chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MENB
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction in a 17 years old male patient after receiving a dose from Trumenba; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 17-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction in a 17 years old male patient after receiving a dose from Trumenba". Follow-up attempts are not needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: My arm is a little sore; I was a little sleepy the first day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Jul2022, outcome "unknown", described as "I was a little sleepy the first day"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "My arm is a little sore".  Additional information: Caller was a consumer (patient) who received fourth dose Adult Pfizer Covid Vaccine on 05Jul2022. She was then contacted by the Pharmacist who told her they recorded the wrong expiration date on the vaccination card "03Jul2022" when it was not actually expired. The vaccine administration facility put a sticker on the vaccine card with extremely small print. The expiration date listed on the vaccine card for fourth dose Adult Pfizer Covid Vaccine is 03Jul2022, two days before caller was administered the fourth dose Adult Pfizer Covid Vaccine on 05Jul2022. The patient did not notice the expiration date because it was like a pen drop on the vaccine card. Got call from pharmacist yesterday, 07Jul2022, stating the wrong information was placed on the vaccine card the Adult Pfizer Covid Vaccine administered was not expired. The pharmacist wanted to send a new vaccine card with the correct information. The patient was uncertain on whether or not she received an expired vaccine. She wanted to know if she should be concerned if the efficacy of the vaccine dwindled or if she would need an additional vaccine. The patient also stated "I am looking it at this way, I had no adverse reaction, I am quite fine, my arm is a little sore, I was a little sleepy the first day. That was it. If there's no real issue and they send the corrected card". The patient stated her concern was if she had received and expired dose, if she should be getting another booster by the end of the year, or if she assumed that they made a mistake and send her a corrected card and she was good for however long. She was just trying to factor in how she need to do her protection going forward. Caller asked "If they made the mistake, do I have any efficacy here? Should it last a few months? I just need to know if I need to assume I need to get one maybe a little quicker than most people who had got one that was not possibly expired".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Dizziness, Fatigue
Clinical narrative: problems with his stomach; dizziness; weakness; running out of energy really fast; He is still getting high fevers; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2021 as dose 1, single (Lot number: FA6780) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "He is still getting high fevers"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "running out of energy really fast"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "problems with his stomach". The events "dizziness", "weakness", "running out of energy really fast", "he is still getting high fevers" and "extreme fatigue" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, asthenia, pyrexia, fatigue, abdominal discomfort.  Additional information: The reporter called because she had some problem with sons health, he had been through a lot of test with his doctors and they found nothing wrong with him. She had been taking him to his doctor and explaining how he was feeling, they have checked for diabetes, they checked his organs and they say everything was okay but he was getting worse. And he was still getting high fevers as well, and she took him to the ER, but they found nothing. The patient did not receive any other products and had no relevant medical history. Also reported as Adverse event: started by Oct2021. He did start a medication for problems with his stomach and was Cyproheptad 4mg. Additional vaccines administered on same date of the Pfizer suspect was no. Prior vaccinations (within 4 weeks) was no.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Investigation, Pyrexia
Clinical narrative: problems with his stomach; dizziness; weakness; running out of energy really fast; He is still getting high fevers; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2021 as dose 1, single (Lot number: FA6780) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "He is still getting high fevers"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "running out of energy really fast"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "problems with his stomach". The events "dizziness", "weakness", "running out of energy really fast", "he is still getting high fevers" and "extreme fatigue" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, asthenia, pyrexia, fatigue, abdominal discomfort.  Additional information: The reporter called because she had some problem with sons health, he had been through a lot of test with his doctors and they found nothing wrong with him. She had been taking him to his doctor and explaining how he was feeling, they have checked for diabetes, they checked his organs and they say everything was okay but he was getting worse. And he was still getting high fevers as well, and she took him to the ER, but they found nothing. The patient did not receive any other products and had no relevant medical history. Also reported as Adverse event: started by Oct2021. He did start a medication for problems with his stomach and was Cyproheptad 4mg. Additional vaccines administered on same date of the Pfizer suspect was no. Prior vaccinations (within 4 weeks) was no.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Colonoscopy normal, Constipation, Endoscopy normal
