chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Influenza like illness, Investigation, Nasal congestion
Clinical narrative: being kind of stuffed up; flu-like symptoms; severe allergic reaction/allergic reaction; This is a spontaneous report from a contactable consumer (patient) reported that a 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150), via an unspecified route of administration, administered in arm left on 10Apr2021 12:30 (at the age of 22-years-old) as a single dose for covid-19 immunisation. The patient medical history included was reported as none. Concomitant medication included ethinylestradiol, levonorgestrel (LUTERA) taken for birth control from Jan2018 and ongoing. No prior vaccination within four weeks. This consumer is the patient who reported severe adverse reaction/allergic reaction to the first dose of Pfizer-BioNTech Covid-19 Vaccine she was administered. She called to ask if there are any recommendations of whether it is or is not advised to get the second dose of the Pfizer-BioNTech Covid-19 Vaccine after having severe adverse reaction/allergic reaction. On 11Apr2021 approximately 24 hours after the first dose of Pfizer-BioNTech Covid-19 Vaccine was administered-which would have been about 12:30. Severe adverse reaction/allergic reaction was further described to include swollen face, hands were like tingling, then shortness of breath, and lightheadedness. Then on top of that a lot the normal vaccine side effects like being kind of stuffed up, flu-like symptoms as well. She reported she was just in the emergency room where she was hospitalized related to severe adverse reaction/allergic reaction. She clarified that she was actually admitted to the hospital today (14Apr2021), and was also discharged from the hospital today (14Apr2021). She reported that the events as improved, but she has also taken some medicine for it. She does not plan to get the second dose, she did not want to and the doctor at the Emergency Room said not to get the second dose, but advised her to contact Pfizer regarding recommendations for that, so unknown at this time. She will be going out of the country for her honeymoon in Nov2021. Regarding testing/investigations she reported that they did all the testing in the emergency room and nothing came back abnormal, everything came back fine so no relevant results to provide for report. The events did require to visit an emergency room. The outcome of the events was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Choking, Cough, Insomnia, Productive cough
Clinical narrative: He is not sleeping because he is constantly chocking and coughing every second.; having excess mucous/ He has fits where he is trying to cough up mucous/ having a mucous coughing spell/He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EM6208), via an unspecified route of administration, administered in Arm Right on 15Mar2021 11:00 (received at 59-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history and concomitant medications were not reported.  The patient just got his second Pfizer shot Monday 12Apr2021 10:45 am (lot number: EW0162) administered in Arm Right, and he got his first one on 15Mar2021. He wants to report what he thinks is a side effect. He does not know if it is related or not, but at the end of Mar2021/ beginning of Apr2021, he started having excess mucous. He has fits where he is trying to cough up mucous for 45 minutes. Ever since it started there has been a lot of mucous. He has been taking Benadryl and stuff like that. He headed to urgent care on 11Apr2021 but decided to go to the ER (emergency room) instead because he was having a mucous coughing spell. They checked for pneumonia, but it was negative. The chests x-ray was clear with no pneumonia. They are saying it is allergies, but he has never had a reaction like this with mucous.  He has been wearing his mask too. He knows the allergy season is supposed to be bad, but they said on the news the masks were actually helping with the allergies. That people were having less symptoms. They were contributing it to allergies, but he has never had them this way before. He wants to report because he is thinking maybe it was something from having the vaccine. He thinks the mucous first started the end of Mar2021 or the first day of Apr2021. He went to ER on 11Apr2021. He also went back and forth with the doctor. They gave him allergy medicine. The ER gave him codeine cough syrup and Allegra D. His GP has him on Sudafed now, Flonase, Allegra, and Benadryl. He has fits at night nothing seems to change. He is not sleeping because he is constantly choking and coughing every second. Last night, 13Apr2021, he finally fell asleep at 3 am and woke up at 9am. They do not want to give him prednisone yet. He would have to wait 2 weeks after his last shot for it. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dementia, Headache, Tremor
Clinical narrative: dementia; Shaking; chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number: unknown) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient was having a reaction to the COVID shot. She had chills most of the day on 14Apr2021 (today as reported) and they just now subsiding. They were so bad she couldn't hold still she was on the phone for three hours waiting to speak to someone and she had chills for several hours. Upon follow-up received on 14Apr2021, the patient reported that she has dementia on an unspecified date. She was calling about the COVID shot that she got yesterday at (Vaccine facility name). She was having chills and shaking (on an unspecified date). Yesterday on 13Apr2021, she had a headache and she didn't think about attaching it to the shot. The patient was asking what does she do about it, should she go to the ER or what should she do? The outcome of the events was unknown. The event dementia was considered as serious (medically significant).  No follow-up attempts are needed. information about lot/batch number cannot be obtained.  Follow-up (14Apr2021): New information reported from a contactable consumer (patient) includes: new events (dementia, shaking, headache). Seriousness assessment was also upgraded as serious (medically significant).  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Eye pain, Eye swelling, Immunodeficiency
