chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 38-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received (refer case US2018200133)). Concurrent medical conditions included spina bifida. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, injection site swelling, injection site erythema and inappropriate age at vaccine administration. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were received as follows: The patient at 38 years of age received a dose of SHINGRIX, which led to inappropriate age at vaccination. The patient experienced flu-like symptoms, including a fever of 103 degrees Fahrenheit, and chills. These symptoms lasted for approximately 2.5 to 3 days. He also developed mild redness and swelling at the injection site that resolved after 1.5 weeks. The patient did not give consent to follow up. The reporter was unable to obtain additional information. This case was linked with the case US2018200133, reported by the same reporter for the same patient.
given only 1 vial of the 2 vial presentation; given only 1 vial of the 2 vial presentation; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, an unknown time after receiving Meningitis ACWY vaccine (potential Menveo), [the patient experienced inappropriate preparation of medication (Verbatim: given only 1 vial of the 2 vial presentation) and inappropriate dose of vaccine administered (Verbatim: given only 1 vial of the 2 vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was submitted by public reporting reference via the online direct entry reporting system. The pharmacist reported that the patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo). Nursing thought they were giving the one vial presentation. The reporter did not consent to follow up. The patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2023AMR037153 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR037153:same reporter
Developed slight itching about two hours later. Then increased itching with rash on trunk, face and arms. Two areas of hives
Large red, raised band at injection site about 6 inches in length that nearly goes all the way around arm. Painful, some itching. MD advised pt, to take ibuprofen, BENADRYL and apply cold compress MD told her to go to ER if got any worse.
Patient said 2 days after receiving the vaccine it was swollen under his arm. He said his arm still hurt. Felt better in about a week.
Pt. reported nausea after waiting. 30 minutes observation period.  Seen by Medic . No intervention. Left on stable condition at 15:12 p.m. Recorded by RN.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anylosing Spondolytis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. Concomitant medication(s) included: ENBREL, start date: 01May2009, stop date: 19Jun2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Apr2021, stop date: 12Jul2022; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 01Apr2021, stop date: 12Jul2022. Past drug history included: Indocin, reaction(s): "known allergies: Indocin", notes: known allergies: Indocin. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19".Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid.  Clinical course: He received Paxlovid from 26Jun2022 to 30Jun2022. he also had rebound of symptoms on 11Jul2022.
Soreness, pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation in left deltoid.
Information has been received from a consumer concerning a 4 year old male patient with no pertinent medical history and no drug reactions/allergies who in July 2009, was vaccinated with a 0.5ml single dose ATTENUVAX. Concomitant therapy included DTaP. In June 2009, the patient had a titer test done which showed that the patient's titer level for measles virus was nearly five times greater than it should be. Unspecified medial attention was sought. At the time of the report, the patient had not recovered. No further information is available.
Delusions and hallucinations.  Severe anxiety. Continue on a daily basis. Telephoned primary care giver and psychiatrist.  No one could provide any help.  She has never had these symptoms before. Telephoned health department, no assistance.
A couple of days after receiving the third dose (april 2022)  the outer side of right foot hurt badly.  After a week, Saw podiatrist who took xrays and said its arthritis.  10 days later, right food pain starts to dissipate but next morning, its on my left foot.  It took about 5 weeks before pain really subsided.  Intermittently reappears for a day or so. .  Had next vaccine on oct 19th and pain in feet are back.  Especially tough getting out of bed in the morning.  Taking motrin to manage the pain.  Unfortunately motrin and pain raise my glucose numbers.  Saw P.A. At endocrinologist  office in may and she said that both of my feet were swollen.  Said its not from the diabetes.  No recommendations.     The podiatrist said its caused by ill fitting gym shoes and get compression stockings. Suggested physical therapy. Said its just an age issue.  When i bring up the potential correlation between the vaccine and my feet pain that hust say they have never heard anything and proceed with their recommendations.   I never xperienced arthritis in my feet before the shots.  I pkay alot of sports (baseball, basketball, hockey, running on occasion, golf) and never had issues with my feet.  Suddenly one day i wake up and have arthritis?!
