chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (swelling back of throat), MUSCLE SPASMS (muscle spasm) and HEART RATE INCREASED (rise in heart rate) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling back of throat), MUSCLE SPASMS (muscle spasm) and HEART RATE INCREASED (rise in heart rate). At the time of the report, PHARYNGEAL SWELLING (swelling back of throat), MUSCLE SPASMS (muscle spasm) and HEART RATE INCREASED (rise in heart rate) had resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication: diphenhydramine and Steroid. Patient went to urgent care then to ER and the issue lasted 3 weeks. Patient went to a Ears mouth and throat specialist. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No significant information was received.
SX Rash on upper extremities, lower extremities, trunk & face. Pt started Ceterizine syrup 3MG/5ML 2.5ml as needed for allergy symptoms
My skin on my back is extremely sensitive to anything touching it, as if I had a sunburn. It started in the middle of my back, but has expanded to my entire back. No redness, just sensitivity. I have had this before if I am fighting a cold, but it always goes away within 24 hours, this has been going on for almost a week and is now affecting my abdomen.
Redness, swelling, warmth, low temp, pain. Area kept spreading over arm.
This spontaneous report as received from a physician and a pharmacist refers to an 87 year old male patient with diabetes, essential hypertension, hypothyroidism and hyperlipidemia. The patient had experienced diarrhea with historical drug metformin (manufacturer unknown). On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX vial (dose unknown, lot # J001698, expiry date 08-MAY-2013 (reported as May 2014) via subcutaneous route. Concomitant therapies included Levothyroxine Sodium (manufacturer unknown), Flomax, Fenofibrate (manufacturer unknown), Vitamin 12, Rosuvastatin (manufacturer unknown) Altace, Vitamin D (unspecified) (manufacturer unknown) and Liraglutide (manufacturer unknown). On 06-NOV-2013 (reported as today), 65 days after onset of therapy, the patient had presented with a case of shingles. No treatment was given for the event. Lab diagnostic studies performed were none. The outcome of shingles was reported as not resolved. The patient sought medical attention by presenting himself to the primary care physician. Additional information has been requested.
I administered a covid booster 6-11 years of age. When we do the order set for the bivalent booster it has a different NDC number than what is on the bottle for the moderna booster 6-11 years of age. The dose that it says for booster is 0.5 on the bottle for age group 6-11 years of age. When I reordered the moderna covid booster (non bivalent) , in the order set it is populating the primary series as 0.5 with the correct NDC number that is also on the bottle itself. I administered 0.5 to my pt who is 6 years old. The correct dose for moderna bivalent booster 0.25 ML this vaccine also falls in the order group 12+ with just a smaller dose which is were this error has occurred. Informed Immunization coordinator and was told there in no concern to patient and this still does count as a booster. Pt has been contacted and informed of situation.
Productive deep cough, mild sore throat, loss of full voice, fatigue. Slight nasal congestion, sore joints and muscles.
Patient returned to the emergency department 12/15/2005 -  experiencing pain with movement right arm as well as tenderness.
Severe muscle pain, headache and tiredness. Took 24 hours. Tylenol was taken 3 times.
Pt developed hives bilateral arms/chest/abd and itching over whole body 4 hours after recurring Influenza A (H1N1). Pt present to office 11/06/09 hives and itching still present.
A report has been received from a Pharmacist concerning a 34 year old, male subject, who had been receiving nasal FLUMIST. FLUMIST started on 04-SEP-2013. It was reported that the patient was not feeling anything on the first nostril and felt a burst of spray on the second nostril. FLUMIST was discontinued on 04-SEP-2013. The outcome of the event of not feeling anything on the first nostril and feeling a burst of spray on the second nostril /possible partial dose is unknown. The report was considered to be non-serious.
Pt presented wit hypoglycemia, and tested positive for covid.  Treated with remdesvir. Dicharged home once stable.
1 week very sore arm both A and B. 1/2 dose booster a little sore arm.  3 days of rigors and aches. both A and B. none with booster
SHORTLY AFTER GETTING HER SHOT, PATIENT SLUMPED OVER IN HER CHAIR AND WAS UNRESPONSIVE.WE LOWERED HER TO THE FLOOR AND ELEVATED HER FEET. IN 2-3 MINUTES SHE STARTED RESONDING TO QUESTIONS. THE PARAMEDICS ARRIVED IN ABOUT 5 MINUTES. THEY TOOK HER BLOOD PRESSURE WHICH WAS NORMAL WHEN SHE WAS LYING DOWN. THEN THEY STOOD HER UP AND TOOK IT AGAIN AND IT WAS VERY LOW AND SHE BECAME VERY DIZZY. THEY TRANSPORTED HER TO THE HOSPITAL. WE DO NOT KNOW WHAT HAPPENED AFTER THAT.
Had Flu shot and Pneumonia shot on 10/27/06. Erythema, Cellulitis given Cephalexiro 500 mg 4x days. Had side effect after 13 doses. Two days later came down with shingles given Acyclovir by my own Dr. I seem to be on the mend after 18 days. I hope so.
