chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ANAPHYLACTIC REACTION; PAIN ON LEFT ARM AT SITE OF INJECTION; MINOR SWELLING OF LEFT ARM AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic reactions to Penicillin and erythromycin, tetracycline, Streptomycin, sulfa, salmon, eggs, sensitivity to nuts, orange juice, anaphylaxis, non smoker, and non alcohol user and asthma other pre-existing medical conditions included: The Patient did not had history of drug abuse/illicit drug use. Patient not on any other medication at the time the adverse event started. Patient did not had illness at the time of vaccination and adverse event after any previous vaccination. Patient did not had pre-existing acute illness 30 days prior to vaccination, history of hospitalization in last 30 days, with cause. Patient did not had family history of any disease (relevant to vaccination) and allergy. Patient was not pregnant at time of vaccination and currently was not breastfeeding. The patient experienced achiness and tired when they received covid-19 vaccine ad26.cov2.s (Series 1) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Series 2 Booster dose) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, frequency one total, administered at left arm, on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021 within 5 minutes of received the booster, the patient experienced anaphylactic reaction and pain on left arm site of injection and minor swelling on left arm site of injection .The patient experienced coughing non stop, it was more a reaction and not exposure to something therefore the patient took a dose of rescue inhaler pro air and did not tell the pharmacy staff as the patient did not want to give epi-pen or the ambulance to be called. The patient waited in the pharmacy for 15 minutes then went to a store and realized that face felt hot, as prone to allergic reactions and anaphylaxis so went home and took liquid Benadryl (4 doses). The patient experienced swollen face red and hot and had a post nasal type drip type reaction (difficulty breathing). The patient was much better and it was about an hour and 10 minutes. The patient only had a little achiness and felt tired after the original dose, patient received (Series 1) on 11-MAR-2021, lot number was 1802072 and it was also administered on left arm. Treatment medications included: salbutamol sulfate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from anaphylactic reaction ,Pain on left arm at site of injection, and minor swelling of left arm at site of injection. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211122735.; Sender's Comments: V0: 20211106318-covid-19 vaccine ad26.cov2.s-anaphylactic reaction. This event(s) is labeled per regulatory authority and is therefore considered potentially related.
Around 3:30am on Sunday, I woke up due to feeling very cold. My teeth were chattering and regardless of the amount of layers of clothes or blankets added, I could not get warm. Later in the day I checked my temperature and it registered at 100.6 degree Fahrenheit, but I did not feel as cold as I had earlier that morning. I also had what felt like a sinus headache and my whole body felt stiff/achy. There was also some slight nausea that occurred. The nausea and slight fever went away by 11am, but the headache and body aches lasted until about 9PM Sunday night. After my nausea went away I was able to take some Aleve to help with the stiffness.  At the site of injection, it is slightly raised red bump (about two inches across horizontally and vertically), and there is some slight pain  in the armpit area on this side as well. The swelling of the bump was slightly bigger yesterday, but the swelling has gone down some this morning.
Swelling at injection site as well as entire arm down to fingers, red, warmth, pain, body aches.
Patient came into pharmacy on Tuesday, 7 November , 2023 and said that he experienced a sore arm the day after receiving  Fluad on 3 November 2023. The patient seemed to be in pain and had difficulty in removing his sweater. The patient's arm was examined, there were no visible rash or swelling on the shoulder at the injection site. Patient indicated that it was painful  on top of his shoulder between his neck and shoulder. Patient's right hand was swollen. Patient stated that the pain improved when he took Ibuprofen, he also stated that he was on Prednisone daily as he had a kidney transplant. Patient purchased Diphenhydramine and was going to follow up with his physician and will report back to the pharmacy in 2 days
This spontaneous prospective pregnancy report was received from a nurse and refers to a 25 year old female patient. There was no information regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. The patient was pregnant at the time of the report. On an unknown date in 2017, the patient was inadvertently vaccinated with VARIVAX for prophylaxis (lot number and expiration date were not provided). The vaccine was reconstituted with sterile diluent MRK (lot number and expiration date were not provided). The patient had pregnancy test done on 15-MAR-2017, with the negative result. Then, subsequently the patient was determined to be pregnant (unknown date in 2017). The patient had an ultrasound investigation performed, which determined conception occurred on an unknown date in mid February 2017. The ultrasound result was normal (performed in approximately 2017). The last menstrual period was calculated as approximately 01-FEB-2017 and estimated delivery date was calculated on 08-NOV-2017. The patient sought medical attention by visiting a physician's office. The pregnancy outcome was pending. No product quality complaint was involved. Additional information has been requested.
