chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Vaccination site haemorrhage
Clinical narrative: The daughter heard a pop; a lot of bleeding after the needle came out; now 2 hours later her arm is numb; The daughter heard a pop; a lot of bleeding after the needle came out; now 2 hours later her arm is numb; Her left arm is warm and numb; This is a spontaneous report from the contactable consumers (including patient's mother) from a Pfizer-sponsored program. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included metoprolol. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021 for covid-19 immunisation. The patient received the second dose of the Pfizer COVID-19 vaccine today (04May2021). She received the vaccine in her upper left arm, when they put the needle, she heard a pop. A lot of blood was floating down her arm when they took out the needle. Her left arm is warm and numb. The reporter wanted to know if this will get better and if the vaccine would be effective. It was reported that the nurse had put the shot in left arm and the patient heard a pop and a lot of bleeding after the needle came out and now 2 hours later, her arm is numb. When they pulled the needle in, she heard a pop and when they pulled the needle out, that's when the blood came out and it ran down her arm and now her arm is numb. It's warm to touch but she's feeling that it's numb. They are not sure if she put the shot into the blood vessel or if she went through the blood vessel and they are not sure if it will be affective and if this numbness will dissipate and go away. The patient gets a checkup every year and everything was fine. The outcome of the event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Her doctor told her it was a rheumatoid arthritis flare up; This is a spontaneous report from a contactable nurse reporting for herself.    A 52-years-old female patient received bnt162b2 (BNT162B2) dose 2, intramuscular, administered in Arm Left on 18Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 30Jun2021) as single dose,  for covid-19 immunisation (Age at vaccination 52 years).  Medical history included rheumatoid arthritis , coagulopathy. On 25Feb2021 the patient received the first dose of BNT162B2.  Concomitant medications included adalimumab (HUMIRA) taken for rheumatoid arthritis from Jan2021 to an unspecified stop date.  The patient experienced  a rheumatoid arthritis flare up  on an unspecified date with outcome of unknown.  The vent was treated with steroids.  Course of the event.  After the first dose of the covid vaccine, she had no problems. She started having symptoms after the second dose of the covid vaccine.   Symptoms began about a week after receiving the second dose of the covid vaccine. She also had joint stiffness. Her rheumatoid arthritis was well controlled before taking the covid vaccine. The way  she is feeling now, she has never felt before. She can hardly work every day. Her doctor put her on Prednisone to ease up the pain and swelling. Her rheumatoid arthritis flare up is about the same. She thinks that it might be worse, because it goes from different joints to different joints. One day it might be her left and shoulder, and then the next day be her right hand and leg. Her doctor told her it was a rheumatoid arthritis flare up.  She is on Humira. After the second dose of the covid vaccine, she was supposed to take Humira. She did not take her Humira because of the symptoms she was experiencing from the covid vaccine.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event rheumatoid arthritis flare up cannot be excluded. The event being part of the natural course of pre-existing RA cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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. ,Linked Report(s) : US-PFIZER INC-2021499905 same patient/drug, different vaccine dose/AE
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flare up; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had a rheumatoid arthritis flare up on an unspecified date. The outcome of rheumatoid arthritis flare up was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of rheumatoid arthritis flare up.  The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; sweating; burning/tingling in my entire arm,; fatigue; aches; burning/tingling in my entire arm,; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW 0175) (at the age of 51 years old) as 1st dose, single for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing, and COVID in Mar2020 (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The patient's concomitant medications were not reported. It was reported that patient had COVID in Mar2020. She tested positive for antibodies in Apr2020. Upon receiving the first dose this past week, she ended up reacting just like she had COVID all over again. Within 4 hours she had chills, nausea, headache, fever, sweating, burning/tingling in my entire arm, aches, fatigue, etc, then she developed a swollen lymph node in the left armpit the size of a grapefruit. Acute symptoms persisted for 5 days (she was in bed the whole time) and she still have the swollen lymph node. She expected some symptoms for the second shot, but not the first. She was now very concerned about getting the second dose, especially since she read studies showing she could have as much protection after one shot since she had COVID as people who didn't have COVID. Additionally, she was a smaller woman and feel like maybe the dosage was too high. She was very healthy with no comorbidities except she had COVID previously (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination. PCR (Nasal swab) was done on 03May2021 with negative result. The outcome of events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Paraesthesia, Polymerase chain reaction
