chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 48 year old male with dermatitis and no known drug allergies who was vaccinated with a 1st and 2nd dose of Hepatitis A virus vaccine inactivated on 03/07/00 and 09/15/00, respectively. Subsequently on 09/26/00, the patient presented to the physician's office with severe dermatitis that may require hospitalization. It was reported that the patient experienced a rash after the 1st dose in March 2000, however neglected to inform the health care professional before administration of the 2nd dose. Follow-up information from the physician indicated that "she didn't think that this was an adverse event. The patient's dermatitis has been present for years with a recent flare after the vaccine. It was reported that the dermatitis was still flaring, but was not related to the vaccine". No further information is expected.
Dizzy spells; Tingling going down that side and into her leg; arm didn't hurt much; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 14:30 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset May2021, outcome "not recovered", described as "Dizzy spells"; PARAESTHESIA (non-serious) with onset 30Apr2021, outcome "recovering", described as "Tingling going down that side and into her leg"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm didn't hurt much". Therapeutic measures were not taken as a result of dizziness, paraesthesia, pain in extremity. Additional information: Patient Age at Time of Vaccination was reported as 58 years. She got the COVID-19 vaccine about 3.5 weeks ago, the first shot. It was fine. Her arm did not hurt much. On the side a few hours later she had a tingling going down that side and into her leg. It took a while over week for this side effect to kick in. She was wondering if other people have had it. She had been having it ever since. Vaccination facility type was reported as Hospital. She was having dizziness. It is not total vertigo, but it was dizzy spells. It is unnerving. She had never had it before. A friend sent her a website saying it was a possible side effect. The dizziness had been for 10 days. It was sporadic. It came and went. She is a little dizzy right now. The dizziness started a little over a week after getting the vaccine, or maybe 10 days.  The tingling was prior to that. The dizzy spells are persisting. She thought they had improved for 1 to 2 days, but they are back again. They are consistent. One day it was not as bad and she went on a long walk, but she did not feel like she could do it the day before or after. Not so much tingling now. She had a little bit, but not like when she first got the shot. It started the day she got the shot, a couple of hours after. She was most comfortable to get Pfizer and went to a specific place to get Pfizer. She had no medications or conditions and that was why she was weirded out. She had good health. This was the first time she has had this. She has had every now and then if she gets up too fast a little thing, not like this. She has not done treatment it because she thought it would dissipate. That is why she was calling. Her friend sent her a link and there were quite a few people experiencing it. She wanted to report it and to see if other have reported it. The adverse events did not result into a visit to Emergency Room or Physician Office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client started to complain of itchiness and hives within 5-6 minutes of receiving the vaccine. She was red in the face. Described herself as shaky inside, had shortness of breath along with a scratchy throat. 50mg of Benadryl was given IM in right deltoid at 6:03 pm. EMS was called for further evaluation and release form. She had improvement of symptoms by the time they arrived. She signed the release form to go home. Upon attempting to leave, she had difficulty standing, became lightheaded and nauseous. Unable to get to vehicle, unsteady on her feet and complained of chest tightness. EMS called for transport to ER.
Very light-headed and dizzy, had some nausea. This lasted all day and into the night, woke few times to prop head up, so wouldn't be so dizzy. Felt like a bad case of the flu. Next day was feeling perfectly normal in all aspects.
Patient received .1ml of purple cap NOT orange cap therefore patient was under dosed with 1st dose. Health Department contacted along with local state immunization registry to report the error
Metalic taste in mouth; This is a spontaneous report from a contactable Other HCP (patient). This 39-year-old non pregnant female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EN5318), dose 2 intramuscularly, administered in Arm Left on 29Jan2021 23:00 as 2nd dose, single for an COVID-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing, milk allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EL0142, Expiration date: unknown), dose 1 intramuscular, administered in Arm Left on 08Jan2021 12:00 PM as 1st dose, single for an COVID-19 immunisation. The patient experienced metalic taste in mouth on 02Feb2021 12:00. No treatment was received for event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Feb2021 Nasal swap rapid test. The outcome of the event metalic taste in mouth was recovering Follow-up attempts are completed. No further information is expected.
pt recv vax 12JUL97 & 14JUL97 pt approx 10 lesions (small spots) on the chest;
Unknown if had emergency, a corona virus reaction after taking Unspecified Medication; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that he had an emergency, a corona virus reaction his wife is having and he trying to get some help. It was reported that on an unspecified date patient was in emergency as she experienced corona virus reaction after taking unspecified medication. The outcome of the event was unknown.
