chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Belle's Palsy within 48 hours; This is a spontaneous report from contactable consumers. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 03Feb2021 16:00 at single dose (left arm) for COVID-19 immunisation. Medical history included prostate cancer from 1994. The patient was not diagnosed with covid prior vaccination and since the vaccination, patient was not covid tested. Patient was not aware of any known allergies. Concomitant medication included bisoprolol. The patient did not receive no other vaccine in four weeks prior to Covid vaccine. On 05Feb2021, 15:00, the patient developed bell's palsy within 48 hours. The patient was treated with a prescription of prednisone 5mg. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of event was not recovered.  Information on the Lot/batch number has been requested.
Patient received first GARDASIL vaccine, after admin patient was to wait 15 mins for adverse reaction. Upon assessment Pt stated she felt "dizzy", pale. Patient was layed down for 45 mins still C/O dizziness, water given no relief. BP within range, PEDIALYTE popsicle given after 5 mins patient stated she was no longer dizzy. Assessed by MD, ok to go home.
big red itchy circle at the injection site.; 6 days post injection, area was a littleitch/day 8 I have a big red itchy circle at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on the left arm on 01Apr2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, ADHD and hypertension. Concomitant medications included ethinylestradiol/levonorgestrel (KURVELO), lisdexamfetamine mesilate (VYVANSE), losartan (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient was allergic to penicillin and lisinopril. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, 6 days after the vaccination, the patient's injection site area was a little itch. On 09Apr2021, 8 days after the vaccination, the patient had a big red itchy circle at the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events area was a little itch and a big red itchy circle at the injection site was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax; devel an anaphylactic rxn (characterized by itching & shortness of breath) & a local rxn at the inject site;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PAIN (Injection site is tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PAIN (Injection site is tender). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is red) had not resolved and VACCINATION SITE PAIN (Injection site is tender) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient stated she had redness whenever administered with vaccine. Concomitant product use of  blood thinner was reported. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received contain no new information.
flush, something kind of went over her whole body; hands started tingling; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in left arm on 02Feb2021 at 08:00 (at the age of 71-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported previously received pneumonia vaccine for immunisation (4 weeks before the covid vaccine). On 02Feb2021, 15 minutes after taking the covid-19 vaccine, the patient had a flush, something kind of went over her whole body and then her hands started tingling, it lasted a few seconds. The patient reported it started at the top, you could feel something inside of you go from the top and then just down and that was it and then the tingling started. The patient reported it was localized to hands and clarifies it was both hands. Patient did not any AE(s) require a visit to emergency room and physician office. The patient had not received any treatment for event. The outcome of the event was recovered on 02Feb2021.   Follow-up attempts are completed. No further information is expected.
Caller states that a nurse just gave the (DTaP-IPV component) diluent portion of the PENTACEL vaccine without adverse event; Initial information received  on 10-Jun-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient to whom nurse just gave the (dtap-ipv component) diluent portion of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] vaccine without adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (prevnar) for immunisation; and rotavirus vaccine live reassort oral 5v (rotateq) for immunization.  On 10-Jun-2022, the patient received a dose of 0.5 ml, total, Frequency: 1 day (once) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine, strength = standard via intramuscular route in the right thigh for immunization liquid diluent (Lot: U6986AA, expiry: 7/22/22), lyophilized powder (lot: UJ52AA exp 7/22/22) single dose vial with diluent.   On 10-Jun-2022 the nurse just gave the (dtap-ipv component) diluent portion of the pentacel vaccine without adverse event (incomplete course of vaccination) as only the DTaP-IPV component was administered, and the lyophilized powder was missed. Caller wanted to know if dose needs to be repeated.    Action taken was 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.
A minute after injection, she got up and didn't feel good. I had her sit down and asked what her symptoms were. She felt a fullness in her chest, a regurgitation sensation with a bad taste, her face (rt side) felt numb & her speech was slurry for a minute or 2. Just felt off. We took her BP (pt & I) which was normal - she's a CMA in a hospital. I kept asking if she wanted paramedics called. Since she was not feeling better, paramedics were called. They checked her blood glucose at her request (high). She refused a trip to the ER, sat a while more and then left -- refused my escorting her to her car. She has experienced something similar once before 3-4 yrs ago w/pneumococcal injection, but has no issues with flu shots.
tingling around body, episodic low-grade joint pains, low-grade foot pain in left foot (resolved), moderate dizziness, pain around head, pronounced left hand weakness, difficulty with daily tasks/had to leave work.
