chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 52y.o. male with a medical history of multiple sclerosis on a previous who presented to the emergency department for urinary/stool incontinence, diarrhea, and weakness. Patient was found to be positive for cold 19. This is his second infection with his previous infection being roughly one year ago. The patient had generalized weakness and was evaluated by neurology with suspicion for Uthoff phenomenon as cause of weakness. Patient was also evalauted by infectious disease and was treated with monoclonal antibodies. Patient remained on room air and had significant improvement in symptoms. He was stable for discharge and will require close outpatient follow-up with PCP and neurology.
The following day after receiving the vaccine, I experienced a tightness in my chest that has been on going.  3 Days after vaccine I experienced fever, sore throat, chills, extreme fatigue, and cough.  I am breast feeding an infant and the infant also began to experience same symptoms of illness. On the 8th day after receiving the vaccine, I discovered a large, swollen, itchy and painful rash at the injection site.
Severe Chills, Acute Headache, Joint and Muscle Pain, Temp of 101.4, Nausea, Fatigue
Chills; Body hurts; Running fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), MYALGIA (Body hurts) and PYREXIA (Running fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), MYALGIA (Body hurts) and PYREXIA (Running fever). At the time of the report, CHILLS (Chills), MYALGIA (Body hurts) and PYREXIA (Running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Patient did not experience any symptoms during the temperature excursion; COVID-19 Test postive on 14-Jan-2022; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 Test postive on 14-Jan-2022), DRUG INEFFECTIVE (Lack of drug effect) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient did not experience any symptoms during the temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Shellfish allergy (Shrimp).   On 24-Dec-2020 at 1:34 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Jan-2021 at 6:22 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Jan-2022, the patient experienced COVID-19 (COVID-19 Test postive on 14-Jan-2022) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient did not experience any symptoms during the temperature excursion). At the time of the report, COVID-19 (COVID-19 Test postive on 14-Jan-2022), DRUG INEFFECTIVE (Lack of drug effect) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient did not experience any symptoms during the temperature excursion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (COVID-19 Test postive on 14-Jan-2022) to be not related. No further causality assessments were provided for DRUG INEFFECTIVE (Lack of drug effect) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient did not experience any symptoms during the temperature excursion).    No Concomitant Medications were provided by the Reporter. No Treatment Medications were provided by the Reporter.  Company Comment: This spontaneous case concerns a 30-year-old female patient, with no relevant medical history, who experienced the unexpected events of COVID-19 (AESI) and Drug ineffective. The events occurred approximately 1 year after receiving the second dose of mRNA-1273 Vaccine. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-504756 (Patient Link).; Sender's Comments: This spontaneous case concerns a 30-year-old female patient, with no relevant medical history, who experienced the unexpected events of COVID-19 (AESI) and Drug ineffective. The events occurred approximately 1 year after receiving the second dose of mRNA-1273 Vaccine. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
At 1052am post Vaccination during observation patient notified nurses of irritation/itching of the tongue. Vital signs initiated at 10:58am, patient requested Benadryl.   Patient stated that she carries her own Benadryl, frequently taken prior to food intake. Patient was provided Benadryl from the site as  requested. Nurses ensured airways were potent. Three sets of vital signs were taken and within her normal range.  At 11:45am patient states that she felt better and that she no longer felt any discomfort or irritation in her tongue. Patient stated, "She feels comfortable walking home." Patient was educated on if any adverse reaction occurs to seek medical attention. Patient left the site in stable condition with no physical or apparent distress.
Information has been received from a pharmacist concerning a 67 year old female with no drug allergies who on 03-MAR-2009 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot #663673/1710X). On 03-MAR-2009 the patient developed an injection site reaction after vaccination with ZOSTAVAX (Merck). The reaction was manifest as a red area of about 2 inches by 2 inches. The area was raised, hot to touch and the patient also had chills. As of 06-MAR-2009, the patient was recovering. The patient called pharmacist for medical attention. Additional information has been requested.
