chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/30/07 @ 1400 "getting wound up and experiencing a lot of stress and experiencing chest d/c. Then after shot chest d/c and dull ache in L arm.  Dull ache in front of the cheston L. Soreness in arm around injection site upper and lower arm." 5/2/07 @1040 "States just soreness around injection site"
About 16-18 days post vaccination had onset of Bilateral eye pain with lateral movement. Eye examination revealed papilledema (bilateral). 2 Normal eye examinations 12/15/2004. Pt seen by neurologist and neuro ophthomologist ( the latter raised the question of after vaccination reaction. As I stated earlier, vaccine was administered 8/22/05. She was seen at optomertrist on 9/15/05 with one week history of Billateral eye pain (especially w/noticed movement) and vaug headache associated with it until 9/15/05. Pt maybe able to supply more details.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 04-SEP-2015, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, expiration date, dose and route of administration were not reported) 10 microgram/ml. Subsequently, the patient was vaccinated with the second and the third dose of RECOMBIVAX HB (lot number, expiration date, dose and route of administration were not reported) 10 microgram/ml on 03-NOV-2015 and 25-NOV-2015, respectively. No concomitant therapy was reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
The patient presented to the ED or fever, cough and ostomy evaluation (infection at site?). This vaccinated nursing home patient tested positive for COVID-19. The patient received a 5 day course of remdesivir but no steroids. Maximum O2 flow rate via NC was 2L. IV ceftriaxone, and azithromycin given for possible superimposed bacterial pneumonia Both set of blood cultures grew gram-negative rods (Proteus mirabilis).  Repeat blood cultures done on 5/31/2021 shows no growth.  Completed 7 days course of IV cefepime. Source of bacteremia unclear.  Possible urine versus infected ulceration This is a nursing home resident and he was required to remain hospitalized until testing negative. Patient is stable for discharge.
patient got the first dose of Shingrix on 2019 and the second dose was administered on 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: patient got the first dose of Shingrix on 2019 and the second dose was administered on 2021).  The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date:24-AUG-2023 Pharmacist reported on August 24th 2023 that patient got the first dose of Shingrix on 2019 and the second dose was administered on 2021 (Late dose due to pandemic). Asked Should restart the series. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The health care professional did not have vaccine or patient's identifiers available.
Eight days later a red rash appeared, somewhat itchy, two inches in diameter, about one and one-half inches below injection site.  Injection site is bruised.
3-09-2021-4:30 am,Immobility, felt like I took a muscle relaxer, sever muscle and joint pain, blinding headache, chills, I felt frozen all day. Some diarrhea  and felt severely fatigued. Was unable to work I took a sick day. 3-10-2021 Another sick day still had symptoms.
positive measles infection; Information has been received from the authors of a published article, regarding a 22 year old male patient who was more than four years post-allogenic bone marrow transplant as management for Philadelphia-chromosome positive (Ph+) Pre B-cell Acute Lymphoblastic Leukemia (ALL) in complete remission.  In September 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, dose number, anatomical location, lot number and expiration date were not provided), for prophylaxis.  On an unknown date in 2019 (reported as nine days after receiving the vaccine), the patient presented with a fever of 104 degrees Fahrenheit, itchy throat, and minimal cough. Physical examination showed mild scleral icterus, mild tightness on digits, skin mottling, and erythematous papules and vesicles on dorsal forearms, neck, face, and trunk. The Department of Public Health was contacted and confirmed positive measles infection via polymerase chain reaction (PCR)of urine and throat samples.  The authors stated that the patient, to their knowledge, was the first report of a major adverse reaction in the current era to the measles, mumps, and rubella vaccine post hematopoietic cell transplant.  At the time of reporting, the patient's outcome for measles was unknown. The authors considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)  Upon internal review, measles was determined to be medically significant.
Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA189752 (same reporter). This case involves an eight-years old male patient who was vaccinated with a 0.5 mL Booster dose of QUADRACEL (lot C532BA, expiry date: 14-Nov-2019) intramuscularly in left arm on 02-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that this was patients fourth polio and fourth DTAP dose. No other vaccines were given at the same time. The doctor was aware of this. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none.
