chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, in Mar2021 at 01:00 pm as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 at 01:00 pm as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 at 10:00 am as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years (as of dose 1 and dose 2), in right arm for covid-19 immunisation. The patient's relevant medical history included: "overweight" (unspecified if ongoing); "Prediabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included nirmatrelvir; ritonavir (PAXLOVID) from 03Jul2022 to 07Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had allergic reaction to the first dose.; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a Single dose for covid-19 immunization. The patient past medical history and concomitant medications were not reported. The patient had allergic reaction to the first dose on 14Apr2021. Inquiring how well she is protected. The outcome was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mother noticed red bump on right thigh, 12/5/02 in the PM. Rash has spread to entire thigh, area is warm, papular confluent with irregular border to right thigh, anterior aspect, about .5 cm in diameter. 1% HC cream prescribed. Follow up appt on 12/7/01.
Patient appears to have a brief seizure just after vaccine administration. Pt stabilized quickly with no apparent injury. Patient declined RPh suggestion to call EMS. Patient agreed to call primary MD after leaving pharmacy. Pt left in stable condition.
Patient developed a red rash that started on the back of her upper right arm and migrated lower and to the inside. Rash was raised/swollen and warm to the touch.
This spontaneous report as received from a 62 year old female registered nurse with no drug reactions or allergies, refers to herself. On 17-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intra-articular in the arm (lot number was not reported). On the same day (17-OCT-2014), the patient was concomitantly administered a dose of influenza virus vaccine (unspecified). The patient reported she had had an unspecified pneumococcal vaccine (manufacturer unknown) years ago (date not provided), could not rule out PNEUMOVAX 23. The patient stated she received her influenza virus vaccine (unspecified) and the pharmacist went to administer the PNEUMOVAX 23, on 17-OCT-2014, he stuck the needle in very high up on the shoulder and he could not inject it, so he stuck the needle a second time right next to the first location and also could not inject. On the third needle insertion, he was able to inject the PNEUMOVAX 23. The patient stated that on 17-OCT-2014, about 2 and a half hours after the vaccination, her shoulder began to have severe pain. She stated that it was throbbing and painful, so painful that she was nauseated. She stated that she took ibuprofen and BENADRYL and went to an unspecified urgent care center. She also went to her unspecified internal medicine physician who referred her to an orthopaedic surgeon, who, on an unknown date in 2014, took Magnetic Resonance Imaging (MRI) of her shoulder and found fluid in the bursa with bursitis with a small high grade superficial tear partial tear (onset date 17-OCT-2014). The patient also reported that on 17-OCT-2014 the pharmacist injected the PNEUMOVAX 23 into her shoulder joint and it was so tender and painful that she could not lie down, sleep or even put ice on it. The patient was scheduled for surgery with the orthopaedic surgeon to repair the torn ligament but the surgery had to be delayed related to unspecified problems with blood work (date unspecified in 2014). There was no treatment given for the events of fluid in the bursa with bursitis with a small high grade superficial tear partial tear, shoulder joint and it was tender and painful that she could not lie down, sleep or even put ice on it, problems with blood work and torn ligament. The outcome of the events was not recovered. Relatedness between the therapy and the events was not reported. Upon internal review, the events "shoulder joint/it was so tender and painful that she could not lie down, sleep or even put ice on it" and "could not sleep" were considered to be disabling. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 20 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 21-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
patient experienced shallow breathing, hives, sweating and low systolic blood pressure 85 within  5-10  minutes of receiving first moderna   covid vaccine.  Had pt lie down on his back and  administered epinephrine 0.3mg on thigh within 5-10 minutes of monitoring pt.  Patient became more alert and sbp came up to 110. EMT came and took him to er
Began having UR symptoms a month ago. c/o cough, stuffy nose, myalgia, malaise. 12/21/06 Received medical records from hospital which reveal patient admitted 11/25/-12/1/06. Had SOB for approx 1 week prior to admit which had started after the flu vax. Presented to ER w/CHF & acute renal failure.  Cardio & nephro consults done. Final Dx: CHF secondary to acute viral myocarditis; and BPH.