Day 1: woke up to my heart racing, lethargy later in the day along with startling to sounds, seeing things not there in periphery, felt sunburned in armpits, bend of legs & front of shins, rash in armpit that came & went, hot spots on skin in various areas, felt I was burning up from the inside out, waves of nausea.  Day 12: random itching on throat, chest & arms(started slight on day 10 increased til day 12 then went away), felt sunburned all over, rash on chest that went away in approx 10 min, shoulder & wrist aches
Red rash left arm towards the right of site of injection. Red rash forehead ,  nose and both sides of nose , little red dots
Aches; Pain on her left arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced general body pain and pain in arm. On an unknown date, the outcome of the general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer herself reported that she received the 1st dose of Shingrix vaccine in her left arm and on the same day she got a Pneumonia vaccine in her right arm and after the vaccination patient experienced symptoms such as aches and pain on her left arm and that last 3 to 4 days. The reporter consented to follow up.
excruciating painful; hardness in injection site; visible raised hard excruciating painful knot at injection site; fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced fever, injection site pain, injection site induration and injection site lump. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain, injection site induration and injection site lump were unknown.   It was unknown if the reporter considered the fever, injection site pain, injection site induration and injection site lump to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced local adverse reaction. The patient developed visible,raised, hard excruating painful knot at the injection site and fever for 2 days. The patient's parents were concerned about getting the patient second dose. They were realized that getting meningitis is much worse but none of their childrens had reacted this way to a vaccine.
PATIENR RECEIVED 2ND DOSE AT AROUND 11 AM, CAME BACK AT AROUND 1230 PM COMPLAINNING OF ITCHINESS ALL OVER HER BODY. PATIENT WAS ASSESSED AND COULD SEE SMALL HIVES ON HER ARMS. ASKED PATIENT IF SHE IS EXPERIENCING DIFFICULTY BREATHING AND SHE DENIED. ADMINISTERED ONE DOSE OF BENADRYL LIQUID PROVIDED BY THE FACILITY. MONITORED PATIENT FOR AN ADDITIONAL 30 MINUTES AFTER RECEIVING BENADRYL. SHE SAID HER ITCHINESS WAS RELIEVED AND FELT GOOD ENOUGH TO RETURN BACK TO WORK.
Patient went to the pharmacy to receive the second vaccine dose, and it is been 2 months since the patient received the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient went to the pharmacy to receive the second vaccine dose, and it is been 2 months since the patient received the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient went to the pharmacy to receive the second vaccine dose, and it is been 2 months since the patient received the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient went to the pharmacy to receive the second vaccine dose, and it is been 2 months since the patient received the first dose) 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.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
pt recv vax & devel a fever of 104 that persisted for 2 days;6/18/98 pt exp uncontrollable crying & took 45min to calm down;pt recovered;
Blister like rash developed on the arm of the injection site.  Spread to neck and abdomen.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 13:15 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 at 13:15 as dose 2, single (Lot number: EN6201), in right arm and on 21Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NASH" (unspecified if ongoing); "Stage 2; arthritis (hands Lumbar Spine)" (unspecified if ongoing), notes: Stage 2; arthritis (hands Lumbar Spine); "dupuytren's contracture/Dup" (unspecified if ongoing), notes: dupuytren's contracture/Dup; "Blood Pressure" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Elevated Cholesterol" (unspecified if ongoing), notes: Elevated Cholesterol; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: ACETAMINOPHEN, start date: 21Sep2021; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jul2021, stop date: Jul2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: Antiviral details: Paxlovid from 30Jul2022 to 31Jul2022, lot number=GD3007, for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax; unconssolable screaming cry p/ dtp > 4 hrs; no tx needed
I had the routine side effect of mild fever and chill on the second day of the vaccine. then in june I had mild pain on the right jaw muscle in the middle of the night. was seen bu dental and was told possible TMJ ordered bite guard as the time go by I noticed the pain is increasing and is radiating to right ear. the pain used to start after sleeping for 3-4 hours. hydration tends to ease the pain also NSAIDs help the pain in the beggining. now the intensity and duration of pain is increasing to the point the pain starts at 2-3 pm and last most of the night. NSAIDs has no effect on the pain. also I noticed the pain is radiating to the entire right side including the4 sinuses and the pusles on the lower jaw is very
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. The pharmacist reported that multiple unknown patients were vaccinated on multiple unknown dates with improperly stored ZOSTAVAX lot number M015925, expiration date 15-JUN-2017 and lot number M009773, expiration date unknown, (dose, route and frequency not reported). No adverse effects were reported. The pharmacist reported that the temperature of the excursion was -14.4 C, and that the time frame was 12 hours and 15 minutes. There were no previous temperature excursions and the report was because of a data logger. No product quality complaint was reported. Lot numbers M015925 and M009773 were confirmed to be valid lot numbers for ZOSTAVAX. This is one of several reports from the same reporter. Additional information has been requested.