Patient was administered his 2nd dose of the Pfizer COVID-19 vaccine 8 days after the 1st dose
Rash & and severe itching on buttocks & back.  Started in November 2020, cleared up in December & came back in January 2021
pt recv vax & post vax during the evening exp a dull h/a, malaise, fatigue & myalgia;sx lasted 3 days & then totally resolved;
Wife reports while on vacation patient experienced tingaling in hands and legs, returned home, follow-up with physician, progressive deterioration, hospitalized Oct. 31. Now in rehab. The discharge summary received on 1/28/04 states Guillain-Barre syndrome, urinary tract infection, urinary retention, hyperglycemia, gastritis, cholecystitis, back pain, and thrombophlebitis.
Red, firm skin at site of injection. Noticed on the 2nd morning after the injection, around 48 hours after dose, but could have potentially been there longer.  Event is still occurring 12 housr after first noticed.
After client received vaccine client states he felt dizzy.  Vitals obtained bp 120/78, pulse 100, O2 sat 97%. Client stated he feels better. Client discharged home.
Breakthrough case admission after 3 vaccines Pfizer 3/22/21 Lot# En6207;  Pfizer 4/12/21 Lot# ER8733;  Pfizer 12/9/21 Lot# 032H21A
This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Doses of (Oka/Merck) VARIVAX lot# K015971, expiry date 23-SEP-2016 or lot# K021485, expiry date 03-NOV-2016 or lot# K026385, expiry date 15-DEC-2016 or lot# L001333, expiry date 13-JAN-2017 or lot# L005299, expiry date 17-FEB-2017 or lot# L015049, expiry date 29-APR-2017 (routes and sites of administration, doses were not reported) which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 24-SEP-2015- the date of the excursion. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient woke up in the middle of the night after getting her shot and reports having severe foot and leg cramping. She got up to stretch and passed out.
Evaluation of arthralgias that began after she received a Pneumovax injection on March 3, the same day she developed some aching and swelling in her left forearm and wrist, and she has developed some aching in both ankles and in the left knee. She thinks there may have been some swelling. She has had no fever or chills. She has had problems with recurrent upper respiratory tract infections. She had recent quantitative immunoglobulins on 2/07/2008, that were normal. A CBC was done on 3/05, which showed a white count of 7200. Her hemoglobin was 12.8. Sedimentation rate was elevated at 35. She was started on prednisone 2 mg b.i.d. at the Clinic. Pt concerned. Probably had localized reaction to the Pneumovax.  Did not improve with taking prednisone.
Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number j95h7, expiry date 22nd May 2022) for prophylaxis.   On 24th May 2022, the patient received Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The patient received expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Swollen, sore and itchy arm, Hospital visit, due to elevated temp, high blood pressure and SOB.
Patient received the injection on May 2nd.  Following the injection, we noticed an increased weakness and general achiness.  On the  8th she was so weak that we purchased a gait belt to assist her.  We were not super concerned as we were expecting the second shot to cause body aches or flu like symptoms based on what we had heard from others who had received both vaccine shots.  She continued to be unsteady and we found that she has a mild UTI which we had begun treating with prescribed antibiotics. Late afternoon on the 11th, mother suffered a major stroke.  we did not take her to the hospital because we had already been told that they would not be able to do anything at her age should she suffer a stroke.  On the 12th I called the doctors office and asked for them to send Hospice to the house as we could tell that she was dying.  Mother died on the 13th.    Just a week prior to her death I had spoken with Dr. and we had discussed how that she was declining in health but that she was not even close to needing Hospice, yet she is dead a week later.  Less than 2 weeks after getting her second Covid Shot.
