chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was administered too high on the deltoid; Extreme pain at the injection site; Difficulty raising arm/Weight bearing difficulty; Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 42-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional information was received as follows: The patient reported extreme pain at the injection site which remained at the time of reporting. The patient has difficulty raising his arm and lifting objects. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms. Consented to follow up. Emergency Room Visit Required. This was 1 out of 8 cases reported by same reporter.
The patient, my father, told me he had been having various symptoms and felt unwell for months, which he associated with the initial Moderna experimental COVID-19 gene therapy  injections in March and April of 2021. After the booster dose of Pfizer's experimental COVID-19 gene therapy injection at a routine physical in December 2021, at which he was said to be in good condition for his age, he began to have digestive problems including incontinent diarrhea. He began to have pain in his "guts," to the point he could not lie on his back and sleep became difficult and later nearly impossible. He lost significant weight. Various tests were done. Doctors began to suspect a pancreatic cyst after an MRI. After a PET scan, they then suspected pancreatic cancer. After a biopsy, they finally diagnosed pancreatic cancer in June 2022.  The tumor was believed to be inoperable. Chemo and radiation were not advised because of his age and severely weakened condition after months of poor digestion, severe pain, and little sleep. Hospice care was advised. Once palliative pain relief was finally prescribed he was able to eat and sleep. However, after only a few weeks of improved symptoms, he deteriorated rapidly and died July 14, 2022.   While he may have had pancreatic cancer developing for a long time before the experimental injections, I am reporting this as a potential adverse event from said injections because of its rapid progression from January-July 2022. I have read about concerns that the injections impair the immune system in various ways, including negative impact on toll-like receptors and killer T cells. Thus, I am interested in the possibility that his own immune system was keeping the pancreatic tumor in check until such time as the injections damaged his immune system.  I feel it is important for his case to be in VAERS in case enough other rapidly progressing cancers are reported to rise to the level of a safety signal that should be investigated, since this is the purpose of VAERS.   In addition to the booster dose of Pfizer listed above, he received two doses of Moderna on 03/05/21 (Lot 011A21A) and 04/02/21 (Lot 044A21A). My understanding is that there is little to no data on the safety of mixing the different experimental COVID-19 gene therapy injections. Thus his case may also be of value in investigating outcomes following use of mixed products.
HEMOPERTUSSIS; PULMONARY EMBOLISM; ELEVATED FURITAN; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient had no pertinent history and was healthy up to now. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 06-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2022, patient had fever, then cough and all the symptoms like covid but tested negative. On 10-JAN-2022 or 11-JAN-2022, he got tested again and the result was negative. On JAN-2022, the patient then went to a mass Polymerase Chain Reaction (PCR) drive through testing and the result came out to be negative. He then went to a doctor and underwent a lung X-ray which was fine, but was still coughing. The patient's fever kind of went away, but around 100 (no unit). On 19-JAN-2022, the patient suddenly started coughing with blood consistently for 2 days. On 21-JAN-2022, the patient went to the emergency room, where they collected his cough with blood sample and run some tests and X-rays and found blood clots in both the lungs, pulmonary embolism, hemo pertussis and elevated furitan. According to the doctors, it looked like the health issues were caused by the vaccine. The reporter stated that the patient was almost paralyzed and was on blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, hemo pertussis, and elevated furitan. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213715.; Sender's Comments: 20210738088- Covid-19 vaccine ad26.cov2.s- pulmonary embolism, hemo pertussis,. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I have an extremely big hive on my right arm, same area I got the shot. I was very worried about having an infection or developing blood clot. I saw my family doctor this morning, she hasn't seen such a reaction in any other patient.  She prescribed Benadryl and hydrocortisone cream. and a follow-up  on Friday. If there is no change she said she might have to prescribe antibiotics.   She told me to contact her if any changes develop, and yes it has I will be contacting her in the morning because the hive is getting much bigger. I am very worried any my health right now since the hive is spreading and its itching, burns and looks very inflamed.  I hope to hear from someone very very soon.  Thank you.
