chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.  No treatment information was provided.
pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PCR confirmed Monkeypox; Case reference number US-BN-2022-004665, is a spontaneous case report initially received from a physician via Agency (reference number: USBAV22-1943) on 11-Nov-2022 and concerns a patient of unknown gender or age.  The patient medical history included human immunodeficiency virus (HIV).  The patient's concomitant medication was not provided.  On unspecified date, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: unknown), at unknown dose, route of administration and anatomical location, for indication reported as to decrease the incidence of monkeypox.  On unspecified date, an unspecified amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at unknown dose, route of administration and unknown anatomical location.  On unspecified date, as reported one month after second Jynneos vaccination, a polymerase chain reaction (PCR) test confirmed the patient had monkeypox.   At the time of this report, outcome of event monkeypox was unknown.  The reporter assessed the event monkeypox as non-serious and related to Jynneos vaccination.   Additional information received from the physician via Agency on 11-Nov-2022: New information included seriousness and causality assessment for event monkeypox.  Additional information received from Bavarian Nordic on 14-Nov-2022 included the local BN case ID.  This case is linked with US-BN-2022-004662, US-BN-2022-004663, US-BN-2022-004664, US-BN-2022-004666, US-BN-2022-004667, US-BN-2022-004668, US-BN-2022-004669 (same reporter).; Reporter's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after the second dose of Jynneos vaccine was administered to decrease the incidence of monkeypox. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.; Sender's Comments: A patient of unknown age and gender developed serious event monkeypox (medically significant) one month after the second dose of Jynneos vaccine was administered to decrease the incidence of monkeypox. Monkeypox is unlisted per the CCDS v1 and the PI. The patient's medical history included human immunodeficiency virus (HIV). Concomitant medications were not reported. Considering that the vaccine is non-replicating and does not contain monkeypox virus, monkeypox has been assessed as not related to Jynneos.
Patient felt fine after the vaccination, no ADR's reported at all.  On day 10, she felt a "wave go through her body" followed by immediate diarrhea and tingling/breathing constriction in her throat.  Dizziness and headache reported with intermittent shaking/chills and leg pain that comes and goes.  Shortness of breath with exercise after patient felt she had improved enough to run.  Patient has not exercised today as she was feeling apprehensive on what is happening in her body.
My menstrual cycle was not like the usual cycle for many years. I had my period 5 days earlier.
lightheadedness pressure on forehead, flushed cheek. anxiety.  tingling on both tips of fingers.
Pt received vax 03/1999. Experienced breakthrough chickenpox 01/2000. Developed insulin dependent diabetes mellitus 02/2000. Unspecified medical attention was sought. The diabetes mellitus was considered important medical event. Follow-up was received which indicated the pt was not vaccinated with varicella virus vaccine. Therefore this id was voided from the database.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Shakiness-Mild, Additional Details: I have him the shot around 7.15 pm. he has stated that he passed out after the first dose as well and I told him we will monitor him for at least half hour. He sat on the outside chair and passed out, his wife held him and we had him lay on the floor. 911 was called and he was taken to the hospital. He came back to his consciouness after about 2 minutes.
Mom stated that she took client to PMD because her arm was red and swollen. Dr stopped client from taking TYLENOL. Continue to use cold packs then warm. Dr started client on BENADRYL OID d/T itching at site.
Hep B AG screening test showed positive. 1-17-19 (It was done 2 days after TWINRIX #1 vaccine shot). (False positive). 2-15-19 Hep B Ag Screening-Neg test negative.
Developed urticaria within an hour after; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Developed urticaria within an hour after) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Developed urticaria within an hour after). At the time of the report, URTICARIA (Developed urticaria within an hour after) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  NO treatment was provided for events.
Started running as  I always do on the weekend- I am an avid runner, cyclist, swimmer and consider myself in very good health-  Normally for my pace my heart rate would have been 144-156- it spiked to 177-181 and continue to rise.  I stopped and walked- it dropped to 168 so I slowed down and it spiked again.  With any exercise since vaccine my heart rate has been elevated.  I have had heart palpitations- two days after the vaccine and blood pressure was high for me.  Blood pressure is not back down but still slightly higher than usual- I have slowed my normal exercise routines down but I am experiencing tightness in chest.
Redness around the injection site area and swelling; Redness around the injection site area and swelling; This spontaneous case was received on 06-Oct-2020 from pharmacist via Health Authority (reference number: SEQW20-03030) and concerned a 7-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On 03-Oct-2020, on Saturday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: no reported) for an influenza prophylaxis. The batch number reported was 276578.   On 04-Oct-2020, on Sunday, one day after vaccination, the patient experienced an injection site reaction that was described as some redness around the injection site area and swelling. The patient had no hives and allergy. It was reported that the patient had no any corrective treatment.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: The events of 'vaccination site erythema' and 'vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site swelling' are assessed as related to Flucelvax Quadrivalent.
