chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours after vaccine i has chills, fever 101, headach, muscle soreness in my shoulders and upper back, hive like swelling and itching at vaccine site for the next 24 hours.
This spontaneous report was received from a physician referring to an unspecified number of patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in 2018, the patients were vaccinated with PROQUAD lot number R017629 expiration date 18-DEC-2018 and VARIVAX lot number involved R007695 expiration date 14-MAR-2020 and R012531 expiration date 01-MAY-2020. Concomitant therapies included (DILUENT MRK INJ). On an unknown date in 2018, the patients' experienced product storage error and no adverse event. Temperature 6° Fahrenheit to 14° Fahrenheit (11.6 Fahrenheit) the time frame was 10 minutes No previous temperature excursion and there was no data logger. This is a non-valid case due to lack of patient identifiers.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-SEP-2016, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K010577, expiration date 22-SEP-2016; lot # L045713, expiration date 14-JAN-2017; lot # L023232, expiration date 25-FEB-2017; lot # L039659, expiration date 15-MAR-2017; lot # reported as L009945, expiration date 01-JUN-2017 (dose and route of administration were not reported). The administered doses experienced temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
a patient was inadvertently given a dose of Act-Hib, reconstituted with sterile water/no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (MI) (Reference number- 00798637) and transmitted to Sanofi on 05-Oct-2021.   This case involves a 7 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] which was inadvertently reconstituted with sterile water.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); POLIO VACCINE INACT (IPV); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 27-Sep-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ545AA, expiry date-22-Jul-22 via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product preparation error (latency same day).  At time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
next day p/recvd vax pt had t104.7 & constant screaming for 2 hrs;
Information has been received from a company representative, concerning her sister-in-law who mentioned that a few years ago she developed zoster right after both her children were vaccinated with VARIVAX (Merck).  The zoster lasted for about six weeks, and the patient was completely recovered now.  Additional information has been requested.
pt recv'd vax & start crying for approx 22 hrs; screaming w/ periods of non responsive behavior; low grade f; inject site leg became swollen, hot, red after inject;
Membranous nephropathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) in a 47-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: glomerular disease (abnormal) glomerular disease.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy) to be related.    No concomitant and treatment medication were reported. COMPANY COMMENT: This is a literature-non-study case concerning a 47 -years-old male patient with no clinical history reported  who experienced the unexpected  event  of GLOMERULONEPHRITIS MEMBRANOUS unknown  days after the 2nd  dose of mRNA-1273 vaccine. On an unknown date, Biopsy kidney was performed with diagnosis of abnormal glomerular disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539885 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a literature-non-study case concerning a 47 -years-old male patient with no clinical history reported  who experienced the unexpected  event  of GLOMERULONEPHRITIS MEMBRANOUS unknown  days after the 2nd  dose of mRNA-1273 vaccine. On an unknown date, Biopsy kidney was performed with diagnosis of abnormal glomerular disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided. The case was assessed as serious by the Regulatory Authority´s report due to IME
Pt had first dose of Shingrix shot at our pharmacy 03/05/23. Pt complained of his shoulder pain (starting from elbow up to shoulder) the day after the shot until now. MD office did X-ray but it's negative. There's no inflammation nor other symptom. Pt saw MD & got Ibuprofen 600mg, but it didn't help much. Patient had to get Triamcinolone shot yesterday 8/22/23 at MD office because he didn't have money to get the shot since April 07/23  when pt saw MD the first time
2-3 minutes after vaccine given pt felt faint.  Has a history of syncopal episodes in high school. Taken to medical observation at 3:29 PM BP 140/67 HR 67 Pulse ox 99% Patient placed in trendelenberg 3:32 PM BP 140/75 HR 65 Pulse ox 98% patient flat, states she feels better 3:35 PM BP 135/66 HR 71 Pulse ox 99% HOB elevated, no symptoms of feeling ill 3:40 PM BP 133/75 HR 75 Pulse ox 99% Sitting up independently, feels well. Discharged from medical observation in stable condition via wheelchair to exit.
Pt complains of mild itchiness on the left arm at 10: 45am, assessment was done pt. had slight erythema on the left arm, no rash was found on the torso. pt. was offered a Benadryl but she refused. she also refused additional 15 mins.
Initial report was received from a consumer, under reference number 1-440511116, on 07 March 2013. A male patient received a dose of tetanus toxoid, manufacturer unknown, (lot number, route, site, side and dose in series not reported) as a small child on an unspecified date. He did not remember when (age or year), did not remember specific vaccine and had "no idea what the reaction was". The patient reported, "My mother told me I almost died". He stated he wore a bracelet that had "tetanus allergy" on it. The reporter said his mother would not be helpful in obtaining more facts. Laboratory or diagnostic testing and treatments were not reported. The patient's history as a child was not reported. The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Minor Arm Pain; Aches; Chills; High fever; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 15Apr2021 at 07:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 19:30, the patient experienced minor arm pain, aches, chills and high fever. On the same day, the patient underwent body temperature test and the result was 102.7(unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event minor arm pain, aches, chills and high fever was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 06May2021 at 07:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Tired, run-down, flu-like symptoms with coughing. Large bump at injection site and redness/burning.
pt recv vax 19APR99 & pt exp a rash over 90% of body w/itching on back, painful urination (burning sensation)  & an asthma attack;Lymerix was discontinued & pt was treated w/DPH & pred;pt out of work from 20APR99 to 28APR99;
Extreme fatigue; Headache; Pain at injection point; Extreme neck pain; Pain from neck and arm was so bad; Didnt sleep for another 2 days/ Unable to sleep or find relief.; Couldnt move neck; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included propranolol (MANUFACUTURER UNKNOWN), medroxyprogesterone (MANUFACUTURER UNKNOWN) and levonorgestrel (PLAN B), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced extreme fatigue, headache, pain at injection point, extreme neck pain. Could not move neck. Did not sleep for another 2 days. Pain from neck and arm was so bad she had been up crying every night and unable to sleep or find relief. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme fatigue, headache, pain at injection point, extreme neck pain. Could not move neck. Did not sleep for another 2 days. Pain from neck and arm was so bad she had been up crying every night and unable to sleep or find relief was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Sudden onset of weakness of being unable to stand, was diagnosed with Guillain Barre.
