chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unkonwn gender. The patient's drug allergies and pertinent medical history was not reported. On 17-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385 and expiry date: 10-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
COVID POSITIVE VIA NURSING FACILITY, WEAKNESS, ACUTE CONFUSION, COUGH, AND MUSCLE PAIN
Patient's arm developed redness that spread around the injection site. Arm was painful and patient experienced fever and chills. Patient took ADVIL for the pain. Patient states that symptoms are improving.
swelling in the lymph nodes; painful lymph node; This is a spontaneous report from a contactable HCP (patient). A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9264), via an unspecified route of administration, administered in left arm on 04Feb2021 16:00 (at the age of 33-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (Lot number: El1283) on 14Jan2021 at 16:00, administered in right arm. The patient did not receive other vaccines in four weeks. Medical history included asthma and allergy to Sulfa. She did not have COVID prior vaccination. Concomitant medications included sertraline, montelukast sodium (SINGULAIR) and chlorphenamine maleate/ibuprofen/phenylephrine hydrochloride (ADVIL ALLERGY AND CONGESTION RELIEF). On 06feb2021 at 08:00 the patient experienced swelling in the lymph nodes in neck and painful lymph node. The patient reported that when she woke up around 08:30 or 09:00 she noticed swelling in the lymph nodes in her neck. The patient stated that they were tender and painful on one side. She stated it was the left side only in which the vaccine was given in her left arm. The swelling was very visible and is where her neck and shoulder meets. The patient did not receive treatment for events, and she was not COVID tested post vaccination. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
near syncope, hypotension, nausea/vomiting, tachycardia (120-150) within 5 minutes of administration. did not resolve and worsened within 1 hour. Pt went to ER for workups. Received IV benadryl without improvement.  Admitted to hospital overnight for continuous cardiac monitoring. Improved overnight and discharged in the afternoon 12/24/20.
BAD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. 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 bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious.  Version created to amend previously reported information on 27-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Localized redness, swelling left upper arm - subcutaneous tissue mild tenderness area 4 x 3 inches.
Fever (T-Max was 100.9); body aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 18Dec2020 at 10:30 (at the age of 37-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not receive any other mediations within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (temperature maximum (T-Max) was 100.9), body aches, and fatigue on 18Dec2020 at 13:30. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: T-Max of 100.9 on 18Dec2020 and nasal swab: negative on 04Jan2021. The patient did not receive any treatment for the events. The clinical outcome of fever (T-Max was 100.9), body aches, and fatigue was recovered on 19Dec2020 at 22:30.
The patient had a positive PCR for COVID-19 on 4/4/2022.
Four-and-a-half hours after receiving the vaccine I became cold and started shivering/trembling (mostly above the waist). My teeth were chattering also. After 20 minutes of this I went to bed and pulled on a warm blanket. This seemed to help, but the trembling continued. I found that if I took a deep breath and relaxed, the trembling would subside, but only for 10 seconds or so. After about 40 minutes of this, the trembling diminished and I could fall asleep. I slept for almost an hour and then returned to my daily life. I had no temperature but my face felt flushed.
blisters on his hands as well; rash on both hands; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th March 2022, the patient received the 1st dose of Shingrix. On 19th March 2022, 2 days after receiving Shingrix, the patient experienced rash. In April 2022, the patient experienced blister. On an unknown date, the outcome of the rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the rash and blister to be related to Shingrix.     Additional Information: GSK receipt date: 22-Apr-2022 Reporter's comment: The case was reported by patient's wife on behalf of her husband who was also on the call as the consumer.  The patient stated that he received the Shingrix vaccine and two days later he developed a rash on both hands. The patient stated that the rash still persists. Less than 2 months after vaccination, the patient was now developing blisters on his hands as well.  Gave medical disclaimer.  Referred to health care professional.  Spoke as per package insert and content.  Consented to follow up.
I started with red spots on my right deltoid about 30 hours after vaccine administration. By 36 hours I started feeling my deltoid with lumps. The next day, my hives/redness was larger along with the swelling and tenderness of lumps. By the end of the 2nd day, my deltoid is very swollen/red/warm and causing pain and tingling to entire arm.
no symptomatic side effects reported for the patient; Inbound call from HBP reporting a patient was inadvertently administered PROQUAD after it's expiration date. No temp excursions reported for the product and no symptomatic side effects reported for the patient.; This spontaneous report was received from Healthcare Business Partner (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 16-MAR-2023, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status has been verified as recombinant human albumin (rHa), lot #U028180, expiration date was reported as 08-MAR-2023 (expired product administered), for prophylaxis (strength, dose, anatomical location, and route of administration were not provided); and sterile diluent solution for injection/infusion, lot #U028180 has been verified to be invalid, expiry date was reported as 08-MAR-2023 (strength, dose, route of administration, and indication were not provided). No temperature excursions were reported for the product and no symptomatic side effects were reported for the patient (no adverse event).