Patient came in for a 1st dose of Pfizer on 1/2/22. Father, created the appointment with an incorrect DOB. Dad attested to the incorrect DOB during registration and again with the Vaccinator/Data person. Patient received a pediatric dose (FK5127) instead of an adult dose. Father was contacted 1/3/22 to verify his son's DOB. He said the he erroneously reported the wrong DOB, but that his son was small for his age. I informed dad that his DOB was corrected and that patient would need a new card when he returns for his second dose.
April 12 - stomach pains, came and went April 15 - stomach cramps, dizzy, like was going to faint, heart palpitations, felt really hot, disoriented/brain fog, had to sit April 16 - went to urgent care, checked blood levels, normal Went to doctor on Tuesday, tests normal Pain went away Thursday
After receiving my second COVID vaccine, I experienced dizziness, shortness of breath and when tested it was determined that the right ventricle of my heart was not pacing resulting in a pacemaker being inserted at Hospital.
This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported.  On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (strength, dose and route of administration were not provided) (lot # K010215 expiry date 05-MAY-2017, K011562 expiry date 08-MAR-2017 and L040459 expiry date 06-MAR-2017). The Certified Medical Assistant (C.M.A) stated that GARDASIL was exposed to the following temperature conditions: -7 degrees C for 36 hours. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
High levels of pain and stiffness in joints, tendon anchorages and muscles. Initially concentrated in hips; migrating to shoulders joints, deltoids, trapezoid, front of pelvis, buttocks.
Information has been received from a RN concerning a 2nd grade male student who on 02/10/1998 was vaccinated with dose of varidella virus vaccine live. In mid December 2004 the student developed chicken pox. According to the school nurse, there were 58 other elementary school students who developed chickenpox in mid December. 34 of them had been vaccinated with a dose of varicella virus vaccine live. No product quality complaint was involved. Addtional information has been requested.
Influenza administered right arm; 2 inch radius around shot, red blotched and hot with touch. Arm all the way to hand tingles (next day at 1600).
Patient reported dizziness and became faint.  Patient lost consciousness for approximately 30 seconds, and was woozy and not fully coherent upon awakening.  EMS was notified and arrived within five minutes.  Upon their arrival the patient was conscious and oriented,x3, but not confident in her ability to drive home or remain alert.  Patient chose to go to hospital with EMS.  She was discharged from the emergency room later that day; no additional ill effects were reported to the pharmacy.
Case number PHEH2016US023422, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 44 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into left arm on 01 Feb 2016. On 01 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 9th April 2018 16:00, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, fatigue and pain in arm. On an unknown date, the outcome of the muscle pain, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: The case was reported by the patient's wife. The patient received SHINGRIX on the left arm. At evening, the patient started to experienced arm pain which progressed. The reporter also reported that the patient felt fatigue. The symptoms resolved approximately after a week. This case has been linked to the case US2018GSK129717, reported by the same reporter for the same patient.
chills, shivering, fatigue, muscle pain, joint pain, fever.  symptoms began approximately 12 hours after vaccination and continued for approximately 40 hours after onset.   Acetaminophen was administered intermittently for pain/fever mitigation.
Extreme redness and itchiness at injection site. Symptoms appeared several days after injection; temporarily went away after taking Benadryl and Claritin but came back days after.
Large pinkish-purple welt on upper right arm that is firm to touch, sore, itchy, warm,  slightly raised, and over 2 days grew in diameter. Can send pictures if needed.  Other symptoms: severe migraine, sinus pressure, stuffy nose, sore throat physician said looked red, cough that was neither dry or wet, and severe fatigue From my perspective, the symptoms to me were very similar to an allergic reaction I would get from a high dose allergy shot my body didn't handle well. That being said, I have not had an allergy shot after the moderna dose Doctors initially prescribed Sudafed and flonase to treat symptoms, and recommended I continue my allergy medications as prescribed and use hydrocortisone cream to relieve discomfort in the area. After the welt became noticeably bigger the next day (today; 3/17), an antibiotic was prescribed: cephalexin 500 mg to be taken 4 times a day for 7 days
Patient says within 2 days after receiving vaccine, he felt weak, stomach sick to the stomach, sneezing, coughing/wheezing, sore joints, both feet sore/uncomfortable, burning in feet, nausea, diarrhea, feeling faint, can't stand up or down, stiff feeling. He got ZOSTAVAX and FLUZONE HD on 8/3/17. He did not see or speak to MD yet. Told pt to see doctor and let him know.
