covers the lung. Because of that pain she couldn't take a deep breath. She has tried different things such as taking Tylenol and placing ice packs to numb the pain. It presented until yesterday (15Mar2021) then it became better, then it came back again last night. She was feeling better today. She can't think of anything physical that might have contributed to her adverse event. She is scheduled for her second shot on 31Mar2021.  Additional information included that there was a horrible sharp pain on the right side of her back underneath the scapula, hurt like crazy, couldn't take a deep breath . Patient took Pfizer BioNTech Covid vaccine (Verbatim): so that she will be able to see her grandkids again, and she wants to be safe. Patient reported she did not do anything to injure herself, so she was wondering if this could be caused by the vaccine. the pain was almost gone today; she can take a deep breath and it only hurts a little bit. She could not take a deep breath yesterday (14Mar2021), but she can today (15Mar2021). She described that it was really bad yesterday. She wants to know if other people have reported the pain on the muscle that goes around the back of the lung. She asked if this was related to the shot. The vaccine was given in a high school gym. There was no history of all previous immunization with the Pfizer vaccine considered as suspect neither additional vaccine administered on same date. Patient did not require to visit emergency room and physician office. She added thather husband received the vaccine at the same time and he didn't have any reactions. She also reports she was tested one time for covid and it was negative; clarified this was months ago and she doesn't remember any testing that came out bad. Outcome of the events back pain and muscle pain were unknown while Dyspnea was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fall, Headache
Clinical narrative: paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Pyrexia, SARS-CoV-2 test
Clinical narrative: paralyzed with no sensation at all in her legs till her waist; headache; fever 101.2; weakness; chills; fell; This is a spontaneous report from a contactable Physician. A 69-year-old female no pregnant patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 10:30 AM at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included prior spinal cord trauma with rt foot drop. No Known allergies. No COVID prior vaccination. The patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 69-year-old, via an unspecified route of administration at single dose for COVID-19 immunisation. The patient started the next day on 11Mar2021 02:00 PM, after the 2nd shot with headache, fever 101.2 and weakness. Took Tylenol and went to have a nap. She woke up with still fever and chills, when she tried to get up she fell. She was currently in the hospital, paralyzed with no sensation at all in her legs till her waist. AEs resulted in Emergency room/department or urgent care, Hospitalization for 5 days, disability or permanent damage. Lab data included Nasal Swab on 11Mar2021: Negative. No COVID tested post vaccination. Solumedrol 1000mg IV were received. Treatments were received for the events. Outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Hypoaesthesia oral, Lip swelling
Clinical narrative: angioedema; swelling of lips; numbness in tongue and mouth; This is a spontaneous report from a contactable other hcp.  A 56-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 16Mar2021 09:30 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant. No Known allergies. The patient took other medications (many, none new) in two weeks. The patient experienced angioedema, swelling of lips, numbness in tongue and mouth on 16Mar2021. The AEs resulted in Doctor or other healthcare professional office/clinic visit. The patient received zyrtec and allegra and epi pen for prn use. No covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the compatible temporal association and the product's known safety profile,  there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable pharmacist (patient).  A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 13:00 (Batch/Lot Number: EL9261) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 (Batch/Lot Number: EN6201), at the age of 72-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient did not have COVID prior vaccination. The patient was not patient at the time of vaccination. The patient's concomitant medications were not reported. The patient got COVID and underwent PCR with saliva with positive result on 10Mar2021. The outcome of the events was recovered. No treatment was received for the events.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Inappropriate schedule of product administration, Nasal congestion, Off label use
Clinical narrative: I missed my second dose; I missed my second dose; I have been sick for 11 days with a respiratory thing; I have been sick for 11 days with a respiratory thing; I still have some cough; I still have some congestion; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) of unspecified age (pregnancy is unknown) female patient receive first dose of bnt162b2 (BNT162B2, Solution for injection), via unknown route of administration at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller states "I received the first dose of COVID-19 vaccine on 19 February 2021. I have been sick for 11 days with a respiratory thing. I was tested negative to COVID. It was reported that I still have some cough and congestion. I missed my second dose last week. Should I post pone my appointment which is today at 9:50?" and in response to informed caller I am not aware of the clinics policy and procedure. They might not accept you at the clinic if you show COVID like symptoms. Please discuss this with the clinic and bring your negative result with you. These symptoms have not been listed as contradiction in receiving the second dose of the vaccine. However, if you are still symptomatic please discuss this with your HCP to determine if you should get the vaccine now or post pone it. The outcome of events for "I missed my second dose", and "I have been sick for 11 days with a respiratory thing" was "Unknown", and for "I have been sick for 11 days with a respiratory thing", "I still have some cough", and "I still have some congestion" was "Not recovered".  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test
