chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441.
Fever, hypertension, tachycardia, tachypnea, near syncope, lethargy.
Terrible headaches, worst arm pain I?ve ever experienced. Worst sickness I?ve ever had in my life. Overall pain was comparable to labor pains. I could not sleep the entire night.
red swollen area around the injection site around day 1-2 that went away then came back after 8-9 days. It was swollen, red, and somewhat painful and itchy.
Swelling, pain, erythema at injection site. Tx included TYLENOL.
Initial report was received 18 October 2010 from a health care professional. A male patient (child) had received an injection of ACTHIB (lot number route, site and date of vaccination unknown) and an unknown amount of time later, the patient experienced a "true anaphylactic reaction to ACTHIB" - "went limp". The patient's status with regard to concurrent illness, concomitant medications and pre-existing medical conditions were all unknown. The patient's outcome was unknown. The reporter declined to provide any further information. Documents held by sender: None.
ACUTE NON ST ELEVATION MI 11/2/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 19Mar2021 14:45 (Lot number: EP6955) at the age of 44 years 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive other vaccines in four weeks. The patient did not have COVID prior vaccination. The patient had not been tested for COVID post- vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
I have debilitating Tinnitus and associated hearing loss. I have trouble concentrating because of the ringing in my ears. I have associated anxiety and difficulty sleeping. I also have neurological pain in my face and also in my right arm and hand. I have has changes in my vision.
Slight fever, difficult catching breath, projectile vomiting, whole body aches, joint pain, headache.
Muscle ache; This case was reported by a consumer and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles shot for muscle ache. The reporter was requested to provide consent to follow up.
The patient received Spikevax on 9/23/23. Began "feeling bad" on 9/24/23 as reported by his wife. Patient has underlying heart condition according to his wife.  The evening of 9/24/23, had low blood pressure and increased heart rate, felt clammy and was taken by ambulance to the hospital. Patient is still inpatient with ventriculary tachycardia.
itching; hives in the shot area; 4 inches redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (hives in the shot area) and VACCINATION SITE ERYTHEMA (4 inches redness around injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (hives in the shot area) and VACCINATION SITE ERYTHEMA (4 inches redness around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE URTICARIA (hives in the shot area) and VACCINATION SITE ERYTHEMA (4 inches redness around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided
Fever of 101.6 F, body aches, chills, headache, nausea and vomiting, and fainting.
Patient has hx of anaphylactic reaction to Amoxicillin ( difficult breathing) arrived at the site with her mother, was informed about the risk of getting vaccinated at non-clinical setting due to her condition. Patient verbalized understanding, agreed to stay 30 minutes in observation area, proceeded with vaccination. After 5 minutes in observation ( 13:35 PM), patient complained of feeling nauseous, dizzy and tingling/ numbness in the upper extremities. Patient vomited x 2, 40 mL of greenish output, noted with pale complex. EMS presented at site was activated. Vital signs initiated, noted with low BP ( 60~/UNK), HR: 70, O2: 99, R:18 in room air. Patient was taken to the ambulance for further assessment by EMT. Patient received an Epinephrine shot to the L thigh by EMT at 13:52 PM. Blood pressure improved to 110/70, HR: 81, R:18, O2: 99%. Patient also received 1 albuterol treatment 6 LPM. Patient was taken to Hospital at 2:04 PM via Bus.
a patient was given TRUMENBA but was supposed receive MENACTRA vaccine/ No AE; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case received from an other health professional via physician via Medical Information number: 00736080.  This case involves a 12 years old male patient who received a dose of MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] and who was supposed to receive MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (wrong product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included Human papillomavirus (HPV) VACCINE and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for prophylactic vaccination respectively.  On 26-Aug-2020, the patient received a 0.5 ml first dose of suspect TRUMENBA not produced bySanofi Pasteur lot number: CH2637, expiry date: 28-FEB-2022, strength: standard, frequency: once via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered (latency: same day).  It was reported "Caller stated that after reviewing charts, they found that a patient received the wrong vaccine one year ago. The patient was given TRUMENBA at 12 years old, but was supposed to have gotten MENACTRA. Now that he's 13, the patient still needs MENACTRA. Is it okay to give the dose of MENACTRA at the next visit. The patient has not received any doses of MENACTRA."  Adverse event (AE) symptoms or no AE.  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 guidelines. 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.
Hep B was given in error to the patient. No harm done to patient. Patient's mother was advised of additional dose given in error.
Around 4:30- 5:00 pm pt noticed pain in left arm with redness, swelling and heat. She contacted pharmacy where she was instructed to take Benadryl. Pain and swelling persisted she contacted doctor office who advised to use warm compresses. Follow up with pt indicates improvement with decreased swelling and pain with time. Redness persist and is moving down arm.
