chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme dizziness, weakness, excessive vomiting, fever, 9 hours after injection.  Could not lift myself from floor for 20 hours after the weakness/dizziness began. Booster administered by pharmacy.
Pt developed pinpoint petechiae on BLE that developed into weeping sores over the course of about 10-14 days.  Tx was clobetasol 0.05% bid for 7 days.  Sores resolved with some hyperpigmented  areas.
This spontaneous report was received from a registered nurse reporting on a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient might have been vaccinated with a dose of one of the improperly stored vaccines: VAQTA (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018), LIQUID PEDVAXHIB (dose, route of administration were not reported; lot # N003698, expiration date 31-OCT-2019), GARDASIL 9 (dose, route of administration were not reported; lot # M040412, expiration date 30-JUN-2019) or PNEUMOVAX23 (dose, route of administration were not reported; lot # N004564, expiration date 22-OCT-2018). The vaccines underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. Additional information has been requested.
Random bruising outside of injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Random bruising outside of injection site) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Random bruising outside of injection site). At the time of the report, VACCINATION SITE BRUISING (Random bruising outside of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
SORE LUMP TO LEFT CALF AREA; BRUISE ON CALF; BIG BROWN SPOT ON LEFT CALF; LEG SPASM WITH MUSCLE TIGHTNESS AND PAIN TO LEFT SIDE HIP TO KNEE AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bad wiring heart condition, neuropathy, arthritis through out the body, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, sacubitril valsartan sodium hydrate for heart condition, and montelukast sodium for seasonal allergies. On 20-APR-2021, the subject experienced leg spasm with muscle tightness and pain to left side hip to knee area. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative.  On 26-APR-2021, the subject experienced big brown spot on left calf. On 27-APR-2021, the subject experienced sore lump to left calf area. On 27-APR-2021, the subject experienced bruise on calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg spasm with muscle tightness and pain to left side hip to knee area, and bruise on calf on 28-APR-2021, and big brown spot on left calf on 27-APR-2021, and had not recovered from sore lump to left calf area. This report was non-serious.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Reports ackey flu like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain". Additional information: 77 year old Male 169 lb. 5'6". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101138190.
Fatigue, disorientation, nausea, aches in back of head, neck, shoulder, amd legs, exhaustion, shortness of breath, worsening pain with head and neck movement.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
After receiving last vaccine patient complaint of nausea, abdominal pain and feeling warm. VS observed 89/50 pulse 59 r 16. continued to monitor for 30 minutes, patient vs. stable at 101/64 p 64 and no further reaction. Dr saw patient and discharged patient with no further treatment.
vaccine of Feb 1; started amoxicillin and metronidazole on evening of Feb 2; early morning hours of Feb 8th had intense itching and rash.   Called pharmacist who told me i was probably allergic to one of the antibx, even tho i had been taking them >5 days and to stop one of the antibx.  Also told her i had had covid vaccine on 2/1. I stopped metronidazole but itching/rash continued whole day. Next day stopped amoxicillin and restarted Metronidazole.  This is also day i had root canal surgery.  Again itching and rash continued.  Today, 2/10, I have stopped both antibiotics and itching/rash is still present but seems to be lessening.   Resesarched online; called CDC, etc- no one knows about antibx and covid reactions occurring
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of MMR II (dose and route were not reported) lot number J002505 expiration date 20-FEB-2015 that were exposed to 52 F for 12 hours on February 2014. No adverse effect reported. It was also reported that MMR II was not supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Follow vax, at approximately 10:45 the pt began having difficulty breathing, mom was instructed to call 911. The pt was taken to the ER, was treated and released. The pt ate 2 donuts post vax and got sick.
This case was reported by a pharmacist via call center representative and described the occurrence of bedridden in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced bedridden, pain, fever and injection site pain. On an unknown date, the outcome of the bedridden was recovered/resolved and the outcome of the pain, fever and injection site pain were unknown. It was unknown if the reporter considered the bedridden, pain, fever and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was very petite and weighs barely 100 pounds. The patient experienced several side effects after receiving a SHINGRIX vaccine. The patient experienced severe injection site pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient previously received COVID-19 vaccine. Patient did not took any other medication or product within two weeks of COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Vaccination given at 1:00pm, by 6:00pm that night she had fever, chills and severe arm pain. On 3-4-2020, she had a headache and extreme fatigue. She had no symptoms on 3-5-2020.