Clinical narrative: swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; sweating; burning/tingling in my entire arm,; fatigue; aches; burning/tingling in my entire arm,; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW 0175) (at the age of 51 years old) as 1st dose, single for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing, and COVID in Mar2020 (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The patient's concomitant medications were not reported. It was reported that patient had COVID in Mar2020. She tested positive for antibodies in Apr2020. Upon receiving the first dose this past week, she ended up reacting just like she had COVID all over again. Within 4 hours she had chills, nausea, headache, fever, sweating, burning/tingling in my entire arm, aches, fatigue, etc, then she developed a swollen lymph node in the left armpit the size of a grapefruit. Acute symptoms persisted for 5 days (she was in bed the whole time) and she still have the swollen lymph node. She expected some symptoms for the second shot, but not the first. She was now very concerned about getting the second dose, especially since she read studies showing she could have as much protection after one shot since she had COVID as people who didn't have COVID. Additionally, she was a smaller woman and feel like maybe the dosage was too high. She was very healthy with no comorbidities except she had COVID previously (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination. PCR (Nasal swab) was done on 03May2021 with negative result. The outcome of events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: swollen lymph node in my left armpit the size of a grapefruit; chills; nausea; headache; fever; sweating; burning/tingling in my entire arm,; fatigue; aches; burning/tingling in my entire arm,; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW 0175) (at the age of 51 years old) as 1st dose, single for COVID-19 immunisation. Medical history included migraines from an unknown date and unknown if ongoing, and COVID in Mar2020 (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The patient's concomitant medications were not reported. It was reported that patient had COVID in Mar2020. She tested positive for antibodies in Apr2020. Upon receiving the first dose this past week, she ended up reacting just like she had COVID all over again. Within 4 hours she had chills, nausea, headache, fever, sweating, burning/tingling in my entire arm, aches, fatigue, etc, then she developed a swollen lymph node in the left armpit the size of a grapefruit. Acute symptoms persisted for 5 days (she was in bed the whole time) and she still have the swollen lymph node. She expected some symptoms for the second shot, but not the first. She was now very concerned about getting the second dose, especially since she read studies showing she could have as much protection after one shot since she had COVID as people who didn't have COVID. Additionally, she was a smaller woman and feel like maybe the dosage was too high. She was very healthy with no comorbidities except she had COVID previously (including long haul effects such as loss of smell for 6 months and losing handfuls of hair). The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient diagnosed with COVID-19. The patient has been tested for COVID-19 since the vaccination. PCR (Nasal swab) was done on 03May2021 with negative result. The outcome of events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: The patient got two shots and went through COVID; The patient got two shots and went through COVID; This is a spontaneous report from a contactable consumer reporting for the doctor. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got two shots and went through COVID on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain in extremity, Urinary tract infection, Vaccination site movement impairment
Clinical narrative: Urinary tract infection; Her right arm got real sore, she could not lift her arm; Her right arm got real sore, she could not lift her arm; back hurting/lower part of back on right-hand side; soreness in legs; headache; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored-program. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 65 years old, dose 1, intramuscular, administered in arm right on 29Mar2021 (Batch/Lot Number: EP7533) (time given: 10:30 or 11:00) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first Pfizer COVID shot and she became sick after receiving it. She was supposed to go back on 19Apr2021 for the second dose but she was still recovering then. Patient was asking if she can she still get the second dose. Her right arm got real sore, she could not lift her arm. Then her back started hurting like it settled in lower part of back on right-hand side, she developed a real bad urinary tract infection (UTI) and soreness in legs, she could not even lay on her left side since she was in such pain. She ended up going to urgent care because she was in such pain with her back and arm. They gave her a steroid shot, antibiotic shot and oral antibiotics to take. Patient also experienced headache. She is feeling a lot better. She recovered completely around 26Apr2021. Did not require a visit to emergency room, required a visit to physician office.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Urinary tract infection; Her right arm got real sore, she could not lift her arm; Her right arm got real sore, she could not lift her arm; back hurting/lower part of back on right-hand side; soreness in legs; headache; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored-program. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 65 years old, dose 1, intramuscular, administered in arm right on 29Mar2021 (Batch/Lot Number: EP7533) (time given: 10:30 or 11:00) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first Pfizer COVID shot and she became sick after receiving it. She was supposed to go back on 19Apr2021 for the second dose but she was still recovering then. Patient was asking if she can she still get the second dose. Her right arm got real sore, she could not lift her arm. Then her back started hurting like it settled in lower part of back on right-hand side, she developed a real bad urinary tract infection (UTI) and soreness in legs, she could not even lay on her left side since she was in such pain. She ended up going to urgent care because she was in such pain with her back and arm. They gave her a steroid shot, antibiotic shot and oral antibiotics to take. Patient also experienced headache. She is feeling a lot better. She recovered completely around 26Apr2021. Did not require a visit to emergency room, required a visit to physician office.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Condition aggravated, Erythema, Infection, Neuralgia
Clinical narrative: cellulitis; infection; pain seemed to spread to my inner elbow area / It was intense pain; pain seemed to spread to my inner elbow area / It was intense pain; skin became red; skin became red and swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0172), via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), chronic constipation, silent reflux, allergies to several antibiotics and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN), omeprazole, magnesium citrate. The patient previously took doxycycline, clarithromycin (MACROBID), and erythromycin and experienced allergies to all. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 07Apr2021 (at the age of 48-years-old) for COVID-19 immunisation and experienced pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area about 10 days after the first shot (there was nothing visible, just pain). The patient did not receive any other vaccines within 4 weeks of the vaccination. At the time of the second vaccination, the patient still had ongoing pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area, which she experienced 10 days after the first vaccination on 17Apr2021. On 02May2021, after the second vaccination, the pain seemed to spread to the inner elbow area, and it was intense pain. The skin became red and swollen and in that one location. The patient visited the doctor on 03May2021, and he was not sure if it was cellulitis or another type of infection, and prescribed antibiotics, cefdinir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of cellulitis, infection, "pain seemed to spread to my inner elbow area / It was intense pain", skin became red and swollen was not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: cellulitis; infection; pain seemed to spread to my inner elbow area / It was intense pain; pain seemed to spread to my inner elbow area / It was intense pain; skin became red; skin became red and swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0172), via an unspecified route of administration in the left arm on 29Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), chronic constipation, silent reflux, allergies to several antibiotics and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN), omeprazole, magnesium citrate. The patient previously took doxycycline, clarithromycin (MACROBID), and erythromycin and experienced allergies to all. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 07Apr2021 (at the age of 48-years-old) for COVID-19 immunisation and experienced pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area about 10 days after the first shot (there was nothing visible, just pain). The patient did not receive any other vaccines within 4 weeks of the vaccination. At the time of the second vaccination, the patient still had ongoing pain (like nerve pain) on the interior side of the upper arm that went from the elbow up to almost the underarm area, which she experienced 10 days after the first vaccination on 17Apr2021. On 02May2021, after the second vaccination, the pain seemed to spread to the inner elbow area, and it was intense pain. The skin became red and swollen and in that one location. The patient visited the doctor on 03May2021, and he was not sure if it was cellulitis or another type of infection, and prescribed antibiotics, cefdinir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of cellulitis, infection, "pain seemed to spread to my inner elbow area / It was intense pain", skin became red and swollen was not resolved.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: After the first dose her husband tested positive of Covid 19/ came down with COVID symptoms.; This is a spontaneous report from a Pfizer-sponsored program, COVAX US support, via a contactable consumer. This consumer reported similar events for two patients (herself and her husband). This is the second of two reports.   A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EW0161, Expiry Date: 31Jul2021) via unspecified route in the left arm on 17April2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that after the first dose the patient tested positive of COVID-19. On 21Apr2021 he came down with COVID symptoms. On 22Apr2021 he got a positive COVID test. He was due for the second shot on 06May2021 and reporter was asking if he needed to wait some time before getting the second dose. The reporter stated they (herself and husband) both got the vaccine and they both got the virus. The clinical outcome of "after the first dose, patient tested positive of COVID-19" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021511584 same reporter/drug, different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Hypersensitivity, Pruritus, SARS-CoV-2 test