Immediately after receiving the second dose of Pfizer on Tues May 18, I felt prickly sensations throughout my body. After sitting for the recommended 30 minutes (due to known allergies to previous medications), I began to feel dizzy. They monitored me in the tent for several minutes and checked my vitals, which were fine. The nurse thought I may have hyperventilated. I thought I must have just had a mild panic attack.   But the attacks did not stop. Rather, the first three days post vaccine, I had several panic attacks a day, even being woken from sleep because of them. It's not fear or a racing mind but a constant racing heart, weakness, feeling faint. I feel prickly sensations and sensation of heat, which are common in panic attacks. But even after three days, they were not letting up. In addition to the attacks, I felt lightheaded, weak and extremely fatigued, even at rest. There is also constant pain and tightness in my neck and jaws.   Thursday evening (May 20), I had an episode where I nearly passed out. Once I got seated, my body froze. I was unable to get my words out clearly. Instead of saying the full sentence in my head, I could only get a word or two out. Instead of being able to lift my arm to eat, I couldn't move. The episode lasted about 15-20 minutes. I had several of these episodes on Saturday, two on Sunday and one on Monday.   Thinking it was purely anxiety, I reached out to my psychiatrist who prescribed Klonopin to ease the symptoms. I took 0.5mg on Friday afternoon (5/21) and 0.5mg on Saturday morning (5/22).   Realizing the Klonopin was likely making my symptoms worse, I have not taken any since Saturday morning (05/22).   Most of the day I am breathless, weak, feel faint doing nearly nothing. I have an hour or so a couple of times of day where I'm more functional but still have to move very slowly. Otherwise, I'm either like a zombie or unable to speak clearly, stuttering when I speak, and unable to operate without feeling faint.
Approximately 15 seconds after administration of the vaccine the patient passed out.  The patient almost immediately regained consciousness and shook a couple of times.  The pt. reported feeling dizzy so I moved her to the waiting area, with her mother, to wait to make sure she was feeling ok and that there were no more adverse reactions.  After 5 minutes the pt. reported that her legs felt like jelly, that her head and legs felt like they were burning and that her throat was feeling dry/tight.  I gave the pt. 25mg of oral diphenhydramine and immediately called 911.  I monitored the patient and her breathing until the paramedics arrived.  Upon arrival the paramedics took over the patient care, the pt. was eventually transported to the hospital.
I contracted COVID-19 on 07/20/2022 with symptoms of fatigue, sore throat, congestion, and fever while on vacation. I did not seek care until I was back home. I was ill for 10 days during my initial illness before my symptoms began to improve. I have been experiencing lingering fatigue, and new symptoms of shortness of breath, chest pain, which hinders me from exerting myself. I am still undergoing testing and treatment. I have also been seeing a pulmonologist and have an upcoming pulmonary function test that is pending scheduling.
Have been having frequent episodes of angioedema after random foods and events. Had allergy testing and only allergic to shellfish and oysters, avoided all of these and had two 911 ambulance transports, plus numerous EPIPEN administrations since shot.
Developed severe neuropathy in right arm, face, right torso area, right upper thigh, both hands within a few hours of receiving the vaccine. Still have arm neuropathy in upper right arm, upper thigh, right side of face  and left hand. I have burning and nerve shooting pain on the surface of my skin. (The same thing happened in 2015 after I received the flu shot -- I did not get the shot in 2016 or 2017 but my employer is now requiring the vaccine so I got it this year). When it happened in 2015, the neurologist I was seeing then said the only thing I can do is double my gabapentin 3 times a day so that is what I am doing this time as well.
hives then fevers then diffuse joint pains, fatigue ongoing as of 2/5/2021
Fever of 101 for over 24 hours, cresting at 103.1 on 2nd day following injection. Slightly sore arm, body aches. Excessive chills after 24 hours and excessive sweats( drenched night clothing) 48 hours after shot. Slight nausea for about 30 minutes.
Severe abdominal pain.  The shot was given at approx 11 am.  Abdominal pain started around 6 pm, gradually got worse.  At 1 am I was awoken in pain and I took hydrocodone leftover from a previous surgery in hopes of making it to the morning for urgent care.  (ER Bills)  At 4 am I was re-awoken in even worse pain, decided I was about to die, and went to the ER.  Cold sweat on way to ER.  Throat dry.  Made it to ER, received Morphine, the first dose calmed the pain down, did not make it go away.  A lot of tests and several hours later, a second dose was given when the pain returned to its terrible state.  Approx 15 min into the second dose pain was finally subsiding (roughly 1 or 2 pm).  Went home and took Tylonal as requested by Docs and filled an Oxy prescription in anticipation of the return of the pain.  This has not happened.  Slept great last night.  Dry Mouth Persists.  Also slight arm tenderness.