chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurred vision; Big knot at site of injection; Itchy at site of injection; Red at site of injection; Welt at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), VACCINATION SITE INDURATION (Big knot at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection) and VACCINATION SITE SWELLING (Welt at site of injection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VISION BLURRED (Blurred vision), VACCINATION SITE INDURATION (Big knot at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection) and VACCINATION SITE SWELLING (Welt at site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurred vision), VACCINATION SITE INDURATION (Big knot at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection) and VACCINATION SITE SWELLING (Welt at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified high blood pressure medications.
w/in 48hrs of vax pt had marked swelling & redness w/pain in arm (upper) where shot was given & extending to shoulder & down to elbow;seen in ER & given rx for Ceclor & inst in using DPH 18OCT95
Sweating, vomiting and nausea, shaking, pale skin, extremely large swelling, redness covering entire front of thigh (shot area) pain and itching on that site, inability to put weight on leg (shot in thigh), fatigue, crying, poor attitude, poor appetite, fever of 99.3 for 40 hours before breaking.
WRONG MODERNA FORMULATION GIVEN.  SHOULD HAVE BEEN 0.25 MG/ug BUT GAVE 0.2 MG/ug FORMULATION.  PATIENT HAD HISTORY OF ONE DOSE MODERNA BIVALENT GIVEN ON  5/4/23  STARTED HAVING DIFFUSE RED RASH ON BACK.  MOM STATES THAT IT APPEARS TO BE LIKE "HEAT RASH" & IS NOT RAISED OR BUMPY.  MOM DENIES RASH ANYWHERE ELSE.  SHE CRIED & WAS "INCONSOLABLE" FOR THE ENTIRE NIGHT.  THIS STARTED ABOUT 4-5 HOURS POST VACCINATION.  MOM STATES THAT THEY HAD TO TAKE SHOWERS WITH THE CHILD ALL NIGHT INTERMITTENTLY.  SHE THINKS SHE WAS FEBRILE BUT DID NOT TAKE HER TEMPERATURE.  SHE STATES THAT HER FOOD INTAKE HAS BEEN "MINIMAL" FOR 24-HOURS.  SHE STATES THAT HER URINARY OUTPUT IS "THE SAME AS USUAL... SHE'S BEEN HAVING NORMAL WET DIAPERS."   MOM STATES THE CHILD'S LEFT LEG IS HARD TO THE TOUCH BUT DOES NOT APPEAR READ OR SWOLLEN.  THE CHILD IS ALLOWING HER TO RUB ON THE SITE & SHE IS "DOING SO TO TRY & HELP SOFTEN IT".  SHE &  HER HUSBAND HAVE BEEN ADMINISTERING CHILDREN'S TYLENOL Q  HOURS SINCE YESTERDAY.  MOM DENIES THE NEED TO CALL HER PEDIATRICIAN, AS SHE FEELS THE CHILD IS IMPROVING SOME TODAY. .
Patient reported experiencing severe pain in the whole arm. It continues even more than two weeks after vaccination. Patient also has swelling in the arm. No fever reported. Patient took over-the counter Tylenol and Ibuprofen; also trying Voltaren gel and Lidocaine cream per his doctor's advise.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
he got the Pfizer vaccine and had a very liquid bowel movement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EN6198) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number EN6198, Dosage text Unknown dose shot in left arm), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "he got the Pfizer vaccine and had a very liquid bowel movement".  Additional Information: Reporter reported that the seriousness for Xeljanz is not as effective as it used to for loose bowel movements over the past couple of months: (From: 2020, Ongoing) Complainant does not have the product with them at the time of call. Patient had no History and No Investigation Assessment, reoprter calling about Xeljanz not being as effective as it used to be. Wanted to know there is anything he can do to make more effective. Wanted to know they only allow one pill. He Stated that he got the Pfizer vaccine and had a very liquid bowel movement. He Stated that he had the second one on 27Feb. Stated that he did not have loose bowel movements before the vaccine. Is for the Pfizer Covid vaccine. Clarified medication as Xeljanz slow release. Stated that he has not changed his diet or medication. Reporter details: Email address captured as provided. Physician details: Does not provide an address, phone number or email address. Event details: Stated that it started not being as effective three months ago. He Stated that it is not being as effective as it used to Wanted to know there is anything he can do to make more effective. Product strength and count size dispensed: 11 mg, Reporter not provided Is a sample of the product available to be returned, not provided Packaging sealed and intact.  No follow-up attempts are possible. No further information is expected.
PATIENT HAS A CLUSTER OF BLISTERS NEAR THE INJECTION SITE  OF THE SHINGRIX VACCINE THAT APPEARED 2 DAYS AFTER THE INJECTION SHE CONTACTED HER PRIMARY CARE PHYSICIAN AND HE TOLD HER TO COME BY THE PHARMACY TO HAVE A PHRAMCIST TAKE A LOOK.
