chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: BCG
Symptoms: Mycobacterium test positive, Mycobacterium tuberculosis complex test positive, Norovirus test positive, Pyrexia, Renal impairment
Clinical narrative: Patient diagnosed with extrapulmonary tuberculosis; Positive Quantiferon gold (thought to be secondary to BCG vaccine); Information has been received from the authors in the published literature article entitled as stated below, referring to a 48-year-old male with a history of type 1 diabetes complicated by end-stage renal disease status post kidney and pancreas transplants (performed on an unspecified date reported as 5 years ago). The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with bcg live (manufacturer unknown) administered for tuberculosis bladder (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient had taken a Quantiferon gold test that resulted positive and was thought to be secondary to bcg live (manufacturer unknown) vaccine. Afterwards, on an unspecified date (reported as for the past 7 months), the patient experienced chronic diarrhea, abdominal pain, and weight loss, so he was admitted to hospital. Initial infectious work-up was positive for norovirus and entamoeba histolytica. On an unknown date (reported as hospital day 3), he developed fevers and hemorrhagic shock, and an urgent colonoscopy revealed multi-focal large ulcers throughout the colon evidencing pan-colitis. Additional biopsies showed granulomas, positive acid-fast bacilli (AFB) stain for AFB, and positive mycobacterium bovis on AFB culture. Finally, the patient was diagnosed with extrapulmonary tuberculosis (TB) and started anti-TB therapy with rifabutin, isoniazid, pyrazinamide, and ethambutol. He initially improved, but subsequently had multiple complications including transaminitis concerning for hepatoxicity and worsening renal function from hemorrhagic shock caused by a bleeding mesenteric artery; therefore, the anti-TB regimen was held. The reproted complications significantly impacted drug levels as well as the dosing of anti-TB medications and immunosuppressants. After clinical stabilization, improvement in renal function and transaminitis, he was re-started on anti-TB medications in a step-wise approach. According to the authors, the patient improved with anti-TB treatment. Pulmonary TB was ruled out with AFB sputum and mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR). The patient was eventually discharged on anti-TB medications and close follow-up.  The reporting authors of the article described extrapulmonary tuberculosis diagnosis in the context of a previous bcg live (manufacturer unknown) vaccine administration.  Upon internal review, extrapulmonary tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
Sex: M
Vaccine: BCG
Symptoms: Shock haemorrhagic, Weight decreased
Clinical narrative: Patient diagnosed with extrapulmonary tuberculosis; Positive Quantiferon gold (thought to be secondary to BCG vaccine); Information has been received from the authors in the published literature article entitled as stated below, referring to a 48-year-old male with a history of type 1 diabetes complicated by end-stage renal disease status post kidney and pancreas transplants (performed on an unspecified date reported as 5 years ago). The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with bcg live (manufacturer unknown) administered for tuberculosis bladder (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient had taken a Quantiferon gold test that resulted positive and was thought to be secondary to bcg live (manufacturer unknown) vaccine. Afterwards, on an unspecified date (reported as for the past 7 months), the patient experienced chronic diarrhea, abdominal pain, and weight loss, so he was admitted to hospital. Initial infectious work-up was positive for norovirus and entamoeba histolytica. On an unknown date (reported as hospital day 3), he developed fevers and hemorrhagic shock, and an urgent colonoscopy revealed multi-focal large ulcers throughout the colon evidencing pan-colitis. Additional biopsies showed granulomas, positive acid-fast bacilli (AFB) stain for AFB, and positive mycobacterium bovis on AFB culture. Finally, the patient was diagnosed with extrapulmonary tuberculosis (TB) and started anti-TB therapy with rifabutin, isoniazid, pyrazinamide, and ethambutol. He initially improved, but subsequently had multiple complications including transaminitis concerning for hepatoxicity and worsening renal function from hemorrhagic shock caused by a bleeding mesenteric artery; therefore, the anti-TB regimen was held. The reproted complications significantly impacted drug levels as well as the dosing of anti-TB medications and immunosuppressants. After clinical stabilization, improvement in renal function and transaminitis, he was re-started on anti-TB medications in a step-wise approach. According to the authors, the patient improved with anti-TB treatment. Pulmonary TB was ruled out with AFB sputum and mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR). The patient was eventually discharged on anti-TB medications and close follow-up.  The reporting authors of the article described extrapulmonary tuberculosis diagnosis in the context of a previous bcg live (manufacturer unknown) vaccine administration.  Upon internal review, extrapulmonary tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: Vision loss; Multiple outbreaks of herpes zoster; Multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information has been received regarding the pt.'s past medical history, concurrent conditions, or concomitant medication.  On an unknown date,  the pt was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration lot number and expiry date were not provided) for routine health maintenance and prophylaxis.  After receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster (herpes zoster and herpes zoster reactivation) and loss of vision. As a result of these symptoms, the pt was seen and treated by medical providers and was still under care. As a direct and proximate result of the  vaccine, the pt symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of pt condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the vaccine the pt sustained severe and permanent personal injuries and  serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Also the pt  had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.The outcome of blindness and herpes zoster reactivation was reported as not recovered/not resolved.   The reporter considered blindness and herpes zoster reactivation to be related to Zoster Vaccine Live(ZOSTAVAX).  The event blindness was consider to be medically significant.