Clinical narrative: problems with his stomach; dizziness; weakness; running out of energy really fast; He is still getting high fevers; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2021 as dose 1, single (Lot number: FA6780) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "He is still getting high fevers"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "running out of energy really fast"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "problems with his stomach". The events "dizziness", "weakness", "running out of energy really fast", "he is still getting high fevers" and "extreme fatigue" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, asthenia, pyrexia, fatigue, abdominal discomfort.  Additional information: The reporter called because she had some problem with sons health, he had been through a lot of test with his doctors and they found nothing wrong with him. She had been taking him to his doctor and explaining how he was feeling, they have checked for diabetes, they checked his organs and they say everything was okay but he was getting worse. And he was still getting high fevers as well, and she took him to the ER, but they found nothing. The patient did not receive any other products and had no relevant medical history. Also reported as Adverse event: started by Oct2021. He did start a medication for problems with his stomach and was Cyproheptad 4mg. Additional vaccines administered on same date of the Pfizer suspect was no. Prior vaccinations (within 4 weeks) was no.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, General physical health deterioration, Nausea
Clinical narrative: problems with his stomach; dizziness; weakness; running out of energy really fast; He is still getting high fevers; extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2021 as dose 1, single (Lot number: FA6780) at the age of 15 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "He is still getting high fevers"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "running out of energy really fast"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "problems with his stomach". The events "dizziness", "weakness", "running out of energy really fast", "he is still getting high fevers" and "extreme fatigue" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, asthenia, pyrexia, fatigue, abdominal discomfort.  Additional information: The reporter called because she had some problem with sons health, he had been through a lot of test with his doctors and they found nothing wrong with him. She had been taking him to his doctor and explaining how he was feeling, they have checked for diabetes, they checked his organs and they say everything was okay but he was getting worse. And he was still getting high fevers as well, and she took him to the ER, but they found nothing. The patient did not receive any other products and had no relevant medical history. Also reported as Adverse event: started by Oct2021. He did start a medication for problems with his stomach and was Cyproheptad 4mg. Additional vaccines administered on same date of the Pfizer suspect was no. Prior vaccinations (within 4 weeks) was no.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: Posterior auricular lymphadenopathy; Current age: 1 year/Lot Number: Ft9142; vaccine location Left leg; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 12-month-old male patient received BNT162b2 (BNT162B2), on 07Jul2022 at 09:00 as dose 1, single (Lot number: Ft9142) at the age of 12 months, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 07Jul2022 at 09:00, outcome "unknown", described as "Current age: 1 year/Lot Number: Ft9142"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Jul2022 at 09:00, outcome "unknown", described as "vaccine location Left leg"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022 at 21:00, outcome "not recovered", described as "Posterior auricular lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Facility type vaccine: Doctor's office/urgent care. The patient did not have COVID-19 prior to vaccination. The patient had not been tested post vaccination. The patient had no known allergies.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Acute lymphocytic leukaemia, Blood test, Decreased appetite
Clinical narrative: Acute Lymphoblastic Leukemia; appetite reduced; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 14:00 as dose 2, single (Lot number: Fl8094) at the age of 5 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number FI8092, dose administration time 3:00 PM, vaccine location Left arm), administration date: 19Apr2022, when the patient was 5-year-old, for COVID-19 Immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The following information was reported: ACUTE LYMPHOCYTIC LEUKAEMIA (hospitalization, life threatening) with onset 12May2022, outcome "unknown", described as "Acute Lymphoblastic Leukemia"; DECREASED APPETITE (hospitalization, life threatening) with onset 12May2022, outcome "unknown", described as "appetite reduced". The events "acute lymphoblastic leukemia" and "appetite reduced" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Oct2021) growth are all normal, notes: Child was 100% healthy and previous blood reports Oct2021. Therapeutic measures were taken as a result of acute lymphocytic leukaemia included Chemotherapy. After receiving COVID vaccine, kids appetite reduced and after a month kid diagnosed "Acute Lymphoblastic Leukemia".
