chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her 18 year old son with drug allergies to CEFZIL, ELAVIL, REGLAN. The patient's medical history included acid reflux and IBS (Irritable Bowel Syndrome). In 2013 the patient was vaccinated with his three doses of GARDASIL (dose, strength, route, lot number were unkonwn) separately. Concomitant therapies included CELEXA 25mg, omeprazole (manufacturer unknown) 40mg and hyoscyamine sulfate 125 mg. In the "latter part of the 2013 school year" the patient had been experiencing tiredness, shortness of breath and continued stomach problems since receiving the GARDASIL vaccines. The mother also repeated the same AE symptoms and provided additional details such as that her son's blood work at an unspecific date showed his "white blood cell count was high" and he was given an ultrasound of his thyroid, and showed swollen lymph nodes. She indicated that was after the second shot that her son had "unusual tiredness" and that 2-3 weeks after the final dose he developed stomach problems. He had also had dizziness, chills, and "almost passed out" in HCP's office. He was diagnosed with anxiety, but the anxiety medication "didn't help." He was taking unspecified "supplements" and "immune boosters." After the unspecified naturopath exposed the patient "HPV serum," physician believed this verified that GARDASIL caused the AE. Patient sought unspecified medical attention. At the time of the report, the outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Rec'd PENTACEL, PREVNAR 13, ROTATEQ at 1030A. Went home slept 3 hrs. - woke at 2P - mom called this office at 4P child screaming non-stop x 2h. Advised to give TYLENOL (160/5ml) 2.5 ml - mom called office back at 535P and infant improved and has done fine and was himself after that.
none of them actually prevent getting the disease/ hospitalized after second dose; Suspected vaccination failure/ none of them actually prevent getting the disease/ hospitalized after second dose; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that new mRNA jabs had a whole list of adverse side effects. The three people whom reporter knew where hospitalized after receiving their second dose of Shingles jabs. The reporter reported that none of them actually prevent getting the disease. The reporter also mentioned that Flu vaccine was still only 40 to 60 percent effective. This was 1 of 3 linked cases reported by same reporter for different patients. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR156126:Same reporter US-GSK-US2022AMR156127:Same reporter US-GSK-US2022AMR156128:Same reporter (case deleted, case created in error) US-GSK-US2022AMR156129:Same reporter (case deleted, case created in error)
The patient failed to bring immunization card to the office visit. The patient states he is due for his 2nd booster dose and the physician went based on the patient verbal information and failed to check Check the history on the medical record of the patient. Patient vaccine doses of Moderna 1st dose 2/11/21, 2nd dose 3/11/21, 3rd dose (half dose) 11/30/21, 4rd dose (half dose) 4/8/22 and patient received 5th dose today 7/5/2022 which is 1 month earlier than the schedule at 4 month dose. The physician learned about the vaccine doses when the medical assistant was entering on system and went ahead an notified the physician.
Patient, Received first dose vaccine (LOT#: EW0150) on 4/02/21. Pt raised hand to alert EMT. Pt reported having an itchy throat and mild shoulder pain 2/10 on pain scale. EMT took vital signs. BP: 100/80, HR: 73, O2: 97%. Pt stated that she was taking thyroid medication but was unaware of the name and had taken the medication at 0900. Pt was offered Diphenhydramine 50 mg/mL by PHN. Pt agreed to take Diphenhydramine. Pt stated that she had NKA. Diphenhydramine was administered by PHN at 1347. Pt was asked to stay an extra 30 minutes for observation. Pt was assessed three times with each check having  better vital signs results post Diphenhydramine medication. Final vital signs were taken at 1415, results were BP: 120/90, HR: 74, 02: 97%. Pt finished her observation and left vaccination site with a steady gait.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/26/2023 PROSTATE CANCER
Patient got her last Pneumo23 and stated that night her arm got really red, swollen, and hot. She also got the shivers and a fever. She also stated she felt really tired for a few days. She did not go see any Drs but did get better after a few days and taking TYLENOL/ ibuprofen/ using ice packs. She came in today to tell me what happened.
Since day of immunization in the RIGHT arm until present: pain when laying on or moving this arm.
Baby began crying, became irritable 6 hours after vaccination. Fever over 101 degrees by 18:00 PM. Temp at 14:15 on 12/31 was 103.2 (102.2 axillary). Restless. 12/30 Acetaminophen at no one and every 4 hours since then. 12/31/13 at 1500 101.5 axillary. No swelling or redness of legs. 2 stools. Sl. runny.
