chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna vaccination (Lot # 044A21A) on 04/05/2021 at 1015 in the right arm and was escorted to Observation by the Escort Team. RN assessment findings are as follows: Patient is awake and alert, oriented to person, place, and time. Patient is responsive to all verbal commands. Upon checking out of observation at approximately 1034 patient reported chest pain. Patient is sitting upright in a chair.  Patient stated that after he received the vaccine and sat in observation, he started to feel chest pain to his mid sternum.  Patient?s blood pressure is 120/80, pulse 79 and O2Sat 98% room air. Patient was given 2 bottles of water. Section Chief, at the ICP of the patient at 1046.  Staff called  on the phone because the radios were not working properly then called Incident Commander (IC). RN was notified that patient is complaining of chest pain.  1047 Patient assessed by RN.  Patient is a 20 year old with no past medical history, patient sitting in an upright position awake, alert and oriented X3, answers questions appropriately.  Patient denies allergy to any medication or food.  Patient verbalized he did not eat breakfast prior to vaccination. Patient stated he started to experience chest pain after he received the moderna vaccine when he got into observation.  Patient rates pain 4/10 which has remained the same since he?s been in observation.  Pain does not radiate, no diaphoresis or change in color noted.  Patient denies using any illicit drugs or has taken any medication in the past 24 hours.    IC, aware and called 911. 1055 Patient?s blood pressure was s rechecked: 122/68, pulse 70, O2Sat 98% room air. No sign of distress noted.     1059 Patient was placed in a wheelchair and brought to the other side of the room away from other patients for confidentiality and privacy.  Patient awaiting EMS.
have low grade fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (have low grade fever after second dose) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (have low grade fever after second dose). At the time of the report, PYREXIA (have low grade fever after second dose) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Pt recvd vax & 1 hr p/inject flet tightening of throat & chest; took Seldane; exp dizziness; hospitalized for 1 day;
PATIENT REPORTED AFTER RECEIVING FIRST SHOT, WITHIN THE SAME WEEK, STARTED TO FEEL NUMBNESS ON LEG AND FOOT THAT LASTED  ABOUT 10 DAYS, AND IT WENT AWAY.  HE WAS CONCERNED BECAUSE HE HAD NOT EXPERIENCED THAT BEFORE AND DID NOT HAVE ANY MEDICAL HISTORY OF IT.  SINCE IT WENT AWAY, HE DID NOT SEE MEDICAL CARE.
Called with complaints of welps on both legs with itching. Denied any breathing difficulties.  Referred patient to emergency room and/or walk-in-clinic unless she had difficulty breathing then advised to call 911. Stated no other new foods or medicines were introduced other than the Hep B vaccination.
This spontaneous report was received from a Certified Medical Assistant (C.M.A), regarding to multiple unspecified patients of unknown ages and gender. The patient's medical history or concurrent conditions were not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L032761, expiration date 24-FEB-2017 and Lot # L050910, expiration date 14-JUN-2017) (dose, route of administration and anatomical location were not provided). The vaccines were subjected to temperature excursion of 23.0 degrees C for a time frame of 1 hour and 29 minutes. Back in range was reported as yes and there was no previous temperature excursion. Concomitant medications were not provided. No adverse effects were reported. Product quality complaint was not filed. This is one of several reports from the same source (MARRS # 1605USA012734, 1606USA005737, 1606USA005738, 1606USA005739 and 1606USA005740). Additional information has been requested.
