chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hyperhidrosis, Nausea
Clinical narrative: fainted; aches; headache; fever; nauseous; excessively sweating; heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8735/expiration date: not provided), via an unspecified route of administration, on 20Apr2021 at 08:30 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 04Jan2021 at 12:00 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included melatonin, fish oil, calcium.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 02:00, the patient fainted, experienced aches, headache, fever, nauseous, excessively sweating, and heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The patient went to the emergency room due to the events and received treatment for these events which included fluids. The clinical course was as follows: after experiencing expected side effects (aches, headache, fever), the patient got up to use the restroom in the middle of the night. About 1-2 minutes after getting up, he fainted. The patient awoke shortly after on the floor and felt nauseous and was excessively sweating. His heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The outcome of the events was recovering. Since the vaccination, the patient had been tested for COVID-19 (saliva test) on 20Apr2021, and the result was negative.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Syncope
Clinical narrative: fainted; aches; headache; fever; nauseous; excessively sweating; heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8735/expiration date: not provided), via an unspecified route of administration, on 20Apr2021 at 08:30 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 04Jan2021 at 12:00 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included melatonin, fish oil, calcium.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 02:00, the patient fainted, experienced aches, headache, fever, nauseous, excessively sweating, and heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The patient went to the emergency room due to the events and received treatment for these events which included fluids. The clinical course was as follows: after experiencing expected side effects (aches, headache, fever), the patient got up to use the restroom in the middle of the night. About 1-2 minutes after getting up, he fainted. The patient awoke shortly after on the floor and felt nauseous and was excessively sweating. His heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The outcome of the events was recovering. Since the vaccination, the patient had been tested for COVID-19 (saliva test) on 20Apr2021, and the result was negative.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 21Apr2021; Tested positive for COVID-19 21Apr2021; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation.  Medical history included prior cancer (nonspecific) from an unknown date and unknown if ongoing. Patient was not pregnant. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 at 03:00PM on 24Feb2021, Lot EL3247 for covid-19 immunization.  Concomitant medication(s) included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for an unspecified indication, start and stop date were not reported.  The patient received Dose 2 on 17Mar2021 then had fever 16Apr that resolved in 2 days. Three days later she experienced loss of smell. Patient was tested positive for COVID-19 21Apr2021. Outcome for events vaccination failurewas unknown , 21apr2021. Outcome for tested positive for covid-19, fever , loss of smell was recovering.  The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 21Apr2021.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscle spasms
Clinical narrative: Back cramps could not lift arms past neck; Back cramps could not lift arms past neck; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; This is a spontaneous report from a contactable consumer (Patient) .  A 51-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:00 (Batch/Lot Number: Er8734) as SINGLE DOSE for covid-19 immunisation  .  Medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, Lot number En6205, Administration date on 25Mar2021 at 10:30 AM on left arm for covid-19 immunisation. Patient did not have COVID-19 prior to vaccination. There were no concomitant medications.  The patient experienced back cramps that patient could not lift arms past neck, complete numbness in both arms and hands on 15Apr2021 20:00 with outcome of recovering , complete numbness in both arms and hands(hypoaesthesia) (disability) on 15Apr2021 20:00 with outcome of recovering. The patient added that a week later finger tips in right hand were still numb (outcome recovering). The events resulted in doctor's office/clinic visit with seriousness of disability or permanent damage. The patient was not tested positive post vaccination.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Mobility decreased, Muscle spasms
Clinical narrative: Back cramps could not lift arms past neck; Back cramps could not lift arms past neck; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; This is a spontaneous report from a contactable consumer (Patient) .  A 51-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:00 (Batch/Lot Number: Er8734) as SINGLE DOSE for covid-19 immunisation  .  Medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, Lot number En6205, Administration date on 25Mar2021 at 10:30 AM on left arm for covid-19 immunisation. Patient did not have COVID-19 prior to vaccination. There were no concomitant medications.  The patient experienced back cramps that patient could not lift arms past neck, complete numbness in both arms and hands on 15Apr2021 20:00 with outcome of recovering , complete numbness in both arms and hands(hypoaesthesia) (disability) on 15Apr2021 20:00 with outcome of recovering. The patient added that a week later finger tips in right hand were still numb (outcome recovering). The events resulted in doctor's office/clinic visit with seriousness of disability or permanent damage. The patient was not tested positive post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I received the first dose and have tested positive for Covid; I received the first dose and have tested positive for Covid; chills; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:  unknown), single dose, dose 1 via an unspecified route of administration in 2021 for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose and tested positive for covid and had chills in 2021.  The patient was scheduled to be tested again on 28Apr2021 and to get the second dose of the vaccine on 30Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of tested positive for covid and chills was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Hearing loss and tinnitus in ears - primarily right ear; Hearing loss and tinnitus in ears - primarily right ear; This is a spontaneous report from a contactable consumer (patient). This 50- year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EP7533), via an unspecified route of administration, on 7Apr2021 at 11:00 am (at the age of 50-years-old) as a single dose for COVID-19 vaccination, in left arm, at a Pharmacy or Drug Store. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP6955, expiration date: unknown) via unspecified route of administration in on 17Mar2021 at 12:00 pm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. Medical history included: Rheumatoid arthritis, hypothyroidism. Concomitant medications included: Thyroid medication. The patient reported hearing loss and tinnitus in ears - primarily right ear on 09Apr2021. No treatment was received. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplegia, Gait disturbance, Lumbar puncture, Pain
Clinical narrative: paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient).   A 27-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose  in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital.  She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking  on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced  horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test abnormal, C-reactive protein increased, Dysstasia, Electromyogram
Clinical narrative: paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient).   A 27-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose  in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital.  She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking  on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced  horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibromyalgia, Gait inability, Impaired work ability, Lip swelling, Lumbar puncture
Clinical narrative: paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient).   A 27-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose  in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital.  She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking  on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced  horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Malaise, Muscle spasms, Muscular weakness, Pain
Clinical narrative: paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient).   A 27-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose  in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital.  She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking  on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced  horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient).   A 27-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose  in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital.  She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking  on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced  horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted covid and has not had the 2nd dose of the vaccine yet; 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted covid; This is a spontaneous report from a contactable consumer (a pharmacy intern). This consumer reported on behalf of a 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 30Jan2021 as single dose for COVID-19 immunization. Medical history included chronic kidney disease (CKD) requiring weekly dialysis. The patient's concomitant medications were not reported. The patient was not enrolled in the clinical trial. The consumer reported that the patient received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted COVID and has not had the 2nd dose of the vaccine yet. The consumer also stated the patient has had several COVID tests recently that were negative. The patient was tested negative on COVID tests on unspecified dates. The consumer was calling to find out if the 2nd dose is ok to give now or if the patient can go without the 2nd dose or if they need to restart the series. The clinical outcome of the patient "received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted COVID and has not had the 2nd dose of the vaccine yet" was not reported at the time of reporting on 21Apr2021.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Chills, Computerised tomogram, Condition aggravated
Clinical narrative: vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pancreatitis acute, Vomiting
Clinical narrative: vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Facial pain, Headache
Clinical narrative: Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia, Joint noise, Laboratory test
Clinical narrative: Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle fatigue, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Paralysis, SARS-CoV-2 test, Tremor
Clinical narrative: Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Haemoptysis
Clinical narrative: Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself.  A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Lung disorder, Malaise, Night sweats, Pyrexia
Clinical narrative: Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself.  A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.