chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a very sore arm by 12 hours post vaccination that was completely gone after about 48 hours duration.  This was expected.  However, the morning of Jan. 29 the injection site had moderate itching and a slight pink color I attributed to having briefly scratched the area through my sleeve.  I did not scratch again, but discovered a bright red 5 cm circle around the injection site had formed by midnight.  It is the same on Jan. 30 with mild pruritis.  It is also possible to still see the exact spot where the needle injected the vaccine.  We took a photo of it if you want it for your records.  This is not a major reaction at this time, but seems strange that it developed nine days later, with no previous visible evidence of a reaction before now.
Injection site soreness starting on day of injection and has improved today.  Headache, nausea and vomiting at least 6 times. Not pregnant but unsure if food poisoning
Knee Replacement; first dose of Shingrix vaccine on June 26, 2019; This case was reported by a consumer via call center representative and described the occurrence of knee replacement in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 9th October 2019, 105 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced knee replacement (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the knee replacement and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the knee replacement to be related to Shingrix.  Additional details were reported as follows: The patient went through a knee replacement surgeryafter administraion of 1st dose of Shingrix vaccine. The reason for knee replacement surgery was not reported. The patient was hospitalized for 2 days. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not consent to follow up. The age at vaccination for 2nd dose ofShingrix vaccine could not be deleted due to unexpected behavior.
Recipient left the vaccine location and while driving he started to feel dizzy approximately 30 minutes after receiving the vaccine.  He drove back to the vaccine site and asked to see a nurse.  He reported that he was nervous about receiving the second vaccine and had heard that you could die from the second vaccine.  It was explained that the second Moderna vaccine did not cause recipients to die.    12:22pm    BP 160/90                          HR - 118                          Pulse oximeter - 98%    12:26pm BP 150/94                        HR - 106                        Pulse oximeter - 99%    He was taken by wheelchair to the Health Office to lay down.  He rested there and drank 2-3 bottles of water.      12:33pm BP - 148/91                        HR - 95                        Pulse Oximeter - 98%    12:45pm BP - 133/84                        HR - 102                        Pulse Oximeter - 98%    12:55pm BP 137/92                        HR - 98                        Pulse oximeter - 99%    1:15pm   BP 132/90                      HR - 96                      Pulse oximeter - 98%    He continued to rest in the SWHS Health Office and a family member was called to pick him up.  He was dismissed to family member after 1:45pm.
DTAP administered 2/19/04, 2/21/04 ER visit for convulsions and temperature 105.6, Pediatric follow up 2/22/04 & 3/4/04 resulting in death 3/4/04 No new information from Med Record rec'd 01/11/2006/sr Autopsy report received which revealed COD as H. influenza infection, otitis media & febrile seizures.
This retrospective pregnancy spontaneous report was received from a currently 32-year-old female patient reporting on herself. The patient's concurrent conditions included high blood pressure. On an unknown date (reported as "when they were very young"), the patient was vaccinated with VARIVAX subcutaneously (dose, anatomical location, lot# and expiration date) as an active immunization for the prevention of varicella in individuals. The patient has been vaccinated "when they were very young". On unknown dates (reported as "in the last few years") the patient was pregnant multiple times and had multiple miscarriages. The last menstrual period date and estimated conception date were not reported and could not be calculated. The patient sought medical attention and visited physician. The outcome of the event of multiple miscarriages was reported as recovered. The causality between the event and VARIVAX was not reported. Upon internal review, the event of multiple miscarriages was considered to be medically significant.
Fine for 8 hrs after shot. Developed chills ,sore arm and headache . Fever shot up quick to 102. 8. I took Tylenol, cold pack for my arm went to bed. Woke 3 times during night soaked sheets and cold chills. Fever up and down thru next three days. Called family doctor continued to use cold pack, Tylenol and Aleve for fever alternatively. By Sunday evening still achey fever only 100.4. Arm VERY SORE feel like an orange hard under the skin. Not super swollen but large in size. I hope the last shot doesn't have this reaction.
Systemic: Dizziness / Lightheadness-Mild, Systemic: loss of hearing (which has subsided now), clogged feeling in ears (pt had hearing loss prior to vaccine but thinks this temporarily made it worse)-Mild
On April 12th, I took a pregnancy test and it was positive. I started feeling sick and feeling pain on April 26th. I started bleeding and had blood clots, which continued to April 28th. I went to the ER. I took an ultrasound and took lab work every 3 days. I was told that I may have been having a miscarriage or an ectopic pregnancy. On April 30th, I did lab work. On May 4th, I took a transvaginal and a regular ultrasound. On May 5th, the doctor believed I was having a ectopic pregnancy. On May 6th, I went in for surgery and they had to remove my left fallopian tube. I also had a D&C.  I suffered a miscarriage.