Age: 76.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Abdominal pain upper, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: I had something that felt like I was punched in the stomach so my stomach is real sore; so I do have pain already in that area but now it is like worse; I have had one that was really bad in my arm but at the injection point it went all the way down my arm to my fingers; This spontaneous report has been received from a consumer, concerning herself a 76-years-old white female patient. The patient's concurrent conditions included osteoporosis, mitral valve prolapse, neuropathic pain, and non-ulcer dyspepsia. Her medical history, previous drug reactions, and allergies were not provided.   On an unspecified date in 2012, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (conflicting information reported as Prevnar 23) injection, as prophylaxis (strength, dose, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided). On the same date she was vaccinated with pneumococcal vaccine conj 13v (PREVENAR 13) (formulation, strength, dose, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided). Later, on an unspecified date in 2022 (reported as "in 10 years"), when she went to receive her flu shot (not specified) she also received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23).  On an unknown date, the patient experienced really bad pain at the site of injection (vaccination site pain) in her arm which went all the way down to her fingers and noted she had never had that. In addition, she felt like she was "punched in her stomach" so her stomach was sore (abdominal pain upper). Moreover, the reporter mentioned that due to her current condition of neuropathic pain, she presented with pain in the area, however now it has gotten worse (neuralgia). She also mentioned she was "pretty healthy" for her age and was inquiring if having received an extra dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) could cause her any side effects. At the time of reporting, the patient had not recovered from neuralgia and abdominal pain upper, as for vaccination site pain the outcome was unknown.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE details were provided and no additional AE's were reported.; Patient that received a dose of PROQUAD intramuscularly instead of subcutaneously.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 19-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliters, intramuscularly,  lot number U019288 had been verified to be a valid number; expiration date 15-DEC-2022, and upon internal validation established as the same date, for prophylaxis (vaccination scheme, frequency, and anatomical site of injection were not reported), the vaccination was intramuscularly instead of subcutaneously (incorrect route of product administration).
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects; Pharmacist states she accidently gave an expired dose of MMR-II because she looked at the lot and expiration for sterile diluent but not MMR-II.; This spontaneous report has been received from a pharmacist, referring to a 30-year-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On 20-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 milliliter subcutaneously (lot number T034380 has been verified to be a valid lot number, expiry date 08-OCT-2022) (expired product administered) concomitantly with the sterile diluent, indicated as prophylaxis.  No additional adverse events were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned an 82 year old male of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-Hodgkin lymphoma (compromised immune system due to a rare blood cancer). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1708609 and expiry: UNKNOWN) dose was not reported, 1 total, primary dose administered in right arm on 23-MAR-2021 for covid-19 prophylaxis. On an unspecified date in NOV-2021 following vaccination with primary dose of covid-19 vaccine ad26.cov2.s, the patient had covid-19 with symptoms of coughing and tested positive for COVID-19 virus test on 08-NOV-2021 (confirmed covid-19 infection and confirmed clinical vaccination failure) (Dose number in series: 1). It was also reported that patient was home quarantined for 5 days (Date unspecified). On an unspecified date and month in 2021, the patient experienced COPD (Chronic obstructive pulmonary disease) (Dose number in series: 1) and had received treatment with Doxycycline. The outcome of the confirmed clinical vaccination failure, confirmed covid-19 infection and COPD were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: UNKNOWN) dose was not reported, 1 total, first booster administered in right arm on 07-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 82 years old. No concomitant medications were reported. On an unspecified date in FEB-2022 following vaccination with covid-19 vaccine ad26.cov2.s (first booster), the patient experienced diarrhea and viral infection, and tested positive for COVID-19 virus test which was confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000256360. This case, involving the same patient is linked to 20211208454 (Dose number in series 1) and 20221046895 (Dose number in series 3).; Sender's Comments: V0: 20221045009-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.; This vial was removed from the freezer to the refrigerator on 9/2/22.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.), PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.), PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered on 18Oct2022 with bivalent booster dose which was beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (This vial was removed from the freezer to the refrigerator on 9/2/22.).    