chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA "25U/0.5ml-SD Llok wCap Ped" which had a lot number of L02259 and expiration date on 06-APR-2017 (route of administration and anatomical location were not reported).There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On unspecified date, the VAQTA had two temperature excursions; one of 96 hours and other one of 360 hours. The lowest recorded temperature of 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Pt had arm swollen up the next day at the injection site. Arm was sore a little. Pt went to visit her Dr after a few days of swelling not clearing up. Patient was given a course of Doxycyline and prednisone. After following up with patient in a week, pt reported having fully recovered from her skin reaction.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 13-DEC-2013 at 17:30 ZOSTAVAX (Lot # J007858) was exposed to a temperature noted as equal to or > 12 degrees C for an estimated total time out of range of 9.75 hours. On 18-DEC-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # J007858, expiration date 28-SEP-2014) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Information has been received from a physician via Pfizer (Manufacturer Report Number: 2015140640) on 24-APR-2015 referring to a patient of unknown gender in his or her fifties. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient developed allergic reactions to PNEUMOVAX 23. The outcome and causality of the event was unknown. The reporter wanted to known if the patient should be give PREVNAR 13. Additional information has been requested.
Body aches, chills, fever, arm soreness, nausea, heartburn, headache, tiredness
urinary tract infection; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient was taking some unspecified medication and had some side effects. The patient was taking Macrobid for 6 weeks as a low dose antibiotic to prevent urinary tract infection. She had side effects with that medication for 2 weeks including dry mouth and a raspy voice. She is scheduled to take her updated booster on Wednesday.
She experienced consistent rash all over body that involved itching. Rash blotches were on her neck, legs, and arm.; This is a spontaneous report from a contactable pharmacist received via regulatory authority portal. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 (Batch/Lot Number: EL8982; Expiration Date: 31May2021) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number not reported) on 05Jan2021 for COVID-19 immunisation. The patient experienced consistent rash all over body that involved itching, rash blotches were on her neck, legs, and arm on an unspecified date in 2021. The rash at times would disappear from one area and appear in another. It would also appear in multiple sites at once. As of Wednesday, 10Feb2021, rash was still present. The patient did not experience the event with the first dose. The outcome of event was not recovered. The adverse event resulted in none.  No follow-up attempts are possible. No further information is expected.
Neurological issues, dizziness, weakness, walking to the side, off balance, nausea
PATIENT STATES HE HAD COVID TWICE LAST YEAR AND THE VACCINE HAS BEEN WORSE. STARTING 2 HOURS AFTER VACCINATION HE HAD CHILLS, INTOLERABLE BODY ACHES, NAUSEA, VOMITING, FEVER. THEY LASTED 48 HOURS. BODY ACHES ARE STILL OCCURING 96 HOURS LATER. FEVER BROKE WITH TYLENOL. PATIENTS POA (HIS AUNT) CONCERNED ABOUT BLOOD CLOT.
About 7 hours after I became ill with a fever, chills and dizziness.  I had the cold sweats and chills throughout the night and next day.  It was the sickest I have been in over 15 years.  I was bedridden until late afternoon the following day.
Horrible itching rash on my chin to my breast and  chest and my toes, nail beds of my toes turning bruised and loosing toe nails.  The dermatogoit gave me predizone,   Dr.  (dermatology)
vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022; No Adverse Event; Received 2nd primary dose 2 days after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022) and NO ADVERSE EVENT (No Adverse Event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 053B22A and 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received 2nd primary dose 2 days after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 26AUG2022 and administered on 28SEP2022).    No concomitant medication were reported.  Patient received Monovalent product. Individual vials from broken carton with vial size of 5.5 ml. The vial was initially stored in the refrigerator on 26-AUG-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Patient developed a large bruise one week after receiving the vaccine. The bruise wrapped around her arm.
