chrisvoncsefalvay/vaers-outcomes huggingface dataset:
death after 1 dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death after 1 dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death after 1 dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          The reporter stated that she was not sure of the vaccine name that the patient used.; Sender's Comments: This is a male patient of unknown age,  who received mRNA-1273 Vaccine and died on an unknown date after receiving first dose of vaccine. No medical hx or conmeds were provided. The fatal outcome may be related to the patient's pre-existing comorbidities Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: death after 1 dose of vaccine
On the 6th day following immun w/HIB-titer, infant seen in MD office & presented w/fever of 101-102, maculo-papular rash, & irritability; PE normal; No tx initiated;
Pt. received her vaccines on Friday, March 24th. Pt.'s leg swelled and was bruised at the site of the injection and there were a few raised hives around it.  I have two older children and I have never seen bruising or raised hives around an injection site like this.   Of more concern was the fact that she keep nodding her head back constantly several times a day since the vaccines.  These episodes lasted anywhere from 5-10 seconds.  I brought her to her pediatrician the next time the office was open, which was Monday, Feb 27th.  The doctor examined her and said she thinks her leg looked normal.  I also showed her videos of Pt.'s abnormal head movements and she said to just keep documenting it and watch it.  I went home and was still nervous about it because she was doing it so often, even when she woke up the next morning with her eyes still closed on the 28th.  I called a neurologist office but the soonest appointment they could give was June and if I was concerned that it was a reaction to a vaccine I should go to the hospital.  So, on 2/28/23 I went to Hospital.   The ED doctor was such a kind man.  He watched all the videos I took and examined her and consulted with the neurologist affiliated with the hospital, who ordered a brain EEG.  The test took 25 minutes and came out normal, however during that test she did not experience any head tics.  I was discharged and instructed to follow up with a  neurologist within two weeks.  Her head movements have since decreased since, however I am concerned it was an acute reaction to one of the vaccines and I am unsure what to do about her next scheduled vaccinations.
Mother of child reported that she removed the child's bandaid on Saturday and found his upper arm red, swollen, and warm to touch.  Mother stated she contacted her pediatrican and child was prescribed Augmentin.
Patient developed cough-mucous in mouth.  Wheezing and generalized itching with no rash.  He was treated with 0.2cc without SVA cut and albuterol inhaloation x1.  He was also given oral steroid 15mg BiD x2 days 15mg OD x 2 days.
None aware of at this time, patient given kids dose instead of adult by RN, he came back a day later and was given adult Pfizer full dose for 1st immunization. He was well today with no adverse event noted. He is aware of the concern.
given 21 doses that it was expired recently, had just taken it out of the freezer; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19.  It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination.  It was known if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer).    No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20Sep2022. The vial did not undergo any temperature excursions  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received: Reporter address updated.
child received Fluzone Quadrivalent doses two weeks apart, no AE; Initial and additional information received on 26-Sep-2019 and 30-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 years old male patient who received twice 0.5 ml INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ237AB, expiry date: 30-Jun-2020), two weeks apart, on 11 Sep 2019 and 25 Sep 2019 in left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate schedule of vaccine administration.  At the time of reporting the patient had no adverse event.  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.  List of documents held by sender: none.
Since May 2021 have developed right shoulder tendonitis which has gradually progressed to bilateral medial epicondyle elbow tendonits follwed by bilateral radial wrist tendonitis. Symptoms have remained mild but persistant and are bothersome when doing tasks typically considered routine.
Second day after shot had severe site pain radiating to upper left arm to left collar bone and left side of neck and left shoulder blade. Lasted several days.  First second and third week gradually started having spasm of my entire neck radiating to collarbone and top of shoulder and left top arm and to my top of head. The third week my neck spasm got so severe I could hardly move my head because I would get severe pain.  Still having severe stiff  neck  with pain radiating to head collar bone and top of shoulder.  Not sure if these symptoms are related to the vaccine or my neck artritis.  My neck Artigas never given me these types of symptoms. MY QUESTION I AM SCHEDULE TO HAVE MY SECOND   Injection February 11. Not sure I should take it. My entire life been sensitive to medication. PLEASE ADVISE.
