chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: blood clot; swelling and pain in right leg; swelling and pain in right leg; right arm hurting tremendously; This is a spontaneous report from a contactable Nurse. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:45; at the age of 52-years-old,  (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing hypertension, ongoing memory impairment (She states that she was diagnosed either last year or the year before that she can't remember. She states that it is ongoing, but it is well controlled). Historical vaccine included vaccine to tetanus (About 3 or 4 years ago). There were no concomitant medications.   The patient experienced blood clot (thrombosis) (disability) on 13Apr2021 with outcome of not recovered, swelling and pain in right leg (disability, medically significant) on 09Apr2021 with outcome of not recovered, right arm hurting tremendously (disability) on 01Apr2021 with outcome of recovered on 04Apr2021.   The patient underwent lab tests and procedures which included ultrasound scan: positive   on 13Apr2021 had a blood clot.  Therapeutic measures were taken as a result of blood clot (thrombosis) included Xarelto and due to pain in extremity the patient received ibuprofen (7 ibuprofen every day); Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Thrombosis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Sex: U
Vaccine: PNC13
Symptoms: Nephrotic syndrome
Clinical narrative: newly diagnosed nephrotic syndrome; This is a spontaneous report from contactable physician via. This physician reported that an 8-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. Patient was fully vaccinated with PCV 13 earlier as a baby-some resources mention an additional Prevnar would be needed in addition to a PPSV23. The patient was newly diagnosed nephrotic syndrome on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The association between the event nephrotic syndrome with PREVNAR 13 use can not be fully 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling cold, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient).  A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom.  She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown.   Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: Fainted; fell down to the ground after using restroom; I was cold; sweating; slowed heartbeat and pulse; extreme nausea; This is a spontaneous report from a contactable consumer (patient).  A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Batch/Lot number was not reported), at the age of 43 years, as single dose for covid-19 immunization. Medical history included fibromyalgia and t5 back fracture. The patient is not pregnant. Concomitant medications included pregabalin (LYRICA); buspirone and cannabidiol (CBD OIL). On 16Apr2021 at 2 AM, the patient fainted 12 hours later and fell down to the ground after using restroom.  She was cold, sweating, slowed heartbeat and pulse, extreme nausea. The patient did not receive treatment for the events. The patient had No COVID-19 prior to vaccination and had not been COVID-19 tested post vaccination. The outcome of the events fainted, fell down to the ground after using restroom, she was cold, sweating, slowed heartbeat and pulse, extreme nausea was unknown.   Information about lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Eye pain, Hallucination
Clinical narrative: hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; muscle pain; vomiting; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 24Mar2021. On 02Apr2021, the patient experienced hallucinations, headache, chills, fever, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The patient was hospitalized for all events for 4 days. The patient further stated that after 3 hours getting the vaccine she experienced a terrible adverse event like headache, muscle pain, diarrhea, vomiting and chills, she contacted her doctor and she was advised to call the ambulance and go to the hospital but since she was designated next to the isolation of COVID patients she decided to go home after getting the saline that will help her to increase the potassium, she mentioned that until now she was experiencing hallucinations and severe headache and she was not feeling well. The patient also stated that she got the first vaccine last 24Mar2021 (less than 21 days interval). The patient mentioned that she had taken diarrhea medications and antibiotics after the 2nd dose. Therapeutic measures were taken as a result of hallucinations, headache, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The outcome of all events was unknown.  Information on lot number/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Inappropriate schedule of product administration, Malaise, Myalgia
Clinical narrative: hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; muscle pain; vomiting; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 24Mar2021. On 02Apr2021, the patient experienced hallucinations, headache, chills, fever, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The patient was hospitalized for all events for 4 days. The patient further stated that after 3 hours getting the vaccine she experienced a terrible adverse event like headache, muscle pain, diarrhea, vomiting and chills, she contacted her doctor and she was advised to call the ambulance and go to the hospital but since she was designated next to the isolation of COVID patients she decided to go home after getting the saline that will help her to increase the potassium, she mentioned that until now she was experiencing hallucinations and severe headache and she was not feeling well. The patient also stated that she got the first vaccine last 24Mar2021 (less than 21 days interval). The patient mentioned that she had taken diarrhea medications and antibiotics after the 2nd dose. Therapeutic measures were taken as a result of hallucinations, headache, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The outcome of all events was unknown.  Information on lot number/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Off label use, Pyrexia, Vomiting
