chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My throat swelled; This spontaneous case was received on 01-Mar-2021 with additional information received on the same day (being process together) from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00438) and concerned a 54-years-old female patient.  The patient's medical history and concomitant medications which she was taking on daily basis were not reported. The patient's historical vaccine included flu vaccine with no reaction ever.  On an unspecified date in Sep-2020, reported as Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; indication, dose, route of administration and anatomical location: not reported). The batch number reported was 276554.  On the same day in Sep-2020, reported as Sep-2021, reported as four hours after receiving Flucelvax Quadrivalent, the patient's throat swelled.  The outcome of the event was not reported.  The reporter assessed the event to be related to Flucelvax Quadrivalent. The patient had a reaction to that flu shot. The patient wanted to know which ingredient exactly caused her reaction.   The event of 'throat swelling' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Case updated on 12-Mar-2021: Correction made to information received on 01-Mar-2021: Start date for vaccine administration and onset date of the event changed from 'Sep-2021' to 'Sep-2020'. Narrative updated accordingly.   Company comment: A 54-year-old patient was vaccinated with Flucelvax Quadrivalent. Four hours after receiving Flucelvax Quadrivalent, the patient's throat swelled. Chronology is suggestive. Causal role of the suspect vaccine is assessed as possibly related.; Reporter's Comments: The patient had a reaction to that flu shot. The patient wanted to know which ingredient exactly caused her reaction.; Sender's Comments: A 54-year-old patient was vaccinated with Flucelvax Quadrivalent. Four hours after receiving Flucelvax Quadrivalent, the patient's throat swelled. Chronology is suggestive. Causal role of the suspect vaccine is assessed as possibly related.
burning; hot pain too sensitive to touch; sensitive to touch; affect sciatic nerve uncomfortable; under stress sick husband; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a 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 burning sensation (Verbatim: burning), pain (Verbatim: hot pain too sensitive to touch), touch sensitivity increased (Verbatim: sensitive to touch), discomfort (Verbatim: affect sciatic nerve uncomfortable) and stress (Verbatim: under stress sick husband). The outcome of the burning sensation, pain, touch sensitivity increased, discomfort and stress were not reported.   It was unknown if the reporter considered the burning sensation, pain, touch sensitivity increased, discomfort and stress to be related to Shingles vaccine.   It was unknown if the company considered the burning sensation, pain, touch sensitivity increased, discomfort and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that a burning, hot pain too sensitive to touch, it affected his/her sciatic nerve so was very uncomfortable.  The patient had the shingles vaccine also but had been under lots of stress with a very sick husband. The follow up would not possible as no contact details were available.
sore arm , increase heart rate, feverish ,fatigue was prescribed triamcinolone ointment but couldn't confirm if it was for the arm (unable to reach patient via phone, i wasn't present when the patient reported the side affects)
Patient received flu vaccine after that poke hurt/no AE; Initial information received on 03-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves adult and unknown gender patient received flu vaccine after that poke hurt (vaccination site pain) after receiving vaccine INFLUENZA VACCINE.  The past patient medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious patient received flu vaccine after that poke hurt (vaccination site pain) (same day) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the batch number for this case for influenza vaccine.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has received vaccine Tuesday and will be receiving second dose but he tested positive for covid and wanted to know what to do. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, cough, confusion and fever on 3/27/21. He was started on supplemental oxygen, remdesivir, and dexamethasone and was admitted to hospital for 3 days.
PT c/o vertigo and lightheadedness immediately after post vaccination at 11:02 am. Pt transferred to post observation cot via w/c. VS at 11:10 am with PT supine were HR 95 BP 144/88 O2 sat 100. PT c/o nausea,? clammy?. PT states that she feels better laying supine with cold pack and knees bent.  PT sat up and reports a decrease in nausea, requesting H20 and tolerated drinking without emesis. Continued to monitor; PT anxious, but without agitation and was affable. PT presented with HTN (does not believe she has a hx of HTN, except for preeclampsia with my twins), though PTs BP did drop once when attempting to sit. (See below for progression of vital signs) PT recovered BP quickly and reported feeling better at 1147, denies dizziness/nausea and shakiness?. PTs VS improved after bathroom visit, PT was able to stand without VS change at 1208, verbalized that she was feeling better. PTs appearance had returned to baseline. At 1219, after further monitoring, PT exited facility accompanied by daughter, reports she will be at home with family today.    1110 BP 144/88 HR 95 O2sat 100 supine    1114 am HR 108 BP 160/100 O2 sat 100%   1119 BP 146/96 HR 94 O2sat 99% sitting did not tolerate well resumed supine position    1122 BP 142/88 HR 87 O2 sat 100%   1126 BP 150/88 HR 94 O2sat 100% sitting    1137 BP 104/70 HR 105 O2sat 100% sitting and immediately reverted to supine position   11:38 BP 132/80 HR96 O2sat100% Pt states feels much better   1150 BP 168/96 HR 103 O2sat% 100. sitting   1201BP 130/84 HR 71 O2sat 100% post bathroom break    1205 BP 144/98 HR81 O2sat 100%   1208 BP 136/8 HR 89 O2sat 100% standing
Fever 100.6; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiry date: Unknown), via an unspecified route of administration at left arm on 25Feb2021 at 08:45 AM (at the age of 39-years-old) at single dose for COVID-19 immunisation. Patient had historical vaccine received first dose of BNT162B2, lot number: EL3247 at left arm on 05Feb2021 08:45 AM for COVID-19 immunisation. Patient did not have allergies to medications, food, or other products and also did not have medical history. Concomitant medication was not reported. No other vaccines within 4 weeks prior to the COVID vaccine and No other medications within 2 weeks of vaccination. On 25Feb2021 at 09:30 PM the patient experienced fever 100.6 on. The patient underwent lab tests and procedures which included fever (Body temperature): 100.6 on 25Feb2021 at 09:30 PM. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The reporter reported seriousness criteria as non-serious. Patient did not receive any treatment for the event. The outcome of event was recovering.