UNDER DOSE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced under dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of under dose was not reported. This report was non-serious.
2 days post vaccine Pt reports that he experienced sever flu like symptoms with the worse being fatigue, tachycardia, and shortness of breath. He reports the symptoms lasted for about 1 day except the tachycardia and shortness of breath. He reports 8 days after onset of adverse symptoms with complaints of continue shortness of breath with walking or going up stairs. At time of visit Patient positive for tachypnea and tachycardia. Wheezes audible throughout lung fields.
"The day I received the shot I had a general feeling of un-wellness. About 45 min after being given the shot the left side of my face began to go numb but subsided after about an hour." "My Crohn's symptoms started 5 days after receiving the shot. My Crohn's symptoms have not subsided yet but are not as severe as they were last week. I have been having severe stomach pain and diarrhea. I have also began having rectal pain, swelling and bleeding. These symptoms are common with my Crohns as it is mostly in what is left of my colon. I have also been experiencing severe fatigue. Exactly 5 days after I received the shot, I had to leave work due to weakness and fatigue. This is still affecting me some." I am having her contact our Nurse Triage line and get a referral to the clinic to be seen by an MD.
pt recvd vax 21dec93; as of nov94, pt unable to walk & exp muscle weakness; recvd physical therapy 3 times/wk;
rash on the inside of both arms and around her stomach and both side of rib cage; rash itched on her right wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the inside of both arms and around her stomach and both side of rib cage) and RASH PRURITIC (rash itched on her right wrist) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RASH (rash on the inside of both arms and around her stomach and both side of rib cage) and RASH PRURITIC (rash itched on her right wrist). At the time of the report, RASH (rash on the inside of both arms and around her stomach and both side of rib cage) and RASH PRURITIC (rash itched on her right wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided
Request patient to stay 15 minutes and before the 15 minutes patient felt in the floor but did not lost conscience. Patient felt very cold and complaint of rapid heart beat and It was sweeting. Call 911 paramedics came all the test were fine. Patient was still a little dizzy after paramedics came. Relatives came and took patient home.
chills; nausea; It goes from mild then goes to a point where she feels really tired; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 13Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, after receiving the first dose of the vaccine, the patient experienced chills and nausea. The event nausea does not go away. It was mild then it goes to a point where she felt really tired. The patient wanted to know if it is normal for her nausea to last for 7 days. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PT WAS FULLY VACCINATED WITH PFIZER 3/20/21 (LOT EN6207) + 2/26/21 (LOT EL3248). PT TESTED + 8/23/21 - S/O 8/23/21
Patients arm was sore, red, and hot. went to Dr's to make sure she was ok. He gave her antibiotics.
This is a spontaneous report from a contactable pharmacist reported that a 70 year-old female patient of unspecified ethnicity received on 01Feb2018 a single dose of PREVNAR 13 (lot 574424, expiration date Dec2019, NDC number 00005197102) to prevent pneumonia and FLUAD (lot 178903, expiration date May2018, NDC # 70461000201) for immunization. Medical history and concomitant medications were not reported. In Feb2018, the patient presented some side effects or local reactions like piercing pain and swelling on the injection site. Outcome was unknown.
also now has this tremor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization; Bnt162b2 (second dose), for Covid-19 immunization. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "also now has this tremor".  Additional Information: Reporter states she would like to report a side effect that was unusual and rather interesting. States that her first 2 were fine. States that she got the booster sometime around 02Oct2021 and around 18Oct2021 she developed a tremor, a violent tremor that is controllable, she could stop it but if she didn't bother it would go on. Reporter states it is the arm where she got the shot and she doesn't notice it and if she puts her hand in a certain way it happens. While reporting the caller states the interesting thing is she has an identical twin sister and she got the booster and she also now has this tremor. Reporter states her sister's name was withheld and she had the Pfizer Covid booster.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101454971 Same reporter/drug/event, different patient.
