chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.; Sore arm; Redness all over the body except the face like wheal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness all over the body except the face like wheal) and RASH (Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Redness all over the body except the face like wheal). On an unknown date, the patient experienced RASH (Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency; CORTISONE on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) on 24-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Redness all over the body except the face like wheal) and RASH (Reporter stated she had a very bad rash./ ever since she received the vaccine her skin has been breaking out.) 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 concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Additional event of rash added. Patient verbalized consent to FU with her HCP and contact information was provided.
Mother reports patient had shaking, was unresponsive and turned red. Patient brought to the ER and was Dx with a Sz after EKG abnormalities.
Diarrhea which included mucous and blood starting day after administration of FLUMIST.  Saw on call MD on 10/18 and was to call for stool culture orders if persisted to today.  Reporting per O/C MD request.
Patient developed fever 24 hours after 2 month immunizations which persisted. Septic work up was negative and on day 4 of fever patient developed sx of Kawasaki disease. Patient was treated for Kawasaki disease with IVIG on day 5 of fever and dx improved. 12/26/07-incomplete record received for DOS 11/23-11/27/07-4/28/08-record received for DOS 11/22/07-DX: febrile illness. 6/3/08-records received from PCP-note for 11/23/07 seen for conjunctivitis and fever persists up to 101. Not eating well, irritable. PE-scleral injection. DX: Kawasaki Disease.
Tremors seems to been out of control; Tremor get more violent; Weak; passed a horrible day with a lots of tremors; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (passed a horrible day with a lots of tremors), INTENTION TREMOR (Tremors seems to been out of control), TREMOR (Tremor get more violent) and ASTHENIA (Weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Neurological disorder NOS (Patient has been suffering from functional neurological disorder, for almost 2 years. She had headaches, neck aches, ringing ears and tremors but all that was under control prior to vaccination). Concomitant products included SIMVASTATIN for Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (passed a horrible day with a lots of tremors). On 07-Mar-2021, the patient experienced INTENTION TREMOR (Tremors seems to been out of control), TREMOR (Tremor get more violent) and ASTHENIA (Weak). At the time of the report, TREMOR (passed a horrible day with a lots of tremors), INTENTION TREMOR (Tremors seems to been out of control), TREMOR (Tremor get more violent) and ASTHENIA (Weak) 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.   Treatment medication included duloxetine 30 mg.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNI
Patient received an adult Hep A vaccine on 6/23/22. When entering the information into the system the MA noted that a Hep A vaccine was given 6/9/22. However this vaccine was charted incorrectly as a pediatric vaccine thus system voiding the HEP A on 4/9/22 . Patient received two HEP A  vaccinations two weeks apart.
This case is linked to case number 2012-06120 and 2012-06129. A 4-year-old female patient, who has medical history of any known allergies, and concomitant medications were not reported, received first dose of IMOGAM (batch number, route and site of administration not reported) and IMOVAX (batch number, route and site of administration not reported) on 10 August 2011. The patient received subsequent dose of IMOVAX on 13 August 2012, 17 August 2012, 24 August 2012 and 7 September 2012 in alternate arms. On 11 August 2012, the patient complained of redness, itching and swelling on the site of injection and also the tops of her ankles were hurting. Corrective medications were not reported. The patient had recovered on an unspecified date. List of documents held by sender: none
needle leaked, only received part of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 30th August 2022, the patient received the 2nd dose of Shingrix. On 30th August 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.       Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's comment: Pharmacist reported that she was administering a dose of Shingrix to patient, when the needle leaked and so the patient only received part of the vaccine.  Pharmacist did not know how much of the vaccine the patient actually received. At the time of reporting, the patient had not been redosed. The reporter consented to follow-up. Additional Supportive Information: The patient received only the part of the vaccine, which led to Incomplete dose administered.
Heart palpitations starting very suddenly and intensely starting at night and lasting through the next morning.   Watch showed Afib so went to MD for an ECG.  I have a history of PVCs and that is what this ended up being.  I took metoprolol for 7-10 days and it went away.  I have not had them since.  Even with my history I do believe this "episode" was brought on by the vaccine.  It started at a very specific moment and very intensely where I was more uncomfortable than I have been in the past and concerned it was something else.
elevated blood pressure 188/87 noted within the first 24-48 hours blood pressure continued to be well above baseline for several days, gradually approaching normal  by 10-12 days increased anxiety over blood pressure being so elevated
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's husband reported that on or about December 2015, the patient received the ZOSTAVAX, (lot# and route unknown) vaccine for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered multiple outbreaks of shingles around her left eye. She passed away from an unrelated medical condition on 27-OCT-2016.  As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using this product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Upon internal review multiple outbreaks of shingles around her left eye and passed away were considered medically significant events. Additional information has been requested.; Reported Cause(s) of Death: passed away.
rash appears after 10 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash appears after 10 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (rash appears after 10 days). At the time of the report, VACCINATION SITE RASH (rash appears after 10 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medications and concomitant medications were not provided by reporter.   Reporter did not allow further contact
This spontaneous report was received from a medical assistant concerning 15 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, 2 patients were vaccinated with RECOMBIVAX HB injection, lot # M000442, expiration date: 31-MAR-2018 (dose, route and anatomical location of administration were not reported); and 13 patients were vaccinated with RECOMIBVAX HB injection, lot # L048236, expiration date: 31-MAR-2018 (dose, route and anatomical location of administration were not reported); which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was injected on the right arm below the deltoid muscle. Injection site has been red & swollen since 12/30/20.
