chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee developed skin itching after Hepatitis B injection #2. Began around 30 minutes to 45 minutes post injection. No hives. Took Benadryl over the counter with some relief but it made her very drowsy so she quit taking it.  Over the next few days she reported joint aches, fever, mucous membranes peeling around mouth and nose. Also experience some nausea and stomach upset that has resolved. Itching continues 6 days later but is less than the first few days. Still no rash or hives.
6 days after her 1st COVID vaccine, pt developed joint pains and rash. Her left TMJ was stiff and painful. Also had aching in joints in bilateral knees, right hip, left jaw. She also developed bilateral leg itching. Had particular itching over a varicose vein in her L medial calf. Itching and rash spread up to her hips, and also had rash/hives on her bilateral elbows. Last night developed hives over her R lateral ankle.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 13-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Localized redness and swelling to entire Left Thigh, both anterior and posterior as of 01/21/2023. Skin is blanchable but warm to the touch. No discharge from injection site. Pt is afebrile. No symptoms of anaphylaxis or facial swelling. No decreased ROM to either leg.   Right Thigh has a small area of redness around injection site but not nearly as severe as Left thigh. No swelling or warmth to R thigh.
Patient woke up day after receiving vaccine with a few spots on her body. Thought she had shingles so went to doctor. Talked to doctor, he said he didn't think it was shingles but treated her with acyclovir and mupirocin.
as soon as he got the covid vaccine he starting feeling significantly better his resporitory issues went away and he feels a lot better; as soon as he got the covid vaccine he starting feeling significantly better his resporitory issues went away and he feels a lot better; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "respiratory issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "as soon as he got the covid vaccine he starting feeling significantly better his resporitory issues went away and he feels a lot better".  Additional information: The patient said that he was having respiratory issues before receiving the 1st dose of the covid vaccine and said that as soon as he got the covid vaccine he starting feeling significantly better his respiratory issues went away and he feels a lot better wanted to thank Pfizer for all of their hard work and is excited to get the 2nd dose of the covid vaccine. Faxing for possible AE with respiratory issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called pharmacy one day after receiving her flu shot (9/20/13) indicating the site of injection is swollen, red, and warm to the touch.
Sleep apnea, arthritis. Headache. Major depression, anxiety, fibromyalgia.
As described by the patient: Patient (driver) was feeling anxious, received the shot and almost immediately started to see white spots and was dizzy. The patient asked to be directed out of the vaccine lane (prior to proceeding to the post administration area) to just get some air. The patient got out of the car, felt dizzy and fainted. Patient fell to the ground in a sitting position. Patient was assessed by BLS and refused transport.  Patient switched positions and allowed his passenger to drive off scene.
Inc yever 104 to 104.5 w/in a few hrs p/vax vomited, dry heaves, extremely sore arm 3 days;
Possible interaction between allergy shot and Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INTERACTION (non-serious) with onset 03May2021, outcome "unknown", described as "Possible interaction between allergy shot and Pfizer COVID vaccine".  Additional information: The manufacturer, start date, NDC number and expiry date of Pfizer COVID vaccine were not reported. The patient got allergy shot a half hour after his first dose of Pfizer COVID vaccine and wanted to know if it would mix with his second dose of Pfizer COVID vaccine.The stop date of the event was unspecified.Other Products and Investigation Assessment was not provided.Reporter seriousness for possible interaction between allergy shot and Pfizer COVID vaccine was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  No treatment drugs were reported.   This case was linked to MOD-2021-369020, MOD-2021-368822 (Patient Link).
I had moderate pain in my right leg, just above my knee, for several days.  It felt like a muscle strain.  It was likely due to a blood clot following my Covid 19 vaccination.
This spontaneous report was received form a physician concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot No. reported as L004104 Expiration date: 04-MAR-2017) (dose, route and anatomical location of administration were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient was anxious to receive vaccine. vaccine was administered. Patient started feeling light headed. We asked her to sit down. Patient said she was light headed and dizzy and hot in temperature. Patient stated she has not eaten anything since the morning.
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jun2021 (Lot number: ER8736) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Nickel" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Bnt162b2 (lot number EW0164, dose number 1, vaccine location Left arm), administration date: 26May2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Jun2021 20:45, outcome "recovered", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.   Follow-up attempts are completed. No further information is expected.
fever and chills for <24 hours. Low back pain and muscle pain that started 1 day  after vaccine, has persisted for 5 days. Patient had similar symptoms with prior COVID infection in November 2020. Patient has muscle spasms in low back with no associated injury or heavy lifting.
