chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was given to patient after it had expired after twelve hours after vial was punctured. (vaccine was expired for 10 hours) vial was punctured on 7/6/2021 at 11am, Vaccine was given to patient on 7/7/21 at 8:30 am side effects from vaccine soreness and swelling on L arm,  7/9/2021 Checked patient she stated she is starting to feel better from her arm.
Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.
About 3:00 pm a lot of heat in 6 inch spot of injection site. 5:00 pm looked at it - it was very red and hives were starting. 7:00 pm - a lot of pain. By 9:00 pm couldn't bend elbow. Patient didn't do anything. Then went to bed after 9:00 pm, slept horribly because pain was extreme. Every time turned or moved pain woke her up. 7:00 am next morning took a shower but couldn't raise right arm. it was swollen and hives spread 3 inches below the elbow, 1/2 around upper arm and 6 inches short of shoulder and 1/4 high, lots of heat. She went to church, left church and laid down for 1/2 hour. Then at 2:00 pm went home and laid down. A friend called her doctor. He said to ice it and take Benadryl. She iced it but felt physically better, but didn't look better. Went to bed early around 8:00 pm and slept fitfully, was still painful, but less than the night before. on 2/5 at 7:00 am was told shot was in her right arm. Went to dentist at 9:00 am and they looked at it and told her to take Benadryl and asked if she was okay to stay for appointment. She said yes. After appointment at 11:00 picked up her mom and drove to pharmacy and bought Benadryl. Waited untl 1:00 pm to take it, until she was home because it makes her drowsy. Took a nap until 2:30 and then picked up son from school at 3:00. Drove him to bass lesson at 4:30, home at 7:00 pm, took another dose of Benadryl at 9:00 pm and ibupropen - 3 tablets of 200 mg and went to sleep. Slept much better. At 6:00 am next morning heat is gone, mild pain, but redness from below the elbow until 6 inches above shoulder.
pt recvd vax;2dec felt warm;ok in am;3pm listless;slept all noc,"like a drugged sleep";at noon PAR took pt outside gradually perked up;no appearance of cold;may have run down; limping;
I developed Covid .  symptoms included low grade fever, very sore throat and difficulty swallowing, head and body aches.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Gave pt ice pack, symptoms significantly improved after apx 15 min.
Immediate pain in left shoulder after injection. Ongoing pain for 3 weeks now, diagnosed with bursitis based on symptoms.
Moderna COVID-19 vaccine on 2/13/21 & 3/11/21 Deceased- Positive COVID related death, 9/13/21
Moderate-Severe chills, fever (maximum temperature: 101F), moderate body aches/joint pain, moderate headache, moderate fatigue,  fainted twice
headache; severe cramps; muscle aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MUSCLE SPASMS (severe cramps), MYALGIA (muscle aches) and NAUSEA (nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (headache), MUSCLE SPASMS (severe cramps), MYALGIA (muscle aches) and NAUSEA (nausea). At the time of the report, HEADACHE (headache), MUSCLE SPASMS (severe cramps), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Shortly after receiving the second covid19 vaccine, I started experiencing tinnitus in my ear/s.  I cannot tell which ear it is coming from since closing off my ear canal does not stop the sound.   The only way to describe the loud sound is a constant sound the cicada makes.  The only time I don't notice the sound is in loud environments but it is constant if my surroundings are silent.
Caller had vaccine and at 12:30 at night caller had extreme paid in left arm and had to take Tylenol. Next day caller stated pain had subsided.
A few weeks after receiving my fourth dose, my right leg wouldn't support me. I fell when I tried to stand up. I went to put my foot down and my leg just collapsed. I can't lift my leg up, I have to use my hands/arms to lift it. I have fallen several times since receiving the vaccine. I started taking gabapentin 300mg 3x per day, about a week after my first episode. I'm also using a cane now. I have an appointment with Doctor (Internal Medicine) on 08/19/2022. I'm also experiencing chest pain. My deep breathing feels affected. I'm not sure if this is a nerve problem, joint, tendon or if I've been infected by a virus. Something similar happened to me back in May of 2020, but that only happened once.
Patient received a dose of Pfizer COVID-19 Vaccine lower formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Periorbital edema. Seen in ER 24hrs after vaccines with severe periorbital edema and facial swelling. She was given Benadryl. Symptoms resolved within another 24hrs.
