chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received expired pentacel and ipol, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare propfessional via Agency (Reference number- 00651982) and transmitted to Sanofi on 22-Jun-2021.  This case involves a age male patient (age not reported) who experienced received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number and expiry date not reported) and IPV (VERO) [IPOL] (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   The mother wanted to know what side effects should they look out for her son.  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Information has been received from a registered nurse concerning a female patient who on unspecified dates was vaccinated with all three 0.5ml doses of GARDASIL (lot # not provided). Recently the patient had a Papanicolaou (PAP) test and results came in as abnormal PAP and HPV positive. But the HPV type was unknown. At the time of the report, the patient had not recovered. Additional information has been requested.
Mother reports child had persistent, inconsolable crying for about 3hrs at a time for 4 days following last vaccine administered in September. Parent reports child had a fever as well.
Information has been received from a healthcare worker (also an office manager) referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with improperly stored GARDASIL 9 (dosage, strength, lot # and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
chills; Body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received primary schedule on an unknown date).   On 14th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced chills and general body pain. On an unknown date, the outcome of the chills and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient received booster dose. After receiving Shingrix, the patient experienced chills and body pain. The patient was asking, how long would this last.
I had both doses/ still got a bad case of shingles/ suspected vaccination failure; Still got a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had both doses of Shingrix vaccine but still got a bad case of shingles. The patient asked did GlaxoSmithKline anticipate that his/her recovery would be better because he/she was vaccinated. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
started with headaches and bodyaches and is having non productive cough, sore throat, facial pain and fever with CP on coughing for last 4-5 days. She denies SOB. starting 10/18/21
approx 9 hr p/vax pt exp episode of paleness & limpness-was taken to hosp; had elevated WBC count & started on ATB; no other problems; released p/4 days; attending MD has ordered ped DT for future in case this was a rxn to pertussis; t100;
SEVERE REACTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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 (series 1). 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 severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20211225526.
Injection site soreness is ongoing.  About 10-11 hours after vaccine (8pm)  I started having mild headache, took 400mg Ibuprofen. 15 hours after time of vaccine (12midnight) developed severe rigors, severe back pain along with  severe pounding headache and mild nausea.  Had very dry mouth and metallic taste.  Symptoms reduced 50% after 2nd dose of 400mg Ibuprofen  taken at 7 am (11 hours after first Ibuprofen).  Reporting these changes that occurred in first 24 hours after vaccine.
This is a 21 year old male who had his first dose Moderna vaccine on 3/18/21 (lot#001B21A) and second dose on 5/9/21 (lot#024C21A).  On 5/13/21, the patient presented to the emergency department with complaints of shortness of breath, chest pain, 'sharp shooting pain going up my leg/thigh,' pain 5/10, and nausea. Onset on 5/12/21.  The patient has a history of a recent ED admission on 4/24/21 for abdominal pain, felt to be related to a recent diagnosis of hepatic stenosis, biliary sludge (unrelated to the 5/9/21 ED visit, however notable; discharged to home to f/u with established surgeon).    The patient stated that this may be related to chronic anxiety.   ED provider determined that acute chest pain was likely due to anxiety and/or a vaccine reaction.  The patient was discharged to home with instructions to f/u if needed.  No additional chart documentation available since discharge.
Fatigue, nausea, fever, chills, headache, gastrointestinal problems, soreness
Chills. Arm (left) continues to swell down to elbow and around inside arm-almost completely circles arm. Arm extremely sore to touch where swollen. Swollen area of arm very hot. Thurs. was freezing and by afternoon had the shakes. I was so cold, my hands were numb. Took bath to get warm. Took my temperature-it was 104. Had sweats. Missed work on 10/18/02.
Erythema around vaccination site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Erythema around vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Erythema around vaccination site). At the time of the report, VACCINATION SITE ERYTHEMA (Erythema around vaccination site) outcome was unknown.        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 concomitant medications provided. No Treatment medications provided. The reporter does not recall any further information regarding the events.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient and event details updated
Began running fever 24 hour after MMR was given. Tactile temp per mom was approximately 102. Fever x 3 days (Friday, Saturday, Sunday). Fever broke Sunday, after fever, rash developed began behind ears and face- body. Increased irritability.
Severe vision loss in both eyes (over 50% in left eye about 50% in right eye), severe headaches, dizziness, nausea, heart palpatations, extremely fatigue, shortness of breathe, back aches, muscles cramps, seizures
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
pt recv vax & exp muscle fatigue & tingling on the lt side of body;ER or MD visit was required;
MIGRAINE HEADACHE; This spontaneous report received from a consumer 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: Unknown) dose, start therapy date were not reported 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 migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210453792.
has a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (has a UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (has a UTI). At the time of the report, URINARY TRACT INFECTION (has a UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  Patient would getting the second dose of the Moderna COVID-19 vaccine but she had a UTI and thought the doctor would prescribe medication so she wanted to know if that would effect the vaccination.