Depression; This case was reported by a consumer via call center representative and described the occurrence of depression in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included escitalopram (Lexapro).   On 3rd September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2019, 1 days after receiving Shingrix, the patient experienced depression. On an unknown date, the outcome of the depression was unknown.   It was unknown if the reporter considered the depression to be related to Shingrix.  Additional information received were as follows: The patient stated that about 24 hours after receiving the second dose of Shingrix, she started experiencing depression, and it was still present at the reporting date. The patient had been on Lexapro before she received the Shingrix vaccine.  The repoter did not consent to follow-up. No further details were provided.  The reporter referred to healthcare professional.
Got Pfizer as booster; Consumer had Moderna Covid vaccine for first 2 initial doses. Got Pfizer as booster; Within 2 hours had face a head itching; From: (Name withheld) Reporter Name: (Name withheld) Reported by: Consumer Reporter Contact Information: (#) Patient Name: (#) Description of Event: Consumer had Moderna Covid vaccine for first 2 initial doses. Got Pfizer as booster when eligible because that's only one that was available in their area. Within 2 hours had face a head itching. Female. 35 years old. No underly( g health conditions Name of Product: Covid Vaccine Booster Awareness Date: 07Dec2021 Country of Occurrence: Event took place after use of product.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 9 months old patient who received PENTACEL at 9 months of age and again at 15 months of age. 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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route. 1 other doses were administered on unknown dates for suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. 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 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.
I have a large rash on my abdomen. The size of a baseball. I went to the local clinic. They could not confirm what it was. I called the center and they told me could not possibly be caused by the shot. It burns and is very painful and very red and swollen.
high fever to 104 (reported by patient), chills, fatigue, HA, and body aches. Red, pruritic raised rash to entire R upper arm, extending into axilla and R side of chest, lasting days
Pt given MMR vax as child; On approx 11SEP90 devel measles; No further details were provided;
Fever, chills, sweating, fatigue, muscle aches, swelling in neck, cough  Ongoing as of 24 hours later
Chest pain Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart
was sick and stayed in bed; This is a spontaneous report from a contactable consumer reporting for a female patient (sister).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer's sister (patient) took the shot and was sick and stayed in bed on an unspecified date. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe aching, fever, chills, swelling around eyes and mouth with itching, treated at home with TYLENOL and BENADRYL. Took a week for swelling, redness and itching to decrease around eyes and mouth. Fever, aching, and chills gone in 48 hours. No other medical intervention needed. Administered by Pharmacist.
12/17/21 developed headache and fever. Following day developed diffuse body rash. Admitted to Hospital for persistent fevers and rash. Rash believed to be Erythema Multiforme, possibly secondary to viral infection; however vaccination received shortly before onset of symptoms.
I know 3 people died because of the vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported similar events for 3 patients. This report is for 1st of 3 patients.   This consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter was reading a letter, asking for the ingredients of COMIRNATY. The reporter asked when was Comirnaty going to be available and why was it already FDA approved then it was not available right now It's scary because people are dying because of the vaccine. Reporter knew 3 people died because of the vaccine. Reporter also mentioned she was concerned about the liability of Pfizer since the available one was the Pfizer Biontech COVID 19 vaccine. Reporter was unsure if it was Pfizer. It was unknown if Autopsy Done. The outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101266047 same drug/AE, different patient;US-PFIZER INC-202101266048 same drug,AE, different patient; Reported Cause(s) of Death: I know 3 people died because of the vaccine
Information has been received from a health care worker concerning a 23 year old female patient with anxiety disorder and penicillin allergy who on 29-JAN-2009, 27-JUL-2009 and 24-MAR-2010 received the first (intramuscularly), second and third dose of GARDASIL respectively (Lot # 662300/0100Y for third dose). Concomitant therapy included clonazepam, CYMBALTA and ORTHO TRI-CYCLEN. On 31-MAR-2010 the patient called the physician's office with arm pain. The physician recommended warm compression alternating with ice, and ibuprofen. The patient's pain did not improve, so she came to the office later that day. While in the office, the physician found "no redness and nothing visible". She complained of pain in the left arm radiating into the elbow, shoulder, and chest wall. The physician continued to recommend ice and heat along with naproxen and hydrocodone with acetaminophen. On 05-APR-2010, she was again seen in the office. The patient still had arm pain. She complained that she needed to sit with the arm supported. She stated that the pain was sharp with motion and radiated to the elbow and upper back. It caused her to miss a few days of work. The physician gave her prednisone and oxycodone with acetaminophen. At the time of this report, the patient was not recovered. The patient sought unspecified medical attention. The reporter considered the adverse events to be disabling and other important medical events. Additional information has been requested.
