chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at the injection site on my arm; Aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Mar2021 11:10 (Lot number: EL3248) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "Soreness at the injection site on my arm"; PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "Aches"; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
My wife has gotten the vaccine and now she has covid for the second time; My wife has gotten the vaccine and now she has covid for the second time; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My wife has gotten the vaccine and now she has covid for the second time".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received FLUARIX QUADRIVALENT. This case was associated with a product complaint. On 18th November 2015, the patient received FLUARIX QUADRIVALENT. In December 2015, 30 days after receiving FLUARIX QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, runny nose, cough and respiratory tract congestion. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the vaccination failure, influenza, runny nose, cough, respiratory tract congestion and pharmaceutical product complaint were unknown. The reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the runny nose, cough, respiratory tract congestion and pharmaceutical product complaint to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The patient stated that, since receiving the FLUARIX QUADRIVALENT she had been sick twice, once in December (approximately one month after vaccination) and again at the time of reporting that is in February. The patient experienced the same symptoms each time, runny nose, cough, and chest congestion. The patient stated that, her husband received the same vaccination at a different pharmacy and has not been sick at all. The patient felt that, the vaccine she received was part of a bad batch. She did not have a physician and has not been seen by a health care provider for her symptoms. This case was considered as suspected vaccination failure case since, the time to onset of the events, the lab test confirmation for influenza and the exact details for the target disease were unknown.
This spontaneous report was received from a registered nurse refers to a  5 year old patient. On 06-DEC-2012, the patient was vaccinated with first dose of MMR II. On 15-JAN-2013, the patient was vaccinated with second dose of MMR II. Other suspect therapies included PROQUAD which was administered on 19-JUL-2013. No adverse effect was reported. Additional information has been requested.
The following morning I was extremely tired and had a headache, chills and a fever.  I felt hot and cold and sweaty.  Zero energy.  When I tried to eat lunch it sort of came up in an acid liquid - indigestion?  I pretty much slept for 32 hours which is completely weird for me because I have a lot of energy and am really active!!!  I was awake only to try to force myself to eat and to text a little.  I got up last night to eat dinner at 9pm then slept all night again!!  crazy.  almost back to normal today
TIA with aphasia/right hand weakness- fully recovered.  On 5/7/21, took a nap after work, when he woke at 6:45PM, realized he couldn't read - knew it was words, but seemed jumbled, so went to talk to his wife but he was speaking jumbled words. He could understand her speaking and hear himself, just couldn't respond in words. Wife called 911, by the time EMS arrived sx were resolving. When EMS arrived, he was evaluated and found that his right hand was slightly tingly/tired.  ABCD2 score of 5 for HTN BP>140/90, speech disturbance , weakness, sx <60 min.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-330408, MOD-2021-330845 (Patient Link).
Complaining of leg swollen, red and pain. Entire thigh inner/outer, groin to knee is red, swollen and warm. No difficulty with ambulation.
Breakthrough case COVID-19 after fully vaccinated with 3 doses of Pfizer. Sore throat, nasal congestion.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient received first covid vaccine dose - no allergies - does not routinely get vaccinated but was not nervous per patient - about 5 minutes after his dose he felt faint and fell down quickly he needed water and was sweating. Patient began to feel better but had the EMS check him out anyways and escort him out after a waiting period to make sure he was ok. His BP was normal.
Severe inflammation and pain in left axillary lymphs; Severe inflammation and pain in left axillary lymphs; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown, via unspecified route, in left arm on 21Apr2021 15:30 (at 47-years age) 1ST DOSE SINGLE for covid-19 immunisation. The patient's medical history included Migraines, past drug advil. The patient's concomitant medications included vitamin D, zinc, magnesio in within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient had experienced severe inflammation and pain in left axillary lymphs. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt states that he passes out just about every time he gets bloodwork and vaccination. Pt lost consciences: blood down heart rate up: Pt was never unstable, maintained sat greater than 95%. Pt quickly became alert and oriented xs 3: responding well within minutes. vital signs stable. pt talking immediately: BP stabilized. drove home. pt refused transport to hospital by ambulance.
A patient received a dose of VARIVAX, then on 09/25/2019, the patient had a positive urine pregnancy test; This spontaneous prospective pregnancy report was received from a physician concerning to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 17-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, for prophylaxis (strength, dose, frequency, lot # and expiration date were not provided), then on 25-SEP-2019, a urine pregnancy test was performed and showed that the patient was pregnant (exposure during pregnancy). The gestation was 4 weeks and 3 days as of 30-SEP-2019. The last menstrual period was estimated as 30-AUG-2019 and the estimated date of conception was estimated to 05-JUN-2020.The pregnancy outcome was outcome pending.
