chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood pressure measurement, Blood test, Cardiac failure congestive, Chronic kidney disease
Clinical narrative: chronic kidney disease; congestive heart failure; Lupus; This is a spontaneous report received from a Consumer. A 58-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Jun2022, outcome "not recovered", described as "Lupus"; CHRONIC KIDNEY DISEASE (hospitalization, medically significant) with onset 2022, outcome "unknown"; CARDIAC FAILURE CONGESTIVE (hospitalization , medically significant) with onset 2022, outcome "unknown", described as "congestive heart failure".  Clinical information: The patient had the first and second dose back in 2021. It was mentioned that the she developed chronic kidney disease. It was later narrated that the patient had never had an issue and she would always get her annual. Then, she started swelling and her blood pressure was going up and she was instructed to see her doctor. Her doctor told her to go to the emergency room (ER) immediately because she had fluid on her heart and lungs and her kidneys were not functioning properly. She went into the hospital in Sep2022 and was in there starting 22Sep2022 and was discharged until 21Oct2022. She was hospitalized for 23 days (as reported). The reason for the hospitalization was they told her it was chronic kidney disease and congestive heart failure. She also mentioned that she and her husband took a trip in Jun2022 and noticed that she had to keep trying to catch her breath while at the airport before. She did not think anything of it and thought she was just tired. She was told now she has Lupus and that was diagnosed while she was in the hospital (while still under the care of a nephrologist). They did a lot of testing and would draw blood and test her blood every day and her creatinine was so elevated it was over 5 and they thought they would have to put her on dialysis but put on her CYTOXAN. She was now on the preventative medication Mycophenolate Mofetil and still taking it.  The events "chronic kidney disease" and "congestive heart failure" required emergency room visit.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Systemic lupus erythematosus
Clinical narrative: chronic kidney disease; congestive heart failure; Lupus; This is a spontaneous report received from a Consumer. A 58-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Jun2022, outcome "not recovered", described as "Lupus"; CHRONIC KIDNEY DISEASE (hospitalization, medically significant) with onset 2022, outcome "unknown"; CARDIAC FAILURE CONGESTIVE (hospitalization , medically significant) with onset 2022, outcome "unknown", described as "congestive heart failure".  Clinical information: The patient had the first and second dose back in 2021. It was mentioned that the she developed chronic kidney disease. It was later narrated that the patient had never had an issue and she would always get her annual. Then, she started swelling and her blood pressure was going up and she was instructed to see her doctor. Her doctor told her to go to the emergency room (ER) immediately because she had fluid on her heart and lungs and her kidneys were not functioning properly. She went into the hospital in Sep2022 and was in there starting 22Sep2022 and was discharged until 21Oct2022. She was hospitalized for 23 days (as reported). The reason for the hospitalization was they told her it was chronic kidney disease and congestive heart failure. She also mentioned that she and her husband took a trip in Jun2022 and noticed that she had to keep trying to catch her breath while at the airport before. She did not think anything of it and thought she was just tired. She was told now she has Lupus and that was diagnosed while she was in the hospital (while still under the care of a nephrologist). They did a lot of testing and would draw blood and test her blood every day and her creatinine was so elevated it was over 5 and they thought they would have to put her on dialysis but put on her CYTOXAN. She was now on the preventative medication Mycophenolate Mofetil and still taking it.  The events "chronic kidney disease" and "congestive heart failure" required emergency room visit.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Illness, Immune system disorder, Loss of consciousness
Clinical narrative: Myocarditis; myocarditis, I am going to see a doctor on that now, it is getting worse; Pass out; Immune system is horrible; Vertigo; Dizzy; I am getting sicker; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2021 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: MYOCARDITIS (medically significant), outcome "unknown"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "myocarditis, I am going to see a doctor on that now, it is getting worse"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Pass out"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system is horrible"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; ILLNESS (non-serious), outcome "unknown", described as "I am getting sicker". Additional information: Consumer stated, "No, that was okay. I am just curious, how do I find out what was put in the COVID shot (Clarified as Pfizer COVID-19 