chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grand mal seizure; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a 6-month-old patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, immediately after receiving DTPa vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was unknown.   The reporter considered the grand mal seizure to be related to DTPa vaccine.  Additional details were provided as follows: This case received from interactive digital media. The patient mother reported case on behalf of her son. The patient received DTPa vaccine and reacted to pertussis. Right after that the patient had Grand mal seizure. The physician advised to the patient's mother that they would remove pertussis from DTPa for next doses.
Left axillary lymph node swelled to size of golf ball, was painful (6-8/10).  Prevented me from sleeping for more than 2-3 hours at a time for 3-4 days. Also prevented me from resting my arm at my side comfortably for 3-4 days. Today (4/23/2021) the lymph node is still enlarged, closer to the size of a grape.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
multi system involvement with substantial disruption in daily life, palpitations, shakiness, fluttering heart, tingling left and right arm, neck and shoulder pain (all muscles), fuzzy head, rigning ears, double vision, heat sensations in brain, face, arms, neck, shoulders, hot flashes,  treatment has been PT, chiro, muscle relaxants, ibuprofen, tylenol, tylenolPM, trigger point injections, massage,
had covid; had covid; vaccinated 5 times with both Moderna and Pfizer Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 65 years, in arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FG3527), in arm and on 10May2022 as dose 4 (booster), single (Lot number: FK9894), in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2021, outcome "unknown", described as "vaccinated 5 times with both Moderna and Pfizer Covid-19 Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "had covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 02Oct2023 to 05Oct2023 (06 tablets every 12 hours).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322857 same patient/reporter, different drug/AE;
Developed chest pains and shortness of breath. Still dealing with and going to see a cardiologist after urgent care, and two days later being turned away after waiting 5 hours in ER because hospital was full.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Barrett's esophagus" (unspecified if ongoing), notes: Other medical history: Hx of Barrett's esophagus. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Patient had 2 negative tests prior to rebound symptoms; (unspecified date) Negative, notes: Patient had 2 negative tests prior to rebound symptoms; (Dec2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 02Dec2022 to 07Dec2022. Clinical Course: It was unknown if he received other medication in 2weeks. No known allergies. Rebound COVID-19 symptoms and positive test after treatment with Paxlovid. Patient had 2 negative tests prior to rebound symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported events and BNT162B2.
I am having high blood pressure problems. I am seeing a cardiologist. I am having a lot of test did. I am on a cardiac monitor.
Pt presented at the ED with leg pain and cellulitis of lower right extremity; 12/02/2021, 12/15/2021, and 01/12/2022. During the first admission on 12/02/21, Pt was found to be COVID positive (despite full vaccination), yet was asymptomatic. The cellulitis was treated with IV antibiotics, and seemed to be healing yet PT returned to the ED x 2 for continued pain. PT was also experiencing increased shortness of breath with minor activities while at home. Pt was admitted to the hospital 01/12/2022. On 01/17/2022 Pt developed a cough. Pt underwent a workup looking for causes, but the final sense was that it was COVID pneumonitis. Ultimately, the decision was made to discharged Pt to Hospice 01/22/2022. Pt died 02/02/2022.
neck was swollen; painful to swallow; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient got the 1st dose on 19Mar2021 and a few days after her neck was swollen and painful to swallow. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administration of expired vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient reported- administered vaccine one day after past expiry date.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains Pregnancy data, Race, Ethnic Group, Vaccine Route & body site updated.
Developed sore left arm pain that radiates down left leg, fatigue and low grade fever 99.9
Three small rashes on left ankle and something that looks like a hive between my fingers on right hand.  Currently after a few days the itching in area subsides a little, but the red mark is still there.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: "Ventricular septal defect" (unspecified if ongoing), notes: Other medical history: VSD; "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was used for treatment of COVID-19 from 27Dec2022 to 31Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Report 2000034593-1 describes maladministration (sprayed in eyes) in a 32 year-old female who received Engerix-B.  The vaccinee has no known drug allergies. Medical history and concomitant medications are unspecified.  On an unspecified date, the vaccinee ( medical assistant) was accidentally "sprayed in the eyes"  when Engerix-B was being administered to a child. Subsequently, the vaccinee experienced an ocular headache and numbness in the eyes.  As of 29-NOV-00, the outcome of the events is resolved.
