chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a staff member concerning her 13 year old daughter who in February 2007, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted after receiving the vaccine. It was reported that the patient recovered, but she fainted again 3 weeks later in school. Unspecified medical attention. Laboratory diagnostic studies included a CAT scan and was reported to be normal. On an unspecified date in April 2007 the patient received a second dose of Gardasil and did not faint. At the time of this report, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Itchiness and hives around area of pneumonia vaccine.  Left arm was swelling and constricting. By approx. 10 PM there was redness just below the elbow to the shoulder. As of 01/14/2015 arm is still swollen and red though not as bad.  At the hospital, Benadryl was given to me and Benadryl cream was applied to location.
On Jan 31 woke up feeling like everything was spinning. Then on Feb I only had it a little spinning on Feb 2 the spinning was so bad ended up er. Said they thought vertigo. That week pulse was going up and blood pressure spikes started. I also started to not see things as clear getting bad pressure in face and forehead. I then had ent do epley maneuver that helped with spinning. However feeling like I wanted to spin would still happen even though I wouldn?t spin. Headaches on and off everyday couldnt sleep right for weeks. Pulse and blood pressure still going up. Then I never had this anxiety that started. Heart doctor put me on a beta blocker that?s been helping. I am 8 weeks from first shot and still not myself. Been on beta blocker for a little over a week starting to feel better bc pressure and headaches are under control. I have been to neurologist also. No one can really explain. I did get the second dose bc doctor said to on Feb 24th. I was fine till I took the vaccine on Jan 27th
Patient stated her eyes and throat felt itchy and her hands were red and itchy. Patient taken to ED via WC. She did not have this reaction to her 1st dose of Moderna on 1/17/21
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium
Hepatitis A vaccine given mistakenly for HIB. Patient will get HIB at 15 months. Patient had a runny nose and was fussy. Rash with itty bitty bumps for 2-3 days; none now. No pain, no fever, no swelling per mom.
Low grade fever right around 100 degrees Fahrenheit; Fatigue; Chills; Flu-like symptoms; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA), at 0.5 mg, single for prevention of meningococcal disease caused by serogroup B, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) at an unknown dose for immunization (Prevention of meningococcal disease serogroups A, C, W or Y); both via an unspecified route of administration on 18Jun2019 02:45. The patient's medical history and concomitant medications were not reported. The patient was administered his second dose of meningococcal vaccine a/c/y/w conj (dip tox) and first dose of meningococcal group b rlp2086 2:45pm on 18Jun2019. The patient's mother reported today, 19Jun2019, that the patient had a low grade fever right around 100 degrees Fahrenheit, feeling fatigue, chills and flu-like symptoms on an unspecified date. The administered dose of meningococcal group b rlp2086 was first dose in a 2 dose series. The outcome of the events was unknown.  Information on the batch number has been requested.
This is a spontaneous report from a contactable consumer who reported for her daughter. A 18-year-old female patient received a single dose of TRUMENBA in 22Aug2017 for immunisation. There were no concomitant medications. Patient was fine until she had the vaccine. On 23Aug2017 evening, the patient wasn't feeling well, she felt sick. On 24Aug2017 the arm where she got the injection was red, it's warm to touch and she had like couple of red patches on her arm. Since an unknown date patient got a little nauseous and her throat did not look good. Therapeutic measures taken in response to the events included 2 EXTRA STRENGTH TYLENOL. Outcome for nausea was unknown, while patient did not recover from the other events.
Pt started 11/7/12 with small quarter-sized lump at injection site-arm itched some with mild redness noted per pt.
nausea, vomiting, sore arm, severe  headache, and overall malaise and tiredness.  unable keep  down water x 2 days
Havrix expired dose administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 17th June 2022) for prophylaxis.   On 4th August 2022, the patient received the 1st dose of Havrix. On 4th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date:04-Aug-2022 Reporter comment: A physician administered a expired dose of Havrix as a first dose. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Fever topped at 103F about a 6 inch red inflammed area around injection site, general tiredness, muscle aches. Symptoms are slowly going away.