Vaccine) that I took in 2021 because I am seeing a lot of bad reports about a lot of bad chemicals that were in that shot that shouldn't  have been in there and to be honest with you, do you have an antidote for it? Because I have been extremely unhealthy ever since I got that shot. No immune system, I am pretty sure I have myocarditis, I am going to see a doctor on that now, it is getting worse. I thought it would fade away, phase away but it is actually multiplying. My immune system is horrible. I get vertigo, I get dizzy, I pass out. I have got all kinds of complications from this so-called lifesaving vaccine shot, which actually we did not need. I do not know if you are aware of that. I am getting sicker every day. What is in it? I got to know because I have to get a doctor to get me antidote to get rid myself, this body before you turn on the 5G and everybody goes anybody, everybody goes mentally insane. We know it was all our hoax okay, so we will pass that part right, you know it was a hoax, right?"  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Vertigo
Clinical narrative: Myocarditis; myocarditis, I am going to see a doctor on that now, it is getting worse; Pass out; Immune system is horrible; Vertigo; Dizzy; I am getting sicker; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2021 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: MYOCARDITIS (medically significant), outcome "unknown"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "myocarditis, I am going to see a doctor on that now, it is getting worse"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Pass out"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system is horrible"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; ILLNESS (non-serious), outcome "unknown", described as "I am getting sicker". Additional information: Consumer stated, "No, that was okay. I am just curious, how do I find out what was put in the COVID shot (Clarified as Pfizer COVID-19 Vaccine) that I took in 2021 because I am seeing a lot of bad reports about a lot of bad chemicals that were in that shot that shouldn't  have been in there and to be honest with you, do you have an antidote for it? Because I have been extremely unhealthy ever since I got that shot. No immune system, I am pretty sure I have myocarditis, I am going to see a doctor on that now, it is getting worse. I thought it would fade away, phase away but it is actually multiplying. My immune system is horrible. I get vertigo, I get dizzy, I pass out. I have got all kinds of complications from this so-called lifesaving vaccine shot, which actually we did not need. I do not know if you are aware of that. I am getting sicker every day. What is in it? I got to know because I have to get a doctor to get me antidote to get rid myself, this body before you turn on the 5G and everybody goes anybody, everybody goes mentally insane. We know it was all our hoax okay, so we will pass that part right, you know it was a hoax, right?"  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Physician.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2024 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), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The clinical course was reported as follows: Reporter and her husband got covid so they both had nirmatrelvir, ritonavir (PAXLOVID). Had no lots, expiry dates or NDC numbers for her husband's vaccines to provide.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: had pain in her arms; felt sick like had the flu; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Lot number: EW0158) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing), notes: in 2019 prior to covid coming; "sick", start date: 2019 (unspecified if ongoing), notes: in 2019 prior to covid coming; "thinks it was early covid", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt sick like had the flu"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "had pain in her arms".  Additional information: There was more a long term reaction and short term reaction and had pain in her arms that lasted a little while and arm pain after being vaccinated and boosted that occurred after all three doses and she also felt sick like had the flu for about 24 hours.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Immune system disorder, Vertigo
Clinical narrative: heart problems; Vertigo; destroyed his immune system; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; VERTIGO (non-serious), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "destroyed his immune system".  Additional information: The patient asked if he was going to get an antidote for what it was done.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product preparation issue