A consumer report has been received. The report concerns a 56 year old, female consumer, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 25-Sep-2013. It was reported that a 56 years old patient received FLUMIST QUADRIVALENT which started on 25-Sep-2013. FLUMIST QUADRIVALENT was discontinued on 25-Sep-2013. The outcome of the event of I received FLUMIST QUADRIVALENT and I am 56 years old is unknown. The report was considered to be non-serious.
Pt. states that after receiving the 3rd Booster of Phizer 10/30/2021, started experiencing symptoms 11/01/2021 of swelling in the Left eye, and mild swelling in the right eye. Primary visit *Telehealth communications recommendation for Follow-Up with Emergency Room visit 11/01/2021 *treating with Steroids & Antihistamines. Pt. still experiencing symptoms.
post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself).  A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.
Vertigo fever  body aches  chills   two days, missed work, tylenol rest and fluids  still have altered sense of smell, some dizziness and constant phlegm and post nasal drip
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient called to inform of adverse event, but unable to reach patient.
COVID-19 Breakthrough Infection; COVID-19 Breakthrough Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old male patient received BNT162b2 (BNT162B2), on 29May2021 as dose 1, single (Lot number: EW0179), on 21Jun2021 at 12:00 as dose 2, single (Lot number: EW0202) and on 24Mar2022 at 12:00 as dose 3 (booster), single (Lot number: FJ6369) at the age of 16 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022 at 15:00, outcome "recovering" and all described as "COVID-19 Breakthrough Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: covid test type post vaccination=Nasal  Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Approximately 48 hours after vaccination was received, I ached all over and was very tired. I developed a severe case of hives that evening 11/21/04. Taking Benadryl relieved the hives. The hives reappeared and disappeared over the next three days, but not as severe as the first onset. Stomach upset occurred on 11/25/04.It was 11/26PM before I started to feel normal. I have had flu shot in many previous years, but never had an adverse effect from the shot.
Expired dose of Moderna Covid 19 Vaccine to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid 19 Vaccine to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid 19 Vaccine to a patient). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid 19 Vaccine to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported
I woke up at 3am on Tuesday with neck and jaw pain.   It was so bad on Tuesday that I stayed home from work. At 3:30 pm I took excedrin like I normally do.  I also applied Hempvana to neck and temples(I've been using for several weeks). At 8:30pm, I began to have non stop diarrhea.  I went to bed at 10pm. Today, I woke up at 3:30 am with neck and pain on right side of face.  A vein is bulging out near temple on right side of face and I have a red bump about the size of a dime in temple area. My stomach is making noises but I don't have diarrhea.
SHORTNESS OF BREATH; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103. On 07-MAR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, fever and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Narrative: Patient COVID positive on 8/9/21 (fully vaccinated) admitted for hypoglycemia and tachycardia. Patient began requiring HFNC with suboptimal saturations and ultimately required intubation on 8/13/21. Patient then developed septic shock and passed away on 8/18/21.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient asked how long and how high can a fever last with the Shingrix vaccine.
Breakthrough case admission after three vaccines Pfizer 2/10/21 Lot# EL9267;  Pfizer 3/3/21 Lot# En6205;  Pfizer 11/16/21 Lot# 320308D
{Note - my first two Covid 19 Vaccination shots were Moderna 2/18/2021 and 3/17/2021} Pain around the right side of the chest from below the right nipple around the flank to below the scapular on the right shoulder (5-6 ) and left side flank (2-3)
I have had muscle inflammation and wide spread pain throughout my body. It started as a pain in my left chest on May 29th, then by June 10th my body is on fire, I cannot use my left arm due to my sore joint. The muscle inflammation has spread throughout most of my body. My appetite has been non existent, and I have swollen lymphnodes in my arms and chest. It started off on one side and eventually spread to both sides of my body. My lymph nodes are still swollen and my body pain and muscle weakness are still here.
An area of redness affecting Rt Deltoid reaction about 6". Non tender and there is no induration. Less than 24 hrs after the injection.
After my second vaccine, I immediately experienced dizziness, light headiness, felt anxious and jittery. I also had heart palpitations and the medic personnel took my heart monitor, it was 80bpm. About 45 minutes of monitoring,  my symptoms were slowly going away and I went back to work. That same night I felt fine and by the next morning I was feeling much better.
