chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness not mild, like water running through my brain, within first 30 minutes and that went away in a few minutes. But I still feel unsettled. Following four days, firstly, I started to feel like a punch headache, it's irregular and not constant. Like someone punched my head, like three punches in the head and then it go away and then the headache goes away. Then I had a mild temple headache., it's not always there. On the 6th day, on May 18th, I started to feel (before I went to bed about 10:00PM) all of a sudden I started to sweat and my whole face turned red. It was like heat just went over my head. I was brushing my teeth and I got scared. It went away within about 10-15 seconds. I started to feel something is wrong, so I went to measure my blood pressure. Knowing that when someone had a stroke, you have sweat etc. My blood pressure was 98/48. The following morning, I woke up and measured my blood pressure again, started to feel blurry vision. I had to make an effort when I talk, like there was no power in my chest. I started to feel pressure on my heart. When I talk, there is no energy from my chest (from lung or heart). It's either my heart or my lung whenever I try to talk, I have to make an effort. Whenever I think, I have to make an effort to think. I use to be fairly quick, responses are usually very quick. With this, everything slows down. My blurry vision and my brain (I don't remember how to write) makes it difficult to come up with a person's name. Like dementia or something. I noticed when I measure my blood pressure, that for the following two weeks my dystonic has never exceeded 55 whether morning or evening. May 28 was lowest:  My heartbeat was only 50; my BP was 76/37. (My BPM was about 50.) I went to see my doctor. My appt was on 8th of June. May 30th my BPM was able to go above 60. I exercise and I was able to exercise but I have a discomfort over my chest. When I bike (slow biking), I was still able to finish 10 miles of biking even though it was pretty hard. I started to do very mild walking since June 8th I started mild walking and not doing hard exercise. I still have temple headache and I still have to make efforts when I talk and June 19th when I talk for 10 minutes, I'm exhausted. If I have to use my brain when I talk, I was exhausted. I have cancelled my second shot of Moderna because of symptoms I have encountered. I almost feel like trembling when doing this report. I can feel it. I'm recovering but not back to my old self.
Patient, after 15 minutes, stated he felt his throat was "tighter". Patient was alert, oriented, and had no injection site reaction. Patient was not in distress, with no other symptoms of reaction. No swelling of lip or tongue and no difficulty breathing Patient was given water, and was monitored for another 15 minutes. At this time, patient reported progression of tightness. Patient was given 10 ml of diphenhydramine 12.5 mg/5ml  (25 mg total). Patient was monitored for a further hour. Patient felt better, and reported that "tightness' had reduced back to close to normal. However, patient and mother were encouraged to seek further evaluation. Pharmacy called his PCP, who was unavailable to receive patients at the time.   Patient and mother were encouraged to go to urgent care facility behind the pharmacy, and they went for further evaluation. Urgent care advised they go to the emergency room.
On February 7th I thought I had a bug bite on my left arm.  I was wearing a black t-shirt in the sun. I got home and it was itchy, I took a Claritin.  I went to work the next day and that night on Feb 8th my head felt itchy, I decided to take a Benadryl.  I woke up about 2 am and I had a really itchy spot on my collar bone and my elbow and my knee.  I thought something was biting me and I looked through all my sheets.  I was so itchy.  Then I woke around 6am on the 9th, my knees, elbow, and neck were still itching.  I looked in the mirror and my body were so activated, my body was so red.  It was also around my lips.  I called the nurse helpline, and I did a phone appointment with the doctor.  They advised to keep using Benadryl and Q4 50mg.  The next day I was miserable and started to have chills. If I was in a normal temperature my body was activated.  I took my temperature on February 10th I had a low-grade temperature.  If I held any anything warm.  On day 5 of the symptoms, my PCP advised that I use Sertorzine instead of Benadryl.  She advised to take a COVID-19 test.  Both came back negative.  She also advised that I should switched to Allegra on February 13th.  Then I noticed less irritation of my skin.  I couldn't work due to not being able to wear a mask due to activation of my skin.  On February 15th, I felt a little better, but my skin was feeling less activated.  Also holding anything or having anything against my skin caused my skin to activate.  I did start Wellbutrin on January 20th, which I know that skin reactions can start about 2-2 1/2 weeks following the initial does of Wellbutrin.  I stopped the Wellbutrin on February 9th.   I still to this day get itchy and have hives show up.
