chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my neck felt swollen and tender; my lymph nodes in my neck are swollen slightly; I had chills; injection site soreness; joint aches; muscle aches; This is a spontaneous report from a contactable Consumer reported for himself. A 35-year-old male patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 25Feb2021 at 09:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. The patient medical history was reported as none. No concomitant medications were reported. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 26Feb2021 at 10:00, patient experienced chills, injection site soreness, joint aches, and overall muscle aches within 12 hours. However, those subsided by the next day (27Feb2021). The next day (27Feb2021) his neck felt swollen and tender. It still is today. Patient cannot see it in the mirror, but it is tender to the touch and he believe his lymph nodes in his neck are swollen slightly. He read this happened with 1% of patients so it seems rare but still wanted to report it. Patient did not receive any treatment for the events. The clinical outcome of chills, injection site soreness, joint aches, and overall muscle aches was recovered the next day (27Feb2021), neck felt swollen and tender, lymph nodes in his neck are swollen was not recovered.  No follow-up attempts are possible. No further information is expected.
Lethargic, temp 103, extremely agitated, fussiness, acting ill-No Other Symptoms
21JAN92 pt recvd vax @ time of inject pt exp pain radiating from inject site, to lower arm & fingers; sx absent p/30 seconds; 23JAN92 pt phone clinic & reports intermittent pain upon movement of lt arm @ posterior elbow;
Vesicular rash to back, arms and legs. Fever X 1 day. Mild case of varicella disease.
Tingling @ inject site & feeling of vax migrating are reported in a pt receiving 1 dose of flu vax;
Patient states on the evening of the 26th into the 27th she did not sleep well because of the pain in arm. When she woke up on the 27th she could not move arm more than 2" from body. She started w/ROM exercises. She continued to work but on Sunday 8/3/13 she went to an urgent care center and then had an OV at dr office on 8-6-13.
ACTHIB was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride ACTHIB diluent, with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1-year-old male patient, HIB (PRP/T) VACCINE [ACT-HIB] was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride acthib diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 20-Jul-2023, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UJ735AA, expiry date: 07-Aug-2023) via intramuscular route in unknown administration site for immunization.  On 20-Jul-2023 the patient had an event of acthib was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride acthib diluent, with no reported adverse event (product preparation error) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  It was unknown if any lab data/tests available.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
VACCINE EXPOSURE DURING PREGNANCY; ANXIETY; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced anxiety. On 12-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine exposure during pregnancy and anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
got the shot and shingles to follow/Suspected Vaccination failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and shingles to follow/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that his/her dad got the Shingles shot and shingles followed up. The patient stated it was worse case ever. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
PATIENT FELT VERY FATIGUE DAY AFTER VACCINATION AND LATER DEVELOPED A RED RASH ALL OVER BODY.
I was orienting alongside second nurse. We drew up vaccines for two children, ages 6 years old and 9 years old, who are sisters. We verified the correct vaccines for each child, and placed the vaccines that each nurse was to administer in separate trays. When administering the vaccines, I accidentally gave the client an additional MMR (the other nurse had given an MMR in the other arm). There was a last minute change on what vaccines the nurse orienting me wished to give. However, I should have been more diligent in verifying that I had the correct vaccine for the correct patient. We immediately reported the event to our supervisor, and informed the parent that a mistake was made. At the time of discharge, the patient did not have any adverse effects.
Within few hours had headache, nausea. That night had chills, body aches, cramping. By next morning had loose stools. Spent 3 days in bed only able to keep down crackers and Sprite. By fourth day did have some improvement but nausea and bouts of diarrhea continue,
This spontaneous report as received from a physician, via a company representative, refers to a currently 19 years old female, non-pregnant patient. No information on medical history, concurrent conditions or concomitant drugs was provided. It was stated that the patient received all three doses of GARDASIL on an unspecified dates in 2010 (reported as "on schedule"); doses, routes and sites of administrations, lot# and expiration dates not reported. On an unknown date in 2013 the patient presented to the physician's office with unspecified symptoms and was diagnosed with rheumatoid arthritis. The outcome of the rheumatoid arthritis was not recovered/not resolved. Relatedness between the GARDASIL and the adverse event was unknown. Additional information has been requested.
Relapse of ITP: 18 year-old female with immune thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011 following treatment with Rituximab.  Relapse in early April, 2011, followed administration of Gardasil vaccine on 10-26-10 and 1-7-11.   Relapse of ITP led eventually to death from intracranial hemorrhage on 07/06/2011.
menstrual cycle came which lasted 8-10 days of heavy bleeding; experianced spotting; This is a spontaneous report from a contactable consumer (mother). A 17-years-old female patient received BNT162B2 (BNT162B2, solution for injection, batch/lot number: EW0164, expiration date: Aug2021) dose 1 via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation (at the age of 17-years-old). The patient's medical history included nuts allergy and muscle spasms from an unknown date and unknown if ongoing Concomitant medication included ascorbic acid (C-VITAMIN) taken for an unspecified indication, start and stop date were not reported, chlorophyll (CHLOROPHYLL) taken for an unspecified indication, start and stop date were not reported. after the first dose her daughter experienced spotting (on 25Apr2021) for 4 days and then her menstrual cycle came which lasted 8-10 days of heavy bleeding (30Apr2021). it was so excessive bleeding that patient had to change pads a lot. Caller stated it has slowed down since yesterday. The patient usually only spots the day before she gets her period. When the patient came on her cycle, she bled heavy and could not go to work and was changing her pad every 1-2 hours. The caller had the patient take an iron pill. The patient's period finally eased up on day 10 and started slowing down. Today, 13May2021 the patient only had to change her pad once. The patient's second dose is due the 20May2021.  The outcome of event spotting was unknown, whereas the event heavy bleeding was recovering.  No follow-up attempts are possible. No further information was expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was reported.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not provided. No treatment medications were provided.   This case was linked to MOD21-069212 (E2B Linked Report).; Sender's Comments:  MOD21-069212:
pt had rash from thigh up to waist. itching. He took a bath in the evening and had rash after that. He took one dose of Benadryl and got better
Patient described difficulty swallowing. Post shot, first pfizer patient flagged down medical staff with difficulty swallowing. Evaluated by EMT. Dr advised 50 mg PO Benadryl for reaction.  Walked to friends vehicle after fiven 50 mg Benadryl per Dr
8 days after receiving the MMR-Varicella vaccine, patient exhibited a localized rash on lower back which spread to entire torso posterior & anterior face neck shoulders & thighs. Red on clavicle area & rash like sandpaper. Fever 3 days spiking to 102 degrees. Active lymph nodes & glands in neck & shoulders. Inflamed left tonsil with exudate. Tongue coated white. Lighter rash on forearms. Difficulty swallowing with sore throat. ER on 3rd day.
