chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 weeks from my last dose of Moderna Covid19 vaccine I started to experience urticaria in small areas at different parts of the body. I just tried to ignore it and thought it was just one of those that occasionally occurs sometimes. Then on the second week of March it started to occur in bigger spots and more widespread besides they now come daily. I didn't change to a new lotion or shampoo or take any new medicine throughout this time. From this point I started using topical Benadryl to ease up the itch. The urticaria continues to occur daily now but I noticed they will disappear by themselves even if I don't do anything with them. Most noticeably when I go to sleep they normally have disappeared when I wake up. Then they will appear in another spots again or sometimes in the same spot.
laying in bed as sick as ever for the past 3 days, with the flu; laying in bed as sick as ever for the past 3 days, with the flu; Initial information received on 14-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced laying in bed as sick as ever for the past 3 days, with the flu and laying in bed as sick as ever for the past 3 days, with the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.  On an unknown date the patient developed laying in bed as sick as ever for the past 3 days, with the flu (illness) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious laying in bed as sick as ever for the past 3 days, with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (laying in bed as sick as ever for the past 3 days, with the flu, laying in bed as sick as ever for the past 3 days, with the flu).  At time of reporting, the outcome was Unknown for the event laying in bed as sick as ever for the past 3 days, with the flu and was Unknown for the event laying in bed as sick as ever for the past 3 days, with the flu.
Fever 103 within 12 hours lasting 24, severe arm pain, swelling at site. Severely enlarge lymph nodes under that arm. Body aches and fatigue. Unable to stay out of bed. Leg pain when walkin
fever 102.9; Severe joint pain; body aches; headache; chills; weird vivid dreams; nausea; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: unknown), via an unspecified route of administration, on 16Jan2021 09:45 AM (at the age of 52 years old) as a single dose on left arm for COVID-19 immunisation. Relevant medical history was none. Historical vaccine history included first dose of BNT162B2 vaccine (Pfizer product) on 26Dec2020 (lot number: EL1284) on right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ergocalciferol (VIT D), ascorbic acid (VIT C) and Zinc. The patient did receive other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 05:30 PM, the patient experienced severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea. No treatment was received. The outcome of the events severe joint pain, body aches, headache, fever 102.9, chills, weird vivid dreams, nausea was not recovered.
pt recvd vax; 12jan pt woke screaming, knees drawn up, fists clenched;t 100-101, holding breath for 10 secs, rapid heart beat rate; episode lasted 3 hrs;
Breakthrough case admission after 3 vaccines ; Pfizer 3/21/21 lot# ER8727;  Pfizer 4/12/21 lot# EW0151;  Pfizer 11/10/21 lot# FF8841
This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 01-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
24 hours after vaccine,   and 7 hours after onset of expected fever/chills/aches,   triggered atrial fibrillation w/ RVR (130 BPM)     with longest duration ever experienced - 3 days .    Intent of this reporting is that patients with afib may need to choose a Covid vaccine that doesn't have the higher fever, flu symptom response  as Moderna does,   which could trigger the afib.     Was about to need to visit ER to get converted to NSR,   when self converted after 3rd day.
Shingles like rash on area around shot site approx 1" x 2 " in size. Raised red area with small blister like papules. No treatment.
more of metallic taste; something different taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (more of metallic taste) and TASTE DISORDER (something different taste in mouth) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021 at 10:30 AM, 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 26-Apr-2021, the patient experienced DYSGEUSIA (more of metallic taste) and TASTE DISORDER (something different taste in mouth). At the time of the report, DYSGEUSIA (more of metallic taste) and TASTE DISORDER (something different taste in mouth) was resolving.            No relevant concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Outcome of the events was updated from Unknown to recovering
Ringing in ear; This is a spontaneous report received from a contactable other hcp (Nurse). A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EM9810) intramuscular on 08Feb2021 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included BPH (benign prostatic hyperplasia), OSA (Obstructive sleep apnea syndrome), Hyperlipidemia, known allergies: Sulfa and Finasteride. The patient previously took finasteride and experienced drug hypersensitivity. Patient did not receive any other vaccines in four weeks. Patient received other medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and since vaccination patient has not been tested for COVID-19. On 08Feb2021 (started 5 hours after vaccine), the patient experienced ringing in ear, lasted for more than 8 days. Patient did not receive any treatment for event. Outcome of event was unknown.  Follow-up attempts completed. No further information expected.