I woke  up at 3:30 a.m. February 11.  I noticed I had wet the bed (which I haven't done for 60+ years) and felt very weak--afraid to move for fear I would pass out.  I had no pain and no indication of heart attack or stroke.  After 5-10 minutes I walked to the bathroom where I had diarrhea and vomited a small amount. I stayed on the stool for some time because I felt too weak to safely get up.  I did go back to bed after 15 minutes or so.  I got up again with diarrhea an hour or so later. I got up at 9 a.m. feeling  a lot better but still weak.  Took it easy the rest of the day and had regained most of my energy by evening.  I think I may have suffered a seizure of some kind resulting in the wet bed and extreme weakness.
Within a week or so, was unable to digest fats or acidic foods. Food would cause severe pain in the upper back. On June 8 received a chest X-Ray. On June 14 received a CT scan. Both tests showed no adverse signs. Currently taking digesting enzymes with minimal relief.
Patient given COVID-19 vaccine Moderna dose 1 and 2 in past. COVID-19 Pfizer 3rd dose given. Patient denied any adverse affects at this time.
Fibromylgia; Nerve pain is excruciating because of fibromyalgia; painful; Got the vaccine, got singles/suspected vaccination failure; shingles/Got the vaccine, got singles; 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.   On an unknown date, the patient received Shingles vaccine. In June 2022, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the patient experienced fibromyalgia and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, fibromyalgia, nerve pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fibromyalgia, nerve pain and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had fibromyalgia and got the shingles vaccine last year and got shingles a month ago. The patient stated that it was still bothering him/her and was one of the most painful disease ever. The nerve pain was excruciating because of the fibromyalgia.  The patient hope it stops soon. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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. As it was not clearly whether the fibromyalgia was occurred before or after the vaccination, and follow-up was not possible due which in worst approach it was captured as event.
dizziness, headache, diarrhea, arm redness, faitgue. Used Ibuprofen and iced arm. Reports being fine now.
Pt experiencing chills, nausea, muscle aches, couldn't finish lunch after flu shot due to nausea. I advised her that these can be possible side effects of flu shot, but to go to urgent care if symptoms worsen. Pt came back to pharmacy a week later after dr's visit to report that she had had to go to emergency room with fever of 100.3F four hours after flu shot, was given Levaquin and fluids overnight. Had marked no fever on the consent form at the time of the flu shot. Diagnosis still unknown. Possible reaction to the flu shot.
Fever, fatigue, mental fogginess, difficulty breathing due to inflammation in my lungs, random sharp pain all over body, nausea. Treated by steroids and multiple duonebs at the er. At home I had to take 3 albuteral and 3 duonebs as well as 4 extra doses of my symbicort to try to control my breathing and get out under control
Hives, rash, 3weeks on Prednisone, 1 week on Antibiotics
Syncope and generalized tonic-clonic convulsions for approximately 10-15 seconds after last vaccine given (HPV) about 1-2 mins after vaccine received.
torso rash; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (torso rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (torso rash). At the time of the report, RASH (torso rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Menveo only liquid given; Menveo only liquid given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On 26-JUL-2023, the patient received Menveo. On 26-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid given) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 07-AUG-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.   The patient received only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
anemia, elevated d-dimer-done and work up shortness of breath symptoms which started a few months ago heavy menstrual bleeding post vaccine
Exactly 2 weeks following the second dose of the Moderna vaccine i suffered vision loss in the lower half of my right eye, frequent headaches and sensitivity to light.  Upon meeting with my neurosurgeon I was diagnosed with a cyst formation on the pituitary gland in my brain causing said vision loss and headaches.
Patient returned to clinic reporting left sided facial & arm numbness. Reported that her face felt like the numbness for the dentist & reports drooling. She retuned to clinic at approx 1345 & was escorted to the ER.
Patient contracted Covid19 after being vaccinated with moderna EUA 05/04/2021-06/01/2021
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with fourth dose of GARDASIL (unknown route, strength and dose) or GARDASIL 9 (unknown strength and route). The healthcare worker was unsure if the product was GARDASIL 9 or GARDASIL. No adverse affects were reported. There was no product quality compliant involved. Additional information has been requested.
Initial report received from a healthcare professional on 03 September 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT, (batch number UI192AA, dose in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patients experienced local reactions and fevers. The patient had high fevers and vomiting and local reactions such as large patch of redness, muscle pain and was not able to walk. Corrective treatment and laboratory details were not reported. At the time of this report the patient was recovering from the events. Patient was doing better today, and was walking today. Documents held by sender: none.
I was in a lot of pain, I was crying and I couldn't stand up from a sitting position. I couldn't go up any of my stairs, I couldn't get into a car. The pain was in my hip, shoulder and neck. I call my doctor but my PCP doctor had left the practice and I was getting the run around, I needed something for pain. When I do get something for the pain, the PA said that I was having a flare up from the Booster shot.
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight  and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
Within 2 days of receiving injection - she developed severe resp. problems resulting in need for antibiotics, PREDNISONE, and increased use of both bronchodilator and steroids. It took 2 1/2 weeks to get back to normal - has pre-existing COPD.