Woke up in the middle of the night shivering uncontrollably. I have a fever of 101.5 Could not sleep the rest of the night and kept shivering uncontrollably. In the morning I had a throbbing headache and very achy all over.. I felt that way the rest of the day. The fever lasted all day as well. Today (11/6/21) I am feeling a bit better but still a little bit of a headache  It was a very horrible experience. I never felt that sick in my life.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2023, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-Mar-2023 Reporter's Comments:  Licensed vocational nurse (LVN) states that an expired dose of Bexsero was administered to a patient yesterday. The health care professional (HCP) did not have lot number at the time of call but should have it for follow up. The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received Bexsero after expiration date, which led to expired vaccine used.
Case number PHEH2015US004138 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 13 months old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 05 Feb 2015, which reached 31 degree Fahrenheit for two hours. No adverse event was reported following this administration error.
Client with dyspnea at 1135, epi given at 1136, client refused EMS. oxygen saturation level 100 percent on room air, MD determined lungs sounds clear to auscultation, client waited 30 more min. felt fully recovered and admitted most likely anxiety as cause for dyspnea. Client left in no apparent distress.
"Pfizer-BioNTech Covid 19 Vaccine EUA" // reaction: syncope, nausea, drowsiness, headache, weakness, flu like symptoms- lasting for 1.5 days.  treatment: rest, advil, Tylenol, soft diet with small meals, liquids, bedrest. 2 days after vaccine, still tired- arm not sore but axillary lymph nodes are swollen.
suspected Vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's Comments: The reporter did not have the lot number or expiration date.  Daughter of patient was reporting that her mother completed her Shingrix vaccine series with her 2nd dose on 17th August 2019 and currently had shingles. Consent was not given to contact health care professional. The reporter did not consent to follow up. Additional Supportive Information: 2nd dose received on left arm. This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
I received the shot on 1/19/21 and on 1/27/2021 I developed a hot, swollen,  itchy circle on my arm. It has grown in size since yesterday
Pain/soreness on the injection site few hours after shot w/c didn't go away up to this point. Consistent soreness.
Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started about 6/7 hrs post injection. Increased in severity the next day. Non-issue as of 3/24
Information has been received from a physician assistant concerning a 17 year old female who on 01-AUG-2008 was vaccinated with GARDASIL vaccine (yeast) intramuscularly (site unspecified) (Lot #: 660612/0229X). On 02-AUG-2008, after receiving a dose of GARDASIL vaccine (yeast), the patient experienced fever, vomiting and muscle aches. Fever, vomiting and muscle aches lasted 24 to 48 hours. Subsequently, on 07-AUG-2008, the patient recovered from fever, vomiting and muscle aches. It was not specified whether the patient sought medical attention. Additional information has been requested.
No additional AE; Vaccine expired on 06/18/2023 and was administered on 06/20/2023.; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 20-JUN-2023, the patient was vaccinated with first and expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) rHA injection (lot #U019290 was valid, expiration date not reported but upon internal reviewwas established as 18-JUN-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Patient had not reported signs/symptoms of adverse effects. No additional adverse event (AE) (No adverse event) and product quality complaint (PQC).
Vaccine administration on 3/20/01 PM, reaction on 3/21/01 PM; deltoid area below elbows was red, swollen and warm. No puss, non-tender. Saw pt on 3/22/01 and symptoms still present.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-MAR-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) that was reconstituted with Sodium Chloride instead of sterile diluent. No adverse effects were reported. No product quality complaint (PQC) was involved.    Additional information has been requested.
Swollen arm, red and hot on Saturday, Iced Saturday. Sunday temp. and ache in joints.
SEVER JOINT AND MUSCLE PAIN FOR SEVERAL DAYS AFTER THE VACCINATION.