12 hours after vaccine booster shot I got a stomach pain that was followed by breaking out in hives from head to toe. They itched terribly.  I took two benadryls (I had already taken zyzal for the evening) after about an hour the itching became tolerable and i went to sleep with hives still present.  When I woke ip in the morning the hives were gone.
Patient under age 65 administered Fluzone HD in error with no reported AE; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 36 years old female patient who was under age 65 and was administered fluzone hd in error with no reported adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Strength: high dose) lot UJN04AA and expiration date: 30-Jun-2024 at a dose of 0.7ml via intramuscular route in the deltoid nos for immunization.  On 30-Aug-2022 (Latency: same day), the patient  was under age 65 and was administered fluzone hd in error with no reported ae (product administered to patient of inappropriate age) following the administration .   Action taken:not applicable  It was not reported if the patient received a corrective treatment for the event .   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.; Sender's Comments:  01257338: 01258919: 01258920: 01258924: US-SA-2022SA365119:01258901
Prevnar given unnecessarily. Had  4th Prevnar vaccine 7/13/2020.
Rash began 2/15/03 on one arm and spread over her body. She visited her daughter where the rash intensified with itching. She sought medical care, treated for psoriasis, no improvement. Sought medical care again, treated for scabies, no improvement. Rash continued and progressed to sores with blotchy skin. Saw dermatologist. Biopsy confirmed a drug reaction. Pt blames shots but other meds were never stopped or changed. Cortisone cream and warm compresses have resolved situation.
Day 1: erythema, tenderness, lump at injection site x 1 week w/ rash. Diameter of circular rash: 2.5cm. Day 2-day 5: general malaise, weakness, dizziness. Day 3: diarrhea through day 5.  Increased aches & pains. Symptoms started to decrease after day 5. Took TYLENOL arthritis 1300 mg. day 2-6 for some relief.
Chills; body ache; malaise; headache; sore throat; This is a spontaneous report from a non-contactable other hcp (patient). A 25-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 06Jan2021 15:30 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), escitalopram oxalate (LEXAPRO). The patient experienced Chills, body ache, malaise, headache, sore throat on 07Jan2021. Patient was not received treatment for the adverse event. Patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
zoster related hearing loss; zoster related hearing loss; Information has been received from a lawyer regarding to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2013, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for zoster related hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of both events was unknown. The both events was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of deafness was determined to be medically significant.
Case number PHEH2012US013908 is an initial spontaneous report received from a medical assistant on 12 Jul 2012: This report refers to multiple patients. They were vaccinated with MENVEO (batch number: unknown) intramuscularly on unspecified dates. These vaccines had reached 34 degree Fahrenheit on 10 May 2012, 24 May 2012 and 30 May 2012. The vaccine also reached as low as 32  Fahrenheit nearly fifty times from 29 Jun 2012 to 07 Jul 2012 for approximately 30 minutes each. Vaccine was administered to three patients. No adverse event was reported following this administration error.
Vaccine had expiration date in database of 5/31/2022 but the beyond use date was 3/17/22.
a pregnant employee that was given FLUBLOK. with no reported adverse event; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 26 years old female patient who was exposed to vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] in context of a pregnant employee that was given flublok. with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported a pregnant employee that was given FLUBLOK. with no reported adverse event occurred at 21 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at 21 weeks of pregnancy, during second pregnancy trimester for INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  The date of last menstrual period was reported as 13-May-2022. The estimated due date is 17-Feb-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: none.  On 30-Sep-2022, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot USAA225 via intramuscular route in the left deltoid as Immunization.  On 30-SEP-2022 the pregnant employee was given flublok with no reported adverse event (exposure during pregnancy) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (a pregnant employee that was given FLUBLOK. with no reported adverse event).  At time of reporting, the outcome was Unknown for the event
Pt reports having arm/shoulder pain after receiving   Covid vaccine injection.  States the injection "felt high" and was more painful than typical IM vaccines she has had.   Pt concerned about SIRVA.
8/25/04-RT.ARM/SHOULDER SWELLING;+TENDERNESS;NO ERYTHEMA;NO WARMTH;GRANDMOTHER TOOK PATIENT TO EMERGENCY ROOM. PT INSTRUCTED TO USE WARM COMPRESSES/SOAKS; 8/26/04@1500-WARM SOAKS USED;LESS SWELLING;DECREASED TENDERNESS;IMPROVED.
