chrisvoncsefalvay/vaers-outcomes huggingface dataset:
morbilliform rash - information has been received from a physician concerning a 1 year old patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 633570/1655j and the varicella virus vaccine live msd lot 634846/0933k.  the physician reported that 8 days post vaccination the patient developed a mealses like rash.
10 hours after vaccine: nausea, chills, headache, sinus pain, sore throat
Agency contacted 2/19 In evening by employer representative- client Died Suddenly after work"
No adverse effects were reported; Administered a fourth dose of GARDASIL 9; This spontaneous report was received from a nurse, via company representative, referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies/reactions and concomitant medications were not reported.  On unspecified dates, the patient received the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided), as prophylaxis. On 23-SEP-2019, the patient was vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)(extra dose administered)(concentration, dose, anatomical location, route of administration were not provided; lot number S008151 has been verified to be a valid lot number, and expiration date was reported and internally confirmed as 20-NOV-2021) as prophylaxis. No adverse effects were reported.
Pain in shoulder especially during resting.  Pain is not getting better as of 1/19/2013.  Spoke to pharmacist at the facility. He said I don't want to scare you but this doesn't sound good.  I need to see my primary physician but I have to wait until Friday, 1/25.
The incorrect dose was given to patient. Patient received 0.3 of the adult Pfizer product in error. Patient developed a increased temperature on 12/17/2021 of 103. Patient had Headache, body ache, increased temperature and lethargy for 2 days after vaccination.
Swelling of left prescapular region (worsened throughout the day), pain with raising left arm (improved slightly throughout the day where was able to raise arm without extreme pain just mild-moderate discomfort, when very painful was on same level as when dislocated my shoulder), when left arm raised tingling-numbing of left arm (improved throughout the day)
He had fever, vomiting and diahrrea the same evening. from that time on the fever was intermittent and the vomiting was intermittent and the diarrhea has been consistent. over 9 diarrheas in a day in the beginning and now its about 3 per day.  First ER visit (outpatient service) on 9/23 and got IV fluids. Blood work was done. Second ER visit at Hospital on 9/26 and he was given more IV fluids. Blood work was done. He also needed magnesium by IV and by mouth.  Weight loss of about 12lbs minimum
Developed 5 hive like maculopapular rash - red, raised on back, leg, hip, face.
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. On 13-JAN-2016, the patient was vaccinated with an improperly stored dose of the GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration date 21-SEP-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient started be very tired and needed to take Tylenol you know to somewhat get around to keep my temperature down.; patient started be very tired and needed to take Tylenol you know to somewhat get around to keep my temperature down.; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6205, Expiry date was not reported) via an unspecified route of administration, administered in right arm (right shoulder) on 26Feb2021 (age at vaccination was 72 Years) as a dose 1, single for COVID-19 immunization. Relevant medical history and concurrent condition included Multiple sclerosis on 31Aug1989. Concomitant medication was not reported. Patient started be very tired and needed to take Tylenol you know to somewhat get around to keep my temperature down on 2021. Patient wanted to ask about any side effects with the COVID shot that she had. She meant it happened after she had the first shot a little bit. When probed for the exact date for the onset of the adverse events, patient stated, first would have been probably on the 5th of March. She started be very tired and needed to take Tylenol you know to somewhat got around to keep her temperature down. It started to went up then and then it kept on increasing, for that she had to take more Tylenol. When probed if the patient was taking any other medications, Patient stated, "Really no, all she took was Tylenol(Treatment) to keep the temperature down, took like a multivitamin. The patient received treatment for events with Tylenol. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Redness, erythema at injection site, warm to touch, somewhat painful, was treated with Z-pack Tripack 1 po qd x3 days. Site of problem left arm (Pneumovax)
Admission for normal labor and delivery on 5/3/2021. This visit was within 6 weeks of receiving the COVID vaccine.
About an hour after vaccine, felt itchy inside, watery eyes and congestion - treated with 25 mg Benadryl. No anaphylaxis
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Experienced: "excessive" dizziness, "sick to my stomach"; no treatment; called her doctor and "the doctor thought I had inner ear problems"; "I did not have any inner ear problems before that".
During administration by technician, when they removed the needle, fluid (vaccine) began to leak from injection site.; My arm currently is tender; I under the suspicion that the technician did not go completely into my deltoid.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (During administration by technician, when they removed the needle, fluid (vaccine) began to leak from injection site.), TENDERNESS (My arm currently is tender) and UNDERDOSE (I under the suspicion that the technician did not go completely into my deltoid.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (During administration by technician, when they removed the needle, fluid (vaccine) began to leak from injection site.), TENDERNESS (My arm currently is tender) and UNDERDOSE (I under the suspicion that the technician did not go completely into my deltoid.). At the time of the report, VACCINATION SITE DISCHARGE (During administration by technician, when they removed the needle, fluid (vaccine) began to leak from injection site.) outcome was unknown, TENDERNESS (My arm currently is tender) had not resolved and UNDERDOSE (I under the suspicion that the technician did not go completely into my deltoid.) had resolved.            Concomitant medication was not reported. Treatment information was not reported.