Narrative: COVID infections following completion of COVID vaccine series 02/06/21 COVID vaccine dose #1 02/27/21 COVID vaccine dose #2 07/29/21 Pt reports recent exposure to COVID positive person; COVID POSITIVE 07/30/21 Pt reports cough and muscle pain that started 07/28/07/31/21 Pt reports cough, fatigue, and is stable 08/01/21 Pt reports headache 08/02/21 Pt reports intermittent cough and improving muscle pain; no headache today 08/03/21 Pt continues to improve and cough is nearly resolved; clinically resolved
This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 2 months old female patient and was vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009004: US-009507513-1706USA009005: US-009507513-1706USA009006: US-009507513-1706USA003615: US-009507513-1706USA009001: US-009507513-1706USA009007: US-009507513-1706USA009002:
pt recv vax 30OCT96 & 22NOV96 pt exp bell's palsy on rt side;lyme serology was negative;As of mid DEC96 pt had near complete recovery;although still exp some droop of the rt side of mouth & rt eyelid;
HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.,Temperature :8.74 C ,Time frame:35 Min; This spontaneous non -serious safety report, with reference number 02475811, was received by a partner on 20-SEP-2023 and forwarded to company on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Erythema, warmth to injection site starting on 2/12/21 (the day after the injection).  Patient circled the area and monitored.  On 2/15, pt noticed the area of erythema had spread slightly beyond the marked area, but without worsening pain, no fevers, no chills.  + 9cm area of erythema with slight edema, warmth; no induration.  Pt feels well overall.  Given that this is a known reaction to the vaccine, pt was told to monitor the area; a new line was drawn around the erythema; plan to treat for cellulitis only if the area continues to worsen, or does not improve in the next 2-3 days.
a week after injection she gained 10 lb water weight, then over the next 2 weeks an additional 20 lb of water weight. She had decrease in activity, anorexia, and was found to have multiple bilateral pulmonary emboli.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M047662; expiration date 02-DEC-2018) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was -14°C to -10°C for 257 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA003628: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA011937: US-009507513-1708USA003627: US-009507513-1708USA003630:
This case was reported by a consumer and described the occurrence of headache in a 14-year-old female patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, 12 hrs after receiving BEXSERO, the patient experienced headache, nausea and feels awful. On an unknown date, the outcome of the headache, nausea and feels awful were unknown. It was unknown if the reporter considered the headache, nausea and feels awful to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. In the morning at 9:00, the patient received 2nd dose of BEXSERO and in the evening at 9:00 pm, the patient experienced feels terrible, headache, nausea, just gross. The reporter looked on web site and saw the patient experienced common side effects but the web site did not say how long she would experience them.
Fever to 102.8 6-12 hrs after, Tylenol and ibuprofen, Diarrhea and vomiting 6-12hrs after, Pedialyte, vomiting stopped after 24 hrs, diarrhea x 48 hrs, 20 x 1 day
Information has been received from a female patient with psychiatric disorder and drug hypersensitivity to "pain killers and antidepressants" who on 21-JAN-2010 was vaccinated with a single dose of PNEUMOVAX 23 (Lot # 665300/1314Y). It was reported that on 26-JAN-2010 the patient experienced shaking and loss of bladder control. The reporter stated that she did not believe that these events were from the vaccine. At the time of the report the patient had recovered. It was unknown if the patient sought medical attention. It was also reported that the patient experienced hot flashes and dizziness while taking TRAMADOL and experienced heart and kidney problems while taking HALDOL and DEPAKOTE. No further information is available.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/21/2022 ATHEROSCLEROSIS OF AORTA ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/21/2022 SECONDARY PULMONARY HTN
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for an unknown indication.     No Medical History information was reported.    On 15-Apr-2021 at 2:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.96   Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 50, total doses given for the day was 93, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 16-Apr-2021. 9 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 00, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
15 second whole body seizure witnessed by father.  Patient vomited for about 15 minutes.  Father stated that his seizure probably due to being constipated and not reacting to treatment this morning.
Large red rash around vaccination site 8 days after vaccine was given.  Also a little swollen.
Had tachycardia and high blood pressure, headaches and some nausea yesterday.    Tachycardia hasnt repeated but headaches and queasiness continue intermittently along with possible high BP   Never had this before was wondering if possible side effect?  EKG came back same as normal for me and bloodwork fine.    Still feeling poorly.
child was given the adult dose of Havrix.; child was given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 12-month-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th May 2021, the patient received Havrix 1440 adult. On 28th May 2021, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows:  This case was reported by a medical doctor (pediatrician). The patient was given the adult dose of Havrix, which led to adult product administered to child and overdose. The reporter consented to follow-up. This was 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter
18FEB93 pt was @ high school & reported to be disoriented & confused; pt was taken to nurses office reported pulse 120, BP 140/100;; pt was taken to ER; BP 150/100; mom reports testing CAt Scan, blood tests, blood gases, spinal tap, WBC ele
Information has been received from a 31 year old female registered nurse with no pertinent medical history, drug reactions or allergies, who reported that on 15-OCT-2007 while withdrawing PNEUMOVAX 23 she splashed some in her eye. The nurse flushed the affected eye with contact solution, however reported that "it still hurt little bit". The nurse was wearing contacts at the time. She did not seek medical treatment from a physician, she self  treated her self herself. At the time of this report, the nurse had not recovered. Additional information has been requested.