Full hand-sized rash at injection site. Warm, itchy and hard at the site. Fever on day of reaction but resolved by next day. Rash resolved by May 4, 2021 (3 days post reaction)
Information has been received from a parent concerning her 19 year old daughter with sulfonamide allergy who in November 2006, was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast) (lot # not reported). There was no concomitant medication. The parent reported that since March 2007, her daughter has been experiencing severe hip pain after the second dose of GARDASIL vaccine (yeast) 0.5 mg. On an unspecified date she underwent an MRI (results not reported). At the time of the report, the patient had not recovered. The parent reported that her daughter has received all three GARDASIL vaccines (yeast), and that therapy was stopped in January 2007. No further information was provided. Additional information has been requested.
12 hours after vaccination I started to run a fever. the fever ran for ~24 hours peaking at 100.7 F
FLANK PAIN (LEFT); SWELLING (FRONT OF CHEST); LUMP ON LEFT CLAVICLE; NECK PAIN; LYMPHADENOPATHY; PAIN IN ARM; This spontaneous report received from a pharmacist concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 22/JUN/2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced flank pain (left). On 03-MAY-2021, the subject experienced swelling (front of chest). On 03-MAY-2021, the subject experienced lump on left clavicle. On 03-MAY-2021, the subject experienced neck pain. On 03-MAY-2021, the subject experienced lymphadenopathy. On 03-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flank pain (left), swelling (front of chest), lump on left clavicle, pain in arm, neck pain, and lymphadenopathy. This report was non-serious.
swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round) 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 VACCINATION SITE LYMPHADENOPATHY (swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swelling in right armpit. it is the same side got the shot on / The lump is getting larger about 4 inches round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
I have a history of auto immune anemia and ITP.  I checked with my hematologist when scheduled if I should take the shot.  They stated to take it as not enough data was present to prevent me to take.  On 02/11, I spoke with doctors onsite and discussed my medical history.  They advised to take the shot as not enough data was present to prevent me to take.  On 02/14, I noticed bleeding in gums and petechiae at the injection site.  I went to hematologist on 02/15, and platelets were at 2,000.  I started 60 mg of prednisone immediately on 02/15.  By 02/19, took blood sample and eceived one 70g dose of IVIG.  Blood results came back on 02/20, and platelets were at 22,000 but did not cover results from after IVIG treatment.  Hematologist decided to stop follow up IVIG treatment and stick to 60mg of prednisone daily as in the past my body has reacted well to it.  On 02/24, platelet count went to 300,000.  I've started to taper prednisone to 50mg and will continue with weekly blood tests to verify that platelets remain strong.  Hemoglobin and all over blood levels in the CBC remained normal during this time.  Hematologist has advised not to take second Pfizer COVID-19 shot due to risk.
Patient was given their first MODERNA dose on 3//2021. He came back for his second dose on 4/23/2021 and was accidentally given the PFIZER vaccine by the RPH on duty. The patient was made aware. After waiting his 15-20 minutes prior to leaving we checked on him. He was doing well. He went home and his mom called to verify what had happened.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 66 years old male patient who received vaccine FLUZONE HIGH DOSE which was leaked from the needle hub (syringe tip). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ023AA expiry date: 25-Apr-2019 via unknown route in the left deltoid. It was a case of actual medication error due to vaccine underdose. It is also a case of Syringe issue (it was reported that leakage from the needle hub (syringe tip)). It was not reported that if any adverse event was not reported or not. 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 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.
Redness and swelling of the right lower leg. Diagnosed with cellulitis. Prescribed an antibiotic and discharged.