14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date).    The case reported for 9th adult patient.   No concomitant medication was provided by reporter. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 8DEC2022 to 10JAN2023. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case - 1st adult
Fatigue, chest heaviness, chest tightness, chest pain, arm discomfort, arm numbness, tingling arm, jaw pain, shoulder blade discomfort
Slight headache after the first vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Slight headache after the first vaccine".  Additional information included: Patient stated the only reason she took the shot, was because she had health issues, and she thought she was protecting herself.  Patient stated she took the Pfizer shot, over the other vaccines, because she had respiratory issues, and didn't want to get sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
GBS onset days post vax sx numbness, throwing up, h/a, muscle weakness;
A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome; Just a solid red rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included ongoing viral illnesses.  The patient's past medical history included COVID-19 (Patient had developed the same rash after getting infected by COVID) and Viral infection NOS (Patient had also experienced same rash after getting two non COVID viral infections).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash). At the time of the report, RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  It was reported that the adverse events seemed to be an immune response the patient had developed towards an ongoing viral illnesses.   No treatment medications were reported.   This case was linked to MOD-2022-551282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow-up received and contains no new information.
Blurry vision, arm soreness, facial pain, muscle and joint pain throughout entire body, tiredness. All of these side effects are still felt the next day after vaccine. The muscle pain has decreased, but patient still feels uncomfortable.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant product was reported. On an unknown date, the patient felt that Humira was not working. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns an adult, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. No symptoms were reported and treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. No symptoms were reported and treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
PAIN IN ARM; This spontaneous report received from a patient concerned an adult female. 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, intramuscular, batch number: Unknown) 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 subject experienced pain in arm. The action taken with covid-19 vaccine was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
The patient felt drip and wetness while being vaccinated.  Some of the vaccine leaked from the syringe almost at the end of the vaccination.  Patient and pharamcist decided that patient might have not received the full dose. After discussing with the patient, another pharmacist repeated the 0.25 ml of dose with the patient's full permission to ensure the patient got the full dose of vaccine.
Pt received ZOSTER & TD BOOSTER vaccinations on 6Mar2009.  Pt received vaccines on R deltoid.  Zoster vaccine caused localized rxn to include redness, itchiness swelling, and discomfort.
Time and date of adverse event onset is unknown.  Time/date indicated above is the time/date administering hospital was notified. Employee is reporting her doctor told her she had an allergic reaction to the flu shot she got on Friday. She is feeling weak, body aches and fainted at the doctors office with a blood pressure of 70/40. Her PCP recommended hospitalization for those symptoms and including a rash she is developing.
At 12:00 pm, I received the shot.  Sat for 25 minutes.  Felt like head was in a drum.  At 35 minutes, my upper lip below my nose started to swell up.   I made a comment to my husband that it felt like my mask was on.  Thought nothing of it.   I am not prone to allergies outside of sulfa, metforin, radioactive dye.  I had no idea I was having a reaction.  At 45 minutes after shot, while I was driving 20 minutes away from my home, my throat, tongue, started to swell.  My breathing became labored.  I didn't know what was happening to me.  I remained calm.  I drove to my house to seek help from my husband.  At 1:10-1:15 p.m., I took sips of water and tried to eat something.  I started to feel better.  At 1:30 PM, the swelling, etc. ... gone.  From that point, no further swelling reaction other than the start of the effects.
Pt. resides in assisted living. Reported to us today (L) deltoid injection site with red, raised swollen area 5x6 inches. Applying ice to site.
This case was reported by a physician via sales rep and described the occurrence of arthralgia in a 82-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included prostatic specific antigen. Concomitant products included ORENCIA and methotrexate. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced arthralgia, myalgia and malaise. The patient was treated with MEDROL Injection. On an unknown date, the outcome of the arthralgia, myalgia and malaise were unknown. It was unknown if the reporter considered the arthralgia, myalgia and malaise to be related to SHINGRIX. Additional details reported as follows: The patient experienced severe adverse events following administration of SHINGRIX in the week of 10th August 2018. After vaccination the patient developed severe myalgia, arthralgia, malaise. The patient was treated with DEPO MEDROL injection but not sure if it had helped the symptoms as this all just happened within that week. This case has been linked with US2018GSK145212, reported by same reporter.
8-27-12 at 11:32 am. HAVRIX given in left delt then GARDASIL given in right delt. Patient's head dropped down immediately & I laid him back he jerked a couple times & wake.
Rash at inoculation site. Fever. Rapid pulse (100) at rest. Headache. Body ache.
Dose was administered to patients after the 30 days use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.  Nurse stated that patient received the 1st dose of the Moderna COVID 19 vaccine on 20SEPT2021 between 8:10-9:10am. The dose was administered to patients after the 30 days use by date.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Additional information received and Anatomical location was added
Shortness of breath with any physical exertion Racing pulse with any physical exertion  Intense fatigue after any physical exertion  Heart fluttering / palpitations after physical exertion   All consistently have gotten more intense / worse over the past 3 weeks since the day of noticing the adverse reactions.
Left shoulder, neck and arm pain that started a few days after vaccination and have increased.  Each week his pain increased from a 2 to to an 8 now on the pain scale.  He reports neuropathy that started in week 3.  He was given some prednisone and it provided relief but the pain continued after the prescription was completed.  He is now taking Gabapentin, but reports pain so severe that he is unable to sleep much as he wakes up with the arm pin.