chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of the [lips, face], tongue; Swelling of the [lips], face, [tongue]; Swelling of the lips, [face, tongue]; Arm swelling; Small amount of itching; A few 'whelps'; This is a spontaneous case initially received from other health professional (nurse) via Communications (reference number: SEQ19-03769) on 02-Oct-2019, concerning a 60-year-old, female patient.   The patient's current medical condition included egg, beef and shellfish allergy.   The patient's concomitant medications were not provided.  On 02-Oct-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscularly, batch number and expiration date: not provided] for an influenza prophylaxis.  On the same day, two hours after vaccination (reported at 6 pm), the patient experienced a small amount of itching and a few whelps' (as reported). The patient took a cold shower.  On 03-Oct-2019, at 12:30 am, the patient woke up with drooling and arm swelling. The patient also experienced swelling of the lips, face and tongue. Due to tongue swelling, the patient bit her tongue badly. The patient did not have any breathing or swallowing problems.   At the time of initial reporting, all events were resolving.    The case was assessed as serious and reporter did not provide causality assessment.; Sender's Comments: The patient experienced swollen tongue, swelling face, lip swelling, urticaria, peripheral swelling and pruritus after administration of the suspect product Flucelvax QIV. Chronology is plausible. Medical history of multiple food allergies may have contributed to development of the events. No concomitant medications were reported. Based on provided information, causal role of the suspect product is assessed as related for the events.
Had all common side effects i.e. fever, chills, body aches, but also had an elevated heart rate above 100 bps. All side effects lasted for around 15 hours
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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 was waiting in lobby after vaccine. After about 10 minutes her husband, who had been standing by her, called for help. She was pale, dizzy, and lightheaded. Husband and pharmacist worked to get her to the floor during which she passed out. 911 was called by pharmacy staff. She quickly came to and reported ringing in the ear and feeling warm.  She had a sip of water She slowly got better and EMS arrived and  took over. She left with EMS.
Acute DVT of the left lower extremity extending from the proximal femoral vein and proximal deep femoral vein to the popliteal vein and into the gastrocnemius veins.
he has a cold; This is a spontaneous report received from contactable reporter (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 57 year-old male patient received tofacitinib citrate (XELJANZ XR), oral since 03Nov2021 (ongoing) (Batch/Lot number: unknown) at 11 mg 1x/day for rheumatoid arthritis; COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "he has a cold". The action taken for tofacitinib citrate was dosage not changed. Additional information: The patient reports he has a cold. He had his coronavirus vaccine and booster so he thinks it is just a cold. He called his doctor for appointment regarding cold symptoms. He is scheduled for surgery on Thursday, (unknown-patient stated it is not related to arthritis) no additional information or specific symptoms were provided. MD aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low grade fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Pt recvd 1st dose of Hep B vax & later devel Bell's Palsy. Tx w/unspecified steroids.
Info has been recvd from a literature article titled Invasive pneumococcal infections in pediatric cardiac transplant patients concerning an over 2-year-old female pt who recvd vax at 19 mos of age. Subsequently, the pt developed an infection (pneumococcal bacteremia). Upon internal review, the pt's infection was considered to be an other important medical event. F/U states: The pt also developed otitis media with the 1st episode. It was noticed that both isolates were susceptible to penicillin and ceftriaxone. The pt was not taking prophylaxis at the time of either infection. It was noted that this information was received from medical records of all cardiac transplant pts receiving their care at a hospital from 3/90 to 11/00 that were reviewed for cases of invasive bacterial infections caused by S. pneumonia that occurred after transplantation. The pts involved developed pneumococcal bacteremia. The risk factors for the development of invasive pneumococcal disease included African-American race, transplantation at age less than 12 years and having idiopathic cardiomyopathy as the indication for transplantation. It was noted that the 1st infection occurred at median age of 30 months post/transplant (range 3 to 48 months). Fever over 101F was the presenting sign/symptom in 75% of cases. Other clinical presentations included pneumonia, otitis media and petechia/purpura. In 25% of episodes pts had received a course of oral antimicrobial therapy within 30 days before their invasive disease. All pts were taking immunosuppressive medications at the time of infection including cyclosporin, axathioprine, systemic corticosteroids and mycophenolate mofetil. It was also noted that 3 other pts were vaccinated with 1 dose of pneumoncoccal vaccine 23 polyvalent and developed similiar events (WAES01102590, 01104801 and 01104802). No further information is available. This is a consolidation of 2 reports concerning the same pt. It has been determined that WAES01104802 is a duplicate of WAES01104800. Therefore, WAES01104802 is being deleted from our files and the reports consolidated into 01104800. WAES01104802 was previously submitted to the FDA on 11/1/01.
Pimple like rash all over body (was not present on feet, hands, ears, or lips), it was not itchy; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 02Sep2021 at 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish, bee venom and mild latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included black elderberry gummies (NATURE'S TRUTH) for an unspecified indication from an unknown date and unknown if ongoing. On 03Sep2021 at 07:00, the patient experienced pimple like rash all over her body (was not present on feet, hands, ears, or lips) and it was not itchy. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pimple like rash all over body (was not present on feet, hands, ears, or lips), it was not itchy was resolving at the time of the report.    No follow-up attempts are possible. No further information is expected.
Patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (First dose) on 28-Apr-2021 and Pfizer vaccine (Second dose) on 19-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Face felt tingly and a bit numb, puffy, but it wasn't visually puffy.
Medical assistant obtained pediatric Pfizer formulation for patient. Patient was contacted after realization of event and revaccinated with 12+ yo Pfizer formulation on the same day. Patient responded well post-vaccination in monitoring for both vaccine administrations.