Clinical narrative: he has Hashimoto's Disease and is immunocompromised; he has Hashimoto's Disease and is immunocompromised; Approximately 12 hours after receiving the first dose he began to have pain in his right eye only.; swelling of the soft tissue behind the eye and believes it is from the vaccine; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. Approximately 12 hours after receiving the first dose, the patient began to have pain in his right eye only.  He stated that he couldn't touch it, it felt like "my eye ball was going to explode out of my eye socket."  The pain continued for the next two days and is still there a bit now.  He saw his eye doctor last week and she saw swelling of the soft tissue behind the eye and believes it is from the vaccine. Also, on an unspecified date, the patient experienced Hashimoto's disease and is immunocompromised. The outcome of the events eye pain was not recovered. The outcome of other events was unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test, Seizure
Clinical narrative: Spasms in left arm; Went to ER bc I thought it was a seizure; This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65 years, via an unspecified route of administration, administered in Arm Left on 20Jan2021 (Batch/Lot Number: EL3247) as a single dose for covid-19 immunization. Medical history included cancer from an unknown date and unknown if ongoing. Concomitant medications included levetiracetam (KEPPRA); mesalamine; prednisone; and folic acid, all taken for an unspecified indication, start and stop date were not reported. In Jan2021, the patient experienced spasms in left arm  and went to ER because she thought it was a seizure.  The patient was hospitalized due to the events for 2 days.  The patient underwent lab tests and procedures which included negative test for Covid-19 on 26Mar2021. The outcome of the events was recovered with sequelae
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Cataract, Chills, Feeling abnormal
Clinical narrative: She is forming a cataract; low grade fever; headaches; body aches; chills; felt miserable; anxiety; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program support. A female patient of an unspecified age (Age: 69; Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 03Apr2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 12Mar2021 for COVID-19 immunization and felt a little tired. The patient was scheduled to get an eye examination and her optometrist will be putting some solution to both of her eyes next Tuesday. She wanted to know if she should wait longer because she doesn't want to mess up the vaccine's efficacy. The patient stated that she will be dilated at the optometrist. She was forming a cataract and she did not know if the vaccine would cause the eye exam to be misleading. The patient stated that she read an article that said if you were having a mammogram that you needed to wait two weeks or four weeks. The patient stated she had a low grade fever, headaches, body aches and chills after the second dose of the vaccine. She stated she took Tylenol on the way home after the second dose. She stated that during the nighttime her temperature was creeping up to 100.9. She stated she felt miserable. She stated she took two pills two different times of 500mg each. She stated she took another pill four hours after the first pill because she was miserable and then the temperature started dropping. She stated the symptoms went away after three days. The patient stated that the anxiety was intense for the second dose due to the possible side effects. The patient underwent lab tests and procedures which included body temperature: 100.9 on an unspecified date. Therapeutic measures were taken as a result of low grade fever and felt miserable. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: She is forming a cataract; low grade fever; headaches; body aches; chills; felt miserable; anxiety; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program support. A female patient of an unspecified age (Age: 69; Unit: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 03Apr2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 12Mar2021 for COVID-19 immunization and felt a little tired. The patient was scheduled to get an eye examination and her optometrist will be putting some solution to both of her eyes next Tuesday. She wanted to know if she should wait longer because she doesn't want to mess up the vaccine's efficacy. The patient stated that she will be dilated at the optometrist. She was forming a cataract and she did not know if the vaccine would cause the eye exam to be misleading. The patient stated that she read an article that said if you were having a mammogram that you needed to wait two weeks or four weeks. The patient stated she had a low grade fever, headaches, body aches and chills after the second dose of the vaccine. She stated she took Tylenol on the way home after the second dose. She stated that during the nighttime her temperature was creeping up to 100.9. She stated she felt miserable. She stated she took two pills two different times of 500mg each. She stated she took another pill four hours after the first pill because she was miserable and then the temperature started dropping. She stated the symptoms went away after three days. The patient stated that the anxiety was intense for the second dose due to the possible side effects. The patient underwent lab tests and procedures which included body temperature: 100.9 on an unspecified date. Therapeutic measures were taken as a result of low grade fever and felt miserable. