chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse events: Rapid/racing heartbeat, extended heart flutters (longer than a minute per event), chest pain that radiated to the back, heart palpitations, shortness of breath, and first time AFib event with RVR. Caught on ECG. Was prescribed a beta blocker (metoprolol), which I didn't start because I wanted a diagnosis by my cardiologist after holter monitor results came back.
Information has been received from a kindergarten teacher concerning her husband's relative's churchmember's daughter's friend at school, a girl who in August 2008 was vaccinated with the third dose of GARDASIL. The patient developed similar symptoms as her friend (WAES #0902USA01121) noted below, most of which started in September 2008. Headache, seizures, quit eating, passed out, lost weight, gastric disorder, blood pressure dropping extremely low, dizziness, tremors, and digestive disorder. It was also noted that this patient's digestive tract issues were worse. At the time of the report, the patient had been out of school about the same amount of time as her friend, approximately 8 or 9 weeks. The reporter considered both girls' symptoms to be due to the vaccine. Attempts are being made to verify the existence of an identifiable patient and reporter. Upon internal review, seizures is considered to be an other important medical event.  3/23/09 MR received from Vax provider. Seen 1/14/2008 for eval of menorrhagia.  PE WNL. Started on OCs to regulate menstrual cycle. HPV#1 given.  TC from parent 1/23/09 reporting worsening of abdominal pain since HPV vaccine #3 in 8/2008. Parent reports severe nausea and vomiting, anorexia, weakness and syncope. Pt has been unable to attend school. Seen by GI with DX:  Non-infectious gastroenteritis and colitis.  Unspecified vaccines causing adverse effects in therapeutic use. Forms completed for home school. 7/6/09 Per parent, pt has not seen a neurologist-only a phone consult. No records available
On 11/08/2021--I started having heavy vaginal bleeding. It stopped on 01/07/2022, and it started right back the very next day, 01/08/2022 The doctor put me on a birth control pill, Sprintec, and utilized it like a dose pack, I started at 5 days, and 4 days, and decreased, etc. That did not help. She also put me on iron pills 324 mg, twice a day. Then she put me on Provera, 10 mg once a day, I took that for 2 weeks and that did not help. Then she put me on Provera 10mg, until I had the surgery.  The heavy bleeding stopped on 01/21/2022, when I had surgery at outpatient surgery. I had a uterine ablation. I would say unknown at this point in time. I have a follow up appointment tomorrow, 02/09/2022.
12 hours after vaccine patient experienced severe chills, bilateral muscle spasms in legs, muscular/ joint pain, resolved on its own, patient did not take any medications, attempted to warm herself with clothing. tTme course at least 4 hours.
Information has been received from a third party claims administrator for a pharmacy concerning a male patient. ON an unspecified date the patient was vaccinated with PNEUMOVAX23 (lot # H011780 and expiration date 16FEB2014) and a flu vaccine (manufacturer not specified). On 11SEP2013 the patient experienced adverse reaction (NOS) to PNEUMOVAX23 and the flu vaccine (manufacturer not specified). Per the reporter, it was unclear which vaccine the patient had a reaction to. The outcome of the adverse reaction was unknown.  Additional information has been requested.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unknown dates, unspecified number of patients were vaccinated with doses of M-M-R II (lot number, expiry date, dose and route unspecified) that were exposed to 49 degrees Fahrenheit (F) for 31 days, which was an unsupported excursion based on in-house stability data. No concomitant therapy was reported. No adverse symptoms were reported. This is one of the two reports from the same source. Additional information has been requested.