Intense itching at injection site, large swelling, heat at injection sight, pain, breathing difficulty, tight throat
Fever, chills, vomiting, headache, fatigue, body aches, racing heart rate, heart palpitations for about 24 hrs.    Rest & Tylenol
This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL, (lot #, strength, dose, frequency and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
a little sore on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little sore on the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little sore on the injection site). At the time of the report, VACCINATION SITE PAIN (a little sore on the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.  No Treatment medication was reported.   This case was linked to MOD-2021-052533 (Patient Link).
Later after receiving vaccine,  patient reported that a red, wide band appeared starting below the injection site ending towards the armpit. The red band did not cause pain or itching and it did disappear about 1 week later.
Dose was diluted incorrectly with 2.0mL of diluent instead of 1.8mL.
a couple hours after receiving the vaccine, I began to feel very tired and "out of it". I walked around in a mental fog and couldn't seem to focus or concentrate on any given task. Taking a nap helped, but I still felt bad. I woke up this morning to my arm being sore, feeling as though it had been hit with a hard object at the injection sight. My husband noticed a densely packed, red, raised rash at the injection site- hot to the touch, inflamed, but is not seemingly spreading. Im still pretty tired today but more clear headed.
@ 1220 Lightheaded, numb tongue (back), no SOB, states previous anaphylactic reaction to Naproxyn.  @1230 OxSat 98%, HR 114, BP 140/112, BS 111.  @ 1250 BP 150/110, RR 18, OxSat 99.  Monitored pt until 1308.  Stated light headedness gone, throat better, ready to leave.  Son will drive her home.  Was epi-pen in her purse and know where we are.  Advised to contact PCP or seek medical attention if needed.  Pt verbalized understanding of instructions and walked out with son.
Information has been received from a county health registered nurse concerning a 7 year old male who on 22-JAN-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 08-APR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
DIARRHEA -9/22/2017 UNTIL 10/03/2017 IT'S SLOWLY LESSENING.
Soreness at injection site throughout day.  Experiencing unusual tiredness, sleeping at 7 or 8 PM, but normal sleep time is 12 or 1 AM.
Patient received varivax on 4/10/97 without incident. She now has active varicella infection in spite of vaccination.
Developed a rash in body and unusual mottling in lower extremities, consisting of dark pink feet progressing to bright red and dark purple horizontal band mid calf and pink upper thighs.  Bands of differing color were very clearly demarcated. Raised red/pink rash with white centers evenly distributed on bottom of feet.  Red irregular shaped areas about noted on left chest, top of head, in folds of arms and knees. Feet bright red with maculopapular rash.  No respiratory distress; no drooling; child alert.  Epi 0.05ml given IM in Rt anterior thigh @10:44 with agreement of parent. Sent to ER @10:48.  Leaving ER @ 2:30PM and hive appeared on top of head.  Given Dexamethasone 0.5ml.  Had Pediatric follow up appointment on 6/13/14.
Approximately 36 hours after the vaccine (Day2) a large hive (Urticaria) developed on the left upper thigh and lower buttock, approx. 12 x 12 cm in size.  Initially raised swollen margin with intense itching which progressed rapidly to vessicle formation in the center with weeping/drainage that lasted over 48 hours (Days 3-4). Initial treatment was cortisone cream topical, Claritin, and topical anti-itch ointment.  Day 3 a prescription  of 0.1% mometasone furoate  cream was begun once daily, and benadryl to control the intense itch.  Additional satellite rash began to appear at Day 5 on the left side,;  the largest urticaria stopped draining day 5-6 and measured 13 x 14 cm in size.  The margins of the largest urticaria retreated to 12 x 11 cm but remained intensely itchy until Day8.    Day 6-8  additional outbreaks of intensely itchy rash developed on both  upper thighs and buttock.  Physician appointment Day 8 is planned.
