chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 on the 10th; Tested positive for Covid 19 on the 10th; 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.  A 74-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 1, 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) all with onset 10Oct2022, outcome "unknown" and all described as "Tested positive for Covid 19 on the 10th". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: Tested positive for Covid 19 on the 10th. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller was consumer reporting that he "tested positive for Covid 19 on the 10th", and he just picked up the Paxlovid, and "I took it yesterday morning at 8:30 and last night at 8:40 pm.   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: Arthritis reactive
Clinical narrative: mild form of reactive arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: ARTHRITIS REACTIVE (medically significant), outcome "recovered", described as "mild form of reactive arthritis". Clinical course: During report caller stated that her dad got the Pfizer Covid 19 vaccine and the booster and got Covid. Also had a mild form of reactive arthritis and that went away. Reporter stated that many people have died from heart attack or stroke, and they are kids with no health problems prior.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224810 similar report from same reporter;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 3:Pfizer /Dose Number: 2:Moderna / Dose Number: 1:Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Lot number: 027A21A) and on 08Apr2021 as dose 2, single (Lot number: 036B21A) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Nov2021, outcome "recovered", described as "Dose Number: 3:Pfizer /Dose Number: 2:Moderna / Dose Number: 1:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Oct2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Took Paxlovid and tested negative on day 7; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 30Sep2022 to 05Oct2022, for the treatment of COVID-19.   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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), 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 immunization. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID; PRAVACHOL; PRILOSEC [OMEPRAZOLE]; ASA; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022 at 16:00, outcome "not recovered" and all described as "COVID 19". Patient had no known allergies. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (10Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: The Paxlovid Treatment received on 02Oct2022 and stopped on 06Oct2022. The patient tested negative for 3 days following treatment then rebounded with testing positive and return of symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushing; 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.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose., On my ears, and my nose was hot and red. Also, on my chest and neck.), administration date: 2021, for COVID-19 immunization, reaction(s): "Flushing"; Bnt162b2 (First dose., I felt extremely dizzy and extremely awkward for 2 or 3 days), administration date: 2021, for COVID-19 immunization, reaction(s): "Extremely dizzy", "Extremely awkward"; Flu vaccine (had these reactions when she received the flu vaccine), for Immunization, reaction(s): "Reactions". The following information was reported: FLUSHING (non-serious), outcome "unknown".  Additional Information:.For the first dose, in 2021, I had some flushing. On my ears, and my nose was hot and red. Also, on my chest and neck. Later on, I felt extremely dizzy and extremely awkward for 2 or 3 days.For the second dose, I had the flushing again. No dizziness. I was curious, because I was kind of energized and there were no other symptoms other than the initial flushing.For the third dose I don't remember any particular symptom.Now, for the fourth dose, my last one, the flushing appeared once again. On my face and ears, and I didn't detect anything else.Within the next two weeks, after 20May2022 I've had severe cramping. My legs, calves, and feet. Also, hands and arms. It's random. It doesn't happen all the time, it's not continuous, but it's there every day.Caller stated that she also had these reactions when she received the flu vaccine.First dose she had blushing and dizziness. Second and third doses she didn't seem to have much of a reaction. Fourth dose there was something that kind of happened but she didn't think it was related to the vaccine but her doctor said it might be. Would Pfizer be able to say if it is likely her event was caused by the vaccine?.Product clarified to COVID-19 vaccine MRNA, Pfizer Inc from her vaccine card. On her vaccine card there is a number on there that says: EL9264. Caller does not know what that number is for, not indicated on her vaccine card. That is the only information on her vaccine card. COVID-19 vaccine MRNA cap color unknown by caller.Declined report and requested transfer to Medical Information.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: 2692147) for covid-19 immunisation. The patient's relevant medical history included: "stage 3 COPD" (ongoing), notes: Reporter said he is a husband and has a wife in ICU now due to complications. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The reporter (patient's husband) stated that his wife (patient) in ICU now due to complications of her stage 3 COPD and she tested positive for Covid-19. A 74 year old husband stated his wife is 3 years older than him and she is on 3 liters of oxygen all the time and her medications. The reporter stated wife has received Pfizer Covid-19 vaccines.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Generalised tonic-clonic seizure, SARS-CoV-2 test negative
