chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Muscular weakness, Night sweats
Clinical narrative: Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vertigo
Clinical narrative: Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature decreased, Dizziness, Fatigue
Clinical narrative: The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date.  The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported.  The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hypertension, Loss of consciousness, Nausea
Clinical narrative: The second day after injection temperature dropped to 93.7; I was very cold; I was dizzy almost passed out; tired; nausea; headache; almost passed out; Hypertension/BP 155/103; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6203, expiry date not reported) via an unspecified route of administration, administered in left arm on 04Mar2021 at a single dose for COVID-19 immunisation. Medical history included interstitial cystitis and endometriosis, known allergies to milk and sulfa, have had a complete hysterectomy, and patient was getting hormone injections. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior to vaccination. Concomitant medications were unspecified; it was reported that patient had other medications in two weeks. The patient previously took ibuprofen and experienced known allergies; and had first dose of bnt162b2 for covid-19 immunisation on an unknown date.  The patient had no other vaccine in four weeks. The second day after injection (06Mar2021), temperature dropped to 93.7, BP 155/103, and patient was very cold. Patient was dizzy, almost passed out (Mar2021). Patient temp ran from 97 to 98 and was able to get temp up to 95 (2021) but it's been there and dropping to 94.9 since 06Mar2021. Patient did have hypertension BP but take meds for it (Mar2021). Patient was also very tired, nausea and headache on and off (Mar2021). But all those have been reported. It's not normal for the patient to be cold because patient have had a complete hysterectomy and was getting hormone injections. Therapeutic measures were taken as a result of the event hypertension. No treatment received for the other events reported.  The patient was not tested for covid post vaccination. The outcome of the events was not recovered.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Hyperpyrexia, SARS-CoV-2 test
Clinical narrative: temperature of 107; COVID-19 confirmed by postive COVID-19 test; COVID-19 confirmed by postive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 AM (at the age of 81-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included back surgery for which he had a complication and was in a Rehabilitation facility for the first shot. The patient did not have any allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 19Jan2021, the patient experienced a temperature of 107. The patient was taken by ambulance to the hospital and was hospitalized for one week. The patient was tested for COVID-19 post vaccination via a nasal swab test on 20Jan2021 and the results were positive. Therapeutic measures were given for the event temperature of 107 (unspecified). The clinical outcome of the event temperature of 107 was recovered on an unknown date; COVID-19 was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood magnesium decreased, Blood potassium, Blood potassium decreased, Blood sodium
Clinical narrative: low white and red blood cells; low white and red blood cells; low potassium; low sodium; low magnesium; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included history of lupus, myocarditis, heart attack and chronic kidney stage 3, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that "I have received the first vaccine and my second dose is scheduled for 08Apr2021. I have read the literature which indicates to get the second dose 21 days apart." It was added that the patient has been recently discharged from ICU. She reported low white and red blood cells, low potassium, low sodium and low magnesium. She cannot have a heart transplant. She is on wheelchair and bed rest currently. She doesn't want to wait 4 weeks to get the second dose because it states clearly in the fact sheet to get the second dose 3 weeks apart. She believes the CDC has a political agenda and they are trying to get as many to get first dose, so the number looks good. She states" I know all about corporate world and the pharmaceutical bureaucracy. It's disaster." The patient wanted to know if she can override and get the vaccine sooner as the clinic refuse to give it to her earlier then the scheduled appointment. The CDC has information on the prioritized population and distribution process during an Emergency Use Authorization. In the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was allowed to be given 19-23 days after the first dose.  We are independent of CDC recommendations anything outside of the 19-23 day interval. It was also stated that the patient had taken the vaccine 11Mar2021 and wanted to know what would happen if she taken it outside of the 3 week window period. She was told that she can go and take it within four weeks. The patient also said she had a lot of medical issue and wanted to know if its okay for the four week period. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Red blood cell count, Red blood cell count decreased, White blood cell count, White blood cell count decreased
Clinical narrative: low white and red blood cells; low white and red blood cells; low potassium; low sodium; low magnesium; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included history of lupus, myocarditis, heart attack and chronic kidney stage 3, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that "I have received the first vaccine and my second dose is scheduled for 08Apr2021. I have read the literature which indicates to get the second dose 21 days apart." It was added that the patient has been recently discharged from ICU. She reported low white and red blood cells, low potassium, low sodium and low magnesium. She cannot have a heart transplant. She is on wheelchair and bed rest currently. She doesn't want to wait 4 weeks to get the second dose because it states clearly in the fact sheet to get the second dose 3 weeks apart. She believes the CDC has a political agenda and they are trying to get as many to get first dose, so the number looks good. She states" I know all about corporate world and the pharmaceutical bureaucracy. It's disaster." The patient wanted to know if she can override and get the vaccine sooner as the clinic refuse to give it to her earlier then the scheduled appointment. The CDC has information on the prioritized population and distribution process during an Emergency Use Authorization. In the Pfizer-BioNTech COVID-19 Vaccine clinical study, the second dose was allowed to be given 19-23 days after the first dose.  We are independent of CDC recommendations anything outside of the 19-23 day interval. It was also stated that the patient had taken the vaccine 11Mar2021 and wanted to know what would happen if she taken it outside of the 3 week window period. She was told that she can go and take it within four weeks. The patient also said she had a lot of medical issue and wanted to know if its okay for the four week period. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration, Wound haemorrhage