she felt a little sore in the part of her arm where the vaccine was injected.; This is a spontaneous report from a consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 31Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 as a single dose for covid-19 immunization. The patient had the 2nd dose on 31Mar2021 and she felt a little sore in the part of her arm where the vaccine was injected. She has more than the usual 21 days interval scheduled date of doses. She also stated that one doctor told her friend not to get the Covid-19 Vaccine because it causes liver cancer and other cancers. So, she was asking if does the doctor have the right to tell other people not to get the Covid-19 Vaccine. She also shared that one of the Doctors in Walgreens agreed with her that a doctor does not have any right to tell something like that especially if the doctor does not know the person or the patient very well. There were some unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
first 24 hours 10/13 extreme fatigue, aches, headache, chills, weakness; seemed to recover next day 10/14; subsequently tiredness ;lack of energy; seem to get winded easily with little activity;
Myalgia, NauseaVomiting, Site swelling and soreness, Tiredness Narrative:
Information has been received from a physician concerning a 5-year-old female with Ventricular septal defect and cerebral palsy who on 04-SEP-2007 (in the AM) was vaccinated intramuscular in the right thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658178/1013U). Concomitant therapy included a dose of Havrix (manufacturer unspecified). There were no illnesses at the time of vaccination. On 05-SEP-2007, post vaccination, the patient developed on her right leg at the injection site large big bullous 2.5 X 2.5 cm (size of a small donut), with small bullae surrounding (previously described as "with blisters around it") that was fluid filled. There was also a large area of redness and warmth 5 X 5 cm also present at the site of injection and the patient experienced leg pain. The patient was referred to an infectious disease doctor for follow-up. On 06-SEP-2007, anaerobic and aerobic cultures of the bullous fluid were cultured and drained the results showed no growth. The patient was being treated with Clomacin. On the 10-Sep-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Hand/arm and foot/calf tingling which has continued from the time of vaccination to date; period of lapsing into unresponsiveness including while in the emergency room the evening following the vaccination.
Information has been received from a physician concerning a 11 week male with gastrointestinal reflux disease and no known allergies who on 30-JAN-2007 was vaccinated with the first dose of Rotateq (Lot # 656102/1165F). Concomitant therapy included Prevnar, Comvax and PREVACID. On 15-FEB-2007 (several weeks after receiving first dose), the patient experienced bloody stool, and was irritable and lethargic. The patient had bloody stools for two days. The patient was taken to an emergency room but later was released. A KUB X-ray and abdominal ultrasound were performed (results were not provided). On 17-FEB-2007, the patient recovered from bloody stool, irritable and lethargic. Upon internal review, bloody stool was considered an other important medical event. There was no product quality complaint involved. Additional information has been requested.
On 05/17/2021 patient presented to the emergency department with elevated WBC, lethargy, hypoxia, and increased cough. He was admitted to the health unit on April 26 with dementia. He was diagnosed with aspiration pneumonia on May 11 and has been  taking Augmentin by mouth.  He seemingly was doing much better until 05/16/2021 when his oral intake decreased and his level of consciousness also decreased. He was admitted to hospice on 05/17/2021. Date of death 05/20/2021
Patient had preterm rupture of membranes at 10:30 pm on the same day the vaccine was administered.  She was preterm (35 3/7 wks) and weighed 1860. Mom has a history of IUGR with her first pregnancy. 11/10/09:  Hospital Labor and Delivery Records and Prenatal records received for date of service 11/5/09. Dx:  Premature delivery  Assessment:  Gravida 3 Para 1 at 35 3/7 weeks EGA presented to L&D with premature rupture of membranes on date of H1N1 vaccine administration.  Baby had reassuring HR during labor.  Apgar scores were 8 and 9 at 1 and 5 minutes respectively.  Birth weight was 1860 gms.  Placenta with 3 vessel cord.  Estimated blood loss 100 ml.  Abnormal placenta sent to pathology.   11/9/09 Medical records received for dates 11/4/09 OB records. 35wks exam WNL. c/o back pain lying down. FHR 140's.