ARM FELT WARM & SLIGHTLY ITCHY ABOUT 2 INCH WELT THIS MORNING 11/08/2012 7:00 AM FEELS MORE PAINFUL & SLIGHTLY ITCHY ABOUT 2 INCH RED WARM WELT.
Fever that has gotten as high as 105.4, rash that was on his behind and spread up his back. At times appeared lethargic and dazed.
patient was administered expired daptacel vaccine, no AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (dose number: 4) (lot C5254AB, exp.date: 18-Sep-2019) via intramuscular route in right Vastus Lateralis on 20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
Unproperly thawed vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Unproperly thawed vaccine administered) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Unproperly thawed vaccine administered). At the time of the report, PRODUCT ADMINISTRATION ERROR (Unproperly thawed vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Around 1/27/21 patient noticed numbness of bilateral legs and progressive weakness.  Admitted to hospital 1/29/21 and diagnosed with Guillen Barre.  Initially paresthesia was from feet to groin and has been improving.
Patient was given Moderna Bivalent Booster 0.25mcg and was to be given 0.5mcg. Patient was given wrong dose.
some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular in the left arm on 17Dec2020 16:15 at a single dose for COVID-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, Factor V Leiden, GERD (Gastroesophageal reflux disease), DVT (deep vein thrombosis), hypertension, neck pain on left side, rhinitis, and rhomboid muscle strain. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone nasal spray, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone, and sodium chloride nasal spray. The patient had no other vaccines in four weeks before covid vaccine. The patient had no prior vaccination and she had not been tested post vaccination. The patient noticed some numbness on the right side of face after receiving the first dose of vaccine on an unknown date. She was concerned for early Bell's Palsy on 15Jan2021 at 09:00 AM. She will be treated with valganciclovir and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events early Bell's Palsy and some numbness on the right side of face was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "concerned for early Bell's palsy". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Evening of the day I received the vaccine was just a headache.  Took Ibuprofen and it went away.  Also very tired. Day after the vaccine, very tired, arm was getting sore and by the afternoon I had a low grade fever of 100 and chills.  Slept most of the day.  By that evening, started having pain in my right armpit and along the side of my right boob, along up into my shoulder blade. The fever went away but continue to have pain in my right armpit with swelling, right pectoral muscle, arm, and shoulder blade.  Is also hurting in my right arm as well.  This has continued through for 3 days, and I'm assuming will be like this for another while. Using ibuprofen and hot compresses to help with the pain.
17 people were given vaccines during improperly stored; This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 02-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(rHA, recombinant human albumin) lot # S035110, expiration date: 03-MAY-2021, 0.5 milliliter (dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine was exposed to the temperatures: -13.9 Celsius degrees (C) to -14.7 Celsius degrees, in the following time frames: -14 C to -10 C (-13.9 C): for 30 minutes; -14 C to -10 C (-14.2 C) for 15 minutes; -14 C to -10 C (-14.7 C) for 20 minutes and -14 C to -10 C (-14.6 C) for 5 minutes, as recorded by digital data logger.
pt recv vax 22DEC96 & approx 7JAN97 pt devel a macular papular rash all over body that was pruritic;rash appeared to be more severe on extremities;also devel some petechiae;
Patient was given Covid 19 shot instead of the flu shot. Patient had already received 3 doses of the Covid 19 with the last dose given on 10/01/2021
ringing in both ears; This is a spontaneous report received from a non-contactable consumer, the patient. An adult patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 25Feb2021, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, the patient experienced ringing in both ears. The patient did not receive any treatment for the event ringing in both ears. The clinical outcome of the event ringing in ears was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information:Patient initials updated from "PRIVACY" to "UNKNOWN". Relevant Med History: None added. Final sentnence was updated from "Information about lot/batch number cannot be obtained.   No further information is expected." as "No follow-up attempts are needed; information about lot/batch number cannot be obtained."
I experienced itching over 100% of my body. PCP suggested Benadryl and report to UC if symptom did not resolve. I reported to UC who prescribed Prendisone. After the Predisone was used the itching stopped and the gastric issues started. It is now 7 months later and I'm still struggling with the aftermath. I need help!
Child started "jumping" & mom could not get child's mouth open. Seen at ER had temp of 103.9. Given Tylenol.  Improving w/o further complications on 11Jan91.
Seizures lasting 15 minutes, vomited while unconscious, fever 102.7 EMS transport to ED, required BVM to support breathing O2 Sat 90%.