Clinical narrative: recently cut herself with a piece of metal which led to some bleeding; recently cut herself with a piece of metal; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 07Mar2021 (lot number/expiration date: unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine last Sunday (07Mar2021) and reported no side effects post-vaccination. On an unspecified date, the patient recently cut herself with a piece of metal which led to some bleeding. She hasn't had her tetanus shot in the last 20 years and she wanted to know if she can get it. The event outcome was unknown.  Information on the batch/lot number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Headache, Neck pain
Clinical narrative: Facial Paralysis of the left side, including the forehead of acute onset that occurred two days after receiving the vaccine; moderate to severe pain on the left side of the back of the neck and head.; moderate to severe pain on the left side of the back of the neck and head.; This is a spontaneous report from a contactable consumer (patient).  This 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3247) at the age of 66 years via an unspecified route of administration at single dose in the left arm on 28Jan2021 05:30 for COVID-19 immunisation. Medical history included appendicectomy, prediabetes, aortic valve calcification, allergy to Sulfa. Concomitant medication included pantoprazole. The vaccine was administered at Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient previously took codeine and experienced allergy. On 30Jan2021 07:00, the patient experienced facial paralysis of the left side, including the forehead of acute onset that occurred two days after receiving the vaccine (medically significant), moderate to severe pain on the left side of the back of the neck and head. Primary Care physician prescribed Prednisone 20 mg BID (twice a day) for 5 days with improvement of neck pain but no improvement on facial paralysis. Facial paralysis has improved in 60%, still with some degree of compromise. The outcome of the events was recovering.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Speech disorder
Clinical narrative: Trouble speaking; legs are swollen and numb; legs are swollen and numb; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6202, via an unspecified route of administration, administered in left arm on 27Feb2021 18:00 as single dose for COVID-19 immunisation. Medical history included Parkinson's disease. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient experienced trouble speaking, and legs are swollen and numb on 01Mar2021. The patient was hospitalized due to the events. No treatment was received. The outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Nerve injury, Radiculitis brachial
Clinical narrative: Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; This is a spontaneous report received from a contactable physician (who is also the patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 12Jan2021 13:30, as single dose, for COVID-19 immunisation. There was no medical history. The patient did not have COVID-19 prior to vaccination and has not tested for COVID-19 post vaccination. The patient had no known allergies and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 12Feb2021, the patient experienced brachial neuritis w/ suprascapular nerve injury and weakness. The events required physician's office visit and resulted to disability or permanent damage. Treatment for the events included physical therapy. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Muscular weakness, Neuralgic amyotrophy, Peripheral nerve palsy, Radiculitis brachial
Clinical narrative: Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; This is a spontaneous report received from a contactable physician (who is also the patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 12Jan2021 13:30, as single dose, for COVID-19 immunisation. There was no medical history. The patient did not have COVID-19 prior to vaccination and has not tested for COVID-19 post vaccination. The patient had no known allergies and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 12Feb2021, the patient experienced brachial neuritis w/ suprascapular nerve injury and weakness. The events required physician's office visit and resulted to disability or permanent damage. Treatment for the events included physical therapy. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal X-ray normal, X-ray limb normal
Clinical narrative: Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; Brachial neuritis w/ suprascapular nerve injury and weakness; This is a spontaneous report received from a contactable physician (who is also the patient). A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 12Jan2021 13:30, as single dose, for COVID-19 immunisation. There was no medical history. The patient did not have COVID-19 prior to vaccination and has not tested for COVID-19 post vaccination. The patient had no known allergies and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 12Feb2021, the patient experienced brachial neuritis w/ suprascapular nerve injury and weakness. The events required physician's office visit and resulted to disability or permanent damage. Treatment for the events included physical therapy. The outcome of the events was not recovered.