chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to his wife, a 56 year old female patient. The patient has no known allergies and medical history included polycystic ovaries, unspecified sinus issues and gastrointestinal stromal tumor. On 04-JUL-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number not reported). Concomitant therapies included GLEEVEC, unspecified decongestant, and metformin. On 05-JUL-2016, the patient experienced a "bumpy, raised rash that is painfully, itchy." Additional information has been requested.
A CLOT IN BRAIN; This spontaneous report received from a consumer via a company representative via social media concerned a male of an unspecified age, race and ethnic origin. 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 administration was not reported, and batch number: unknown expiry: unknown ) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  It was reported that, on an unspecified date, Johnson and Johnson vaccine caused a blood clot in patient's brain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a clot brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20220161645-COVID-19 VACCINE AD26.COV2.S -A clot in brain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Client presented  to receive Moderna Booster. Client informed RN that when he received Moderna dose 1 on 2/3/21 client experienced itching 3 hrs. after vaccine for one day, at injection site only. No other symptoms. No meds taken. Dose 2 same thing happened 3 hrs. after. No meds taken. Client has high blood pressure.   Client received approval to receive Moderna Booster COVID vaccine by MD. Client received Moderna Booster Lot#084J21A.  Client reported no symptoms while waiting in observation area for 30 mins. Client left vaccination area in steady gait.
Itchy red raised welt 7 days after injection. Not painful but very itchy and red.
patient given Prevnar20 in error on 11/3/2023,  received one already on 5/11/2022.
patient smells smoke (his description was cigarette smoke/nicotine). onset 1 week after Moderna booster vaccine. patient is a non-smoker
9/11/13 Pain at site of injection and weakness in arm. Bruising from injection site to elbow continuing through 9/16/13. 9/12/13 Diarrhea started and continued through 9/16/13.
Information has been received from a physician concerning a 22 month old female patient. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 (lot # N000326, expiration date: 14-OCT-2019, strength, dose, frequency and route were not reported) for prophylaxis (drug administered to patient of inappropriate age) during her well checking up. No adverse effects were reported.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 63-year-old female 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 10:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 63.26.  Concomitant products were not provided.  Excursion time was 09 AM, 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 was sent to clinic. Vaccine BUD dates was 29-Apr-2021.  Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches was not reported. This report was non-serious.  .
Erythema, warmth & swelling at inject site. Tenderness of affected area & mild temp/fever.
Information has been received from a healthcare professional referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # K025760, expiration date 08-JUN-2016, 0.5 ml, subcutaneously in the right thigh. No adverse effects were reported at this time. Additional information has been requested.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 9:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 9:26 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 82.35.  No concomitant medication was reported by reporter.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. Vial was moved to fridge on 08-Jan-2021 and moved to clinic on 11-Jan-2021. Vial was punctured right before administration. Vial best before use date was 07-Feb-2021.After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Client was given first dose of Moderna COVID vaccine on 4-1-2021 at age 16 at a COVID vaccine event held at a school. Apparently the error was identified immediately after the fact by the vaccinator. The client then presented to our facility - COVID Vaccine Clinic - on 4/30/2021. He and his father denied any adverse effects after the first vaccine and requested a second COVID vaccine. The CDC website was consulted and the client was administered a Moderna vaccine as the second dose of the COVID vaccine after discussion with the client and his father that this would be off label use  of a vaccine approved for use in people aged 18 and older due to the client's age at the time (17 y.o.).
Herpes Zoster; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 19-AUG-2014 (reported as on or about 19-AUG-2014), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (strength, dose, route of administration, lot number and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of herpes zoster to be related to the suspected vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Systemic: pain backside of thigh, butt area-Severe, Systemic: Weakness-Severe, Additional Details: Patient called on 6/13 and said she got Moderna shot on 5/31. Next morning felt extreme pain in backside of thigh/butt area. Dizziness. for several days. she is getting better but wanted us to send the info in case other patient were reacting to the shot like her
Pain at injection site, rash around injection site, fatigue, behavioral disturbances, distant, with-drawn behavior.
Patient described immediate pain and experienced bleeding after the injection. Upon removal of needle patient experienced bleeding, potentially from a punctured vein in the deltoid muscle of the right arm. Patient quickly developed a hematoma at the site of injection and bleeding stopped with direct pressure at the site.
One of nine cases: An event of Expired Drug Administered occurred in a ten year-old male.  The report was received from a registered nurse.  No medical or drug history was reported for this child.  The child received a one-time dose of FluMist intranasally on 15-Jan-2008.  On 15-Jan-2008 the child received FluMist which had an expiration date of 19-Dec-2007.  The reporter stated this is one of nine children that was vaccinated on the same date.  In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box.  The reporter indicated they also administered a competitor's product which is good for the entire season and does not expire until May/June time frame.  One reporter also stated many of the vaccines they give do not have an expiration date.  She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season".  The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with a product that was to expire in less than three weeks.  Outcome: the child had no ill effects, the site has not had any contact from the child's family.  Further dosing with FluMist is not indicated.  Causality assessment is not applicable for this vaccination error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
This spontaneous report was received from a other health professional refers to a 22 year old patient.  On 23-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis. On 22-AUG-2017, 7 months after onset of therapy, the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration is unknown. Therapy with GARDASIL 9 was restarted and no adverse event did not recur. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Member states that he received the Varicella injection Sat 7 Dec 2013. He states that on Sun 8 Dec 2013 in the afternoon, he noticed that his right arm was swollen, sore, red and the size of a lemon. On 9 Dec 2013 it seemed to have worsened and was larger than the day before. He took a dose of Benadryl which seeemed to help. Area is still a reddened knot but smaller and less sore. Member denies any allergies. Member will continue Benadryl.