Headache, body aches, sore throat, skin aches, nausea, diarrhea, arm aching where injection was given, numbness in arm, rubber arm. Localized redness/swelling.
administered PROQUAD/concurrently with VARIVAX; No adverse effects; pediatric patient was inadvertently administered PROQUAD instead of M-M-R II concurrently with VARIVAX; This spontaneous report was received from a registered nurse and refers to a 15 month old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 20-MAY-2020, the patient was inadvertently administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot S031495 and expiration date 07-OCT-2021, lot # confirmed to be non valid) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) concurrently with varicella virus vaccine live (oka/merck)(VARIVAX) (lot S012533 and expiration date 20-OCT-2020, lot# confirmed to be non valid). The suspect vaccines were administered for prophylaxis, dose, strength, and route of administration were not reported. The vaccines were reconstituted with properly stored sterile diluent.  No adverse events were reported.
Received at 1:00 pm - Became very tired about 2 hrs after, by bed time my eyes were burning, I was sneezing, coughing and had a terrible sore throat. had chills, fever that night and next 2 nights.
Body aches, felt feverish, chills, scratchy throat. Lasted about a hour.  Chills repeated about 12:00 AM When patient awoke in the morning the next day, felt like she had the flu.
This spontaneous was received from a consumer as part of a marketing research program, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry date, dose and route were not reported). On a unknown date, the patient experienced rash type reaction in site area of vaccine, red area and cellulitis a few days after vaccination. On an unknown date (also reported as once every few years) the patients experienced fever and achiness. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as reporter did not wish to contact further.
Received Pneumovax 10 AM 11/18/08.  Complained of some immediate discomfort.  Noted some minor warmth and erythema at the injection site the morning of 11/19/08 which worsened over the day and by the time of evaluation at 5 PM had fairly extensive erythema over the right deltoid and a large, oval area of erythema and warmth over the triceps region.  Low grade fever of 100.2 (temporal) noted but no other systemic symptoms or signs.  Given Solumedrol 125 mg IM and Rocephin 1 gm IM and given prescriptions for Prednisone 20 mg 3 tabs daily x 3 days and Keflex 500 mg 1 tab qid x 7 days to start 11/20/08.
Felt tired after the vaccine and continued to be more and more tired each day after the vaccine. 3 days after the vaccine I had to leave work to sleep and felt terrible (weak, shortness of breath, extreme exhaustion) on the 5th and 6th days after the vaccine with shortness of breath. On the 7th day, I went to the ER and was diagnosed with pneumonia.
About 10 hours after shot I started feeling nauseous, with a really Bad headache, and body aches so bad as to not wanting to move at all,, chills (internal tremors), dry cough, and sore throat.  I felt HORRIBLE as though I may die. ,
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 18-MAR-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered to be not recovered. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered disabling.
Information has been received from a physician concerning an 8 month old male, with no medical history and no allergies, who was vaccinated with a first, second, and third oral dose of ROTATEQ vaccine live (human-bovine) on 15-MAR-2007, 21-MAY-2007 and 23-JUL-2007, respectively. There was no concomitant medication. The patient's parents reported to the physician that diarrhea started on 04-OCT-2007. On 09-OCT-2007, during an examination, there was a positive stool test for rotavirus. No product quality complaint was involved. No other information was provided. Additional information has been requested.
J&J COVID-19 Vaccine EUA Fever around 100 F (about 6 hours) Muscle aches (about 12 hours) Headache (about 12 hours) Diarrhea (about 6 times over the course of 8 hours) Vomiting (about 4 times over the course of 1 hour)
After having experienced the typical side effects associated with the COVID vaccine I had a gradual onset of crippling pain on the right side of my chest. Pain became so intense that I became nauseous and felt that I had to throw up. Instead of throwing up I actually passed out (syncope) for about 30 seconds. Chest pain remained, but gradually lessened over the following 30-45 minutes while laying stool on the ground on my right side. I was transported to the hospital. Numerous EKG?s and blood draws were taken which did not reveal I had suffered a cardiac event. I spoke with several doctors and nobody could conclude the cause for the intense chest pain.