left sided chest  pain started day following second Pfizer vaccine dose.  tactile fever. presented to Hospital ED 9/9/2021. found to have elevated troponin and ST elevations. Admitted to PICU .  Treated with NSAIDS. ECHO  done 9/10 showed  fair LV function with EF 55%, no effusion. Serial EKGs stable.  Pain resolved with NSAIDS . Cleared for discharge on 9/12 with outpatient cardiology follow up. Discharged on motrin and ppi
Information has been received from a physician concerning two 17 year old female who on an unspecified date were vaccinated with a 0.5 ml second or third dose of GARDASIL. Subsequently the patients experienced muscle pain. Subsequently, the patients recovered from muscle pain. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
pt recvd vax 16OCT95;19OCT95 irritable, cry, arching-15NOV dx Hdydrocephalus-shunt
Fever; Chills; Achiness; nausea; flu-like symptoms; waking up over night; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on Left upper arm via an unspecified route of administration on 27Jan2021 2:30/3 PM at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took first dose (lot number: EJ1685, EXP: 31Mar2021) at 4:30 PM for covid-19 immunisation. Caller says she got this number from the pamphlet that was given to her when she gotten her first dose of the Pfizer COVID Vaccine. She got the second dose yesterday. Early this morning (around 2 or 3 AM this morning 28Jan2021) in the middle of the night she started having flu-like symptoms. She was calling to make sure to report them and she wanted to know if it was okay to take Tylenol. She cannot remember if the people who gave her the vaccine said if she could take Tylenol if she needs it. She had a fever this morning of 100.6. She also has chills and achiness. She volunteers at a healthcare facility, which is where she got the vaccine. She will call them about it. Got the second dose yesterday 27Jan2021. She kept waking up overnight and could not get warm. She just was unable to get warm. It was early this morning. She had went to be around 11:30 PM and felt perfectly fine. She tried to drink OJ and keeps trying to drink lots of water. She ate some protein, some cheese. She was concerned not to eat because she did not want to counter balance the nausea and it get worse. She had a tinge of nausea this morning. Outcome of the events nausea and flu-like symptoms was unknown, Outcome of the event waking up over night was recovering. Outcome of the other events was not recovered.   Information on the Lot/Batch number has been requested
Initial physician report received on 21 Dec 2009: This patient (9 month old child) was vaccinated with 0.25 mL dose S-OIV FLUVIRIN (batch no: unknown) on 15 Dec 2009. No adverse event was reported.
Information has been received from a medical assistant concerning a 19 year old female patient who on approximately 14-Oct-2007, was vaccinated IM with the 0.5 ml first single dose of Gardasil. After the vaccination the medical assistant left the room and came back, the patient reported to the medical assistant that about a minute later, she "convulsed and then fainted". Medical assistant reported that when she returned to the room, she gave the patient some amonia to smell, the patient woke up and was fine. No product quality complaint was involved. Upon internal review convulsion considered to be an other important medical event. Additional information is not expected.
Blistering rash on right and left arms near inter part of the elbow near biceps and forearms
BEGAN ON 11/6 WITH FLUSHED FEELING (SHE THOUGHT SHE MIGHT BE FEVERED, FATIGUE ITCHY SKIN WITH NO VISABLE RASH, SUGGESTED SHE TAKE TYLENOL OR IBUPROFEN (HER CHOICE) AND BENADRYL IF HER SKIN CONTINUED TO ITCH. PT LEFT THE PHARMACY AREA AND CONTINUED TO SHOP.  AFTER SHOPPING SHE RETURNED TO PHARMACY AND SAID NOT FEELING BETTER, I ATTEMPTED TO CALL PCP AND SUGGESTED SHE DO SAME, AT THIS POINT RXN WITH EXCEPTION TO ITCH WAS NORMAL RXN TO SHOT. AS THERE WAS NO VISABLE RASHING THOUGHT THAT SHE MIGHT FEEL ITCHY DO TO THE FLUSHING. TRIED TO CALL PCP AFTER CHECKING WITH PATIENT TO VERIFY PCP AND WAS TOLD THEY WERE NO LONGER HER CARE PROVIDER AND I TRIED TO CALL PT AND WAS UNABLE TO REACH HER PROGRESSED TO SWELLING SAID WAS UNDER CHIN AREA AND HAD SOME TROUBLE SWALLOWING UNSURE OF THE TIMES SHE PROGRESSED TO THIS AND WAS HOSPITALIZED.
