chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report received from a contactable pharmacist from a Pfizer-sponsored program. A 70-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist was asking if there have been any reports of blood clots associated with the COVID-19 vaccine as the patient developed blood clot 1.5 weeks after receiving his first Pfizer COVID vaccine on an unspecified date. The outcome of the event was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Blood clots 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient wanted to know if he should receive the second dose of the Pfizer COVID-19 vaccine after he has been diagnosed with COVID-19. On 12Apr2021, he was diagnosed with COVID-19 and hospitalized, he improved and left the hospital yesterday (21Apr2021), his appointment for the second is today (22Apr2021). The patient was hospitalized for diagnosed with covid-19 from 12Apr2021 to 21Apr2021.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive (diagnosed with covid-19) on 12Apr2021. The outcome of the event was recovering.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Glomerular filtration rate decreased, Renal function test, Renal impairment
Clinical narrative: her kidney function usually has been in a 55-57 range; GFR went down to 44; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 16Apr2021, she went to get blood work done and her GFR went down to 44. She stated that her kidney function usually has been in a 55-57 range. The patient wanted to consult if this is a known side effect. The patient would like to consult if she should get the second dose of the COVID-19 vaccine after presenting side effects from the first. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haemorrhage urinary tract, Urine analysis
Clinical narrative: Bright red blood and blood clots in urine on 4 consecutive days; Bright red blood and blood clots in urine on 4 consecutive days; This is a spontaneous report from a contactable nurse (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:30 (Batch/Lot Number: ER8733) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicilline allergy, both from an unknown date and unknown if ongoing. Concomitant medication included bisoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 14:30 (Batch/Lot Number: ER8737) (at 70 years of age) for COVID-19 immunisation. The patient had no other vaccine in four weeks prior to covid vaccine. He had no covid prior vaccination. He had not been tested for covid post vaccination. It was reported that the patient experienced bright red blood and blood clots in urine on 4 consecutive days. The events started on 19Apr2021 10:30 AM with outcome of not recovered. The patient had not received any treatment for the events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Laboratory test, Magnetic resonance imaging
Clinical narrative: Loss of vision in left eye.; This is a spontaneous report from a contactable consumer.  A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration, administered in right arm on 13Apr2021, at  10:00 as single dose for covid-19 immunisation.  Medical history included Lupus, Hashimotos, chronic obstructive pulmonary disease, asthma, non- alcoholic fatty liver disease, and allergy from unknown dates. The patient experienced loss of vision in left eye on 13Apr2021, at 10:00.  The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent other tests and magnetic resonance imaging in Apr2021 with unknown results. Therapeutic measures were taken as result of the event. No COVID prior to vaccination was noted. No  COVID test was performed post vaccination. The outcome of loss of vision in left eye was not recovered.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day; scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day. The patient wanted to know when to receive the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot in the calf; Swelling/pain behind the knee; Swelling/pain behind the knee; A 62-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included vitamin d3 (VITAMIN D3). The patient experienced blood clot in the calf and swelling/pain behind the knee on 10Apr2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included nasal swab: negative on 17Apr2021. Therapeutic measures were taken as a result of thrombosis, joint swelling and arthralgia included anticoagulation medication. The patient did not have COVID prior vaccination. Outcome of the event was recovering.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Cognitive disorder, Dementia
Clinical narrative: Stroke; Dementia; Lost most of cognitive abilities; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 04Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination). The patient's concomitant medications were not reported. On 10Apr2021, the patient experienced adverse events (AEs) including stroke, dementia, and lost most of cognitive abilities. The AEs resulted in doctor or other healthcare professional office or clinic visit, hospitalization from Apr2021, and disability or permanent damage. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Erythema, Investigation, Limb mass, Pain
Clinical narrative: 2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness, Ultrasound scan
Clinical narrative: 2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Disorientation, Dyspnoea, Ear discomfort
Clinical narrative: Neurological disorientation such as staggered  motor function. It has been challenging  to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned  24-48 hour period of visual abnormalities  Extreme pain at injection site since shot and untol now although getting better  Extreme Lethargy  Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics  ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021  All over rolling from extreme to mild pains  Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site  A deep cough not severe and frequent but significant and persistent
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Neurological disorientation such as staggered  motor function. It has been challenging  to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned  24-48 hour period of visual abnormalities  Extreme pain at injection site since shot and untol now although getting better  Extreme Lethargy  Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics  ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021  All over rolling from extreme to mild pains  Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site  A deep cough not severe and frequent but significant and persistent
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Muscle twitching, Pain, SARS-CoV-2 test negative, Visual impairment
Clinical narrative: Neurological disorientation such as staggered  motor function. It has been challenging  to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned  24-48 hour period of visual abnormalities  Extreme pain at injection site since shot and untol now although getting better  Extreme Lethargy  Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics  ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021  All over rolling from extreme to mild pains  Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site  A deep cough not severe and frequent but significant and persistent