Child in for routine well visit 16 years old. Immunizations due Bexsero #1, Menactra #2, and HPV #1. Nurse administered Bexsero vaccine in Left Deltoid and patient had near syncopal episode. Nurse immediately notified MD, got vital signs, checked Bs, all WNL. Gave patient something to drink. Mom gave child piece of candy and stated that child always has near syncope episodes with Injections,Lab draws and Procedures and she forgot to tell Nurse. Child rechecked by MD and reported feeling fine again. Observed a while longer and then patient left with mom feeling fine.
Case number PHEH2014US021970, is an initial spontaneous report received from a medical assistant on 30 OCT 2014. This case refers to a 41 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601), intramuscularly on 30 OCT 2014, which was reached 33 F for 16 hours. No adverse event was reported following this administration error (incorrect storage of drug).
Menstruation cycle started earlier than expected (by over a week) and lasted longer than typical (by two days at the time of the submission of this form). The patient is trans masculine, so while his sex is legally male, he does still menstruate. This cycle is not more severe than typical in terms of pain, but the patient is still reporting the adverse event so that there may be data collected through official means and not just on internet platforms.
Cough elevated temperature, dry cough, runny nose clear drainage, probable viral illness/URI.
Raised erythematic wheal about 3" in diameter visible injection location - became itchy. Better now still raised & red not as bad.
Nausea, legs felt like jelly, weakness, unable to drive herself home from college class.
Pt describe that he had debilitating "kidney pain" for two days after recieving first dose of Moderna shot. He states that  he nearly went to the ED because it was so intense.
Flu shot administered in right deltoid--sore at injection site same day. Next day progressed to swelling under arm at right axillary--generalized swelling, not large nodule. Patient stated not hot or red; just painful and swollen. Encourage patient to see physician.
Hive-like rash spreading arms/legs -> torso, started around 24 hours after vaccine. No other known exposures. Tx; BENADRYL ->hydroxyzine, prednisone
Patient was given 0.5mL of the Pfizer vaccine instead of 0.3mL. She called about an hour later complaining of a headache.
Patient received smallpox vaccine and Anthrax #2 on 02/21/2003.  4 days later, he had flu-like symptoms, sore throat, headache.  He was seen by PCP and prescribed with 2-pac, motrin, and cough syrup.  Smallpox site at day 8 with 1/2 blister with 1/4 in erythema around the blister.
called and reported dizziness; called primary provider and told to take Meclazine; stated not any better; advised to seek care at PCP/urgent care or ER and not to drive
Immediate(3-5 seconds) and rapid injection site swelling and redness, bleeding more than usual from a shot, dizziness, full body sweating, rapid heart rate, hives, as well as general body swelling that caused great difficulty in starting an IV. I did not have any significant issues with breathing. They treated me with a IV fluids, an intramuscular injection and IV injection of Benadryl and a steroid that I cannot recall the name of, I apologize.
TEMPERATURE EXCURSION. Vaccine was stored in freezer longer than manufacture recommendations. Patient did not have any adverse reaction.
crazy episodes of hiccups next day .  3 periods of hiccups lasting one to two hours all afternoon..by  night time it was gone ?..i rarely have hiccups ever ..the fact it went on for hours while i was feeling not so hot from the shot  made it pretty unique to the shot and stopped when the side effects did
2 days after child received DTaP #4, mother returned with him to clinic because he developed localized immunization reaction (R) thigh with redness, warmth and swelling. No fever. 9x7 cm erythema, macular rash, circular in shape. ? of cellulitis. Dr examined and treated the pt. Cephalexin 125mg/5ml tsp 4x day for 5 days. To follow up if symptoms do not improve. Temp 97.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: pt was not responding well, urinated on self and felt nauseas. Pt is on hospice and felt dizzy even before the vaccine.-Mild, Systemic: Nausea-Mild, Additional Details: Pt was dizzy and fell 02/21/21 at the site; paramedics called; refused to be hospitalized. Pt vaccinated 02/22/21, was dizzy and urinated on self,  paramedics called, refused to be hospitalized. Staff told vaccinators then that pt was hospice and own guardian, so nothing could be done.
PT'S ARM HAS BEEN SORE, ON AND OFF, SINCE HE RECIEVED HIS VACCINE.  AS THE WEATHER HAS GOTTEN COLDER, THE SITE IS SORE MORE OFTEN.  STRETCHING CAUSES SORENESS.
Vaccination Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination Adverse reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-significant FU: enquiry regarding case number On 30-Jun-2021: Non-significant FU: enquiry
This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 9th May 2018). On 15th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia. On an unknown date, the outcome of the myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia were unknown. It was unknown if the reporter considered the myalgia, headache, fatigue, nausea, shivering, autoscopic phenomena and insomnia to be related to SHINGRIX. Additional details were provided as follows: The patient experienced reactogenicity greater than with dose 1 and believed these symptoms were related to the vaccine. She was experiencing out of body feeling which was unusual for her. She was feeling better on the day of reporting morning and anticipated continuation of improvement in symptoms. She preferred not to be contacted for follow-up.