3/23/2022 at 0822 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Moderna Vaccine Date - 3/21/2022 Booster Dose - Yes Date of Symptom Onset - 3/22/2022 Symptoms - Fatigue, Migraine, Fever (Tmax 101.4F), Generalized Joint Pain, Achy Muscles Last Day of Work and Shift - 3/22/2022 (Regular shift 8am - 5pm) Home Remedies - Ibuprofen 200 mg, 3 tablets, twice on 3/22/2022 Any Improvement - Yes  Recommendation - Treatment per COVID-19 Vaccine Adverse Reaction Triage and Return to Work Procedure algorithm, is to Manage per Illness in the Workplace Policy
Started "w/ hot, itchy lump under clot has approximately size of silver dollar". Pt put ice on it which helped. Next day 1-10-16 says double size less re more pinkish color a bit itchy. Tried ice again and BENADRYL monitoring will seek med attention if worsens other wise will check in w/PCP 1-11-16. No other sxs just local.
rash that started on face 8 days after MMR shot, fever, runny nose. Rash spread to back and then next day to the stomach. Today he has been clawing at himself and has been throwing fits, I looked on his leg and now he has a rash there, we also noticed some bumps around the groin area. I called the nurse and she said all of this was normal so it will fade, it just seems to be getting worse and it has been 4 days now and no signs of relief.
This spontaneous report as received from a pharmacist via company representative refers to a 59 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (dose, dose number, lot/batch number, exp. date not reported) subcutaneous. On an unspecified date, immediately after vaccination, the patient experienced hard lump that was itchy and painful to scratch at the injection site. There was not treatment give for the events. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved, all symptoms cleared up after 5 days (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Extreme burning and sharp pain at the base of the skull, neck area, and both shoulders.  Loss of ability  to move the head to either side, up or down. The symptoms lasted approximately  10-12 hours, then slowly faded to mostly  discomfort and tenderness. I used ice, laid flat on my back, slept and cried. Everything  was back to normal,  then on 2/16/21, approximately 3:00 PM, my neck started  hurting, I had a terrible  headache,  muscle  weakness  and  pain and no energy. I couldn't  make  it to work, I took some tylenol, iced  my neck then slept over 11 hours, straight. Today things  feel  normal  again.
Pharmacist was looking at clinical services tab in profile during visual process to promote vaccines. Discovered patient had received 3 prevnar 13 vaccines (duplicated and 1 inappropriately spaced from pnemovax) and a pneumovax and 3 doses of shingrix instead of 2.
This spontaneous report as received from a non-pregnant nurse (age unspecified) via a company representative refers to herself. Information about concurrent conditions, concomitant medication and medical history was not provided. "Last week", on an unspecified date of September 2014, the patient was vaccinated with a dose of ZOSTAVAX, (lot#, dose and route were not provided). And the patient experienced a "knot" in her arm which was itched on an unknown date of September 2014. No treatment was given for the adverse events. The outcome of the events was reported as recovering. Additional information has been requested.
Covid positive on April 9; Covid positive on April 9; body aches; cough; Cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43-year-old patient received BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Apr2022, outcome "unknown" and all described as "Covid positive on April 9"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "Cold like symptoms"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body aches"; COUGH (non-serious) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Apr2022) Positive.  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional adverse effect reported.; V ARlV AX that underwent a temperature excursion was administered.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 22-FEB-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T022315, expiration date 30-JUN-2022) for prophylaxis. The vaccine administered experienced temperature excursions: -10 degrees Celsius to 8 degrees Celsius with with an average of -3.7 degrees Celsius for 22 hours. There was no previous temperature excursion. No additional adverse effect reported.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, indication, route not reported) preventing shingles. On the same day after receiving ZOSTAVAX, the patient developed swelling at the injection site. The patient took BENADRYL and put ice at the injection site on an unspecified date and the swelling went away a "couple days later". The reporter did not provide the seriousness or causality of the event. Additional information has been requested.
A week after 2nd vaccine, my feet started freezing and after they warmed up, they burned! The left foot was the worse!!! About a month after my left hand started burning, a couple weeks after that, my right-hand started burning. My hands And feet stay RED and painful all the time!! About a month after hands and feet, my legs started shaking, feels like lightning bolts shooting through them. Now something new, I keep the hardest cold chills and I'm not cold, keep them all the time. I'm so painful I can't do anything for my family anymore, I can't cook, can't hardly walk, and have a hard time sleeping. It feels like the sheets are rubbing blisters on my feet.
Dizziness Narrative:  Pt felt dizzy and did not feel comfortable standing up ~ 10 minutes after vaccination. Pt reported she hadn't eaten in awhile and was given crackers to eat. She was observed for 15 additional minutes and felt better so was released.