Clinical narrative: hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; muscle pain; vomiting; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 24Mar2021. On 02Apr2021, the patient experienced hallucinations, headache, chills, fever, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The patient was hospitalized for all events for 4 days. The patient further stated that after 3 hours getting the vaccine she experienced a terrible adverse event like headache, muscle pain, diarrhea, vomiting and chills, she contacted her doctor and she was advised to call the ambulance and go to the hospital but since she was designated next to the isolation of COVID patients she decided to go home after getting the saline that will help her to increase the potassium, she mentioned that until now she was experiencing hallucinations and severe headache and she was not feeling well. The patient also stated that she got the first vaccine last 24Mar2021 (less than 21 days interval). The patient mentioned that she had taken diarrhea medications and antibiotics after the 2nd dose. Therapeutic measures were taken as a result of hallucinations, headache, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The outcome of all events was unknown.  Information on lot number/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passing out; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced passing out on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mitral valve disease, Vaccination site pain
Clinical narrative: slight ache in left arm; headaches; surgery is hopefully a mitral valve repair; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203) intramuscular, on left arm, at the age of 67-year-old, on 26Feb2021 5:45pm, single dose, for covid-19 immunisation. Medical history included asthma and Allergies. Concomitant medications were not reported. On 27Feb2021, the next morning when she woke up, she had like a slight ache in her left arm and then everything was fine. She clarifies she was getting headaches after the first injection but she didn't know if it was from the vaccine or not. The headaches were not that severe. She took Tylenol and the headaches kind of went away. The patient found out that she had to have a surgery on 29Mar2021 and was subsequently moved on 15Apr2021. It was determined her surgery was going to happen after receiving the second vaccine. The surgery is hopefully a mitral valve repair. Outcome of headache and slight ache in her left arm was recovered in 2021 while it was unknown for mitral valve disease.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Headache, Peripheral swelling, Syncope
Clinical narrative: Fainting; Swelling of arm; no taste; headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 13:30 as a single dose for COVID-19 immunization.  Medical history included narcolepsy from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took Cymbalta and experienced allergies. The patient was not tested for COVID post vaccination. On 13Apr2021 at 05:30 PM, the patient experienced fainting, swelling of arm, no taste and headache. The patient did not receive treatment for the events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Haemorrhage, SARS-CoV-2 test, Thrombosis
Clinical narrative: after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal; This is a spontaneous report from a non-contactable consumer. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 20 years). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that after 3 years of not having her period, she suddenly started bleeding heavily and having menstrual cramps. The bleeding was very clotted and seemed somewhat abnormal. The patient underwent lab tests and procedures which included nasal swab: negative on an unspecified date. The patient did not have COVID prior vaccination. The patient was not pregnant. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Asthenia, Diarrhoea, Dysstasia, Pain
Clinical narrative: Vomiting/vomiting from almost a month now; can't stand up/not even stand up; Diarrhea; Weakness, not even stand up; don't need to be feeling like this; Pain; Lost my sense smell; This is a spontaneous report from a non-contactable consumer (patient).  A 77-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Lot Number: EN6148; Expiration Date: Dec2021) as single dose, dose 2 via an unspecified route of administration on 02Apr2021 (Lot Number: EP7534; Expiration Date: Jul2021) as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  When probed for the concern, consumer stated, "I got sick after the shot, I am reporting side effects.". When paraphrased the concern with Covid vaccine, consumer stated, "Yes on both of them, I got two (shots), first one on (12Mar2021) and second one (02Apr2021) and I got sick from both of them.". In response, consumer stated, "I got problem from both of them, vomiting, diarrhea, weakness not even stand up. I am 77 years old, I don't need to be feeling like this from these shot, I was fine before I got." When probed for vaccine expiration date, consumer stated, "The first one EN6148 was "Dec21" (not clarified) and the second one just got the expiration date "7/21" (not clarified the date), but I am going to ask a question when they gave me the shot, the shot was lying on the table and an hour after a gap they gave us the shot, was that still good at that time, an hour after out of the ice?" When probed for height and weight, consumer stated, "It has nothing to do with my height and nothing do with my weight. This shot has almost killed (intent: general) me." Consumer stated, "I got sick after this, I have been vomiting from almost a month now, I can't stand up, paining, with time I lost my "pace" (not clarified), I lost my sense smell every time, it's started with me like COVID, based the symptoms I am having it seems like that I am having COVID." The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting/vomiting from almost a month now; can't stand up/not even stand up; Diarrhea; Weakness, not even stand up; don't need to be feeling like this; Pain; Lost my sense smell; This is a spontaneous report from a non-contactable consumer (patient).  