5 1/2X 4CM AREA OF INFLAMMATION AT INJECTION SITE.  USE TYLENOL FOR SWELLING/PAIN AND ICE PACKS TO AREA
Administration of Infanrix instead of Boostrix; Pt of 11 years old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported inadvertent administration of Infanrix instead of Boostrix to an 11 year old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration. Health care professional gave consent for safety team to follow up The reporter consented to follow up.
pt recv vax SEP96 & OCT96 approx 2wk p/vax pt exp shingles;
12/4/06 96 temp, 47lbs 12.8 oz. On 12/4/06 patient had immunizations in clinic. Right thigh had flu and MMRV and Left thigh had Dtap and IPV. On 12/5/06 in the evening child woke up per mother with hives on his face and neck. Treated with Benadryl. Mother reported left thigh had redness lasting 2 days and now has different rash. 12/13/06 left thigh 2-3 inches area of confluent lesions pattern pink red rash with raise border, bumpy, similar rash on the right thigh about 1x1 inch.
throwing up twice the next day; Nausea; after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sickness), VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN GLARGINE (LANTUS XR), METFORMIN, ATORVASTATIN, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) and VITAMIN D3 for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sickness). On an unknown date, the patient experienced VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything). On 30-Mar-2021, VACCINATION COMPLICATION (Sickness) had resolved. At the time of the report, VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood glucose increased: increased (High) increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   N0 treatment medication provided by reporter.   This case was linked to MOD-2021-239097 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up appended
Received COVID vaccine early September. Left arm felt "off" since then. Increased weakness, heaviness.   Then...  Received vaccine in left deltoid on Thursday, symptoms started that night. Joint pain, aches. The following morning, left side felt heavy, increased weakness, numbness, tingling. Electrical volts shooting through left side. Difficulty holding on to items with left side. Increased thought coordination/word finding.   Saw Dr. in clinic on Monday, November 1st due to worsening symptoms. Labs completed. He states it is a vaccine reaction and to come back if symptoms worsen.
8/28/21: Patient arrived at the ER with generalized weakness, nausea, vomiting and diarrhea. Patient tested positive for COVID on 8/11/21 and states that her symptoms have been worsening over the past 4 days. EMS notes that the pt was hypoxic at 88% on RA.
Shortness of breath, numbness of left hand and waves of chest pains from left to right.
measles booster given; pt had swelling about the size of a quarter, erythema & a wheal @ inject site; pt seen by MD who recommeneded that an ice pack be applied & that pt reamin 1/2hr;
the 15 yr old female was vaccinated with the Janssen JJ vaccine- not age appropriate
On the evening of 1/20/04, pt received a pneumococcal vaccination in the right deltoid. On 1/21/04, there was a raised area the size of a baseball at the site of injection. The physician on call ordered the pt to receive were compresses to the area. The pt and the nurse reported the area to be red in color and warm to the touch. The nurse manager contacted pharmacy and a recommendation was made to give the pt diphenhydramine to control a possible allergic reaction. Swelling was down by 1/22/04. By 1/26/04 the problem was resolved, area resembled a whelt.
Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022 at 7:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that patient received a booster dose. This vial was stored in the freezer until this morning (04Apr2022) at 6AM. Vial did not undergo any temperature excursions. No treatment medications were reported.
Gave a 17 year old the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant medications were reported.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, a health care professional gave a 17-year-old the Moderna COVID-19 vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, gave a 17-year-old the vaccine/product administrated to patient of inappropriate age, was considered resolved on 10 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number not provided) with no associated AEs reported.
Left leg pain, swelling, and tingling. Patient was found to have DEEP VEIN THROMBOSIS of LEFT LOWER EXTREMITY - POPLITEAL VEIN.
pt recv vax & w/in a few hr spiked a fever of 104, became listless & incoherent;following day could not use legs;had nl speech development prior to vax;p/vax had no vocabulary;no in intensive therapy;
K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type K92.2 - GI bleeding K92.0 - Hematemesis K92.1 - Hematochezia R00.0 - Tachycardia
tested positive for COVID; tested positive for COVID; body aches; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 58-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history 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 "tested positive for COVID"; PAIN (non-serious), outcome "unknown", described as "body aches"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
4/10/19 Patient came to clinic. Reports that after vaccines he wasn't feeling well. Last evening he went to be at 5 pm and slept till this morning. He has an open area on back of right arm approximately 1/4 in wide and 1 inch long. Posterior to that their is a blister about the same size. Circular area around that is firm but not hot. Applied antibacterial ointment and covered with a 2 x 2 gauze. Patient called the next day and said he went to urgent care and they said it was a reaction to Hep A. The blisters were where the MMR was given.