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 28-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Manufacturer unknown), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: THROMBOSIS (medically significant) with onset Jun2022, outcome "unknown", described as "Blood Clot". It was unknown if therapeutic measures were taken as a result of thrombosis.  Clinical course: it was unknown that if covid prior vaccination and if covid tested post vaccination   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Crying, Eating disorder, Product administered at inappropriate site
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent. A 17-month-old male patient received BNT162b2 (BNT162B2), on 07Jul2022 at 16:15 as dose 1, single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Dairy allergy" (unspecified if ongoing), notes: Dairy allergy, Severe dairy intolerance allergy and possibly celiac,(still going through testing); "Severe dairy intolerance allergy and possibly celiac" (unspecified if ongoing), notes: Severe dairy intolerance allergy and possibly celiac,(still going through testing). There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Jul2022 at 16:15, outcome "unknown", described as "vaccine location Left leg"; ABDOMINAL PAIN (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "belly pain/ pointed at abdomen crying"; CRYING (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022); EATING DISORDER (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "he would not eat or drink"; PYREXIA (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "running a fever of 102 Fahrenheit, by 37 hours it was 104.9 F."; VOMITING (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "two episodes of vomiting". The events "crying", "belly pain/ pointed at abdomen crying", "running a fever of 102 fahrenheit, by 37 hours it was 104.9 f.", "he would not eat or drink" and "two episodes of vomiting" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of crying, abdominal pain, pyrexia, eating disorder, vomiting. Additional information: The patient didn't receive any vaccines in four weeks and no other medication took. Patient not been tested covid prior to vaccination. At the 30-hour mark after received vaccine the patient started crying about belly pain (pointed at abdomen crying "owwie"), and at around 36 hours he started running a fever of 102 Fahrenheit, by 37 hours it was 104.9 F. We went to an urgent care at around 48 hours after vaccine due to the very high fever, his abdominal pain, and the fact that he would not eat or drink, and they did PCR testing for covid and other viruses and everything was negative. He also had two episodes of vomiting when his fever was around 104. After 24 hours of fever, the fever broke and went away and he seemed back to normal. The patient received the treatment ibuprofen and Tylenol. Post vaccine covid tested positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Viral test, Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent. A 17-month-old male patient received BNT162b2 (BNT162B2), on 07Jul2022 at 16:15 as dose 1, single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Dairy allergy" (unspecified if ongoing), notes: Dairy allergy, Severe dairy intolerance allergy and possibly celiac,(still going through testing); "Severe dairy intolerance allergy and possibly celiac" (unspecified if ongoing), notes: Severe dairy intolerance allergy and possibly celiac,(still going through testing). There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Jul2022 at 16:15, outcome "unknown", described as "vaccine location Left leg"; ABDOMINAL PAIN (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "belly pain/ pointed at abdomen crying"; CRYING (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022); EATING DISORDER (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "he would not eat or drink"; PYREXIA (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "running a fever of 102 Fahrenheit, by 37 hours it was 104.9 F."; VOMITING (non-serious) with onset 08Jul2022 at 22:00, outcome "recovered" (Jul2022), described as "two episodes of vomiting". The events "crying", "belly pain/ pointed at abdomen crying", "running a fever of 102 fahrenheit, by 37 hours it was 104.9 f.", "he would not eat or drink" and "two episodes of vomiting" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of crying, abdominal pain, pyrexia, eating disorder, vomiting. Additional information: The patient didn't receive any vaccines in four weeks and no other medication took. Patient not been tested covid prior to vaccination. At the 30-hour mark after received vaccine the patient started crying about belly pain (pointed at abdomen crying "owwie"), and at around 36 hours he started running a fever of 102 Fahrenheit, by 37 hours it was 104.9 F. We went to an urgent care at around 48 hours after vaccine due to the very high fever, his abdominal pain, and the fact that he would not eat or drink, and they did PCR testing for covid and other viruses and everything was negative. He also had two episodes of vomiting when his fever was around 104. After 24 hours of fever, the fever broke and went away and he seemed back to normal. The patient received the treatment ibuprofen and Tylenol. Post vaccine covid tested positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; COVID-19, Pneumonia in Left Lung Then Entered Right; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4327066-00 (AbbVie).  A 64-year-old male patient received BNT162b2, on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), on 18May2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2022, outcome "recovered" (2022) and all described as "COVID-19"; COVID-19 PNEUMONIA (medically significant) with onset 14Feb2022, outcome "recovered" (2022), described as "COVID-19, Pneumonia in Left Lung Then Entered Right". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2022) Positive. The action taken for adalimumab was unknown. Clinical course: Solicited report from the RA by a consumer of a 64-year-old male with events of non-serious COVID-19, Pneumonia in Left Lung Then Entered Right and Pain/Still Hurt Everywhere with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced pain/still hurt everywhere. In 2021, the patient experienced COVID-19. On 14Feb2022, the patient experienced COVID-19 and pneumonia in left lung then entered right. In 2022, the COVID-19 and pneumonia in left lung then entered right resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 26Apr2022, received updates to event information, reporter opinion of causality, concomitant drug information and narrative description. On 29Jun2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. "Pain/Still Hurt Everywhere" was added. The reporter's causality for the event(s) of COVID-19 onset 14Feb2022 and Pneumonia in Left Lung Then Entered Right with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of "covid-19" and "covid-19, pneumonia in left lung then entered right" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: caller had three vaccine doses and tested positive; caller had three vaccine doses and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (COMIRNATY), on 10Mar2021 as dose 1, single (Lot number: EL3247), in arm, on 31Mar2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839, Expiration Date: Mar2022) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "caller had three vaccine doses and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive, notes: BinaxNOW ; (05Jul2022) Positive, notes: caller had three vaccine doses and tested positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient said her symptoms have been fairly mild for her, and she has done no treatment at this point. She said she has stuffy sinuses, but did not have a fever or anything so she hasn't had to take anything. She said the stuffy sinuses started on the Tuesday the 05Jul2022, and seemed like allergies but then they got worse and she found out she was exposed to someone who was positive with Covid and that is why she took the test.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Sinusitis, Thinking abnormal
Clinical narrative: caller had three vaccine doses and tested positive; caller had three vaccine doses and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (COMIRNATY), on 10Mar2021 as dose 1, single (Lot number: EL3247), in arm, on 31Mar2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839, Expiration Date: Mar2022) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "caller had three vaccine doses and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive, notes: BinaxNOW ; (05Jul2022) Positive, notes: caller had three vaccine doses and tested positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient said her symptoms have been fairly mild for her, and she has done no treatment at this point. She said she has stuffy sinuses, but did not have a fever or anything so she hasn't had to take anything. She said the stuffy sinuses started on the Tuesday the 05Jul2022, and seemed like allergies but then they got worse and she found out she was exposed to someone who was positive with Covid and that is why she took the test.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Sick; can't think straight; stuffy sinuses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839, Expiration Date: Mar2022) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: comirnaty (DOSE 1, SINGLE; LOT: EL3247; Anatomical location: arm    , NDC/EXP: unknown), administration date: 10Mar2021, when the patient was 43-year-old, for covid-19 immunization, reaction(s): "caller had three vaccine doses and tested positive for COVID", "caller had three vaccine doses and tested positive for COVID"; comirnaty (DOSE 2, SINGLE; LOT: EL3247, EXP: May 2021; NDC: unknown), administration date: 31Mar2021, when the patient was 43-year-old, for covid-19 immunization, reaction(s): "caller had three vaccine doses and tested positive for COVID", "caller had three vaccine doses and tested positive for COVID". The following information was reported: SINUSITIS (non-serious) with onset 05Jul2022, outcome "unknown", described as "stuffy sinuses"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "can't think straight".
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Sinusitis, Thinking abnormal
Clinical narrative: Sick; can't think straight; stuffy sinuses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839, Expiration Date: Mar2022) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: comirnaty (DOSE 1, SINGLE; LOT: EL3247; Anatomical location: arm    , NDC/EXP: unknown), administration date: 10Mar2021, when the patient was 43-year-old, for covid-19 immunization, reaction(s): "caller had three vaccine doses and tested positive for COVID", "caller had three vaccine doses and tested positive for COVID"; comirnaty (DOSE 2, SINGLE; LOT: EL3247, EXP: May 2021; NDC: unknown), administration date: 31Mar2021, when the patient was 43-year-old, for covid-19 immunization, reaction(s): "caller had three vaccine doses and tested positive for COVID", "caller had three vaccine doses and tested positive for COVID". The following information was reported: SINUSITIS (non-serious) with onset 05Jul2022, outcome "unknown", described as "stuffy sinuses"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "can't think straight".