5 hours after MMR immunization, hives head to toe. 10-12 hours after immunization, neck felt swollen (ant) and cough. Took Benadryl with good relief of throat/neck/cough symptoms and decreased hives.
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 12-year-old patient (sex not reported) received the following injections on an unknown date (route, site, manufacturers and lot numbers not reported): DTaP, MENINGOCOCCAL VACCINE and Hep A. The patient was healthy. On an unknown date the patient developed chronic inflammatory demyelinating polyneuropathy <21 days after vaccination. The causality was reported as possible. The outcome was not reported. Documents held by sender: None.
Pain in liver area; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up). At the time of the report, HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jan-2021 and was forwarded to Moderna on 12-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up). At the time of the report, HEPATIC PAIN (Pain in liver area) and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed chicken pox lesions starting 04/16/2003.  Had only a few, possible slight fever.  Lesions were scabbed over and healing by 04/21/2003.  Light case.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was vaccinated at pharmacy on 2/9/2021, first dose of Moderna COVID-19 vaccine.  Per medical records from hospital: patient developed fever, diarrhea, nausea and abdominal pain on 2/25/2021 and presented to the hospital E.R. on 3/1/2021. Patient was diagnosed with Sepsis and Pneumonia. Cardiac arrest on 3/6/21, renal failure, seizures. Patient tested negative for COVID-19 on 3/1/2021 and 3/8/2021. Patient has declined, was placed intubated and placed on a ventilator. Patient admitted to hospice services on 3/8/2021 and plan is for compassionate removal of life support at hospice. Prognosis is poor.
Case number PHEH2014US019247, is an initial spontaneous report from a pharmacist received on 23 SEP 2014. This report refers to a 77-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) intramuscularly into left arm below the deltoid side on an unknown date. On 12 SEP 2014, the patient experienced bruise on her arm at the injection site. It was reported that the event was not getting worse but was not healing (at the time of this report). Seriousness and causality of the event was not reported.
RED RASH AROUND INJECTION SITE (RASH EXACTLY MATCHES THE ADHESIVE PORTION OF THE BARRIER BANDAGE USED) NERVOUS HEADACHE DOESN'T FEEL GOOD
27MAR2023 I went to my OBGYN. I went to for what is designated as a non stress test, my blood pressure was high with a headache and I had floaters in my eye while in the hospital. My liver enzymes were high, they were elevated so that I was required to deliver my child the next days with a scheduled C section. The delivery weight of three pound fifteen ounces. Estimated date of delivery MAY2023.
She had a syncopy.  She was sitting on the chair after vaccination.  I checked her about 5 mins later, sitting still but her eyes were closed and her phone was on the floor.  I went out and asked her how are you feeling?   she said, she is a bit dizzy and I always have a very low BP.  i do have sometime get dizzy... I asked her whether she wanted to lay on the floor.  She said yes.   She was alert and answered all my questions; she did not want any Eip Pen or Meds.  Her BP at the time was 80-50.  Then, She said I am feeling better now and wanted to get up.  I told her we should have the EMT and have a doctor to check her out.  So, EMT came and carried her out.  About 1 hour later, she called me and she was released from EMT and going home.
Allergic rash rxn. Administered benadryl to patient. Observed for 15 mins; rash began to improve. Patient was then released from observation to attend scheduled doctor appointment.
Right deltoid muscle pain, erythema, swelling, reduced arm range of motion. Fever to 101.4. Intermittent nausea. Took acetaminophen, applied ice.  Antihistamines recommended.
vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was administered after 7 days of first puncture of vial. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant FU added.
IM vaccination of BOOSTRIX TDAP on 6/3/15 adverse reaction reported by pt on 6/10/15. Pt states arm sore hard lump on deltoid area of LA. No redness or sign of inf. NSAIDS and ice and f/u if does not resolved or worsens.
REDNESS AND SWELLING STARTING AT VACCINE SITE IN RIGHT DELTOID DOWN TO ELBOW
Child with leg swelling from ankle to hip with severe rash and refusal to walk on leg. Symptoms began 36 hours after MMR vaccine. Majority of lesions were at the injection site.
Information has been received from a registered nurse concerning a female who on Jul 09 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 648139/009P), intramuscularly in the left upper arm. Subsequently, on Jul 10 2004, the patient developed redness, warmth, soreness, raised area at injection site and discomfort at injection site. the patient recommended ice and ibuprofen (Motrin) for treatment. The patient recovered. No product quality complaint involved. no further complaints were reported. Additional information is not expected.
pt recv vax 25APR95, that noc got fever; next day got rash on face which then spread to body; fever lasted 3 days; no emesis, diarrhea; little cough 25APR95 only; on PE appeared to be roseola;
10cm area of redness around area of the head/arms/back/chest/legs with eruption of acneoform pustules.
This spontaneous report as received from an unspecified reporter via a field representative refers to a 16 year old male patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported. On 12-FEB-2018, the patient was vaccinated with the third dose of GARDASIL 9 (lot # N019103, expiry date: 12-FEB-2019) for prophylaxis. Dosing details and route were not reported. On 12-FEB-2018, immediately after administration of the vaccine the patient became lightheaded, pale and dizzy and vomited right after administration. The patient was still at the office at the time of the events and was treated with ZOFRAN. It was reported that the patient vomited 3-4 times throughout the night. The patient's current status was unknown. The outcome of the events was unknown. Product quality complaint was not involved. Causality assessment was not provided by the reporter.
Patient reported that she developed a slight case of shingles approximately 4 weeks after receiving SHINGRIX dose #1. She stated she contacted her physician and was prescribed a course of "an antiviral".
Fever of 100.7 Fatigue Chills Headache  Tiredness
The day after the flu vaccination, patient experienced a 2 1/2 to 3 inch red circle with itching around the injection site. Both itching and redness were resolving within 48 hours.