swelling & tenderness in both arms beginning in the afternoon on the day the shots were given;pt stated lt arm swelled up in to shoulder & neck;used ice, cool cloths & APAP to treat self;
recv vax 930AM 3JUN96-4hr later screaming, unconsolable for 12hr, t101, cold, RN symp cough, still cough rash
Vaccine administered past 6hr post puncture of vial. No adverse reaction occurred. Per Moderna, no actions required at this time, proceed with 2nd dosing as scheduled.
Vaccine 7/25/06. Mother presented to HD on 8/9/06 arm site where shot given purple area with pustules starting to form around the site no pus not itchy.
Patient was administered Prevnar20 in error. They have already received Prevnar13 10/21/2020,  and Pneumovax23 6/20/22.
Approximately 2 minutes after giving vaccinations, pt started sneezing repeatedly. Doctor gave pt 5 ml of Zyrtec and we asked patient to stay to monitor. Approximately 5 minutes later, patient started itching on his feet and began to get hives on his torso , arms and legs. 40 mg Depo Medrol was given IM and patient who released approximately 15 minutes later.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered on 15-Jul-2022).    Concomitant product use was not provided by the reporter.  Patient received half dose.  On 04-Jun-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Treatment information was not provided.
Developed "pink and itchy eyes" shortly after receiving flu shot, duration ~4 hours. States same thing happened last time she received flu shot in 2009.
Information has been received from a registered pharmacist concerning a 62 year old male with no medical history or drug reactions/allergies who in approximately 2001 (more than 5 years ago) may have been vaccinated with Pneumovax 23. On 14-OCT-2006, the patient was vaccinated with Pneumovax 23 (lot # 651399/0486F) 0.5 ml subcutaneously. Concomitant therapy included influenza virus vaccine (unspecified) also given on 14-OCT-2006. Several hours later on 14-OCT-2006, the patient experienced tenderness, warmth, swelling, and redness at the injection site with soreness of his whole arm with movement. The patient sought medical attention. The patient was treated with TYLENOL and BENADRYL. The events improved. At the time of reporting, the patient was recovering. Additional information has been requested.
A report has been received from a Health Professional concerning three children of unknown gender, who had been receiving FLUMIST, 0.2 Millilitres, once/single administration. FLUMIST started on an unknown date. It was reported that the patients were administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the events was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious by the company physician.
A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observed for a few minutes and she stated that the dizziness was worse and that she felt flushed so she was given 0.3mg of IM epinephrine after which she began to immediately improve. She was also given 50mg PO diphenhydramine. She was observed for 60 minutes after the epinephrine dosing without any recurrence of her symptoms and she was discharged home with strict ER return precautions.
seasonal allergies; Pain-soreness at the injection site; shortness of breath - after walking, once I sit down for 20 minutes then I am fine; heart palpitations; severe headache; total fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (seasonal allergies), DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine), PALPITATIONS (heart palpitations), HEADACHE (severe headache) and FATIGUE (total fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE BESILATE, VALSARTAN (EXFORGE), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ) and VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (severe headache) and FATIGUE (total fatigue). On 08-Feb-2021, the patient experienced DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine) and PALPITATIONS (heart palpitations). On an unknown date, the patient experienced SEASONAL ALLERGY (seasonal allergies) and VACCINATION SITE PAIN (Pain-soreness at the injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, SEASONAL ALLERGY (seasonal allergies), DYSPNOEA (shortness of breath - after walking, once I sit down for 20 minutes then I am fine), PALPITATIONS (heart palpitations), HEADACHE (severe headache), FATIGUE (total fatigue) and VACCINATION SITE PAIN (Pain-soreness at the injection site) outcome was unknown.