No additional AEs or PQC reported.; Caller reported expired dose of MMR II was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concurrent condition and drug reactions/allergies was not reported. Concomitant therapy included sterile diluent (manufacturer unknown).  On 20-APR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (therapy type: rHA, 0.5 milliliter, lot #U011149, expiration date: 08-APR-2023, strength was not reported) subcutaneously for prophylaxis (expired product administered). No additional AEs or PQC reported (no adverse event).
syncope; Dizziness; headache; diarrhea; This is a spontaneous report from a non-contactable physician (patient) reported for herself. A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date: unknown), via an unspecified route of administration on 17Sep202116:00 as dose number unknown, single (at the age of 41 years) for COVID-19 immunisation. Medical history included immunodeficiency common variable, interstitial lung disease, colitis and allergy unspecified. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Dizziness, headache, syncope, diarrhoea on 17Sep2021. The patient did not undergo prolonged hospitalization. The patient did not receive any treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the event syncope and the suspect drug BNT162B2 cannot be excluded. 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.
1030PM t104 all noc; didn't react to stimulus; went to hosp next AM t104.6, eye red-crusty;
After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body,  had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future.  For a early few days  had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!
12/24/2021 11AM ET Vaccination. I started to experience some arm pain within a 2 hour window. It took forever to fall asleep, tossing and turning and I'm not sleeping. I am getting maybe 3-4 hours total of disturbed, interrupted sleep. I have not had a full night sleep since I had the booster. The lymph nodes were swollen the following morning for a total of 3 days. Called neurologist cause I was afraid it would trigger migraines. He recommended the Tylenol PM. It helped arm and lymph nodes, nothing for the sleep. I have not called him back since. Experiencing insomnia.
Employee states that within four hours after receiving flu vaccine  four weeks ago she experienced acute right upper arm pain in the area of the injection site without swelling or redness. Describes her right upper pain as unresolved dull throbbing at rest and sharp pain when moving the arm in certain directions. Has modified her ADL's because of the pain. Taking two Tylenol at night with some benefit.  Advised by NP to continue periodically applying ice or heat to the right shoulder. Physical therapy ordered, employee states will go to PT at least 3 times prior to returning to office visit in 1-3 weeks. NP recommended a referral to orthopedic surgery for an examination and possible anti-inflammatory treatment. MD concurs with evaluation and treatment plan as presented by NP.
Itchy rash, inner legs (most), fold of knees, armpit area, fold of arms and lighter upper arms.
Onset of headache after a couple of hours. Severe enough that couldn't work or focus.  Onset of body aches at 3am on 4/22. Didn't go away until 7pm on 3/22. Headache lasted on and off for approximately 72 hours.
Patient presents to the ER with 10 days with a fatigue and difficulty breathing.  She has been vaccinated against Covid.  She started to feel bad and she tells me she quarantine herself however her symptoms have gotten much worse over the last couple days.  She tells me typically she can walk without any assistance however currently she is needing a wheelchair and was unable to get off the toilet herself here in the emergency department.  SARS-CoV-2 positive on 10/12/21. Now with oxygen requirements.
Woke up the next morning after Moderna booster vaccine and noticed left arm had a little red lump where shot was given and it was itchy. The lump was gone yesterday ( 3/1/2022) when she went to see the doctor, but the redness was getting bigger. Doctor measured redness to be 10 cm long x 6 cm wide. Doctor prescribed Cetirizine.  Today reports that redness has decreased since yesterday. "not all the way gone, still a little bit there."
Developed chills, sweats, shortness of breath later in the evening. Did not seek medical care and felt fine in the a.m.  Since then has gradually developed marked stiffness in fingers of both hands. Has not sought medical care yet, but will have insurance next week and will do this.
This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012738 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.