Clinical narrative: Tonic Clonic Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 3, BOOSTER SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1 , MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant) with onset 09Oct2022 at 20:15, outcome "unknown", described as "Tonic Clonic Seizure". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 1 day(s)). The event "tonic clonic seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Negative.  Clinical course: The patient received more than 3 dose. The most recent dose is of Pfizer dose 4 (Lot unknown reason: Not available/provided to reporter at the time of report completion) is bivalent on 29Sep2022. There was no other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination on 09Oct2022 was negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.1 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heart valve incompetence
Clinical narrative: leaky heart valve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2), 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: HEART VALVE INCOMPETENCE (medically significant), outcome "unknown", described as "leaky heart valve". Clinical course: Agent relayed she had a patient on the line regarding Pfizer Covid 19 vaccine that she received Sep2021. Wanted to report side effects. The caller's best friend who was younger than her has side effect of leaky heart. Reported that every single person in her workplace had an adverse reaction or someone in their family had an adverse reaction. Mentioned stroke and heart attack. Mentioned trying to call VAERS and can't get to them and agent informed caller that is CDC, not Pfizer. During report caller confirmed her best friend got a leaky heart valve. Does not want follow up as she does not have her permission to share information. States she was the same age as her. Believed she had Pfizer Covid 19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), 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 immunization. The patient's relevant medical history included: "hypercholesterolemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN [OLMESARTAN MEDOXOMIL] oral, start date: 01Mar2021, stop date: 12Oct2022; ATORVASTATIN oral, start date: 01Mar2017, stop date: 28Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: Confirmed positivity with RT-PCR; (30Sep2022) Positive, notes: After testing positive on 30Sept2022 on rapid antigen test; (10Oct2022) Positive, notes: Positive rapid antigen test on 10Oct,11Oct2022; (11Oct2022) Positive, notes: Positive rapid antigen test on 10Oct,11Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Vertigo
Clinical narrative: vertigo just got a lot worse after received the second dose; balance issue; 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.  A 77-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Periods of vertigo" (unspecified if ongoing), notes: Has had vertigo for years.; "balance issue" (unspecified if ongoing), notes: she doesn't have hearing disturbances, 40 years ago and it did go away in past. Concomitant medication(s) included: PREMARIN. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "not recovered", described as "vertigo just got a lot worse after received the second dose"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance issue".  Additional information: She experienced on her last dose of Pfizer COVID-19 vaccine, periods of vertigo and wanted to know if anyone else has reported this before. Received two doses of the Pfizer Covid 19 Vaccine. The first dose Pfizer COVID-19 Vaccine was a while back actually. The second dose Pfizer COVID-19 Vaccine was received a few months ago. Caller is thinking about getting a third dose of the Pfizer COVID-19 Vaccine because is old and has been around a lot of people who have COVID lately. Caller also clarified that she doesn't have any hearing disturbances, but she has balance issue. She said that she had this 40 years ago and it did go away in the past, and now have experience it but it does not go away. Patient also receives Premarin Cream through the Patient Assistance Program: Receiving Premarin Cream through the Patient Assistance Program is why the caller contacted Pfizer originally.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 positive; COVID 19 positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207), on 06Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 02Dec2021 as dose 3 (booster), single (Lot number: 552590), in left arm and on 19May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 63 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: COVID-19 (medically significant) with onset 02Oct2022, outcome "not recovered", described as "COVID 19 positive"; VACCINATION FAILURE (medically significant) with onset 02Oct2022, outcome "not recovered", described as "COVID 19 positive ". The patient underwent the following laboratory tests and procedures: Body temperature: (10Oct2022) 101, notes: fever of 101; SARS-CoV-2 test: (02Oct2022) Positive; (08Oct2022) Negative; (10Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was COVID 19 positive on 02Oct2022. She took Paxlovid for 5 days as directed. She then tested negative on 08Oct2022 and felt great. On 10Oct2022, she felt really sick again with a fever of 101 and tested positive.