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 1 week after second dose I developed a blood clot behind my left knee, in hospital for 9 days; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:00 (Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, controlled from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. The patient previously had first dose of BNT162B2 in the left arm (lot number: EL3244) on 20Jan2021 for COVID-19 immunization. Concomitant medications included apixaban (ELIQUIS), metformin, caredevil and fish oil; all taken for an unspecified indication, start and stop date were not reported. On 24Feb2021 12:00 PM, it was reported that the patient 1 week after second dose, developed a blood clot behind left knee, in hospital for 9 days that also resulted in emergency room/department or urgent care. The event was treated with blood thinners. The patient had no COVID prior to vaccination and has not tested for COVID post vaccination. The outcome of the event was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: facial drooping/Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received dose number 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206) via an unspecified route of administration, administered in the left arm, on 11Mar2021 08:15 AM at a single dose for COVID-19 immunisation. Medical history included diabetes, thyroid, and hernia. The patient had no known allergies. Concomitant medication(s) included metformin hydrochloride (METFORMIN ER); levothyroxine; and omeprazole. The patient had no other vaccine in four weeks. On 12Mar2021 at 2AM, the patient woke up and had facial drooping; went to the ER and was admitted for possible stroke. It was further clarified that it was not a stroke but she has Bell's palsy. The adverse event (AE) resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization (duration for 1 day, from 12Mar2021 to 13Mar2021). AE treatment included medicine, methylprednisolone, valacyclovir, eyedrop. The patient had no COVID prior to vaccination. The patient underwent lab tests which included COVID test type post vaccination (nasal swab, rapid test): negative on 12Mar2021 (COVID tested post vaccination). The outcome of the event was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Nasopharyngitis
Clinical narrative: Bell's Palsy; Sharp headaches; cold; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, on an unspecified date at 57 years old (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced sharp headaches and cold then she went to ER, diagnosed with Bell's Palsy on an unspecified date. The events resulted in a Doctor or healthcare professional office/clinic visit and/or Emergency room/department or urgent care. Treatment was received for the events. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Accident, Fall, Pelvic fracture, Rib fracture
Clinical narrative: broken ribs; broken pelvis; bike accident; fell off his bike; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking how to get her husband his second vaccine dose which was due on 17Mar2021 not that he is in the hospital. The reporter then explained that the patient received his first Pfizer Covid vaccine on 24Feb2021 but on the day of the report, 13Mar2021, the patient had a bike accident. The patient fell off his bike and is now admitted to the hospital with broken ribs and a broken pelvis. The outcome of the events was unknown. The case was reported as non-serious.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain
Clinical narrative: Severe headache, too much pain; suffers from migraine normally; Severe headache, too much pain; suffers from migraine normally; Severe headache, too much pain; suffers from migraine normally; This is a spontaneous report from a contactable consumer (patient daughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included migraine (she suffers from migraine normally). The patient's concomitant medications was not reported. Reporter stated, "Me and my daughter had vaccination Sunday (07Mar2021). My daughter is in severe headache, too much pain, migraine on 08Mar2021. We were in a hospital yesterday with IV (treatment) and she got home last night, but she is still having headache. She has been getting it from Monday to this date. We don't know what we can do, she suffers from migraine normally." The outcome of the events headache was not recovered and the outcome of the events migraine and pain was unknown.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Loss of consciousness, Nausea, Pain, Vomiting
Clinical narrative: near loss of consciousness; Sudden, intense nausea; vomiting; soreness across entire body; very sensitive skin; This is a spontaneous report from a contactable consumer. A 22-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 12Mar2021 13:30 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 12Mar2021, roughly 4 hours after receiving shot, the patient experienced sudden, intense nausea, vomiting, near loss of consciousness, soreness across entire body and very sensitive skin. No treatment was received. The outcome of the event was recovering.   Information on lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Asthenia, Chills, Dizziness
Clinical narrative: peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate, Heart rate increased, Joint stiffness
Clinical narrative: peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Neuropathy peripheral, Palpitations
Clinical narrative: peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Suspected COVID-19
Clinical narrative: peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypothermia
Clinical narrative: Hypothermia; I had a horrible headache; This is a spontaneous report from a contactable consumer. A 26-year-old male consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 05:30 PM (at the age of 26-year-old) for COVID-19 immunisation. Relevant medical history included asthma and hypertension. Concomitant medications were not reported. On 12Mar2021, 24 hours after vaccination (also reported at 01:00AM), the patient had a horrible headache and temperature was 94F (hypothermia). The patient was treated with hot water baths. He had no COVID prior vaccination and was not tested post vaccination. The event resolved on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Basedow's disease, Body temperature, Neck pain, Swelling