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination complication, Vaccination site swelling
Clinical narrative: After searching in Google it seems I have "Covid arm": site of vaccine is swelling, reddish and itchy. It's been 2 weeks I received the first Moderna dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Area of upper right arm feels painful, heavy and stiff, as if I just got the vaccine. I experienced the same symptoms with the first dose, but to a lesser degree. I have had these symptoms up to this very day.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: Viral symptoms developed on 5/5/21. Diagnosed with COVID on nasal swab on 5/6/2021, despite being fully vaccinated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Confusional state, Full blood count, Mental status changes, Metabolic function test
Clinical narrative: altered mental status.  Pt was found sitting on lawn mower confused A o x 1-2.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: altered mental status.  Pt was found sitting on lawn mower confused A o x 1-2.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Herpes zoster, Pain, Rash
Clinical narrative: Left shoulder pain began 2 weeks after vaccine. 3 days after the pain, a rash began to form on my back. The rash got bigger and received Shingles diagnosis 19 days post vaccination. Blisters have spread from upper back, to shoulder, and down left arm. Currently dealing with shooting nerve pain.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: High Blood Sugars,
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breast disorder, Mastitis, Off label use, Product use issue
Clinical narrative: patient was a breastfeeding mother and got a plugged duct resulting in mastitis; patient was a breastfeeding mother and got a plugged duct resulting in mastitis; patient was a breastfeeding mother and got a plugged duct resulting in mastitis; patient was a breastfeeding mother and got a plugged duct resulting in mastitis; This is a spontaneous report from a contactable consumer (patient).  This consumer reported information for both mother and baby. This is the maternal report.   A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Apr2021 (lot number: ep 6955) at the age of 29 years old, as single dose for COVID-19 immunisation. Medical history included hypothyroidism and known allergies to sulfa drugs; both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines received in four weeks. The patient was a breastfeeding mother and got a plugged duct resulting in mastitis on 18Apr2021 11:45 with outcome of recovering. Therapeutic measures were taken as a result of plugged duct resulting in mastitis and included unspecified antibiotics. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452792 same reporter/drug, different patient/event (baby case)
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological infection, Tic
Clinical narrative: Neurological vocal and motor tics; Neurological vocal and motor tics; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included ehlers-danlos syndrome from an unknown date. The patient previously took codeine, metoclopramide, prochlorperazine, vancomycin and experienced allergies. The patient experienced neurological vocal and motor tics on 02Mar2021 seriousness criteria was reported as disability and medically significant. Therapeutic measures were taken as a result of neurological vocal and motor tics. Outcome of the events was not recovered.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: He received his first dose back on 18Feb2021 then, tested positive for Covid; He received his first dose back on 18Feb2021 then, tested positive for Covid; This is a spontaneous report from a contactable consumer (reporting for himself). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he received his first dose back on 18Feb2021 then, tested positive for COVID. The patient was treated "with and infusion". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Off label use
Clinical narrative: The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient's last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Echocardiogram, Head injury, Hypertension
Clinical narrative: everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP it was quite high; Blood began to drip from head wound.; blood began to drip from head wound; limbs felt rubbery and out of sorts; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 08:30 (Lot Number: ER8732) (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient not tested positive to COVID-19 pre or post vaccination. The patient medical history was not reported. Concomitant medications included amlodipine; fluoxetine; metoprolol and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient reported that on 24Mar2021 at 9:15 everything began to swim in front of her, the sink, counter, coffee pot, etc. Grabbed edge of sink to steady herself. Felt her knees giving out. Woke up face down on floor. Her limbs felt rubbery and out of sorts. Blood began to drip from head wound. Grabbed counter edge and pulled herself upright. Grabbed paper towel for compress. Wobbled over to sofa. She laid down. Her husband came home measured her blood pressure (BP) it was quite high and would not go down. She went to ER immediately. At ER, they took blood, observed, did Echo on heart and sent her home. No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Syncope, Wound haemorrhage
Clinical narrative: everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP it was quite high; Blood began to drip from head wound.; blood began to drip from head wound; limbs felt rubbery and out of sorts; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 08:30 (Lot Number: ER8732) (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient not tested positive to COVID-19 pre or post vaccination. The patient medical history was not reported. Concomitant medications included amlodipine; fluoxetine; metoprolol and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient reported that on 24Mar2021 at 9:15 everything began to swim in front of her, the sink, counter, coffee pot, etc. Grabbed edge of sink to steady herself. Felt her knees giving out. Woke up face down on floor. Her limbs felt rubbery and out of sorts. Blood began to drip from head wound. Grabbed counter edge and pulled herself upright. Grabbed paper towel for compress. Wobbled over to sofa. She laid down. Her husband came home measured her blood pressure (BP) it was quite high and would not go down. She went to ER immediately. At ER, they took blood, observed, did Echo on heart and sent her home. No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Contusion, Deep vein thrombosis, Feeling hot