Clinical narrative: I missed my second dose; I missed my second dose; I have been sick for 11 days with a respiratory thing; I have been sick for 11 days with a respiratory thing; I still have some cough; I still have some congestion; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) of unspecified age (pregnancy is unknown) female patient receive first dose of bnt162b2 (BNT162B2, Solution for injection), via unknown route of administration at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller states "I received the first dose of COVID-19 vaccine on 19 February 2021. I have been sick for 11 days with a respiratory thing. I was tested negative to COVID. It was reported that I still have some cough and congestion. I missed my second dose last week. Should I post pone my appointment which is today at 9:50?" and in response to informed caller I am not aware of the clinics policy and procedure. They might not accept you at the clinic if you show COVID like symptoms. Please discuss this with the clinic and bring your negative result with you. These symptoms have not been listed as contradiction in receiving the second dose of the vaccine. However, if you are still symptomatic please discuss this with your HCP to determine if you should get the vaccine now or post pone it. The outcome of events for "I missed my second dose", and "I have been sick for 11 days with a respiratory thing" was "Unknown", and for "I have been sick for 11 days with a respiratory thing", "I still have some cough", and "I still have some congestion" was "Not recovered".  Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via intramuscular, in arm left, on 27Feb2021 (at the age of 64-year-old), at single dose, for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD), and coronary artery bypass graft (s/p CABG x2). Patient had no known allergies, and no COVID prior vaccination. Patient had no other vaccine in four weeks. The concomitant medications included atorvastatin, omeprazole, acetylsalicylic acid (ASA), carvedilol, minocycline, salbutamol sulfate (PROAIR), and olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT). On 13Mar2021 (also reported "or 14th") patient began having symptoms of a runny nose and minor/ slight cough. The nurse stated that the patient was supposed to get his second dose on "Saturday" and asked if this is recommended or should be rescheduled. The patient underwent COVID tested post vaccination, which included nasal swab (rapid antigen) was positive on 15Mar2021, nasal swab (PCR) was positive on 15Mar2021. No treatment received for events. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Negative antibody test after receiving both doses of Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the second of three reports. A 69-year-old elderly female received the first and second doses of BNT162b2 (solution for injection; Lot reported as unknown) as single doses via unspecified route on unspecified dates in 2021 for COVID-19 immunization. There was no medical history, concomitant medications or past drug history reported. The reporter was inquiring about the efficacy of the COVID-19 vaccine. The reporter stated that on an unspecified date in Feb2021, the patient had a negative antibody test after receiving both doses of the Covid-19 vaccine. The outcome of event negative antibody test after receiving both doses of Covid-19 vaccine was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296623 same reporter/drug/AE, different patient.;US-PFIZER INC-2021293985 same reporter/drug/AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Rheumatoid arthritis, X-ray
Clinical narrative: could not sleep last night; shooting pains above ear into head; rheumatoid arthritis, it was the worst she's ever had her arthritis in 78 years/Her right arm, she couldn't lift her arm, her wrists, her arms, her foot.  She knows this was her rheumatoid arthritis; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization; she had mild symptoms and was fine by the third day. The patient's concomitant medications included unspecified autoimmune pill.  On Wednesday the day after second shot (10Mar2021), the patient was okay but from Thursday (11Mar2021) until Saturday (13Mar2021) she had shooting pains above her ear into her head. Every day the pains got milder. She's never had a migraine. She went to the dentist yesterday (15Mar2021). She was using process of elimination to figure out what was wrong. If it was her bridge or anything in her mouth. The dentist took x-rays and everything was normal. She was wondering what those shooting pains in her head could have been.  She also stated that her rheumatoid arthritis, it was the worst she's ever had her arthritis in 78 years. She could not sleep last night. Her right arm, she couldn't lift her arm, her wrists, her arms, her foot.  She knows this was her rheumatoid arthritis. When she goes to the bathroom, she can't even do that, her arm hurts so bad. She was on an autoimmune pill and she can't take her autoimmune medicine with the Covid shot. She started taking her medicine today.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Gingival swelling, Injection site rash, Oral pain, Palatal swelling