Pain in neck and upper back with second dose, started after 1 day of vaccine.  Extremely sore arm started the night of the vaccine.   1st dose Sep  24 2021 2nd dose October 30 2021 28weeks 4 days pregnant, EDD January 19 2020 - High risk pregnancy at time of both vaccines. 2 prior pregnancies, 2 living children
Client was 6 years old and received TDaP instead of Dtap. Client was with mother. Waited 15 minutes after injection and then left. Error discovered after departure
Lymph node under arm is severely swollen and extremely sore, fever of at least 101, severe headaches, drowsiness, chills, & hot flashes. Mainly reporting due to the size of swelling under arm and the amount of pain she's in. We will make an appointment if it doesn't get better in a couple more days. So far it's only gotten worse.
Admission Date: 1/24/2023 Discharge Date: 2/3/23  PRESENTING PROBLEM: Septic shock (HCC) [A41.9, R65.21] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73 y.o. woman s/p right lung transplant 8/3/2015 for RA related pulmonary fibrosis, admitted 1/24/23 due to COVID-19 pneumonia and shock related to hypovolemia. Receiving decadrone and remdesivir. Now with persistent dyspnea, tachycardia on exertion. Cardiac MRI repeated while here, structural heart stated stable and no intervention at this time.  O2 was able to be weaned to room air at rest and 2 liters with activity, She continues to have DOE and tachycardia with exertion (had for past year +) - suspect this is due to multifactorial etiology: deconditioning, underlying heart disease (valvular), single lung, recent COVID. PT recommended acute rehab, palliative had goals of care discussion  -  hospice vs rehab - they wanted to try a week of rehab then go home and re-assess hospice vs continued palliative care. Her insurance denied rehab - family and patient wanted to go home.
Patient received 3rd dose of Covid19 Pfizer vaccine on 3/3 due to facility not keeping proper records. Patient condition unknown at the time of reporting.
Onset redness, exquisite pain over site of vaccination.  Fever, chills, WBC 25 with bandemia.  5/1/08 Reviewed hospital medical records for 3/11-3/12/2008. FINAL DX: cellulitis right deltoid s/p immunization Records indicate patient experienced fever, nausea, chills, soaking night sweats, reduced oral intake, rigors, pounding HA & arm pain after multiple vaccinations in preparation for foreign travel.  No reaction to prior vaccinations.  Had sore throat x 1 week prior to vaccinations w/tonsillar exudate.  Seen in ID clinic on day of admission.  Improved & d/c to home on continued oral antibiotics.
Pt recv vax on 4/13/99; on 4/14/99 pt exp left thigh red swelling from knee, groin, then to back, fever, limp; tx=cold packs
TENIVAC administered after the expiration date with no reported adverse event; Initial information received  on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 36 years old male patient and it was reported that tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) administered after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022 via intramuscular route in the right deltoid as Immunization.  On 28-OCT-2022 the tenivac administered after the expiration date with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  Treatment: none.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
General malaise x 3 days began approx 18 hours after shot. Muscle soreness all over body approx 30 hours after shot took ibuprofen lasted about 24-36 hours. Intestinal distress then diarrhea began approx 50 hours after shot. Lasted 24+ hours. Fever 101.1F began approx 50 hours after shot. Took ibuprofen. Seemed to break in a few hours. Approx 72 hours after shot still general malaise. Not feeling 100%.
Pt presented vaccine card with only on vaccine. He stated he needed another vaccine for admission to the homeless shelter. After consultation, the patient got Pfizer monovalent and was educated about the primary series and educated to return in 28 days for a second dose. The patient stated he already received the primary series but he dose not remember the dates, so he  took  the vaccine again to get the vaccine card.
Mother indicated child began running a fever last evening-temp went up to 104 at one point-administered Tylenol-also c/o headache, dizziness, blurred vision-plans to take child to doctor now-stopped at clinic to inform staff that shots caused these side effect. 2/6/01-syndia answered phone, said she is feeling better, can see fine.
Information has been received on 15-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During October 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster the very virus the ZOSTAVAX is intended to prevent. During July 2016, the patient was treated at a health care center for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
She received her second dose of COVID 19 vaccination (Pfizer) in left deltoid the afternoon of February 23, 2021.  That night and since then she has been experiencing insomnia.  The day after she received the injection she developed head pressure, and head ache, body aches, rash around the injection site, pain at the injection site, and her arm is very sensitive.  She went to the emergency room with complaints of abdominal pain and headache.  She is not sure if the abdominal pain is related to the vaccination.  Imaging studies performed in the ED revealed she has a cyst on left ovary, and a kidney stone in left kidney.  She was prescribed cefdinir 300mg, take one tablet by mouth twice a day for seven day, and acetaminophen-codeine 300-30.  She is taking cefdinir 300mg, one tablet by mouth twice a day.  She is not taking  acetaminophen-codeine 300-30.    The day after she was seen in the ED she found a lump at the bottom of her left underarm.  The lump is hard and the size of a quarter.
