chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FX9896) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Re-tested 5 days after completion and found to be positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Other medication in 2weeks.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
20-30 erythematous lesions with central papule. Dad dx'd with varicella 10-14 days after child's breakout.
dehydration; Racing heart beat; fever; nausea; vomiting; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On 25-Feb-2021, DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 150 breaths per minute High.         No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Red and swollen bilat. thigh worse on right. Diagnosed with cellulitis; treated with Cephalexin 125mg.
pt recv vax in 1998 & 5/4/99 pt hosp w/meningitis & treated w/ATB;5/13/99 pt exp a breakthrough case of chickenpox w/less than 20 lesions on neck & bottom;it was reported that pt is on the cancer ward;
A LITTLE CHILLS; TIRED; This spontaneous report received from a patient via a social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced a little chills, and tired. The action taken with covid-19 vaccine  was not applicable. The outcome of the a little chills and tired was not reported. This report was non-serious.
Narrative: COVID infection following COVID vaccine series 07/19 Janssen, dose #1 10/05 pt cc: cough, fatigue, diarrhea, congestion, loss of taste or smell exposure: unknown 10/06 COVID swab, result: detected 10/06 SARS-COV-2 Variant Seqencing result: pending 11/06 CXR Impression: NO acute abnormality. Remainder of finds as above.
Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included CARVEDILOL (COREG), GABAPENTIN, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and MACROGOL 3350 (MIRALAX) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-416295.
Pt recvd vax & pt had redness & sl swelling @ site of DTP inject; 1FEB94 along w/tremors on 24FEB94 3 days later; pt seen by pvt MD;
This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source Additional information has been requested.
Lethargic 12 hrs p/immun; Rash generallized, erythematous onset unk; Persisted >48 hrs p/inject; fever (not measured) for 48hrs, onset 4 hrs post inject;
Severe middle back pain beginning February 21. Initially thought it was a kidney stone, but a visit to a urologist on February 25, determined it wasn't a kidney stone. The urologist ordered some blood work and that indicated that I most likely had blood clots. Went to the ER on the 25th and had further tests that determined that I indeed did have blood clots in my lungs.
2/12/17: Fever, chills, rash and swelling. 2/13/17 Fever, chills, rash and swelling. Diagnosed with influenza, treated with Tamilflu 75mg twice daily. 2/15/17 Localized tenderness, rash, inflammation right arm extending 2/3 down from shoulder to elbow and right axillary area. Recommended cold packs and ibuprofen 800 mg every 8 hours. Symptoms resolved 2/17/17 per patient report.
Arm soreness began 7PM on 2/11.  Vasovagal syncope episode at 2:25AM on 2/12; triggered by combination of arm soreness, body aches, and low-grade fever. Senses returned back to normal within 5-10 minutes.   Consistent low-grade fever from 1AM on 2/12 until 6PM on 2/13.  Treated with 1000mg liquid acetaminophen every 6 hours per manufacturer instructions.  Notable ache in legs (akin to Restless Leg Syndrome)  from 3AM on 2/12 until around 9AM on 2/13. Urge to move calmed by acetaminophen.  Highest recorded fever: 99.5°F at 9AM on 2/12. Fever subsided as of 6PM on 2/13.
Started feeling dizzy around 9PM, woke up the next morning with balance issues and falling due to dizziness, went to PCP and diagnosed with Vertigo. Lasted days.
Approx 6 hours post injection, a large, red, painful, hard, golf-ball sized swollen lump formed under the injection site apprx 3 inches in diameter. 12 hours post injection, the hard, red, painful blotch has increased to nearly 6 inches in diameter and is hot to the touch. Seems to be spreading down the arm. Pain radiates from the muscle in the arm at the injection site into the neck. Decreased strength in arm.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 4-month-old male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant) and fever (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, whooping cough and fever were unknown. It was unknown if the reporter considered the vaccination failure, whooping cough and fever to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was 28 years of age at the time of reporting. At 4 months, the patient ended up in neonatal intensive care unit (NICU) with a 106 degree F temperature after receiving DPT vaccine. Thereafter, his vaccines were given to him one at a time with 3 week intervals. He had the same reaction after the pertussis vaccine. It leads to another trip to emergency room with very high fever. The patient's immunologist said no more vaccinations would be given until the age of 5 years. The reporter was pro vaccination, but after the patient's kindergarten vaccinations, he had no negative reactions but got a horrible case of whooping cough a year later. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for pertussis, time to onset for event and laboratory confirmation for pertussis were not provided. Lab Comments: On an unknown date, lab test was performed.
