chrisvoncsefalvay/vaers-outcomes huggingface dataset:
local rxn to DTAP 6x6cm red, warm area-no hardness or knot in muscle;
I was 21 weeks pregnant in September and had a regular scheduled appointment with my OB on the 12th and they couldn't identify the heartbeat. I then went into natural labor that night and delivered in the morning. They tested and the baby spinaldifida and triploidy.
I injected the patient with an empty syringe into his left arm.  He didn't exhibit any symptoms, however, he was concerned if air was injected, he could get an embolism.  After that happened , I did inject the Moderna Vaccination into the left arm in a different injection site.
Pt recvd vax & exp unspecififed adverse reaction; No further details were provided;
1st dose on 18Nov2019, 2nd on 10Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number Y44ZT, expiry date 10th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th November 2019).   On 10th June 2022, the patient received the 2nd dose of Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The reporter stated that a patient received a late second dose of Shingrix. The reporter asked should they get another dose. The reporter did not consent to follow up. Additional supportive information: As patient received late 2nd dose of Shingrix which led to lengthening of vaccination schedule.
NECK PAIN (day of vaccination), CHEST TIGHTNESS, CHOKING SENSATIONS, and GENERAL BODY RASH (all within 24-hours); all symptoms were still present last visit (08/08/2011).
Seizure at home - called on-call physician and was instructed to call 911. Child was fever free at time of seizure per hospital report. Seizure/febrile 1-5-12 and 1-22-12 history.
24 hours after flumist was adminsitered patient complained of a severe migraine. The migraine has lasted for 7 days. She has been seen by her PCP and has been prescribed narcotic pain relievers which have no relived her symptoms.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unspecified dates in 2014, since 20-AUG-2014, those patients were vaccinated with doses of (Oka/Merck) VARIVAX injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
A cluster of 7 patients who received Adacel lot #C2769AA and experienced adverse events. This case is for the 2 patients with the injection site redness and "hard knots".  This cluster is detailed in cases 2007-02921, 2007-02929, 2007-02995.  Initial report received on 28 August 2007 from a health care professional.  6 unidentifiable patients received on an unspecified date Adacel (lot #C2769AA) (site, site and route of administration not provided) and experienced redness at injection site.  2 of the 6 patients experienced "hard knots" at injection site and were treated with antibiotics.  The patients had not recovered.
Pt  fainted a minute after pfizer vaccination witnessed by his mom, his twin, and two waiters in the vaccination room. He didn't fall, just fainted for a second and spilled some water on the floor. His mom requested no EMS. He is a fainter according to his mom. Whenever he witness any medical procedure done he became anxious and fainted  per pt's mom. We gave him some water and remain him in the vaccination room for additional 30-45 minutes for observation. Pt left pharmacy in stable condition.
No adverse event but a administration error.  He got this booster shot before it was 2 months after his J%J primary dose.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an elderly patient of unknown gender who was at least 73 years old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 28-OCT-2013, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) at a physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for shingles, resulting form the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not reported. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
7-31-2022 patient presented to our ER with c/o SOB while resting.  Pt was already aware that he had covid.  Pt also c/o weakness, AMS and coughing.  Pt was admitted for further evaluation and treatment.
Allergy reported to COVID MRNA vaccine. Medium reaction, water under skin and rash.
1FEB-2FEB devel fever by 3FEB; fever down to 100; seen by MD dx w/ear infect; placed on ATb; fever subsided;
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient with a history of lupus on canabis reported that he started feeling chest tightness the night of getting the covid vaccine. Patient has a history of GERD and reported taking sucralfate and pepcid a day later which helped alleviate some of his symptoms. patient reported that his symptoms can be a combination of the canabis (which sometimes causes him to experience chest tightness), GERD and an adverse effect of the vaccine
late entry: ADDENDUM: 7/25/12 12:05pm  was called to room by interpreter stating that pt was having some difficulty breathing and c/o severe itching all over his body that alll started about 10mins ago - which is right after pt got multiple vaccines; notified Dr. and we both went to see pt; Pt c/o severe itching everywhere - raised areas noted covering neck and trunk and legs; pt reported that he couldnt stop scratching all over trunk and legs;  pt also c/o some difficulty breathing - states he is having hard time swallowing - per interpreter; Vitals:  76/46;  HR 116;  O2 sat: 86% room air;  (99% after on 3L NC); resp rate 20  12:15pm Epipen Jr 0.15mg given IM L thigh per proper protocol 12:20pm Benadryl 25mg po given;  no change in normal color;  12:25pm pt continues to wheeze, breath sounds are tight- reported by Dr.; Albuterol neb tx 0.83mg - 2 vials - given per dr order 12:30pm Epipen 0.3mg given IM R thigh per proper protocol vitals:  106/84;  HR  98;  o2 sat 100%on 3L 02 via NC;  resp rate 20reg; 12:35 - pt still c/o unable to catch his breath but has improved greatly by time EMS came to get pt; 12:40 - pt transferred to EMS via stretcher in stable condition; will be transferred for f/u;  7/26/12 - f/u - interpreter - spoke to pts mom today - pt was seen at ER until around 9pm last night; he was then sent home with some meds to treat allergic rxn - will also f/u with allergist/immunologist;
Patient developed early menses/vaginal bleeding and pelvic cramping 48 hours after Pfizer vaccine.  Reporting as this has been the second patient I have encountered with this presentation.