Information has been received from a registered nurse concerning a 65 year old female who on 05-JUN-2007 was vaccinated with a dose of Zostavax. On 07-JUN-2007 the patient experienced a shingles rash on left buttock. The patient returned to the clinic on 07-Jun-2007 with back pain that felt like it was musculoskeletal. "On 17-Jun-2007 the patient went to the emergency department with some breaking out rash and it they felt it was shingles on the left buttock area". The patient had four small blisters and was having pain that rotated around to the abdomen. She was given Famvir and Lortab for treatment. Patient was hospitalized for unspecified period of time. Follow-up information received from a registered nurse indicating that the lot # was 0290U. The patient had fully recovered. The nurse did not know if the patient had a history of chicken pox or not. The patient was seen in the emergency room and discharged ("not hospitalized as previously reported"). The patient did not have recent exposure to chicken pox or herpes zoster. Follow-up information received from the physician indicating that the patient received the vaccination in the left deltoid. The patient did not complain of any pain. There was mo direct flourescent antibody done. A specimen for PCR was not collected, nor was a photo of the rash taken. Patient did recover.  No further information is expected.
Mom thinks headaches started right after HPV (2). Mom reported on 5-29-13 possible severe reaction right after HPV (3) 4-23-13. Went to ER for low grade fever, V and D, hallucinations.
Shingles, required valtrex, gabapentin,  rx cream and meds for nerve pain
24 hours after injection, sharp, shooting pain in right hip, intermittent, quick hitting , still happening after three days, took 2 aspirin evening of first signs, called doctor..
Patient receiving the vaccine slapped the needle out of the right arm while being injected. Therefore the patient had only received a partial dose of the vaccine. Patient had also scratched right arm with the needle when she slapped at it. Injury site was cleansed by an RN and a band-aid was applied. An additional 0.3mL dose of Pfizer (same lot) was administered in patient's left arm. Dose was well tolerated by patient. Patient was assessed for 15 minutes following injection.
Patient had numbness on right side of body, slurred speech, right side aches, dizziness, head fullness
HEAD TO TOE RED HIVES/RASH (Face, neck, shoulders, chest, back, arms, stomach, buttock, legs, feet). Headache, total body aches, arm pain, total body itching, nausea, stuffed and runny nose, sore throat, fatigue. Missed work, had to pay for doctor visit, had to take additional medications including BENADRYL, ZYRTEC, and prednisone.
Patient described swelling, heat, and redness at the site of injection. She also complained of a hard knot at the site. She said that her arm was so sore she could hardly lift it. She said that most of the reaction seemed to be slightly below the injection site. She visited her dr 2 days after presentation of reaction. Dr said there was an infection at the injection site but it did not appear to be cellulitis. Dr advised patient to apply ice packs and watch the area. Dr prescribed antibiotics to be taken in the event that the infection did not improve over the next couple of days.
Dizziness, palpitations,headaches, ear pressure, weakness  and high blood pressure
Patient had pain and by 6 pm could not lift her arm. She also had a rash of at least 4 inches in diameter that circled her arm. The pain and rash lasted several days. There was no "heat" with the rash.
Vaccine exp: use by date 10/7/2022 8 wk after defrost Exp Date 10/31/2024
*The spot was red, swollen, and itchy to the patient. *Ibu as needed, topical Benadryl during the day, and oral Benadryl before bedtime.
got my flu shot and still got the flu; Initial information received on 18-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got Influenza vaccine flu shot and still got the flu.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, route, formulation, expiry date and administration site unknown) for flu vaccination.  On an unknown date the patient developed a non-serious event "got my flu shot and still got the flu (influenza)" (unknown latency) following the administration of Influenza vaccine.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.    Outcome: Unknown
Posterior vitreous detachment -stable.  Vitrectomy left eye (2019)- no symptoms. Stable condition until 2021 after the vaccines vision started to get distorted. I saw ore than 6 retina specialist, one ophthalmologist, one cornea specialist and I was in emergency room, but they still cant figure out why my symptoms are getting worse. I did not relate them to the vaccine until 02/25/2022 when I got the Pfizer booster shot. My vision is getting worse. I need help since nobody can figure out what is going on. I'm sure it is related to the vaccine.
this person recieved Moderna vaccines on 2/3/21 & 3/3/21.  reported dyspnea and chest pain with initial visit to MD on 6/9/21.  subsequently has had decreasing ejection fractions via ECHO from 25 to 20 to 10 at present.  was admitted into a local Medical Center's ICU on 12/3/2021 and air transfer to another Medical Center on 12/4/21.  at present, he has an Impella device inplanted to support cardiac function, looking at LVAD and possible transplant needs.  his diagnosis was made within a few weeks of Moderna 2nd dose and progressive decline
This spontaneous report as received from a nurse refers to a 5 months 17 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified). No concomitant medication were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
I did not take very good notes because when it happened, I could not find a lot of information about my symptoms being linked to the COVID vaccine nor did I know the importance/availability of reporting. I  only recently saw my symptoms as being similar to mild cases of immune thrombocytopenia and thought it important that I report my strange side effects.   Within perhaps 48 hours of receiving my second COVID shot, my husband noticed a large bruise on the back of my leg. I didn't remember getting it but thought I must've forgotten a bump. I got more large bruises over the next couple days. A spot that bruised on top of my right thigh from my toddler playfully falling into me was the worst bruising I've ever had in my life, by far. It was very painful to walk and I needed ibuprofen for a couple days. The bruise was approximately 6"x2" and developed many petechiae about the size of a piece of coarse kosher salt. It lasted about a week.  At two weeks post-shot, I have no bruises whatsoever, even with a rambunctious toddler.  One more thing that happened during this time is that when I'd blow my nose upon waking, there would be blood/dried blood on the tissue. One morning, within a few days of my shot, I got a mild bloody nose after blowing my nose and it took about 10 minutes before I could remove the kleenex from that nostril.  I am still having some trace dried blood when I blow my nose in the morning but it's improving.