Shingles rash noted 10/31/2008.  No fever or other symptoms.  Self resolved.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL. Subsequently the patient broke out in warts all over her feet. At the time of reporting, the outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
rash for him looks like "as if been scratching" and it is itchy; rash for him looks like "as if been scratching" and it is itchy and scabs over; skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash for him looks like "as if been scratching" and it is itchy), SCAB (rash for him looks like "as if been scratching" and it is itchy and scabs over) and RASH (skin rash) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash for him looks like "as if been scratching" and it is itchy), SCAB (rash for him looks like "as if been scratching" and it is itchy and scabs over) and RASH (skin rash). At the time of the report, RASH PRURITIC (rash for him looks like "as if been scratching" and it is itchy), SCAB (rash for him looks like "as if been scratching" and it is itchy and scabs over) and RASH (skin rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Follow-up received does not contain any significant information, reporter's email address updated.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves 69 year old female patient who received two 0.5 ml dose of FLUZONE HIGH DOSE (batch number UI985AC, expiry date 22 Mar 2019, route and site of administration were not reported) on 24 Sep 2018 and again on 01 Oct 2018. It was a case of actual medication error as Extra dose administered. It was unknown if any 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. Documents held by sender: none.
This spontaneous report has been received from a consumer via Pfizer, who was the patient's girlfriend, referring about a male patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided. On an unknown date in 1991 (reported also as "30 years ago"), the patient was vaccinated with a dose of a measles vaccine (manufacturer unknown) for prophylaxis (trade name, formulation, strength, dose, dose number, frequency, route of administration, anatomical location, lot number and expiration date were not provided). On an unknown date in 1991 (reported also as "30 years ago"), after the measles vaccine (manufacturer unknown) administration, the patient experienced an allergic reaction such as body rash that started in the patient's torso and under the patient's arms, spread up the patient's neck  and was red and itchy; there were some hives involved, as well. The hives extended to his neck, his shoulders, his body, his private parts, and his butt. The caller also reported that the patient's right hand was swelling and had swollen to at least 1 or 2 sizes bigger than normal. The patient's left hand was swollen too. It was reported that the patient had difficulty squeezing both hands into fists due to the swelling. It was reported that the patient also presented some irritation in throat (hypersensitivity). On an unknown date in 1991, the patient also experienced a burning sensation in esophagus (esophageal pain). Caller reported that the patient's primary care physician did take blood work but the patient's allergist said that the results of the bloodwork would probably not be relevant based on fact that the patient was on medication at the point that the labs were drawn. The reason for the medication was not specified. At the time of reporting, the outcome of the aforementioned events was not reported. The causal relationship between the measles vaccine (manufacturer unknown) and hypersensitivity and esophageal pain was not provided.
Event: Somewhat painful and fairly swollen lymph node in armpit, close to breast tissue.  Treatment: Ultrasound Outcome: Recommend receiving second does of Moderna vaccine on 2/14/21. Follow up in three months with additional ultrasound.
inadvertently administered an expired dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA723Z, expiry date 31-AUG-2023) for prophylaxis.   The patient's past medical history included splenectomy.   On 29-SEP-2023, the patient received Menveo (left deltoid). On 29-SEP-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired dose of Menveo).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The office manager called and inquired that should the patient be revaccinate as was inadvertently administered an expired dose of Menveo which led to expired vaccine used. The reporter did not consent to follow up.
an expired dose (beyond use date) of modena was administered on 19-jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose (beyond use date) of modena was administered on 19-jan-2022) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose (beyond use date) of modena was administered on 19-jan-2022). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (an expired dose (beyond use date) of modena was administered on 19-jan-2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Expired vaccine may have been administered to a Patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered to a Patient) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered to a Patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered to a Patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. The treatment information was not provided
Fever; Chills; This is a spontaneous report from a contactable Consumer. This consumer reported for a male patient (brother). This report is cross referenced to reportum 3. While reporting on her mother, caller wanted to report side effects for her sister and brother after receiving the Pfizer COVID vaccine. This report is to capture information for her brother. A adult male patient of an unspecified age (probably 48-49) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On an unspecified date, the patient had fever and chills. He stated he felt really bad, but it only lasted a week and then he felt better. He was glad that he got it. Outcome of the event was recovered, at the time of this report. No follow-up attempts are possible; information about lot/batch can not be obtained.
Received COVID 19(Pfizer-BioNtech) vaccine LOT number: EL0142 on 01/04/2021 at Medical Center as the 2nd dose in the vaccine series.  On 02/11/2021, I developed unusual heart palpitations and shortness of breath a few hours after eating a meal.  Shortness of breath was typical of asthma exacerbations but was resistant to albuterol nebulizer treatment.   I had never experience the heart palpitations before and decided to seek medical treatment.  Just prior to arrival to the emergency room the shortness of breath had resolved and the heart palpitations had also resolve.  ER work up done, nothing was found by EKG, labs, and with a recent history of GERD (later diagnosis of Hiatal Hernia), discharged with a diagnosis of GERD induced bronchospasm.    On 02/20/2021, I awoke with shortness of breath, severe palpitations, and noticed that I had missing heart beats in conjunction with the palpitations. I went to Medical Center where Premature Ventricular contractions and hypertension was diagnosed.  A stress test was conducted and unremarkable.  Discharged on cardizem.  PVCs resolved after about 4 months.  On  09/27/2021, received booster vaccine .  On 9/29/2021, severe PVCs resumed.  Diltiazem restarted, seeking further cardiology workup.
