chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cerebral edema; diarrhea; fatigue; nausea; vomiting; This is a spontaneous report from a contactable pharmacist. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly administered in left deltoid on 18Apr2021 (at age of 52 years old, Lot Number: EW0161) as single dose for covid-19 immunization. Medical history included hypertension, hyperlipidaemia, depression, anxiety. Concomitant medications included amlodipine, baclofen. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 28Mar2021 (at age of 52 years old) as single dose for covid-19 immunization. The patient not took any other vaccine. The patient took some medication (prescribed regularly) for there disease state prior to the event being reported. No allergies reported. Pharmacist stated, "Cerebral edema following within less than 24 hours of the second dose of vaccine. There was no anaphylactic reaction reported. The patient had fatigue, nausea, vomiting, diarrhea. Patient enter ER and was now requiring ICU level of care, intubated for respiratory support. They came in overnight emergency, they do have lab. He had done a whole work up he came in to the ICU. Pharmacist stated, "He did not take anything and ended up into the hospital. So they are requiring antibiotic and they also require intubation. So he needs to be intubated for respiratory support. Duration of stay was undefined and they arrived to the ER at 9:11 AM today (19Apr2021) this morning. That is the time of admission. Before 19, today's date. The events required the initiation of new medication or other treatment or procedure. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Cerebral edema and other reported events  due to temporal relationship.  However, the reported event of Cerebral edema may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Hives on face, neck,abdomen, arms, and feets. Took Benadryl 50mg by mouth. 15 to 20 minutes later hives gone.
severe h/a x 2 days beginning @ the base of neck;unusual tightness & aches in base of neck & radiated to shoulders x 4 days;
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, oral, ROTATEQ of lot # K006458, expiry date 24-FEB-2016 and lot number K006805, with expiry date 24-MAR-2016 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored ROTATEQ, oral. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. Additional information has been requested.
tingling in hands and arms/tingling came back up the arm and up head; hand got cold; itchiness at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), VACCINATION SITE PRURITUS (itchiness at the injection site), PARAESTHESIA (tingling in hands and arms/tingling came back up the arm and up head) and PERIPHERAL COLDNESS (hand got cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced AXILLARY PAIN (sore arm).   On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site).   On 10-Feb-2021, the patient experienced PARAESTHESIA (tingling in hands and arms/tingling came back up the arm and up head) and PERIPHERAL COLDNESS (hand got cold).   The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   On 06-Feb-2021, VACCINATION SITE PRURITUS (itchiness at the injection site) had resolved. At the time of the report, AXILLARY PAIN (sore arm) and PERIPHERAL COLDNESS (hand got cold) outcome was unknown and PARAESTHESIA (tingling in hands and arms/tingling came back up the arm and up head) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
On 01/26/2001 the patient was seen in the office and diagnosed with chicken pox. The patient presented with an itchy, maculopapular rash on the face, hands, back and stomach with a slight fever. The reporter noted that on the day of the original vaccination, the patient had received no other vaccinations. Additional information has been requested.
Shortness of breath with wheezing.  Required 3 nebulizer treatments, prednisone, and Benadryl.
Wound infection. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
ASYMPTOMATIC - PT WAS IN THE HOSPITAL FOR SMALL BOWEL OBSTRUCTION AND TESTED POSITIVE FOR COVID. HISTORY OF COVID 11/30/2020
Tightness in throat, tightness in chest patient took Benadryl when got home.