Clinical narrative: Redness at the injection site lasting for >1 week; swelling the injection site lasting for >1 week; pain at the injection site lasting for >1 week; Subcutaneous injection in back of upper arm (after not having shaken the pre-filled syringe per PI); Subcutaneous injection in back of upper arm (after not having shaken the pre-filled syringe per PI); This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Jan2025 at 17:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years subcutaneous, in arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CENTRUM SILVER WOMEN 50+, start date: Jan2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: Oct2024; ZEPBOUND, start date: Sep2024; NADOLOL, start date: May2020; OMEPRAZOLE, start date: Jan2019; TYLENOL, start date: Sep2024; BUPROPION, start date: Apr2021; VITAMIN D2, start date: Apr2021. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 22Jan2025 at 17:30, outcome "unknown", INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Jan2025 at 17:30, outcome "not recovered" and all described as "Subcutaneous injection in back of upper arm (after not having shaken the pre-filled syringe per PI)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Jan2025, outcome "not recovered", described as "Redness at the injection site lasting for >1 week"; VACCINATION SITE PAIN (non-serious) with onset 23Jan2025, outcome "not recovered", described as "pain at the injection site lasting for >1 week"; VACCINATION SITE SWELLING (non-serious) with onset 23Jan2025, outcome "not recovered", described as "swelling the injection site lasting for >1 week". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain, incorrect route of product administration. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID after vaccines; COVID after vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after vaccines". The event "covid after vaccines" required physician office visit.  Clinical course: The patient just got out of the clinic and was told that he has COVID. So, he came to the pharmacy to get Paxlovid as prescribed, but it's too expensive. The patient has the insurance, but it's still too expensive. Patient is wondering if Pfizer could give him a coupon or maybe lower the price.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: get so far four times COVID vaccine by Pfizer/ have a COVID; get so far four times COVID vaccine by Pfizer/ have a COVID; This is a spontaneous report received from a Consumer, Program ID. A 59-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "get so far four times COVID vaccine by Pfizer/ have a COVID". Clinical information: It was reported that the patient COVID vaccine by the Pfizer for four times but got COVID. He was COVID positive right now and his doctor send a prescription of PAXLOVID (at three tablets in the morning and 3 tablet in the night) to the pharmacy. However, his insurance did not approve the prescription and was asking what to do.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Insomnia, Mobility decreased, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; developed extreme soreness in my upper arms and shoulders; severely restricted movements; sleepless nights; Initial information received on 25-Jan-2025 regarding an unsolicited valid serious case received from a Other health professional.  This case involves, an unknown age and gender patient who had polymyalgia rheumatica after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2024, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe produced by unknown manufacturer (lot UT8409AB) (unknown strength, dosage, expiry date and route) in unknown administration site for prophylactic vaccination.  On an unknown date in 2024, the patient developed polymyalgia rheumatica (unknown latency), extreme soreness in my upper arms and shoulders (arthralgia) (latency-Within one month), severely restricted movements (hypokinesia) and sleepless nights (insomnia) (unknown latency) following the administration of USP Trival A-B High Dose Subvirion Vaccine.  Reportedly, Patient believed that this resulted from the high dosage of the vaccine.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  Seriousness criteria: The event (polymyalgia rheumatica) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 30-Jan-2025: This case involves, an unknown age and gender patient who had polymyalgia rheumatica after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: YF
Symptoms: Contraindicated product prescribed
Clinical narrative: patient who is on an immune modifier, Skyrizi, was administered YF-VAX today, with no reported adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was on an immune modifier, SKYRIZI [RISANKIZUMAB], was administered Yellow Fever Vaccine  [Yf-Vax] today, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking SKYRIZI [RISANKIZUMAB], (form, strength, lot, expiry date: not reported) (Unknown dosage and frequency) for immune modifier (Immunomodulatory therapy).  On 28-JAN-2025, the patient received an unknown dose of suspect Yellow Fever Vaccine - Us Solution for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site.  On 28-JAN-2025 the patient who was on an immune modifier, skyrizi, was administered yf-vax today, with no reported adverse event (Contraindicated product administered) (latency: same day) following the administration of Yellow Fever Vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HEP
Symptoms: Blood immunoglobulin M normal, Hepatitis A antibody negative, Hepatitis B, Hepatitis B surface antibody negative, Hepatitis C test negative
