chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, SARS-CoV-2 antibody test
Clinical narrative: now but sometimes early in the morning when he wakes up and until he gets the temperature up in his apartment he experiences chills; temperature is in the high number and he has a little chills right now while speaking; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the male patient of 82-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 01Apr2021 13:00 (Batch/lot number was not reported) (at the age of 82-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Th patient family medical history relevant to events includes none. Concomitant medications included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect includes none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in arm left on 11Mar2021 for covid-19 immunisation and experienced very itchy episode, chills and runny nose. On an unspecified date in Apr2021, patient stated it was not going on now but sometimes early in the morning when he wakes up and until he gets the temperature up in his apartment, he experiences chills. Patient stated if the heat was on, he does not notice chills but if the heat is not on, he does notice it. The temperature was in the high number and he has a little chill right now while speaking. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included Covid-19 antibody test which showed negative (on not exposed to virus) on an unknow date in 2021. Therapeutic measures were taken as a result of event chills included Tylenol. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pruritus, Rhinorrhoea
Clinical narrative: now but sometimes early in the morning when he wakes up and until he gets the temperature up in his apartment he experiences chills; temperature is in the high number and he has a little chills right now while speaking; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the male patient of 82-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 01Apr2021 13:00 (Batch/lot number was not reported) (at the age of 82-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Th patient family medical history relevant to events includes none. Concomitant medications included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect includes none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in arm left on 11Mar2021 for covid-19 immunisation and experienced very itchy episode, chills and runny nose. On an unspecified date in Apr2021, patient stated it was not going on now but sometimes early in the morning when he wakes up and until he gets the temperature up in his apartment, he experiences chills. Patient stated if the heat was on, he does not notice chills but if the heat is not on, he does notice it. The temperature was in the high number and he has a little chill right now while speaking. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included Covid-19 antibody test which showed negative (on not exposed to virus) on an unknow date in 2021. Therapeutic measures were taken as a result of event chills included Tylenol. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injection site nodule, Polymerase chain reaction
Clinical narrative: Patient presents nodular reaction on injection site of the filler but they are not visible but palpable; This is a spontaneous report from a non-contactable other hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included hyaluronic acid (Juvederm VOLIFT) taken for an unspecified indication, start and stop date were not reported. Healthcare professional (HCP) reported side effects received today on a patient case injected with Juvederm VOLIFT. HCP reports patient had Covid-19 a year ago with a positive PCR test. The patient was vaccinated for Covid-19 with the Pfizer vaccine 10 days ago, since then the patient presents nodular reaction on injection site of the filler but they are not visible but palpable. HCP has put patient on Corticosteroids. Volume of filler and injection location not provided. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on an unspecified date. Outcome of the event was unknown. No Follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Feeling cold, Headache
Clinical narrative: rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Loss of consciousness, Pyrexia, Rash
Clinical narrative: rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urinary incontinence
Clinical narrative: rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Swelling
Clinical narrative: This is spontaneous report from a non-contactable healthcare professional (other HCP).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Co-suspect drugs included lidocaine (unknown manufacturer) and hyaluronic acid (JUVEDERM VOLUMA), both on an uspecified date(s), at unknown dose(s), for unknown indication(s), with no problems until four months ago. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had a flare up of rheumatoid arthritis and experienced swelling on an unspecified date. After one week the patient contacted the HCP who saw the patient and prescribed clarithromycin 500 mg twice a day and prednisone. After two weeks the swelling appeared to be going down but slowly. The patient contacted the HCP after Christmas with further swelling and now areas they had had treated by another practitioner around the mouth and tear trough started to swell. One week prior to this, on an unspecified date, the patient received the BNT162B2 vaccination. The patient started to swell again a few days after this. HCP saw the patient and began to use hyaluronidase. HCP did not know what the previous practitioner had used and the patient was reluctant to ask and didn't want to get in touch with the previous practitioner. HCP had seen the patient a few times and used hyaluronidase at three separate appointments. Symptoms resolved on an unknown date. Patient failed to inform the HCP that they had rheumatoid arthritis and since told them as it wasn't bothering them they didn't think it was important. Patient was now waiting to see the consultant regarding this.  