Vaccination failure; Flu; This is a spontaneous case from, initially reported by other health professional on 11-Apr-2019, concerning a 46-year-old, adult male patient.  On 29-Sep-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell cultured derived, dose:  0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] for active immunization against influenza.  On 11-Apr-2019, 6 months and 13 days after vaccination, the patient was diagnosed with flu (considered as vaccination failure). It was reported that, the patient was not hospitalized, and the symptoms were not very strong or long. The patient was treated with unspecified antiviral drug which shortened the length of her symptoms to about 4 days. The patient felt better.   This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding QAIR reference number was 1039510. Based on the investigation performed, it can be concluded that Flucelvax 252664 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the lack of efficacy complaint was the result of the Fill Finish or Bulk manufacturing process at the facility and no trend was identified for the batch. Therefore, no internal root cause could be confirmed.   The outcome of the event was recovering.  The reporter assessed the case as serious (medically significant).  Follow up report received from other non-health professional on 06-May-2019: It was reported that the patient's symptoms were not very strong or long. The patient was treated with unspecified antiviral drug which shortened the length of her symptoms to about 4 days. The outcome of the event was updated from not recovered to recovering in the event tab. The patient confirmed that she could not recall the exact dates. The narrative was amended accordingly.  Non-significant follow-up received from the reporter on 07-May-2019: Info Number (SEQ19-01470) was added in additional information tab. No new information received, hence no changes were made in the narrative.; Reporter's Comments: A 46-year-old male patient was diagnosed with Flu (influenza), 6 months 13 days after receipt of Flucelvax QIVc (considered as vaccination failure). Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the event influenza cannot be ruled out. Hence, company assessed the events influenza and vaccination failure as related to suspect vaccine.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. There have been no power outages that would have impacted the Moderna vaccine. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022. Thus, they considered need to treat this issue as a temperature excursion. No adverse event was reported. No treatment medications were reported.
Chills; fever; severe headache; This is a spontaneous report from a contactable consumer. This 60-year-old-year female consumer(patient) reported for herself that:  A 60-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (at the age of 60-year-old) (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced chills (non-serious) on an unspecified date with outcome of unknown, fever (non-serious) on an unspecified date with outcome of recovered in 2021, severe headache (non-serious) on an unspecified date with outcome of not recovered.  The clinical course of events was as follows: Chills, fever along with a severe headache on the day of third dose. Fever subsided next day but headache remained for several days.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
10/1/21 pt brought to ED via EMS; EMS called by wife, states pt got SOB and stopped breathing; she started CPR; EMS intubated pt; pt in full arrest; pt brought to ED; unable to revive pt; pt had a positive COVID test on 9/9/21
Left arm had marked tenderness and slight swelling that lasted over four days with soreness when elevating arm.  On the next day (July 3rd), woke up and started to have aches and lethargy.  Most joints ached, most notably in fingers to the point that it hurt to curl my fingers or type.  Developed chills that happened intermittently during the day about every 2-3 hours and had low grade fever in the evening.  Developed lethargy and needed to take a nap, which I never do. Total body aches. Subsided by July 4th - reported it to my MD on the 3rd.
Fever (up to 103.1 F) Migraine Muscle stiffness blurry vision
On Thursday morning at 5 a.m., when she woke up she had an abscess between her neck and shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Apr2021 11:20 (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: ABSCESS (non-serious), outcome "unknown", described as "On Thursday morning at 5 a.m., when she woke up she had an abscess between her neck and shoulder".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
body aches, nausea followed by vomiting, feeling sick, moderate headache, diarrhea.