Patient describes left shoulder where the injection site was along with itchiness, big red rash but has not spread or gotten larger
Patient was shaking violently for less than 20 seconds accompanied by pallor & diaphoresis. No loss of consciousness.  7/14/09 Records rec'd from PCP.  In for WCC and vax on 6/23/09. After leaving office, parent noted child to be pale with extremity shaking. No LOC.  Returned to office. Noted to be pale. VSS. Assessment:  ? brief seizure
Tested positive for covid-19 the week after first dose; A spontaneous report was received from a (Reporter like HCP ) concerning a41  Years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  the following week became symptomatic to covid-19. The patient's medical history was not provided. No relevant concomitant medications were reported.    On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) intramuscularly  for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient felt covid-19 symptomatic. now she is afebrile, still has a cough and mild flue  like symptoms.  Laboratory details was not  provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event  became symptomatic to covid-19 is considered as unknown.  The patient is due for their second dose on 3-feb-2021
EXPOSE TO CHICKEN POX AT DAYCARE. WOKE UP ON 2/13 WITH A FEW SAMLL BUMPS ON HEAD AND UPPER CHEST, AS DAY WENT ON MORE BUMPS APPEARED THEY BECAME LARGER AND HAD RAISED WHITE HEADS.  HE CAME DOWN WITH A FEVER, WITH MORE BUMPS NEXT FEW DAYS. WHITEHEADS ERUPTED 6 DAYS LATER AND FEVER BROKE.  SUPPORTIVE CARE AT HOME ADMINISTERED.
Fever 2nd day of 101.8, went down and up over next 3 days. Chills, no appetite, very sore arm, fatigued for 3-4 days
Within 8hrs of vaccination, extreme chills, joint aches, dizzyness migraine headache, and fever lasting throughout the night into early morning of 5/09/2021, fever lasted into evening of 05/09/2021.  As of 05/10/2021 still have periodic migraine headaches and dizzy spells.
on 1/8/2021 I woke up about 6 am and was extremely dizzy and my legs felt like noodles.  Dizzy throughout the day.  Every morning for two weeks was like I had vertigo.  It is getting less and less but definitely still there.  Frequent Headaches as well I also experienced low sugars for 5 days, could not get my sugar above 80-100.  even eating with out blousing for the carbs that I ate.  That is better now.
pt recv vax 14NOV94 & 23JAN95 pt devel muscle aches & a fever of 102;pt was seen by nurse practitioner & tx w/Darvon;30JAN95 consulted the NP again stating that sx had not resolved & that devel a cough
Got shot yrs ago, had 2 break outs, Suspected vaccination Failure; 2 break outs; Itches; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot yrs ago, had 2 break outs, Suspected vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: 2 break outs) and pruritus (Verbatim: Itches).  The patient was treated with tocopherol (Vitamin E Cream). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient via interactive digital media. The reporter reported that he or she got shot several years ago and he or she had two break outs. One last year and one the other day.  The patient stated that mine really itches.  The patient got medication from doctor the first time, it made his or her blood sugar go way up, put vitamin E cream on it this time.  It was helped a little, did not get it bad either time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test, confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Shaking head, unresponsive, non verbal, hand flapping...Happened 4-5 times until 12 days past vaccine.
Tingle and numb in left arm where I got shot.; Tingle and numb in left arm where I got shot.; This is a spontaneous case received from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 14:30 (age at vaccination 37-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks were reported as none. On 25Feb2021, the patient experienced tingle and numb in left arm. The patient did not receive any treatment for the event. The patient did not had any vaccination prior to COVID vaccination and had not tested positive  after vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
The patient experiences tingling and numbness along with sharp pains in upper left arm. She also experienced swelling at the site of the injection. She now has nerve damage in the area of the injection. The site of the shot is still sore and has lumps beneath the skin.
Patient developed hives 7 days after injection which continued to recur for several months and was treated with antihistamines and topical steroids.
Whole body soreness, soreness at site of injection, fatigue, headache, body sweats, low grade fever. It lasted intensely for 48 hours and started to diminish. After a total of 60 hours, I began to feel like my usual self. I ended up taking 2 days off from work.
Within a day or so after receiving the vaccine, her left arm became swollen and painful. There was a hard, round lump at the vaccine administration site. As weeks went by, the arm became increasingly painful to the extent that she could no longer sleep on her left side. The pain radiated up her shoulder. About one-year later, she developed an occasional shakiness in her left arm and subsequently developed a shakiness in her left leg, though pain-free & not as shaky as her arm. Her left leg soon began to drag; and she became chronically fatigued. All of this occurred over the course of around two years. While the above symptoms are classic symptoms of Parkinson's, it took nearly two years for her to receive a Parkinson's diagnosis. Her primary care physician wouldn't so much as entertain the possibility that the flu vaccine could bring on these symptoms, stating that "There is more Mercury in a can of tuna than in a vaccine;" and the neurologist who ultimately provided the P.D. diagnosis told her that the vaccine was merely the "red herring," and could not have resulted in her illness.