Rectal fever of 105.2, injection site violaceous and tender; pt unwilling to bear weight on same leg where injection was given. 2 vesicles 3-4 mm each medial to injection site.
Severe Cold, fluid in lungs, raspy breathing, irregular breathing, fussiness, restlessness. To this day, 2 weeks later, she is still restless and cranky.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly storred doses of RECOMBIVAX HB (lot # L038018, expiry date: 13-SEP-2017) (dose and route of administration not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. There was previous temperature excursion for RECOMBIVAX HB: 47 degree of Fahrenheit to 77 degree of Fahrenheit for 3 hours. Data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012563: US-009507513-1705USA012564: US-009507513-1705USA012562:
Patient did not experience any adverse reaction to the COVID 19 immunization, but was given a 0.2ml dose of the pediatric dose instead of the 0.3ml adult dose.
Information has been received from a registered nurse concerning a female who on 8/23/99 was vaccinated with the 3rd dose of Hep B vaccine in her left arm. On 8/25/99, the pt reported that she was unable to lift her left arm above the shoulder level. It was noted that the pt is employed as a cook and unsure if the pt is seeking disability or if the reaction could actually be an injury."  Follow up information provided indicated that the pt had medical complaints and sought treatment. Can not provide any further details. No further information is available.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Patient started to witness chest pain 10 minutes after receiving Shingrix. Her chest pain remained for about 5 minutes then patient stated she was feeling better. Chest pain was the only symptom patient witnessed and stated she did not have any trouble breathing which was also discussed with EMTs that were called. Patient refused to go to ER with EMT and stated she was fine prior to leaving pharmacy.
Found dead in crib after being put for nap. 4/18/04 afternoon. Autopsy results pending.
Pain and swelling in my right armpit area. Applying ice. Still experiencing symptoms 48 hours out from my booster dose.
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
Immediately soreness in arm that continued for two days.   Severe rash on hands/ wrists that has lasted over two months, rash is also located on either side of my neck and ears. Severe itching, dryness of skin and raised bumps. This started to happen about 10 days after 2nd dose, not sure if its related or not but wanted to provide information just in case.
8/6: Fever of 101, Difficulty walking and holding head up. Severe muscle aches and pains. Muscles felt on fire with pain at times. Couldn't hold things in my hands like water to drink. Heart palpitations with feelings of dizziness lightheaded and feeling as if I was going to pass out, SOB. Took Tylenol and Ibuprofen rotation with water and broth. 8/7:  Fever 100 Continued Tylenol and Ibuprofen with water. Same heart palpitations with SOB and muscle aches slightly improved, could walk without assitance.  8/8: No longer fever continued muscle aches and left arm markedly more swollen and weak than right. Heart palpitations with same feelings as above slightly less often 8/9: Migraine, muscle aches and Heart Palpitations no medications taken  Will be contacting provider today to see if she wants me to do anything about the heart palpitations.
He had a generalized seizure just over 48 hours from the administration of the second dose in the series. He has a longstanding seizure history with periodic seizures. He was hospitalized for two days which infection was ruled out and he had returned to baseline. There was no attribution of the seizure to the vaccine by the hospital team.
Respiratory Failure related to positive covid test. PCR positive on 07/01/2021 and PCR positive 07/07/2021.  Patient placed on BIPAP due to hypoxia in ER and admitted.  Remdesivir and decadron administed as inpatient.  unknown exposure date admitted 07/07/2021
Tachycardia; Hypertension; Chest discomfort; Dizziness; Chills; Weakness; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Lot Number: EL1284), via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tachycardia, hypertension, chest discomfort, dizziness, chills, weakness, and fatigue within 1 hour of shot on 12Jan2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for a day. The outcome of the events was unknown. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
12 hours sore "felt bruise" about 18 hours pain swelling "hives" at site only, c/o HA. Went to ER 0200 9/13 - hives "cellulitis" appearance.
13dec89 pt vax 2nd hepta B. 16dec89 pt ex fever, aching,nausea, vomiting, upper right quad abdo pain, rash on face, arms, and on and off each leg.  26dec90 pt complained of cola colored urine.    See worm...
Adverse event following immunisation; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Side Effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Side Effects). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Side Effects) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported.  No treatment information was provided.