PAIN AT INJECTION SITE, WITH IRREGULAR SHAPED REDNESS. PAIN IN BACK, TEMP 100.1. EVALUATED BY MD, GIVEN ZYRTEC. DOCUMENTED AS MILD ADVERSE REACTION.
Patient is 4 months old. KINRIX was given in error. Patient should have received PEDIARIX. Age of patient at time of event: 4 months.
Immediate headache, pains in legs/feet after 5 hours, low grade fever after 8 hours, pain in hands and fingers after 10 hours, skin felt bruised and sensitive to touch starting 10 hours after vaccination and skin sensitivity/pain remained until 30 hours after vaccination, fever rose to 104.5F as measured at 2AM overnight (17 hours after vaccination), day after vaccination fever never dropped below 102.0F, day after vaccination all but unable to eat due to nausea, total loss of appetite, mind foggy with difficulty concentrating, difficulty in forming detailed sentences. Pain in feet was agonizing, especially while attempting to walk.  Husband?s assistance required to walk to and from bathroom, unable to walk by self most of day of vaccination, and entire day following vaccination.  Two days after vaccination fever still present, 99.5-100.0F, appetite returning, mental fog clearing,   Still ?really exhausted.?
Pt felt very flush and had redness in her face; was in store over an hour and indicated anxiety w/shots. Left with daughter feeling better.
3/20/2023 @ 1120am- Clinic staff RN received phone call from Mother. Notified nurse of child's post vaccination adverse event, onset 3/18/2023, mother noted Left arm deltoid swelling with a golf size, mild rash at injection site. Denied any other symptoms. RN confirmed Left arm vaccines given were DTAP & Hep A. Mother reports giving child 1 dose of Motrin. Per mother 3/19/2023 reported rash worsened and spread to neck region, reported swelling improved, denied other symptoms. Per mother's report 3/20/2023, L arm swelling had resolved, rash continued to worsen and spread from neck region to torso and mid back. mother denied hives and reports appearance "like a diaper rash", reports mild itching. No other symptoms and no further L arm swelling present. Mother reports administering 1 dose of Claritin medication OTC. Mother reports child having no medical provider eval nor Urgent care visit. Per mother reports issue with no current active Medical and no established PCP due to transfer from County. Reviewed with Mother of provider resources given on 3/17/2023, for funded clinics and referral to clinic. Strongly advised mother to seek medical provider evaluation for further follow up. Mother agreed and acknowledged information provided. VAERS report completed by initial vaccination nurse, RN BSN.
Stated 2 days post injection, numbness and tingling down legs. Congestion (chest & nasal), general malaise.