The medical assistant giving the vaccine (COVID19 Pfizer 6 month - 2 years) diluted the vial with 0.2 mL instead of 2.2 mL. She then drew out 0.2 mL and administered this to the patient. She let us know 3 hours later after realizing the mistake. We called the patient to see how they were doing, dad said the patient was doing well and napping. We advised the family to monitor for increased side effects (fever, fussiness, pain at the injection site). We will check in over the phone for the next 2-3 days.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 22-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv", lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 48 hours, where the lowest recorded temperature was 26 F (1 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
No adverse event, just submitting because someone called and said the MIIC let them know that pt was under 18.  She is staff at the facility we serve and her underage status was not noticed at the time.  However, since she is so close, and patient age with regard to this vaccine can be thought to be arbitrary (even if pt age <18 wasn't studied), common sense indicates pt has no increased danger of adverse effects, and further, should receive the 2nd dose on schedule even if before 18 years of age.
PATIENT FELT FAINT AFTER SHOT, SAID IT HURT A LITTLE MORE THAN THE FIRST ONE, AND SAID HE HAD NOT DRANK ANY WATER OR LIQUID.  GOT PATIENT SOME WATER AND HE QUICKLY FELT BETTER AND WENT ON HIS WAY.
This spontaneous report as received from certified medical assistant (CMA) concerning to a 6 years old male patient with no drug allergies or reactions and no pertinent medical history. The patient received the first dose of HAVRIX in November 2011. On 01-OCT-2012, the patient was vaccinated with the second dose of 0.5 ml VAQTA (lot no. 0669AE, exp date: 07-DEC-2014). No other co-suspects were reported. Concomitant medications included FLUZONE. On the same date, the patient experienced fever of 104 degrees F, 1 day after onset of therapy, fatigue, loss of appetite, diarrhea, nausea and headache. The patient could not go to school. The patient was treated alternated taking acetaminophen and ibuprofen. The patient sought medical attention office visit. There were no laboratories diagnostic test performed. On 04-OCT-2012, the patient recovered from all the adverse events. Fever of 104 degrees f, fatigue, loss of appetite, diarrhea, nausea and headache considered disabling by the reporter. Additional information has been requested.
My cycle has never been the same since my vaccine. Each cycle is 15+ days longer than previous cycles. I have charted my cycles for serval years. I also have not been able to get pregnant despite trying since March
Redness covering entire upper arm (from Shoulder to elbow).  Extreme pain and difficulty moving arm.
Recently diagnosed (5 days prior to admission) but now presented feeling worse with dyspnea on exertion, cough and fever and now with oxygen requirement as welll, believes he got sick at work (no specific sick contact however). Patient vaccinated x2 against covid (Pfizer). He was scheduled to receive MAb however due to sickness was held off and rechecked spike protein Ab 8/30 and positive.On admission started Remdesivir on admission 8/29 (5 day course- 200 mg x 1, 100 mg x 4). Discussed with ID given renal function but felt benefit outweighs risk given symptoms. Dexamethasone was added 8/30. Pt had poor po intake so received 1l of LR 8/31 with some improvement of his Cr. Also started Albuterol inhaler ATC.  Due to slow improvement and persistent 02 requirement discussion had with ID and Pulm started on Baricitibib (9/1).
Swollen lips and nose, rash on upper anterior chest and bilateral thighs on 11/20/21.  2-day transient fever starting 11/18/21.
Loss of use of arm due to extreme shoulder pain. Nausea and dizziness. No swelling or redness at site.  Worst symptom happens onboard a flight. Nausea and siziness left prior to landing. Pain remained.
Pt had vasovagal episode, became obtunded, no loss of consciousness, BP and HR stable. Pt placed in supine position for 15 minutes, assisted to sitting position with no issues, was able to leave after 15 mins.