Fatigue, pain at injection site, hot to touch at injection site, redness, swelling.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II albumin status unknown, lot # M045390, expiration date of 14-NOV-2018; lot# M011667, expiration date of 08-MAR-2018 and lot# M004899, expiration date of 27-JAN-2018 (doses and route of administration were not reported). Administered doses of M-M-R II underwent a temperature excursion between 32 degrees Fahrenheit and 35 degrees Fahrenheit for 11 hours, which was detected by a digital data logger. There was the previous temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 45 minutes reported. No adverse symptoms were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA004651.
COVID-19 HOME INSTANT TEST  POSITIVE; FEELING A LITTLE BIT OFF; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2021, the patient experienced feeling a little bit off. On 28-NOV-2021, the patient experienced covid-19 home instant test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On 29-NOV-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 home instant test positive and feeling a little bit off was not reported. This report was non-serious.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml Single-Dose Vial (SDV) (lot # L019297, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced cellulitis and swelling in the arm that lasted over a week on an unspecified date with outcome of recovered.  The events required treatment with antibiotics. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the events. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2016541234 same reporter drug event different patient.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL.  After receiving GARDASIL the patient fainted and had a severe seizure.  The patient was listless and had a dusky color after the seizure.  The physician observed the patient for 1/2 hour and then sent her home accompanied by her mother.  The patient was then sent to a neurologist.  At the time of the report, it was unknown if the patients had recovered from faintness, listless and dusky color.  Upon internal review, seizure was considered to be an other important medical event.  This is one of several reports from the same source.  Additional information has been requested.
Rash and inflammation  about 4 inches long and 2 inches wide at the vaccination site. Began on morning of the 7th day after the vaccination
Only liquid portion administered; Only liquid portion administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-MAR-2023, the patient received Menveo. On 17-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion administered) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Mar-2023 The reporter stated that Menveo was not properly reconstituted and only the liquid portion was administered to a male patient.  The reporter consented to follow up via email. Information about the lot number and expiration date for the vaccine were asked but declined. The patient only received liquid portion only of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/20/21.pfizer,Lot#EK5730 2nd dose: 01/06/2021 ,Pfizer,Lot# EL3248 Diagnosed covid positive:07/14/21 Exposure:Home exposure Symptoms: Asymptomatic.
A report has been received from a health professional concerning an adult female patient. The patient's medical history and concomitant medications were not reported. The patient took FLUMIST in Dec-2011 and developed Guillain Barre symptoms. Four hours after administration of FLUMIST she had numbness and tingling on right side of body, then at eight hours her whole body was affected. The symptoms lasted through Jan-2012. The symptoms still occurred off and on. She had been hospitalized on occasion. Doctor ran a CT scan, MRI, and ultrasound while hospitalized and nothing could be found. At the time of reporting, the event of numbness, tingling and Guillain Barre symptoms was ongoing. Assessment of the serious criteria for the report was as follows: hospitalized as per reporter.
partial deafness left ear; pain at injection site; Headache; This serious case was reported by a consumer via call center representative and described the occurrence of deafness unilateral in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-APR-2023, the patient received the 2nd dose of Shingrix (left arm). In APR-2023, an unknown time after receiving Shingrix, the patient experienced deafness unilateral (Verbatim: partial deafness left ear) (serious criteria GSK medically significant). On 21-APR-2023, the patient experienced injection site pain (Verbatim: pain at injection site ) and headache (Verbatim: Headache). The outcome of the deafness unilateral was not resolved and the outcome of the injection site pain and headache were resolved (duration 2 days).   It was unknown if the reporter considered the deafness unilateral, injection site pain and headache to be related to Shingrix.     It was unknown if the company considered the deafness unilateral, injection site pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2023 The patient reported that he received Shingrix dose in left arm.  He experienced pain at injection site and a headache that lasted 2 days and resolved now.  He also experienced partial deafness in left ear that was not resolved. The reporter did not consent to follow-up.
2 days after 1st shot -both  eyes were watery and very itchy, started swelling.  Swelled to the point of not being able to drive.  Took Benadryl, no change.  Went to a clinic and they put me on 6 days of prednisone.  Swelling decreased.  Took 2-3 days.
INJECTION WAS STARTED IN LEFT ARM, NEEDLE ON HUB WAS LOOSE AND LEAKED OUT THE SIDE.  IMMUNIZATION WAS REGIVEN ON RIGHT ARM.  PATIENT STATES BOTH ARMS ARE SORE AND THERE FEELS LIKE A "BALL" IN HER LEFT ARM.
Pt vaccinated with Pneumovax developed lump "size of a lemon w/redness + itching" at site - instructed to apply warm compresses locally - report to ER for respiratory distress.
Muscle pain; Joint pain; Feeling cold; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 27Apr2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 01:45, the patient experienced muscle pain, joint pain, felt cold, headache and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, joint pain, felt cold, headache, tired was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash; itchiness; Redness; pain; Tightness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), INJECTION SITE INDURATION (Tightness), RASH (Rash), PRURITUS (itchiness) and ERYTHEMA (Redness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history). Concomitant products included BENAZEPRIL, AMLODIPINE and PEGINTERFERON BETA-1A (PLEGRIDY) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN (pain) and INJECTION SITE INDURATION (Tightness). On 21-Feb-2021, the patient experienced RASH (Rash), PRURITUS (itchiness) and ERYTHEMA (Redness). The patient was treated with Benadryl cream at an unspecified dose and frequency. At the time of the report, PAIN (pain), INJECTION SITE INDURATION (Tightness), RASH (Rash), PRURITUS (itchiness) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl Cream.
