chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report was received from a pharmacist (PVX2019-572) on 04-Mar-2019. The report described an adult female consumer who "did not take Vivotif according to schedule". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer did not take Vivotif according to the schedule. The doses were taken on 25-Feb-2019, 27-Feb-2019, 02-Mar-2019, and 03-Mar-2019, respectively. Also, she was leaving to an endemic area on coming Friday.  The action taken with Vivotif with respect to the event "did not take Vivotif according to schedule" was not applicable.  The clinical outcome of the event "did not take Vivotif according to schedule" was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" was considered as not applicable.
Pt recvd 1st dose of Engerix-B approx 1 mo ago (from 25APR91) & exp fever & nausea, h/a, sl temp, lethargy, & felt very tired lasted 3 days; no tx given;
pt recv vax 25SEP95 & 27FEB96 lab eval revealed HBsAg positive and anti-HBs negative;
went to local immediate care to have ear pain and overall bodyaches checked.  Positive covid 19 test at that time.  Severe ear infections is both ears for a duration of 1 month.  Fatigue, muscles aches and headaches, no appetite for the first seven days.  The second week ears still painful, slight reduction in muscles aches and fatigue.  Quaranteened for 14 days before returning to work.  Had an elevated level of fatigue for up to 1 more month.  had three rounds of antibiotics to solve the ear infections.  Continue to deal with vertigo from the ear infections to this date, 4/12/2022
This spontaneous case was reported by a consumer and describes the occurrence of OSTEOMYELITIS (Osteomyelitis is acting up again) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Compound fracture - tibia (Bone-setting and skin-grafts were done) in 1975, Compound fracture - fibula (Bone-setting and skin-grafts were done) in 1975, Motor vehicle accident (Bone-setting and skin-grafts were done) in 1975, Osteomyelitis in 1976, Staphylococcus aureus infection in 1976, Bone prosthesis insertion in 1976, Bone graft in 1976 and Bone operation (metal plate removal, with no significant 'osteo' remembered) in 1979. Previously administered products included for Osteomyelitis: Dicloxacillin in 1976, Keflex (In-patient treatment of osteo using Keflex (antibiotic) every four hours and followed by outpatient treatment with oral Dicloxacillin) in 1976. Past adverse reactions to the above products included No adverse reaction with Dicloxacillin and Keflex. Concurrent medical conditions included Osteomyelitis (Dormant case of osteomyelitis for about 47 years).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OSTEOMYELITIS (Osteomyelitis is acting up again) (seriousness criterion medically significant). At the time of the report, OSTEOMYELITIS (Osteomyelitis is acting up again) had not resolved.            No concomitant medication provided.  Description: The patient recently had the first and second shots of vaccine and now patient's osteomyelitis was acting up again. Patient did not see a doctor for this worsening of symptoms because it wasn't yet draining pus and recent problems in patient's lower left leg (redness, pain and change in appearance of the bony looking scar) might go away on their own.   No treatment information reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Very limited information regarding this events has been provided at this time.  However, the underlying condition in this advanced age patient remains a confounder. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, the underlying condition in this advanced age patient remains a confounder. Further information has been requested.
rash has become worse and is covering her body; Initial information received on 24-May-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse.  This case involves a 66 years old female patient who experienced rash has become worse and is covering her body, while she received vaccines TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 22-May-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA via intramuscular route in unknown administration site. On 22-May-2018, the patient received a dose  dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot N1C154M via intramuscular route.  The patient developed a non-serious rash has become worse and is covering her body (vaccination site rash) <<Unknown latency>> following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and <<Unknown latency>> following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Final diagnosis was rash has become worse and is covering her body.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for rash has become worse and is covering her body.
Woke up December 11th unable to bare weight or touch left foot. Purple spots. Inflammation. Hospitalizations. Still discolored in foot and up leg now. Wheelchair bound,unable to attend school or daily functions. Tremendous amounts of pain and had IV antibiotics and pain management involved at local hospital. Is covid toes possible?
FEEL LIKE GOT HIT BY A TRUCK; SWEATS; ON AND OFF CHILLS; RIDICULOUS HEADACHE; This spontaneous report received from a health care professional concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no co-morbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced feel like got hit by a truck. On MAR-2021, the subject experienced sweats. On MAR-2021, the subject experienced on and off chills. On MAR-2021, the subject experienced ridiculous headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like got hit by a truck, on and off chills, sweats and ridiculous headache was not reported. This report was non-serious.