No Concomitant medication was reported.  It was reported that vial was removed from the freezer to the refrigerator on 9/2/22.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661812 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Non-Significant Followup received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661812:Bivalent Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was at room temperature for 25 hours; No Adverse event; Bivalent vaccine given to patient from a vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours).    Patient was over the age of 65. No concomitant information was reported. The size of the vial was 5.5ml. The vial was initially stored in the refrigerator on 12-Oct-2022. The date and time vial was first punctured on 19-Oct-2022 at 10:00am. The vial was administered to 3 different patients on 20-Oct-2022 at 10:13,10:15 and 11:00 respectively.  The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range was just over 25 hours. This case was for 3rd patient out of 3 patient which reported by reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661792, US-MODERNATX, INC.-MOD-2022-661788  Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661792:patient 2 US-MODERNATX, INC.-MOD-2022-661788:Patient 1
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna/dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 14:00 as dose 5 (booster), single (Lot number: Czm970z) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9267), in left arm and on 06Mar2021 as dose 2, single (Lot number: EN6200), in right arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 28May2022 as dose 3 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild emphysema" (unspecified if ongoing), notes: Mild emphysema; "Graves disease" (unspecified if ongoing); "Subarachnoid haemorrhage (SAH)" (unspecified if ongoing); "Transient ischemic attack (TIA)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28May2022, outcome "unknown", described as "vaccine brand other: Moderna/dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; Paxlovid 20 was taken from 05Oct2022 till 10Oct2022. Details were as follows: event was noted as COVID rebound, runny nose, and a positive test on 14Oct2022 at 08:00 am.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Insomnia, Night sweats, SARS-CoV-2 test
Clinical narrative: the entire night after the vaccinations I was sweating very much; next day may portable EKG machine show a very disturbed heartbeat not an arrhythmia but constant disrupted beat and I felt my heart strange beat; I couldn't sleep at all last night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 18:30 as dose 5 (booster), single (Lot number: GJ6739), in left arm for covid-19 immunisation. The patient's relevant medical history included: "I was Covid positive first week of May 2022", start date: May2022 (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: flu vaccine vii, administration date: 27Sep2022, for Immunisation; Covid-19 vaccine (Dose 4 Booster), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Booster), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 15Oct2022 at 12:00, outcome "not recovered", described as "I couldn't sleep at all last night"; HEART RATE IRREGULAR (non-serious) with onset 15Oct2022 at 12:00, outcome "not recovered", described as "next day may portable EKG machine show a very disturbed heartbeat not an arrhythmia but constant disrupted beat and I felt my heart strange beat"; NIGHT SWEATS (non-serious) with onset 15Oct2022 at 12:00, outcome "not recovered", described as "the entire night after the vaccinations I was sweating very much". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported entire night after the vaccinations she was sweating very much and needed to change her PJ. She slept 10 hrs (in general  she was a very weak sleeper up to 5-6 hrs). The next day her portable EKG machine show a very disturbed heartbeat not an arrhythmia but constant disrupted beat. This continued for the next following day (Sunday). There was a slow hear improvement but yesterday (3 day after the injection) but still not normal. She still sweat a lot at night, and on the contrary, She could not sleep at all last night.  She felt her heart strange beat.  She wish she never took this new vaccination as she concern that affected her heart. The patient had received other vaccine in four weeks included flu vaccine vII on 27Sep2022, administration date: 27Sep2022. Other medications in two weeks  included Metoprolol 12.5 mg per day. The patient had covid prior to vaccination. The patient had not tested covid post vaccination. The patient had no known allergy.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: fever; extreme chills; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sensitive to chemicals" (unspecified if ongoing), notes: He mentioned that he is always on the outside of the reactions and that he is sensitive to chemicals. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, He added that he already received 3 other boosters before this and the last booster received was last Feb2022), for COVID-19 immunization; Covid-19 vaccine (1st booster,He added that he already received 3 other boosters before this and the last booster he received was last Feb2022), for COVID-19 immunization; Covid-19 vaccine (2nd Booster, He added that he already received 3 other boosters before this and the last booster he received was last Feb2022), for COVID-19 immunization; Covid-19 vaccine (3rd Booster, He added that he already received 3 other boosters before this and the last booster he received was last Feb2022), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Oct2022, outcome "unknown", described as "extreme chills"; PYREXIA (non-serious) with onset 14Oct2022, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: HCP called for patient regarding the Pfizer Covid19 vaccine bivalent booster dose. Caller stated that he received the booster dose 8 days ago, 10Oct2022 and 4 days after he developed fever and extreme chills. He added that he already received 3 other boosters before this and the last booster he received was last Feb2022. He mentioned that he was feeling good the first several days after receiving the vaccine, however, for the last 4 days, he was confined in his home with fever and extreme chills. He just recently taken note of his temperature, just this last 2 days. He also mentioned that he was still able to go on hiking last Sunday. He wanted to know if these SEs his been feeling are reported side effects, considering the duration of the SEs.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: every time I got a vaccine or a booster, my PSA readings go up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "PSA increase"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up". The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "every time I got a vaccine or a booster, my PSA readings go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that he had 2 vaccines and 2 boosters and then the paxlovid, every time he got a vaccine or a booster, his PSA readings go up because he contracted Covid 19, he have a chart. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. He took Paxlovid took 2 months ago, on 12Aug2022 also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: She had no problems with the first dose, there was a bit of sore arm. Event did not require a visit to Emergency Room or Physician Office. No additional Vaccine was administered on Same Date of the Pfizer Suspect. Patient had no prior Vaccinations (within 4 weeks). Patient had no other Conditions. No Investigation or relevant tests were conducted. The report was not related to a study or programme.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: My knees hurt real bad; my lower legs are swollen up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Bnt162b2 (DOSE 2, SINGLE, (again confirmed the name of vaccine as Pfizer Covid-19 vaccine: Consumer stated, "Yes, I had both the vaccines and one booster.")), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, (again confirmed the name of vaccine as Pfizer Covid-19 vaccine: Consumer stated, "Yes, I had both the vaccines and one booster.")), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "My knees hurt real bad"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "my lower legs are swollen up".  Additional information: The patient was also the reporter. This report was not related to a study or programme. Covid-19 vaccine was a Pfizer product, manufacturer was unspecified. Patient characteristics, batch/lot number, NDC, UPC number and expiry date of Covid-19 vaccine was unknown. The reporter wanted to know the symptoms about the reaction to the virus shot and the side effect to the Pfizer shot. The patient had taken both the vaccines and one booster. The Patient knees hurt real bad and lower legs were swollen up and wanted to get it fixed, purchase details and other details were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: nauseated; Extreme headache; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 01; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 02; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 03; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Oct2022 at 22:45, outcome "recovering", described as "Extreme headache"; CHILLS (non-serious) with onset 18Oct2022 at 22:45, outcome "recovering"; PYREXIA (non-serious) with onset 18Oct2022 at 22:45, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 18Oct2022 at 22:45, outcome "recovering", described as "nauseated". Therapeutic measures were not taken as a result of nausea, headache, pyrexia, chills. Additional information: The patient did not receive any other vaccines within four weeks or any other medications in two weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
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: 4: Pfizer / Dose Number: 3: Moderna / Dose Number: 2: Moderna/ Dose Number 1: Moderna; This is a spontaneous report received from 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 21Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FW1333) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Feb2021 as dose 1, single (Lot number: 032L28A), on 08Mar2021 as dose 2, single (Lot number: 014M20A) and on 16Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 014F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: FLUOXETINE, start date: Jan1993; CRESTOR, start date: Jan2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022 at 12:00, outcome "unknown", described as "Dose Number: 4: Pfizer / Dose Number: 3: Moderna / Dose Number: 2: Moderna/ Dose Number 1: Moderna"; DRUG INEFFECTIVE (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: (Oct2022) Negative, notes: tested twice 48 hrs apart with Binax home antigen and was negative on day 9 and 11 of Covid; (Oct2022) Negative, notes: tested twice 48 hrs apart with Binax home antigen and was negative on day 9 and 11 of Covid; (Oct2022) Positive, notes: now positive 2 days later with sore throat, nasal congestion, muscle aches; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient took other medications in two weeks. The patient took Anti-viral treatment from 01Oct2022 to 06Oct2022 for treatment of Covid-19.