A 77-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Lot Number: EN6148; Expiration Date: Dec2021) as single dose, dose 2 via an unspecified route of administration on 02Apr2021 (Lot Number: EP7534; Expiration Date: Jul2021) as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  When probed for the concern, consumer stated, "I got sick after the shot, I am reporting side effects.". When paraphrased the concern with Covid vaccine, consumer stated, "Yes on both of them, I got two (shots), first one on (12Mar2021) and second one (02Apr2021) and I got sick from both of them.". In response, consumer stated, "I got problem from both of them, vomiting, diarrhea, weakness not even stand up. I am 77 years old, I don't need to be feeling like this from these shot, I was fine before I got." When probed for vaccine expiration date, consumer stated, "The first one EN6148 was "Dec21" (not clarified) and the second one just got the expiration date "7/21" (not clarified the date), but I am going to ask a question when they gave me the shot, the shot was lying on the table and an hour after a gap they gave us the shot, was that still good at that time, an hour after out of the ice?" When probed for height and weight, consumer stated, "It has nothing to do with my height and nothing do with my weight. This shot has almost killed (intent: general) me." Consumer stated, "I got sick after this, I have been vomiting from almost a month now, I can't stand up, paining, with time I lost my "pace" (not clarified), I lost my sense smell every time, it's started with me like COVID, based the symptoms I am having it seems like that I am having COVID." The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction. Unable to achieve erection and no reaction to any type of stimulation at all; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 49-years-old via an unspecified route of administration, administered in arm left on 23Mar2021 14:00 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lisinopril and hydrochlorothiazide both taken for an unspecified indication, start and stop date were not reported. The patient experienced erectile dysfunction on 25Mar2021. It was further reported that he was unable to achieve erection and no reaction to any type of stimulation at all. Did not have this issue at all prior to receiving vaccine. The patient did not recover from the event.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis reactive, Condition aggravated
Clinical narrative: reactive arthritis flare in right knee and left foot/2 weeks after second shot, reactive arthritis flare again same locations; reactive arthritis flare in right knee and left foot/2 weeks after second shot, reactive arthritis flare again same locations; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 09:00 (Batch/Lot Number: EN6208) then the 2nd dose on 01Apr2021 (Batch/Lot Number: ER8733) both given via an unspecified route of administration administered  on arm left as SINGLE DOSE for COVID-19 immunization.  Medical history included arthritis reactive, attention deficit hyperactivity disorder (ADD) and elevated blood pressure. The patient also had allergies with nonsteroidal anti-inflammatory drug (NSAID) manifested as NSAID related bleeding. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metoprolol (METOPROLOL), rosuvastatin (ROSUVASTATIN) and methylprednisolone acetate (METHYLPREDNISOLONE) all taken for unspecified indications and therapy dates.  The patient had received his first dose of PFIZER-BIONTECH COVID-19 VACCINE on 11Mar2021 09:00. On 25Mar2021 06:00 (2 weeks after first shot), the patient had reactive arthritis flare in right knee and left foot. Then, the patient received the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE on 01Apr2021. On 15Apr2021 (2 weeks after second shot), the patient again reactive arthritis flare again same locations. The patient stated that this was uncommon in winter/spring season transition, but the timing of flares was strange. The patient requires doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care for the events and was treated with "MERRILY DOSEPAK". The patient had no COVID-19 prior vaccination no not tested for COVID-19 post vaccination. The patient was recovering from the events.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Renal infarct
Clinical narrative: renal infarction; This is a spontaneous report from a contactable consumer (patient). An 84-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Mar2021 at 12:00 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (lot number: EN5318) on 05Feb2021 at 12:00 PM (at the age of 84-years-old), administered in right arm for COVID-19 immunisation. The patient received other medications in two weeks (unspecified). Fourteen (14) days after the 2nd dose on 16Mar2021, the patient experienced renal infarction. The patient was hospitalized for renal infarction for 1 day on an unspecified date. Therapeutic measures were taken as a result of renal infarction. The outcome of the event was recovered with sequelae on an unspecified date. The event resulted in Emergency room/department or urgent care, hospitalization.