Clinical narrative: anti-HBs levels confirmed immunity. Despite this, our patient still developed an acute HBV infection; Literature Report:   This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 30-year-old male patient. The patient's concurrent conditions included human immunodeficiency virus (HIV), acquired immunodeficiency syndrome and Social alcohol drinker. Historical conditions included meningitis, syphilis, chlamydia, and anal herpes papillomavirus. Concomitant medications included efavirenz (+) emtricitabine (+) tenofovir.  On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant)(unknown manufacturer) Intramuscular Injection (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) as prophylaxis.  On an unknown date in 2023, the hepatitis B surface antibody (anti-HBs) level before the change in therapy was 14.5 mIU/mL, consistent with immunity, and the hepatitis B surface antigen (HBsAg) was negative. Laboratory findings revealed a reactive HBsAg and hepatitis B core immunoglobulin M. HBV viral load was 52,200 IU/mL. Hepatitis C antibody, hepatitis A immunoglobulin M, and a monospot test were negative. In October 2023, the patient was transitioned from bictegravir (+) emtricitabine (+) tenofovir alafenamide (B/FTC/TAF) to cabotegravir (+) rilpivirine (CAB/RPV) for HIV infection.   On unknown dates, HBV viral load results decreased to 27,700 IU/mL and 8,500 IU/mL.  On an unknown day, the patient experienced vaccination failure, as despite being vaccinated, the patient developed an acute hepatitis B virus (HBV) infection. However, the patient's anti-HBs levels confirmed immunity with a level greater than 10 mIU/mL (14 mIU/mL). The outcome of the event of Vaccination failure was not reported.   The causality assessment between Hepatitis B Vaccine (Recombinant)(unknown manufacturer) and the event of vaccination failure was considered as related. The authors concluded that the only other case report that provided an association with a patient with HIV, vaccinated from HBV, who developed an acute HBV infection after CAB/RPV treatment.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP
Symptoms: Mononucleosis heterophile test negative, Vaccination failure, Viral load increased
Clinical narrative: anti-HBs levels confirmed immunity. Despite this, our patient still developed an acute HBV infection; Literature Report:   This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 30-year-old male patient. The patient's concurrent conditions included human immunodeficiency virus (HIV), acquired immunodeficiency syndrome and Social alcohol drinker. Historical conditions included meningitis, syphilis, chlamydia, and anal herpes papillomavirus. Concomitant medications included efavirenz (+) emtricitabine (+) tenofovir.  On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant)(unknown manufacturer) Intramuscular Injection (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) as prophylaxis.  On an unknown date in 2023, the hepatitis B surface antibody (anti-HBs) level before the change in therapy was 14.5 mIU/mL, consistent with immunity, and the hepatitis B surface antigen (HBsAg) was negative. Laboratory findings revealed a reactive HBsAg and hepatitis B core immunoglobulin M. HBV viral load was 52,200 IU/mL. Hepatitis C antibody, hepatitis A immunoglobulin M, and a monospot test were negative. In October 2023, the patient was transitioned from bictegravir (+) emtricitabine (+) tenofovir alafenamide (B/FTC/TAF) to cabotegravir (+) rilpivirine (CAB/RPV) for HIV infection.   On unknown dates, HBV viral load results decreased to 27,700 IU/mL and 8,500 IU/mL.  On an unknown day, the patient experienced vaccination failure, as despite being vaccinated, the patient developed an acute hepatitis B virus (HBV) infection. However, the patient's anti-HBs levels confirmed immunity with a level greater than 10 mIU/mL (14 mIU/mL). The outcome of the event of Vaccination failure was not reported.   The causality assessment between Hepatitis B Vaccine (Recombinant)(unknown manufacturer) and the event of vaccination failure was considered as related. The authors concluded that the only other case report that provided an association with a patient with HIV, vaccinated from HBV, who developed an acute HBV infection after CAB/RPV treatment.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Hello, I was made aware that the daughter of a cousin residing in another country was diagnosed with HPV post Gardasil vaccination.; This spontaneous report was received from a Company Representative and refers to a 26-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date in 2014, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration and anatomical site of injection were not provided).  The reporter became aware that on an unspecified date, the daughter of a cousin residing in another country was diagnosed with Human Papillomavirus (HPV) following the vaccination (Papilloma viral infection).   On an unknown date, her medical reports indicated a positive p16/Ki67 result; however, serotyping was not mentioned. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the reported event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  No further information was provided.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Had One Dose Last Year in September of 2023 of the HEPLISAV-B; Initial report received on 12-Dec-2024 with additional information received on 19-Dec-2024.  