chrisvoncsefalvay/vaers-outcomes huggingface dataset:
55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported No treatment medication was provided   This case was linked to MOD-2021-418964 (Patient Link).
Exhausted,  no energy, no motivation, not wanting to get out of bed or go to work.   Maybe depression from shot
I had a really high fever between 103-104 over a 2-day period. I had coughing and body aches with a headache.
Mild fever of 100. Tiredness and sore joints. There was redness and extreme swelling on the arm for two weeks. There was a bruise the size of a softball after the swelling went down. Extreme itching which was helped by Benadryl.   On Saturday September 2, a tendon on my finger of the arm that received the vaccine ruptured and ripped away from the bone. I have never broken anything or had any injury of any kind. I was doing an activity I normally do.   I received the vaccine (Tdap) on August 25 at 10:45 am.
COVID booster given. Patient stated she had Benadryl in her car. She went to her car to get Benadryl and came back inside. On the elevator, a nurse noticed that she was having shortness of breath, slurred speech, and per-orbital edema. Vital signs were checked, oxygen applied. Benadryl had already been taken. EpiPen administered. 911 called, and patient was taken to ER.
pt came in on the 28th complaining of extremely sore arm ( dead arm) and lost range of motion
Narrative: COVID infection following COVID vaccine series 03/03, Pfizer, dose #1 03/24, Pfizer, dose #2 12/17, Pfizer, dose #3 12/25 COVID swab, result: not detected 12/27 COVID swab, result: detected 12/27 pt cc: exposure: unknown  12/27 pt admit ED cc: exposed to COVID (Lx: COVID-19 LOS: 1 day
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 19-MAY-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Error: Wrong Dose of Vaccine - Too Low, Additional Details: pt states her arm swelled up the 2nd day (sunday) and could not move it. Sought an opinion from her pcp who gave her a cortisone shot, told her to take ibuprofen and take a week off.  Vaccination nurse from another day said an "X" was marked where the md said the shot site was.  She pointed near her elbow (about 3 fingers above). Per phone conversation with pt, she thinks the site was 3 fingers above the elbow but on the back of the arm. The swelling is between and orange and grapefruit size
Information has been received from a health professional concerning a 6 year old male with no known medical history or allergies who on 10-JUL-2001 was vaccinated with a SC dose of Varivax (lot # 638818/0499L). There was no concomitant medication. On 07-APR-2006 the patient developed chickenpox spots. Unspecified medical attention was sought. He was treated with Benadryl. No laboratory diagnostic tests were performed. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was inpatient when receiving his second COVID-19 dose on 2/9/2021. Patient was admitted on 2/4/21 with acute encephalopathy, respiratory failure, and septic shock after being transferred from MICU. Hospital course included a internal jugular thrombus and a hematoma formation in his muscle. Plan was to be discharged to short term rehab but patient was uncooperative and left on 2/19/21 against medical advice. Patient readmitted on 3/13/21 with swelling in his legs and abdomen primarily as a result of his progressing hepatic encephalopathy from his liver cancer. Patient transitioned to hospice were he deceased on 3/25/21. Patient's comorbidities include metastatic inoperable multifocal hepatocellular carcinoma, cirrhosis in setting of Hepatitis C, lymphoma, polysubstance abuse, COPD.
Patietn was found to have acute RIGHT lobe Pulmonary Embolism. Presented to the hospital on 4/21/2021. Was due for his second vaccine 4/22/2021
Today, pt reported swollen, red, hot to touch, sore to touch skin above her elbow that started the evening of the vaccine. She also said it was very sore to move and touch. She said it is improving quite a bit today and showed me. I saw an area about 1 inch by 3 inches just above her elbow that was light  red, mildly swollen and hot to touch.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 06Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 06Jul2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 06Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 06Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 06Jul2022).    No concomitant medication information was reported. Patient received half dose. The vial was initially stored in refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment information was reported.
Approximately 2 hours post injection, my  left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled  my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription.  When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.
Scattered erythema papule lesions right shoulder, neck, back and into scalp back hip and on ankle.
Patient got moderna booster on 12/02/2021.  On evening of 12/03/2021 - she reported hives - itchy on tummy, groin, trunk.  She took 50mg benadryl and she was feeling better by morning.  She had no rash or hives at site of injection.  She had no rash for 1st two doses.  I asked if she has taken any new meds, food, soaps.  She reported that she restarted a hormone patch about less than month ago and she took an epsom salt bath day after the shot (before rash started).  I told her that the hives she is experiencing may or may not be related to the shot, but would report on this site.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with an unspecified dose of GARDASIL (lot number, dose and route not reported). The nurse reported that an unspecified patient received an unspecified dose in the GARDASIL series on an unspecified date. The patient had a preexisting wart on her finger which became "worse and bigger" following the GARDASIL administration. The patient sought unspecified medical attention. At the time of reporting, the outcome of event was unknown. Additional information has been requested.