Two days after received the J&J Janssen vaccine I developed soreness in my right lower leg in the calf muscle. The pain was intense and localized. At the time a vein looked to have popped up and was noticeably visible under the skin. The area also developed a bruise about 3 inches diameter around the area of pain and the area where the vein popped up.  I talked to a doctor relative of mine, she said I likely had a minor blood clot and to take some aspirin over the next few days. Also said to be careful because blood clots can move. The pain and bruising went away in about 10 days.
"covid arm": inflammed/red, itchy, tender, and painful oval on the skin a couple inches distally away from injection site First noticed 3/24/21 8:00AM. 1"x2" oval Grew continuously at least until today (3/26/21 3:00PM) to 4"x6" oval, still distal from injection side  Other adverse events: 3/22/21 7PM: fever; 3/23/21: fever, chills, nausea, dizziness/unsteadiness; 3/24: fever, nausea after eating, dizziness/unsteadiness, headache; 3/25: nausea after eating, headache <-- All of these other adverse events have resolved by 3/26/21.  Same adverse effects, though to a lesser degree, after 1st dose in series.
Patient was seen on 2/3/17 for lumbar strain, received 2nd dose of HPV vaccine. Patient and family flew on 2/4, patient awoke in morning with fever, malaise, headache. Then after landing, headache returned vomiting x2, with altered mental status and petechial rash. Admitted to Medical Center from 2/4-2/7. Had lumbar puncture, started on CFTX/Vancomycin for presumed meningitis, then had drug allergy- hives and perioral edema. Switched to Meropenem and Linezolid, acyclovir. Mild leukocytosis- cultures, RPR, strep cultures negative Blood cultures negative CT showed subtle hypodensities in supratentorial white matter, MRI recommend MRI.
felt weak; pain in their arm; Headache; little pain in their muscles; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (patient 1 had a headache), ASTHENIA (felt weak), MYALGIA (little pain in their muscles), NAUSEA (nausea) and PAIN IN EXTREMITY (pain in their arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced HEADACHE (patient 1 had a headache), ASTHENIA (felt weak), MYALGIA (little pain in their muscles), NAUSEA (nausea) and PAIN IN EXTREMITY (pain in their arm).            This case was linked to MOD21-024814, US-MODERNATX, INC.-MOD-2021-029243 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-024814:Patient 2 US-MODERNATX, INC.-MOD-2021-029243:Crosslinked case
About two hours after the shot I experienced swelling face, eyes and itchy eyes. My heart rate also steadily increased. Benadryl eased the symptoms in 30 minutes to an hour.
The hospital ER called HD at 13:30 on 7/18/02 to report that baby was having 2 episodes of focal type seizures. No fever. Thought possibly related to vaccine. On 7/17/02 or 7/18/02, child saw pediatrician and as of 7/18/02, child at hospital being evaluated. There may be another underlying reason for the seizures. The 60 day follow up states the child has had five hospital visits since the initial VAERS report. He is still having seizures and is still undergoing tests to determine cause. The follow up received on 10/1/03 states pt has not returned to so a call was made to the family. The father reported "pt still has a lot of disabilities. Both mental and physical and no one is really sure that they were caused by vaccine or that they were not." Annual follow up on 11/21/2003: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  11/17/2003: Patient still has seizures and is lethargic all of the time.  Patient has low immunity and gets sick a lot because of it.  Patient was hospitalized and received a G-tube in Dec 2002.  They are not sure that the vaccines caused problems but, he never had any problems before he received the vaccines and then hours later he was having seizures reports his mother. "
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INJECTED LIMB MOBILITY DECREASED (can not lift up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021 at 8:00 PM, the patient experienced PAIN IN EXTREMITY (sore arm) and INJECTED LIMB MOBILITY DECREASED (can not lift up). At the time of the report, PAIN IN EXTREMITY (sore arm) and INJECTED LIMB MOBILITY DECREASED (can not lift up) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR  information received on 08JUL2021 contains significant information outcome recovered.
One week after the vaccine on January 19th, I noticed a rash on my left arm around the site of the vaccine. By later that day, it was red, about 4 inches long and 2 1/2 inches wide, oval shaped. It had small blisters all in it and my skin felt very leathery. It also was very itchy, not painful.I went to my Primary Care doctor the next day. They prescribed Benadryl and a prescription for a hydrocortisone cream, which I have used for 6 days. Today, the 24th of January, it is finally fading. The blisters are not visible and the leathery feeling is gone.