chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Mild, Additional Details: fainted for less than 30 seconds and regained consciousness. Called ambulance but patient did not get on ambulance. sat for 30 mins next to the pharmacy before leaving.
Cold symptoms; Chills; Fever of 101.5; Body ache; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: er8727), via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 47-years-old) at 09:45 as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no allergies to medications, food and other products. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), and digestive enzymes (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 28Mar2021 at 08:00, the patient experienced cold symptoms, chills, fever of 101.5 (unspecified units), body ache, and slight headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The clinical outcome of the events cold symptoms, chills, fever of 101.5, body ache and slight headache were resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist who referred to an unspecified number of patients of unknown demographics. No information regarding the patient's pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot# M035694 and expiration date: 07-NOV-2017; dose, route of administration and anatomical location were not reported) as prophylaxis. The vaccines were stored at 21 degrees Fahrenheit (F) for 1 hour with a previous temperature excursion of 8 degrees Celsius (C) for 1 hour. The temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003438.
? with varicella. Developed lesions on hairline, abdomen, neck, trunk-spreading.
Pt came into office on 10/24/19 c/o chest pain, tachycardia, heaviness in chest, hard to breath, hurts to breath, pupils dilated, falling, off balance, light headed, bad joint pain, severe headache, body aches, eyes hurt, weak, light sensitive, and nausea.    (per Dr Note) Only vaccine given on 10/23/19  patient has headache, nausea, weak with joint and muscle aches, but had chest pain ,SOB and heart racing all of which are gone, no redness at injection site.  Still has headache, mild aches and fever which is better. All symptoms gone and feels much better.  No chest pain or SOB now.  Looks active and  good.
Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenza vax; On f/u, reporter stated pt had a gastrointestinal virus that was not related to vax;
On morning after 2nd pfizer dose, woke up and fell after getting out of bed.  Started having intractable N/V. Finally work up in May revealed a brain stem glioma. Patient to this day still has dizziness
Received vaccine on Saturday. Rash appeared on Monday - on chest,left arm (whole length) Mom took a picture. (papular rash Rash resolved by todays visit (there are hyperpigmented spotty areas on distal forearm and proximal arm anterior aspect.
Patient 2 years of age received FLUARIX 0.5 ml instead of pediatric FLUZONE 0.25ml.
Pt received Pfizer COVID-19 vaccine on 3/25/21 at around 11:15 am and immediately lost consciousness.  Nurse administered epinephrine and called 911.  Pt regained consciousness shortly after receiving epinephrine.  Pt did report history of syncope with injections before receiving the vaccination.
Information has been received from a licensed prn concerning a male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and presented today, on 30OCT2003 with the "same type local site reactions" a red, swollen and painful arm. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently the pt recovered. The reporter expressed concerns about the particular lot of vaccine and requested a lot check on 1026M. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Two weeks (3/26/2021 )after 2 shot develop 24 hour flu like symptoms .  I had had a Covid-19 test on 2/27 /2021 for pre test fora 3/1/2021 Colonoscopy.   So did not think it was COVID.    during that period from  3/1/2021  till 3/26/2021 had limited  outside contact and always with a mask.  I very rarely get  sick ( once every 10 years)  Symptom have continued for about a mouth slowly getting better Tired, mild sore throat ,and morning congestion
I had an allergic reaction. Doses 1 and 2 were Pfizer. The reaction started 4 minutes into the observation period and resolved 26 minutes into the observation period. My throat felt like it was closing and the pharmacist said I looked red/flushed. I got extremely warm. They had 2 pharmacists observing for worsening and ready with an epipen but epipen wasn't needed and it resolved on its own.  If this happens with other mix and match boosters then it might be worth advising people with a history of severe allergies to boost with the same vaccine as the original dose?
This spontaneous report was received from a 61 year old female patient, reporting on herself. The patient concurrent conditions included high cholesterol, drug allergy to penicillin and sulfa drugs. The patient no concomitant medications. On 06-JUL-2016, the patient was vaccinated with ZOSTAVAX, in the right arm, 1 time, lot # L046896, (dose, route and expiry date not reported). Subsequently, on the same day, the patient had reaction at injection site, on the right arm. The injection site became red, swollen, tender, feverish and spreading up her arm. The outcome of the events and causality assessment was not provided. Additional information is not expected as reporter did not wish to be contacted.
Patient reported to the ED on  01/16/2022 and  states that approximately 3 AM this morning she was walking to get up to the bathroom tripped and fell over a toy and landed on her right side, specifically her hip.  She denies hitting her head or neck.  This occurred after receiving covid vaccine 01/06/2022. Per guidelines, all hospitalizations are recorded.
