chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 20-SEP-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Fatigue, then joint/muscle pain followed by fever/chills night sweating at 12 AM and rapid/irregular heart rate.  Patient took aspirin, fluids, bed rest for the day.
sz, t102 @ hosp;no appetite on Saturday;found red ear &  sore throat;
vaccine temperature execursion at 31.5° fahrenheit for 2 hours 45 minutes was administered to the patient with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA239548.  This case involves a 10 years old male patient for whom vaccine Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was administered to the patient after temperature excursion at 31.5° Fahrenheit for 2 hours 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) for Prophylactic vaccination.  On an unknown date in Jun-2023, the patient received a dose of 0.5 ml suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] (solution for injection) (route, administration site, lot number; strength; expiry date unknown) for Immunization, after temperature excursion at 31.5° fahrenheit for 2 hours 45 minutes due to potential mechanical issue with the refrigerator with no reported adverse event (Poor quality product administered) (latency: same day). Information regarding batch number was requested in the case.   It was reported, "Adacel, Daptacel, IPOL, Menquadfi, Pentacel, Quadracel, Tenivac, Vaxelis. Product activated/prepared? NO Due to a human error: NO and Does extended stability data cover the excursion: NO These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023."  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.    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.
About 30 minutes after receiving 5 vaccines and ibuprofen, developed small welts on face, legs, arms, trunk, very, very itchy. Agitated tachycardia, lower lip swelled, crying.
I presented to my PCP with complaint of bilateral tinnitus on 5/16/2022.  Symptoms had been going on for at least a couple of months before I presented.  Examination was unremarkable.  I did go on to have a thorough hearing evaluation (audiogram) on 8/10/2022 at Hospital Clinic on 8/10/2022.  Hearing was within normal limits in both ears.  In spring 2021, I did have a loud noise exposure to my left ear (shotgun) when I was in turkey hunting in a blind with my son.    Dates of my COVID-19 immunizations were:  12/30/2020, 1/27/2021, and 11/29/2021.  All were Moderna.  Dates and Lot #'s are:  12/30/20   Lot # 025J20-2A 1/27/2021 Lot # 041L20A 11/29/2021 Lot # 939909
Patient received a flu shot IM in the left leg on 11/19/04. He developed muscle achiness, diarrhea for 1 day, and low grade fever 6 days after the vaccination. No local reaction at the injection site. Physician documented myositis, etiology viral versus influenza based. No further complication noted.
Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and woke up with just a headache, which went away in the evening.
Information has been received from a physician concerning a 3 year old female patient who on 17-MAR-2002 was vaccinated with a dose of MMR II (Lot #, expire date and route not reported). Physician stated that on an unspecified date, mumps titers were measured and were negative. At the time of the report, the outcome of the patient was unknown. The patient had a history of shingles and negative varicella antibody titer on therapy with VARIVAX (Merck) (WAES # 1008USA01283). Additional information has been requested.
This spontaneous report as received from a pharmacist  refers to a 78 year old female patient with high blood pressure, high cholesterol and GERD (gastro-esophageal reflux disease). On 10-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J002242 (administered subcutaneously). Concomitant therapies included simvastatin (manufacturer unknown), ATENOLOL, AVAPRO, and PRILOSEC. On 11-OCT-2013, the patient developed pain at the site of ZOSTAVAX injection. No therapy was given for the adverse event and no lab-tests were performed. The outcome of pain at the site of ZOSTAVAX injection was reported as not recovered/not resolved. A causality assessment was not provided by the reporter. Additional information has been requested.
Covid19 illness - Nov2021 (vaccination May2021); Covid19 illness - Nov2021 (vaccination May2021); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Nov2021, outcome "recovering" and all described as "Covid19 illness - Nov2021 (vaccination May2021)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT STATED SHE HAD SWOLLEN LIPS, SWOLLEN AND WATERY EYES, TONGUE WAS TINGLING, GROGGY, AND FELT HOT.  SYMPTOMS WERE SLIGHTLY IMPROVED WHEN SHE CALLED TO ASK ABOUT THEM. PATIENT UNDERSTOOD THAT IF SYMPTOMS WORSENED SHE SHOULD CONTACT 911 AS WELL AS HER DOCTOR.