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He and his wife took the Pfizer vaccine and it caused them to have cardiomyopathy and they got the covid virus; He and his wife took the Pfizer vaccine and it caused them to have cardiomyopathy and they got the covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) 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 "He and his wife took the Pfizer vaccine and it caused them to have cardiomyopathy and they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: He and his wife took the Pfizer vaccine and it caused them to have cardiomyopathy and they got the covid virus. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient had heart problems and skin eruptions since she had taken the vaccine and documented everything with Pfizer and the Regulatory Authority. Patient was spending 600 dollars a month on heart medicine. Patient had no lots for anyone else other than herself for the Pfizer or Moderna vaccines and had no expiry dates or NDC numbers to provide. Stated she did provide this information 40 times and she took the same lot on the same day of the vaccine and that was EN6207 and her second dose was the lot number of ER8734 and she screwed up and got the second vaccine. It was reported the vaccine product had a bad batch of vaccine and she does not know if she got that bad batch or not, but it caused major problems of blood clots and has clots in her lungs and legs. Patient took the Pfizer vaccine and it caused her to have cardiomyopathy and she got the covid virus which caused problems and Paxlovid was only 3% effective in helping with the covid virus and after she met with the cardiologist, they were going to put her in the hospital and give her Tikosyn, and Pfizer made the vaccine, made Paxlovid and may make Tikosyn too and not one of those products work. She had no lot numbers, expiry dates or NDC numbers to provide for the Tikosyn or the Paxlovid as she refused to take those products. There was a product complaint to this report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225643 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: My upper back felt like it was on fire. Like something was activating. I felt my body fighting something. Ended up in the hospital.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: Ew0173), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Long covid" (unspecified if ongoing), notes: Other medical history: Long covid; "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "PPD" (unspecified if ongoing), notes: Maybe samll dose of Zoloft for ppd. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot Number was Ew0187, Vaccine location was right arm), for COVID-19 immunization. The following information was reported: BACK PAIN (hospitalization, disability) with onset 12Jun2022, outcome "recovered with sequelae", described as "My upper back felt like it was on fire. Like something was activating. I felt my body fighting something. Ended up in the hospital.". The event "my upper back felt like it was on fire. like something was activating. i felt my body fighting something. ended up in the hospital." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Magnetic resonance imaging: Unknown results; Ultrasound scan: Unknown results, notes: they don't know what's wrong. Therapeutic measures were taken as a result of back pain.  Clinical information: My upper back felt like it was on fire. Like something was activating. Patient felt my body fighting something. Ended up in the hospital. Patient have been in and out of the hospitals, mris, cat scans, zrays, ultra sounds they don't know what's wrong.AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage.If covid prior vaccination was yes and if covid tested post vaccination was no.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 79-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. Concomitant medication(s) included: SYNTHROID; DUTASTERIDE; LIPITOR; PROZAC; B12 [CYANOCOBALAMIN]; PREGABALIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DONEPEZIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received vaccine. The patient received other medication in two weeks. Synthoid, Dutesteride, Lipitor, Prozac, B12, pregabalin, Zyrtec and donepezil. The patient experienced Full itchy body rash on 03Oct2022 with outcome Not Recovered. The patient received Oral Prednisone as a treatment for Full itchy body rash. The patient received Paxlovid as Covid-19 treatment from 01Oct2022 to 03Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK 9231), in right arm, on 04Feb2021 as dose 2, single (Lot number: EN 5318), in right arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 019F21H), in right arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 83 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; FISH OIL; FINASTERIDE; GLUCOSAMINE; MONTELUKAST; OMEPRAZOLE; TAMULOSIN; SYMBICORT; VITAMIN C [ASCORBIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12Oct2022) Positive, notes: Retested positive 24 hours after last dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: The reporter stated, Patient received paxlovid  as treatment medication. The patient received vaccine and other medicines within in two weeks. The patient did not experienced any chronic health conditions as medical history.