chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of Bexsero on July 18,2019 / May 18th 2021, the patient received Trumenba as a second dose; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th May 2021, the patient received the 2nd dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient received a dose of Bexsero and she received Trumenba as a 2nd dose which led to interchange of vaccine products. The reporter consented to follow up.
Seizure 9 days after immunizations. No fever or other illness at time. On 10th day child peppered with rash over entire body with was gone the following day.
The pt experienced a swollen right deltoid that was hard, red in color and warm to the touch. The pt complained of pain with touch and movement. No treatment to date. Symptoms began on 12/19/99. The vaccine was a PPD. No other vaccine was listed.
Patient fainted after receiving vaccines. Vaccines administered at 1503, fainted at 1510, monitored until 1545 and discharged to home.
t105 x 1 wk was listless; fever started 2-3 hrs p/shot; taken to MD 4 days p/shot; returned to MD a few days later & was given DPH;
1/22/21 - 6:30 p.m. extreme chills; temp 101.8 - bundled up and went to bed under electric blanket; arm sore and hot 10:00 p.m. sweating, nausea: temp 101.9 - Tylenol 500 mg  1/23/21 - 4:00 a.m. sweating; temp. 101.6 - Tylenol 500 mg -  took lots of naps; arm sore and hot with rash 1/24/21 - 9:00 a.m. felt almost normal - temp 97.8 - which is my normal; arm still sore and hot with rash 1/25/21 - 9:00 a.m. arm still sore and hot with rash
I woke up at 1:00 a.m. feeling like an ice-pick was driven into my skull, dizzy, terrible body aches, shaking uncontrollably, freezing cold. I couldn't control my moaning from pain. I was pretty incapacitated that day, but I felt better in the evening. It took a few days for me to feel normal again.
Fever, red bumpy rash all over body, swollen lymph nodes, dizziness, loss of balance, conjunctivitis, and possible loss of hearing.
within 2 hours of injection: injection site pain onset 24 hours after injection: severe chills, headache, muscle aches, joint aches, back pain, nausea
This spontaneous case, initially received from the other non-health professional (consumer) on 31-Oct-2018, concerns a 56-year-old, adult male patient. On 19-Oct-2018, around 1 PM, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252674, expiry date: 30-Jun-2019 and anatomical location: not reported). Roughly 24 hours after vaccination, the patient experienced mild flu-symptoms. In the subsequent 15 hours, the patient became quite ill with fever, body aches and cough. On 22-Oct-2018, the patient visited urgent care facility where he received the vaccine. Clinic staff performed a point of care flu test which was reactive for Influenza Type A. The reporter believed that, the FLUCELVAX QIVc contained infectious influenza. At the time of report, the outcome of the events was not reported. The reporter assessed the case as serious (medically significant).
4.5 hours after receiving the COVID-19 vaccine second dose I experienced a sudden 50% loss of hearing in my right ear. I was otherwise asymptomatic. This persisted for 8 hours at which time my hearing mostly returned with perhaps only a 10% reduction. I had complete resolution after 24 hours.
I tested positive for Covid-19 on August23, 2022 I experienced the following: Low grade fever; sore throat; painful neck lymph nodes; fatigue; headaches. I was taking Motrin for my symptoms.
pt recv vax 28JUN95 & 27NOV96 pt exp vaccine failure & chickenpox consisting of lesions that were scabbed & non-vesicular;another pt was reported as well (WAES96121480);
Fever Wed, painful red swelling an inch above inj site, down to elbow more than 1/2 way around her arm.
fainting; Patient had palpitations; panic attack; patient "zoned out"; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had palpitations, fainting, panic attack and patient zoned out. The patient had to see cardiologist who said that the patient was not to get any further COVID vaccines. Outcome of the events was unknown.  The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between syncope and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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, and Investigators, as appropriate.