About 24 hours after the injection I had a painful lump about 3" in diameter, with itching and redness. I iced it, took Tylenol and Benadryl at bedtime. Today it is less painful, but larger, redder and with itching. It is raised and looks like a small pancake on my arm. I did not have this reaction with my first dose.
A physician reported the occurrence of a fever in a 5-year-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were unknown.  The vaccinee had not experienced any adverse events following pervious immunizations.  On 05/07/2002, the vaccinee received his fifth injection of Infanrix (lot DTPA548A2).  On 05/10/2002, he returned to the physician's office with a fever and an injection site reaction characterized by swelling and redness.  The events were treated with paracetamol (Tylenol) and applications of ice.  These events resolved on 05/10/2002.
Approximately 8p, patient had a temperature of 100.4 and had been receiving Tylenol for vaccines. she began with her tongue sticking out and drooling. She began panting about one hour later. She did sleep OK and wake to nurse but by the morning, she had an increased resp rate, worsening panting, drooling. Mother took her to the ED and was diagnosed with possible epiglotittis. She was given a dose of steroids and monitored. She did have some improvement after steroids. Symptoms gradually improved but didn't resolve until Wednesday. She had no cold symptoms prior to or after vaccination.
Patient presented to the emergency department with fatigue weakness and shortness of breath.  He also had an episode of falling to the ground.   His workup in the ER was noted to be febrile and hypoxic on room air at 88%.  He was found to be COVID-19 positive, D-dimer was elevated and nearly 10,000, white blood cell count was 8,000, BUN/Cr are 51/3.2 which is slightly worse than his baseline creatinine of mid to upper 2s, procalcitonin is elevated at 38, high sensitivity troponin was mildly elevated at 67 which peaked at 98 and now is down to 53, chest x-ray noted ill-defined patchy opacities in the bilateral lower lobes.  He was admitted and started on dexamethasone, intravenous antibiotics including cefepime and vancomycin, and a heparin drip given his elevated D-dimer but no CTA was completed due to his elevated creatinine.  He was also started on Remdesivir.   Vancomycin has been changed to doxycycline.  December 17, blood culture is positive for proteus, pan sensitive. Urine culture is positive for Gram negative rods. He is on cefepime.  Pulmonology has indicated no indication for anticoagulation nor doxycycline and stopped Remdesivir in light of CKD. Both are stopped. WBC is 21. Repeat blood culture is ordered. D Dimer improved to 4,500 from 10,000.  December 20, he is discharged home on ciprofloxacin 500 mg daily and dexamethasone 6 mg daily for five additional days. His amlodipine was stopped and nifedipine started for HTN.
Complained of rush upon rabies vaccine injection. BP 138/78. Seen at health clinic. Diagnosis acute reaction to stress.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 07-APR-2015, the patient was vaccinated with improperly stored PROQUAD lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via field employee, refers to a 11 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 26-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L038503 and lot # L0038506, intramuscularly, (dose and frequency were unknown). On 26-MAY-2016, the patient became "very lethargic and did not want to eat" after receiving GARDASIL 9. Unspecified lab work was performed. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other adverse event information was reported. Additional information has been requested.
Diaphoretic, pale, hands tingling, abdominal pain, vomited - BP 98/60 and 98/50, P 80 but weak. Gave Adrenal 1:1000 0.5 ml SQ - called ambulance and went to ER.
very sick 3 days not functional, fever of 103 for 5days,  7 or 8 days before felt good enough to return to work.
17 year old received vaccine; A spontaneous report was received from a nurse concerning a 17-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17-year old received vaccine.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the Moderna COVID vaccine was given to a 17- year- old. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 17-year old received vaccine, was considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
4 days post vaccine I started with daily urticaria and it is continuing now still; This is a spontaneous report from a contactable consumer or other health care professional (patient). A 42-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration (at the age of 42-years), administered in arm left on 09Apr2021 as dose 2, sin-gle for COVID-19 immunization. The patient medical history was not reported. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diag-nosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient was allergic to amoxicillin but as a child. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historical vaccine included first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration (at the age of 42-years), administered in arm left on 18Mar2021 as dose 1, single for COVID-19 immunization. On 13Apr2021, the patient experienced 4 days post vac-cine started with daily urticaria and it is continuing nowstill. The treatment was received for the ad-verse event included medrol pak, benadryl, zyrtec. The adverse event result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was reported as not re-covered.  Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the known safety profile and plausible temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded
Patient was walking out and started feel dizzy and lightheaded. She tripped and fell near the appointment desk. Denies hitting head. Initially felt nauseous and dizzy. Taken to a room. Initial vitals were: BP 75/50, pulse 53, 02 96%. Patient received some water. After five minutes vitals were: BP 92/62, pulse 63, 02 100%. She stated she was feeling better. Walked in the hallway and then took vitals 5 minutes later. BP 92/50, pulse 68, 02 96%. Discussed drinking and eating well prior to vaccination. She had not had much to eat or drink prior to vaccine. She admits to getting very anxious with shots.