At 1130 pt reported feeling anxious.  OxSat 94%, HR 55, BP 94/58, sweaty, clammy, At1142 Spoke to father, informed him of reaction and treatment.  Parent verbalized understanding.  @1157 BP 110/68, HR 65, OxSat 98%
Seasonal Influenza vaccine administered through student health via a third party Received injection at 1050 on 19 October 2022. Late night on 19 October experienced vomiting  and went to sleep with nausea. Early morning on 20 October I awoke to full-body itching, which felt identical to my allergic reaction to amoxicillin from 2018. Promptly broke out in cheetah-spot-shaped rashes on arms, inner legs, chest, stomach, feeling like I would claw my skin off. Drove to UC where I was administered Benadryl and Pepcid and given a script for a topical steroid and prednisone if symptoms did not improve. Also took ceterizine later that day to further reduce itching. Symptoms were gone by evening and have not re-emerged.
15 min after receiving vaccine became drowsy. VS stable. Observed x 30 min - seen in ER later in the day due to excessive drowsiness, symptoms continue.
Information has been received from a medical assistant concerning a 20 year old female with no medical history or drug allergy who on 24-MAR-2009 was intramuscularly vaccinated with her first 0.5 ml dose of GARDASIL (lot #661952/1129X). She was also vaccinated with a dose of meningitis vaccine on the same day. Subsequently the patient developed an injection site reaction after receiving GARDASIL. The patient complained that the injected site was red, swollen, and painful. She did not recover at time of reporting. The patient called the office for medical attention. Additional information has been requested.
Pfizer vaccine was administered - reported by patient- ? NO LOT NUMBER WERE SUPPLIED   ACUTE RESPIRATORY FAILURE 1/20/2022 SEVERE OBESITY, BMI 40-44.9, ADULT HYPOXEMIA 12/31/2021 SEVERE OBESITY, BMI 40-44.9, ADULT ACUTE RESPIRATORY FAILURE 1/20/2022 ACUTE RESPIRATORY FAILURE HYPOXEMIA 12/31/2021 ACUTE RESPIRATORY FAILURE
Nothing at first, sat for 30 minutes per instructed, then once I left within the hour developed extreme fatigue, sweats, started itching and rash all over. Assumed side effects, had to drive to pharmacy and purchase Nivea Cream and shea  butter for itching. Also took Benadryl.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-DEC-2018 the patient was vaccinated with PROQUAD lot # N015625 for prophylaxis. Concomitant therapies included sterile diluent. On 31-DEC-2018, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown.
Second dose of Trumenba given at 1mo, instead of 6mo. No adverse effect reported by patient or parent.
Patient developed an injection site reaction. RN called saying a silver dollar size welt had developed that was raised & warm to the touch. They counseled patient on how to manage the rxn.
w/in 5-10mins pt began to feel like could not pass air;also felt throat was swollen-later described as numb (like w/novacaine);described blurry vision; was visibly tremulous; BP sl elevated 150/85, P72 & reg;resolved in 15mins
Late evening after vaccination, patient complained of feeling bad. No temperature taken at that time.  After midnight, he developed testicular pain, also had body aches and chilling. The morning of 1.9.18, he had a temperature of 102. Advil was given throughout the day on 1.9.18. Still had temperature spikes during the day. Patient's parents provided Advil at midnight on 1.9.18. According to his mother, patient told his family he was feeling better yesterday. This morning, patient's mother reports he has nasal congestion.
Delayed reporting by Parent-  Parent reported 4 hrs after vaccine administration, child experienced severely swollen neck and difficulty breathing. Child was treated in the local emergency room and given 3 days of steroids and benadryl. One PMD follow up appt.  Parent was told it was probably a reaction to Pertussis although she had never had any reactions with previous doses of DTP.
This spontaneous report as received from a registered nurse refers to a 12 month old patient (gender was not reported). On 05-DEC-2013 the patient was vaccinated intramuscularly in the right arm with a 0.5 mg dose of PNEUMOVAX23 (lot # J007059, expiration date 31-JUL-2014) in error. The child was indicated to receive a dose of PREVNAR 13. No adverse effect had been demonstrated at that time. Additional information has been requested.