nearly immediate swelling, erythema, pruritis at injection site. Remained localized, no oral/airway involvement. Improved with oral anti-histamines and oral steroids
Patient called 11/22/02 stated she received flu shot on the morning of 11/18/02 in right arm.  By that evening she had extreme pain in right hip pain was better on 11/22.
popped up welt; tender to touch; itchy; sore arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (popped up welt), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (tender to touch) and VACCINATION SITE PRURITUS (itchy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness). On 02-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (popped up welt), VACCINATION SITE PAIN (tender to touch) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE URTICARIA (popped up welt), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (tender to touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
He became extremely lethargic and difficult to wake 6 hrs after receiving vaccine. Vitals were stable reported by daughter.~ 1/22/21 BP 120/72, pulse 76, O2 level 98, 1/23/21 BP124/88 P-77 O2 92 T 97.6, 1/24/21 BP 105/65 P 77, O2 88 and O2 provided per daughter. The extreme lethargy lasted for 72 hrs and had 2 hospice nurses asses  for possible s/s of stroke and was told did not feel was a stroke. during this time also had "dreams" as noted by talking in his sleep a lot. Is now "slowly" coming out of sleepiness and starting to eat very little.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CETIRIZINE; VITAFUSION MULTIVITES. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was received other medication in 2 weeks. No Known allergies was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Prickly feeling on elbow to hand; arm was red with hives; warmness on the site of injection; Itchy on site of injection; feverish; headache; difficult breathing; numbness in the fingers; felt needles going down her legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers) and PAIN IN EXTREMITY (felt needles going down her legs and arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers), PAIN IN EXTREMITY (felt needles going down her legs and arms) and HEADACHE (headache). On 26-Feb-2021, the patient experienced PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), VACCINATION SITE WARMTH (warmness on the site of injection), VACCINATION SITE PRURITUS (Itchy on site of injection) and PYREXIA (feverish). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Prickly feeling on elbow to hand), URTICARIA (arm was red with hives), DYSPNOEA (difficult breathing), HYPOAESTHESIA (numbness in the fingers), PAIN IN EXTREMITY (felt needles going down her legs and arms), VACCINATION SITE WARMTH (warmness on the site of injection), VACCINATION SITE PRURITUS (Itchy on site of injection), HEADACHE (headache) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported was Excedrin for Migraine and sinus pills for her sinus.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: New events added
Generalized dermatitis  rash that is still  ongoing. I took topical steroids and it did not help. I?m currently taking 40 mg prednisone daily and it has not improved
On 03/11/2021 pt noticed a red rash, itchy, spots from knees down to ankle. Pt applied Aveeno lotion to effected areas, which provided some symptom relief. The redness and itchiness are going away slowly and the skin is returning to normal color. 3/22-Red rash, itchy, spots from knees down to ankle- Started 03/11/2021- Diminishing but still present
experienced Shingles after receiving the first of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AS54, expiry date 15th May 2022) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced Shingles. The followup consent was granted.
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
Patient reported general malaise, possible low grade fever, myalgias, extreme fatigue beginning in the morning following his first dose of the Moderna vaccine the afternoon prior. Symptoms have persisted without improvement for 4 days. He recently recovered from Covid-19 illness that started on April 2oth and he had returned to work on May 3rd reporting that he was asymptomatic at that time. States his symptoms are consistent with symptoms he had when he was ill with Covid-19.