Clinical narrative: Skin redness; started having whole body hives; Face allergy which never have before; started having whole body hives which is like your body is like burning and itching; started having whole body hives which is like your body is like burning and itching; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number EW0170, expiration date unknown), via an unspecified route of administration administered in Arm Left on 22Mar2021 at 12:00 am as single dose for covid-19 immunization (at the age of 31-years-old). The patient medical history and concomitant medications were not reported. The patient previously took penicillin [benzylpenicillin] (can be Penicillin) and had Known allergy. It was stated that, after her first dose vaccine which was received on 22Mar2021, she started having whole body hives which is like your body was like burning and itching and It got worse almost every day and mentioned that she was having this allergy and she started to have skin redness, body hives, face allergy which never have before which experienced on 28Mar2021 at 01:00 am. The patient also stated that she never got any side effect from any vaccination before this Pfizer COVID vaccination and after this she started to have hives and it got worse almost every day. She did not get anything from any vaccination, and she did not get any allergies of skin and after this vaccination her system went very down. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test which was negative. The outcome of all the events was not recovered.  Follow up needed, further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Skin redness; started having whole body hives; Face allergy which never have before; started having whole body hives which is like your body is like burning and itching; started having whole body hives which is like your body is like burning and itching; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number EW0170, expiration date unknown), via an unspecified route of administration administered in Arm Left on 22Mar2021 at 12:00 am as single dose for covid-19 immunization (at the age of 31-years-old). The patient medical history and concomitant medications were not reported. The patient previously took penicillin [benzylpenicillin] (can be Penicillin) and had Known allergy. It was stated that, after her first dose vaccine which was received on 22Mar2021, she started having whole body hives which is like your body was like burning and itching and It got worse almost every day and mentioned that she was having this allergy and she started to have skin redness, body hives, face allergy which never have before which experienced on 28Mar2021 at 01:00 am. The patient also stated that she never got any side effect from any vaccination before this Pfizer COVID vaccination and after this she started to have hives and it got worse almost every day. She did not get anything from any vaccination, and she did not get any allergies of skin and after this vaccination her system went very down. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test which was negative. The outcome of all the events was not recovered.  Follow up needed, further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Concussion, Dizziness, Electrocardiogram, Head injury
Clinical narrative: became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 test, Skin laceration
Clinical narrative: became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Syncope, Vomiting
Clinical narrative: fainting; Very intense dizziness; vomiting; headache; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 25Apr2021 11:45 (43-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. Patient was not pregnant. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Vaccination Facility Type was Pharmacy. The patient experienced very intense dizziness, with a few seconds of fainting on the first day, vomiting, headache 10 hours following the administration of the second dose and continuously since then, for 10 days now. All events started from 25Apr2021 22:00 with outcome of not recovered. Events resulted in Emergency room/department or urgent care. No treatment was given.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Head injury, Headache, Myalgia
Clinical narrative: fainted; hit my head; I woke up disoriented moments later; ears are ringing from my head hitting; Headache; Feel dizzy; noticed muscle aches; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:15 (at 43 years old, not pregnant) as 2nd dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC); mometasone furoate (NASONEX). The patient took Fioricet before and had allergies. The patient had her first dose of bnt162b2 vaccine on 13Apr2021 for Covid-19 Immunisation on left arm at 43 years old. All events reportedly started on 05may2021 03:00. Patient woke up in the middle of the night to use the bathroom. She thought she was feeling fine, but then noticed muscle aches as she walked. She decided to take Motrin. She walked to the sink and felt dizzy. She got so lightheaded, She sat on the edge of the tub with my head between her legs. That was the last thing She remembered. Based on the evidence the next morning, she must have stood up put Motrin in my mouth and poured a glass of water. Then she fainted and hit her head on the bathroom floor. She had never fainted before in her life. She woke up disoriented moments later with two Motrin still on her tongue and having no idea where she was. She had to crawl back to bed. The next morning, she found the spilled a glass of water and Motrin pills all over the floor. She now had a persistent headache and her ears are ringing from her head hitting the bathroom floor. She did not know that dizziness was a potential side effect or she may have taken precautions. The outcome of the events was recovering. No other vaccine in four weeks.No Covid prior vaccination.Not Covid tested post vaccination.  Information about the Lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tinnitus