Clinical narrative: DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin discolouration
Clinical narrative: DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: deep vein thrombosis left leg/Vascular u/s showed clot from the ankle to the groin in left leg; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at the hospital. Medical history included prediabetes, relapsing polychondritis, obesity, intolerant to gluten and cow's milk protein, and penicillin allergy. The patient is not pregnant at the time of report and vaccination. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included fish oil; ergocalciferol (VIT D); methylfolate; metformin; and desvenlafaxine succinate (PRISTIQ). On 12Jan2021 at 19:00, the patient's left ankle swelled double normal size. On 13Jan2021, left leg swelled. On 14Jan2021, patient knew it was a deep vein thrombosis left leg based on pain and swelling and past experience but waited till her day off on 15Jan2021 to seek medical care. Vascular u/s (ultrasound) on 15Jan2021 showed clot from the ankle to the groin in left leg. Sent to emergency department and started on Zarelto x 6 months for long term anticoagulation. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose on 01Feb2021 at 16:45. Outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deep vein thrombosis and the suspect drug.  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  Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Lung carcinoma cell type unspecified recurrent
Clinical narrative: Reoccurrence of lung cancer; This is a spontaneous report from a contactable consumer (friend).  A female patient of an unspecified age received BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included lung cancer. Concomitant medications were not reported. The consumer reported that her friend (the patient) got the vaccine and had a reoccurrence of lung cancer on unspecified date, in which she was told would not happen. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Syncope, Vital signs measurement
Clinical narrative: fainted twice shortly after waking up/diagnosis was vasovagal syncope; fainted twice shortly after waking up/diagnosis was vasovagal syncope; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) on 31Mar2021 for COVID-19 immunization. Relevant medical history included a history of fainting on an unknown date in the past. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. It was unknown if the patient was tested for COVID-19 post vaccination. The morning after receiving the second vaccine dose, on 22Apr2021, the patient fainted twice shortly after waking up. The patient went to the emergency room (ER), and the diagnosis was vasovagal syncope. Vital signs were normal on an unspecified date. The adverse event (AE) resulted in an emergency room/department or urgent care. The patient did not receive any treatment for the AE. The patient recovered from the event on an unspecified date in 2021.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), first dose on an unspecified date and second dose on 08Apr2021 via an unspecified route of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain on an unspecified date and took Tylenol (2x500mg) after the first dose. It was sore for two days. She had arm pain again after the second dose and took Tylenol (2x500mg) twice daily for the event after the second dose. Caller stated she was never told about not taking Tylenol after getting the COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: a woman who was paralyzed after getting her doses of the Pfizer vaccine.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, second dose 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 medical and concomitant medications were not reported. The reporter reported that they are doing a story with a woman who was paralyzed on an unspecified date after getting her doses of the Pfizer vaccine. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Near death experience, Pain, Pyrexia
Clinical narrative: feels like she's dying; flu like symptoms; low grade fever; aches; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 11:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient's mother reported that her daughter was experiencing flu like symptoms. Her daughter felt like she's dying. She has a low grade fever and aches. Her symptoms started today (22Apr2021). The outcome of the events were not recovered.  Information on the batch/lot number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dysstasia, Headache, Infectious mononucleosis
Clinical narrative: I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscle spasms, Muscular weakness, Myalgia, Oropharyngeal pain
Clinical narrative: I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Pyrexia, SARS-CoV-2 test, White blood cell count
Clinical narrative: I can't be standing for more than a few minutes; My legs begin to cramp up; Muscle aches; Sore throat; Couldn't get out of bed all weekend; White blood and platelets count abnormally low; White blood and platelets count abnormally low; Mononucleosis; Cough; Dizziness; Muscle weakness; Fever; Headache; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in left arm on 15Apr2021 10:00 as single dose for Covid-19 immunization. Medical history included gastritis and sensitive stomach from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination. Concomitant medications included drospirenone, ethinylestradiol (NIKKI); pantoprazole sodium sesquihydrate (PROTONIX); and an unspecified vitamin, all taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for Covid-19 immunization. The patient received her second dose on 15Apr2021, Thursday, and on 16Apr2021, Friday night, she got a mild headache. Beginning 17Apr2021 09:00, Saturday, she got severe headache, dizziness, muscle weakness, and a fever. Symptoms worsened throughout the days. On 19Apr2021, Monday, she also got a sore throat. She couldn't get out of bed all weekend. She went to the hospital and they found that her white blood and platelets count were abnormally low, among other low things (white blood at 1.8). She was hospitalized until 20Apr2021, Tuesday, and was found to have mononucleosis. Cough developed and ended Tuesday, 20Apr2021. Beginning 20Apr2021 onward, the muscle aches were the biggest complaint, she can't be standing for more than a few minutes or her legs begin to cramp up. Headaches and dizziness continued. Sore throat stopped, and fever began to subside. On 19Apr2021, the patient underwent lab tests and procedures which included platelet count: abnormally low, Nasal Swab/PCR: negative, and white blood cell count: 1.8. The events resulted in Doctor or healthcare professional office/clinic visit, Emergency room/department or urgent care, and events from 19Apr2021 caused hospitalization until 20Apr2021. Treatment for the events included Tylenol and IV fluids. The outcome of sore throat recovered in Apr2021, cough resolved on 20Apr2021, fever was recovering and for other events was not recovered.