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech - Dose number: 4 / Moderna - Dose number: 2; 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 26Feb2021 as dose 2, single (Lot number: 002A21A), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 011F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Just dry eyes for which I take Xiidra" (unspecified if ongoing), notes: Just dry eyes for which I take Xiidra. Concomitant medication(s) included: XIIDRA taken for dry eye; TURMERIC [CURCUMA LONGA RHIZOME]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Jun2022, outcome "unknown", described as "Pfizer / BioNTech - Dose number: 4 / Moderna - Dose number: 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 26Sep2022 to 01Oct2022.  Clinical course: Patient had no known allergies. patient received Other medication in 2weeks.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: experienced swelling/Patient is still swollen on left breast/swelling on breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "both breasts removed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST SWELLING (non-serious), outcome "unknown", described as "experienced swelling/Patient is still swollen on left breast/swelling on breast".  Additional Information: Proprietary medicinal product name was Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. It was reported that the Patient had both breasts removed, and experienced swelling after the vaccine. Other Conditions, other products and investigations were not provided. COVID-19 vaccine manufacturer was unspecified. NDC number and Expiry Date of COVID-19 vaccine was unknown. Reason for no lot number of COVID-19 vaccine was Complainant does not have the product with them at the time of call. The patient that reporter mentioned was not a blood relative, but a family member and had swelling on breast on the side where the shot was given, but that was not reporter, reporter had no swelling. Thought patient was a year older than reporter, so patient should be 79 years old. Patient was told not to get any more of the vaccine in the arm, was told to get things in the hip, hard time getting someone to give vaccines in hip. Patient found someone to give vaccines in patient's hip. Should everyone be getting vaccines in hip. Patient never had cancer of breasts, nothing, just a low thing, patient just had BRCA in the family. Patient was still swollen on left breast, got shot on left side. Hard for patient to wear clothes. Confirmed patient had breasts removed prior to receiving the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle enzyme
Clinical narrative: Legs felt funny; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: Rheumatoid arthritis diagnosed 5 year ago. The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 18Apr2021, outcome "unknown", described as "Legs felt funny". The event "legs felt funny" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb discomfort.  Additional information: There was no family medical history relevant to AE(s) reported. No other products administered. The reporter reported about his wife that she had the first COVID19 vaccine and her leg felt funny. They didn't know the vaccine was causing it. She was seeing a rheumatologist that said never get another COVID vaccine and to report this. The rheumatologist does video conferences with doctors around the country. The rheumatologist said that half of the doctors are saying that they believe it is from the vaccine and the other half are on the fence. The next step is to go for a biopsy because none of the medicines are working. No further details provided. Since first COVID19 vaccine, no other vaccines besides COVID19 vaccine. No additional vaccines administered on same date of the Pfizer suspect. It was hard to read on the card because they wrote it. Reporter can't read the NDC/lot/exp for the first or second doses on the card.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: entire right arm aches from injection site to tips of her fingers; entire right arm aches from injection site to tips of her fingers; All over aches that didn't go away stronger at the joints; All over aches that didn't go away stronger at the joints; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 10:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gastroesophageal reflux disease (Gerd)" (unspecified if ongoing); "Attention-deficit/hyperactivity disorder (ADHD)" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Supraventricular (SVT) arrhythmia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "thrombocytosis" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "iron deficiency anemia" (unspecified if ongoing). Concomitant medications included: IRON; PROBIOTICS; ASPIRIN [ACETYLSALICYLIC ACID]; ADDERALL; DEXILANT. Past drug history included: Augmentin, reaction: "allergy", notes: known allergies. 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: PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 12Oct2022 at 12:00, outcome "not recovered" and all described as "All over aches that didn't go away stronger at the joints"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 12Oct2022 at 12:00, outcome "not recovered" and all described as "entire right arm aches from injection site to tips of her fingers". The events "entire right arm aches from injection site to tips of her fingers" and "all over aches that didn't go away stronger at the joints" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, pain, arthralgia, which included unspecified pain relievers.  Additional information: The vaccination facility was a hospital. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash erythematous, Skin disorder, Vitiligo