Body aches, headache in lower area of back of head, slight spasms in legs, very tired
This spontaneous report as received from a registered nurse refers to a 16 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis (incorrect product storage). The vaccine underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008666: US-009507513-1710USA014905: US-009507513-1710USA014904:  US-009507513-1710USA014903: US-009507513-1710USA014906:
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 2:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 2:45 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided
Pt recvd 1st dose of Hep B vax approx 20FEB91; Pt devel a very swollen arm starting @ inject site;
ongoing recurrent migraine headaches and vascular swelling in the head; ongoing recurrent migraine headaches and vascular swelling in the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8733) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillins" (unspecified if ongoing), notes: known allergies: penicillins; "dairy allergy" (unspecified if ongoing), notes: dairy allergy. There were no concomitant medications. Past drug history included: Neosporin, reaction(s): "known allergies: neosporin", notes: known allergies: neosporin. The following information was reported: ANGIOEDEMA (medically significant), MIGRAINE (non-serious) all with onset 24Mar2021, outcome "not recovered" and all described as "ongoing recurrent migraine headaches and vascular swelling in the head". The events "ongoing recurrent migraine headaches and vascular swelling in the head" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid test type post vaccination=Other. Therapeutic measures were taken as a result of angioedema, migraine. Clinical course: Patient did not take any other vaccine in four weeks and any other medications in two weeks. Patient took meloxicam as treatment. Patient had no Covid prior vaccination. Patient was tested for Covid post vaccination. other medical history none. Patient took dose 2 on 13Apr2021 (Lot number: EW0169) right arm, dose 3 on 12Nov2021, (Lot number: FG3527) left arm and dose 4 on 27May2022 (Lot Number: FN2908) right arm all Pfizer Covid-19.
Muscle pain in arm where shot was received, the pain radiates up the shoulder and into the neck. No redness or swelling at the site.
chest heaviness/discomfort/ dull pain next to left arm till today no treatment usually constant discomfort till today
Narrative: 91yo M with h/o HTN,CAD, bladder cancer, prostate cancer, HLD, & OA died on 7/15/2021. Pt died on 7/15/2021. Pt received covid vaccinations on 1/20/21 & 2/23/21. Likely death is unrelated to covid vaccinations.
expired dose of Fluzone was given to a 24 year old pregnant patient, no AE; expired dose of Fluzone was given to a 24 year old pregnant patient, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 years old female patient who received expired dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number not reported, that expired in June) via unknown route in unknown administration site on an unknown date, while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The vaccination occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  It was also a case of vaccine exposure during pregnancy.  At the time of report, no adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number was requested.  List of documents held by sender: none.
It was reported that a pt rec'd a TD adult vaccine on 4/13/01. Reportedly the next day after the injection the pt developed itching at the site. The pt recovered from the experience. This case is closed.
Swollen lymph glands under left armpit, pain under arm.   I was seen by my Physician and she ordered an Ultrasound.  Pain in legs on skin when touch, numbness tingling,
This spontaneous report as received from a consumer refers to a 23 year old female patient. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1, intramuscular for prophylaxis.  Other suspect therapies included GARDASIL. On an unknown date the patient experienced depression and anxiety. The outcome of depression and anxiety is unknown.
Initial misuse report received from a healthcare professional (nurse) on 25 October 2013 and the case was received on 21 March 2014 at agency. A 24-month-old patient (gender was not reported) had received a dose of 0.5 ml of FLUZONE vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient was given 0.5ml of FLUZONE vaccine instead of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
About 6 hours later I began to experience "pulsations" from my neck, up to my head and down my arms to my hands. The "pulsations" typically occurred  when I would move my head (left, right, up, down). This lasted several hours. I did not experience them anymore the following day, or thereafter. These events are similar to symptoms I experienced after a spinal cord injury in 2013, and they have not occurred since I recovered from that injury, until I had the 3rd Moderna vaccine (for immunocompromised individuals, so it was a full dose).
Received Pfizer vaccines on 1/20/21 and 2/15/21. Had exposure to COVID 19 and tested positive for COVID-19 by PCR on 3/30/21. Symptoms of sore throat, congestion/rhinnorhea w/ onset date of 3/29/21. Received monoclonal antibodies.
Swelling, itching, bruising treated with ice packs, Tylenol, Benadryl.
Tested positive for COVID 19 four weeks after 4th dose of the vaccine.  Symptoms were severe headache, bad cold, fatigue
This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a adult male patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. In August 2013, the patient received the 1st dose of ENGERIX B adult. On an unknown date, the patient received the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIC B adult. On an unknown date, an unknown time after receiving ENGERIX B adult and ENGERIX B adult and 30 days after receiving ENGERIX B adult, the patient experienced autoimmune disorder (serious criteria GSK medically significant), gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity. On an unknown date, the outcome of the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss, itchy skin, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity were unknown. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, hair loss and itchy skin to be almost certainly related to ENGERIX B adult. The reporter considered the autoimmune disorder, gastritis, vitamin B12 deficiency, rheumatic disorder, knee pain, neurological disorder nos, neck pain, pain in spine, connective tissue disorder, numbness in hand, pain in hand and spasticity to be almost certainly related to ENGERIX B adult. Additional details were received as follows: In August 2013, the patient received 1st dose of ENGERIX B adult. After receiving 1st dose of ENGERIX B adult, the patient experienced hair loss and itching of skin. After receiving the 2nd dose of ENGERIX B adult, the patient experienced worsening of the hair loss and itching of skin. On an unknown date, 1 month after receiving 3rd dose of ENGERIX B adult, the patient experienced rheumatological disorders in his left knee and neurological disorders such as pain in his neck and spinal cord (symptoms similar to cancerous mellitus). In the winter of 2015, the rheumatological disorder spread to both knees and elbows. In July 2015, it was determined that the patient might have a connective tissue disorder in these joints. On an unknown date, patient underwent blood test and it was confirmed that the patient had an autoimmune disorder in the form of a B12 deficiency and gastritis. The patient also experienced numbness, shooting pain and spasticity in his hands. The patient believed that these events were caused by the autoimmune disorder. The patient had denied permission to contact their physician.