8/16/04 Pre-travel counseling appointment.  Received 4 vaccines, 3 injectable and 1 oral (to be self-administered at home).  8/17/04 Telephoned to report elevated temperature (did not exact degree, I'm extremely hot", general malaise, muscle soreness and fatigue, instructed use preferred OTC analgesic and proceed with oral vaccine.  8/19/04 Telephoned to report intense stomach pain, severe nausea and episodes of diarrhea; had ingested 1 dose of oral vaccine on 8/17/04 and again on 8/19/04.  Reported decrease in overalll symptoms that he had c/o 8/17/04  but now reported intolerable GI distress.  To return to office on 8/20/04.  8/20/04 opted to receive injectable alternative instead of completing oral vaccine.
On 01/12/2021, I was notified that the patient stated she had a rash on her left arm near the immunization site.  I examined this site on 01/12/2021.  Noted 2 in diameter area where vaccine was injected, that showed a faded induration, but no redness now. The patient states this was red at the site for several days but then faded to the current appearance.  She states one week after administration of the vaccine, she developed a rash trailing to inner aspect of her left arm. Rash was blotchy in appearance, in small clusters. No induration or erythema noted.  Patient reports mild pruritis. States she has been taking her allegra since the immunization, has not taken any benadryl or other new medications for this rash.  Denies any systemic systemic symptoms. No shortness of breath, angioedema, wheezing, chest pain, or GI/GU symptoms.  She states earlier in the day on 01/12/2021, she had site examined by her primary care provider, PA and was told to put hydrocortisone cream on site and to monitor.   Patient denies taking any new medications since vaccine administration.  On 01/13/2021, patient was examined by another provider at clinic, APRN.  She noted, the arm is erythematous, mildly raised and with no induration or fluctuance at site. The patient complains of slight burning and significant pruritus. There are no excoriations. She has been using hydrocortisone and taking claritin. She encouraged patient to start taking benadryl as directed and continue hydrocortisone. Edges of erythema were marked and advised patient to monitor for progression today. If progression occurred within a few hours she planned to send RX for treatment of acute delayed reaction to vaccine.  Patient was examined at 3:18PM by RN and she reported that it looked like the erythema had improved and had gotten smaller, it had not progressed beyond the pen markings. Pt complains of some itching still but had not been able to take benadryl yet today. She will keep an eye on it and will check back in with us tomorrow.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown ages. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (Lot # not reported). The physician reported that within a month of vaccination, the patients experienced shingles. The outcome of shingles was unknown. Additional information is not expected.
quadracel is given to a 4 yo a day after expiration date with no reported adverse event; Initial information received on 08-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old patient of unknown gender who was given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] a day after 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 07-Jul-2023, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot: c5916aa; expiry date: 06-Jul-2023) via unknown route in unknown administration site for Immunization.  On 07-Jul-2023 the patient was given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] a day after expiration date with no reported adverse event (expired product administered) (latency: same day).  Action taken was 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 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.
A cluster of 3 patients who received ADACEL (lot number C3068AA), and developed injection site reactions. Initial report received on 17 March 2009 from a healthcare professional. A patient, whose age, gender, medical history and concomitant medications were not reported, received ADACEL (lot number C3068AA) on an unspecified date and developed a sterile abscess at the injection site. Corrective treatment was not reported. The patient's outcome was unknown. Follow-up information received 19 March 2009 from a health care professional. The patient was a 34-year-old female who received a right deltoid injection of ADACEL on 27 February 2009 at 14:30 pm. On 12 March 2009, 13 days after receiving the vaccine, the patient developed a 3 x 2 cm abscess at the right deltoid which required a doctor's visit. On 16 March 2009, a culture was performed which showed no growth. The patient had no past medical history, no concurrent illnesses and she had not been taking any concomitant medications at the time of vaccination. According to the reporter, the patient recovered from the event (date of recovery not reported). Cases 2009-01136 and 2009-01137 with the same reporter and same ADACEL lot number were created for the other 2 patients. Documents held by sender: None.
On 12/31/2018, patient called c/o redness and swelling at site. On 1/2/2019 patient called c/o of increased selling, tenderness. Instructed to come in same day, and NP notice swelling, tenderness at site with redness of entire upper arm to the elbow. T 97.7. Diagnose with Cellulitis of Rt arm and placed on Bactrim DS bid x 7 days.
Patient states for about she had facial swelling, her skin turned red, she was hot and itchy for about 3 days after receiving the FLUAD vaccination.
Swelling, numbness, tingling and pain at injection site that radiates down my right arm and right thumb numbness and tingling. I notice this approximately one week post vaccination and it?s still an issue. I have reported this to my primary physician.