Herpes Zoster in a vaccinated individual. Unilateral rash lasting less than 4 weeks. Given a prescription of valtrex to treat illness.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced erythema, pain in arm, fever, pain and sleep deprivation. On 27th March 2019, the patient experienced raised rash, tingling, skin discoloration and head pressure. On an unknown date, the outcome of the erythema and pain in arm were recovered/resolved and the outcome of the fever, pain and sleep deprivation were not recovered/not resolved and the outcome of the raised rash, tingling, skin discoloration and head pressure were unknown. It was unknown if the reporter considered the erythema, pain in arm, fever, pain, sleep deprivation, raised rash, tingling, skin discoloration and head pressure to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, she got SHINGRIX a week ago before the date of reporting. The patient's arm was sore and had a red area 1 by 2 inches that lasted for a few days. She also has been feeling feverish and achy and when she woke up in the morning it did not feel like she has slept. At the day of reporting morning she woke up with 4 spots on her forehead which are darker in color than her skin and might be a little raised. She could feel pressure or tingling in the area of the spots. The reporter consented to follow up.
Chills; Body aches; Fever; Sweating; Stomach pain; Pain in legs; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 27Mar2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included heart issues (supraventricular tachycardia [SVT]). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included acebutolol, diphenhydramine (BENADRYL), and guaifenesin (MUCINEX) from unknown dates for unknown indications. On 27Mar2021 the patient experienced chills, body aches, fever, sweating, stomach pain, and pain in legs. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of chills, body aches, fever, sweating, stomach pain, and pain in legs were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected
Pt said she had difficulty swallowing about 5 minutes following adminstration, gave patient a dose of Benadryl waited and patient got better. Called in an hour to check up on patient and she said the symptom has resolved.
the patient was administered improperly stored VARIVAX; This spontaneous report has been received from a physician referring to a 4 years old patient of unknown gender. Information about pertinent medical history, concomitant medication or drug reactions/allergies was not provided.  On 03-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX); lot # S032355, expiration date 14-OCT-2021 (strength and dose were not reported) subcutaneously for prophylaxis (reported as routine vaccination) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S032591, expiration date 16-AUG-2022).  The storage temperature of the vaccine was reported as 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.6 Fahrenheit degrees) for a time frame of 12 hours (multiple excursions) and in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (16 Fahrenheit degrees) for a time frame of 30 minutes recorded by a data logger. There was no previous temperature excursion. No product quality complaint involved.
Swelling of face, lips (so swollen could not close lips enough to drink water), ocular area and eyelid (right eye 1/2 way swollen shut), rash on neck, swollen lymph nodes.
swollen lip, lt side only; lt eye swollen-mom said almost shut; rash over chin;
Patient received vaccine after expiry date; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE on 30-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        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 provided.
Approximately two weeks after receiving this mandatory investigational injection I started having severe headaches. The headaches last only about 3-5 seconds, but they are so severe, I would probably lose consciousness if they lasted any longer.  The pain in my head is more extreme than getting burned or passing a kidney stone, and I've passed three kidney stones. This mystery shot was "fixing" what was not broken to begin with.  Having had the chinese corona virus I already had natural immunity to it.  I was never getting headaches, now I get severe episodes every 2-3 days.  I will NOT take any more of your mystery clot shots!  Fire and prosecute me, but my employer or this government is not my doctor and I won't let it make medical decisions for me!!  My body, my choice!
lip swelling; Earlier Seasonal Allergy Response; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip swelling) and SEASONAL ALLERGY (Earlier Seasonal Allergy Response) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028AZ1A) for COVID-19 vaccination.     The patient's past medical history included post traumatic. Concurrent medical conditions included Seasonal allergy.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced LIP SWELLING (lip swelling) and SEASONAL ALLERGY (Earlier Seasonal Allergy Response). At the time of the report, LIP SWELLING (lip swelling) and SEASONAL ALLERGY (Earlier Seasonal Allergy Response) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  The patient generally treats seasonal allergy with a 'double' dose of Allegra.  The patient said that her next shot is due on 26APR2021.
About 10 to 15 minutes after receiving vaccine patient complained of tightness in the chest. After a short time she experienced tingling in  lips. We moved her to the floor and laid her flat with head raised  as she began to experience uncontrolled movements in arms and legs (seizures?) I administered epinephrine for tightness in chest and tingling lips and 911 was  called. Rescue squad arrived stabilized  her and transported to hospital.