The morning after receiving immunizations, the patient woke up fine. She then developed vomiting and intermittent crampy abdominal pain later that morning. Parents brought her to Medical Center ER, where abdominal ultrasound revealed intussusception. She was then transferred to Medical Center that afternoon. A barium enema was ordered, which revealed no abnormalities at that time. The patient's vomiting subsided, and she was felt stable for discharge.
pt recvd vax; 6 hrs later devel redness, swelling, pain at inject site & fever
Arm has a rash near injection site. It is red, irritated, swollen, itchy, hot to the touch, and painful.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 10:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 10:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 39.32 for dose administered on 27-Mar-2021. No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35, 35 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I had swelling on the left side of my neck at my lymph gland. Also exp swelling on left side face down to my collar bone and neck felt stiff. The doctors stated it would gradually go away may take up to two weeks. I have taking Ibuprofen as needed. I wanted to make a note that had Covid April 2020 and had a antibody test in Dec. 2020 wanted to inform.
Patient felt anxious prior to vaccine. Shortly after vaccine was given patient felt lightheaded. Patient laid down and was observed to have pale skin and diaphoresis. Patient soon stated that she felt better and noted that this is a normal anxiety reaction for her.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved were from 6° F to 14° F for 72 hours. It was not previous temperature excursion, and a data logger was not involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA002218: Original Case : 1704USA001049; US-009507513-1704USA001049: Original Case : 1704USA001049.
Per patient, she is experiencing muscle aches, nausea, nightmares, lost appetite, and tiredness. It is almost like flu-like symptoms.
Pt received 4 vaccines on 6/23/00. That evening he had swelling, redness on right upper thigh, low-grade fever and fussiness. At times he had high pitched cry and difficult to console. Gradually improved. Seems fine now. On 11/7/00, gave DT, Prevnar, Hep-B and he did fine.
Pain/Aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose.), administration date: 01Mar2021, for COVID-19 immunization, reaction(s): "Sore muscle".  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain/Aches"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".   Additional information: Patient wanted to know whether a chronic herpes infection outbreak and the medicine. Patient take for it would or should prevent patient getting second herpes shot on schedule patient know that these outbreaks affect immune system and that the medicine (Valacyclovir) suppresses the virus Herpes. Patient was able to reschedule second shot when the outbreak was over and the medicine out of patient system.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticarial lesions at bilateral axillae approx. 18 hours after influenza vaccine administered.
Around 5-7 minutes after injection, I started having heart palpitations and visual disturbances that lasted maybe 30 seconds or so
devel 5cm wheal, redness & blotchy skin sorrounding inject site immed p/receiving MMR; No problems w/DTP/HIB;
4 x 3 area of blanching erythema with central 1 cm area of ecchymosis is R deltoid area.
Localized reaction less than 24 hours did not report until 12/3/14.
Headache; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07May2021, outcome "unknown", described as "Headache"; DIARRHOEA (non-serious) with onset 07May2021, outcome "unknown", described as "Diarrhea".  Additional information: It was reported that the reporter's husband (consumer) and her had Pfizer first shot on Wednesday but her (Husband) got headache yesterday and also diarrhea which he had all overnight, it seems. Now he is just wondering if that is possibly a side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was really sick for a few days after the vaccine, starting that night; exhaustion, nauseua, headaches, stuffiness, body aches, chills, fever, arm pain were all symptoms I had, as well as painful and swollen lymph nodes in my neck and armpit. Thankfully these cleared up by three days, though the exhasution lasted a couple days more. The reason I'm filling out this form is that I am still experiencing mild stuffiness as well as tender and slightly swollen lymph nodes in my neck, even after two weeks. I know this is probably not a big deal, but all my internet research said that COVID vaccine effects don't last more than a few days, so that's why I've filled this all out.
Patient was vaccinated on May  6,2021.  On Friday May 14 ,2021 a  relative of the patient report that the patient died on May 9,2021..She report that the patient  doesn't take the prescriptions needed for a vascular condition he have and was suppose to received medicines by mail on tuesday before vaccination
sore arm (including right arm from first injection), temperature 100.8, hard shaking chills for eight hours (then low grade for 48 hours, very severe muscle pain, very severe joint pain accompanied by severe muscle cramps torso to feet for 48 hours, severe headache for at least 72 hours, drenching night sweats for two nights, nausea, bowel cramping and frequent stools, fatigue but inability to sleep, loss of appetite (but increased sense of smell).
Patient felt light headed and so layed down on floor.  Patient recovered and walked out of facility on own.
Case number PHEH2012US006788 is an initial incomplete report received from physician on 20 Mar 2012: This case refers to multiple patients (number unknown). The reporter stated that approximately 65 doses of unconstituted MENVEO (batch number: unknown) may had been exposed to 33 F for 30 minutes on 16 Mar 2012 during the afternoon. The reporter stated that 2 out of 3 thermometers indicated that vaccine temperature was in refrigeration range, however 1 thermometer indicated excursion occurred. The reporter did not know whether the vaccine froze. He stated that vaccine doses may had been administered to patients since the excursion, however he was unable to confirm the number of patients that may had been vaccinated. No other additional information was available.