chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates since 01-OCT-2015, the patients were vaccinated with improperly stored ROTATEQ (lot # L008054, expiration date 30-NOV-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
33 Y/O FEMALE PATIENT WHO REFERS TACHYCARDIA 30 MINUTES AFTER COVID VACCINE, B/P 141/92,HR 87BPM SAT 100%, RESP 21 BPM, PATIENT IS PLACE ON CARDIAC MONITORING  PER 30 MINUTES, LEAD II HR 81, SINUS RHYTUM. PATIENT WAS DISCHARGE HOME, FEELING WELL NO TACHICARDIA, HEADACHE , NAUSEA OR VOMITING.
Pt with Dx of H1N1 influenza beginning 6 days after intranasal vaccination; unclear if got virus from vaccine or they were exposed before immunity complete.
August 23 he woke up with ringing in his ears bilaterally and an "electrical feeling" as if he could not shut his body off.  He also experienced a burning sensation in his stomach. He reports that his eyes felt as though he had slept in contact lenses and felt raw. In addition, was not able to sleep. He describes a trembling throughout the upper part of his body from the hips up. This sensation felt like a vibration and at times it was visible to others. He believes that this was the cause of his inability to sleep. He was only able to get 2 hours of sleep per night.  On August 30, 2003, he reports that the right side of his face went numb from above the ear down to the jaw. This numbness lasted 24-48 hours. This was not painful and happened twice within the following one-week period.  He sought medical attention for the numbness. He started experiencing tinnitus in October and this continues. In addition, he now suffers short term memory deficits.
Within an hour- hives, painful, and hot to touch.   That night- Wheezing, fever 104.3, body aches, and headache. Still as of 4 days later- injection site red, hot and painful
11/15/2021 my period started 6 days earlier than normal. This is not normal for me. Very painful craps followed by heavy bleeding with 100's of tiny blood clots. This heavy period with clotting lasted 12 days. I haven't had clots in my period in 20 years.   11/19/2021 Six days after my booster I developed a raging yeast infection. I have not had a yeast infection in a long time. The doctor prescribed me 2 Diflucan. That wasn't enough to make it go away. It took another difulcan.   11/22/2021 Nine days after my booster shot I developed Oral Thrush. The doctor had to prescribe meds for that. I've NEVER had thrush.
Bell's Palsey of left side of face; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 at 11:00 (Lot Number: EN6199) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included rheumatoid arthritis (RA), fibromyalgia, gastrooesophageal reflux disease (GERD) and high blood pressure, all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 before vaccination and since vaccination has not tested positive to COVID-19. Concomitant medications included oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET); valsartan (DIOVAN); levothyroxine sodium (EUTHYROX); orphenadrine and quetiapine, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously took ALUPENT and ADVAIR.  The patient experienced Bell's palsy of left side of face on 29Mar2021. The event required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with steroids and antiviral. The patient outcome of the event was not recovered.
Major bone pain, throbbing of every joint, bone & musle. Still neck, arms, legs with throbbing pain, massive headache, zero ability to get up out of bed, brainfog & lightheaded, stomach ache.
Dizziness for several hours. Vomiting.  Dizziness again on Monday, 03/01/2021 all day.
Patient should have received DTaP not Tdap (Boostrix); 18 month old  received BOOSTRIX; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9Zk5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2022, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 24th August 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The medical assistant from a doctor's office reported that the 18 months old patient was administered with Boostrix (Tdap) at the time of reporting.  As per package insert Boostrix was Food and drug administration approved for individuals aged 10 years and older.  The patient should have received DTaP not Tdap. The injection was given intramuscularly in unspecified leg. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient was administered with Boostrix (Tdap) instead of DTaP at inappropriate age ,which led to wrong vaccine administered and inappropriate age at vaccine administration.
This spontaneous report was received from a health professional, who happens to be also the patient (female patient of unknown age), reporting on herself. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date while opening a dose package of VARIVAX, the reporter noticed that the vial was broken and she got some medication on her hands. No adverse event was reported. A product quality issue was reported because of the broken vial. Additional information has been requested.