Heart palpitations; Felt a rush under her throat; Heart was skipping beats; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), THROAT IRRITATION (Felt a rush under her throat) and EXTRASYSTOLES (Heart was skipping beats) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination.     Concurrent medical conditions included Drug side effect (Patient stated Spiriva inhaler and anything that has acetaminophen and Sudafed caused heart palpitations for her.). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), FAMOTIDINE, MONTELUKAST SODIUM (SINGULAIR), POLYCARBOPHIL CALCIUM (FIBERCON), DOCUSATE SODIUM (COLACE), VITAMINS NOS, SERTRALINE HYDROCHLORIDE (ZOLOFT), PANTOPRAZOLE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PALPITATIONS (Heart palpitations), THROAT IRRITATION (Felt a rush under her throat) and EXTRASYSTOLES (Heart was skipping beats). At the time of the report, PALPITATIONS (Heart palpitations), THROAT IRRITATION (Felt a rush under her throat) and EXTRASYSTOLES (Heart was skipping beats) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Heart rate increased: increased High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Pt states had numbness in both hands for 2 weeks after last GARDASIL (#2) shot. Wanted to know when she can get #3 (last one).
After the vaccine was given, my heart began racing and I felt flush. I felt like the room was spinning. The pharmacist took my blood pressure and it was 228/128. My heart rate was 122. My blood pressure is always 120/60. I was trying to call my husband but the room was spinning and I felt like I was going to throw up. I was flushed and my arms and legs felt numb. I was gasping at air because it felt harder to breathe.  I tried to stand but had to sit back down. My blood pressure went down after 15 minutes but was still elevated. My heart rate has stayed high. I finally left and when I made it home, I threw up all night. My heart is continuing to be above 100. It has been racing for the past two days. I woke up the past two nights with spitting headaches and my heart rate at 113, 110. I am dripping in sweat both nights which has never happened to me. My glands are now swollen as well and I still feel lousy two days later.
Chest pain following Imovax thought he was having a heart attack even though pain was right side of chest. Cardiac work up was negative.
I received the 2nd Pfizer vaccine on a Friday morning at 10:30am.  Severe flu like symptoms began 1am that night until 1am Sunday night.  That Monday night at 6:00pm I had really bad pains in my chest when I would breathe. It hurt so bad I describe it as a lightning bolt hugging my heart. It kept me up all night and then Tuesday I went to the ER around 9am. After doing multiple test they found elevated Troponin levels in my blood. They assumed it was from the vaccine. I stayed the night and they took blood every few hours and the troponin levels kept rising. They wanted to keep me another night but my insurance kicked me out because  I wasn?t sick enough. I went to a cardiologist and he referred me to the hospital and I got an MRI that confirmed the left side of my heart was inflamed and delayed. My pain lasted consistently for 3 months. I still have a pain every now and then.
Left arm was hot and swollen from shoulder to elbow. Mom took baby to PMD and he dx'd with cellulitis and was given Keflex.
Large, red, swelling at site. Treatment Benadryl, cool packs, observation.
On 04/27 Varicella Vaccine given left thigh SC on 05/08/04, mom noticed 1/2 dollar size red, raised area with itching.  On 05/11/04 mom called UMA with report of quarter size red area with improvement noted. No other problems identified. Benadryl cream applied.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 40, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
On Sept. 9 2021, around 4 pm, I picked my children up from daycare. My youngest had a stuffy nose and a cough. I was dealing with him, and around 6 pm I felt very rundown myself. I was very achy and had a slight headache. On the 10th, I kept my kids home from daycare. I had a severe headache, a cough and fever. I had body aches still. Same thing on Saturday the 11th, so I went and did a drive thru COVID-19 test. The symptoms continued for over a week. I just called in sick today as well 9/21/2021.
About three hours after injection I started having a dry cough that lasted approximately  six hours. I had pain in the area of injection for a few days, but  then i started to feel heaviness and  tiredness, that have lasted until now.  I still feel a dull ache, but the heaviness is affecting the whole arm up to the left side of the shoulder and neck. When using the left arm, i get tired. Sometimes it gets numb. I am writing now because it does not get better.
Had both doses and got shingles / Suspected vaccination failure; Got shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient stated that she had shingles in the past before getting the vaccine).   In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the Shingrix series vaccine at the end of June 2020.  Patient stated that she had shingles in the past before getting the vaccine. Patient also reports that she had shingles when she got the vaccine. Patient did not clarify if it was after the 1st dose or the 2nd dose. Patient did not provide the dates of each vaccine. The patient only provided at the end of June 2020 when she got the vaccine. Patient stated she had shingles the entire year after that. Not all information was available. Lot and expiration dates were unknown. Patient sounded confuse when providing information of having shingles. She reported having them before the vaccine , when she got the vaccine and after getting the vaccine. She stated she got vaccinated in June 2020 and since then she has had Shingles and it does not go away. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The reporter requesting consent to follow up. This case has been linked with US2021192927 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192927:Same reporter, Same patient. 1st dose.
High pitched "ringing" - tinnitus - in left ear.  Treatment thus far - chiropractic.  Issue remains unchanged.
Received FLUVIRIN, ADACEL, PNEUMOVAX. Went home. About 6PM started to vomit. Felt bad and sore. Went to work Thur. Felt worse. Went back to work Fri. Went home sick with 101 temp. Went to MD office temp 104. MD put her on antibiotics monitored and sent home. She was sick all weekend.
AFTER THE SHOT MINUTES AFTER I FELT A BURNING SENSATION AT THE POINT OF NEEDLE ENTRY, DURING THE DAY MY ARM BECAME EXTREMELY SORE (SIMILAR TO THE FEELING OF A ROTATOR CUFF TEAR WHICH I previously had years ago in the other shoulder). The next day it was worse and I could barely move my arm to get out of bed, could not brush my hair and had trouble dressing or lifting the arm at all. The arm hurt bad and today three days after it has gone to my shoulder and I still cannot lift arm, brush hair with that arm and still have a lot of trouble dressing. It also hurts in my neck!!
Patient developed myalgia, arthralgia, and low-grade fever (100.6 F) 5 days post-vaccination.  On the 6th day post-vaccination patient developed erythematous, macular papular confluent pruritic rash over her face and back.  The rash worsened in intensity and pruritis (though  it did not spread from the initial sites) on day #7.  No mucosal  involvement was noted.  Patient took diphenhydramine x 2 on day # 7 with subsequent improvement in symptoms.  Marked improvement in rash noted on day # 8 post-vaccination.  This was the patient's second vaccinia vaccination in the prior 2 weeks (first on 01/31/03 and revaccinated on 02/13/03 when it was determined there was no "take" on the first).  Patient had received her primary vaccinia vaccination as a child.
Adacel at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes were administrated post excursion with no AE; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01266980  This case involves a 33-year-old male patient who experienced Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes were administrated post excursion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA370866, 2022SA372086, 2022SA373534, 2022SA371564, 2022SA371948, 2022SA372095, 2022SA372180, 01266982, 2022SA372199, 2022SA373167, 2022SA372080, 2022SA372581 and 2022SA372584.    It was reported that a temperature excursion of unknown cause, reporting two excursions occurring overnight, no staff present, no human error. Caller reporting ADACEL at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes.  On 30-Aug-2022, the patient received a dose post excursion of suspect Adacel Vaccine at dose 0.5ml once via intramuscular route in the left arm (lot U7461AA, expiry date: 12-Jul-2024) for immunization with no reported adverse event (poor quality product administered) latency same day.  Action taken: Not applicable.  At time of reporting, the outcome 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 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.
Yesterday (11/16/11) began with rash to (L) thigh. Today has pink/red macular rash to (L) thigh, lower abdomen, (B) axilla with scattered pink/red papules to abdomen, upper thighs & arms.
Topamax is the only new medication. Been taking 4 months. When full blood work up was done for department of infectious health all labs were optimal. On Feb 5 was admitted to the ER with Hypokalemia potassium level of 2.6 and arrhythmia
Pt seen in ER on 04/21/2003 for ecchymoses and petechai. Platelet count was 5,000. Diagnosed with ITP. Treated with WinRho and sent home. Repeated platelet 236,000 on 04/25/2003 in follow up in clinic.
pt was admistered the above vaccines instead of the covid 19 booster he was to be given.  pt responed the the name of the patient to be given these vaccines and did not contest  the fact he was not the other patient the vaccines were intended for.  he was addressed by the other patients name twice.  he had no adverse reaction to the vaccines and was okay with receiving them and agreed to come in after a few weeks for his covid booster.  no adverse heath effects were seen.
Redness, heat, swelling at and around injection site. Diagnosed as cellulitis.
I experienced cartilage loss in both knees after my vaccine, I do not know if it is related to the vaccine. I saw an orthopedic doctor. My knees started bothering me in my lower legs. I went to see my podiatrist, he gave me a prednisone pack and all of a sudden my left knee was not usable and I was prescribed physical therapy. I had trouble ambulating due to my loss of cartilage in both my knees. The doctor saw me again and he took x-rays and did not see anything at that time. I was not making progress in my physical therapy and about 4-5 weeks I went back to see the doctor and took another set of x-rays of my knees and he did not see any cartilage in my knee was gone. I am still having issues with my knees and told me I need a knee replacement to both knees.
Three days after receiving dose #1 of COVID-19 vaccine, patient had a first potential seizure event. Patient reports waking up with LLE pain and weakness and a bite mark on the right side of is tongue. He also noticed he had urinated on himself (a small amount). Pt presented to ED on 1/22 where seizure work-up performed. MRI brain showed "non-specific gliosis along the L cerebellar hemisphere along with chronic BG infarcts." Unremarkable EEG. Started on levetiracetam 500 mg BID at discharge and continues to follow with outpatient neurology.
No Adverse event; While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5) and NO ADVERSE EVENT (No Adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (While administering the bivalent boosters, the needle for one of them wasn't screwed on all the way and a couple of drops came out and the patient only received about 0.4 ml of the dose versus a 0.5).    No concomitant medications were reported.  No treatment medications were reported.
developed Tinnitus.  Going to Otolaryngologist for further evaluation. There is no cure for Tinnitus.
Right away, tingling in lips and tongue. lasted for 4 weeks.   Ringing in ears started about 3 week after 1st shot. Still present
Patient received the flu shot on Monday 8/31/30. Today 9/3/20 arm still sore, patient reports feeling raised bump around administration site and clearly defined redness/swelling (about half a palm size). Patient tried ibuprofen, aspirin and Benadryl but no effect. Site has not gotten worse, just stayed the same and is bothersome.
Mother stated 12 MN Woke up not feeling well, legs hurting. 2 Am Up again crying not feeling good - fever - given ibuprofen. 700 A Given KEPPRA then started vomiting (see next pg). Took patient to hosp around 230. Was given IV fluids ZOFRAN. Improved. Discharged home.
The site where the vaccine was adminstered, which is the left shoulder, has been extremely sore and I am unable to lift my arm up over my head, nearly four weeks after the vaccination.
She got her vaccine, no reaction other than a sore arm.  Saturday had the common side effects.  Sunday it started out with little welts that were red and itchy, today it is one big welt that is red and itchy.  Fever to 100, but that has subsided.  Has not taken anything for the reaction.
Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------ G60.8 NOTALGIA PARESTHETICA 2/8/2023 ATRIAL FIBRILLATION, UNSPECIFIED
Total body urticaria, agitation about 1 hr following MMR/VARIVAX increase RR increase HR also, chills. BENADRYL, EPI, ORAPRED administered - hives resolved out to ER via transport for observation.
Patient reports having fever and chills overnight. At approximately 6am he had a fainting episode followed by two other fainting episodes later in the morning. At approximately 3pm when I talked to him, he was still fatigued but feeling better.