Information has been received from a female Medical Assistant with no drug reactions/allergies and no medical history who on an unknown date, was vaccinated with GARDASIL, a Pregnancy Registry product. There was no concomitant medication. The medical assistant reported that "after receiving a dose of GARDASIL she became pregnant, she is about 5 months pregnant." No adverse event involved. The patient sought unknown medical attention. Follow up information has been received from the reporting Medical Assistant reported that she delivered vaginally a healthy baby girl on 02-FEB-2011 at 36 weeks gestation. She also reported that the baby weighed in at 6lbs, 10 oz. She reported that the baby was born with a "birth mark on her lip" classified as a "hemangioma". She said her baby's health otherwise was good. No other problems encountered. Based on the deliver date 02-FEB-2011 at 36 weeks, the patient's LMP would be approximately 24-MAY-2010, and the EDD calculated by the system is 28-FEB-2011. The baby's experiences has been captured in WAES# 1009USA03287B1. Additional information has been requested.
Narrative:  75yo male patient with metastatic lung cancer committed suicide with gunshot to self. Death is not related to covid vaccine.
Patient experienced large swelling in the upper arm the day after her vaccination. There were bumps in the affected area about the size of a quarter and presented with a rash. Patient felt fine otherwise stating there was no pain or itching. We counseled the patient (6/30/17) to monitor the swelling to see if it worsens since the reaction is only localized to the site of injection. We told her the symptoms of anaphylaxis (difficulty breathing and rash/hives spread throughout the body) and to call 911 if she experiences those symptoms. Lastly, we told her to call the pharmacy if there are any signs of the swelling getting better or worse.
One hour after administration of DTAP-left deltoid swollen.  Ice pack applied per school nurse.  Not taken to doctor per parent.  04/30/2003 spoke to school nurse area improved.
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), Suspected COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid rebound on day 12 after initial covid symptoms / day 5 after completing paxlovid treatment; Unknown results, notes: covid rebound on day 12 after initial covid symptoms / day 5 after completing paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information : The event covid rebound on day 12 after initial covid symptoms / day 5 after completing Paxlovid treatment with outcome as recovering. Anti viral details: The drug paxlovid started on 27May2022 and stopped on 01Jun2022 was taken for indication as treatment of COVID-19.  Follow-up attempts are completed. No further information is expected.
experienced an injection site reaction, described as red and itchy; experienced an injection site reaction, described as red and itchy; This spontaneous report has been received from a consumer, referring to a 80 years old female patient. The patient's history condition and concomitant medication were not provided. It was reported that the patient was in the hospital and was a patient prior to receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  On 13-MAY-2020, the patient was administered the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.         On the same day, the patient experienced an injection site reaction, described as red and itchy. The outcome of the events was unknown. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
After being given a vaccination for Tetanus, Diphtheria, and Pertussis my body began reacting to it. I began to feel dizzy, nauseous, and tired even though I had felt good prior to the vaccine. My left arm was swollen and red. I had severe pain where the shot was given up to my shoulder for the next 3 and a half days. I felt a numbness in my middle finger the next day as well as other parts of my hand.
COVID Breakthrough Case  Pfizer Dose 1 2/20/21 (el3302) Pfizer Dose 2 3/5/21 (EN6199) COVID Positive 9/20/21  9/21/21: 97-year-old lady presented to the emergency room with complaint of shortness of breath.  The patient reports shortness of breath with activity.  She reports fever.  She was tested positive for COVID- 19 infection and received an antibody infusion today.  She denied nausea, vomiting, diarrhea.  She was discharged from the hospital about 3 weeks ago for the management of CHF and atrial flutter.  9/27/21: 97-year-old female with heart failure with preserved ejection fraction presented with worsening shortness of breath, received outpatient antibody infusion for recent COVID-19 diagnosis.  No pulmonary embolism on chest CT.  Patient admitted for acute hypoxic respiratory failure secondary to COVID-19, sepsis and diastolic heart failure exacerbation.  She was initially on BiPAP subsequently weaned off to room air.  Treated with IV diuretics, worsening acute kidney injury. diuretics discontinued renal function subsequently improved.  PTOT evaluated patient and recommended in-home therapies and patient will be discharged with VNA.  Patient lives alone, daughters are planning to stay with the patient  for the next several days with the patient . On discharge patient was afebrile and hemodynamically stable.  She was discharged home.
This is a spontaneous report from a contactable consumer (patient's husband). A female patient, of unknown age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unknown route, on Aug 8, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medication not reported. Since the past 15 days, patient has experienced multiple types of symptoms: pain in forearm, in the palm, in the wrist, pain in the neck, shoulders and back (lower back). The outcome of the event pain in forearm, in the palm, in the wrist: recovering; and all other events unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.