Pt recvd 3rd dose of vax on 20APR92 & devel low grade fever (99.2 to 100), & felt achy & uncomfortable; On 16MAY92 sx were resolved & pt returned to work;
A little over an hour after shot: Numbness on back of tongue, lasted about 1 hour after shot 3.5 hours after shot: Swelling and small lump formed on left wrist, last appx 16 hours  2 days after shot: Small lump and soreness along the left collar bone area, lump, soreness still ongoing (as of 2/5/2021, date of this report)  2 days after shot: Soreness in both breast, still ongoing (as of 2/5/2021, date of this report)
Vaccine given 8/31/21 9/25/21 left temporal lobe hemorrhage, acute cerebral venous sinus thrombosis, hypercoagulable state, stroke
Pt vaccinated with MMR/DTP developed severe swelling X reddness at vaccine site (4X10CM area).
Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine.    The morning of the 26th (day 3 after vaccine)  , I woke up and felt great.. I took my normal 4- 5 mile run.  I felt a little  dizzy , & hungry when I ran (not my  normal)  , got home had diarrhea  1 x ,  then for next two days  very faint GI discomfort and I had   fever for two days , temp range 99-100
Started out as red splotches like rash. Splotches first noticed approximately 2-3 days after Anthrax vaccination. Diffuse urticarial, no angioedema, no wheezing, no palatine itching.
VG on worksite delivering covid #1 dose of vaccine Pt was approx 10 min into her 15 min observation time and had sudden dizzines- no LOC, dyspnea, emesis or cough.  She reports feeling well prior to the vaccine and ate a good breakfast prior to work. No allergies or prior issues with vaccines   She reported PMHx: predm and chronic myalgias for which she takes neurontin- no other meds   Vitals: Pox 99%, P 79, BP 118/82 Appears well   Pt was provided an apple juice and immediately felt back to baseline and wanted to return to work - reviewed symptoms to call clinic to go to hospital for
significant arm burning et flu like s/sx which started the evening after receiving vaccine.. Sx lingered for approximately 48 hrs Kept well hydrated et took tylenol 650mg po q 4 hrs which helped. Feel "back to normal" today 1/13/2021.. lots of sleep!!
A Patient Received a Dose of Heplisav-B by Error; Initial Report Received 06-Sep-2019  A physician reported that a patient (unknown age, race, and gender) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization by error.    Relevant medical history and concomitant medications were reported as unknown.    On an unknown date, the patient previously completed the Engerix-B (hepatitis B vaccine) three series vaccine.   On an unknown date, the patient was administered a dose of HEPLISAV-B (lot # 933837, expiration date: 08-May-2021, and NDC # unknown).   On 06-Sep-2019, the physician reported that a patient received a dose of HEPLISAV-B by error. No further information was provided.   At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of vaccination error as non-serious. The event of vaccination error is unlisted per HEPLISAV-B.; Sender's Comments: The company assessed the event of vaccination error as non-serious. The event of vaccination error is unlisted per HEPLISAV-B.
Severe chills; nausea; headache; extreme fatigue; injection site pain and swelling; injection site pain and swelling; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 at 10:45 as dose 1, single (Lot number: HJ7221), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Nov2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Gerd" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HCT; TYLENOL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered", described as "Severe chills"; FATIGUE (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 04Nov2023 at 13:00, outcome "not recovered" and all described as "injection site pain and swelling"; NAUSEA (non-serious) with onset 04Nov2023 at 13:00, outcome "not recovered". Therapeutic measures were not taken as a result of chills, nausea, headache, fatigue, vaccination site pain, vaccination site swelling.  Additional information: Patient took also Vitamins.  No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the Dept of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working on a compliance improvement plan and has been reinstated vaccination privileges.
The patient experienced redness, itchiness, and heat along the length of her arm. The reaction began four days after the vaccine was administered.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No information on their medical histories, concurrent conditions or concomitant drugs was provided. On an unknown date, the patients were inadvertently vaccinated with doses of improperly stored VARIVAX (Merck) (dose and route of administration were not reported), lot # L000454 with expiry date 06-JAN-2017, and lot # K021485 with expiry date 03-NOV-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The same day of injection - Severe soreness at injection spot  a day after injection- Started breaking out on left arm with a hot rash  Fast heart rate and fatigue.
Dissection of the right ICA with occlusion of tthe right ICA, right MCA and portions of A1 segmenet of the ACA