Patient was given the vaccination. About 30 minutes later she noticed a small, blister like bump that she thought looked kind of like a blister. Over time the injection site reaction grew. Finally 6 hours later the site was hard to the touch, hot, and about 3 inches in diameter. Also, at this time pt reported feeling achy and not well. She was advised by her boss to go to the ER. At the ER, pt was given a shot of prednisone and told to take Benadryl and Zyrtec at home before being released. The patient felt achy and "rough" throughout the night but does report improvement this morning.
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Ringing in both ears, started a few hours after vaccination and continues. Left ear is more audible.  Headache in the evening left temple
weakness in legs, a little energy to shuffle around, lack of energy, weakness; extreme anxiety; crying of despair; Feeling shaky; headache; fatigue, intense fatigue; a little nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair), NERVOUSNESS (Feeling shaky) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VILAZODONE HYDROCHLORIDE (VIIBRYD) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (First dose.), Pfizer (First Booster Dose) and Pfizer (Second dose). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.   On 09-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In May 2022, the patient started VILAZODONE HYDROCHLORIDE (VIIBRYD) (unknown route) Viibryd thirty. On 10-May-2022, the patient experienced HEADACHE (headache), FATIGUE (fatigue, intense fatigue) and NAUSEA (a little nausea). On 12-May-2022, the patient experienced ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair) and NERVOUSNESS (Feeling shaky). At the time of the report, ASTHENIA (weakness in legs, a little energy to shuffle around, lack of energy, weakness), ANXIETY (extreme anxiety), CRYING (crying of despair), NERVOUSNESS (Feeling shaky), HEADACHE (headache), FATIGUE (fatigue, intense fatigue) and NAUSEA (a little nausea) had not resolved.            No concomitant product was provided. No treatment information was provided.
Information has been received from a nurse concerning a female teenager who on 18-JUL-2007 was vaccinated with a dose of Gardasil. On 18-JUL-2007, the patient experienced syncope. The patient outcome was unknown. Additional information has been requested.
Initial report received 01 April 2009 from a health care professional, who is also the patient. According to the reporter, they developed the "flu" an unspecified amount of time after they had received an influenza vaccination (manufacturer and lot number not reported) during the same influenza season. No laboratory or diagnostic testing had been performed. Information pertaining to the event symptoms, dates of onset, duration and severity were not reported and the patient declined to provide additional information. The patient's recovery status was not reported. Documents held by sender: None.
Syringe failure during injection = unquantified amount dripped to the floor and on the patient's arm/clothing from point of where needled screwed on the syringe.  Had discussion with patient - unknown if quantity lost was more or less than half of the dose.  Explained risk of not a full dose (potential less immune response) vs risk of excessive dose with another booster dose (myocarditis).  Patient opted to be re-dosed. Recommended she contact physician if she were to experience any cardiac symptoms.
This spontaneous report was received from a medical assistant and refers to a currently 69-year old female patient. Information regarding the patient's medical history and concurrent conditions was not provided. The patient had drug allergy to sulfamethoxazole (+) trimethoprim (BACTRIM), meperidine hydrochloride (DEMEROL), cephalexin (KEFLEX) and tramadol hydrochloride (ULTRAM). On 27-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N020502, 08-FEB-2019, as a routine vaccination (dose and route of administration were not provided). On an unknown date (reported as: "after PNEUMOVAX 23"), the patient experienced a red, rash over wrist, that physician diagnosed as rheumatoid arthritis. The patient came to a physician's office and received an unspecified treatment. Subsequently (also reported as "on 11-OCT-2017"), the patient was vaccinated with PREVNAR 13 lot# S35324 (expiration date, dose and route of administration were not provided). The outcome of the event and causality assessment were not provided. Upon internal review, the event of rhematoid arthritis was considered to be medically significant.
No additional AE reported; Temperature excursion of 47.9°C for 47 min; This spontaneous report was received from a medical assistant referring to a 2-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 47.9°C (Celsius degrees) for 47 minutes which occur as a result of a reading from a data logger (product storage error).  On 20-DEC-2022, the patient was vaccinated with previous doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W006596 with an expiration date on 11-OCT-2024), administered intramuscularly in left thigh for prophylaxis (strength and dose were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1892784 with an expiration date on 03-DEC-2023), administered orally for prophylaxis (strength and dose were not provided).  No adverse events were reported.
Went home and later that night could not lift arm. Went to ER and they cleared her but still cannot lift arm.