This spontaneous report as received from an other health professional refers to unknown number of unknown age. The patients were vaccinated with GARDASIL (lot number not reported) which was stored as low as 24F on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
MMR given 14:00. Returned at 16:30 with hives over arm, legs and face. Benadryl 50mg IM, Zyrtec, and Prednisone PO given. As above, respiration was normal, airway intact. Rx as above.
Colleague was fully vaccinated and tested positive on 27Aug; Colleague was fully vaccinated and tested positive on 27Aug; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for Injection, Batch/Lot Number: EN5318), via intramuscular route of administration, administered in right arm on 03Mar2021(at the age of 37-year-old) as Dose 1,Single and received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for Injection, Batch/Lot Number: EN5318) via intramuscular route of administration, administered in Arm Right on 25Mar2021(at the age of 37-year-old) as Dose 2,Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient allergies were unknown. Patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 27Aug2021, the patient experienced colleague was fully vaccinated and tested positive on 27aug.  Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient underwent lab tests and procedures which included nasal swab: positive on 27Aug2021. Treatment received for the events was unknown. The clinical outcome of events were recovering.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
The injection site bled, then it stopped and clotted; When the Pharmacist injected the Moderna vaccine he told her he hit a blood vessel in her upper right arm; Vaccine administered via intravenous route; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (The injection site bled, then it stopped and clotted), PRODUCT ADMINISTRATION ERROR (When the Pharmacist injected the Moderna vaccine he told her he hit a blood vessel in her upper right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered via intravenous route) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 050E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Aug-2021. Concomitant products included ETONOGESTREL (NEXPLANON) from 02-Aug-2018 to an unknown date for Birth control.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021 at 10:25 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (When the Pharmacist injected the Moderna vaccine he told her he hit a blood vessel in her upper right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered via intravenous route). On 04-Nov-2021 at 10:25 AM, the patient experienced VACCINATION SITE HAEMORRHAGE (The injection site bled, then it stopped and clotted). The patient was treated with Wound care (Bandaid) for Vaccination site haemorrhage. On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (When the Pharmacist injected the Moderna vaccine he told her he hit a blood vessel in her upper right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered via intravenous route) had resolved. On 04-Nov-2021 at 10:35 AM, VACCINATION SITE HAEMORRHAGE (The injection site bled, then it stopped and clotted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Polymerase chain reaction: positive (Positive) Positive.         Concomitant products included ETONOGESTREL (NEXPLANON) from 02-Aug-2018 to an unknown date for Birth control. No treatment mediation provided  Patient stated that pharmacist put a band-aid on the bleeding site.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received on 11Nov2021, dose 1 details, patient initials and address updated, medical history, concomitant medication and new event of VACCINE ADMINISTRED VIA INTRAVENOUS ROUTE  were updated.
I went to bed on Monday 01/16/2023 with slight chills and a slight sore throat. I woke up the next day on Tuesday 01/17/2023 with a fever of 101, a sore throat and a headache. I took a COVID-19 test and tested positive. On that day, I had a telehealth visit with my doctor who prescribed PAXLOVID. I filled and took that the same day as well. I took the PAXLOVID for 5 days. The symptoms went away, then a few days later, I had a relapse and had symptoms for another 5 days. After that, the symptoms finally went away. One thing to note: the side effect of the bad taste in my mouth while taking PAXLOVID was the worst part of taking the medication.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 02-MAR-2009, patient received improperly stored VARIVAX dose 2, from lot # 661445/0525X expiry date: 27-MAR-2010. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a 63 year old female with history of shingles (two times) and hypertension, hyperlipidemia and codeine allergy who on 04-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included atenolol, simvastatin (MSD) and estrogens, conjugated (+) medroxyprogesterone acetate (Prempro).  In July 2007, the patient developed rash over entire body.  The patient had undergone biopsy which was inconclusive of shingles.  The patient was prescribed skin creams and ointments by her physician which were ineffective.  The patient had undergone blood test (results pending).  At the time of report the patient had not recovered.  A product quality complaint was not involved.  No further information is expected.
A non-serious spontaneous report of red rash on nose has been received from a physician concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST at the end of the last influenza season 2011. After receiving FLUMIST the patient's nose became red for a short period of time, and he developed a rash on the nose which dissipated quickly. The outcome of the event resolved.
My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has subsided but the area is still red and itching.
Patient developed left-sided neck and shoulder pain/stiffness as well as right-sided butt, groin, leg, and knee pain/stiffness.
Left arm at injection site began to itch, it was swollen and bright red and warm and tender to touch.