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Five days after the first vaccine started experiencing severe psoriatic arthritis symptoms in hands, fingers, feet, toes, arms, legs, back and neck; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN) at the age of 65-years, via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER8737) as a single dose for covid-19 immunisation. The patient's medical history included known allergies to tetanus shots, contrast solution, antibiotic; and arthritis (for three years prior to the vaccine). There were no concomitant medications. The patient previously took tetanus vaccine and experienced drug allergy. The patient experienced five days after the first vaccine started experiencing severe psoriatic arthritis symptoms in hands, fingers, feet, toes, arms, legs, back and neck on 08Apr2021. The patient was not treated for the event. The outcome of the event was not recovered. The patient did not have Covid-19 prior to vaccination and has not had a Covid test post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: Retinal vein occlusion; This is a spontaneous report from a contactable consumer (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 18Mar2021 13:00 as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient was not covid-19 tested post vaccination. There were concomitant medications. The patient received oral contraceptives in two weeks. The patient had no other vaccines in four weeks. On 25Mar2021, the patient experienced retinal vein occlusion. The patient received Avastin injection as treatment for the event. The event was resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the event was not recovered.  It was reported that the patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) via an unspecified route of administration, administered in arm left on 15Apr2021 as a single dose for covid-19 immunisation.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Nausea
Clinical narrative: Weakness; nauseous; asthma attack; This is a spontaneous report from a contactable consumer (patient). A 76-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 14Feb2021 09:30 am (Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included high blood pressure and patient took two blood pressure medicines, take that one in the morning and one in the night, asthma and pre-diabetic. Concomitant medication(s) included amlodipine taken for hypertension; candesartan taken for hypertension; cetirizine hydrochloride (ZYRTEC) taken for asthma; calcium carbonate, colecalciferol (VITAMIN D); cyanocobalamin, folic acid (VITAMIN B12); vitamin b complex (B COMPLEX). Patient previously took BNT162B2 first dose on 23Jan2021 for covid-19 immunisation. Patient stated first one didn't give Asthma. The first shot patient was sick for about 5 days, very nauseated, very unstable with balance and very tired. Patient stated had pneumonia, shingle shot (unspecified shot) and Flu shot. The second shot patient had on 14Feb2021 the Valentine's day and patient had about 9:30 am and by 11:30 pm it caused an asthma attack on patient and when went to get up patient was very weak and very nauseous in the morning but the asthma attack it going all night patient did have asthma but wasn't had any attacks for a couple months, so it was that patient tried to pull himself (or herself) and had very hard time to pulling himself (or herself) up to sit on the bed and when patient sat on near to bed to stabilize and when went to step down on patient's legs which gave up and couldn't get back up, and finally hours after when patient could not back up, patient live alone and called and the paramedic team to pick patient up and the asthma continues and the weakness continues that whole week and then went to the doctor, patient was given antibiotic and prednisone, patient took steroid for two weeks to get recover from it. Patient stated about 147 pounds. Patient stated have a lab test done, a blood test done on February may be done on. Patient didn't have the results yet, it was basically for "A1C" (not clarified) and sodium because patient go "low" (not clarified) on sodium, it was a CBC or something 4-5 and patient didn't know what all test. Patient was pre diabetic. Patient was not taking because kept exercise up and it kept weight down. Patient stated took asthma medicine including "Claritin" and "Singulair" (further not clarified name). Patient took Zyrtec and had asthma but patient had not having any asthma symptoms, patient's nebulizer used was not even charged and patient was clear of asthma and upon having the Pfizer shot that morning that was second one and took over the counter like Vitamin D and take B12 and patient took B Complex. The event outcome for events was recovered on unspecified date.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Insomnia, Nasal congestion, Pulmonary congestion
Clinical narrative: Her lungs did the same thing where they had closed; Her lungs did the same thing where they had closed/her nose did the same thing where it closed as well/only it was a lot worse with her lungs and her nose; her nose did the same thing where it closed as well; She was breathing through her mouth because she couldn't breathe through her nose.; She had sat up for 4 nights trying to sleep.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8733) via an unspecified route of administration into left arm on 30Mar2021 (at the age of 67-year-old) in the morning as single dose for COVID-19 immunisation. The patient's medical history were not reported. There were no concomitant medications. Historical vaccines include: INFLUENZA VACCINE on an unspecified date for immunization where she got sick for a week and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 09Mar2021 08:30 AM  (at the age of 67-year-old) for COVID-19 immunization and feeling like her lungs were starting to close up and her nose closed up completely, hard time breathing when doing anything that was exerting herself, she still had a hard time with her breathing and short of breath. It was reported that patient got her second dose on 30Mar2021 in the morning and on 31Mar2021 almost the same thing pretty much happened as the first one, only it was a lot worse with her lungs and her nose. Her lungs did the same thing where they had closed and her nose did the same thing where it closed as well. She already had everything ready to use for nebulizing and that opened her lungs but it didn't open her nose. It was further reported that since 31Mar2021 she had sat up for 4 nights trying to sleep and she was breathing through her mouth because she couldn't breathe through her nose. The patient went to her doctor's clinic where she was given treatment for the events reported; she was put on a heavier nebulizer; that kind of opened up her lungs and her nose and then her doctor also put her on prednisone. Outcome of events "she was breathing through her mouth because she couldn't breathe through her nose" and "she had sat up for 4 nights trying to sleep" was unknown while for all other events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Seizure