Patient received a COVID-19 vaccine Moderna 1/13/21 around noon. Left deltoid; he was monitored for 30 minutes after administration, and then intermittently assessed throughout the evening showing no signs of reaction. Overnight, he did not sleep and began to become restless and 0400 his prior normal 97s-98s temp had increased to 99.8. At 0500 he vomited a large amount and temp was 102.1, at which point he was given PRN acetaminophen for fever. SpO2 fell to 90%, and he was started on O2 at 4 L it was also noted his abdomen was distended, and he had erythema on his left arm extending from the base of his neck to his wrist. Dr. was called, and Benadryl was given for suspected allergic reaction to the vaccine. Over the next hour the erythema resolved, though other effects continued throughout the day( vomiting, fever, etc)
Site: Pain at Injection Site-Mild, Additional Details: pt said after a day or 2 from the second shot ( may 28th 2021) she experienced soreness and  pain ( scale 5/6 out of 10). they come and go and she is able to do her normal activities
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 18-MAY-2016, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 PFU, (dose, route and lot # were not provided). The expiration date was reported as 15-MAR-2016. It was unknown if the product had any previous temperature excursion. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
presented ED on 5/14/21 -  O2 in 60's., SOB, cough lower body edema, dx with covid pneumonia
Light rash on face, scalp and chest.  Rash itches and is red.  Rash occured about 1 week after vaccine.  Vaccine was given on Feb. 11th, 2021 and rash started on Feb. 18.  Today is Feb. 21 and still have rash, but has not spread.  Still itches and is red.
On 4th day after the booster shot, a small bump appears on the arm inner elbow. on the next morning five more rash appeared. Small clustered rashes appeared on the wrist with blisters came with extreme itch. Symptoms appears similar of the Shingles, on 6th day (on 11/30), I went to see doctor and the doctor prescribed me the medication for Singles
Patient received incorrect covid vaccine. Patient received dark pink cap with yellow box moderna Lot # 216K22A. Should have received dark blue cap and label moderna
This spontaneous report as received from a register nurse refers to a patient of unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL lot #, dose and route not reported). The primary reporter reports that an unspecified patient received the first dose of GARDASIL (lot #, dose and route not reported) series on an unspecified date, the second dose in the series was administered "2 months later" and the third dose in the GARDASIL (lot #, dose and route not reported) series was administered 2 months after the second dose. No adverse effect reported. Additional information has been requested.
Patient was seen on 10/18/23 for flu and covid vaccination. This visit was performed by APRN. On 11/10/23 a billing error was discovered. This patient was 12 years old at the time of covid vaccination, however per the documentation in the chart she received the product intended for 5-11 yo age group. The paper vaccine consent is not present in the chart.\  Pfizer was contacted and recommended we revaccinate with appropriate product. Mother was notified by provider.
Flu-like symptoms - fever, chills, body aches, vomiting for 3 days.
COVID-19 symptoms started on 06/23/22; tested positive same day. I didn't have fever but I had hot and cold flashes, a headache, and tremendous body aches. I'm used to body aches with lupus but these were much worse. I called Doctor on 06/24/22 and she prescribed Paxlovid for 5 days and my last dose was on the 29th or 30th. I tested negative but then I developed other symptoms and on 07/01/22 I was positive again and I've been positive since. The new symptoms are secondary infection to COVID-19 and the Paxlovid is rough and side effects are just as bad as COVID-19. My voice is not normal and I've had a bad cough the whole time and it got worse recently. She put me on cough pearls alongside the Paxlovid.
This spontaneous report as received from a physician referred to a patient of unknown age and gender. Physician stated that patient today (27-FEB-2013) received the first dose in the ROTATEQ series (oral, lot#, dose/frequency were unspecified), but regurgitated some of the dose. No adverse effects noted. It was unspecified whether patient had sought medical attention nor not. The outcome of "regurgitated some of the dose" was unknown. The relationship was not provided.  Additional information has been requested.
Received second anthrax shot. Noticed severe local reaction 2 days later in arm. Swelling extends below elbow. site is red, arm painful enough that patient had trouble sleeping. Patient also experiences "hot flashes" at night when she tries to sleep. Arm is hot and red during the daytime. Patient was seen in ER prior to filing VAERS. Arm is still very swollen at time of VAERS filing (4 Nov 02 8:36) ER Physician reports that swelling looks like cellulitis. Treated with Keflex.
patient came to our clinic complaining of "vaccine reaction" after receiving covid vaccine at another clinic. stated "it bled and bled" and receiving shot in left deltoid. pt appeared to have small hematoma and mild localized cellulitis. patient denied any type of allergic or immune reaction to vaccine contents.