Information has been received from a physician concerning a patient with gastrooesophageal reflux disease (GERD) who was vaccinated PO with a dose of Rotateq. Concomitant therapy included medication to control GERD. The physician reported that the patient subsequently vomited the dose up after the vaccine was administered. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested. 04/04/2010 Information has been received from a physician and registered nurse concerning a 9-week-old female with gastrooesophageal reflux disease (GERD) who on 05-OCT-2006, at 1130, was vaccinated PO with the first dose of ROTATEQ (Lot #654248/0577F). Concomitant vacciantions administered on that same day and time included the first dose in the right leg of PEDIARIX (Lot #AC21B069AA), the first dose in the left leg of PEDVAXHIB (lot #651986/0527R) and the first dose in the left leg of PREVENAR (Lot #A25969C). Other concomitant drug therapy included medication (not further specified) to control GERD and Tylenol (given 1 hour prior to vaccination). It was reported that on 05-OCT-2006, at 1130, the patient vomited the dose back up after the vaccine was administered. Unspecified medical attention was sought and no laboratory/diagnostic tests were performed. On that same day, the patient recovered. Additional information is not expected.
started on 6/16, 36 hours ago, chest pain, chest pressure, myocarditis, elevated troponin
Low grade fever that night. Next day had stiff neck, body aches, Headaches. Had 104 degree fever on Tuesday nite.  Off work on Wednesday--treated with Tylenol & Ibuprofen.  Back to work on Thursday.  Had congestion/cough on Friday. Feels back to normal self today.
At first I started to become dizzy, then sick to my stomach.  My heart began racing rapidly and my vision went black and I fainted.  I have no appetite and the only thing I can keep down are freezer pops.  I am extremely fatigued and I hurt all over.  I was FINE after my first dose...I should have stopped there!!!
This is a spontaneous report from a contactable consumer reporting for himself via a Pfizer sales representative. It was reported that a male patient of unknown age received PREVNAR 13 at a single dose for immunization on an 08Feb2018. Patient medical history and concomitant medications were not reported. It was mentioned that the patient experienced chills the same day of vaccine administration. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
medication error due to the inappropriate administration of FLUZONE QIV MDV that was no longer suitable for use post excursion with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 30 years old female patient who experienced medication error due to the inappropriate administration of fluzone qiv mdv that was no longer suitable for use post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Feb-2023, the patient received 0.5 ml (frequency: once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ879AA and expiry date: 30-JUN-2023) (strength: standard) via intramuscular route in the deltoid (unsure which arm) for Immunization.  On 06-FEB-2023 the patient had medication error due to the inappropriate administration of fluzone qiv mdv that was no longer suitable for use post excursion with no reported adverse event (product storage error) (latency: same day).  Action taken: not applicable.  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.
Tinnitus became very apparent about a week after my second dose.  Had second dose on 02/19/21, that lot # is 004M20A.  It is not affecting my ability to hear yet, but it is still extremely annoying.  Previous to these vaccines, I did have very mild tinnitus, I would only hear the whine in a very quiet room.  Now I hear it all the time and it does not go away when there are normal sounds in the household or even outside.
Patient is a 64 y.o. presents to walk in clinic with diffuse rash over bilateral upper arms some extension to the left lower arm, across the upper chest the past 2 days and also some in the medial proximal thigh and and popliteal right side.  These begin like pustule or papule; some were more vesicular over the area superior to where he had Shingrix #2 vaccine on 23 Jan.  .   Symptoms began on 8 hrs after receiving Shingrix (Left deltoid) and Pneumovax-23 (Right deltoid).   Last day worked was 1/31 - has not missed any work with this.   Rash is extremely itchy; Some pain with the sores as they develop.   Hydrocortisone cream has not been much help;   Has prior allg to Sulfa.. O) Afebrile;  Diffuse maculo papular lesions on upper arms with excoriation.  Waxy indurated area over lateral left arm without deep abscess noted.  Superficial follicular like lesions also noted across superior anterior chest.  Excoriation noted.   No vesicular lesions noted.   Minimal lesions on medial thigh and right popliteal, 3 crusted, none with exudate or serous drainage.
3 days after PROQUAD - hives bilat. legs, arms, back, face, lip, toes. Itching. Lesion on leg and back are vesicular; otherwise. Eating, playing and sleeping as her usual. Low grade fever.
muscle aches, fever (100.3), mild chills, fatigue.  Treating with rest and fluids (water).
Cellulitis left upper thigh - 9 X 11 cm w/ redness/firmness.  Treated w/ BACTRIM.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5/9. Patient does not plan to get revaccinated at this time.
Staff member received TD rather than PPD to LFA by Intrathecally injection causing moderate induration with subsequent erosion and slow healing open wound.
I went to Urgent Care to get a PCR test because of COVID-like symptoms that had lasted longer than booster side effects should. I missed work that day and the next because of fatigue and cough. Here's the timeline of symptoms starting with the booster on 12/16:  four days of intermittent fatigue, chills, muscle aches, diarrhea, and I think runny nose. Then starting Mon 12/20, 3 days of fatigues, headache, nasal congestion, rattling in throat/chest and cough -- sometimes dry, sometimes rattling, which made me thing of asthma cough. Worked fewer hours than usual those days. Then starting Thu 12/23 until today (12/27), fatigue; congestion in nose, sinuses, upper chest, and occasionally ears; cough; occasional breathlessness after light exertion. All the symptoms except cough and upper chest congestion/rattle have decreased over that period and are nearly gone.