Clinical narrative: sore mouth; She has swelling on her gums, on the side of her mouth and on the roof of her mouth; She has swelling on her gums, on the side of her mouth and on the roof of her mouth; She has swelling on her gums, on the side of her mouth and on the roof of her mouth; she developed a little bit of rash at the injection site; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: Unknown), via an unspecified route of administration on 14Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got the Pfizer COVID-19 vaccine on 14Mar2021 and she developed a little bit of rash at the injection site and it has been going down. This morning (19Mar2021), she has developed a sore mouth. She has swelling on her gums, on the side of her mouth and on the roof of her mouth. She wanted to know if these have been reported adverse events associated with the Pfizer COVID-19 vaccine and if she should see a doctor for this reaction. The outcome of event rash at the injection site was recovering; for other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: muscle stiffness; This is a spontaneous report from a contactable consumer.  A 59-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization.The patient's medical history and concomitant medications were not reported. Caller states she received the first dose of the Pfizer COVID vaccine this morning between 09:30 and 10:00 am EST. Caller states she has some muscle stiffness and she already took some Tylenol. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Somnolence, Weight bearing difficulty
Clinical narrative: sleepy; tired; cannot put weight on her right leg; She has not been out of bed for over a week; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included arm and leg nerve damage; cardiac, liver and lung disease. Concomitant medications included lorazepam taken for an unspecified indication from an unspecified start date and ongoing; melatonin taken for an unspecified indication from an unspecified start date and ongoing; cetirizine hydrochloride (ZYTREC) taken for an unspecified indication from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from an unspecified date; the patient also took her heart medication she did not know the name. The patient wanted to report that after taking shot she was sleepy and tired and could not put weight on her right leg. She took a Benedryl before taking the shot and was told she should not have done that after receiving the shot (pharmacy name) gave her another after taking the shot. She had not been out of bed for over a week. She was afraid to take the second shot. The patient further stated that she was experiencing serious adverse effect from COVID vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller got both doses of the Covid vaccine and within two and half weeks later after the 2nd dose she got Covid.; Caller got both doses of the Covid vaccine and within two and half weeks later after the 2nd dose she got Covid.; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.   A female patient of an unspecified age received the 1st and the 2nd dose of BNT162b2 (BNT162B2, Batch/Lot number not reported), both an unspecified route of administration as single dose on an unspecified date for COVID-19 immunisation.  Medical history included Covid-19. She stated she had Covid twice before vaccination, before getting the Covid vaccine. The patient's concomitant medications were not reported.   Within two and half weeks after the 2nd dose the patient got Covid. She was in hospital 14 to15 days, she was on ventilator, she had very serious attack. The events were considered serious as per hospitalization and medically significant. She had Covid twice before this, before getting the Covid vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date (before vaccination) and SARS-COV-2 test: positive on an unknown date (after vaccination). The outcome of the events was not reported.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Seborrhoea
Clinical narrative: he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail.; sensation as if you had oil on your skin.; he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail.; This is spontaneous report received from a contactable consumer (patient) via medical information team. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on thursday, on the same side he received the injection he is experiencing middle finger tip pain, middle finger tip pain, then he mention the pain was in the first and second finger underneath the nail Mar2021. Patient describes the pain as not severe, only noticeable when he touch something with his finger, he also called this symptom "jalapeno finger" from what he found on the internet and mentioned it was a sensation as if you had oil on your skin. Referred patient to his HCP. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle and joint problems/pain; muscle and joint problems/pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not re-ported) as single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 13Feb2021 for Covid-19 immunization. The patient was experiencing muscle and joint problems/ pain in Mar2021. The outcome of the events was unknown.  The information on lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Heart rate irregular, Palpitations, Pharyngeal swelling
Clinical narrative: anaphylactic reaction; Throat swelling; heart racing; irregular heart rate; gasping for air; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration in Right buttocks, at the age of 67-year-old, on 08Mar2021 10:00 as SINGLE DOSE, for covid-19 immunisation.  Medical history allergies: Sulfites, urinary tract disorder, Birth defect bladder w/ recurrent kidney stones, kidney infection, Grave's disease, and lyme disease. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. Concomitant medications included levothyroxine and epinephrine.  The patient previously took sulfur dioxide and experienced drug hypersensitivity.  The patient experienced anaphylactic reaction with throat swelling, heart racing, irregular heart rate, gasping for air on 08Mar2021 10:45. Therapeutic measures taken in response to the events included self administration of epinephrine. The events were assessed as serious (life threatening). Outcome was recovering at the time of the report.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body height, Body height decreased, Malaise, Syncope