LATENT TUBERCULOSIS; JOINT PAIN; INJECTION SITE SWELLING; RED SKIN/MARK AT INJECTION SITE; CHILLS; This spontaneous report received from a patient concerned a 64 year old female of unspecified race and ethnicity. The patient's weight was 178 pounds, and height was 69 inches. The patient's past medical history included: migraine, and covid-19, and concurrent conditions included: non alcoholic, non tobacco user, bee sting allergy manifested by skin rashes, and crohns disease. The patient experienced anaphylactic reaction when treated with infliximab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 and expiry: unknown) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination (Dose number in series 1). Concomitant medications included calcium, clonazepam, colecalciferol, colestipol hydrochloride, ergocalciferol, isoniazid, mesalazine, methocarbamol, metoprolol, omega-3 nos, thiamine hydrochloride, trazodone hydrochloride, zolmitriptan.  On MAR-2021, patient experienced chills but other than that no other side effects. patient had chills for a couple hours, missed a few hours work. On MAR-2021, After blood work and patient tested positive for latent tuberculosis. patient was hospitalized (date unspecified and for unspecified days) due to this. On an unspecified date, the patient experienced joint pain, injection site swelling, and red skin/mark at injection site. On JUN-2021, Laboratory data included: Liver function test (NR: not provided) Normal function. On an unspecified date, patient stated a pulmonologist did a chest x-ray on her and everything came back clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from latent tuberculosis on 2021, and chills on MAR-2021, and the outcome of joint pain, injection site swelling and red skin/mark at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211218498-COVID-19 VACCINE AD26.COV2.S- Latent tuberculosis. 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).
This is a spontaneous report from Pfizer Medical Information for a contactable reporter who reported for her son. This 13 month old, male consumer received PREVNAR 13 (expiration date: 696157) on 01Jul2013 single dose on his right upper thigh as a preventative vaccine. There was no relevant medical history as well as relevant concomitant medications. The patient developed red lump (red, firm, and raised area) on 01Jul2013 evening and a red firm on the vaccination site, which did not required treatment and had pain since 7:00am on 02Jul2013. There was no relevant laboratory data. The therapeutic measures included MOTRIN since 02Jul2013 at an unknown dose every 8 hours for pain. The consumer was still experiencing the events at the time of the report. The physician stated the mother called and reported the red spot on the leg, but the physician never saw the patient for the problem. The reporter could confirm the occurrence of the events. The reporter and was willing to be contacted again by Pfizer for follow-up information on the reported adverse event. Follow-up (23Jul2013): New information received from a contactable physician includes: expiration date; onset date; reporter informed about the event; reporter confirmed the events; reported confirmed further contactability. Follow-up (09-AUG-2013): Follow-up attempts completed. No further information expected.
No adverse event; Received expired 2nd primary dose, beyond 12  hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 011B22A and 011B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022 at 10:50 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2022 at 10:50 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture). No concomitant medications were reported. On 03-Oct-2022, at 03:18 PM the vial was first punctured. Dose was administered post 12 hours of puncture. Vial was stored in room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was19 hours and 30 Minutes. Vial did not undergo any temperature excursions. No treatment details were provided.
Had some pain at the time of initial injection but nothing extreme. Patient reports that he developed pain in his left arm and shoulder with a sensation of numbness and cold feeling within 1-2 days of his vaccine.    Also reported some muscle twitching.  Had pain and numbness in left neck for the first week which has now resolved.  No significant redness or swelling of his left arm.  He is now 31 days post vaccine and the symptoms are not fully resolved.  Continues to note some pain in his left shoulder and sensation of weakness if he uses his left arm a lot.    He did have some typical fever, chills, headache, bodyache for a couple days after the vaccine as well - but the arm symptoms were less typical.    On exam over telemedicine, he has full range of motion in his shoulder with mild discomfort with external rotation - states it feels like something is in his shoulder.  He has no redness or swelling.  On self-palpation, he notes no swollen axillary nodes.
debilitating horrible back issues; This case was reported by a other health professional via call center representative and described the occurrence of back discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced back discomfort. On an unknown date, the outcome of the back discomfort was recovered/resolved.   It was unknown if the reporter considered the back discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The reporter stated that, the patient had debilitating horrible back issues within a couple days of 2nd dose of shingrix for 1 or 2 weeks. Till the time of reporting, the back issue recovered. The patient unsure if the back issue was related to Shingrix vaccine. The reporter did not consent to follow up.