Clinical narrative: fainted; hit my head; I woke up disoriented moments later; ears are ringing from my head hitting; Headache; Feel dizzy; noticed muscle aches; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:15 (at 43 years old, not pregnant) as 2nd dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC); mometasone furoate (NASONEX). The patient took Fioricet before and had allergies. The patient had her first dose of bnt162b2 vaccine on 13Apr2021 for Covid-19 Immunisation on left arm at 43 years old. All events reportedly started on 05may2021 03:00. Patient woke up in the middle of the night to use the bathroom. She thought she was feeling fine, but then noticed muscle aches as she walked. She decided to take Motrin. She walked to the sink and felt dizzy. She got so lightheaded, She sat on the edge of the tub with my head between her legs. That was the last thing She remembered. Based on the evidence the next morning, she must have stood up put Motrin in my mouth and poured a glass of water. Then she fainted and hit her head on the bathroom floor. She had never fainted before in her life. She woke up disoriented moments later with two Motrin still on her tongue and having no idea where she was. She had to crawl back to bed. The next morning, she found the spilled a glass of water and Motrin pills all over the floor. She now had a persistent headache and her ears are ringing from her head hitting the bathroom floor. She did not know that dizziness was a potential side effect or she may have taken precautions. The outcome of the events was recovering. No other vaccine in four weeks.No Covid prior vaccination.Not Covid tested post vaccination.  Information about the Lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: My left arm is locked in a paralyzed stage where I haven't been able to lift it no more than a few inches since the second week that I got the Pfizer shot three weeks ago.; muscle spasm; The left side of my shoulder and neck was stiff; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in arm left on 15Apr2021 at 13:00 (at the age of 55-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included breast cancer, is diabetic and anemic, thyroid disorder, peripheral neuropathy, history of blood clot (reported as 'clog') in leg and pineapple and watermelon allergy, all from an unknown date and unknown if ongoing. On 23Apr2021 at 08:00, the patient's left arm is locked in a paralyzed stage where she hasn't been able to lift it no more than a few inches since the second week that she got the Pfizer shot three weeks ago. The left side of her shoulder and neck was stiff like she had a muscle spasm for about the whole second week. She will not be getting the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures [acetaminophen (TYLENOL), heat on areas, move and rotate areas] were taken as a result of all events. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: muscle spasms; SORE; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient experienced muscle spasms and sore after 11 days. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Pain, Palpitations
Clinical narrative: chills and aches; chills and aches; my heart was racing; my heart was racing/ went up to 150 and never got below 70 while resting/ resting heart rate is 58 normally/ would jump to 90 to 120 to 150 and then just keep going up and down; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 30Mar2021 (lot number: ER8727) as 1st dose, single and on 19Apr2021 09:00 (lot number: ER8731) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. Concomitant medications included levothyroxine sodium (UNITHROID) and gabapentin. 12 hours after vaccination on 20Apr2021 08:00, patient got the chills and aches. When she woke up the next day her heart was racing. It went up to 150 and never got below 70 while resting. Her resting heart rate was 58 normally. The whole day it was racing. If she would stand up it would jump to 90 to 120 to 150 and then just keep going up and down. When she called her doctor, they told her to go to the ER because she could go into Cardiac Arrest. She chose to wait to see if she would be better the next day. It was so, she never did end up going. No treatment was received for the events. Patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Head hurts; Received both doses of the Pfizer-BioNTech COVID-19 vaccine; 3 weeks after the second dose, the patient was diagnosed with COVID-19; Received both doses of the Pfizer-BioNTech COVID-19 vaccine; 3 weeks after the second dose, the patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH-COVID-19 VACCINE; Lot Number was not reported), via unspecified routes of administration, on 17Mar2021 as first dose, single, and then on 07Apr2021 as second dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer-BioNTech COVID-19 vaccine. 3 weeks after the second dose (26Apr2021), the patient was diagnosed with COVID-19. The patient was COVID-19 virus test positive on 26Apr2021. The patient wanted to know why the vaccine did not work for her; why was she in the 5%. The patient knew that the vaccine is 95% effective, so she asked why she got COVID-19 after both of the vaccines. The patient also wanted to know information about the 5% of people who still had COVID-19 after receiving both doses of the Pfizer-BioNTech COVID-19 vaccine (or are getting COVID-19 after receiving the vaccine). The patient was asking if the company was doing any studies to find out why this happened, and she is willing to give blood or whatever the company needs for research. The patient's head hurts on an unspecified date. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Movement disorder, Pain