The patient was given Engerix-B  Hepatitis B vaccine  was given to this employee and approximately 30 minutes later she complained of "funny taste in her mouth", with a sensation of "difficulty swallowing", soon was complaining of tingling around the lips, felt she wasn't able to "talk right". She was sent to the local ER, given antihistamine while there sent home with a prescription of Zyrtec. Reported that later she developed a rash on her wrist and tingling at the tips of her fingers. She had no difficulty breathing, and no obvious swelling of the mouth.  .
pt recv vax & exp numbness & tingling of the rt arm;pt was examined by MD 7NOV97;MD noted approx 20% of reduction in sensation to touch on the posterior aspect of rt upper arm, rt forearm & dorsal aspect of ring & little finger;
Information has been received from a nurse concerning a 14 year old female who on 22-AUG-2008 was vaccinated with first dose of GARDASIL (lot #660557/0072X) intramuscularly. Concomitant therapy included MENACTRA and atenolol. The patient experienced a headache that lasted for a period of three days after receiving the first dose of GARDASIL. On 25-AUGg-2008, the patient recovered from headache. Additional information has been requested.
Mom stated patient developed hives on his body and took him to ER. They diagnosed an ear infection. The next day she took the pt to his physician and he stated it was not an ear infection but hives from his polio vaccine. No fever or local reaction to site.
Cold/flu like symptoms. Sore throat, dry cough, migraine, severe fatigue
1 week after getting vaccine developed a rash left side of neck at hairline. In linear distribution craniocaudal cluster of approximately 6 lesions maculopapular with central scabbed area.
approximately 4 1/2 days after administration in the morning, patient woke up with a rash near the injection site of Shingrix vaccine.  She described it as "narrow," approximately 1 inch wide and 2 inches long by her estimation.  The area has remained sore for the duration since vaccination.
patient experinced syncope directly after adminastrion lasting about 40 to 60 seconds.
Diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Traumatic brain injury. Concurrent medical conditions included Dementia and Type 2 diabetes mellitus.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        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 relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Near Syncopal Event on 1/8/2021, Er visit on 1/8 Ct of Brain and Ct chest done as well as blood work On 1/10 Return to Er visit with observation MRI of brain done as well as blood work
Pt stated when she received first dose of vaccine she had vomiting for 2 days.  Pt was given 2nd dose and asked to wait in observation area for an extended period of time of 30 mins.  After 15 mins pt stated her chest was feeling tight and bilateral wheezing could be heard in lung bases.  Pt was brought back to exam room in our urgent care area and pt began to vomit.  Pt was given dexamethasone and zofran.  Pt continued to state her chest felt tight and she also continued to vomit.  Pt was not improving and in fact stated she was feeling worse.  911 was called and pt was transported to the nearest ER via ambulance.
Lymph node on cervical area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Lymph node on cervical area) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph node on cervical area). At the time of the report, LYMPHADENOPATHY (Lymph node on cervical area) outcome was unknown. Not Provided      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.   Concomitant medication included birth control injection and unknown allergy medication.  No treatment information was provided.
Lymph node in left armpit was very swollen; Brain fog; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 29 year-old patient received bnt162b2 (COMIRNATY), administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 29 years as dose number unknown (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "peanut allergy" (unspecified if ongoing); "mild asthma" (unspecified if ongoing), notes: mild asthma; "Eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose,Manufacturer Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 29Jan2022, outcome "unknown", described as "Lymph node in left armpit was very swollen"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "Brain fog"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed mild erythema on both hands followed by degumation on palms surfaces four days after vaccination.
Patient was given the injection and then she started feeling dizzy right after administration.  She sat with her head against the wall and dropped her phone and passed out for just a moment.  She had a slight tremor/shake for a few seconds. (I did not witness, unsure exactly what happened or how long)   She came too fairly quickly after being yelled at, are you ok?  When she regained consciousness she complained of being hot all over for a bit.  We gave her ice packs to cool down.  She felt hot for maybe 10-15 minutes, but felt relief with the ice packs.  She also drank some sips of cool water which seemed to help her cool down.
pt developed rash from elbows down to fingers within 48 hours of recieving flu vaccine
About 5 hours after receiving my first Moderna shot, I experienced extreme soreness on my left arm (arm that was injected) where it greatly hurt to move my arm. I also experienced intense headache, body aches, high fever (103), and was extremely tired. I took medication to help my pain and fever (NyQuil). This all lasted about 48 hours except the headache/tiredness continued for another day (72 hours). Saw on the news that my lot number dose the was dose that was recalled so I wanted to report this. I still have a bruise on my left arm where the injection was (5 days later).
hives, anaphylaxis, given epinephrine and Benadryl, EMS called
Patient stated she got rash all over body the day after high dose flu shot with redness, swelling, hives and red streaks. Started in the morning. She went to the doctor and was given a steroid shot and oral prednisone. The doctor told patient that the reaction was most likely from the vaccine.
arm pain; possible Vaccine administered at inappropriate site; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2019, the patient received Bexsero. In July 2019, less than a week after receiving Bexsero, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Bexsero possibly too high above the deltoid three days before the date of reporting, which led to vaccine administered at inappropriate site. The patient was experiencing arm pain. The reporter gave consent to follow up. Lot number and the patient date of birth were not available.
I had the current vaccine for the flu given at the clinic. About 10 hours later, I had the chills with body shaking. I was nauseated with gag, had muscle pain especially in the upper legs. I had an initial fever of 101 degrees that went to 103 degrees. This lasted about 4 hours. After taking Motrin, the issues subsided around midnight the day of the vaccination.
ipol (opened) exposed to a temperature excursion accidentally left the refrigerator door open too long. 3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event; ipol (opened) exposed to a temperature excursion accidentally left the refrigerator door open too long. 3 separate excursions low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes administered to the patient: Yeswith no ae; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old male patient who received vaccine IPV (vero) [IPOL] (opened) that was exposed to a temperature excursion (accidentally left the refrigerator door open too long; 3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine for Prophylactic vaccination.  On 05-Jun-2023, the patient received 0.5 mL dose of suspect IPV (vero), suspension for injection (batch number: V1A021M; Expiry date: 27-Feb-2024) via intramuscular route in unknown administration site for immunization that was exposed to a temperature excursion (accidentally left the refrigerator door open too long; 3 separate excursions with the same vaccines. total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes) with no reported adverse event (poor quality product administered) (same day latency) (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
The day after Receiving the vaccine, patient Experienced Redness at the injection site and the area was raised. In several days after the first, patient Experienced Red bumps on the face and body to the lower Extremities with itching. Patient did go to the doctor and Received steroids and benadryl
Left arm snd left side of face went numb, tingling within 20 min of injection, then swelling ++( approx 10 cm ) and redness at injection site within 1-2 hours, then redness and swelling of left side of face with persistent numbness and tingling.  Redness and swelling resorbed within 4 days.. tingling and numbness persisting still on day 5 (today )   We applied cold first 2-3 days, and tylenol 3-4x a day.  He felt feverish but not temp higher than 99 recorded
At approximately 12 hours after vaccinations 2 and 3 of human papilloma virus,Gardasil, patient exhibited severe abdominal pain for a period of time lasting 2-3 hours.
Information has been received from a physician assistant concerning a 15 year old female patient who in December 2007, was vaccinated with the first dose of GARDASIL (lot number not reported). The dose was given by another provider at another facility. There was no concomitant medication. '1 week later', approximately in December 2007 the patient had a single bruise on the forehead. On 30-SEP-2009, the patient was seen in the office, it was reported that the bruise was not there but in place of the bruise there was a darkness of the skin and discoloration. The patient did not receive any further doses of the GARDASIL. There were no lab studies performed. Additional information has been requested.
Four days after I was fatigue lasted for 7 days. I had joint and muscle ache.  I had flu like symptoms with no fever.
shingles; Information has been received from a lawyer and a male  patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a rehabilitation center and clinics  for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Immediate bulge on are and not feeling well. Sleepy, tired, bad headache,low grade temp day 1. Day 2 and 3 temp over 101 and body hurt all over.  Days after joint pain in legs, major  fatigue  And headaches. This continues till May 8th when she started passing out and having non- epileptic seizures. Episodes that lasted 17hrs that left her walking abnormal. This still continues with bad headache, body and joint pain and daily not feeling well. To date she has had over 300 passing out and seizures.
No additional adverse event.; the patient was inadvertently administered a dose of VARIVAX, that had been improperly stored.; This spontaneous report was received from a nurse, referring to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 20-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T002844 which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of 70 degrees Fahrenheit, during a time frame of 48 hours, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Pt's mother reported "golf-ball sized lump" on (R) arm, itchy, on 3/20/13. Denied heat/induration/redness/rash/hives/difficulty breathing or swallowing. Advised to give BENADRYL and/or ibuprofen if painful, bring by clinic to be assessed if mother prefers.