Dental implant fell out; This is a spontaneous report from a contactable nurse. This nurse reported similar event for two patients. This is the 2nd of two reports.  A male patient of an unspecified age received bnt162b2 (also reported as COVID-19 Vaccine, lot no. and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced dental implant fell out on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011228 same reporter/drug, similar event with different patients
No additional AE was reported; PROQUAD was administered to a patient that had undergone temperature excursion; This spontaneous report was received from a nurse referring to a 4 year old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 30-NOV-2020, the patient was vaccinated with dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 1 dosage form (route of administration, lot number and expiration date were not provided) for prophylaxis, that underwent a temperature excursion.  The temperature excursion was of 72.1 Farhrenheit degrees (°F) for 3 hours and 15 minutes. The vaccine had no experienced previous temperature excursions. The call was due to digital data logger.
Pt reported dizziness, hearing ringing and feeling anxious prior to vaccine admin.  Admin in private cot area.  NO LOC.  Pt stated she was not driving home.  Pt refused vital signs.  Observed 30min w/ no additional adverse effects.  Pt stable and released from the vaccination site.
No adverse event; The dose was administered after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The dose was administered after the published expiration date).    It was reported that patient received monovalent first dose. It was unknown that the vial underwent any temperature excursions The patient had not reported any symptoms. No additional doses, medications, or treatments had been administered at that time.
Localized Reaction - Lg red, swollen, itchy area x 10 days
Since 10/31/2021, the day on which Patient had received her second dose of COVID-19 vaccine (Pfizer). She has reported residual soreness and stiffness in her left arm (original injection site) as well as soreness in both knees (more prominent on the right). This has been reported to the Center of Disease Control and Prevention via the VAERS (Vaccine Adverse Event Reporting System).
Vaccine area was painful, red, hard, and hot.  Took Aleve but it did not help. Patient could not sleep or lay on it.  On 9/18, patient had Flu like symptoms; was tired and had chillsslept at lot.  Pain felt like had the shingles.  Affected area got larger as wide as hand.  On 9/23 went to pharmacist who recommended follow-up with doctor; specified she might need antibiotics.  On 9/23 had yearly follow-up with oncologist.  Doctor marked the affected area to see if grows outside boundaries and recommended moist/warm compresses.  Problems continued including chills and body pain, affected area did not grow outside boundaries.  Compresses helped.  Patient went back to pharmacist on 10/3 and tried some Benadryl; compresses helped. Patient is taking Benadryl every day and it is helping with itching and discomfort.   The flu-like symptoms ended over the weekend.  Patient can still see the outline of the affected area.
5 mins after Pfizer vaccine given at 1:45pm pt became pale, diaphoretic, tingling to hands/ feet. felt lightheaded. bp check 99/61 hr 103, placed in a lying position. contacted MD. BP recheck 105/69 hr 103. 1402 pt c/o cp. contacted the MD again who gave order to call 911. 911 called, 1417- ambulance arrived and transferred to the ED
I blacked out after awaking, brushing teeth, and urinating. I had been standing for 3-4 min before passing out. Conclusion presumed from symptoms the following day. I also had a welt and abrasion on head, and split upper lip.
10 days after initial vaccine arm was red and warm to the touch at vaccine site. Upper arm was also sore for several days.
VIOLENTLY ILL THE WHOLE NEXT DAY, COULD NOT GO TO WORK; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced violently ill the whole next day, could not go to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill the whole next day, could not go to work was not reported. This report was non-serious. This case, from the same reporter is linked to 20211222865.
patient reported back to the clinic about 2 hours after receiving immunization. Patient reported that her arm was sore and red. On examination the injection site was red and there was a diffuse papular rash on the upper extremities. No evidence of rash on neck, chest, face, abdomen, or legs. patient denied any trouble breathing, trouble swallowing or itching. vital signs were within normal limits and patient was afebrile. 25 mg of Benadryl was administered to patient. Discussed with patient that if any troubles breathing or swallowing to report back to clinic immediately and that if symptoms occur at home or clinic is closed to call 911 immediately. Patient was sent back to class in no acute distress.