Real bad chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Real bad chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 CHILLS (Real bad chills). At the time of the report, CHILLS (Real bad chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment has been taken by the patient.
Morning of 7-30-14 child had temp 104. Mother took child to the ED and temp was 105 (TA). Has knots and redness at injection site that are improving. Child is afebrile since 7-30-14 in the afternoon.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unknown amount of improperly stored doses of VARIVAX lot numbers: M047660, N000682, M038857 and M040137, reconstituted with properly stored diluent. No adverse events reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004482:
pt recv vax & exp low back pain, flu sx, arm soreness & weakness;pt hosp;flu sx resolved p/3 days;the weakness resolved p/ 5 days;
I experienced extreme jaw pain on the morning of March 1, Day 5 after receiving Dose 2.  I could barely eat, the pain was so intense and my ability to open my jaw so limited.  Six weeks later, I am finally having less pain but it has not gone away completely.  I am not sure it is associated with the vaccine but wanted to report it.  This is extremely unusual for me.  And the duration of the tightness/pain was exceptionally unusual.  I saw my dentist to redo a filling on March 29 and I could not open my jaw enough for him to do the work.  He said that I was unable to open my mouth more than an inch less than my baseline.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-MAY-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX "10 PK 0.5 ml SD-PFS LLokwTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at 1.11 Celsius Degrees for 88 hours and 0 Celsius Degrees or 40 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
non-COVID-19 viral lung infection requiring use of 2 Inhalers and 2 prescription cough medicines.
Information has been received from a published literature article. Over 16,000 patients were listed for liver transplantation (LT). The medical evaluation prior to listing for LT was rigorous and included screening for potentially preventable infections like viral hepatitis and Pneumococcus. Super-infection of hepatitis A (HAV) or hepatitis B virus (HBV) in patients with cirrhosis can lead to decompensated liver failure and increased mortality. A study of LT candidates showed that almost three quarters met criteria for needing HBV vaccination, but screening and vaccination rates were unknown. This study aims to determine the frequency of HAV, HBV and pneumococcal screening and vaccination at a high volume LT center. There were 297 patients on the LT list in July 2014. The cohort was 63% male with median age 60 years and 49% having hepatitis C cirrhosis. The median listed MELD (Model For End-Stage Liver Disease) was 17 and 39% had hepatocellular carcinoma. Overall, there was nearly universal HAV and HBV serologic testing (97% and 98%, respectively). Of 70 HAV non-immune candidates, 7 (10%) received HAV vaccination with 2 having confirmation of successful vaccination. Pneumococcal vaccine was more frequent with 63/297 (21%) having a documented vaccination. There was no association between age, gender, listed MELD, and etiology of liver disease on the likelihood of receiving any vaccine. This is one of 2 reports received from the same literature (other case # 1506USA000178). Additional information has been requested.
Flare episode: swelling and joint pain, unable to return to work after receiving H1N1 vaccination
Numbness in left side of face/lips beginning 15-20min. after injection. Called health provider after an hour, who recommended taking an antihistamine. Took a 10mg antihistamine pill. The numbness subsided in about 30min.
On 10-31-09, developed joint pain in lower legs, arms and shoulder with worst pain in feet bilaterally. Pain so severe (according to patient) that she required MOTRIN for enough relief to sleep. She notified office on 11-3-09 at which time she was seen by Dr. Recommended "around the clock" TYLENOL (1000 mg Q 6 hours or TYLENOL arthritis 2-650 mg tabs Q 8 hours). Will add prednisone if no relief by 11-5-09. Has been afebrile throughout episode.
ADMINISTERED AN EXPIRED DOSE OF VACCINE; This spontaneous report received from a health care professional concerned a female 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 (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-OCT-2021, the patient experienced administered an expired dose of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administered an expired dose of vaccine was not reported. This report was non-serious.
accidently received  Boostrix instead of Infanrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTPA (last series of DTAP).   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: accidently received  Boostrix instead of Infanrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 07-SEP-2023 The health care professional (HCP) did not have any other details and would call back with more information. They were on the last series of DTAP. The patient accidently received  Boostrix instead of Infanrix, which led to wrong vaccine administered  The reporter consented to follow up The case is linked with US2023122484, by same reporter.; Sender's Comments:  US-GSK-US2023122484:Same reporter
Pt recvd vax on 5MAR92 & on 17MAR92 rash on neck, face, chest, arms, & hands, itching; no temp; rxn to MMR;