This spontaneous report was received from a physician via a company representative and refers to a 11-year-old male patient. Information about concurrent conditions and medical history was not provided. On 13-NOV-2014 the patient was vaccinated with GARDASIL (lot # K004205, expiration date 12-JAN-2017, dose 1, 0.5 ml) intramuscular. Concomitant therapies included influenza virus vaccine reported as flu vaccine; TDAP reported as TDAT vaccine; tuberculin purified protein derivative (PPD) and meningococcal vaccine. The physician reported that the patient experienced being lightheaded, becoming pale and then fainting after receiving GARDASIL. Physician stated that the patient lay down for 15 minutes and was fine afterward (outcome recovered). Additional information has been requested.
Information has been received from a RN concerning a female who was vaccinated with a 2nd dose of Hep-B vaccine recombinant. Subsequently, the pt experienced hives. No further information is available.
Headache, Myalgia, NauseaVomiting, Chills, fatigue Narrative:
itchy rash appearing to be allergic in nature, resembling eczema/hives with welts and scaling lasting for at time of reporting 4 weeks and requiring medical attention, course of steroids prescribed   patient also describes overwhelming fatigue, muscle fatigue and significantly diminished ability to perform daily activities/work, partially resolved but still present/recurring
This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, they have one store with a patient who reported facial swelling within 24 hours after receiving SHINGRIX vaccine. The reporter wanted to know if there was any literature on facial swelling. This case was linked with US2018GSK089617, reported by the same reporter.
Patient developed febrile convulsion at about noon on 5/10/11. Observed in emergency room and sent home.
Patient was sitting in waiting room when tech noticed left leg had bright redness that was going down to the knee cap.  Tech also saw hives on the left side of the stomach and upper back.  Patient was not in distress or having trouble breathing.  Patient was brought back to the exam room and was seen by the on-call provider.  1 teaspoon of 12.5 mg oral diphenhydramine was given and vitals were monitored for 30 minutes.  Referral to allergy doctor placed.
Had a low fever (99.5) last night.  Minor aches.    This morning I woke up and the lymph nodes under my left arm are swollen
Mother called 12/4/01. Child has been exposed to chicken pox at school. Fever for 3 days, then broke out with several pimple like bumps with clear fluid blisters on back, face and arms. Itching.
A patient was administered an improperly stored PROQUAD.; No additional adverse events.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.  On 20-FEB-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) (product storage error) for prophylaxis (lot number S027459 has been verified to be a valid lot number, expiration date reported and validated as 02-MAR-2021) (concentration, dose, dose number, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).   It was also reported that the sterile diluent used to reconstitute the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin) (PROQUAD) was properly stored.   No additional adverse event was reported.
Information has been received from a registered nurse concerning her 23 month old nephew who had on and off eczema and no known allergies who in approximately September 2002, at about 1 year old, was vaccinated with a dose of varicella virus vaccine life. The RN reported that on 9/14/03 the patient started to develop itching spots and had a fever. On 9/17/03 and 9/18/03, the patient again developed a fever. The patient's fevers were treated with acetaminophen. On the evening of 9/19/03, the child also developed hives which were treated with diphenhydramine and hydrocortisone cream. By 9/20/03, the patient was still breaking out with new itching spots. The nurse indicated that her nephew was covered with the itching spots and they were the worse case she had ever seen. As of 9/21/03, the child was still breaking out and had developed bruising under his skin. Unspecified medical attention was sought. Subsequently, the patient recovered from her events. Additional information has been requested.
pt recvd vax 15mins p/vax exp pain in rt leg & knee;
Inadvertently administered an expired Havrix dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th March 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 11th March 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 licensed practical nurse stated that they inadvertently administered an expired Havrix dose to a patient on the day of reporting, the vaccine was expired on 26th February 2022, which led to expired vaccine used. The reporter inquired that whether the patient had to be revaccinated. The reporter denied for follow up.
expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 2sm24, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 19th September 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 patient was administered an expired dose of Flulaval Quadrivalent, which was expired on 30th June 2021, which led to expired vaccine used.  The patient would be revaccinated.  The reported did not consent to follow-up. Health care professional declined follow- up from Safety.
On Sunday Feb. 21st, in the evening before bed, I noticed that my left lower leg and ankle were swollen, (as complared to my right leg.) I was also experiencing shortness of breath.