Frequent Body Stiffness , neck stiffness , back pain and leg pain, headache
Pt left the counseling room and walked around the store for about 5 min. She then said she was feeling heart palpitations, sweaty, and light headed, ran to a chair to sit down and then fainted. The person who was with her woke her up thankfully and we called 911. The patient said her breathing was not affected and that she was allergic to epinephrine, so I did not give her an epipen. The EMS rep directed us not to give any food or drink. When EMS arrived her blood pressure was less than 90/60 and they carried her out in a chair and brought her to the nearest hospital. They did not allow her to stand yet. After regaining consciousness we learned that she got off a plane last night, slept late this morning, only ate a lentil flat bread a few hours prior to getting the vaccine and was already taking Benadryl and Zyrtec.
Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throughout entire body, had very bad chills, and was unable to sleep. By 9 am I was finally able to sleep one hour and awoke sweating, but chills had subsided. Body aches did not subside until Wednesday morning (vaccine was administered Monday).
Developed shingles on the left side of body; Started having PVC's whenever lying down; Nerves on left side & upper left thigh kept twitching; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Started having PVC's whenever lying down), MUSCLE TWITCHING (Nerves on left side & upper left thigh kept twitching) and HERPES ZOSTER (Developed shingles on the left side of body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Left) and Hysterectomy. Previously administered products included for Breast cancer: Tamoxifen. Past adverse reactions to the above products included Premature ventricular contractions with Tamoxifen. Family history included Autoimmune disorder (Family history.) since an unknown date.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (Started having PVC's whenever lying down) and MUSCLE TWITCHING (Nerves on left side & upper left thigh kept twitching). On 09-Mar-2021, the patient experienced HERPES ZOSTER (Developed shingles on the left side of body). At the time of the report, VENTRICULAR EXTRASYSTOLES (Started having PVC's whenever lying down) and HERPES ZOSTER (Developed shingles on the left side of body) had resolved and MUSCLE TWITCHING (Nerves on left side & upper left thigh kept twitching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Electrocardiogram ambulatory: 1 pvc (Inconclusive) Experienced 1 PVC during the 24 hour period..         No concomitant medications were not reported. The treatment information was not provided.  Post vaccination on 18-MAR-2021 patient took an Echocardiogram at cardiologist's office. On 23-MAR-2021 cardiologists reported that the events were triggered from neurological factors. The events were recovered after two weeks.   The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-216609 (Patient Link).
5 days after PREVNAR 13 vaccination patient had redness and soreness at injection site. Site was warm. MD is treating her w/ KEFLEX for cellulitis.
Patient developed swelling, redness and knot under skin at site of injection. Arm is sore when moved. She thinks she may have a slight fever. Counseled to use ibuprofen and apply ice pack.
Significant Vertigo starting 2 days after lasting for 3 weeks after each shot.; ''Apparent dopamine receptors blocked for the same time period''; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in left arm on 30Mar2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 08:00, the patient had experienced significant vertigo starting 2 days after lasting for 3 weeks after each shot and ''apparent dopamine receptors blocked for the same time period.'' The symptoms stopped abruptly 3 weeks after each injection. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant vertigo and ''apparent dopamine receptors blocked for the same time period'' was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Patient had a vasovagal response after the COVID vaccine. He was seated, saw his own blood and warned me. He began to start blacking out. He had full conciousness, only loss of sight and difficulty hearing for about 5 minutes. I took his BP while he was seated, 104/54 (he reports a normal BP around ~110/60).  He sat until he regained sight and drank a full bottle of water. I continued to watch him for an additional 15 minutes and retook his BP= 116/58. Patient informed to call the pharmacy at any time for questions, follow up, etc. Full recovery, patient reports being fine and went about his day.
Patient was sitting in chair and fainted, would not respond to sternal rub or name. Called rapid response and was taken to ED. Patient was not responding for 2 minutes, proceeded to take vitals and gave him some orange juice in case low sugar. Took vitals and patient had low BP, felt cold, all other vitals were WNL. Taken to ED after about 15 minutes where they ran tests and made sure patient was okay.