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 1, single (Lot number: fa7584), in right arm, as dose 2, single (Lot number: fa7484), in right arm and as dose 3 (booster), single (Lot number: fj1611), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies cipro", notes: known allergies cipro; Doxycycline, reaction(s): "known allergies doxycycline", notes: known allergies doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 07Jul2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-19 after getting the Pfizer vaccine; got COVID-19 after getting the Pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19 after getting the Pfizer vaccine". Additional Information: Respondent and husband both got COVID-19 after getting the Pfizer Vaccine. The reporter considered event was caused by suspect product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200019371 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: finished her 5 days treatment for PAXLOVID / should you re-test for covid /receive 2 doses of the Pfizer vaccine and a booster; finished her 5 days treatment for PAXLOVID / should you re-test for covid /receive 2 doses of the Pfizer vaccine and a booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Addisons" (unspecified if ongoing), notes: "I do have 'Addisons' that is very mild and very rare that I get an episode,. Concomitant medication(s) included: ELIQUIS; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "finished her 5 days treatment for PAXLOVID / should you re-test for covid /receive 2 doses of the Pfizer vaccine and a booster". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated she has finished her 5 days treatment for PAXLOVID and wanted to know how long it stays in your system. She stated she is healthy 80 years old and walk 5 miles a day in her apartment. she stated if you are still coughing should you re-test for covid. She did receive 2 doses of the Pfizer vaccine and a booster, will have to wait for the 2nd booster dose. Reporter answered her question because she did mention that she was coughing so it was an adverse event that you need to file a report on and that's all the information has. Patient stated she just threw the box of Paxlovid away Let me see if I still have the prescription hold on. She just threw the box away. Maybe she shouldn't throw the box away can give the prescription number which will not help.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: could get a blood clot that could go to your brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood clot" (unspecified if ongoing), notes: Caller said that one clot was previous to the vaccine. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "could get a blood clot that could go to your brain". Therapeutic measures were taken as a result of thrombosis.  Clinical information: Caller was a consumer that was calling about the COVID-19 vaccine booster dose. She had the booster shot before and now they are saying that there is a problem that they said you could get a blood clot that could go to your brain. Caller said that with her previous booster they never told her that. She has had several clots and is wondering if she would be more prone to get a blood clot in her brain and said that one clot was previous to the vaccine and one was after surgery and she already had the shot then.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 at 15:00 as dose 1, single (Lot number: EL9265), in left arm, on 10Mar2021 at 15:00 as dose 2, single (Lot number: ENU199), in left arm, on 02Nov2021 at 09:45 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 11Apr2022 at 10:15 as dose 4 (booster), single (Lot number: FJ8762) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "herpes (sacral)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Clinical course: Reverb infection. Began Paxlovid 36 hours after symptoms and 12 hours after first positive covid test (evening of Day 2 of infection). Followed intake rules-every 12 hours until ten (3-pill) doses were swallowed without chewing. Rapid test outcomes related to onset of covid (Day 1) and period of Paxlovid intake. Day 1 symptoms begin, test is negative; Day 2 symptoms worse, test positive (distinct band); begin Paxlovid in pm; Day 3-6 symptoms begin to lighten, one test (Day 5) positive( distinct band); Day 7 last Paxlovid dose in am, test positive, light band; Day 8 milder symptoms, test positive (distinct band); Days 9-11 mild symptoms, test positive (nearly invisible band); Day 12 symptoms increasing, test positive (distinct band); confirmed with 2nd rapid test. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Negative; (28Jun2022) Positive, notes: (distinct band); (01Jul2022) Positive, notes: (Day 5) positive (distinct band); (03Jul2022) Positive; (04Jul2022) Positive, notes: (distinct band); (05Jul2022) Positive, notes: Days 9-11 (nearly invisible band); (06Jul2022) Positive, notes: Days 9-11 (nearly invisible band); (07Jul2022) Positive, notes: Days 9-11 (nearly invisible band); (08Jul2022) Positive, notes: (distinct band) Day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 treatment included Paxlovid from 28Jun2022 to 03Jul2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 09Jul2022 after booster in May2022; Tested positive for Covid 09Jul2022 after booster in May2022; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 01May2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "recovering" and all described as "Tested positive for Covid 09Jul2022 after booster in May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear discomfort, Headache, Lymphadenopathy
Clinical narrative: Chills; slight fever; swollen lymph node; body aches; joint pain; shakes; headache; nasal congestion; clogged ears; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 09:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 24 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers-Danlos Syndrome" (unspecified if ongoing); "Mild cerebral palsy" (unspecified if ongoing), notes: Mild cerebral palsy; "Gastroparesis" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: LEXAPRO; BIOTIN; CETIRIZINE; TYLENOL; MOTRIN [IBUPROFEN]. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: Known allergies: Prednisone. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FE3590, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 21Nov2021, when the patient was 23-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 08Mar2021, when the patient was 22-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; PAIN (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "body aches"; EAR DISCOMFORT (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "clogged ears"; HEADACHE (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "joint pain"; NASAL CONGESTION (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; TREMOR (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "shakes"; PYREXIA (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "slight fever"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "swollen lymph node". Therapeutic measures were taken as a result of chills, pyrexia, lymphadenopathy, pain, arthralgia, tremor, headache, nasal congestion, ear discomfort. No follow-up attempts are possible. No further information is expected.