Shot didn't work on me/suspected vaccination failure; Shot didn't work on me; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The case was received from the patient via  interactive digital media. The patient stated that the shot (Shingrix 2020) did not work for him/her. 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.
Information has been received from a Registered Nurse concerning her 64 year old husband with no allergies and a history of shingles, a high and bad fall in December 2004, and a collapsed lung and pain as a result of the fall, who on approximately 01-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included methadone HCl and atorvastatin calcium (LIPITOR). It was reported that the patient was having some pain and discomfort within his chest wall below the left armpit. On the night of 05-MAY-2008 the patient had about 4 to 5 raised areas that were not itchy and looked like poison ivy. It might be the beginning of a rash and it is at the same area as the discomfort. At the time of this report, the patient had not recovered. It was noted that the patient's collapsed lung from the fall was "around the same location as the discomfort area and rash area." VZV was offered and the nurse will inform the physician that this program is available. Currently the nurse does not think it is necessary. No diagnostic labs were performed. No product quality complaints were involved. Additional information has been requested.
severe headache dizziness fatigue arm soreness muscle weakness myalgia moderate chest pain heart palpitations  the dizziness appeared approximately 11 hours after the 2nd dose and the other symptoms appeared later in the day. the chest pain and heart palpitations also occurred with the first dose of the vaccine. symptoms resolved within 24 hours of onset.
Patient developed a large rash to injection site. It was red, raised, and itchy. She also had swelling to the arm and both of her feet. She also had heart palpitations with a pulse in the 140's.
awoke at 2 am  with nausea, chills, generalized pain. Immediately felt myself start to pass out or have a seizure- I am not sure which. Family member reports my eyes were open with absent stare however I lost consciousness, <60s. My right calf was in a severe muscle spasm as soon as I became conscious which leads me to believe I had some convulsions. Nausea chills and generalized pain persisted throughout the rest of the morning. Stopped around 10 am and turned into pounding headache and fatigue.  Additionally my left arm is in moderate to severe pain (not like the typical soreness I get with the flu shot). I am in  significant  pain  moving my arm, but also changing body positions while keeping my shoulder still and close to my body (bending over, scooting over in bed).
Left side of face became numb continuously for 24 hours then off and on for a few days. Muscle aches for several days.
she received an unspecified pneumonia vaccine on an unspecified date in 2017 / however, she contracted pneumonia for 3 months in 2018; however, she contracted pneumonia for 3 months in 2018; This spontaneous report was received from a 71-year-old female patient who was reporting on herself. No information about the patient's concomitant medications was reported. Her drug reactions/allergies included levofloxacin (LEVAQUIN).  On an unspecified date in 2017, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (reported as unspecified pneumonia vaccine) (site and route of administration, lot# and expiration date were not provided) for prophylaxis and she did not experience any adverse reactions, however on an unspecified date in 2018, she contracted pneumonia for 3 months (vaccination failure).  The outcome of the pneumonia and vaccination failure was not provided.  Causality assessment between Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and pneumonia was not provided. The event of vaccination failure was considered to be related to the suspect vaccine. Upon internal review the event of pneumonia was considered to be medically significant.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-2202USA004583:
No Adverse Event; HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; Improper storage of product; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with the dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot #W029552, expiration date: 14-MAR-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered).  Administered dose of vaccine was exposed to the temperature excursion of 8 degrees Celsius for 1200 hours (improper storage of product in use). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Arm hurt, redness at injection site, deep arm pain, feeling there was a knot inside her arm. She claimed that fluid leaked from the injection site.