they gave a patient expired Pentacel, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a two months old male patient who received first 0.5 ml dose of expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5573AA, other lot C5427BA, Exp. Date 13-Oct-2019) via unknown route in the right deltoid on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HEPATITIS B VACCINE for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He started throwing up Tuesday morning. He spiked a temperature of about 101 degrees. I had tested positive the day before, so I called the pediatrician and they said it may just be a COVID-19 infection as well. They said to try treating the symptoms and if they got worse to go to the ER. He spent yesterday and today vomiting. He has been running fevers, so we?ve been treating that with Motrin and Tylenol. Last night he also developed a slight wet cough. The vomiting has stopped. He has a slight fever right now, but it has not gone over 100 degrees.
Pts throat felt itchy, she felt like her tongue was tingling. Normal Vital signs, O2 sat 98%, no hives, no difficulty sipping water, speaks without difficulty. Pt was transferred to medical center for evaluation
Chills about 12 hours after the dose. Woke up with slight headache and body ache and it worsened throught the day. I napped for 3 hours and still feel the same. I haven't taken andy additional meds. for symptons yet. Will likely take tylenol.
did not go for second dose; This case was reported by a consumer via and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in late December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not go for second dose for various reasons and decided to postpone until now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter provided very limited information when asked. The reporter gave a consent to follow-up with health care professional. However, he did not have the name of the facility, full mailing address, phone/fax number and an email address to health care professional at the time of the call. The reporter chose not to provide his personal email address. The VAERS details were reported fopr 1st dose of Shingrix.
pt recv vax 1JUL96 in lt deltoid by 3JUL96 pt had devel 6-7cm circular edematous area circa inj site which has not resolved;swelling is soft, non-red, skin temp nl, w/o pain on palpation;
Inappropriate age at vaccine administration; Fever; Chills; bodyache; Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-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) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (bodyache). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, SEIZURE (Seizure), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (bodyache) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.   No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events Seizure, Pyrexia, Chills, and Myalgia, a causal relationship cannot be excluded.  This report also refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Seizure, Pyrexia, Chills, and Myalgia, a causal relationship cannot be excluded.  This report also refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.
On 11/20/06 this well 13 YO male had Hep BW3 and 1-1 1/2 hours after Hep B # IM the patient felt dizzy, lightheaded and had a tickle in her throat. Her school nurse did BP 100/80 P 98. Her mother took her at me request to urgent care where she had angioedema (throat swollen and lips swollen) and hives. She was treated for anaphylaxis with IV fluids, Epinephrine and Benadryl and IV steroids and released to home care.  04/02/2007 MR received for an ER visit for c/o feeling dizzy with a tickle in her throat 1 hour after 3rd Hep B vax.  While in the ER a rash developed on her back. PMH: none.  Allergies:  none.  Meds:  none. PE:  Slight eyelid edema, initially erythema at the site which resoved with Benadryl. Clinical Impression:  Allergic reaction to hep B shot.
husband contracted Covid after receiving the Moderna vaccine lot 057M21A; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (husband contracted Covid after receiving the Moderna vaccine lot 057M21A) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (husband contracted Covid after receiving the Moderna vaccine lot 057M21A). At the time of the report, COVID-19 (husband contracted Covid after receiving the Moderna vaccine lot 057M21A) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No treatment medications were reported No concomitant medications were reported    This case was linked to US-MODERNATX, INC.-MOD-2023-714020 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714020:Wife case
Day 1 Post SHINGRIX #1 injection: Woke to chills, 101 oral temperature, headache, Right arm soreness, mild swelling and some redness at injection site. Rested, then alternated taking Extra-Strength TYLENOL (2 tabs) with ADVIL (4 tabs) every 4 hours and drinking water. Symptoms persisted throughout day with oral temperature not below 100.6 until 8:00 PM.
pt brought to ED in hospital via EMS with CPR in progress; pt never regained pulse, PEA on monitor; pt had a positive COVID test on 1/24/22 from family practice
03/24/2021 inflamed joints  the whole body to start it is now  06/30/2021 lower back left hip and right big toe still in very much pain! I have just been patiently waiting  for it to subside.
Rapid heart beat (200 bpm) occurring during physical exercise.  Heart palpitations.
Within hours severe headache, both head and ocular.  Very swollen arm with beet red from shoulder to elbow.  By following day extremely ill with flu like symptoms, affected all muscles bones and back ache.  Couldn?t hardly move for two days, third day still pretty sick but up and moving.   Ruffed it out no treatment, my husband talked with pharmacist who said it was good I got the booster.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017; dose and route not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.