04/24/2021 COVID vaccine dose #1 at non-VA pharmacy 05/03/21  Veteran relaying message to the provider re: symptoms post #1 Covid19 vaccine at non VA pharmacy - April 24, 2021: slight chills, no SOB no dizziness. (+)constantly dey mouth. Veteran was tested negative last Saturday May 1,2021. He declined to go to an urgent care to be evaluated. 12/23/21 PCP documents ADR to COVID vaccine: muscle pain, vomiting, fatigue; no further information in progress note so unclear extent of symptoms No further follow up or evaluation symptoms
Patient came into clinic with vaccine records in another language.  The vaccine nurse reviewed records and transcribed Pentavalente as doses of DtaP and IPV only given on 7/7/14, 8/10/14, 12/3/14.  Due to no transcribed vaccines given for Hep B, the patient was given what was supposed age-appropriate doses of Tdap, IPV, MMRV, Hep B, Hep A and Flu.  Upon chart review the PNP in-charge of clinic noted that Pentavalente may contain an additional antigen.  It was discovered with further research on the following websites that Pentavalente contains DTaP, Hep B, HiB.    This therefore rendered the Hep B given on 2/24/2023 as an additional dose and was a vaccine error.  This was reported to the parent/guardian who verified that the vaccines were given in another country in 2014.  The patient is well and will start school.  The vaccine records have also been corrected and a copy of the new records will be provided to the parent/guardian on an appointment for pick-up on 2/27/2023.
moderate muscle aches; mild fatigue; mild fever; mild cough; felt faint; ears were ringing; began sweating pretty; felt a little too ill to get up and walk away; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 13Apr2021 15:00 (Lot number was not reported) (at age 46 years old) as single dose for covid-19 immunisation in a pharmacy.  Medical history included covid-19 from an unknown date and unknown if ongoing. Patient was not covid tested post vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 13Apr2021 15:00, within one minute of receiving the vaccine, his ears were ringing, he felt faint, and began sweating pretty significantly. He took a seat immediately, and these symptoms seemed to pass after about 8-10 minutes. He stayed seated for 40 minutes after in the pharmacy as he felt a little too ill to get up and walk away. Next day, on 14Apr2021, symptoms are mild fatigue, mild fever, mild cough, and moderate muscle aches. Treatment not given for the events. The patient was recovering from the events.  Information on the batch number has been requested.
Day after shot, injection site became very red and swollen. Two days after, large redness around the injection that has been spreading since. Visited urgent care, was put on antibiotics as a precaution. Was told to take Benadryl as well.
Kinrix(age 4-6years) was given to 7 yr old. Pediatrician called parent- no side effects.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from Licensed Practical Nurse (also reported by a health worker) refers to unspecified number of patients of unknown age. On an unknown date the patient were vaccinated with ZOSTAVAX lot # J006828, expiry date 14-SEP-2014 dose unknown. No concomitant medications were reported. The nurse reported that on an unknown date unspecified number of patients were vaccinated with improperly stored and not supported vaccine. No adverse effects were reported. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to antibiotic, allergy to ciprofloxacin, allergy to clindamycin, allergy to erythromycin, allergy to PERCOCET, allergy to SUDAFED, breast cancer, codeine allergy and penicillin allergy. Concurrent medications included Tamoxifen,  OSCAL, CENTRUM mvi, Vitamin E, Vitamin C, Vitamin B12 and Fish oil. On 7 October 2010 the subject received a dose of FLULAVAL (.5 ml, unknown route and site). In October 2010, less than one month after vaccination with FLULAVAL, the subject experienced flu like symptoms, palms of hands were red, injection site redness and body rash. The subject was treated with BENADRYL. At the time of reporting the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Pt recvd 3 doses of Engerix-B & was determined to be a non-responder; pt recvd a booster dose of Engerix-B 13AUG91; 4DEC91 HBSAB was pos & hence resolved;
2 days post vax, the pt developed an erythematous indurated lesion on the right thigh, no tenderness or itching. Most of leg is normal and the pt is walking well.
Screaming/crying, raging temper tantrums, no eye contact, all speech lost.