Clinical narrative: Graves's thyroid; Swelling on my neck, tender when I touch it; Swelling on my neck, tender when I touch it; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6200), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "Well, today before my second vaccine which is due tomorrow of the Pfizer vaccine, I noticed that I have some I could have "Graves's thyroid" (not clarified), swelling on my neck. So, I don't have a temperature. I don't have any other symptoms except that is tender when I touch it but I just wanted to know should I proceed with the second dose." The patient underwent lab test and procedure which included body temperature: unknown result ("So, I don't have a temperature") on an unspecified date. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with Bells Palsy after first dose of vaccine on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: A causal relationship between the event Bells Palsy and suspect product BNT162B2 is possible based on the information provided, drug profile and a temporal association. This case will be reassessed should additional information become 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: I was also tested positive/pneumonia; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. In 2021, a week later, the patient was tested positive and was there in the hospital for 5 days, the patient had pneumonia in the hospital. Still recovering on 15Feb2021 supposedly the date of patient's 2nd shot and cannot get it and cannot go down due to the storm. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, chills, fatigue, body muscle aches, headache - began about 15 hours after vaccine administered   Sore arm about 12 hours after  Redness, swolleness, pain, slight itchiness around injection site
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, fatigue, body muscle aches, headache - began about 15 hours after vaccine administered   Sore arm about 12 hours after  Redness, swolleness, pain, slight itchiness around injection site
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: Red and itchy at the site of the vaccine on my upper arm.  Arm pit sore and swollen.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, Chest pain, Fatigue, Headache
Clinical narrative: Saturday afternoon start to feel fatigue  8:00 pm 102.7 degrees (2 Tylenols)  9:00 pm 103.2 10:00 pm 103.7  11:00pm 2 Tylenols 11:00 102. degrees Frim 8:00 - Monday 7:00 am; pain was immense; legs, arms, abdomen, jaw, neck and a headache to the moon and back. offset every 4 hrs Tylenols' Monday; continue pain on right side, left chest and headache; continue to us Tylenols' every 4 hrs.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Saturday afternoon start to feel fatigue  8:00 pm 102.7 degrees (2 Tylenols)  9:00 pm 103.2 10:00 pm 103.7  11:00pm 2 Tylenols 11:00 102. degrees Frim 8:00 - Monday 7:00 am; pain was immense; legs, arms, abdomen, jaw, neck and a headache to the moon and back. offset every 4 hrs Tylenols' Monday; continue pain on right side, left chest and headache; continue to us Tylenols' every 4 hrs.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site  pain at injection site  Fever  Chills Nausea Trouble sleeping Muscle aches  Fatigue  Headache
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Swelling at injection site  pain at injection site  Fever  Chills Nausea Trouble sleeping Muscle aches  Fatigue  Headache
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Death, Mental status changes, Rhabdomyolysis, Troponin increased
Clinical narrative: ALTERED MENTAL STATUS Bradycardia Elevated troponin Non-traumatic rhabdomyolysis Death
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Retching
Clinical narrative: Two minutes after receiving her vaccination, she experienced lightheadedness, nausea, and dry heaving. She was taken to a private section of the arena monitored.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: 36 hrs ongoing significant myalgia, mild headache
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: death
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: Started with general headache and malaise the evening of the injection, 26Mar2021. Woke-up 27Mar2021 with slight headache and achiness. Went on walk and came back and napped. Woke up around 06:00 pm with increase in headache, achiness, fatigue, chills, and fever. These general symptoms continued through Sunday evening when a rash covering half of my torso became apparent. The rash had progressed by 11:00 pm when  I went to bed. Woke-up 29Mar2021 with rash still present, but diminished.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Started with general headache and malaise the evening of the injection, 26Mar2021. Woke-up 27Mar2021 with slight headache and achiness. Went on walk and came back and napped. Woke up around 06:00 pm with increase in headache, achiness, fatigue, chills, and fever. These general symptoms continued through Sunday evening when a rash covering half of my torso became apparent. The rash had progressed by 11:00 pm when  I went to bed. Woke-up 29Mar2021 with rash still present, but diminished.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 104, body aches, vomiting and nausea, headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Injection site pruritus
Clinical narrative: Pt c/o itching at injection site and feeling of flushing. Pt also had not eaten or had anything to drink for 3.5. After pt ate symtoms subsided and pt left.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Chronic kidney disease, Death, Dyspnoea, Pleural effusion
Clinical narrative: SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscle tightness, Tremor, Vomiting
Clinical narrative: Vomiting, Shaking violently, muscle contractions throughout body, joint pain, headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills - mild, fever-mild, body aches-moderate, fatigue-major Lasted about 20 hours, patient slept nearly entire time
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Lip swelling
Clinical narrative: Swollen and a rash in my lips.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: About 30 - 40 minutes after my 2nd vaccine, while driving home, I got dizzy enough to stop driving. I pulled over and let my spouse drive. Within an hour the dizziness passed and I felt fine after.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: Fever up to 103.9,extreme joint pain,exhaustion,overall malaise,lack of appetite
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Fever up to 103.9,extreme joint pain,exhaustion,overall malaise,lack of appetite