patient was given pediarix at 15m wcc thus giving a #4 IPV and #5 Hep B
After I received the vaccine I started walking to my car and I got dizzy with chest pain. I was taken to the ED and they did an EKG and took vitals. Around 1 pm I made it home and I started getting violently ill (throwing up with severe headache) Sat night I called my OB and they told me to go to the family center were i received fluids, medication for my headache and nausea meds. Sunday I called the ob again because I started having cluster headaches/migraines and my migraine moved from the right to the left of my head almost felt like fireworks. Monday I went back to the ED for fluids and a migraine medication which actually felt relief.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-FEB-2019, the patient was inadvertently vaccinated with a dose of ROTATEQ (lot# N011648, expiration date of 01-DEC-2018, strength, dose and frequency were unknown) orally for prophylaxis (Expired product administered). No adverse event was reported. No product quality compliant (PQC) was involved.
Moderate high frequency hearing loss diagnosed by audiologist in one ear; Tinnitus in both ears; This is a spontaneous report from a contactable consumer for himself  A 52-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 21:00 (Batch/Lot Number: EW0153) at the age of 52 years as DOSE 1, SINGLE for covid-19 immunisation.  Facility type vaccine: Pharmacy or Drug Store. Medical history included neuropathy peripheral and drug hypersensitivity to Sulfa. Concomitant medications included gabapentin (GABAPENTIN); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]). The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced moderate high frequency hearing loss diagnosed by audiologist in one ear on 20Apr2021 with outcome of unknown and tinnitus in both ears on 08Apr2021 06:00 with outcome of recovering. Clinical course: Tinnitus in both ears began 3 days after the injection and continued until being seen by ENT on 10May2021 and prescribed prednisone which is helping reduce the tinnitus symptoms (recovering). Moderate high frequency hearing loss diagnosed by audiologist in one ear on 20Apr2021.  COVID prior vaccination: No, COVID tested post vaccination: No
Immunizations given on 6-7-07, developed fever of 102 deg within 24 hrs
Approximately 8 days post vax pt experienced fever which is decreasing daily.  On 1/6/00 the pt experienced a rash and an increased size of left carotid. Unspecified medical attention was sought. On an unspecified date the pt recovered. No further information is available.
Received Gardasil on 03/09/2007. Patient reported numbness / tingling feeling in left fingers, arm and left swollen lip, then hands felt floppy / numb. Negative for shortness of breath, chest pain, fever, injury. Physical exam grossly normal, normal neurological exam.
5 minutes post Hep B vaccination arm felt heavy, fingers tingled, and head didn't feel right.  Patient called a co-worker to her office who called nurses to assess patient. Nurses said her face was pale white and her arm was shaking.  Nurse took blood pressure every couple of minutes.  It went as high as 190/110.  Patient fainted and slid from chair onto the floor with assistance from the nurse.  EMS was called.  Patient does not recall regaining consciousness until EMS arrived and was rubbing her sternum.  EMS transported patient to the Emergency Room for further treatment.  Patient reported that she was not given any medication at ED but was observed.  While she was there she reported that she couldn't move her legs for several hours. Finally when she was able to move her legs, she was discharged home.  ED recommended rest and plenty of fluids. Patient reported that she feels pretty good today (1 day post vaccination).
CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities. Patient has not reported any adverse events to health clinic where error occurred.
During the first vaccine pain arm for three days and for the second dose pain body, temperature, arm pain, chills for three days. However, since the first application until today, my arm has not fully recovered. I lost strength at first and with certain movements I get still get intense pain (only for at the moment). At first I thought it might be part of a reaction I had contracted but I went to the doctor and he confirmed that what happens is a secondary reaction to the vaccine, this diagnosis was also confirmed by the neurologist and the treatment I'm getting is LYRICA.
Developed a noticeable increase in tinnitus in both ears yesterday (2 days post 2nd vaccination).
High Fever, constipation, weak and listless, stomach ache, painful body all over, unable to hold her head up, no appetite, spitting up, could not sit by herself or walk without falling, very sleepy all the time, dehydrated.