Clinical narrative: Seizures; allergic reactions; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 and dose 1; both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both vaccines & both times had seizures & allergic reactions. The patient was medicated properly for the second dose and symptoms were severe. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: crohn's disease pain; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 25Mar2021 (Lot Number: ER8730) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The reporter stated that she and her spouse received the 1st dose of ther COVID-19 vaccine last 25Mar2021 and scheduled for the 2nd dose tomorrow 16Apr2021 (22 days apart). She was requesting to reschedule the 2nd dose on 20Apr2021 because she is currently experiencing Crohn's disease pain and can't drive. They have an appointment today for their second dose/second shot and they aren't going to be able to make it. She was wondering if there is anyway possible to reschedule the vaccine for tomorrow, Monday or Tuesday. Outcome of the event was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chrons disease. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fall, Hip fracture, Muscular weakness, Pyrexia
Clinical narrative: Weakness in his legs; went up falling and breaking his hip; went up falling and breaking his hip; fell ill as he had fever close to 102.8 fever; This is a spontaneous report from a contactable consumer (reporting for father). A 75-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm on 08Apr2021 (Batch/Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunization.  Medical history included hypertension, diabetes mellitus and leg bypass surgery. The patient took many medications (unspecified). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on unknown date ( Batch/Lot Number not provided) as COVID-19 immunization. The reporter just recently found out that the patient got the 2nd dose of vaccine on 08Apr2021. On unspecified date, he fell ill as he had fever close to 102.8 fever. The patient also has weakness in his legs and he went up falling and breaking his hip/ fractured his hip.  The patient was admitted on the hospital on that same unspecified day and was being treated for his hip which require the partial hip replacement surgery. Outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: felt a pain in her heart and all the way throughout the back that was like she was stabbed; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. After the 2nd dose (on an unspecified date in Apr2021), the patient felt a pain in her heart and all the way throughout the back that was like she was stabbed. The outcome of the event was unknown.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Formication, Thrombosis
Clinical narrative: blood clot; feels like there is a worm in between her ankle and knee, crawling around her leg; This is a spontaneous report from a contactable consumer (patient reported for herself) received from a Pfizer sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She felt like there was a worm in between her ankle and knee, crawling around her leg. She thought that it might be a blood clot and it might crawl going to her brain. She said she's been up all night and she put an elastic bandage on her leg so that it won't crawl going to her brain. The outcome of the event was reported as unknown.   Follow up attempts are needed. Information about lot/batch number has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RA flare; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional and consumer reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had rheumatoid arthritis (RA) flare. The outcome of the event was unknown.  Follow-up attempts are needed; information on the lot/batch number has been requested.; Sender's Comments: The event rheumatoid arthritis (RA) flare was considered as due to underlying condition and unlikely related to the use of BNT162B2. Patient had rheumatoid arthritis as medical history. 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: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Inappropriate schedule of product administration, Off label use
Clinical narrative: died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; This is a spontaneous report from a contactable healthcare professional (patient's spouse, nurse practitioner). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Apr2021 (lot number: EW0150) as single dose (at the age of 47-years-old) for COVID-19 immunisation, vaccinated at a hospital. Medical history included hypothyroidism, anxiety, and chronic migraine (ongoing). The patient had no known food and drug allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); sumatriptan for migraines; and clonazepam for anxiety. The patient received the first dose of BNT16B2 on 15Mar2021 09:00 am (lot number: EN6708) (at the age of 47-years-old) for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient died on 14Apr2021 01:30 pm of a sudden death. She was found at home unresponsive and pulseless. Efforts at resuscitation were unsuccessful. Her medical history of hypothyroidism, anxiety and chronic migraines do not appear to be contributory. The patient did not receive treatment (as reported). The reporter considered the event to be a serious adverse effect (SAE). A full autopsy has been performed; the results were pending.; Reported Cause(s) of Death: died on 14Apr2021 01:30 pm of a sudden death