After the first shot, extreme pain in the arm, inability to move entire right arm and shoulder. Felt nausea and extreme fatigue. Joint pain at shoulder, wrist, elbow in right arm. Muscle aches all over body. Received 2nd shot vaccine on 9/27/2021, in left arm. Difficulty breathing, extreme fatigue, loss of conciousness,  fever, 38 degrees C,  sweating, chills, slept for nearly 24 hours. Severe headache. Increased heart rate, low blood pressure. Abdominal pain, diarrhea, neasua, and viomitting. Veins in left arm appear darker than usual.
Swollen, redness at the site and down from the site. Size of a half dollar bill.  Still sore at this time. All the way up to should bone.  For elbow to the shoulder. Warm to touch. The redness has gone under the arm. Headache, muscle aches.
shortness of breath/He reports feeling winded walkaing the 10 feet to the washer/dryer; blood sugar over 200; fast heart rate; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, emphysema, diabetes mellitus, "drinking and smoking for 40 years", covid-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood sugar over 200, fast heart rate and shortness of breath/He reports feeling winded walking the 10 feet to the washer/dryer. Patient also reports having had Covid illness in Jan2021, and waiting 3 months before being vaccinated. Patient thought that his increased heart rate could have been a symptom of his inhaler use but read "shortness of breath" in our fact sheet for the vaccine. He reports feeling winded walking the 10 feet to the washer/dryer "and thats without even bending over". Caller does report he's "going to my lung doctor again today". Patients wants to know when normal function will return or if the symptoms will resolve now and return in 6 months. Response Reviewed fact sheet for "tachycardia", "increased heart rate", "blood sugar", "hyperglycemia", and "shortness of breath" with no results in the AEs reported from clinical trials. The only mention of "shortness of breath" was in the description of Covid illness/symptoms. The patient underwent lab test and procedures which included blood sugar which resulted 200. The outcome of the events was unknown.
Palpitations and  SVT , syncope without collapse 1x for the first 24 hrs (off and on throughout the day).   Increased heart rate without exertion for 2 days.    Shortness of breath for 3 days.   lethargic for 1 week.   Spells of light headedness off and on is still on going but decreasing over time.  Extreme arm pain the next day lasting only one day.
Client received Johnson & Johnson vaccine and during the 15 minutes post vaccination waiting period, he complained of lightheadedness and nausea. Client denies all symptoms of anaphylaxis. Client indicates that he has a shellfish allergy. Client was evaluated by paramedic on site and medic 209. Client was moved to the ambulance from the POD for further evaluation.
Breif LOC after vaccine, less than 5 seconds. Became alert and responsive. Assisted via wheelchair to cot. Vital signs taken, stable throughout. Taken to cot to rest, taking fluids, drank 8 ounces of water. Ambulated well, accompanied to door, verbalizes that she was fine. Color pink and alert.
She has chills; Body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: She has allergies to some medications and some things and has strong allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Body pain"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "She has chills". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She has chills"; PAIN (non-serious), outcome "unknown", described as "Body pain". Additional Information: It was reported that she got the vaccines from Pfizer they recommended four doses but she had allergies to some medications and some things and had strong allergies and spoke with someone that Pfizer vaccines did not ask anything that she couldn't have it.  She had chills and body pains and wants to know if the 4 dose has the same things as the first 3 vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282564 Same product, patient, event and different dose;US-PFIZER INC-202201282775 Same product, patient, event and different dose;
Had flu shot on 11/17/06. Stated site slightly sore and itchy on 11/18/06. Said bumped site while at work on 11/19/06 and since that time site swollen and red.
Patient came to ER on 1/25/2021, and complained of feeling sick with nausea, vomiting and chills on 1/20/2021.
deltoid red & swollen following DTAP;area >4" in diameter;seen in ER 8/3/99;
pt has had all necessary childhood immunizations @ MD office w/o incident;4 days p/Hep B vax devel high fever-didn't check-convulsed, mom says gave mouth-to-mouth resuscitation, called amb-ok by time of transport to ER;MD felt cause was vax
This spontaneous report was received from a registered nurse and refers to a 6-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of VAQTA, lot # R018935, expiration date 05-SEP-2019 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.