COVID+ 12/25/22.  Vaccination status - moderna x4 + Pfizer BIVALENT BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 12/25/2022 Discharge Date: Dec 27, 2022   Active Hospital Problems No active problems to display.   Resolved Hospital Problems   Diagnosis Date Noted Date Resolved POA ? COVID      DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 76 year old female with COPD, recent admission for Pneumonia, who presented with acute on chronic hypoxia related to COPD exacerbation secondary to COVID-19 infection. Patient was very short of breath on admission. She was started on steroids and nebulizers and improved. Patient slowly improved, she was transitioned from solumedrol to oral prednisone. She was able to wean back to her home O2. She then was considered stable for discharge. Social work was consulted due to some concerns about the patient's ability to care for her husband at home. Referral was made to community resources for the couple as they navigate caregiver social concerns. Patient then discharged home in stable condition.
This literature report has been received from authors of a published article. This article was performed as urrently, Hepatitis B (HepB) was preventable through vaccination. However the  immunity to HepB among lung transplant candidates at time of evaluation was only 23%, although vaccine response rates among young, healthy individuals are approach 90%. Therefore, the  rapid vaccine series over 21 days was  an attractive alternative to the standard 6 month schedule. Because many lung transplant candidates are immunocompromised, combining the high dose vaccine option (for the immunocompromised) with the rapid schedule was a logical strategy to achieve HepB immunity prior to transplantation. This report refers to 13 patient's of unknown age and gender candidates to lung transplant. No pertinent medical history, drug reactions, allergies or concomitant therapies were provided. Referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, known allergies and concomitant medications was not provided. The purpose of this study was that there is growing use of increased risk donor organs that convey a higher risk of donor transmission of Hepatitis B, Hepatitis C, and HIV. Unknown dates, the patients were vaccinated on days 0, 7 and 21 with hepatitis b vaccine (manufacturer unknown) with a dose of 40 mcg (20mcg/1mL in each deltoid) for prophylaxis ( route, lot number and expiration date were not reported). Then, serologic testing to check immunity was performed at least 6 weeks after completion of the series. If patients did not develop immunity to HepB, the rapid/high dose series was administered a second time. This 13 patients failed to seroconvert after the second series and were considered non-responder and no further action was taken, the vaccine was safe and well tolerated. This non-responder patients tended to be older, male and on immunosuppresive medication. At the time of the report, the outcome of the adverse event was unknown. The reporter considered therapy non-responder to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown).
Fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  Patient reported that after the 2nd dose of Shingrix experienced fever.
This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
At 11:ooam this morning I started to feel light headed a it eventually progressed to trouble swallowing, throat closing and uncontrollably shacks.  Administered the Epi pen myself at about 11:20 right before the paramedics showed up 5 minutes later.   Paramedics stayed until the Epi wore off and the shacks stopped.
Male patient 38 years old was in area of observation waiting 30 minutes after getting MODERNA (0.25ml) and reports feeling dizzy and head pain. Patient was taken to area of observation and treatment, he was evaluated and refers having strong head pain, dizziness and blurry vision. Vital signs were taken: 80dxt, 98 saturation and clear lungs on auscultation, no edema, no itchiness, and no rash. 140/80 mmHg and 16 resp. Later another MODERNA dose was administered 0.25ml since he mentioned having HIV. Later after administering second dose 0.25ml the head nurse noticed the patient was having the same reaction as the first dose. At 6:30pm patient refers feeling better and was offered to go to the hospital but he said it was not necessary. Vitals were taken again 120/80mmHg, 16 respirations, 80 dxt, 98 r/a, 82 pulse. At 7:22pm patient refers feeling better. The case was consulted with Dr.
Approximately 20 minutes after Tdap was given in left arm IM, patient returned to the clinic complaining of sluggishness, feeling hot, seeing stars.  Fifteen minutes later felt nauseous but no longer feeling hot.  Thirty minutes after that feeling better, nausea gone, less sluggish.  Took juice, ambulated in hall.  Vital signs monitored and patient assessed for 40 minutes.  Temperature 98.4 - 98.7.  Doctor felt he had a vasovagal response.
1. Aphthous ulcer (tongue blisters) fatigue, sore throat and left arm numb from shoulder to hand lasted 12 hours -"probably related to recent vaccination.  Will treat symptomatically with magic mouthwash" Doctor stated  2. Adverse effect of drug therapy vaccines "Moderate systemic reation to anthrax vaccination. Treat symptomatically with tylenol." Doctor stated.
Pain in left arm/ runs/ cotton mouth/ Very poor ability to sleep for everyday after/some light headed/ cough / chills/ shakes/ extremely warm/poor appetite