This spontaneous report was received from a pharmacist regarding an unknown number of patients of unknown age and gender. The pharmacist reported that an unspecified patient stated her unspecified primary care physician routinely administers ZOSTAVAX (lot number and expiration date not provided) (dose, route and frequency not provided) for prophylaxis, to an unknown number of patients that are less than 50 years old. No adverse effect reported. Additional information has been requested.
Patient started out with flu-like symptoms starting on the night after the vaccine was administered. Per family, patient never fully returned to baseline state of health. Patient went on to develop chest pain and presented to hospital on 12/27 complaining of chest pain. ACS was ruled out and patient was discharged home the next day with a course of Ceftin for suspected pneumonia. Patient presented to the ED again on 1/22 with complaints of weakness, chills, nausea, dry cough, and increased shortness of breath. Patient was quickly transferred to the MICU with respiratory failure and acute renal failure. Patient was treated for pneumonia but did not respond to antibiotics and all cultures were negative. Patient was subsequently treated for suspected vasculitis based on ANCA studies with cyclophosphamide and methylprednisolone but subsequently expired on 2/23.
This spontaneous report as received from an unspecified reporter via a company representative refers to one or more patients (no patient identifiers were provided). No medical history was provided. During a conference call, the reporter stated that it was possible that GARDASIL may have been given outside the recommended dosing schedule. No other co-suspected or concomitant medications were reported. No details regarding any dosing schedule were provided. Furthermore, it was determined that the call included a possible AE (dates and outcome were unknown). No further details were provided. No causality assessment was provided. Additional information is not expected.
Chest pain with elevated high sensitivity troponin level.   Echocardiogram with normal LV function. LV longitudinal strain was -19.6, which is low normal.  Cardiac MRI with no Myocarditis, but pericardial fluid.  Findings were consistent with pericarditis.  Patient was discharged to home.
mom reports pt started screaming @ 730PM on 25JAN97;mom reports pt would fall asleep for about 15min & wake up screaming;this went on all noc;mom reports screaming subsided the next day but wouldn't eat;pt saw MD 29JAN97 430PM;
Patient stated that she developed a red rash around injection site that was slightly warm to touch about 2 weeks after injection that lasted around 2 days.  She did not contact MD or Pharmacy.
Really bad stomach cramps that is getting worse; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Really bad stomach cramps that is getting worse) 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 ABDOMINAL PAIN UPPER (Really bad stomach cramps that is getting worse). At the time of the report, ABDOMINAL PAIN UPPER (Really bad stomach cramps that is getting worse) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Received 1st Dose of Heplisav-B and Received 2nd Dose from Another Manufacturer; Initial Report Received on 31-May-2022  A patient's mother reported that her daughter, a 23-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and then a second dose of a hepatitis B vaccine from another manufacturer.   No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 26-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route and injection site unknown).   On 31-May-2022, 36 days after having received the HEPLISAV-B injection, the patient received a second dose of hepatitis vaccine (unsure which one) from a different manufacturer. The patient had an appointment that day with her physician.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This non-valid spontaneous report as received from a medical assistant refers to the patient of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 23-OCT-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # M013156, expiration date: 15-OCT-2017, dose and route of administration were not reported) for prophylaxis. The patient did not experience any adverse events. Product quality complaint was not involved. Follow-up information has been received from the medical assistant on 28-NOV-2017. Information about the patient updated from an unspecified patient to a 63 year old male patient. Information about the vaccine administration had been updated.
stomach still feels uncomfortable, GI upset; decreased appettite; food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach still feels uncomfortable, GI upset), DECREASED APPETITE (decreased appettite) and TASTE DISORDER (food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach still feels uncomfortable, GI upset), DECREASED APPETITE (decreased appettite) and TASTE DISORDER (food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste). At the time of the report, ABDOMINAL DISCOMFORT (stomach still feels uncomfortable, GI upset), DECREASED APPETITE (decreased appettite) and TASTE DISORDER (food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication reported. no treatment medications reported.
Pt recvd 2 doses of Engerix-B & 2 hrs p/1st dose exp bilateral hand numbness which lasted for 6-7 hrs & resolved; p/2nd inject felt strange, then 1 hr later exp numbness face, hands; vomited & swollen @ site 1st day;