Pfizer is a marketing authorization holder of lidocaine in the country of incidence. This may be a duplicate report if another marketing authorization holder of lidocaine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: It is more likely that the event rheumatoid arthritis flare up was related to an acute flare up of the pre-existing condition and not related to BNT162b2 use.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and pain at the injection sites; pain at the injection sites; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included lidocaine hcl (Solution for injection) taken for local anaesthesia, hyaluronic acid taken for an unspecified indication, start and stop date were not reported. The physician reported that the patient started to experience swelling and pain at the injection sites days after patient received their 2nd dose of the COVID 19 Pfizer vaccine. The patient was injected approx. 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederme VOLITE. Treated with Telfast and betacorten steroidal ointment. Symtoms resolved. This record captures events relating to the first injection with Juvederm VOLUMA with Lidocaine. Outcome of the events is recovered on unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on vaccine-event chronological association and known vaccine safety profile causality between event swelling and pain at the vaccination site and BNT162B2 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Measle-like rash covering torso back & front; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on left arm on 25Mar2021 13:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. No other vaccine in four weeks. Vitamin supplements was taken in two weeks. The patient experienced measle-like rash covering torso back & front on 01Apr2021 which resulted to a physician office visit. Unspecified treatment (anti itch pill) was given as treatment. Outcome of the event was recovering. Patient was not diagnosed with covid prior to vaccination and has not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: very dizzy/ terrible dizziness; so bad that it was hard for her to walk; she probably has benign vertigo; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscularly on her left Arm on 03Apr2021 15:30 (Batch/Lot Number: ER8735) (at the age of 63-years-old) as single dose for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, brain surgery for a benign tumor (5 years ago), bipolar (diagnosed 20 years ago). Family medical history was none. Concomitant medications included other medication (unspecified) for 20 years. History of all previous immunization with the Pfizer vaccine considered as suspect included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Saturday, she had the first shot and was fine that day, but the next morning, on 04Apr2021 10:00, the whole room was running around like a merry go round. She was very dizzy. She panicked and closed her eyes and opened and was not better. It has gotten much better now, but she was still dizzy after 1 week. She said that it was so bad that it was hard for her to walk. She went to her doctor and they said it has nothing to do with Pfizer. They said she probably has benign vertigo and gave her some exercises. She examined her and said it was benign vertigo and gave her some exercises on YouTube. Her doctor said if she doesn't get better, call back on Monday and she will prescribe a pill, but she does not want to take any pill, but she mentioned it did not work. She mentioned that her doctor told her to take the 2nd dose, which was scheduled on 24Apr2021. She was asking for Pfizer's thoughts on what to do as she heard that second dose effects might be worst that first dose. Patient also wanted to know if she can delay her second dose for 3 to 4 weeks due to her upcoming project. The outcome of the event dizziness was recovering, and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Pain in extremity
Clinical narrative: asthma attack; Arm hurt; This is a spontaneous report received from contactable pharmacist reporting for 3 patients. This is one of the 3 reports.  A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: Unknown) as single dose for COVID-19 immunisation.  Medical history included severe asthma. Concomitant medications were not reported. The patient experienced asthma attack, arm hurt on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of asthma attack included a high dose of steroids and was off of them in 10 days.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: The association between the event asthma attack, with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid after receiving the vaccine; Tested positive for covid after receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient's husband). A 44-year-old female patient (reporter's wife) received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 18:00 as single dose and second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 14:00, both for covid-19 immunization. The patient had no relevant medical history and family medical history. There were no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any concomitant medications. On 08Apr2021, the patient was tested positive for covid after receiving the vaccine. Reporter stated that his wife tested positive after she received the Covid 19 vaccine. The patient underwent lab test and procedures included covid positive on 08Apr2021. The outcome of event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder
Clinical narrative: continuous intestinal problems; raging diarrhea; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) as single dose on 24Feb2021 for covid 19 immunization. It was reported that the patient received first dose of of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown) as single dose on 03Feb2021. Medical history and concomitant medication were not reported. The patient reported that after first shot on 03Feb2021, the patient developed raging diarrhea and again after the second shot on 24Feb 2021. A Since then, patient developed continuous intestinal problems. Patient did not feel that this should be a normal outcome and would like to know if there have been similar instances with others who received the Pfizer vaccines. The outcome of the event was unknown.  Follow up (08Apr2021): This is a follow up spontaneous report received from a contactable consumer in response to medical inquiry sent which included that: forwarded as an Adverse Event and Medical Inquiry on 9Apr2021 Reporter provided verification of contact address on 8Apr2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Neuropathy peripheral, SARS-CoV-2 test, Trigger finger
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Asthenia, Autonomic nervous system imbalance, Blood test
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram, Diarrhoea, Dizziness, Electromyogram
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate decreased, Hyperacusis, Hypoaesthesia
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging neck, Muscular weakness, Nausea, Neuropathy peripheral
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Paraesthesia, Photophobia, Postural orthostatic tachycardia syndrome
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tendonitis, Tinnitus, Tremor, Trigger finger, Vision blurred
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Peripheral neuropathy; robotic movement when she tried to make a fist; Having popping/lock on my fingers. Similar to trigger finger; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (Lot Number: EN6205), as SINGLE DOSE for COVID-19 immunisation.  Medical history included depression and anxiety. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient received dose 1 on 03Feb2021 in left arm (lot number: EL9269) and experienced popping/lock on fingers, similar to trigger finger/robotic movement when she tried to make a fist. There were no concomitant medications.  After the first shot, patient started having popping/lock on fingers, similar to trigger finger. A robotic movement when she tried to make a fist. It almost went away. The patient took the second shot and it came back. This time she has been having several symptoms: tingling on her hands and feet, numbness on left arm, hands and feet, pain on hands, loss of strength on left arm. The doctors are told the patient that is peripheral neuropathy. The patient underwent nasal swab (COVID-test post vaccination with negative result. The outcome of the events was not recovered. Treatment for the event includes pregabalin and etoricoxib.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, SARS-CoV-2 antibody test
Clinical narrative: Chills; He also received a positive; This is a spontaneous report received from a contactable consumer, for her husband. A 60-year-old male patient received first dose of (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Lot number: not provided, Expiry Date: Not Provided) via an unspecified route of administration on 26Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Report is not related to a study or program. The caller was calling about the Pfizer, clarified the vaccine for COVID. She said she and her husband received their first shot on 26Mar2021 and the next day her husband had the side effect of chills for a couple of days. She said on monday she still did not feel well, he went to work, someone at his work tested positive for COVID and he also received a positive. She reported that his quarantine is up, he is feeling better, and his second shot is on saturday 17Apr2021. She had heard you should wait, and you shouldn't wait. She asked should he get this shot on saturday or should he wait. She said she was at work and had been on hold and did not have time to file a report. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Vaccination site oedema
Clinical narrative: developed "angioedema" at the injection site; developed "angioedema" at the injection site; This is a spontaneous report received from a non-contactable other healthcare professional. A patient of unknown age and gender received BNT162B2 (BNT162B2, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously received JUVEDERM VOLBELLA XC in the lips on an unspecified date. The healthcare professional reported a patient injection with an unknown number of syringes of JUVEDERM VOLBELLA XC in the lips. The patient was injected with the Pfizer COVID vaccine an unspecified amount of time later and developed "angioedema" at the injection site. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event angioedema cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: her mother tested positive for COVID-19 after being vaccinated with the Pfizer COVID-19 vaccine and this happened about a month after her second dose; her mother tested positive for COVID-19 after being vaccinated with the Pfizer COVID-19 vaccine and this happened about a month after her second dose; This is a spontaneous report from a contactable consumer. This consumer (daughter) reported for a female patient (mother). A female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) on 13Apr2021 via an unknown route at single dose on the unspecified anatomical location for COVID-19 immunization. First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) on 23Mar2021. Relevant medical history and concomitant medication were not reported. On an unspecified date, a month after her second dose the patient was tested covid-19 positive after being vaccinated with the Pfizer COVID-19 vaccine. Consumer stated that she filed a report for herself, however, she did not file an official report for her mother. She did confirm that she informed them about her mother's AE. Vaccine is not providing as much protection as thought since my mom got COVID after being fully vaccinated with the Pfizer covid vaccine for a month. If her mother wants to call she can do a report and reporter declined to complete report at this time on her mother. Outcome of the event is unknown.  Information on lot number/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Vaccination site pain
Clinical narrative: testedpositive for Covid-19 2 weeks after she got her 2nd; testedpositive for Covid-19 2 weeks after she got her 2nd; soreness on the area; This is a spontaneous report from a contactable consumer and received via from a Pfizer-sponsored program. A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported) via an unspecified route of administration on 17Feb2021 as single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number was not reported) via an unspecified route of administration on 27Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive on an unspecified date. The patient tested positive for Covid-19 2 weeks after she got her 2nd dose last 17Feb2021 she took 5 aleve for the soreness on the area. Transfer to the fact sheet. Submitted a manual AE form. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; after the 1st dose, her mother tested positive with the Covid-19; This is a spontaneous report from a contactable consumer reported for mother (patient). An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number, expiration date: not reported), via an unspecified route of administration in Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the vaccine in February, around the beginning of the 2nd week. The patient did not remember the exact date but after the 1st dose, the patient tested positive with the Covid-19. but after 14 days of quarantine, her mother(patient) got tested again and came out negative. The outcome of events was recovered on an unspecified date.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Thrombosis, Ultrasound scan
Clinical narrative: blood clot on the left side of neck; This is a spontaneous report from a contactable HCP (patient). The patient was a Respiratory Therapist. A 60-year-old male patient received his secondo dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on 03Apr2021 (at the age of 60-years-old) as single dose for COVID-19 immunisation.  The patient took the first dose of BNT162b2 (lot number EN6199) on an unspecified date for COVID-19 immunisation. Medical history included high cholesterol and hypertension from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for hypertension, start and stop date were not reported; rosuvastatin taken for blood cholesterol increased, start and stop date were not reported.  The patient experienced blood clot on the left side of on an unspecified date in Apr2021. The event was treated with blood thinner. Patient thought it was called Xarelto because they called him on 07Apr2021. He was not sure how to spell that. Treatment was started on 07Apr2021. Consumer stated he first started having symptoms on the night of the injection. On an unspecified date in Apr2021 the patient did the ultrasound and that's when they found blood clot and he just got the results back. Recently, may be 2 weeks before reporting, patient had routine blood work and It was normal. It was nothing abnormal. The outcome of event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Clot blood cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: Her husband got a heart attack a week after the first dose; there are blood clots on his legs; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband got a heart attack a week after the first dose and there are blood clots on his legs on an unspecified date. Outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ecchymosis, Thrombosis
Clinical narrative: Developed like a blood clot, black and blue in the arm; Developed like a blood clot, black and blue in the arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient was calling about the side effects of Pfizer COVID-19 vaccine and was wondering. The patient got the first and second vaccine of Pfizer for COVID-19. After the second dose of vaccine on an unspecified date, the patient developed like a blood clot, black and blue in the arm. The patient wanted to ask if this is a rare side effects or common. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood test, Chest X-ray, Dizziness, Fatigue
Clinical narrative: I waited about 30 minutes.  Felt tingly and a bit light headed but cracked it up to being tired from the shot.  I got in my car and about 5 minutes out driving in the middle of traffic,  I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel.  There is no mistaking the feeling.  I could not feel my pulse at all.    Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful.  I then took benadryl as advised and the EMS were called.  I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening.  I was told to take benadryl for the next 24 hours and I did.