I am not sure as to which brand of rotavirus vaccine was given as it was not documented in the record given to me. My son was given the rotavirus vaccine on April 25, you will have to find out from the doctor which vaccine they were using. My son developed intestinal intussusception.
After my  first dose of my vaccine, I had a very sore arm and general malaise. After my second dose, I was very ill. Fever, headache, nausea, extreme body aches, pain in legs, noticed change in period cycles. My cycles were very regular every 28 days prior to the vaccine.    I received the Moderna booster on Saturday, November 20th @ 4PM. Like the other two doses I received, I had side effects. But, this time it was different. I got a low grade fever, EXTREME nausea, horrendous aches (the kind where it felt like my bones were breaking), and low and behold a very swollen armpit. All seemed par for the course. However, after what I thought was the worst of it, the next day my heart rate sky rocketed to 187BPM when I was working out. Keep in mind, I am an avid runner, running 6 days a week on my Peloton tread. My heart rate is always 160ish while running so this was alarming. I finally got it below 187 because I was convinced I was going to pass out. I felt subpar for a couple of days, but better? I guess.   That Wednesday evening, I started to feel nauseous. I then got my period (I apologize for the graphic nature) and it was completely out of my norm. It was heavy, my cramps were extremely painful, and it had me taking a 4 hour nap before holiday dinner. This was not normal. For the next two days, I was in bed, nauseous, fatigued, achey, and miserable. I was taking medicine around the clock. By Sunday, I was 85% better. By Monday, I was 100% back to myself like this never ever happened. This was exactly how I was post immunization 1 and 2.
I woke up in the middle of the night on 4/18/2023 with a fever. I took my temperature, which was 102. I had a headache and felt lightheaded. My throat was initially sore on the left side. As the week progressed, the extreme pain moved to the rest of the throat. By 4/20/2023, my breathing was more labored. I began taking Paxlovid on 4/21/2023, and I felt a marked improvement in breathing about 12 hours later. From then on, it improved steadily. My worst days were 4/19/2023 and 4/20/2023; I was too sick to do anything those days, and I basically felt lethargic. I was able to return to work on 5/1/2023.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 13-month-old female patient who received KINRIX (batch number 3ZL2Y, expiry date 27th March 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: Nurse gave 13 month old a KINRIX dose.
This spontaneous report was received from a healthcare worker refers to a pediatric patient of unknown demography. On an unknown date, the patient was vaccinated with GARDASIL in gluteal region. The reporter stated that does the efficacy will be lost because of the wrong site following doses can take are how can get prevention from HPV. No further information was provided. Additional information has been requested.
Initial report received on 17 December 2009 from a health care professional. A 13 year old male patient developed an awkward gait and was "off balance" the evening after he received Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative on 15 December 2009 (manufacturer was thought to be sanofi pasteur, lot not reported). The patient's mother called their physician to report these symptoms. The patient was seen by the physician on 17 December 2009. It was noted that the patient did not have any neurological deficits. Recovery status was unknown. List of Documents held by Sender: none.
Large purple area with blisters around injection site. Patient complained of area feeling hot and hard around the injection site.
2 weeks after shot left arm was red around injection site, warm to the touch, a little swollen, and tender to touch.
This spontaneous report as received from a healthcare worker refers to the 5 patients of unknown age and gender. On an unknown date the 5 patients were vaccinated with a doses of improperly stored, exposed to 9F for 7 hours of VARIVAX (Merck) 0.5 ml injection, subcutaneously (lot number and route were not reported). No adverse effects were reported. The outcome of the patients event was not reported. Additional information has been requested.