BLURRED VISION; DIZZINESS; DRY MOUTH; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: unknown) dose was not reported, frequency once total, administered on 11-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced blurred vision. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced dry mouth. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 11-MAR-2021, and chills, and fever on MAR-2021, and had not recovered from dry mouth, headache, and blurred vision. This report was non-serious; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
age 81 Admit to Medical Center. 3/12/2023 for respiratory failure due to COVID-19. COVID positive 3/11/2023- notes stated she was tested at Rehab and positive the prior Tuesday. Date of COVID death: 3/13/2023 COVID Vaccine: Moderna
Patient complained of extreme dizziness lasting for 3 days (Fri-Mon).  Came to see PCP on Monday 8/10/2020.  Lab work completed.  Patient will follow up later in week.
No adverse effects; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history and drug reactions/allergies was not reported. Concomitant therapy included sterile diluent.   On 14-OCT-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S015460 with expiration date 20-MAY-2021, dose detail was not reported) via subcutaneous route for prophylaxis. The vaccine experienced improperly stored and was stored at minus 11.5 degree Celsius (C) for 76 hours. There was no previous temperature excursion. The call was because of a data logger involved. It could not be determined if the sterile diluent was properly stored. No adverse effects were reported.
I have a lump on my left shoulder underneath the skin and swollen on top towards my neck.
experienced increased immune system response; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003391.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "experienced increased immune system response". Additional information: On 06Sep2022, it was reported that a patient started treatment on an unspecified date with Pfizer-BioNTech COVID-19 Vaccine at an unspecified dose and frequency for COVID-19 immunization. It was reported the patient experienced increased immune system response that lasted for months following her second dose. No further follow-up is anticipated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This subject is a three month old female, who suffered a fatal head injury while enrolled in a comparative post marketing safety study of Daptacel (diptheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the US standard of care. The subject received one dose of study vaccine: the last dose prior to the event was given on 01/14/2003. The subject "expired instantly due to blunt head injuries in motor vehicle accident described as "auto vs. fixed object, ejected," 18 days post immunization and expired the same day. No other information was reported. Death Certificate has been received. Autopsy has been performed but report not yet received. The event of fatal head injury was reported by the investigator as unrelated to the study product.  The autopsy report states accident automobile, death.  Follow up on 09/30/2003: "Autopsy Report received by medical affairs on 09/16/2003.  This three-month-old female is a victim of an apparent accidental death.  "Auto (passenger) vs. F/O, rollover, ejected".  The base portion of the car seat strapped in the center of the back seat.  The car seat carrier was facing rear, however it was behind the passengers seat of the vehicle (not locked in the base) with the seat belts in use.  The car seat canopy was found with the descedent.  She was about 100 feet north of the vehicle, face down with her head against a rock.  There was a blanket covering her.  Death is probably instant and is clearly from crushing blunt injuries to the head.  Other injuries also listed in the autopsy report include a crushed head and multiple severe abrasions and probable compressed chest event due to collapsed lungs and areas of hemorrhagic discoloration on lungs.  This can happen in infants without fractures of the ribs, etc.  Other injuries included fracture of the left femur as well as crushed and avulsed toes of the right foot.  There was no signs of internal torso injuries except for the lungs.  No further information is anticipated, this case is considered closed.
Three months after getting my 2nd dose, late in the day on May 31st, I had discomfort in my glands of my throat. It was painful to swallow. Later that night at  2:30am, I experienced a lot of pain in my throat while lying down. I had a temperature over 101 and I was having sinus pressure, nasal discharge, heaviness in my chest, sore throat, and headaches. I called my doctor June 8th and scheduled a telehealth appointment. On June 9th, I spoke to my doctor and they said that I could possibly have the flu with a sinus infection. They prescribed me with an antibiotic.
I developed a swollen area in my arm that turned into a lump. I had an ultrasound of the lump this week and I believe it was diagnosed as a lipoma.
Urticaria developed the day after Hep A was administered. No recent viral illness or change in food, soap, detergent etc. Pt on no meds at time hives developed this occurred intermittently - responded to BENADRYL but revised had hives on trunk, thighs, and cheeks pt seen 8/22/13 treated with cold compression, AVEENO, cetirizine.
TIRED; ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, and batch number: 1808025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced achy. On 10-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, and tired. This report was non-serious.
Case number PHEH2014US023380 is an initial spontaneous report received from a pharmacist on 19 Nov 2014. This report refers to a 36 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: A14030), intramuscularly reconstituted with a sterile water instead of MenCYW-135 liquid component on 08 Sep 2014. No adverse reaction was reported following this administration error (wrong solution used in drug reconstitution).
patient's ear's turned red post vaccination. she also reported itchy sensation.  she was monitored for 30 minutes post vaccination and did not received any medical treatment, was sent home and advised to seek medical care if symptoms worsened.