Severe soreness in Right shoulder 9-12-16, now its turned into a severe pain that makes my arm hurt when lifting. The area is below the area of where the Flu shot was given and this started on 9/19/16.
Employee vaccinated with Adacel within 4-5 hours experienced pain at injection site and radiated from shoulder to neck and also down left arm.  On 9/14/06 employee presented to Occupational Health Services with complaints of severe pain.  Suspect brachial neuritis -- employee currently being followed by Neurology Service
Today, 10 days after receiving the vaccine, I noticed that both forearms  and lower legs have flaky, blotchy skin.  I thought it was dirt but I wasn't doing anything to make myself so dirty.  That's when I searched the internet and saw others had reported a similar side effect to the vaccine and various manufacturers.
Patient stating she continues to have pain in the area of vaccination that wakes her up at night. Pain can radiate to ipsilateral axilla. Pain improves with taking OTC aspirin. Also reports "brain fog" since 1st vaccination.
Information has been received from a female concerning another female who was vaccinated with Gardasil.  The patient received two "shots" and on unknown date she experienced dizziness and pain.  The outcome of the event and action taking regarding therapy with Gardasil was not reported.  No further information was available.
Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 02-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Per patient's daughter, patient started with headache about an hour after her first Moderna COVID19 vaccine. It turned into a migraine, and she started acting very weak. She was taken to the ER the next morning and presented with mental status changes, weakness, right arm tremor, neck/shoulder pain, and headache. Patient's symptoms were similar to when she had encephalopathy due to COVID in December 2020. She was transferred to the hospital on 3/12/21 for observation. Several tests were ran but nothing specific was found. The doctors overseeing her care felt she was experiencing a reaction to the COVID vaccine.
While hiking, which I do all the time, I suddenly couldn't catch my breath.  It was very scary.  My heart was beating weird and occasionally felt like it was clutching.  I was soaked in sweat and slightly nauseous.  I thought I was having a heart attack.  It went away 98% two miles from the bottom.  The next Saturday, hiking was difficult, my heart was not shifting to the next gear as I pushed it.  Sunday, the next day, I took it easy and went walking.  Two blocks from my home, my heart clutched, and I nearly lost consciousness.  Really thought I was having a heart attack.  Never had any problem like this before.  Terrifying.  I've now met 6 others who had a similar incident after vaccination.
heart issues; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient has experienced heart issues. Not clarified if heart issues were before or after covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, swelling, warm to touch at injection site. No systemic involvement observed. Dr. prescribed MEDROL dose pack 4mg.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.52~  Concomitant products were not provided.   On 27-Feb-2021, Excursion time was 9A temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
March 17, 2008, broke out in rash on head, then moved down body, arms, and legs. Rash was accompanied by fevers ranging from 103.5-104, spots in mouth, he would not eat or drink, lethargic, diarrhea started that evening, visited ER next day as we were out town, and when Pediatricians office finally called back, they said not to worry, give Tylenol for fever and Benadryl for rash, but he was ok. They did not even document in his chart about the reaction.  I have pictures of the reaction, phone call records, ER visit records, so I have proof of the reaction without their documentation in his chart. ER dr where we were said it was just an allergic reaction of some unknown origin, refused to do labs, and said it would go away.  Said the rash, diarrhea, and spots in mouth were a reaction to some virus he was fighting off. Yes, it was the MEASLES virus!
Erythema, numbness and tingling in extremity, heaviness of extremity, warmth, anxiousness. Symptoms lasted for two weeks.