This spontaneous report was received from a physician refers to a 43 year old patient (gender unknown). Information on medical history, drug reactions or allergies was not reported. On 26-AUG-2013, the patient was vaccinated with ZOSTAVAX, 0.5 ml, intramuscularly, (concentration and lot number were not reported). No concomitant medication was reported. The reporting physician stated that there were no adverse effects. Additional information has been requested.
Patient reported significant history of anaphylaxis. Around 40 minutes after receiving vaccine, patient appeared anxious, her throat felt itchy and she felt her lips/tongue were "puffy and numb". Vital signs stable. Patient stated "this is how she feels before having an allergic reaction". Patient was given adult dose of epipen around 12:28pm. A rapid response was called in the clinic and several staff arrived for assistance. Clinic doctor assessed the patient for worsening symptoms. Vital signs remained stable after epipen administration. Report given to two paramedics who transferred patient to the nearest hospital for further evaluation.
Pt was given the HPV9 vaccine and it was one day expired. Pt is fine and will be revaccinated 02/09/2018. Given 02/02/18. Expired 02/01/18.
Woke up with severe dizziness,ringing in the ears,  vomiting. Unable to get out of bed until 3 pm. Lasting into 2nd day, but less severe today.
Patient experienced disorientation to person, time & place for 6 hours. Had difficulty walking & suffered a severe headache at onset of symptoms. Went to ER & CT scan & labs came back normal.
Vaccinated at 10am. Started feeling cold around 8pm. Chills and fever lasted about 8 hours. Went away but develop low grade headache (successfully treated with TYLENOL). Injection site was sore. Most symptoms resolved within a couple days, arm still sore.
Patient was given a pediatric dose of the Pfizer vaccine instead of the regular 12+ year of Pfizer vaccine. Patient had no reactions, mother was notified, dose was not repeated per CDC interim recommendations for administration errors and deviations.
My mother received a shot in Feb 2021, She left for (Privacy) in Mar 2021, where she was riding on horses and in boats. On April 12, 2021 my mother began to feel ill as she exited the plane. She thought she was jetlagged.  Her lymph nodes on her neck began to swell to the size of tennis balls. Lymphocytes began to show up beneath her skin everywhere. We tried to get admitted to the doctors and the hospitals several times, but was accused of seeking drugs.  Her Kidneys were affected the greatest as she was urinating blood from the lymphocyte growths.  I was told she had cancer. When I asked when and where because she is watched so closely due to her current ailments. They advised it was stomach cancer and I advised it could not be because she just had a scope ran down to her stomach to check for cancer, this should be in her medical records. She passed away on 5/26/21 of  Spontaneous Tumor Lysis Syndrome.  This is NOT possible as she NEVER had Chemo and it is extremely rare to die of this condition and never had chemo . Her sudden death was very unexpected as all her prior health conditions were very stable.  I believe my mother had an adverse reaction to the shot aka lymphadenopathy and she died as a result of the Covid Shot.
This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 70-years-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. On an unspecified patient experienced the site of the injection there was a red surface area' It was little warm and there was a deep pinkish look probably 2 inches or by 3 inches around the injection site, It was the little tender, Allergy, Some sort of swelling of some type. It was reported that It was not anything that patient feel like an emergency but it was a first time that patient experience something like this and get this is all pretty new but not allergic to anything and in pretty good health and Patient got the injection (Covid-19 Vaccine by Pfizer) on Monday morning and patient is 70 years old, so ended-up having the wait 30 minutes just to make sure that patient was going to be okay and there were not going to be any immediate side effects and what not and was fine. Yesterday, noticed that the site of the injection there was a red surface area which sure could be very normal and there was, it was little warm and there was a deep pinkish look probably 2 inches or by 3 inches around the injection site, so just felt like it was normal, have not had anything else take place. have not been nauseous. not had fever. not had any aches or pains or anything like that but because it happened on Wednesday afternoon or that when noticed it and noticed it by, patients daughter came over and happened to be leaning up against the wall and talking to granddaughter and patient noticed that it was the little tender not terrible but so took a Benadryl (Treatment) and this morning it better, the pinkishness looks like its faded and took a second Benadryl this morning. have allergies, so keep them around but and noticed it, it appears as though bet it consider it some sort of swelling of some type that going down too but the width of the area look like the pigment on my skin and it was the pinkish colour was probably the largest area like that, that have ever experienced since, I can recall I mean I remember I went to a college and had to have every injection that the college has small pox, tetanus whatever malaria whatever was available for the college they had use the both arms and did not have had any side effects from that and no way that patient had the situation where one injection caused the side effects like that but mean like say in this morning it looks like the pinkish colour is getting lighter and the swelling is going down but just thought would call to ask if mean patient have not experienced anything like shortness of breath or anything like that, need to see somebody just had the curiosity. Therapeutic measures were taken as a result of events. The outcome for the events was reported as unknown at the time of this report.   Follow-up attempts are completed. No further information is expected.