[Moderna] use for COVID-19 under Emergency Use Authorization (EUA):Covid-19 Vacc Mrna (5-11yr)(pfizer)(pf) 10 Mcg/0.2 Ml Im susp (orange.) Covid vaccine was not diluted properly resulting in wrong dose of vaccine given to patient.
Covid Vaccine (Pfizer)administered at 1430..... observed for 15 minutes... went back to work.  1600 - started with headache, took two tablets of Excedrin 325 mg by mouth. 1630-- tightness of throat, raspiness, dizziness..... return to  where vaccine was given initially., heart rate 104 Emergency team called and taken to ER.
Client received flu vaccine on Mon 10/22, by Tue 10/23: she was c/o pain up her arm to neck with a headache. Wed prn she was unable to life her head due to severe neck pain. Thur. she saw her MD who related this to "capsulitis" and instructed her to use Advil and Claritin for 2 wks Along with PT for 2 wks
SORE ARM, LARGE OVAL REDDENED AREA ABOUT 3-4 INCHES IN LENGTH AND 1-2 INCHES IN WIDTH. SWOLLEN, HARD BRIGHT RED AND HOT TO TOUCH. TOOK ADVIL, BUT DIDN'T HELP. TOOK A TUB TO HOT PACK. FELT LIKE AN INFECTED TOENAIL.
Skin rash/hives. Redness and raised skin. Hives will come in waves and show up in certain parts of the body before fading away and appearing on a different part of the body. Initial hives were found on both legs, neck, and stomach.
Pt came in for boostrix, and received meningitis instead.  she also received the boostrix in the opposite arm afterwards at the same facility.
Extreme fatigue onset, headache next am and continued fatigue x approx. 32 hours then body aches head to toe and muscle fatigue that continued for approx 6 more days with intermittent headaches.
Wheezing, coughing, body aches, sweating, headache, nausea.   PER ITEM 20  Vax was given on 01/28/2021 yet my arm is still throbbing. I already have an issue with arm pain , but  it seems the vax  exacerbated the pain. Other symptoms have cleared. PER ITEM 21  Because my arm is still hurting weeks later, I don't know if this is considered permanent damage, or if it will clear in time, so I chose NONE OF THE ABOVE.
Information has been received from a health professional concerning a 76 year old female with no pertinent medical history, drug reactions or allergies who on 13-DEC-2007, at 15:20, was vaccinated into the left upper arm with a first dose of Zostavax (Oka/Merck) (Lot# 658863/1414U).  There was no illness at the time of vaccination.  On 15-DEC-2007 the patient developed a local reaction described as a red area approx a 3 cm. circle that had also been reported as swollen, which was not found at the time of examination on 20 DEC 2007.  Upon examination only "local redness to the superficial skin" was observed.  The patient complained of mild urticaria at the site.  The patient was treated with "antihistamine".  The patient was recovered on 20 DEC 2007.  No further information is expected.  Additional information has been requested.
Upon awakening: severe aching all over body similar to flu; a feeling of deep lethargy, mental fog, and difficulty in moving and rising from bed due to a feeling of heaviness.  Left upper arm VERY stiff, painful and difficult to raise, although I had applied an ice gel pack to it on and off on the day of receiving the injection. No redness or swelling.  Soles of both feet burning, very painful to walk.  Occasional twinges of very sharp stabbing pain where big toe adjoins right foot, about once or twice per hour, pains lasting about 20 seconds each.  Unusual urinary urgency and frequency, with difficulty holding it back before getting to the bathroom.  Uncomfortable feeling of fullness and burning in left breast.... Due mental fog and some dizziness, and pain with walking and moving about, I was unable to do most normal daily activities or work at my job.  I spent the whole day in bed and tried to sleep as much as possible.  Also applied a heating pad intermittently to left upper arm to help with pain.  All symptoms worsened throughout the day and evening.  After dozing in bed throughout the day, I fell soundly asleep between 7:00 and 7:30 PM on April 9 with all symptoms still fully present.  After sleeping soundly for approximately 6 hours, I awakened at 1:00 AM on April 10 and immediately realized that every symptom described here had disappeared.  There was absolutely no trace of any of the symptoms, not even any residual soreness left in my arm.  I felt perfectly well and strong and normal and that has continued.  The only strange thing was that when I awakened at 1:00 AM on April 10 feeling well, even though I was perfectly cool upon awakening and had also not registered ANY fever when taking my temperature throughout the whole day of April 9, my entire body was drenched with perspiration upon awakening, including my hair, which was dripping wet, comparable to what might be experienced after a high fever.
SWELLING IN AREA OF INJECT AND THEN IT MOVED DOWN THE ARM. A COUPLE DAYS LATER STARTED EXPERIENCING PAIN ON THE RIGHT SIDE AND RIGHT KNEE. RIGHT KNEE STARTED TO SWELL. DID NOT SEEK TREATMENT. SWELLING AND PAIN IS 99 PERCENT GONE 6 DAYS POST IMMUNIZATION.