A pharmacist reported that an adult patient (age and gender not provided) received one dose HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Sep-2023 but did not receive the next dose.  No medical history or concomitant medications were reported.  On 01-Sep-2023, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC # 43528-002-01, route, and site not available). At the time of reporting, the patient had not received the next dose.  The reporter called to inquire if restarting the series was necessary. The patient had received HEPLISAV-B at a different location than the reporters.   No other information was available. The reporter declined to be contacted for further information.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 Year Old Received 1st Dose; Initial report received on 20-Dec-2024.  A nurse practitioner reported that a 17-year-old (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.    On 20-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945656, expiration 27-Jan-2027, NDC # 43528-0003-01) intramuscularly in the right deltoid.  The reporter indicated that the patient's titers were negative and that they realized that the patient was under 18 years of age when HEPLISAV-B was administered.    No adverse effects were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Deafness neurosensory
Clinical narrative: Sudden sensorineural hearing loss; This spontaneous case, initially received on 17-Jan-2025, was reported by a health professional (via Pfizer) and concerns an adult male patient.  At the time of the event the patient had drug allergy. Administration of company suspect drug(s): On 06-Dec-2024, the patient received Flucelvax (TIV) for Indication not reported., dose: not reported, route of administration: not reported, anatomical location: left arm. Lot number: 946638.  Non-company suspect drugs: Comirnaty (Tozinameran)  Adverse reactions/events and outcomes: On 18-Dec-2024 20:00, the patient experienced Sudden sensorineural hearing loss (Medically Significant, outcome: Not recovered / Not resolved). The patient was treated with high dose steroid.  The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient was not taking any other medications within 2 weeks of the event starting.   Flucelvax (TIV) action taken: Not applicable Treatment medication: Steroid (high dose)  Reporter's assessment:  The reporter considered the events as non-serious and did not provide the causality of the events.; Reporter's Comments: Causality; Due to spontaneous nature of the case it is considered as related for reporting purposes and considering plausible temporality (after 13 days start of suspect drug). Brighton collaboration criteria is assessed as level 4 due to insufficient information provided.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received vaccination twice, had no short term side effects
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Was given SQ instead of IM. No adverse reaction occurred. Manufacture contacted and vaccine was still valid and no redose needed.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was a walk-in 01/30/2025 - requested RSV, was asked by pharmacist if he has ever received an RSV and informed pharmacist he had not. System also did NOT reflect any past admin of RSV - per archived transaction and vaccine consent form records, appears that patient did receive an RSV from our store 10/19/2023 and patient was called 01/31/2025 and asked if he had ever received it in 2023 said he still had no recollection. Patient has experienced no issues, side effects or negative outcomes from second administration of RSV was not upset and requested vaccine because he thought he never had it.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received duplicate dose of RSV vaccine. Initially received 4/2024. Reports no symptoms at this time
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after leaving clinic,per Mom she was out for around 30 sec. Patient given water to drink and felt fine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Patient reports left shoulder pain after receiving Covid-19 vaccine. The pain is constant, but worsens with sleeping on the left side, reaching over head, applying pressure to the area, and weight-bearing.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: The patient developed rash on both arms 3 days after receiving the vaccine that started to get better a few days later.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: Received vaccines at my workplace clinic.  The Tdap vaccine was administered very high on my right arm, which I originally didn't think anything of. I experienced the usual 2-3 days of soreness in my upper arm. Then for the next  4 weeks, the pain worsened and also included limited range of motion and stiffness. I have no previous history of shoulder pain, injury, or surgery. I scheduled an appt at Orthopedic Clinic on 1/31/25 where I received x-rays and was diagnosed with subacromial bursitis with impingement syndrome and I received a subacromial cortisone joint injection to manage the pain and inflammation. Too soon to report treatment outcome.