3 days post injection, woke at 6am with severe body ache, all over. Felt like I had the "flu". Nasal congestion, clear mucus, copious amount.  Chills, feverish but no temp above 98.6, using oral therm. Slept all day, took H2O, hot teas (ginger, peppermint, green). Unable to sweat to break fever.  (My normal treatment if I have 'flu').  Sunday, 2/28, marked increase in nasal and sinus congestion.  Used nebulizer with H2O and peppermint oil x 2 to break sinus congestion.  Up 5 x at noc.  Woke at 5am on Monday, back to sleep.  Woke at 7am  and felt almost back to normal.  My body knows covid19 after this experience.
Nausea and headache started approximately 21:00. Body aches and chills continued through until 12/22/2020 . On 12/22 I vomited at 7:00 and have continued to have low fever of 99.5-100.0 , chills, fatigue, body aches and headache all over.
Got Covid-19 seven months after their first and only dose of Comirnaty; Got Covid-19 seven months after their first and only dose of Comirnaty; Got Covid-19 seven months after their first and only dose of Comirnaty; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191).  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown" and all described as "Got Covid-19 seven months after their first and only dose of Comirnaty". The patient underwent the following laboratory tests and procedures: antibody test: still had antibodies.  Clinical course: Caller states the family member ended up getting an antibody test 6 months after and it showed she still had antibodies. Caller states her family member subsequently got Covid-19 seven months after their first and only dose of Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ARM PAIN, FEVER, NAUSEA, HEADACHE, CHEST PAIN, PALPITATIONS DIZZINESS, FATIGUE, EFFORT INTOLERANCE.  DIAGNOSES:  PLEURODYNIA, POTS, SMALL FIBER NEUROPATHY
Symptoms at injection site after 6-7 days are... redness, a little swelling, and itchy.
Felt tired and developed fever to 101.8 about 12 hrs after Td continued fever and exhausted 12 more hours and then symptoms resolved. Pt was seen by MD on 05/12/2005.
Day after 4th booster had fatigue, nausea, light headedness  lasting for 3 days (5/15-5/17/22).   On 5/28/22, new symptoms began;  increase in allergy symptoms; hoarse voice, sneezing, itchy eyes. On 5/29/22 afternoon, hoarse voice, congestion, headache, fatigue, sinus pain/pressure started. On 5/30/22 , these symptoms (hoarse, fatigue, congestion, sinus pain) all carried on and worsened and a persistent cough began.  Light headedness and brain fog also began.   These  symptoms all continued through 6/3/22. Symptoms started to decrease on 6/4/22.  Symptoms mostly resolved as of 6/7/22.
suspect anaphylaxis; passed out while driving.; entire body itching; vision issue; This is a spontaneous report from a contactable physician. A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular Right arm on 22Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included diabetes mellitus (DM), hypertension (HTN), hypercholesterolaemia. No other vaccine in four weeks. There were other medications in two weeks. No covid prior vaccination. Clinical course reported as: Patient got vaccine with no issues. 36 hours later he developed entire body itching. He then developed vision issues and passed out while driving. He was hospitalized and no cardiac or neurologic issues were found. The reporting physician suspected anaphylaxis since patient had severe itching with the event. There were no other likely triggers found during history other than the vaccine. Events onset date reported as 23Jan2021. Events resulted in Emergency Room Visit and Physician Office Visit. Covid test type post vaccination: Nasal Swab on 06Feb2021 result: Negative. Treatment received for the events. Outcome of events was Recovered/Resolved with Sequel.   Information on the lot/batch number has been requested.; Sender's Comments: A causal relationship between the events suspect anaphylaxis, passed out while driving, entire body itching, and vision issue and suspect product bnt162b2 is possible based on the information provided, drug profile and a temporal association in this 71-year-old male patient. This case will be reassessed should additional information become available.  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.