Pt. states that after receiving the 3rd dose of Booster Phizer 12/29/2021 (Influenza Quad x 1), started experiencing symptoms 12/30/2021 of facial hives and facial drooping. 12/31/2021 Emergency Room visit Hospital, EKG, Cat-Scan, MRi preformed to determine no stroke had occurred. Diagnosed with Bells Palsy 01/01/2022.  PT with Follow-Up care continue.
No adverse events. Client received yellow fever vaccine on 12/17/10 and learned she was pregnant Jan 8, 2011.
Severe Back Pain - lower lumbar that started 13 hours after injection. Pain was so severe that I screamed and cried just to stand up from the bed.  I had no fever, chills, or other aches and as long as I did not move I was fine. The minute I tried to roll over in bed or stand and walk I had to have help from my husband and it was excruciating.  I am on day 4 and only was able to walk unassisted today.  I was given  a muscle relaxer tizanidine 4mg  for 3 times a day that did nothing.  I was then given  Hydrocodone/acetaminophen 5-325 that took the edge off.
Covid19 breakthrough.  1st vaccine received on 03/29/2021.  51 y/o with PMHx GERD, Hemorrhoids and obesity presents to ED with c/o abdominal pain and found to have acute appendicitis.  Pre-op Covid screen returned positive, pt asymptomatic-no treatment ordered at this time.
Noticed small bumps on the right side of my neck the night of and morning after receiving the first dose. Within two days I had a few small hives across my neck and chest. Day 9 I had larger hives across my neck, arms, back and stomach. I went to urgent care and got a steroid prescription. Took that for 5 days and the symptoms did not improve. Day 13 I have severe hives, the size of dimes and tons of small red bumps entirely covering my neck, chest, arms, stomach and back.
GENERAL BODY PAIN (SORENESS ALL OVER); STIFFNESS ALL OVER; WEIGHT GAIN; BLOOD PRESSURE GONE UP; LIVER PROBLEMS (RAISES IN LIVER ENZYME COUNT); This spontaneous report received from a patient concerned an adult male. The patient's weight was 60 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced general body pain (soreness all over), stiffness all over, weight gain, blood pressure gone up, and liver problems (raises in liver enzyme count). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Increased, Hepatic enzyme (NR: not provided) Increased, and Weight (NR: not provided) 60 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from liver problems (raises in liver enzyme count), and had not recovered from general body pain (soreness all over), stiffness all over, weight gain, and blood pressure gone up. This report was non-serious.
Headache; fever; chills; This is a spontaneous report from a contactable nurse reported for a consumer.  A 31-year-old female patient received second dose bnt162b2 (BNT162B2, reported as Pfizer COVID 19 vaccine, lot number unknown), intramuscular on 20Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient  previously received first dose BNT162B2 on 30Dec2020 for COVID-19 immunization (other vaccine 4 weeks prior Covid-19 vaccine).  The patient experienced headache, fever and chills, all on 20Jan2021. The patient did not received treatment for these events. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Moderna COVID?19 Vaccine Chills (approximately 4 hours), muscle and joint ache (approximately 12 hours), fever (approximately 8 hours), syncope and ears ringing (momentary)
given outside of approved age range, Flucelvax is not approved until 4 years old
I was fine up until 8 days later. At around 4 that afternoon, I noticed my arm was swelling and I developed a fever. My arm was bright red and hot. I called my boss, who is a nephrologist. I had no strength and couldn't even get out of the car. My boss told me to get rest and tested. The next day, my fever was around 101. I was tested the following day and also had blood cultures done, along with antibiotics prescribed. I had the same reaction with tetanus as far a my arm, but I hadn't had any other vaccines within 20 years. I had a milder reaction to the 2nd dose, which only caused me to be fatigued. My boss sent me pictures from the internet showing how this is a common late reaction and told me to not take the antibiotics. I was able to return work Saturday. I do feel as if I'm not as strong as I was prior to the vaccine. I notice a distinct difference in my strength.
This is a spontaneous report received from a non-contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 09:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00, the patient experienced extreme fatigue and ache for at least 24 hours and counting. Being sleeping all day. The patient received first dose on 12Mar2021 and second dose on 29Mar2021 (inappropriate schedule of vaccine administration). The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extreme fatigue, ache and sleepy were resolving at the time of reporting and the clinical outcome of inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.