Clinical narrative: Sudden onset of skin issues; Red itchy rash that calmed followed by white patches; Intensified by sunlight; vitiligo/calmed followed by white patches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 09:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN + HIDROCLOROTIAZIDA. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 28Feb2021, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9263, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (disability) with onset Feb2022, outcome "not recovered", described as "Intensified by sunlight"; RASH ERYTHEMATOUS (disability) with onset Feb2022, outcome "not recovered", described as "Red itchy rash that calmed followed by white patches"; SKIN DISORDER (disability) with onset Feb2022, outcome "not recovered", described as "Sudden onset of skin issues"; VITILIGO (disability) with onset Feb2022, outcome "not recovered", described as "vitiligo/calmed followed by white patches". The events "sudden onset of skin issues", "red itchy rash that calmed followed by white patches", "intensified by sunlight" and "vitiligo/calmed followed by white patches" required physician office visit.  Clinical course: Adverse event: Dr. suspects vitiligo. Adverse event start time: 06:00 AM. The patient did not receive any other vaccine in four weeks. Other medications in two weeks: Losartan- HCTZ 50-12.5. If covid prior vaccination: No. If covid tested post vaccination: No. The patient received fourth dose of BNT162b2 (Lot Number: FM0173) on 11Jul2022 at 10:00 AM, in right arm and fifth dose of BNT162b2 (Lot number: GJ2524) on 06Oct2022 at 09:15 AM, in left arm for Covid-19 immunization.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: four earlier Pfizer COVID vaccines, I had fevers the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: she just takes an unspecified thyroid medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1,, Lot/Batch Number: EP6955,, Anatomical Location: Unknown), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "Fever". The following information was reported: PYREXIA (non-serious) with onset 16Apr2021, outcome "unknown", described as "four earlier Pfizer COVID vaccines, I had fevers the next day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Fever: Experienced this on the day after her second dose of the vaccine; 16Apr2021. Second Dose of the Pfizer Covid 19 Vaccinee: Received by the caller on 15Apr2021; NDC and Expiry Date: Unknown; Lot Number: Reported by the caller as being either CRM29 or LRM29; Anatomical Location: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Off label use, Product use issue, Urticaria
Clinical narrative: Urticaria onset Day 4 generalized upper extremities and face; Pfizer COVID vaccine (01Oct2022 11:00) administered with Influenza vaccine (01Oct2022); Pfizer COVID vaccine (01Oct2022 11:00) administered with Influenza vaccine (01Oct2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 01Oct2022 as single dose (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Oct2022, outcome "unknown" and all described as "Pfizer COVID vaccine (01Oct2022 11:00) administered with Influenza vaccine (01Oct2022)"; URTICARIA (non-serious) with onset 05Oct2022 at 18:00, outcome "recovered" (Oct2022), described as "Urticaria onset Day 4 generalized upper extremities and face". Therapeutic measures were taken as a result of urticaria. Additional information: Treatment for urticaria included unspecified antihistamines. The patient has no covid prior to vaccination. The patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; fever 99-102 over 24hrs; body ache; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 09:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; AMLODIPINE; LOSARTAN; XANAX. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline"; Celebrex, reaction(s): "Known allergies: Celebrex". Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series completed, Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering", described as "Arm soreness"; PAIN (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering", described as "body ache"; CHILLS (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering"; PYREXIA (non-serious) with onset 11Oct2022 at 19:00, outcome "recovering", described as "fever 99-102 over 24hrs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, pain, chills. Additional information: The patient had no other vaccine in four weeks. The patient had no covid prior vaccination and was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 63-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ep6955), in left arm, on 16Apr2021 as dose 2, single (Lot number: ew0162,), in left arm, on 17Oct2021 as dose 3 (booster), single (Lot number: fe359u), in left arm and on 03May2022 as dose 4 (booster), single (Lot number: fj9934), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fib" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergy. Rebound COVID 4 days after last dose and 2 negative rapid tests.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 15:00 as dose 1, single (Lot number: EN 6203), in left arm, on 18Mar2021 at 15:00 as dose 2, single (Lot number: ER 8727), in left arm, on 28Sep2021 at 14:30 as dose 3 (booster), single (Lot number: FE 2592), in left arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FJ 4991) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergy: Sulfa drugs" (unspecified if ongoing), notes: known allergy: Sulfa drugs; "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "obesity" (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 Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) positive, notes: tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as anti-viral drug Paxlovid.