Initial report was received 08 May/2008 from a health care professional. A five-year-old female patient with no known allergies, had received a subcutaneous right arm injection of YF VAX (lot number not reported) on 02 May 2008 and immediately following vaccination, developed redness at the injection site. The patient was given BENADRYL and approximately one week later, the patient's mother called the physician to report that the injection site became bruised with red raised areas around the injection site that appeared to look like mosquito bites. No further symptoms were reported. The patient had also received an intramuscular injection of THYPHIM Vi vaccine (lot number not reported) during the four week period prior to receipt of YF Vax. No further information was provided at the time of the report. A corrective version was created on 28 May 2008, using the receipt date from the previous version, in order to change the age in the patient screen to five (previously entered as "54"). No other medically significant information has been added to the case. Follow-up information was received 06 June 2008 from a health care professional. The reporter provided the patient's date of birth and corresponding lot numbers for the YF Vax and TYPHIM Vi vaccines received by the patient. The lot number for YF Vax had been UF175AA; and the lot number for TYPHIM Vi had been A0923-3. The site of administration for TYPHIM Vi was reported as "not noted". the patient had been evaluated by nursing staff on 09 May 2008 for the event. Prescribed Treatments included children's BENADRYL and MOTRIN elixir. At the time of the report, the symptoms of injection site redness and bruising had been resolved (date not reported), and two small areas similar to mosquito bites remained. The patient had since departed for international travel and her recovery status was not reported. Follow-up information was received from the health professional on 15 August 2008. The date of TYPHIM Vi administration was 21 April 2008. The patient had moved out of the country with her family for a three-year assignment, and the reporter did not know when the family planned to return. The patient's mother had not contacted the reporter since moving out of the country, and recovery status was unknot.
This is a serious study case, initially received on 03-Apr-2019, concerning a 25-year-old, adult female pregnant subject with weight 106 lbs, height 62 inches and body mass index (BMI) was 19.4, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject's obstetrical history had no previous pregnancies. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's concomitant medication included Vitafol one for healthy pregnancy. The subject's last menstrual period (LMP) date was 18-Aug-2018. The pregnancy type was singleton, with no pregnancy complications. On 06-Oct-2018, at 7 weeks of gestational week, the subject was administered Flu Vaccine Cell Subunit QIV NVD (batch number: 252232, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly coded as vaccine exposure during pregnancy). On 20-Oct-2018, the subject underwent cystic fibrosis mutation analysis which showed no major congenital malformations. On 10-Nov-2018, the subject underwent non-invasive prenatal testing which showed no major congenital malformations. On the same day, the subject also underwent first trimester screening which showed no major congenital malformations. On an unspecified date, the subject experienced urinary tract infection. The subject was treated with Macrobid (dose: 100 mg, twice daily via oral route from 05-Jan-2019 to 12-Jan-2019 and from 02-Feb-2019 to 09-Feb-2019) for urinary tract infection. On 15-Feb-2019, 4 months and 9 days after vaccination, the subject underwent fetal echocardiography which showed minimal tricuspid regurgitation and pulmonary insufficiency. The outcome of the event urinary tract infection was not reported. The subject's estimated date of delivery was reported as 25-May-2019.; Reporter's Comments: A 25-year-old pregnant subject experienced urinary tract infection, on an unspecified day after administration of study vaccine at 07 weeks of gestation (coded to Exposure during pregnancy). Considering the inactivated nature of the suspect vaccine and infectious aetiology of the reported event (suspected bacterial), increased risk of urinary tract infection in pregnancy, the causal role of study vaccine was assessed as not related. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Swelling and redness at site of injection infrequent, light itching, slightly warmer than surrounding area.
Headache; Nausea; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot Number: Er8727) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto, depression and allergy to shellfish. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, the patient experienced headache, nausea, feeling unwell and fever on that night but no fever at the time of the report. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department, or urgent care. The clinical outcome of the events headache, nausea and feeling unwell was resolving while the outcome of fever was resolved on an unknown day in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient presented to hospital on 9/29/2021 for frequent urination and burning with urination. He was found to have a fever. He was recently in the emergency room on 9/11/2021 and from 9/12/2021 to 9/15/2021 for E. coli urinary tract infection and bacteremia following a biopsy of the prostate. He remained asymptomatic for COVID-19 during admission.