Age: 45.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Rotator cuff syndrome, X-ray limb
Clinical narrative: Received vaccines at my workplace clinic.  The Tdap vaccine was administered very high on my right arm, which I originally didn't think anything of. I experienced the usual 2-3 days of soreness in my upper arm. Then for the next  4 weeks, the pain worsened and also included limited range of motion and stiffness. I have no previous history of shoulder pain, injury, or surgery. I scheduled an appt at Orthopedic Clinic on 1/31/25 where I received x-rays and was diagnosed with subacromial bursitis with impingement syndrome and I received a subacromial cortisone joint injection to manage the pain and inflammation. Too soon to report treatment outcome.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Papule, Rash, Rash pruritic, Skin hyperpigmentation
Clinical narrative: Pt reported onset of pruritic rash over her knees, ankles, and axilla a few days after her second Gardasil 9 vaccine. She did not seek care for it until two weeks after the vaccination, at which point she had some hyperpigmented, small papules on her ankles and knees that did not appear to be urticarial or related to Stephens Johnson syndrome.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: My arm was sore for a week or more, however, it continues to ache throughout the day and it has been 3 months. At times I can't hardly lift it above my head because it hurts. Other times I can lift it with no problem. I can't identify any other reason why my arm aches other than taking the shingles shot. I am supposed to get a second vaccine within 6 months, however, I dread doing it if it will be a repeat of what I have put up with for the past 3 months.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Erythema, Pyrexia, Seizure, Swelling, Tremor
Clinical narrative: mother said on phone Redness, swelling, shaking Seizure for 15-20 seconds Convulsion 1-2 seconds fever
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Tachycardia
Clinical narrative: The patient experienced tachycardia later at night.; This spontaneous report was received from Other Health Professional and referred to a 32-years-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, (strength, dose, frequency, scheme, lot #, expiry date, route of administration, anatomical location, and indication were not provided).  On an unknown date, the same date of the vaccination later at night, the patient experienced tachycardia.   On an unknown date, the patient recovered from the tachycardia.   The reporter considered tachycardia to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but could be related to the fact that the patient "works night shift".  Lot number is being requested and will be submitted if received.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not report any adverse issues or side effects related to the administration of the expired dose; a patient was inadvertently administered an expired dose of GARDASIL 9 (lot: X005579 expiration: 11/30/2024) on 01/28/2025.; This spontaneous report was received from a other health professional and refers to a 12-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #X005579, expiration date: 30-NOV-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The vaccine had never been exposed to any temperature excursions and the patient did not report any adverse issues or side effects related to the administration of the expired dose.  No other information available.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse called and reported a patient that received their second dose of PROQUAD ten days before the age of 4 years old.; No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 3-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter (ml) per dose, administer(inappropriate  schedule of product administered). Limited patient demographics was provided by reporter. No  additional information was known by reporter.   No additional adverse event (AE).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; administration of a pediatric dose of RECOMBIVAX HB to an adult patient over 20 years of age. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a pharmacist referring to an adult patient) reported as over 20-year-old).  