Clinical narrative: The pain has prevented me from performing my daily routine/ I have to have assistance with minor and major activities, such as getting dressed, holding objects; Soreness and pain has continued since the vaccination was given/ can't lay on my arm; Difficult to move; lack of sleep; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 02Feb2021 at 09:00 (Batch/Lot Number: EN6202) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included morniflumate (FLOMAX [MORNIFLUMATE]), vitamin d nos (VITAMIN D NOS) and tocopheryl acetate, ubidecarenone (COQ10 [TOCOPHERYL ACETATE;UBIDECARENONE]) all taken for unspecified indications, start and stop dates were not reported. The patient experienced the pain has prevented me from performing my daily routine/ I have to have assistance with minor and major activities, such as getting dressed, soreness and pain has continued since the vaccination was given/ can't lay on my arm, difficult to move and lack of sleep all on 27Feb2021 at 09:00. Reporter stated that Soreness and pain has continued since the vaccination was given. Difficult to move and constantly hurts. The pain has prevented me from performing my daily routine. I have to have assistance with minor and major activities, such as getting dressed, holding objects, lack of sleep, difficulty to rest, can't lay on my arm. Using pain medications to try and relieve the pain. Therapeutic measures were taken as a result of soreness and pain has continued since the vaccination was given/ can't lay on my arm. Outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Ear discomfort, Oropharyngeal blistering, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: redness in the back of the patient's throat and blisters or ulcers; Redness in the back of the patient's throat; He can talk a little bit better, but it's still sore; Throat lesions; He developed this ulcer on his tongue and throat; He developed this ulcer on his tongue and throat; Difficulty swallowing; Ear feels plugged; This is a spontaneous report from contactable consumer (patient). A 67-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on Apr2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat lesions on an unspecified date in 2021 which got worse over the weekend. He was able to speak to his healthcare professional (HCP) and recommended the second dose. He was prescribed amoxicillin for throat lesions and mentioned that he was on the way to the appointment for second dose. He asked if he could receive the second dose. The patient had his first vaccine about 1 month ago (Apr2021) and is due to get second dose today (05May2021) in about 30 minutes. The last few days (2021), he developed ulcer on his tongue and throat, difficulty swallowing, and his ear felt plugged. He went to the doctor on 04May2021 and the doctor said he saw redness in the back of the patient's throat and blisters or ulcers and put him on an antibiotic. As the patient has been reading up more, he saw that was one of the symptoms being reported after the vaccine. He was wondering if he should or shouldn't get the second dose as scheduled today relative to these events. It did seem like today he could talk a little bit better, but it's still sore (2021). The outcome of the event throat lesion and throat ulcer was not recovered and unknown for all other events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal ulceration, Throat lesion, Tongue ulceration
Clinical narrative: redness in the back of the patient's throat and blisters or ulcers; Redness in the back of the patient's throat; He can talk a little bit better, but it's still sore; Throat lesions; He developed this ulcer on his tongue and throat; He developed this ulcer on his tongue and throat; Difficulty swallowing; Ear feels plugged; This is a spontaneous report from contactable consumer (patient). A 67-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on Apr2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat lesions on an unspecified date in 2021 which got worse over the weekend. He was able to speak to his healthcare professional (HCP) and recommended the second dose. He was prescribed amoxicillin for throat lesions and mentioned that he was on the way to the appointment for second dose. He asked if he could receive the second dose. The patient had his first vaccine about 1 month ago (Apr2021) and is due to get second dose today (05May2021) in about 30 minutes. The last few days (2021), he developed ulcer on his tongue and throat, difficulty swallowing, and his ear felt plugged. He went to the doctor on 04May2021 and the doctor said he saw redness in the back of the patient's throat and blisters or ulcers and put him on an antibiotic. As the patient has been reading up more, he saw that was one of the symptoms being reported after the vaccine. He was wondering if he should or shouldn't get the second dose as scheduled today relative to these events. It did seem like today he could talk a little bit better, but it's still sore (2021). The outcome of the event throat lesion and throat ulcer was not recovered and unknown for all other events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.