LOCAL TITLE: TELEPHONE                                           STANDARD TITLE: TELEPHONE ENCOUNTER NOTE                         DATE OF NOTE: JUL 26, 2021@11:30:15  ENTRY DATE: JUL 26, 2021@11:30:15             AUTHOR:        EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                          *** TELEPHONE Has ADDENDA ***                           TELEPHONE ENCOUNTER ========================================================================        Date of Visit: 07/26/21 11:17 ========================================================================  Telephone call concerning patient, a 90 year old MALE  Length of call:  1 Minutes     Call from Patient      Pt called to let his provider know that he was hospitalized for 5 days   with covid variant.  He is home now and doing well   but is finishing quarantine.  The doctor there sent him home with a   script for pravastatin but he does not feel like he needs it.  I told him   I would ask Dr. nurse to request his records from hospital   for Dr. review.  He will schedule a follow up appointment or   telemed soon. Please advise.      Pharmacist Signed: 07/26/2021 11:34  Receipt Acknowledged By: 07/27/2021 14:46        MD                                                             Physician                                          07/28/2021 11:21       RN,BSN                                                              Nurse Case Manager                                  07/27/2021 ADDENDUM                      STATUS: COMPLETED Will await records & notify nursing team of case post-vaccination   MD Physician Signed: 07/27/2021 14:46  Receipt Acknowledged By: * AWAITING SIGNATURE *                                                                                                                    07/28/2021 ADDENDUM                      STATUS: COMPLETED lm with patient. Will pull records from Hospital and give to provider. Will also  await information from provider to schedule a f/u via tele if needed and/or any  scripts and instructions.    RN,BSN Nurse Case Manager Signed: 07/28/2021 11:24  07/30/2021 ADDENDUM                      STATUS: COMPLETED Please notify pt - they dc him home on pravastatin because they had it on his med  list when he was admitted. He doesn't need to take it. He is welcome to schedule  f/up at his convenience   MD Physician Signed: 07/30/2021 10:37  Receipt Acknowledged By: 07/30/2021 17:09     RN,BSN                                                              Nurse Case Manager                                  07/30/2021 ADDENDUM                      STATUS: COMPLETED Talked to pt. he understands--no pravastatin (he got into a fight with his  daughter about it). I scheduled a f/u with him in a few weeks--will call him to  remind him.    RN,BSN Nurse Case Manager Signed: 07/30/2021 17:23
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: breathing issues (not otherwise specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route unknown, batch number and expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date after vaccination the patient contacted their primary physician who ordered a blood work to test for antibodies. SARS-CoV-2 antibody test confirmed no antibodies (confirmed immunological vaccine failure). The patient received the first dose of COVID-19 Moderna vaccine on 02-NOV-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint: 90000200479. The suspected product quality complaint has been confirmed to be not voided as the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211110156-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
He woke up this morning and had a temperature of 100.8 degrees Fahrenheit; This is a spontaneous report from a contactable consumer reported for himself.   A 27-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot EH9899) via unknow route at the right upper arm at single dose for COVID-19 Vaccination on 16Dec2020 11:45. The patient had no medical history. Concomitant medications included zinc and Vitamin D. On 17Dec2020 08:30 the patient woke up and had a temperature of 100.8 degrees Fahrenheit. He was supposed to get the second dose on 06Jan2021. He was planning on taking Tylenol for the fever if that was ok. The patient had no history of previous immunization with Pfizer vaccine and he did not receive other vaccine on the same date. The event did not require a visit to Physician the patient felt ok. The outcome of the event was unknown.
This spontaneous report as received from a nurse refers to a 70 year old patient (gender unknown). Pertinent medical history or current conditions were not reported. On 24-MAR-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # H013847, expiry date: 15-MAR-2014, 0.5 ml, intramuscular. No adverse effect reported. Additional information is not expected.
Pt received injection, 5 minutes post injection she c/o dizziness, nausea, ears ringing lasting 10 minutes.  No other c/o.  Discharged to home with no further symptoms or c/o.
RSV  - treated and released in ER. Admission 3 days later for Pneumonia of right lung due to infectious organism. He was started on empiric ceftriaxone and doxycycline for possible superimposed bacterial pneumonia along with RSV infection and was also treated with oral steroids and nebulizers. Patient received 5 days of IV ceftriaxone, and was continued on doxycycline here instead of azithromycin due to concern for prolonged QTc (therapy completed). From a respiratory standpoint is continuing to improve and the plan was to discharge him home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Redness at site. Warmth at site. Edema to left arm. Shortness of breath. Oxygen saturation in 79% Sent to the ER for evaluation
BEGAN TWITCHING HEAD AND CLEARING THROAT. DX BY MD AS A TIC.