Patient began to have hives in the afternoon/evening after receiving second dose of Moderna Covid-19 vaccine (received vaccine in the morning). Patient took OTC Benadryl and woke up 01APR2021 (dose received 30MAR2021) with more hives on trunk, both front and back. Patient came into medical morning of 01APR2021 to be evaluated by provider. Provider encouraged continued Benadryl as needed for comfort and to follow up next week should symptoms persist.
had the shots. Still got shingles/suspected vaccination failure; shingles/Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's aunt) had the shots and guess what, still got shingles, that's why people were laughing. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
cold, shivering, can't get warm, headache, fatigue, arm much sorer then previous two vaccines
Approximately 2 hours after vaccine, I started seeing flashes of light in my left eye, which continued and became worse through the evening with an increase of floaters in my left eye.  This morning I only saw the lights a couple of times but more floaters.
headache; fatigue; Myalgia; muscle pain; Diarrhea; shortness of breath; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), VACCINATION SITE RASH (rash at the injection site), HEADACHE (headache) and FATIGUE (fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (Myalgia) and MYALGIA (muscle pain). At the time of the report, DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), VACCINATION SITE RASH (rash at the injection site), HEADACHE (headache), FATIGUE (fatigue), MYALGIA (Myalgia) and MYALGIA (muscle pain) outcome was unknown.            Treatment drugs were not provided concomitant drugs were not provided
Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely resolved independently on days 4 and 5. On day 6, developed significant welt-like hives, intense burning and itching, and numbness/tingling of entire extremity. Also developed a non-pruritic, flat, diffuse, pinpoint rash to the trunk. Rash and itching resolved with Benadryl. Right upper extremity burning, pain, and numbness persist.
Flublok Quad, which is indicated for ages 18 and older, was administered to a 13 year old.  No adverse effects were reported.
Patient reports extreme dizziness. Unable to stand and walk without feeling lightheaded. Patient was given cold compress, snack and laid on a stretcher for approx 1 hour. Able to leave and drive home on her own.
Extreme chills, moderate muscle aches in arms and legs, weakness in legs, periods of fever of 100.8 degrees Fahrenheit.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with PEDVAXHIB (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 034405, 012M20A and 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-656385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656385:(sons case)
Patient was given a Pfizer Pediatric Covid-19 Vaccine for 5-11 years of age. Patient is 15 years old. Patient stayed for observation and there were no signs or symptoms of distress.
devel dizziness, confusion, fatigue 17OCT98 w/progressive weakness & some paresthesia;hosp;dx GBS;
administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The patient received vaccine which was already expired on 30th June 2021. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207378:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021206979:same reporter
Ashen facial color; diaphoresis; transient stiffness of extremities w/blank stare; occurred immed following vaxs.
Patient developed and experiencing neurological symptoms involuntary tremors, patient is experiencing these tremors on a daily basis of the entire body, not being able to stop tremors of legs all the way up her entire body,  postural and intention tremor of limbs.
Patient received third IPV on 5-10-13. Felt lightheaded, nauseous, numbness in (L) arm and weakness. Sent to ED via ambulance per mom request for evaluation. Sent home. Followed up with PCP in 5-13-13.
Patient pre-treated prior to vaccine as directed to by PCP. She stated that she took 2 zytrec tablets and one pepcid the morning of 2-26-2021; and one hour prior to vaccination health care administered 50mg diphenhydramine intramuscular in her right deltoid at 0915. This was also per her PCP instructions.  COVID Moderna vaccine administered at 1016.  After about 15 minutes she had chest tightness and tongue swelling. We continued to monitor patient, and she said she felt like it was getting harder to breathe and swallow. AT 1046 Epipen auto injector was administered in her right thigh and EMS was called. 1051 pulse was 79, O2 was 99% and she said her tongue was not as swollen.  Follow up BP was 125/70 and pulse 80, and O2 was 99%. at 1104, pulse was 72 and O2 was 98.  1106 EMS arrived to evaluate patient. She was feeling better and declined to go to hospital with EMS. She signed refusal and said she was feeling much better at 1114. 1128 patient left with husband, we advised to seek ER treatment if any further symptoms developed.  She had a personal EpiPen autoinjector to use at home if she needs it. She verbalized understanding and left our office at that time.
Client called on 1/30/02 at 14:15, to report that she had 6 "red, blotchy, hive-like, raised whelps" on right arm where vaccine was given. The largest is 1"-2" in diameter and the other 5 were 1/2" in diameter. She states the area does not itch, nor are they sore. She first noticed areas at 19:00 on 1/30/02. She has not gone to MD and don't plan to since they're not causing trouble. Called us to let us know since she didn't see this as a reaction on the form we gave her. States she doesn't have this rash anywhere else on her body.