Clinical narrative: he is shrinking now; He collapse while he was in the shower; weak/been getting weaker and weaker; feeling more unwell every day; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm (also reported as left upper arm) on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included Kidney cancer, bladder cancer, colon cancer, mantle cell lymphoma and was compromised health-wise. Concomitant medications included amlodipine, atorvastatin, losartan, sotalol, terazosin, and warfarin. On 08Mar2021, the patient was weak and feeling more unwell every day. On 09Mar2021, the patient collapse while he was in the shower. The wife of the patient reported regarding some possible side effects for her husband. He had been weak but on 09Mar2021, he collapse while he was in the shower and that was pretty dramatic but he has been getting weaker and weaker and feeling more unwell every day since 08Mar2021; at this point he was literally appointed for the second shot on the 26Mar2021, so wife was asking if it was advisable being he had what maybe side effects between the vaccine and his other health conditions, that he should take his second shot. On an unspecified date, the patient was shrinking now. The patient was due date for second shot on 26Mar2021. The reporter stated that the lot was EN6203, and it could be ENU203, the handwriting was very bad, and she don't know if it was U or 6. Outcome of events was unknown.  Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Clot blood; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced clot blood on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Blood test, Dizziness, Dyskinesia
Clinical narrative: felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient).  The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization.  Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Facial pain, Feeling abnormal, Heart rate, Limb discomfort
Clinical narrative: felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient).  The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization.  Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient).  The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization.  Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: caller received his first dose of the covid-19 vaccine in January, caller states 10 days later tested positive for covid-19; This is a spontaneous report from a Pfizer-sponsored program Covax  Support. A non-contactable male consumer, the patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, consumer stated 10 days later tested positive for covid-19, caller was questioning second dose. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLEDOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction (hypersensitivity) (non-serious) on an unspecified date. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was diagnosed with COVID-19 following the first dose of the vaccine; COVID-19; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number and expiration date: not provided), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, following the first dose of the vaccine patient was diagnosed covid-19. Patient further enquired, if she should delay the second shot of the Pfizer COVID-19 vaccine as she was diagnosed with covid-19 following first. The patient underwent lab tests and procedures which included sars-cov-2 test which resulted positive for covid-19.. The outcome for the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Tremor
Clinical narrative: legs are weak, shaking and trembling; legs are weak, shaking and trembling; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on an unspecified date in Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced legs are weak, shaking and trembling. Caller stated he already spoke to the safety department and was transferred to us. Caller disconnected the call before agent could finish the call or get additional information about the AE. Caller wanted to know what she can do to stop it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: intermittent brief periods of dizziness; This is a spontaneous report from a contactable consumer (Wife) via medical information team. A 28-years-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced intermittent brief periods of dizziness. On 25Feb2021 lists side effects reported for seven days after each dose. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: she has diverticulitis and is on an antibiotic; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), 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's medical history and concomitant medications were not reported. Patient had the first shot of COVID vaccine on an unspecified date and stated that she had the shot and issue arose that she has diverticulitis on an unspecified date and was on an antibiotic from an unspecified date. Patient was due to get her second and wanted to know if this would interfere with getting second shot of COVID vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: she is a heart attack survivor; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine ended up being a Pfizer vaccine. She received her Pfizer vaccine on 10Mar2021 and the next is scheduled 07Apr2021. She was wondering if she should schedule somewhere else to get another vaccine sooner. The patient was a heart attack survivor on an unspecified date. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Rash
Clinical narrative: Medical Information Potential AE; rash on her lower stomach area; This is a spontaneous report from a contactable consumer (patient). A 60 year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. It was reported that Yesterday morning patient developed a rash on her lower stomach area. Patient wanted to know she could treat this at home with cortaid or anti itch cream or should she see her family physician and get an antibiotic. The outcome for the events was unknown.  Information on the lot number and batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: bleed as much as he did; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he was supposed to bleed as much as he did on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.