MULTIPLE SATELLITE LESIONS OVER BACK & FACE & ARM 3 WEEKS AFTER VACCINATION
PATIENT REPORTED SWOLLEN FACE (JAWS)  STARTING ON 04/09/2021.  TREATED WITH BENADRYL AND SWELLING WAS GONE AFTER A 2 OR 3 DAYS. PATIENT REPORTED AFIB LASTING A 2 OR 3 DAYS STARTING ON 04/09/2021.   PATIENT REPORTED ROUND RAISED RED CIRCLE ON SKIN OF RIGHT LEG WITH WHITE CRUST IN MIDDLE. START DATE NOT GIVEN.  STILL PRESENT AS OF 04/17/2021.
Hives appeared  along the neck on the side of the injection site within 4 minutes followed by a burning skin sensation in the entire upper body and itchiness along the entire upper body, including the trunk, arms, chest and neck.  Anti-histamines were successfully used to treat the hives. Hives resolved in 15-20 minutes. Burning/itching and mild dizziness continued for approximately 4 hours and then subsided.
Rt thigh administered varicella with resultant hive, ice applied with diffuse erythema and induration noted within 10 min. Benadryl and Oraped given resolution to small hives with removal of ice, Benadryl and Oraped continued for 48 hours.
Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was provided
2-3wk p/vax site became red & swollen;1st brought for eval 13OCT96;dx as vaccine rxn, sterile vs bacterial abscess (nonfluctuant) rx augmentin/motrin & warm compresses;
Dose 1 on 2/5/2021 Dose 2 on 3/5/2021  Symptom of loss of hearing in my right ear resulting in tinnitus in the right ear (ringing)
1:35pm Post vaccination reports feeling dizzy w/palpitations; medical monitoring w/vitals assessed: BP 123/85 P71 RR 19 O2 sat 99% RA; rest/ po hydration offered; 1:45pm reports symptoms resolve w/no additional complaints; released from facility w/self.
The following history was presented to the Healthcare Center: The pt received his primary SPV on 3/21/14 in preparation for work. The pt was recovering from a cold at that time. He received his SPV in his upper left arm. The pt denies chest pain, neck pain, malaise, painful lymph nodes. On 3/31/14 he noted a painful lesion on his left wrist. It was "round, raised" with a surrounding area of erythema of about 4cm. This lesion was seen by a provider on 4/1/14 at the clinic just prior to the pt transferring. The pt was told that it looked like a staph infection and he was prescribed PCN. Also, on 4/1/14 the pt noted a papular-vesicular rash on his chest and back which is not painful or pruritic. On 4/2/14 the pt noted a "pimple" on the right side of his neck "which he popped" but it has "returned".
PATIENT WAS IN OFFICE WITH MOM TODAY FOR HIS 5 YEAR WELL EXAM. HE RECEIVED TWO VACCINES MMR AND QUADRACEL (IPV/DTAP), IN HIS LEFT THIGH. HE LEFT THE OFFICE AND ON HIS WAY OUT THE DOOR HE STARTED TO COUGH. MOM LEFT OFFICE AND WITHIN 10 MINUTES SHE CALLED OUT OFFICE AND SAID HE WAS STARTING TO COUGH MORE , HAD A TIGHT WHEEZE AND SAID HIS MOUTH FELT LIKE HE HAD PHLEGM IN THE BACK OF HIS THROAT. MOM GAVE HIM 1/2 TAB OF BENADRYL.  WE SUGESTED MOM TO COME BACK TO OFFICE, WEGAVE HIM AN ALBUTEROL TREATMENT AND 12.5 MLS OF PREDNISONE. MD LISTENED TO LUNGS AND HE WAS CLEAR AND WAS DISCHARGED.