Constipation; Diarrhea; Joint pain in back; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain in back) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis, Asthma and Allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Asthma, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARTHRALGIA (Joint pain in back). On an unknown date, the patient experienced CONSTIPATION (Constipation) and DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, CONSTIPATION (Constipation) and DIARRHOEA (Diarrhea) had resolved and ARTHRALGIA (Joint pain in back) outcome was unknown.            Concomitant medications includes prescription allergy medications.  Patient reported about 30 days after both vaccines he had constipation and diarrhea which lasted about 2 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022 at 08:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive, notes: Tested positive twice on lateral flow and now feel sick and testing positive again; (unspecified date) Positive, notes: Tested positive twice on lateral flow and now feel sick and testing positive again; (09May2022) Positive, notes: Tested positive twice on lateral flow and now feel sick and testing positive, again. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti virals for Covid 19 Treatment, Treatment duration from 02May2022 to 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a immunization coordinator concerning a female who was vaccinated with a first dose of Gardasil. Subsequently after the first dose the patient experienced abdominal cramping similar to menstrual cramps. Unspecified medical attention was sought. Subsequently, the patient recovered from the abdominal cramping similar to menstrual cramps. The patient was vaccinated with a second dose of Gardasil. Subsequently after the second dose the patient experienced abdominal cramping similar to menstrual cramps. Unspecified medical attention was sought. Subsequently, the patient recovered from the abdominal cramping similar to menstrual cramps. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial information has been received from an immunization coordinator concerning a 14 year old female who on 19-APR-2007, at 1:30 pm was vaccinated with a first dose of GARDASIL (lot # 653937/0637F). On 19-APR-2007 one hour after the first dose the patient experienced lower abdominal cramping similar to menstrual cramps. No treatment was required. Subsequently, the patient recovered from the lower abdominal cramping similar to menstrual cramps after 48 hours. On 14-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot # 657006/0188U). On 14-JUN-2007, one hour after vaccination after the second dose the patient experienced lower abdominal cramping similar to menstrual cramps. Subsequently, the patient recovered from the lower abdominal cramping similar to menstrual cramps after 48 hours. No treatment was required. Additional information is not expected.
Case received both doses of Moderna Covid 19 Vaccine 1 = 2/24/21 LOT# 022M20A 2 = 3/31/21 LOT# 006B21A Symptom onset of Covid 19 was 8/5/21 Positive Covid 19 Rapid Antigen on 8/11/2021
four days after vaccine, MS hug (severe pain like tight rubber band around lower rib cage) and severe TMJ pain lasting until 3/1/2021
Patient received Moderna covid vaccine. Within 5-10 minutes patient stated feeling "heart racing" and slight tingling to hands and feet. RN had patient lay down on gurney, loosened constricting clothing. Given water and trail mix. 1021- 134/88; hr 72; 99%O2 1026- 116/66; hr 98; 98% 1048- given 25 mg benadryl PO per verbal order from Dr  1050- 128/68; hr 101; 100% 1107- 116/59; hr88; 100%   1130- patient discharged with friend. States feeling better. Instructed to call clinic advice line if symptoms resume.
Moderna Covid-19 Vaccine EUA  - pain at injection site immediately after.  Nausea and low grade fever(99) hit around 6 hours after receiving.  Lasted only an hour or so.  Fine until around Midnight.  Then had chills for at least an hour.  Covered with extra blankets and eventually fell asleep.  In morning, still had low grade fever and had a headache most of the day.  Eventually took Advil around  2:00 p.m. on the 7th and headache went away but returned in evening.  Did not feel like eating most of the day.  Had a light breakfast and only a couple of bites of food at dinner.  Fatigued all day.  Not sure if from vaccine or from not sleeping well night before.  Took another Advil at bedtime for headache.  Pain in arm also gone...maybe from Advil.  Morning of the 8th, feel fine and  eating/drinking back to normal.
About 30 hours after receiving vaccine, resident was very emotional, called her family numerous times in the middle of the night. Was having increased weakness and hip/back pain which required use of wheelchair. She can normally ambulate with walker. Also complained of nasal congestion.
Information has been received from a physician concerning a fellow male employee who was vaccinated with the 1st dose of  Hepatitis A virus vaccine inactivated. Subsequently, the patient developed Hepatitis A after he should have received the 2nd dose of the vaccine. Additional information has been requested.
Extreme dizziness/ lightheadedness, started approx. 15 min after injection and lasted for 1 hour at which time I could stand and walk, then symptoms slowly decreased over the next 12 hrs until gone. Racing heart and chest tightness, started approx. 20 min after injection and lasted about 40 min.