Multiple lesions (>250) on extremities, torso, face and bucal mucosa 8 days after receiving first varicella vaccine. Tx: Acyclovir 800 mg every 6 hours x 5 days; Dytan 1-2 by mouth as needed every 12 hours; Zantac OTC, Mylanta and Maalox
Patient developed redness on the left thigh, that progressively became larger and more painful and pruritic. She was placed on antibiotic and given Claritin for itching.
Pt brought to med obs #1 via stretcher with c/o lightheadedness, tunnel vision, and brief LOC. Pt placed on floor with BLE elevated prior to stretcher arrival. Pt able to ambulate to stretcher without difficulty. Pt reports he felt better upon arrival to med obs #1. Reports he ate breakfast PTA. Accepted water, declined snack. VSS. Symptoms resolved. Sent home with parents. Escorted to exit with staff. VS are as follows: 1106: BP 124/75, HR 53, RR 18, O2 sat 99% on RA 1111: BP 134/71, HR 59, RR 18, O2 sat 98% on RA
About 4-5 weeks after the vaccines, an ultrasound detected enlarge thyroid and a nodule. My throat hurts. I had a complete physical I April of 2021 and had no symptom. No detection of any problem with my thyroid.
Information has been received from a health professional concerning an 85 year old female with hypertension and hypohydremia and no allergies who on 10/20/2005 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included enalapril maleate. On 10/21/05 the pt stated that the site was swollen and red down to the elbow on the back side of the arm. The pt saw the physician on 10/22/05 where the condition was observed and verified. there were no labs or diagnostics done. At the time of reporting the pt had not recovered. Additional information had been requested.
On Tuesday, January 25 I started itching all over my body, at first it seemed like very dry skin. Hives started to appear more noticeably the next day, by that evening the hives were significant, they appeared on many parts of my body- torso, arms, legs, neck, chest. Benadryl helped with some of the itching. I went to Urgent Care the following morning. I was prescribed Prednisone, 60mg/day for 3 days, taper to 40mg/day for 3 days, then 20mg/day for three days. It was also recommended that I see my PCP for a referral to an allergist to find a cause, because I was unable to trace the reaction to any known changes in environment or things I had ingested. I began the prednisone at about 10:00 AM on Thursday the 27th. I was also taking 50mg of Benadryl. as frequently as allowed per usage directions.  The hives continued, and itching was only partially controlled by the use of Benadryl and anti-itch cream.  The next day I spoke to a doctor at my primary care facility and she recommended I also try Pepcid. I began taking Pepcid in addition to the Benadryl and Prednisone on Friday. On Saturday, the 29th I awoke feeling ill. My entire body ached, I had heartburn and was nauseous. I took the prednisone pepcid, benadryl, and naproxen sodium and slept. I woke up several hours later feeling much better, though still itchy.    On Monday, January 31 I experienced some wheezing and the itching had not stopped. I went to the ER. They checked my breathing and I was ok, but they recommended increasing the dosage of Prednisone back to 60mg and try to resist scratching because the hives were not apparent but my skin was reacting to the scratching, something they called dermatographia.  I upped the Prednisone dosage back to 60mg, continued with benadryl and pepcid. On Wednesday, February 2 the itching had improved, though was still present. My leg felt bruised and upon looking I discovered a large patch of purplish-red on my right leg, on my thigh and around my knee. I went to my PCP and she was concerned about the discoloration and prolonged itching despite prednisone. She prescribed a longer treatment of Prednisone, along with Allegra and Pepcid, and Benadryl at night.  Currently I take Allegra and Pepcid AC each morning, as well as 40mg of Prednisone. At night I take 2 Benadryl. The itching has mostly subsided, I still experience dermatographia and itchy patches on my body- especially hands, feet, face, and scalp. The discoloration on my leg is still present, but is fading and much less painful. It is smooth to the touch and feels more sensitive than the surrounding skin, but not as painful as a bruise or raw skin. I have other patches of discoloration in other spots, but not as significant as the one spot on my right leg.
This spontaneous report as received from an other health professional refers to a patient of unknown age. The patient was vaccinated with VAQTA on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received a dose of VAQTA which was exposed to 22.6 Fahrenheit for 13 hours. No adverse effect reported. No further information is available. Additional information is not expected.
Gave PNEUMOVAX shot approx 5:30 pm on 12/8/10. Pt reported on 12/9/10 (about 6 pm) the injection site is swollen & underside from elbow up is warm & red itches on underside. Pt states she had to take ADVIL to sleep.
pt had PMH severe local rxn to HIB vax requiring hospitalization; 0.1ml DTP was given as test dose; pt had significant local rxn w/induration, heat, some erythema;
Intussusception. Hospitalized 8/26-8/31/04. Hep B #3 and Varicella received 7/21/04. Discharge Summary received on 2/16/2005 states lethargy and hematemisis.