Information has been received from a medical assistant concerning a 14 year old female patient who on 23-APR-2008 was vaccinated with the first dose of GARDASIL, on 23-JUN-2008 she received the second dose of GARDASIL and on 22-OCT-2008 the patient received the third dose of GARDASIL 0.5 ml, I.M. in right deltoid.  The medical assistant reported that after the third dose of HPV vaccine, the patient developed an injection site reaction.  The patient experienced pain at the injection site and massaged the area that evening.  The patient still had what was described as "BB size hard knot" at the injection site with discomfort.  At the time of the report, the patient had no recovered.  The patient sought medical attention at the office.  Additional information has been requested. Follow up information has been received on 12-FEB-2009 from a health care professional who reported that the patient is a 14 year old female student who no known allergies or pertinent medical history (Weight 125 lb and heighth 62 in). On 22-OCT-2008 was vaccinated intramuscularly into her left deltoid with 0.5 ml of the third dose of GARDASIL (Lot# 660359/1968U). There was no concomitant medication. On 04-NOV-2008 the patient developed a small bb size hard knot at the injectio site. Sore to touch. On an unspecified date the patient recovered. There was no illness at the time of vaccination. In further follow-up received from the health care professional and medical records, it was reported that on 04-NOV-2008, the patient complained of a knot still on the arm. No further information is available. All available medical records will be provided upon request.
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4327434-00.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter's causality with humira (adalimumab) for the event of Rheumatoid Arthritis flare up was not provided and probable reported with Pfizer Biontech COVID-19 Vaccine (tozinameran).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event RHEUMATOID ARTHRITIS and BNT162B2. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt had covid vaccine at 1657 today. She was observed for 15 min in post observation as she did not report ever having a severe allergic reaction to anything and ambulated to her car. She states when she arrived at her car she took off her mask and realized her cheeks were flushed and she had mild bilateral tingling of her cheeks. She returned to observation area at 1720. VS taken and stable. She states that she used to get allergy shots and would have this same reaction, but never with a vaccination. At 1740 she states the tingling resolved as well as cheek flushing. Pt drank 24 oz of juice prior to ambulated with steady gait out of building.
Headache; Chills; Swollen lymph node; exhaustion; fever; vomiting; This is a spontaneous report from a contactable consumer reported for self. This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 08Jan2021 09:30 AM at single dose in right arm at nursing home/senior living facility for COVID-19 immunization. The patient is not pregnant. The patient medical history included known allergies: milk products, Crohn's disease. The patient did not have COVID prior vaccination. The patient concomitant mediations included bupropion hydrochloride (WELLBUTRIN XL), hydroxyzine. The patient did not receive vaccine in four weeks. The patient experienced headache, chills, swollen lymph node, exhaustion, fever, vomiting in Jan2021. The onset date of events was reported as "01Jan2021". The events were reported as non-serious by reporter. The patient did not test COVID post vaccination. The patient did not receive treatment. The outcome of events was not resolved.   Information about lot/batch number has been requested.
patient developed redness, warmth and swelling at the injection site of Proquad vaccine.  additionally had muscle aches that persisted for 3 days. mother administer Benedryl, tylenol and Motrin for pain/swelling at the site and used ice for pain relief.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (lot numbers and expirations dates were not known). At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced decreased therapeutic response described as low hepatitis B titers (values not specified). No additional information was known. The reporter was unsure if the patient received Engerix-B or another companies vaccine.
On 8-8-15 (approximately 60 hrs after vaccines), he suddenly became hypothermic (94.9 F in ER), lethargic/altered mental status, and hypoglycemic. Full sepsis/encephalitis work-up completed (CBC with diff, CMP, blood culture, CRP, U/A, Lumbar puncture with CSF studies, head CT, CXR and drug screen completed. (Glucose=40). Life-flighted to hospital-admitted to PICU.