Age: 37.0
Sex: M
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: 2:Pfizer / Dose Number: 1:Janssen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 2 (booster), single (Lot number: Fj8757) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 02Apr2021 as dose 1, single (Lot number: 043 A21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 2:Pfizer / Dose Number: 1:Janssen". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: testing negative two consecutive days; (unspecified date) Negative, notes: testing negative two consecutive days; (Oct2022) Positive, notes: COVID returned 7-8 days after finishing my last dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: COVID returned 7-8 days after finishing my last dose of Paxlovid and testing negative two consecutive days. Patient received Paxlovid  as COVID 19 Treatment.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident, Off label use, Product use issue
Clinical narrative: Vaccine received 13Sep2022. I suffered a stroke on 30Sep2022; Additional Vaccines Administered on Same Date of the Pfizer Suspect: Flu Vaccine; Additional Vaccines Administered on Same Date of the Pfizer Suspect: Flu Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 18:30 as dose 1 (booster), single (Lot number: GH9702 CUS4521) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Sep2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "gerd" (unspecified if ongoing), notes: gerd. Concomitant medication(s) included: SYNTHROID; PANTOPRAZOLE. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 13Sep2022, outcome "unknown" and all described as "Additional Vaccines Administered on Same Date of the Pfizer Suspect: Flu Vaccine"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant, life threatening) with onset 30Sep2022, outcome "recovering", described as "Vaccine received 13Sep2022. I suffered a stroke on 30Sep2022". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 4 day(s)). The event "vaccine received 13sep2022. i suffered a stroke on 30sep2022" required emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: Patient was treated received tPA clot buster medicine to treat event. Patient did not receive other vaccines in four weeks. Prior to vaccination the patient did not diagnose with COVID-19. If patient tested for Covid-19 post vaccination was reported as unknown.  No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac disorder, Drug ineffective
Clinical narrative: she once developed COVID-19; she once developed COVID-19; have significant heart disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she once developed COVID-19"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "have significant heart disorder".  Clinical course: Patient reported that she received the Pfizer COVID-19 booster, the 3 or 4 doses, she was not able to confirm if she received 3 or 4 doses. She informed to have significant heart disorder. She mentioned had a lot of problems and that she had to travel by plane and that she was afraid on planes. She mentioned that she knew that she did not had COVID-19 because she was tested and she was discharged from the hospital 15 days ago. She stated that she read a press release that Pfizer now has a drug for patients who catch COVID-19. Is that correct? Patient asked "do she had to buy some before she go to foreign city?". She also mentioned understanding that the medicine was to avoid being isolated for 10 days. She mentioned that she had to took 2 or 3 heart medications (she named one of the medications but unable to fully understand the name) and that she was a patient of professor. She mentioned that she once developed COVID-19 after moving by bus which she described as 'very light fortunately and now she had vaccinated. She had a pacemaker, a valve, and 2.5 cm hole in the heart that had been patched, she had a monitoring device that records all the data from the pacemaker and sends it to the scientific research center. She was worried because she heard a lot who was flying, who was going up did not had COVID and who was coming down and had COVID-19. She insisted on the fact that she already had a lot of health disorders. Patient asked "What should she do? Do she keep the mask on the plane?"  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: Blister, Eczema, Temporomandibular joint syndrome
Clinical narrative: eczema got worse than before the vaccine; TMJ was exacerbated; blistering on his fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic Lyme's disease", start date: 1999 (unspecified if ongoing), notes: he has had chronic Lyme's disease since 1999 but was only diagnosed on 2013. The patient's concomitant medications were not reported. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "eczema got worse than before the vaccine"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), outcome "unknown", described as "TMJ was exacerbated"; BLISTER (non-serious), outcome "unknown", described as "blistering on his fingers".  Clinical course: Reporter was asking about Paxlovid and explains that he has had chronic Lyme's disease since 1999 but was only diagnosed in 2013 when he pulled a tick out of his leg which he actually got very sick with flu like symptoms for. He stated that his lyme disease presents itself as eczema on his fingers that are brutal have not gone away since 1999. He mentioned that his doctor put him on and off different antibiotics (such as Doxycycline) from 2013. Reporter shared that the eczema on his fingers worsens as the seasons transition and that typically there was only little eczema on the months of Jun, July, Aug, Sep and at the onset of October onwards it got worse. Now, reporter reported that after he got his Pfizer covid 19 shots on Mar2021 and Apr2021, and eventually the booster dose on Nov2021, reporters eczema and TMJ was exacerbated. He reported that his eczema got worse than before the vaccine and that he had blistering on his fingers. Then at around Jul this year, reporter was prescribed Paxlovid for 5 days by his doctor to try it out for his Lyme disease. Reporter then stated that when he used Paxlovid with another antibiotic Ceftin, his eczema healed but when he had to use Paxlovid with Amoxicillin his eczema came back, because of the success of his treatment his doctor had prescribed him again and again to take Paxlovid and is now on Day 39.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 04Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm 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 was not reported. There were no concomitant medications. Past drug history included: Erthromyicine, reaction(s): "Known allergies: Erthromyicine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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; (17Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and Paxlovid was used for treatment of COVID-19 from 08Oct2022 to 12Oct2022.  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.