This spontaneous report as received from a health care professional refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. An unspecified number of patients received unspecified dose of ROTATEQ lot # K011663, expiration date: 24-MAY-2016 (strength and dose unspecified) series between 25-AUG-2015 and 28-SEP-2015 that were improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Received injection in 2 stages. On May 13, 2000 hands, forearms swollen, joints ached, shoulder sore, very tired. Used Benadryl also was given Cicsorex for pain. That did not help. Was given Advil 800 mg. As of 6/4/2000 pt still has fatigue, swelling and pain.
Began with lethargy, progressed to post vaccine vzv. Severe generalized rash with hundreds of large crusting lesions. My daughter was hospitalized and placed on IV acyclovir and antibiotics. This reaction was more severe than any normal chicken pox case.
invalid dose/ patient didn't receive the whole dose; patient using a vanish point syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (invalid dose/ patient didn't receive the whole dose) and SYRINGE ISSUE (patient using a vanish point syringe) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-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 UNDERDOSE (invalid dose/ patient didn't receive the whole dose) and SYRINGE ISSUE (patient using a vanish point syringe). At the time of the report, UNDERDOSE (invalid dose/ patient didn't receive the whole dose) and SYRINGE ISSUE (patient using a vanish point syringe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.; Sender's Comments: This report refers to a case of Underdose and syringe issue for mRNA-1273, lot # unknown, with no associated AEs.
Vaccine expired on 07/12/2022, 3 days earlier.  Pfizer was notified and said they had stability data for 2 days post expiration.  Form submitted to Pfizer to determine if suppliers have more stability data.  Doctor does not think revaccination is necessary.  Parent informed.
Patient reported dizziness and Light headed after 15 minute window. Offered water and/or popsicle. Patient refused. Alerted provider  Checked back in 10 minutes, patient reported symptoms were gone. Released patient and advised to call if any other reaction or if needed.
This spontaneous case, initially received on 04-Oct-2016, was reported by a health professional and concerns a 51-year-old female patient. Weight: not provided; Height: not provided. Medical history was not provided. Administration of company suspect drug(s): The patient received AFLURIA from 01-Oct-2016 to 01-Oct-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 14249211A. Action taken with drug: reported as 'discontinued'. No additional suspect drugs. Adverse reactions/events and outcomes: On 01-Oct-2016 later in the day, the patient experienced soreness at the injection site. On 02-Oct-2016, the patient noticed a small, circular rash at the injection site and a swollen lymph node underneath her armpit in the arm she received AFLURIA. Outcome of all events: not recovered/not resolved. Report's assessment: The healthcare professional considered all events as non-serious and believes that the rash is from receiving AFLURIA, but suspects that the swollen area under her armpit is not a lymph node, but may be due to the patient shaving her armpit the night before.
Mixed bacterostatic sodium chloride instead of sterile sodium chloride with pfizer vaccine and inject into patient. Waiting for CDC recommendations on how to move forward before contacting patient.
Seizure, 104F-sent to hospital; given ibuprofen and sent home.  MD presribed Zithromax for ear infection.  Took to regular doctor on the following morning.  Had strep throat.  Mother had same reaction-hospital for 3 days.
Pt vomited at 4:30pm and had seven episodes of emesis in 7 hours. Pt was taken to ER and given IV hydration and Zofraa IV. Released to home with Brat deat and Tigan supp but had no further emesis. No fever.
Localized reaction to right deltoid 11 x7 cm erthema, induration, warmth.
Slight headache, low grade fever (100) and cough beginning Monday, 11 Jan 2021; lasted through Thursday, 14 Jan 2021.
Pt developed an area of redness, swelling, and pain at least 12 hours after vaccination. The are increased in size and pain, and by Tuesday pt referred to urgent care by her doctor. She was prescribed KEFLEX 500 Q 6-11 x 7 days and SEPTRA DSQ12H x 7 days. Pt to follow up with her primary MD on Thursday (12/10).
Patient phoned stating she was treated in ER for yellow drainage from eyes, tightness in throat, lips swelling and increased blood pressure
This spontaenous report as received from a healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored PNEUMOVAX 23 (lot # K019386 and expiry date: 09-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported PNEUMOVAX 23. This is one of the several reports from the same reporter. Additional information has been requested.