Arm broke out. Redness, swelling about size of 50 cent piece, knot - lethargy, pain. Blisters under tongue & bilateral ears.
First slight itching, then swelling and hard area on arm below injection site; warm to touch. Became larger the next day making a larger area on arm continuing down below the site and around on inside of arm, still swollen and warm to touch. Still noticeable third day, but not as tender to touch, swollen, hard or warm.
Day one very tired. Day two through day five very tired. Slept alot. Day five morning started with speckles all over body. Day five evening deep purple swollen lips. Very tired. Face swollen. Took a benedry. Day six rash all over. Went to and got steroid shot and steroid script plus a steroid cream for rash. After five days on steroids I was nearly completely free of rash.
This spontaneous report as received from a medical assistant refers to a multiple patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and drug reactions were not provided. On an unknown dates the patients were vaccinated with improperly stored PROQUAD lot # L051098, expiration date 17-JUN-2017, once, subcutaneously, (Dose and anatomical location were not provided). No adverse events were reported. No product quality complain was involved. Additional information has been requested.
4 month old female patient was inadvertently given only the liquid portion of Pentacel, as the product was not mixed prior to administration/ no AE; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a other health care professional via non-healthcare professional/consumer via Medical Information  (Reference number- 00832566).  This case involves a four-month-old female patient who inadvertently received only the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (Product preparation issue).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Pneumococcal Vaccine 13V (Pneumococcal 13 Valent Vaccine) for Immunisation; and Rotavirus Vaccine for prophylactic vaccination.  On 27-Oct-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ531AA and expiry date: 22-Jul-2022) (Frequency: series of four) via an intramuscular route in the thigh NOS (not otherwise specified) for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (latency on same day).  It was reported "four-month-old female patient was inadvertently given only the liquid portion of Pentacel, as the product was not mixed prior to administration".  At the time of report, no adverse event was reported.   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.
Client reported adverse event on 6/24/2021. She received dose #2 of Pfizer vaccine at an offsite clinic. 24 hours later she noted alot of bruising on both legs primarily from the knees down but has a few bruises on both upper legs. States bruises are dime size & there are approximately 20 bruises on both legs. She also notes body soreness & denies any known cause of bruising. She does have ITP. Advised to contact medical provider for possible further evaluation.
Initial unsolicited report received from a Nurse on 17-May-2018. This case involves an eight-year-old patient (gender was not reported) who was vaccinated with a fifth dose of QUADRACEL (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event was reported. 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 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. Documents held by sender: none.
Mom has secondary progressive MS and had not had an exacerbation in over 30 years.  The vaccine gave her an exacerbation - lethargic, unable to stand, crippled her 2 fingers and new a new lesion on her brain.  This caused her to be in the hospital for a week and now in skilled care (going on week 3) for PT to learn how to walk again.  She has been on steroids and also needs to take a Hepron injection 4x:day since she can?t get out of bed on her own.
Vaccine was mixed by medical assistant.  MA states she followed the posted procedure of adding 1.8ml of diluent to vial.  She did not double check volume with another staff member as the work flow at our clinic requires.   MA states some of liquid may have squirted out when she added to vial.  MA gave one dose, a second MA gave an additional dose, a third MA went to draw up a dose and noted there was only enough remaining in vial for slightly more than 1 dose.  She was aware (due to log that is kept with vaccine) that only two doses should have been given.  Original MA later stated that she wasted one dose by accidently throwing drawn up syringe into sharps container.  Third MA did not give dose because she was concerned that there was not enough volume remaining in vial and was concerned an error may have occurred.  No additional Covid vaccine was given that day as that was the last vial remaining at clinic for ages 12 and up.  Pt who received first dose called clinic on 1/17/22 stating she has had a headache since receiving the vaccine.  She is also experiencing dizziness especially when sitting to standing.  Pt was seen in clinic today.  MD feels headache may be sinus related and prescribed Zyrtec and Flonase.
headaches/situation was getting worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "not recovered", described as "headaches/situation was getting worse".  Additional information: It was also reported that patient was calling concerning Pfizer's COVID-19 booster shot. He reported that he received the booster last April and that he was suffering from headaches. He added that he was still suffering from headaches and that the situation was getting worse. He would like to know more about the cause. He still had headaches and it was getting worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received on 7/10/01 from an RN concerning a child (demographics unknown) who was recently vaccinated with a dose of MMRII. Subsequently, the child developed a "post vaccine fever and rash". There was no further information provided. Additional information has been requested.