2x2 inch red patch on that arm, but it is 4 inches down from where she got the vaccine; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine  second dose on Thursday a( 18 Feb 2021)nd now she  have a 2x2 inch red patch on that arm, but it is 4 inches down from where she got the vaccine. The injection site itself is perfectly fine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 18 FEB 2021, prior to the onset of events, the patient received their second  of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after second dose of vaccine, the patient experienced ongoing red patch . No treatment medication was reported. MIS making attempts to reach reporter for additional information. No additional information at this time.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, is unknown; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
no event; alarm believed to be due to sensory issues/improperly stored vaccine; This spontaneous report was received from a nurse practitioner and refers to a 02-month-old male patient. There was no information about patient's concurrent conditions or pertinent medical history.  Concomitant therapies included pneumococcal vaccine conj 7v (crm197)(PREVNAR), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(PENTACEL) and hepatitis b vaccine(HEPATITIS B VACCINE).     On 06-JUN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, that was exposed to temperature excursion, lot number 1968386 with expiration 23-MAY-2024 (dose was not reported) for prophylaxis (product storage error). No event was reported.   This is one of several reports from the same source.; Sender's Comments:  US-009507513-2307USA009456: US-009507513-2306USA013096: US-009507513-2307USA009456: US-009507513-2307USA009680: US-009507513-2307USA009660: US-009507513-2307USA009636: US-009507513-2307USA010465:
Patient received MMR vaccine. Approximately 5 minutes after getting vaccination, he developed hives on face and swelling of area around injection site. No respiratory symptoms. Patient was given Benadryl.
neck pain; subjective weight loss; tremors; Initial information received on 16-May-2022 via healthcare professional regarding an unsolicited valid serious case issued from a literature abstract:   This case involves a 63-year-old female patient who experienced neck pain, subjective weight loss and tremors while receiving influenza vaccine (latency: unknown).  The patient's past vaccination(s) and family history were not provided. The patient had meningioma treated with gross total resection (without radiation) three years ago. At the time of report, she had ongoing Graves disease.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, patient was presented to the Emergency Department (ED) with two weeks of neck pain, subjective weight loss (Weight decreased), and tremors (Tremor) after receiving the influenza vaccine.  Action taken: not applicable Corrective treatment: not reported Outcome: unknown  Seriousness criteria: hospitalization Reporter causality: related Based upon the reported information, the role of a vaccine cannot be assessed.; Sender's Comments: Sanofi company comment dated 19-May-2022:  This case involves a 63-year-old female patient who experienced subjective weight loss and tremors while receiving influenza vaccine. Based upon the information the role of suspect drugs cannot be denied however the lack of information related to past drugs, latency and concomitant drugs precludes better case assessment.
Information has been received from a registered nurse concerning a 25-month-old white female with no pertinent medical history or allergies who on 11-NOV-2006 was vaccinated in the left thigh with the first dose of Varivax (Lot # 654759/1064F). There was no illness at the time of vaccination. There were no pre-existing allergies, birth defects or medical conditions. On 02-DEC-2006, the patient presented to the doctor's office with breakthrough with less than 50 lesions. There were no adverse events following prior vaccination for the patient or siblings. No other problems were noted. NO diagnostic or laboratory tests were performed. On 11-DEC-2006, the patient recovered. No additional information is expected.
Information has been received from a licensed practical nurse concerning a 5 year old female pt with no past medical history, no known allergies, and no concomitant medications who on 03/28/2001 was vaccinated with one dose of varicella virus vaccine. On 04/06/2001, the mother reported a swollen, tender leg where the injection was given. There was an induration of approximately 1 to 1 1/4 inches seen along with a small macular papular rash around site. The pt had no fever or other complaints. The pt sought unspecified medical attention. Upon follow-up, it was reported that the pt's initial experience involved the injection site reaction, however, she also had extension of the rash to her leg, was seen by a dermatologist, and diagnosed with eczema "not related to varicella vaccine." Subsequently, all conditions resolved. In addition, it was reported that the pt's 6 year old brother, who was vaccinated with one dose of varicella virus vaccine live that same day, also developed a similar reaction. Additional info has been requested.
She got her vaccine, she got it in her left hip.  She got it in her hip as she has no lymph nodes due to breast cancer and was told that she cannot have any withdrawals or injection in her arm due to that.   She felt swelling and pain in the middle of the night.  When she was able to see it it was pinky red and swollen.  As the day went on it got a little bit larger.  Now if she puts her hand in that area it is the size of her hand, and now it looks like it is going to turn color.    Her other vaccines were given in the left hip as well.  She did have the same type of reaction with the other vaccines, and it takes about a week for the color to clear.