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: had 5 small seizures; felt very dizzy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 09:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included pre-diabetes and depression. Patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. The patient previously took antibiotics and antidepressants and experienced allergies. 5 minutes after getting the vaccine, patient felt very dizzy. She had 5 small seizures on 14Apr2021 10:45 which resulted in emergency room/ urgent care. Treatment was received for the events. Outcome was recovering. Patient had covid prior to vaccination on an unspecified date and had not been tested post vaccination.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Portal vein thrombosis
Clinical narrative: Portal Vein Thrombosis; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206 and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 18Mar2021 17:00 at single dose for covid-19 immunisation. The patient's medical history included obesity. There were no concomitant medications. About four days after vaccine on 22Mar2021, the patient stared having abdominal pain.  On 31Mar2021, the pain caused the patient to go to the ER and physician office visit, where the patient was diagnosed with a portal vein thrombosis. The patient was then hospitalized for 2 days. The patient was treated with Eliquis.  The outcome of the events was recovering.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Influenza, Influenza like illness, Malaise
Clinical narrative: flu; flu like symptoms; fever; vomiting; diarrhea; malaise; dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Mar2021 at 10:00 am (at the age of 76 years old) (Lot Number: El9266, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included prostate cancer. No known allergies. Concomitant medications included levetiracetam (KEPPRA); ascorbic acid (VIT C); acetylsalicylic acid (BABY ASPIRIN); calcium, colecalciferol (CALCIUM +D3). The patient also received first dose of BNT162B2 on 11Feb2021 at 14:00 (at the age of 76 years old; lot number: El3246, unknown expiration) in left arm for COVID-19 immunization. On 05Mar2021, after 2nd shot, the patient just feeling flu like symptoms. He was hospitalized on 26Mar2021 in an emergency situation with fever, vomiting, diarrhea (which started on 04Mar2021). The patient was released from hospital on 29Mar2021 with diagnosis of flu (unspecified date). The patient still experiencing malaise (unspecified date) and dizziness on 14Apr2021.  The patient received antibiotics and diarrhea medication.  The events flu like symptoms, fever, vomiting, diarrhea, and flu resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and had nasal and throat swab on 18Mar2021 with negative result. The patient had not yet recovered from flu like symptoms and malaise, while unknown outcome for the remaining events. The events flu like symptoms, fever, vomiting, diarrhea, and flu were assessed as serious (hospitalization).   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: flu; flu like symptoms; fever; vomiting; diarrhea; malaise; dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Mar2021 at 10:00 am (at the age of 76 years old) (Lot Number: El9266, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included prostate cancer. No known allergies. Concomitant medications included levetiracetam (KEPPRA); ascorbic acid (VIT C); acetylsalicylic acid (BABY ASPIRIN); calcium, colecalciferol (CALCIUM +D3). The patient also received first dose of BNT162B2 on 11Feb2021 at 14:00 (at the age of 76 years old; lot number: El3246, unknown expiration) in left arm for COVID-19 immunization. On 05Mar2021, after 2nd shot, the patient just feeling flu like symptoms. He was hospitalized on 26Mar2021 in an emergency situation with fever, vomiting, diarrhea (which started on 04Mar2021). The patient was released from hospital on 29Mar2021 with diagnosis of flu (unspecified date). The patient still experiencing malaise (unspecified date) and dizziness on 14Apr2021.  The patient received antibiotics and diarrhea medication.  The events flu like symptoms, fever, vomiting, diarrhea, and flu resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and had nasal and throat swab on 18Mar2021 with negative result. The patient had not yet recovered from flu like symptoms and malaise, while unknown outcome for the remaining events. The events flu like symptoms, fever, vomiting, diarrhea, and flu were assessed as serious (hospitalization).   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Thyroid cancer