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a male 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 MYOCARDITIS (myocarditis) (seriousness criteria death and medically significant). The reported cause of death was Myocarditis. It is unknown if an autopsy was performed.            No Concomitant drugs were reported.  No Treatment information  were reported.  Company comment:This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the serious unexpected fatal event of myocarditis(seriousness criteria death and medically significant). Patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on unknown date, with Myocarditis and death occurring within a month of dose.The reported cause of death was Myocarditis.The rechallenge was unknown since there's only information about the second dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  It was reported that, the reporters' father died within a month after his 2nd shot from myocarditis. Just months before his vaccine, he had a full physical, when he was given vaccine he was  in perfect health.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced the serious unexpected fatal event of myocarditis(seriousness criteria death and medically significant). Patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on unknown date, with Myocarditis and death occurring within a month of dose.The reported cause of death was Myocarditis.The rechallenge was unknown since there's only information about the second dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: myocarditis
No additional AE reported; syringes broke/ the second broke after administration to a patient on 23MAR2023; the second broke after administration to a patient on 23MAR2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 23-MAR-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 ml 1DS X 10 syringes (lot#: W027275, expiration date: 09-JUL-2024, NDC: 00064329-03; does, anatomical location, and route of administration were not reported) for prophylaxis. The syringe broke into pieces at the Luer lock after administration (syringe issue and poor quality device used). There were no difficulties trying to attach the syringe needle to the syringe. The syringe was not supplied by the company and the size was a BD safety glide needle 23-gauge, 1 inch. The syringe tip cap was attached to properly prior to use with intact and undamaged status. No additional adverse event (AE) was reported (no adverse event).
bruising at the injection site; red rash at the injection site; swelling at the injection site from elbow to the shoulder; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (red rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site from elbow to the shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), ACETYLSALICYLIC ACID (ASPIRIN 81), CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, METOPROLOL TARTRATE (LOPRESSOR), ATORVASTATIN CALCIUM (LIPITOR), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Apr-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 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 16-Apr-2021, the patient experienced CONTUSION (bruising at the injection site), VACCINATION SITE ERYTHEMA (red rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site from elbow to the shoulder). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, CONTUSION (bruising at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (red rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site from elbow to the shoulder) outcome was unknown.
Information has been received from a physician concerning a white female who on 04Mar99 was vaccinated in the right leg with a first dose of varicella virus vaccine live (lot628694/1663H). On 01Feb06 the pt presented to the office with chickenpox. The outcome was reported as recovering. There was no product quality complaint. Follow up information indicated that the pt recovered. There were no diagnostic lab tests. There were no adverse events following prior vaccinations. Additional information has been requested.
I experienced a  extremely painful kidney stone I was in so much pain that I was vomiting, I went to the hospital and the doctor determined that the kidney stone was too large to pass so they suggested surgery to remove it. I also experienced blood clots in my lungs and I am now on blood thinners to treat the blood clots in my lungs called Eliquis.
Patient was given the vaccination and within minutes she developed a large knot or bump just above the injection.  The raised area was the size of a half dollar and was painful to the patient.  Ice was placed on the arm immediately and the arm was monitored.  Patient remained seated with the ice on her arm for about 10 minutes.  She then decided that she would rather go home and place ice on it and take a diphenhydramine that she had at home.  At about 10:45 am, I called the patient to check up on her.  She said the area was warm to the touch and the raised area was hard to the touch, but she felt okay.  I called her again at 5:20 pm and she said she was doing okay, but still concerned and the area was very sore.  I spoke to her the next morning and she said it was still swollen, red and tender to the touch and it looked as though it was bruising.
1/13/2021 I was feeling fatigue, pain on the vaccine site & I felt very low on energy. It lasted for 1 day only.
Fever; Nausea; Diarrhea; Vomiting; fever/sweats; Chills; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 26-years old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included thalassemia, anaemia, bipolar 2 disorder. Concomitant medications included iron supplements (FLINSTONES VITAMINS). The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 23:00, the patient experienced fever, nausea, diarrhea, vomiting, sweats, chills and vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, nausea, diarrhea, vomiting, sweating, chills and vertigo was recovering at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
PATIENT RECEIVED 2N DOSE OF MODERNA COVID-19 VACCINATION ON 5/18/2021. PATIENT RETURNED TO THE PHARMACY ON 5/19/2021 AND PRESENTED VISIBLE REDNESS AROUND THE ADMINISTRATION AREA ON THE LEFT ARM. PATIENT ALSO REPORTED ITCHING AROUND THE SAME AREA. PATIENT DID NOT EXPERIENCE A REACTION AFTER THE 1ST DOSE. PATIENT TOOK  BENADRYL TO RELIEVE THE SYMPTOMS BUT HAD NO RELIEF. PHARMACY ADVISED PATIENT TO APPLY COLD COMPRESSES AND PROVIDED UPDATE TO THE PHARMACY IN THE NEXT FEW DAYS.
Patient received anthrax vaccine (right upper arm) on 25 Jul 07 and that day developed red raised pruritic papules around the injection site. Since that time, he develops almost nightly similar lesions that can spread from elbow to shoulder.  The lesions present prior to falling asleep and persist into the morning but self-resolve within a few hours of awakening.  No treatment attempted except patient has applied OTC moisturizers that have not resulted in any relief/resolution.