Blood pressure high; Injection site itching; Injection site swelling; Injection site redness; Injection site rash; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressure high), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE RASH (Injection site rash) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced HYPERTENSION (Blood pressure high), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE RASH (Injection site rash). At the time of the report, HYPERTENSION (Blood pressure high) had resolved and INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE RASH (Injection site rash) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Injection site itching, Injection site swelling, Injection site redness, Injection site rash reported as worsened.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of itching at injection site, swelling at injection site, red at injection site and rash at injection site with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event of high blood pressure with humira(adalimumab) was no reasonable possibility.   No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This study case was received from the investigator in a trial on 27 March 2013. A male subject, with no relevant past medical history, was found to have an elevated Troponin result, considered mild in severity, 10 days after he received a left arm injection of ACAM2000, SP Biologics Co., (lot number, route not reported) and concomitantly an injection of ANTHRAX, other manufacturer (lot number, route, site and side not reported) on 11 March 2013. On 21 March, 2013, ten days post vaccination, the subject with negative past medical history, reported no symptoms and Rapid Troponin result was reported as normal; but Troponin I lab value was reported as 1.98 ng/ml. The subject was contacted to repeat lab Troponin I, ECG and referral. The subject did not take any medications to treat the adverse event. The subject's outcome was reported as not recovered, still present being treated. According to the investigator, the event of elevated Troponin was considered an other important event and probably related to the trial product. Follow up information was received from the investigator on 03 April 2013. The 20-year-old male subject returned for unscheduled visit on 28 March 2013 and he was asymptomatic at that time. Troponin I (Tn) on that day was normal, with reported result of < 0.10 ng/mL. The subject was reported as recovered from adverse event of elevated Troponin on 28 March 2013. On 28 March 2013, 17 days post vaccination, an ECG was reported as abnormal, showed inverted T waves, considered mild in severity, (clinical significance was reported as unknown). The ECG was performed due to prior Troponin I result 1.98 ng/mL on 21 March 2013. The subject remained asymptomatic and was referred for care. The subject did not take any medications to treat the adverse event. The reporter was unable to obtain follow-up information, reported as lost to follow-up, and the subject's outcome remained not recovered. According to the investigator, the events of elevated Troponin and abnormal ECG: inverted T waves were considered as other important medical events. The event of elevated Troponin remained considered probably related to the trial product and the event of abnormal ECG: inverted T waves, was considered possibly related to the trial product. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
Patient had swollen, red and felt warm at the site of injection from the evening of giving the vaccine. Patient also felt very fatigued for next day or two but started feeling back to normal after that.
Red swelling size of orange. Skin is raised and warm to the touch. Rapidly spreading to this size over 24 hours.
Got the 2 shots / Each time was very ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (received 1st dose on unknown date, refer case-US2021AMR027656).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.  Additional events were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine and was ill.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027656:Same reporter.
Mild itching, redness, mild irritation. Now specific site redness. Limited to back, axillary, mid sternal area, no dyspnea, or other symptoms noted.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. In November 2017, also reported as "the date between 08-NOV-2017 to 14-NOV-2017", the patient received one separate dose of improperly stored PNEUMOVAX 23 Lot # N010105, expiry date on 15-NOV-2018, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature at or above 32°F (Farenheit) to 35°F during 15 minutes. No previous temperature excursions were reported and the call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006632:
Pt received second dose of varicella virus vaccine live on 01/09/1997. ELISA testing in May of 1997 revealed negative seroconversion.
Pt states she "didn't feel good" after vaccine then developed a fever and rash all over body.