Clinical narrative: thyroid cancer; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 22Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNTech COVID 19 vaccine on 22Mar2021 and she also had a biopsy done the same day. She has subsequently found out she has thyroid cancer and is currently at a cancer clinic to have surgery.  Her doctors have recommended waiting 2 weeks after surgery to receive the vaccine. She was supposed to receive second dose on 19Apr2021 but will be unable to make this appointment. She called her Pharmacy and they said they are unable to reschedule her appointment. She then called the pharmacy and they told her she was unable to reschedule her vaccine she had to go to another pharmacy. She asked how long can she wait to receive the second dose of the vaccine and how she can schedule the second dose. She was very upset Pfizer could not directly give her a vaccine or schedule a vaccine for her due to her extenuating circumstance. She said she had been on hold a very long time and is upset that Pfizer can't do anything. The government doesn't care about her and neither does Pfizer. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bursitis, Carpal tunnel syndrome, Cervical radiculopathy, Menstrual disorder, Muscle spasms
Clinical narrative: Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose.   Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when 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.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Ovarian cyst, SARS-CoV-2 test
Clinical narrative: Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose.   Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when 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.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Carpal tunnel syndrome, Chills, Condition aggravated, Fatigue
Clinical narrative: Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose.   Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when 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.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Myalgia, Psoriasis, Vaccination site pain
Clinical narrative: Cervical radiculopathy; muscle spasms; neurological pain down right arm; bursitis right elbow; menstrual changes - ovarian cyst; menstrual changes - ovarian cyst; carpal tunnel; This is a spontaneous report from a contactable nurse (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 28Dec2020 10:00 (lot number and expiration date were not reported) as single dose (at the age of 40-years-old) for COVID-19 immunisation. The patient was vaccinated in a hospital. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient had no other vaccines in four weeks. The patient did not have COVID prior to vaccination. On 01Jan2021 at 6 pm, the patient experienced cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes - ovarian cyst and carpal tunnel. The adverse events resulted in a doctor/healthcare professional clinic visit and was considered a disability/permanent damage. The patient received treatment of "PT, Mobic, soma, ultram and trigger point injection. The patient has not recovered from the events. The patient had a negative nasal swab test on 16Jan2021. The patient received the second dose administered in the left arm on 19Jan2021 (lot number and expiration date were not reported) at a single dose.   Information about the lot/batch number has been requested.; Sender's Comments: The events cervical radiculopathy, muscle spasms, neurological pain down right arm, bursitis right elbow, menstrual changes, ovarian cyst and carpal tunnel most likely represent intercurrent medical conditions that are assessed as unrelated to BNT162B2. The case will be reassessed when 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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chills, Dizziness, Headache
Clinical narrative: fell out completely; passed out/fell off at the store; feeling dizzy; had terrible headache; chills; weak with shilling; i started sweating; I'm still feeling very sick; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158; Expiration Date: Jul2021), via an unspecified route of administration, administered in left arm on 14Apr2021 12:00 as single dose for COVID-19 immunisation. Medical history included eye allergy. Concomitant medication included amoxicillin sodium, clavulanate potassium (AMOXICILINA CLAV) taken for eye allergy from 12Apr2021. On 14Apr2021, he received the first dose of the vaccine about an hour ago and waited five minutes and went to the bathroom. He had a severe reaction while patient was in the bathroom, he started to feel dizzy, had a terrible headache and chills. He walked out of the bathroom at the store and fell out completely in front of the pharmacists. The patient also experienced weak with shilling (as reported) and started sweating. The pharmacists called 911 and the responders checked his vitals and blood pressure and all of that and everything was fine. Patient clarified he passed out completely for almost 5 minutes. Patient stayed there with everyone until, they were waiting to see how he was doing. He reported he was feeling much better now, still feel a bit dizzy, not 100% but not as bad as when it happened. It has improved and he definitely felt terrible at the time. He was monitoring himself at home to see if he notices something weird going on. He does not have a headache right now and was feeling much better. When he was having the effect, he was mentally sharp, and knew what was going on. He thought about letting himself walk outside the bathroom so he could be seen. He didn't lose track of what was going on and body reacted adversely. He remembered stuff and everything and he felt good. Patient stated the chills went away; however, would not say they went away completely, he was recovering. The events did not require a visit to emergency room or physician office and the paramedic said it was not necessary right now because all the vitals and everything else seemed fine. There was no therapy received for the events. There were no additional vaccines administered on same date of the vaccine and no other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events feeling dizzy, terrible headache, chills was recovering; still feeling very sick was unknown; outcome of the rest of events was not recovered.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Malaise, Vital signs measurement