My throat became dry and irritated, white or nude colored bumps appeared on back of throat and palate.  Eventually became sore after the 2nd vaccine Lot # EL1284 on 1/23/21 worsened and throat became red under the bumps.  To date bumps and redness remain.  Soreness comes on and off, lasts hours improves then returns.  Also headaches daily since initial vaccine.   I saw PMD am currently on Amoxicillin 875 and it is not helping at all.
Chills joint pain  bad muscle aches. Bad headache  brain fog. Bad fatigue.
Case completed her Covid vaccine series in March 2021, then ws admitted to hospital for treatment of Covid in Octoner 2021.
24 hours after my vaccination I began to run a fever as high as 103. Felt very bad but woke up yesterday feeling back to normal. Fast forward to this morning, I woke up barely conscious and in a pool of sweat. I managed to make it to the fridge and chugged apple juice to give me a tiny bit a strength. I took my temperature and it read 94.1, over and over. I called an ambulance because I was not conscious enough to drive to the ER. Paramedics couldn?t take my temperature because their thermometer didn?t read lower than 95F. I went to the ER and got a diagnosis of hypothermia, and since then have recovered.  Dysautonomia can cause low temperature, but I have never experienced anything like this before. I truly thought I was dying I felt so bad. I am just glad I woke up when I did so I could begin the process of warming my body up.
August 28: headache, feeling of throat closure August 29: felt shakey whenever i moved for a short period after waking up (only slept for 3 hours so that could be a result), felt nauseous (had a long car ride after eating that could also be a result) August 30 (today): chest feels tight and slight wheezing, also had an itchy neck for a short period of time.
SHE CALLED HER DOCTOR OFFICE AFTER SHE LEFT PHARMACY SHE TOLD NURSE SHE  DOES NOT NOT FEEL GOOD
approx 2 hrs p/vax pt exp episode of crying w/high pitch cry, lasted from 1:00-4:00;fever went up to 103 & stayed there for a few hrs; fever cont for 2 days between 100-102
Weakness, chills, fatigue 8/4-8/5. Intense itching all over body 8/5.
(R) deltoid very red, hot to touch difficulty moving arm. Received BACTRIM, tried MOTRIN and cold packs.
Covid; Covid; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (177954). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; ILLNESS (non-serious), outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Course: Supplier / Reporter Information Accompanying a Product Safety Report:  Reporter was not a healthcare professional. It was reported that, after receiving the Covid vaccine from Pfizer and getting very sick and then on top of it getting Covid a month later, the patient didn't believe that he would ever try or recommend anything from them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medial assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of PEDVAXHIB (involved lot numbers: M007762 with expiration date at 07-DEC-2018, M025193 with expiration date at 21-MAR-2019 and L033690 with expiration date at 14-JUN-2018; dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit not provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
Sore arm day after - no other affect.   9 days  later I started to get rash on face.  but day 10 , I had a full allergic reaction.  burning, itching face.  I went to my dermatologist and he believes it was a delayed reaction to the vaccine.  Nothing new was introduced to my world.   I started a regime of Prednisone .   Day 11 the redness was gone but residual effects were apparent Day 12 my skin was flaky but otherwise normal
rectal bleeding; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced rectal bleeding on an unspecified date. Outcome of the event was unknown.  Information on batch number has been requested.
Illness consistent with erythema multiforme minor.  Interpretation of precipitant complicated by the fact the the child received vaccines and was on amoxicillin for acute otitis media.
only the liquid component used; only the liquid component administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA750A, expiry date 30th November 2023) for prophylaxis.   On 7th December 2022, the patient received the 1st dose of Menveo. On 7th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter inquired that the patient need to be revaccinated. The reporter consented to follow-up. Additional supportive information: The patient received only the liquid component of Menveo, which led to inappropriate preparation medication and inappropriate dose of vaccine administered.