I think I had a low-grade fever, my head felt weird my right eye felt like something was in it or in the corner of my eye, I waited 3 days and then decided to go to Ophthalmology, and they did a few test on my eyes and he said everything was fine. It's kind of slowly got better.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 11:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 71.59.  No concomitant medications were reported.  On 31-Mar-2021, Excursion time was 8 AM and 9 AM, temp was 32, total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-MAR-2021. 14 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021.  Vial was stored on cooler 1, on 31-Mar-2021 excursion duration at 8AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1 PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vials only punctured right before administration.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This is a literature report. Two serogroup B meningococcal (MenB) vaccines, MenB-FHbp and MenB-4C, are available for use in persons aged 10-25 years. The Advisory Committee on Immunization Practices (ACIP) recommends either three-dose series of MenB-FHbp or two-dose series of MenB-4C. Adverse reactions like anaphylaxis have been infrequently reported. With the relatively new development of the MenB vaccines, IgE-and non-IgE-mediated reactions have not been well documented in the literature. A case of delayed reaction to MenB-FHbp was reported. A 17-year-old female with Hashimoto's disease was evaluated for MenB-FHbp reaction. Six days after vaccination, she developed hives on the arms, torso and face with lip and periorbital swelling. She denied new medications, foods, other culprits or personal history of urticaria and angioedema. Patient required ER visit where she was treated with intravenous corticosteroid and diphenhydramine, with improvement. Subsequently, MenB-4C skin prick testing was performed with full strength of vaccine and intradermal to 1:100 concentration with negative results. She tolerated MenB-4C administered as a challenge without a reaction. Adverse reactions reported for the MenB-4C and MenB-FHbp include anaphylaxis in 0.13/1000 and 4/9,808 vaccines respectively. As the ACIP recommends the use of two-dose series minimum for either MenB vaccines and as more individuals are vaccinated, the knowledge of cross-sensitivity and management of allergic reactions to these vaccines is important. One of the first cases of delayed urticarial reaction with angioedema to MenB-FHbp vaccine was presented with subsequent safe administration of MenB4-C vaccination. Pfizer is marketing authorization holder of meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report if another marketing authorization holder of meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities.; Sender's Comments: 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 Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
15 mins p/inject pt became red & watery; begin to cry-wheezing could be heard w/SOB; pt taken to ER;
TWO RED SPOTS 3.5" APART ON INJECTION ARM. STARTED OUT ITCHING, THEN HURT. 1ST SPOT TORN SKIN, 2ND SPOT INTACT SKIN. PT TORE BANDAID OFF, LATER NOTICED RED SPOTS. TOLD PT TO PUT BACITRACIN OINT ON WOUND. GAVE PT SAME.
Day after shot fever and sleepiness.  On 11/21/2021 broke out in hives- so painfully itchy. Thought I had a reaction to yard work and removing weeds; itching so bad and hives so red;  Hives change locations on my body.  Went to Dr and because I told them about yard work,  she thought it was from allergy to hollyhocks so she prescribed prednisone 20 mg 2 pills daily. Had reaction to that and stopped taking after 2 days.  Taking Zyrtec since then, still have hives if I don?t take Zyrtec. They change locations. I?ve never had hives from anything before and that is why I am thinking it?s from the Covid booster I received on 11/10/2021.
Nausea, fatigue, headache, fever, loss of appetite, joint/body pain, no appetite, memory loss and/or brain fog.
Client presented with edema and redness to (R) upper arm. Mother states she gave the client MOTRIN for an elevated temp this morning.
Right arm, began to become red/swollen. Slight itch, 2 1/2 round swollen area.
Within an hour my right shoulder was very sore.It was too painful to move my arm enough to lift a fork to my mouth.The next day, moving my arm was still extremely painful. I had a fever of ~100.5 (the fever lasted for nearly 24 hrs).By Day 3 small movement was possible but still VERY painful.Today, 5+ weeks since the vaccination, my right shoulder is only slightly better.In the morning it is VERY painful to move.Putting on a coat is painful.During the day, if I move my arm enough, some of the sharp pain goes away & I can move my arm with only moderate discomfort but my arm is now very weak.If I use my arm too much it aches. On Oct 28 I learned SIRVA was a thing.I finally saw my CPC on Nov 1.On Nov 8 I started PT.
Information has been received from a health care worker concerning a 16 year old male patient who on 08-MAR-2011 was vaccinated with a dose of PROQUAD (Merck) (Lot # not reported), instead of VARIVAX (Merck) and MMR II. The health care worker reported that this was supposed to be the second dose of VARIVAX (Merck) and MMR II for the patient. No adverse events were reported. Follow up information has been received, stating that the patient had no adverse reaction. Follow-up information has been received via telephone call from the health care worker, who stated that the girl who administered the vaccine was not sure of the ages and gave PROQUAD (Merck) by mistake. Additional information is not expected.
This is a spontaneous report from a contactable consumer (patient). A 37-year-old (non-pregnant female) patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EL3247), at the age of 37, via an unspecified route of administration, left arm, on Mar 23, 2021, at 13:15, single dose, for COVID-19 immunization. Patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; solution for injection, batch/lot# EL3247) via an unspecified route of administration, left arm, on Mar 2, 2021, at 13:15, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Mar 24, 2021, at 12:00, patient experienced chills and body aches. The patient did not receive any treatment. Outcome of the event recovered (at the time of this report). The awareness date: Feb 24, 2021. Follow-up attempts completed. No further information expected.
RECEIVED FLUARIX FIRST IN LEFT ARM THEN RECEIVED PFIZER BIVALENT - START SEIZING- TWITCHING HAED BACK- NON RESPONSIVE FOR 5 SECONDS - NAUSEOUS AND LOSS OF ALL HIS COLORS-