Urticarial rash over whole body including face, moderate swelling of lips eyes beginning 8pm 1/30/21. Rash most concentrated over trunk and thighs, center of face around nose. Worsened overnight (1/30/21-1/31/21)despite use of benadryl 2 tablets (50mg) night prior and every 4-6 hours following. care provider seen 1/31/21 9AM, prescribed prednisone (first dose 11AM) and advised continuing benadryl 2 tablets 4-6 hours. Prednisone 10mg TID x 3 days, 10mg bid x 3 days, 10mg qd x 3 days. Continued Benadryl every 4 hours. Rash on body and face peaked 1/31/21 3pm, mild improvement overnight to 2/1/21. 2/1//21: Rash increased in intensity on distal LEs (feet/ankles) and UEs (wrists). Appearance of petichiae on trunk, lateral thighs. 2/2/21: Rash improving, fatigue. 2/3/21: rash nearly resolved, petichiae remain 2/4/21: Rash resolved petichiae improving.
Patient received Prevnar 20 vaccine, lot number GM9409, days later was seen in Urgent Care for cellulitis/vaccine reaction. She is the second patient seen this week with a reaction to the same vaccine and same lot.
Erythema/papular rash R arms/hands/face/neck/itching/malaise. Tx: Benadryl/Motrin prn.
LIGHTHEADED, DIZZY, HOT FLASHES IMMEDIATELY AFTER GIVING VACCINE.  FELT VACCINE GO THROUGH ENTIRE BODY.  DROP IN BLOOD PRESSURE.  BP 3:30PM 92/55.  3:40PM BP 113/74.  3:47PM BP 126/80 HR 63.  3:57PM BP 128/88 HR 64. GAVE PATIENT WATER AND GRANOLA.  AFTER 30 MINUTES PATIENT FELT NORMAL.  FOLLWED UP WITH PATIENT 5:44PM. FELT NORMAL AND ONLY HAD ARM PAIN.
Arm hurt a little bit after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt a little bit after booster shot) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt a little bit after booster shot). At the time of the report, VACCINATION SITE PAIN (Arm hurt a little bit after booster shot) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity received in the moderna were missed to be booked-in.
pt recvd vax; exp inject site rxn & high fever of 103-104 following tetramune/opv; fever lasted 3-4 days;
had a severe flu-like reaction to it; Experienced the reaction flu, the reaction was similar to what someone would experience having got on the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 15Mar2021 22:00, outcome "recovered" (17Mar2021), described as "had a severe flu-like reaction to it; Experienced the reaction flu, the reaction was similar to what someone would experience having got on the flu". Additional information: The patient received the Pfizer vaccine on 15Mar2021 (Monday) and experienced a severe flu-like reaction to it on 15Mar2021 22:00 (12 hours after the vaccination). This lasted for 24 hours until 17Mar2021 (Wednesday). So mid-way Wednesday, the patient felt better. The patient reported that the reaction was similar to what someone would experience having got the flu. The patient asked since "I had received such a severe reaction with, you know, I was surprised with that. Can I expect the same kind of severe reaction from second dosage?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed chest pain, on workup was found to have elevated troponin, and elevated PT/INR. These then trended down over subsequent measurements with no acute intervention needed
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  During November 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, ZOSTAVAX suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Clear water like bumps on both left and right of my arms. Wiped them off and they popped.
BODY ACHES; FEVER; SORE INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, administered on 06-APR-2021 to right arm 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. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced sore injection site. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore injection site, body aches and nausea was not reported. This report was non-serious.
3 days /p vax given bright red hard lumps involving the lt leg were seen, office notes states injection was given in the rt leg.  Office notes record this as an injection site reaction.
2 1/2 days p/vax, neck turned bright red, blotches on arms & back;did not see MD;c/o itching;
lt forearm soreness, redness & mild swelling x 2 days; denies fever, + distal pulse, positive ROM; instructed to apply cool compresses & adm advil for inflammation as per MD;
No adverse event; Dose was given 1MAR2023 after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 01-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 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 (Dose was given 1MAR2023 after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose was given 1MAR2023 after the published expiration date) and NO ADVERSE EVENT (No adverse event) to be not related.    No treatment medications were reported No concomitant medications were reported