Clinical narrative: fell out completely; passed out/fell off at the store; feeling dizzy; had terrible headache; chills; weak with shilling; i started sweating; I'm still feeling very sick; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158; Expiration Date: Jul2021), via an unspecified route of administration, administered in left arm on 14Apr2021 12:00 as single dose for COVID-19 immunisation. Medical history included eye allergy. Concomitant medication included amoxicillin sodium, clavulanate potassium (AMOXICILINA CLAV) taken for eye allergy from 12Apr2021. On 14Apr2021, he received the first dose of the vaccine about an hour ago and waited five minutes and went to the bathroom. He had a severe reaction while patient was in the bathroom, he started to feel dizzy, had a terrible headache and chills. He walked out of the bathroom at the store and fell out completely in front of the pharmacists. The patient also experienced weak with shilling (as reported) and started sweating. The pharmacists called 911 and the responders checked his vitals and blood pressure and all of that and everything was fine. Patient clarified he passed out completely for almost 5 minutes. Patient stayed there with everyone until, they were waiting to see how he was doing. He reported he was feeling much better now, still feel a bit dizzy, not 100% but not as bad as when it happened. It has improved and he definitely felt terrible at the time. He was monitoring himself at home to see if he notices something weird going on. He does not have a headache right now and was feeling much better. When he was having the effect, he was mentally sharp, and knew what was going on. He thought about letting himself walk outside the bathroom so he could be seen. He didn't lose track of what was going on and body reacted adversely. He remembered stuff and everything and he felt good. Patient stated the chills went away; however, would not say they went away completely, he was recovering. The events did not require a visit to emergency room or physician office and the paramedic said it was not necessary right now because all the vitals and everything else seemed fine. There was no therapy received for the events. There were no additional vaccines administered on same date of the vaccine and no other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events feeling dizzy, terrible headache, chills was recovering; still feeling very sick was unknown; outcome of the rest of events was not recovered.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Subdural haematoma
Clinical narrative: had a subdural hematoma to his head; stated that he was on floor; This is a spontaneous report from a contactable consumer (patient's son). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9269), via an unspecified route of administration, administered through his left arm on 09Feb2021 13:00 (also reported as 09Apr2021) at the age of 86-years-old as single dose for COVID-19 immunization at a hospital. There were no additional vaccines administered on the same date of BNT162B2. The patient had no medical history and no family medical history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) through the arm on 19Jan2021 at the age of 86-years-old for COVID-19 immunization and did not experience adverse events. The patient's son reported that the patient got the second vaccine on 09Feb2021. He reported that the patient was healthy. On Friday night (12Feb2021 at 24:00, as reported) at midnight, his mom heard a thump and stated that he was on the floor. The reporter stated that he had a subdural hematoma to his head on 12Feb2021 at 24:00, as reported (also reported as 12Apr2021). The reporter stated that the patient thinks that since he had the vaccine and no other health issues that they needed to call and make Pfizer aware. The patient was hospitalized due to a subdural hematoma to his head from 13Feb2021 to 12Mar2021. The patient had to have craniotomy on 21Feb2021 at 13:00. The events required a visit to emergency room. It was reported that there were relevant tests and no investigation assessment. The outcome of the event "stated that he was on floor" was recovered on 12Feb2021. The outcome of the event subdural hematoma to his head was recovering.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Joint stiffness, Syncope, Tremor, Vision blurred
Clinical narrative: severe blurred vision; shortness of breath; shaking; stiffness in his jaws; patient who fainted; This is a spontaneous report from a contactable pharmacist. A 22-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (received at the age of 22-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history SVT (supraventricular tachycardia) (diagnosed with SVT by his cardiologist, however it was never confirmed), palpitation, and had fainted in two different situations in the past. Concomitant medications were not reported. The patient fainted after the first dose of COVID-19 vaccine as soon as he stood up. He was unconscious for about 5 seconds. He was experiencing severe blurred vision, shortness of breath, shaking and stiffness in his jaws. He was 22 years old, 170 pounds, and 6 feet tall. He has history of palpitation. In the past he was diagnosed with SVT by his cardiologist, however it was never confirmed. In addition, he had fainted in two different situations in the past. Based on what the patient says, his health issues and why he faints was never fully understood by medical doctors. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on event syncope cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: Renal failure; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of unspecified age and gender received bnt162b2, 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's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced renal failure on 18Mar2021 with outcome of unknown. The patient was hospitalized for renal failure from 18Mar2021 to an unknown date.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: diagnoses of Bells palsy; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left, at the age of 50-year-old, on 13Apr2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included mitral valve repair in 2017 (4 years ago). Concomitant medications were not reported. The patient was not diagnosed with COVID and did not receive any other vaccine four weeks prior. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left, at the age of 50-year-old, on 23Mar2021 09:45 AM, as SINGLE DOSE for covid-19 immunisation. On 13Apr2021, the patient was brought to the ER and there the patient was diagnosed with Bells Palsy. The event resulted in physician office visit and caused disability/ permanent damage. Therapeutic measures taken in response to the event included administration of doxycycline and prednisone. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Outcome of the event was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering the known safety profile of COVID19 vaccine, BNT162B2, the Company cannot completely exclude the possible causality between the reported Bells Palsy and the administration of the suspect.   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 RA, IEC, as appropriate.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Investigation
Clinical narrative: Blood pressure high; This is a spontaneous report from a contactable consumer reported for herself.  A 85-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Apr2021 12:00, at the age of 85 years, (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation. The patient had received the first dose of the vaccine on 18Mar2021 from lot EN6207, at the left shoulder. Medical history included hypertension from an unknown date and unknown if ongoing, diagnosed about 20 years ago. Concomitant medications included amlodipine besilate (NORVASC) taken for hypertension, start and stop date were not reported; hydrochlorothiazide, losartan potassium (HYZAAR) taken for hypertension, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported.  The patient experienced blood pressure high on 08Apr2021 with outcome of recovering. Prior to receiving the vaccine on 08Apr2021, the caller's blood pressure was slightly high when she went in that day because she was sent to a guy who was taking the blood pressure. The caller's blood pressure was 148 before receiving the vaccine. The caller was told to take her medication in the morning instead of the evening the day starting on 08Apr2021. At first the caller thought that her blood pressure was high the night of 08Apr2021 because she was told to change the timing of her blood pressure medication from the evening to the morning. The caller has had constant high blood pressure after the vaccine and she has never had it that high before. Monday morning, 12Apr2021, her blood pressure was in the 200s and was sent to urgent care, she was told to keep doing what she's doing. This morning the caller's blood pressure was 195.  The caller increased the dose of norvasc from one tablet to two tablets, on 12Apr2021 because her blood pressure was still high.  The patient underwent lab tests and procedures which included blood pressure measurement: slightly high   on 08Apr2021, prior to receiving the vaccine , blood pressure measurement: 148 on 08Apr2021 before receiving the vaccine, blood pressure measurement: 225 or 230-something on 08Apr2021 on the night, blood pressure measurement: 200 on 12Apr2021 her blood pressure was in the 200s and was sent to urgent care, blood pressure measurement: 195 on 12Apr2021, unspecified investigation: done before she had the first dose but she does not have it with her.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Menstruation irregular, Pain, Temperature regulation disorder
Clinical narrative: I was supposed to start my period around March 25, 2021 and I did not get it. I have since gotten my second vaccine, and it has been 5 weeks since my first. I am on my 73rd day of my cycle, and still no period. I have been experiencing fatigue, lots of discomfort around my ability to regulate my temperature, and general discomfort and aches.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Fine itchy trash on back,  arms, trunk,  face.  No difficulty breathing or swelling of tongue or throat.  Treated with typical OTC anti itch spray, and benadryl and zyrtec
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Electrocardiogram, Intensive care, Magnetic resonance imaging heart
Clinical narrative: Chest pains began one day after the vaccine and continued to worsen. The morning of the third day after the vaccine, chest pain became so strong that I went to the emergency room. I spent 3 days and 2 nights in the ICU.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased, X-ray
Clinical narrative: Chest pains began one day after the vaccine and continued to worsen. The morning of the third day after the vaccine, chest pain became so strong that I went to the emergency room. I spent 3 days and 2 nights in the ICU.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in left arm all the way down to fingers
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Frequent facial twitching and on less frequently on the arm
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles