chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said he developed a severe skin rash from his neck down about 1 day after the 1st dose of Shingrix. Pt did not have anaphylaxis, trouble breathing, or any other symptoms.  Patient said he developed this same rash after his 1st dose of his Pfizer vaccine. After both incidents, patient went to his PCP and provider gave him a steroid shot and his rash resolved after approximately 3 days. I left multiple messages with patient's PCP, but messages were not returned. Per guideline recommendations, 2nd dose is recommended if a patient did not experience anaphylaxis after the 1st dose. Counseled patient to consult with PCP if  2nd dose of Shingrix is recommended for the patient. If PCP does recommend 2nd dose, recommend patient should take an antihistamine (ex: Zyrtec) 1 hour before 2nd vaccine.
Irregular coughing, especially at night during my sleep. Coughing does happen during the day at various times. 1. MUCINEX, 2. Cough syrup recommended treatment by dr.
1FEB96 father called stating pt had t100.1 on 30JAN96 & 103 on 31JAN96;1FEB96 t101 inj site described by father as red w/hard lump under skin;APAP given by father for tx;2FEB rash devel @ inj site
Syncope versus seizure  with urinary incontinence and shaking. Transported to ED via EMS.
Continuous ringing in ear, loss of hearing, went to Family doctor, hearing clinic, ENT appointment scheduled for 7/2/12.
The second day after I got the first shot I had atrial fibrillation so I called the doctor. They told me to take magnesium and one of my medications and it should be fine and it went away in about half an hour. I have a heart problem and I get a fib all the time.
Patient vaccinated with first Moderna vaccine on 01/05/2021 and second vaccine dose on 02/02/2021.  Patient developed symptoms of COVID and tested positive for COVID on 03/16/2021.
Case number PHEH2014US020802 is an initial spontaneous report received from a health care professional on 13 OCT 2014. This report refers to a female patient of an unspecified age. Her past medical history and concomitant medications were not reported. On an unspecified date, she was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly. On an unspecified date, after the vaccination, the patient developed  hives. She visited a physician and completely recovered from hives after two days, the seriousness and causality of the event were not reported.
This report describes joint pain and swelling in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from pain and swelling in his joints as well as flu-like symptoms. He also suffers from fatigue." Time to onset following immunization, treatment, and outcomes of the alleged events were not specified. The adverse events "joint pain" and "joint swelling" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Red patch; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch) and FEELING HOT (Warm to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078CUA) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced ERYTHEMA (Red patch) and FEELING HOT (Warm to the touch). At the time of the report, ERYTHEMA (Red patch) and FEELING HOT (Warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Patient felt nauseated after vaccine.  All limbs felt numb.  She became dizzy and sat down on the floor.  Repetitive questioning.  5 minutes to triage area with medics and dr.   Patient started feeling better and able to stand without difficulty. No further symptoms.    discharged home with boyfriend.
Left shoulder pain where needle was inserted going down arm to thumb; up thru nite with pain.
Pt developed a 3 inch raised hard area on L thigh that lasted for two weeks with a fever as high as 102.5 off and on for 11 days. 10 Days after the  vaccines pt developed a rash all over the body and was seen by her family physcian.  The rash lasted 3 days.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed clinical varicella accompanied by fever. The pt was treated with acyclovir.
Swollen lymph nodes in neck (both left and right sides) and at right collar bone. Warm compresses and massage.  Alternating ibuprofen and Tylenol to ease discomfort.
TDAP GIVEN ON 7/20, HAD PAIN AT THE SITE OF INJECTION ON 7/25 NOTED BURNING, SWELLING, AND REDNESS ON RT ARM.  I AM NOT CONVINCED THAT THIS IS RELATED TO THE TDAP.  RX FOR EARLY CELLULITIS ON 7/26 WITH KEFLEX.  8/3/10 PER NURSE, PATIENT DID NOT COME BACK FOR FOLLOW UP AFTER PRESCRIPTION WAS GIVEN.  ASSUMES PATIENT RECOVERED FULLY.
Injection site soreness ..101 fever.. Body aches... weakness...Fever gone by next morning.
Pt given 6m - 4 yr bivalent booster dose for both doses in a primary series instead of the the 6m+ (Blue cap) formulation.   After initial error message in agency, provider called agency to inquire about error message, and was told it was related to a delay in updating the new approval of the bivalent formulation for use as a primary series, and that it would auto correct.  Second dose given at appropriate interval and error not caught until vaccine provider call mentioned it.
Patient was brought in by wife for his booster covid vaccine.  Pfizer was discussed as what we had available, and patient had asked if we had pfizer.  Patient did not have his Covid card available, and Ct Wiz was not confirmed.  Dose was given along with Flu vaccine.  The following day, wife came in for her booster at which then it was discovered when alternate pharmacist checked registery, that husband received 2 prior doses of Moderna, and third dose was given as Pfizer.
Information has been received from a registered nurse (RN) concerning a 6 year old male with reactive airway disease and recurrent otitis media who on 11/30/98 was vaccinated SC in his left arm with a first dose of varicella virus vaccine live (lot # 628149/1325H). Concomitant vaccinations included MMR. Subsequently, the patient experienced breakthrough varicella with less than 50 lesions at 09:45 AM on 10/27/04. Medical attention was sought, the patient was diagnosed with chicken pox, and no treatment was given. At the time of this report the patient was recovered. no product quality complaint was involved. Additional information is not expected.
pt recv vax in 1980 & in 1996 pt tested positive for hepatitis C while volunteering to donate blood;
Systemic: Nausea-Medium, Additional Details: Possible Vasovagal reaction, out for a very short time, then had nausea, a bit confused, shakiness, headache
During the 15 minute observation period post-vaccination, patient was noted to have hives on her neck. Patient was taken to ER. Arrival Vital Signs were WNL. Patient c/o itching, erythema, swollen tongue, changed voice, breathing "a little tight".  Epinephrine and DuoNeb ordered. Seizure like episode at 02.04.21 at 1240 BP 209/81, HR 111, RR 24, Pulse Ox 100% on 15% Non-rebreather mask, Rectal temp 98.4 ED MD wrote:  "At approximately 12:40pm this afternoon the patient was having what appeared to be a seizure versus severe rigors.  She was not verbally responsive and appeared to be apneic with her head shaking in her arms flailing rigidly in an up and down motion.  Symptoms lasted approximately less than 2 minutes and patient was not postictal.  She was not incontinent.  Blood sugar is in the 180s and her rectal temp is normal.  I believe this patient is having a severe reaction to her moderna vaccine that she received earlier today.  Her 1st vaccine was January 7th and today was her 2nd vaccine for COVID."  Teleneurology consult conducted, no documented recommendations. Patient was transferred to higher level of care.
Extreme soreness/pain in the upper arm/shoulder beginning evening after shot. Patient could only raise arm a few inches w/out pain; couldn't roll over on it or lay on it during the night. TYLENOL and Ice helped a little.
Baby was given Pediarix and Prevnar - right thigh at 09:00.  Following which she was & HIB - left thigh.  Slightly fussy.  She took 5oz. of formula at 11:30 and finished at noon.  She had slept for about 20 minutes and woke up screaming at13:15.  With some fullness left thigh.  Advised giving Tylenol 0.4ml with cold compresses locally.
I have side effects that still have not gone away; Had an echocardiogram which showed some ch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have side effects that still have not gone away) and ECHOCARDIOGRAM ABNORMAL (Had an echocardiogram which showed some ch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I have side effects that still have not gone away) and ECHOCARDIOGRAM ABNORMAL (Had an echocardiogram which showed some ch). At the time of the report, VACCINATION COMPLICATION (I have side effects that still have not gone away) and ECHOCARDIOGRAM ABNORMAL (Had an echocardiogram which showed some ch) outcome was unknown.      Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications provided  No treatment medications provided
PRESENTS FOR VARICELLA VACCINE #1. VACCINE WAS SCANNED AND ISSUED FOR ADMINISTRATNION TO PATIENT. VACCINE WAS ADMINISTRED AND PATIENT TOLERATED WELL. REQUESTED PATIENT REMAIN IN CLINIC FOR 20 MINUTES AFTER VACCINE GIVEN TO MONITOR FOR REACTIONS. AFTER VACCINE WAS ADMINISTERED, I WAS UNABLE TO DOCUMENT THE ADMINISTRATION AND REALIZED THAT THE VACCINE HAD, IN FACT, EXPIRED THE PREVIOUS DAY. THE EXPIRATION DATE WAS ON A WEEKEND DAY AND THE CLINIC WAS CLOSED, AND THE VACCINE WAS NOT PULLED TO PREVENT USEAGE.
not feeling well; throwing up; arm was a little sore; This case was reported by a consumer via ((Shingrix GSK Chatbot))interactive digital media and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th February 2022, the patient received the 1st dose of Shingles vaccine. On 11th February 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell and vomiting. In February 2022, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, feeling unwell and vomiting were recovering/resolving.   It was unknown if the reporter considered the pain in arm, feeling unwell and vomiting to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first shot of Shingrix vaccine on Thursday evening and less than a day after vaccination, on Friday morning the patient woke up with little sore arm but that was okay. The patient then started not feeling well. The patient spends half of Friday throwing up. On the day of reporting, the patient was doing better.  The follow-up could not be possible as no contact details were available.
Per mother pt broke out in a rash within 1 hr of receiving the vaccine. She took him to the ER where he rec'd an injection and medication for the reaction.
Patient is a 29 y/o F w no sig past medical history who now presents with a maculopapular rash around her injection site 1 week after Moderna mRNA covid vaccine that then spread to her trunk/chest. Initially pt was advised to pretreat before her second dose, but a web-based consult was done in the interim with the following advice: This doesn?t appear to be an immediate type allergic reaction. Benadryl would not be expected to prevent a reaction. I do have some concern about a second dose having the potential to induce a much more intense reaction. This one is very atypical but doesn?t appear to be insignificant. Unless the patient has very significant risk factors for a severe case of COVID, I would refrain from a second dose. There is nothing wrong in continuing cetirizine if it helps with current itching. A second opinion on the web-based eConsult service yielded the following: Having a delayed reaction is not a contraindication toward getting the 2nd dose. However, I see 1 vesicular/bullous lesion on her rash, which is concerning as the next dose may develop into bullous dermatitis or SJS. In this case, I would definitely encourage patient getting the J&J vaccine given that patient had reaction towards mRNA one. If patient does get the 2nd dose of mRNA vaccine, I would recommend it on the other arm. I would tell her to start taking cetirizine 1 tablet twice daily for 1-2 weeks, and I would also prescribe her topical Triamcinolone twice daily to put on when rash erupts. Having anaphylaxis would be unlikely, but I would still prescribe her an epinephrine autoinjector to be on the cautious side since some people have mixed drug reactions (both type 1 and type 4). I would wait until her symptoms fully resolve before she gets the J&J vaccine. Given that she had a reaction to a prior COVID vaccine, I would prescribe epipen just in case even if she gets J&J. Again, highly unlikely she would react with anaphylaxis but it's always good to be safe. will send pt epipen and give counseling as above.  Allergist #1 response: I think above is reasonable. Reasonable regarding giving J&J. I would not give second dose of Moderna.
chills; fever; arm sore; mouth ache; tired; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills, fever, arm sore, mouth ache, and tired. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 1:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.76.  Concomitant products were not provided.  On 03-Mar-2021, Excursion time was 09 AM, temperature was 51, total doses given for the day was 200, On 03-Mar-2021, Excursion time was 10 AM, temperature was 34, On 03-Mar-2021, Excursion time was 1PM, temperature was 35. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36 and 4 PM: 36.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated 03/19/21and has since received dose 2 on 04/09/21.
A day or two after receiving the first Gardasil shot, I experienced a headache on the left side of my head, concentrated in the mid-to-frontal lobe.  The headache improved a bit with over-the-counter medication.  About two weeks after receiving the shot, I was sitting in class when all of a sudden my right hand went numb and a portion of my right lip and chin.  It was very difficult to comprehend the instructor and I could not spell any of the notes I was taking down.  The episode lasted only about 10 to 15 minutes.  After this episode, I continued to have the headaches-it felt like the left side of my head was heavy and full.  The left part of my neck and scalp were also enlarged.  After this, I went to my primary care physician, not thinking that the shot and headache were related.  The headaches alarmed me because in the past I had headaches very rarely, and never a migraine.  My physician diagnosed me with migraines and gave me a prescription medication for tension headaches.  She said that if the medication did not work, I should get a CT scan of my head.  In the next three months I continued having the headaches-they came on in episodes: first I would start to not think as clear and my hands and arms would sometimes start tingling or feeling numb.  During a few of the episodes there were changes in the vision of my right eye-blurs of color.  I would take the migraine medicine and the symptoms improved within an hour. I also had a rapid heart rate, and when I worked out, often felt dizzy.  A weird effect: when I drank coffee, the headache would become severe- I used to drink at least two cups of coffee a day with out much effect.  In March, I received a second Gardasil shot and the severe headache returned as in the first time and I was very dizzy and a bit faint (I realize that some of these minor side effects are listed in the Gardasil info pamphlet).  I decided to get the CT scan and the results were normal.  I felt reassured by these results and the fact that the symptoms improved over the next few months.  I still had some tingling in my wrists and ankles, and the left side of my head and neck were still more swollen than on the right.  Although the symptoms have improved dramatically, now in August, I still feel my thinking is not as clear as it used to be, and still feel a dull persistent pain in the left side of my head.  Although mild, day to day I do not think as clear and have more difficulties comprehending and explaining. This type of fuzzy thinking increases before a headache.  I would like to have some peace of mind as to what happened and to know if it is serious or not.
I had a really runny nose, coughing, fever of 101 degrees, and tiredness. My doctor called me back at 3:00PM and put me on PAXLOVID, which I started that evening. I was told to stop taking atorvastatin until I finished my prescription. I had about three days of runny nose. The symptoms came back two weeks later but milder.
On 4/8/21 my mother was confused and non-communicative. She couldn't remember events from earlier in the day. We thought she was dehydrated.  On 4/10 she had a second event where she was confused and had a delusion. She was hospitalized that night. She had an mri on her brain and I was informed yesterday that she had a stoke in the last 5 days.
Highest temp 102.9 (hosp); convuls prior to hospitalization w/local rxn l.t. - NONE
Similar to an injection site reaction that didn't appear until over a week after receiving the vaccination. Large raised, red circle around the injection site that is very itchy.
After Hep B vaccine #3 was given, pt c/o nausea, fever, coughing, and dizziness within 2 min. Pt c/o tightness of throat about 50 min after the vaccine. No SOB. Pt was sent to ER for c/o tightness of throat. He has rash around his neck at the ER. He was given SOLU-MEDROL, BENADRYL, and EPINEPHRINE at ER.
Developed chronic fatigue syndrome and dysautonomia symptoms temporally associated with receipt of Anthrax #4 and also had prolonged URI. Symptoms waxed and waned over the next years and now reports continuous symptoms with a great impact on daily functioning.
Starting 02/04/2021 at 6pm, I started developing a fever, fatigue, body aches, joint pain, nausea and a headache. It lasted until the following evening. By 02/06/2021, I felt fine. Around 02/16/2021, I developed a rash on both arms that extended from the mid forearm to the shoulder area. It had a rough texture and it was red, itchy and darker in color. I tried a few OTC ointments but none seemed to alleviate the symptoms. In the summer, it went away before I could see the dermatologist, so I scheduled a consultation for December. When I saw them, it was not present.   In April, I had breakthrough bleeding (which is abnormal since I'm on the pill) and nipple discharge. I went to my OBGYN who referred me out to a breast specialist for the discharge. They sent me for a mammogram in July and then ended up having a biopsy in August (which indicated 2 of the 3 lumps were benign). Now I go every 6 months for a breast check.
Dizziness, fast heartbeat, swollen lips and throat, chest pain. called health care provider, was told to go to emergency.
Enlarged lymph nodes under right arm identified during routine mammogram on June 4, 2021.   Monitored by ultrasound on June 14, 2021 and January 14, 2022.   No change.   Next mammogram and ultrasound will be June, 2022
Arm Numbness and cold not move it, arm discoloration, swollen fingers, muscle weakness in arm and fingers, inability to close fingers, intense pain in arm, hand, and fingers when moved. Inability to stand on his own, faintness with bright white light in vision and could not see anything, loss of vision.  tingling in fingers and weakness in grip of his hand. Numbness in feet and tingling in the toes of both feet. This started 2 minutes after administration of the vaccine and lasted at varying degrees over 72 hours.