About 30-35 mins, after vax, I started noticing my eyes were itching, and I started scratching my face. I got in my car and realized it's not going away. I need advice on what to take for it to go away.  I noticed a itchy throat. Not sure if it's something that's due to the vaccine.
shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  Additional information: Customer Verbatim: Dear Pfizer Company, I have received your developed Covid-19 vaccine, and want to start by saying thank you for developing a vaccine that can save lives including my own. Side effects were a nuisance, including possibly contributing to shingles. I am overall glad the vaccine gives good protection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in arm at injection site along with the development of a hematoma; unresolved since day after vaccination. No treatment per patient.
Pt experiences red, hot, swollen and raise bump at the site of injection. The size of the redness has increased over couple days.
Red itchy Rash at injection site about 4? across.  Still visible after a week.  Also low grade fever 3 days after rash started lasted one day.
4 year old female had vaccines 3/21/10 RA in pain, swollen redness around administered area, hot to touch fussy. Right arm Cellulitis Amoxicillin give.
Information has been received from a nurse practitioner concerning a 24 year old female patient with no pertinent medical history and no drug reactions/allergies who on 18-AUG-2009 was vaccinated with a first 0.5ml dose of GARDASIL (lot#663454/0672Y) intramuscularly in her right arm. Concomitant therapy included DEPO-PROVERA. On approximately 18-AUG-2009, the patient became dizzy and lightheaded, then developed "hives" on her right arm at the injection site after receiving her first dose of GARDASIL. The patient had sought medical attention by phone call. No laboratory diagnostics study was performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Nurse gave Pneumovax vaccine that had expired on June 2005 to this patient.  In talking to the mother on 11/17/05 she reported that child had a red swollen L arm on 11/8/05.  Patient had fever(did not take).  Mom took child to Dr. who gave oral Benadryl and Tylenol.  Arm remained red and swollen on 11/9/05.  Child okay within two days and Benadryl and Tylenol.  MD to check with another MD about whether to repeat in light of local reaction and child condition. (Sickle cell disease)
Began w/ low grade temp X 1 week after 2nd inj.  Then sore throat.... By mid May voice change (Dysarthria) Saw Neurologist 8/31
Per patient received PCV20 vaccine on 10/17/2023 (Tuesday), reports redness and itching that began on 10/19/2023 (Thursday). Patient denies any pain at this time. Redness noted to left shoulder and left arm warm to touch.   Patient prescribed prednisone 20 mg  (2 tablets by mouth daily for 5 days.) and Bactrim DS 800-160 mg (1 tablet by mouth every 12 hours for 10 days. ) Patient scheduled follow up appointment on 11/13/2023 with Dr.
Painful and frequent urination; Painful and frequent urination; This is a spontaneous report from a contactable consumer(patient). A 38-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Jun2021 (at the age of 38-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included high BP. Concomitant medication included amlodipine besilate (AMLOPRES) 5 mg taken for hypertension, start and stop unknown. The patient previously took Varicella for chicken pox in the left shoulder near the armpit on 22Apr2021, BNT162B2 (BNT162B2, solution for injection, Batch/Lot: EW0173) administered in left arm on 09May2021 as 1st dose, single dose for covid-19 immunization. On 04Jun2021, after 2 days of vaccination actually patient experienced side effect of painful and frequent urination. She wanted to understand is this normal, how long the side effects be like that only or she has to check with her doctor. Lab tests: patient stated, "Not recently, last month actually, before the vaccination, before the first shot, just preventive checkups, like to check our immunity.". Outcome of the events was unknown.   Follow up attempts are needed. Further information has been requested.
Awakened crying @ grandparents (not unusual-teething); Given APAP, being bottle fed, whole body jerked approx 5-10 min; Grandfather states pt not that warm; Dx poss febrile seizure;
Reports of increasing pain in "all muscles and joints", making ambulation increasingly difficult. Has also increased pain medication from tramadol 4 tabs per day to also include hydrocodone-acetaminophen 1.5 tabs per day.
itching all over the body after 7 hours of administration of the vaccine lasted for a couple of hours headache, body aches, chills, sweating after 12 hours of vaccine administration lasted for 24 hours
A red raised bump/scab at sight of injection that has not gone away since administered a month ago. It does not hurt/ itch.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient received M-M-R II (strength, lot # and expiration date were not reported) the first dose on 27-MAY-2008, the second dose on 18-MAR-2013, and the third dose on 27-JAN-2017. On 01-FEB-2017, the patient was inadvertently administered  subcutaneously with a fourth dose of  M-M-R II (therapy type: rHA, lot# L005291 and expiration date: 17-FEB-2017). No adverse effects reported. Additional information has been requested.