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 29-JAN-2025, the patient was vaccinated with a pediatric dose of hepatitis B vaccine (Recombinant) (RECOMBIVAX HB) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (Inappropriate dose of vaccine administered). No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP reported no side effects; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a 6 month and 26 days old child was inadverntly administered the PNEUMOVAX 23 vaccine. HCP stated that the patient was supposed to receive the PREVNAR 20 vaccine but wa; HCP calling to report an AE regarding the PNEUMOVAX 23 vaccine. HCP reported that a 6 month and 26 days old child was inadverntly administered the PNEUMOVAX 23 vaccine. HCP stated that the patient was supposed to receive the PREVNAR 20 vaccine but; This spontaneous report was received from a Medical assistant and refers to a 6-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  22-JAN-2025, the patient was inadvertently administered pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, prefilled syringe, lot #X027348, expiration date: 24-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided) instead of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided) (Wrong product administered, Product confusion). No additional adverse event was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site irritation
Clinical narrative: Long term inflammation and irritation in the injection site.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Blood thyroid stimulating hormone normal, Electrocardiogram normal, Fatigue, Full blood count normal, Heart rate irregular
Clinical narrative: Fever the night of 1/18 and 1/20, fatigue 1/19, irregular heart beat intermittently beginning approximately 1/23 or 1/24
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Metabolic function test normal, Pyrexia
Clinical narrative: Fever the night of 1/18 and 1/20, fatigue 1/19, irregular heart beat intermittently beginning approximately 1/23 or 1/24
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Diaphragmatic hernia, Dysphagia, Rotavirus infection, Stool analysis, Swallow study abnormal
Clinical narrative: Pt diagnosed with Rotavirus infection with persistent vomiting 2 months after vaccination on December 16, 2024. It is potentially believed by her GI specialists that the infection caused her seemingly mild diaphragmatic hernia to push through further and cause an inability to gain weight well due to excess vomiting and inability to eat well.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Vomiting, Weight gain poor
Clinical narrative: Pt diagnosed with Rotavirus infection with persistent vomiting 2 months after vaccination on December 16, 2024. It is potentially believed by her GI specialists that the infection caused her seemingly mild diaphragmatic hernia to push through further and cause an inability to gain weight well due to excess vomiting and inability to eat well.
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Hypertension, Psoriasis
Clinical narrative: Adverse effect was increase in uncontrollable hypertension & psoriasis.  Began taking water pills to control hypertension, and terrible psoriasis of the scalp.  My PCP has been following me.  A dermatologist has to step in to control the scalp psoriasis which never occurred until after this was taken.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Fatigue, severe body aches, chills, headache
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an additional dose of Arexvy - above the recommended single dose. Reports no adverse reactions or side effects.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Axillary mass, Axillary pain, Contusion
Clinical narrative: I do not know which flu vaccine I received.    The morning after the vaccine, I flew to another city.  When I woke on the 18th I had a hard very painful  approx three-quarter inch oval lump below my right armpit. The pain extended beyond the localized lump. My guess is the lump was a lymph node. A few days later when I woke, the lump was gone, and I had a bruise extending from my right armpit to the bottom of my right breast and the pain had changed from severe to minor.       Prior to this, I just had mild or no reaction to a vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU3, HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pfizer covid vaccine for age  12 years and up was administered to this 11  year old.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Facial pain, Muscle spasms, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 2 and a half hours after vaccine both feet, toes and legs began to tingle and severe pain that radiated to the arms and left side of face. Toes on right foot cramped and curled.
Age: 78.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient reports redness, swelling, warmth, and itching in her left arm that began the following morning after receiving the immunizations (about 24 hours later). She says it peaked around 48-72 hours after administration. She self-treated with diphenhydramine and said that did help. She was mostly recovered by the time she reported it to us on 2/1/25, but still had some minor redness around the injection sites.
Age: 15.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Myalgia, Pain, Pyrexia
Clinical narrative: +large erythematous local reaction and high fevers, soreness and myalgias 24 hours after getting vaccine