3rd dose; presyncopal episode along with 36hr of chills; presyncopal episode along with 36hr of chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Nov2021 (Lot number: fh8030) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 20Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: fh1950), administration date: 22Apr2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: er2613), administration date: 01Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "3rd dose"; PRESYNCOPE (non-serious), CHILLS (non-serious) all with onset 2021, outcome "unknown" and all described as "presyncopal episode along with 36hr of chills". Therapeutic measures were not taken as a result of presyncope, chills.  Additional information: Patient took the other vaccine in four weeks. Patient did not have covid prior to vaccination. Patient did not tested covid positive post vaccination. Facility type was Public Health Clinic.  No follow-up attempts are possible. No further information is expected.
3 days after vaccine (2/5/21): mild fever (normally 96.5 - consistent temp over the course of several months on two different thermometers, was 98), worsening of sore throat, runny nose, fatigue, chills/feverish feeling. Negative strep that day, negative covid test the following Monday. Resolved within 48 hours.  8 days after vaccine (2/10/21): developed rash at injection site, tenderness, swelling, and itching - right arm had very minimal, minor rash at the same time. Pain was more significant than the two days post injection and improved within 48 hours (still have itchy, dry, raised skin but minimal redness as of 2/22/21).  16 days after vaccine (2/18/21): lymph node in front of neck area by collarbone swollen. No pain but minor discomfort. It feels like a 2 inch squishy mass with a hard node in it. I've never had swelling here before. If my other lymph nodes are swollen as well I cannot tell.  I had the flu shot at the end of December, 2020. Not sure if that was close enough to matter, no symptoms after that one.
3/14/2023     In the late afternoon I began coughing. I felt okay that evening thinking it was allergies.  The next morning, I had a fever of 100.5, bad cough and took an at home COVID test which was positive.  I called my doctor. She prescribed Paxlovid which I began taking and just completed today. I continued to have fever for two days, manageable with Ibuprofen and an annoying cough at night.    I now just have lingering mild head congestion.
lost 16 pounds; diarrhea; pain; was so sick for 3 weeks; chills; headache; tired; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost 16 pounds), DIARRHOEA (diarrhea), PAIN (pain), ILLNESS (was so sick for 3 weeks) and CHILLS (chills) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost 16 pounds), DIARRHOEA (diarrhea), PAIN (pain), ILLNESS (was so sick for 3 weeks), CHILLS (chills), HEADACHE (headache), FATIGUE (tired) and VOMITING (vomiting). At the time of the report, WEIGHT DECREASED (lost 16 pounds), DIARRHOEA (diarrhea), PAIN (pain), ILLNESS (was so sick for 3 weeks), CHILLS (chills), HEADACHE (headache), FATIGUE (tired) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a health professional concerning an 18 year old female who was vaccinated intramuscularly with the second dose of Gardasil (date unspecified).  Per the reporter the patient's period started early and she experienced very bad cramps.  Subsequently, the patient recovered from her period starting early and very bad cramps.  No further information is available.  No further information is available.
Severe leg swelling a couple of days after the Janssen vaccine.  Can not walk very well now and does not drive so no access to a doctor or clinic.  The vaccine was administered at her house by the fire department.
Information has been received from a physician concerning a 4 year old male patient with no preexisiting medical conditions, who on 24Mar2003 was vaccinated with a dose varicella virus vaccine live. The physician reported that the next morning, 25Mar2003, the patient presented to the physician's office at 08:00AM with vesicular chicken pox, about "8-10 lesions" on his abdomen and a few under each arm (physician also reported as developed full blown chicken pox greater than 25 lesions in approximately 15 hours). The physician reported there was no known exposure to another case. It was noted the patient recovered. The reporter noted the patient did not have a fever. It was also noted the patient was not ill at the time of vaccination, and there were no laboratory tests performed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN, start date: 01May2018; ATORVASTATIN, start date: 01May2018, stop date: 10Oct2023; ADDERALL, start date: 01May2018, stop date: 10Oct2023; TAMSULOSIN, start date: 01Jun2021, stop date: 10Oct2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
THE PATIENT RECIEVED THE THIRD 13 DAYS PRIOR TO THE 5 MONTH MARK.
This spontaneous report was received from a physician via company representative and refers to a 70-72 year old female patient. No pertinent medical history reported. Approximately in 2007 (reported as 6 to 7 years ago) the patient was vaccinated with ZOSTAVAX (dose and route unknown). No concomitant medications reported. The physician reported that the patient experienced the worst case of shingles that she had seen after receiving ZOSTAVAX (disability). The patient sought unspecified medical attention. The outcome of shingles was unknown. The causality was not reported for shingles. No product quality complaint involved. The reporting physician considered the event to be serious due to significant disability/incapacity. This case is also related to 1411USA003653 due to same reporter. Additional information has been requested.