Power outage. Vaccine FLUMIST should have been discarded from stock 11/23/10. Discovered 12/7/10 pt vaccinated 11/24/10.
she felt a rash on her arm and the area close to her breast.; she had a fever; she felt cold then warm; she became tachycardic; pulse going up to 110 bpm versus her normal rate of 70-80 bpm.; She began sneezing; a runny nose; and was congested.; Her eyes had a lot of water but she could breathe.; She could not sleep last night.; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0176) via an unspecified route of administration on 03May2021 (at the age of 43-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that within 1st hour after vaccination on 03May2021, she became tachycardic with pulse going up to 110 bpm versus her normal rate of 70-80 bpm. By the 2nd day on 04May2021, she felt cold then warm which felt different to her as she had never felt like that before. By the 3rd day on 05May2021, she had fever which she considered normal. On 06May2021 she felt rash on her arm and the area close to her breast. She was sneezing, had runny nose, and was congested. Her eyes had lot of water, but she could breathe. She reported that she could not sleep at night. The events were reported as non-serious. She asked what to be done. The patient underwent lab tests and procedures which included heart rate: going up to 110 bpm on 03May2021. The outcome of all the events was not resolved.   No follow-up attempts are needed. No further information is expected.
tested positive for COVID 9/19/2021 at Hospital- asymptomatic for covid- went to hospital r/t kidney stones
Patient is a 32 yo G2P1001 with EDD 5/2/2021 by 7w US. She had the first dose of the Pfizer Covid 19 vaccination on 12/17/2020 at the Health Clinic and the second dose on 1/7/2021 at 1115 am. She began having abdominal pain and vaginal bleeding at 315 sm on 1/8/2021 progressing to a previable (22w2d) preterm birth at 739pm on 1/8/2021.
Received first dose 2/13/21. Received second dose 3/12/21. Both doses received at same pharmacy. Jaw numbness 90 minutes after injection on both 1st and 2nd doses. Headache 90 minutes after both 1st and 2nd doses that lasted a couple of hours. Jaw tightness on both sides with 1st and 2nd doses. Ears kept popping after 2 nd dose. Arms felt heavy and tingling on 1st and 2nd doses. Had a itch patch 8 days after 1st vaccine. Chills one hour after vaccination on second dose. Had fever (101), chills and a headache on day 2 after second dose that lasted all day until late evening.
Patient states had 2nd vaccine on 2/9/21 - reports injection site red, warm, slightly swollen body aches, headache on/off, fatigue and states lymph nodes under L armpit was swollen.
Large hives that were itchy on my knees, elbows and face. These persisted for 4 days and were most active at night. I took Benadryl when this happened.
Thurs (1/13/2022) afternoon, my son received a booster shot.   Friday, he complained of headache and muscle soreness from his shoulder to his knee.  On Friday night, he started having chest pains, high heart rate, sweats.  Saturday morning, he told us, his parents, about the chest pains and that it hurt badly enough to keep him awake all night.  I took his bp, temp and heart rate.  bp was high, temp was 99.3, heart rate was 120.  We contacted his pediatrician who recommended we go to an ER with imaging.  We went.   My son's father has a clotting disorder, that was disclosed at the ER.
The LPN inadvertently reconstituted MENVEO powder (MenA lyophilized conjugate component) with MENACTRA vaccine instead of the MenCYW-135 Liquid Conjugate Component). She injected the vaccine into the 18 year old patient. This was discovered during the inventory of vaccines and verified today 7/12/2018 by the LPN. DH notified and CDC consulted. Patient stated she did not have any extra redness or pain at the site of injection when asked. Per the CDC recommendations, the vaccine should be repeated. The provider was informed and decided not to repeat the vaccination. No known adverse effects.
Two weeks after vaccine started feeling having congestion,  sinus problems and really high fevers between 102 - 105. Was prescribed Amoxicillin, felt better after a few days.
DEBILITATING ILLNESS; ASSISTED SUICIDE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced debilitating illness (dose number in series 2). On JUN-2023, the patient died by assisted suicide (dose number in series 2). It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the debilitating illness was not reported. This report was serious (Death).; Sender's Comments: V0: 20230723101- assisted suicide. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: ASSISTED SUICIDE
Injection was too high on the shoulder. Needle went into shoulder capsule. Pain was immediate and didn't clear for 2 weeks. Now 8 months later I have been diagnosed with SIRVA and Frozen Shoulder. I have had 2 MRI's 1 Xray, 5 Medications, 2 PT Sessions and 5 GP appointments, 1 Acupuncture Treatment and 1 Orthopedic visit. PT and Orthopedic will continue for 6mos to 1 yr. I am unable to work, do daily activities, sleep in a bed, exercise due to constant pain.
Developed red splotch on each cheek one day following vax; Seen in ER tx DPH & EPI;