chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner and a RN concerning a 9 year old Caucasian male pt with no known drug allergies who on 06Aug96 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11Nov2003, the pt developed chickenpox. On 12Nov03, the pt presented for a Dr's visit with approx. 85 chickenpox bumps. No treatment was necessary. It was unknown if the pt recovered. A product quality complaint was not involved. The reporter also mentioned a female pt who developed shingles post vaccination with varicella virus vaccine live. Additional information is not expected.
Shot administered by nurse at school.  Student started vomiting within a few minutes after receiving vaccine.  Temperature 98.4.  Pulse 80.  Blood Pressure 108/60.  Observed by school nurse for 30 minutes.  Parent notified and child sent back to class with no complaints.  About 11:30 am  Blood pressure 106/72.  Pulse 80.  Temperature 98.  Respirations 16.  States she thew up again and no one saw it.  States she still has stomache ache.
Pt recv vax on 2/2/99; on 2/4/99 pt exp red vax site & fever
Pt experience local redness and warmth at the injection site, warmth down arm and welts.
pain at injection site after 2nd dose; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows The age at vaccination not provided. The Shingrix vaccine administered approximately 2 months ago and experienced pain at injection site 3-4 days after 2nd dose.
Right after Tdap I started having numbness in feet and (R) leg. This went on for a month and 1/2 and I never put it together at that point. 12/12/08 Hands/face numb. Went to be unable to move body at 2 AM - could not swallow. To ER - transferred to another hospital. Respiratory failure. Once there, I went into respiratory failure - vented x 21 days in ICU. Then given a tracheotomy due to inability to come off vent. Paralyzed from head to toes. EMG performed; + for Guillain Barre. Dr felt it was from Tdap. Impossible to prove. Gradually improved after IVIG treatment - blood transfusion. No longer have trach. I am unable to function in a normal capacity physically. Going to PT. I have worked full-time as a nurse for 28 yrs. Raised 4 children. Never been ill in my life. This is the most debilitating event that could ever occur. I have post traumatic syndrome. I cannot sleep.  3/20/09 MR received for DOS 12/13/08-01/06/2009 with D/C DX:  Guillain-Barre Syndrome.  Respiratory Failure due to muscle weakness.  Pneumonia. Pt presented with 1 day hx of sudden onset tingling and weakness of the whole body.  PE (+) for proximal>distal weakness in all extremities, L>R, nasal speech quality and poor cough effort. Pt intubated for ventilatory failure and IVIG initiated with some improvement.  Failed extubation on 12/17/08 and 12/24/08 re-intubated. Fever noted 12/25/08 and tx with abx for Staph pneumonia. Trach and feeding tube placed. Slow improvement and eventually able to ambulate and trach removed. D/C with 4-5/5 strength for outpt f/u.
The left arm (injection site) started to swell up within 12 hours of getting the test.  The next morning I had gained 5-10 lbs of water weight.   24-48 hours later i started getting a systematic itch.  I took 2 benadryl on april 22 2021 before i went to bed.  by friday april 23 , 2021 my entire body started to swell up with water including my feet and ankles.  by monday april 26, 2021 i had a moon face.  my hands started turning blue and my palms were bright red but it went away.  my hands were so swollen they were almost arthritic it was difficult  to hold things and kept dropping plates when doing dishes.  my middle of my left hand can still swell up and hurt when i bend it.
Two generalized, tonic-clonic seizures while febrile on 5/1/2018, several hours apart. He was admitted overnight for observation after the second febrile seizure.
Muscle pain aches, particularly in back and legs.  Fatigued.  Chills.  Strong headache.  Dehydration.  Symptoms began to subside by the next morning and with acetaminophen.
Throat was closing up; Bones aching; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat was closing up) and BONE PAIN (Bones aching) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced THROAT TIGHTNESS (Throat was closing up) and BONE PAIN (Bones aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Apr-2021, THROAT TIGHTNESS (Throat was closing up) and BONE PAIN (Bones aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient took the first dose vaccine on 21-Apr-2021. He experienced the events 30 minutes after getting home and reported that the problems were resolved after 3 hours by taking Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-149408, US-MODERNATX, INC.-MOD-2021-149232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149408:Same Reporter US-MODERNATX, INC.-MOD-2021-149232:Crosslink case for family member
patient did not get the 3rd dose on day 21 or 28; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] of 1st and 2nd dose nut missed the third dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported.  It was of actual medication error due to  missed dose.. patient received their first Imovax shot on April 10th, 2nd on April 17th, and now would like to receive the third injection. Caller would like to know if the patient can receive the third injection although it is off schedule.  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.  List of documents held by sender: none.
Full body hives for more than 5 days, full body joint aches and stiffness. Treated with prednisone.
within a couple hours of the vaccine my arm felt swollen, by 8pm my upper arm was visibly swollen and warm to the touch, by the next day the area immediately surrounding the injection site was red and warm to the touch and itchy and firm; it remained this way for 7 days; I expressed my concern to my doctor; by the next day the red area had grown and continued to grow for several more days; I  was placed on antibiotics (Cephalexin 500mg three times daily) and it has since gone down
1/13 vaccination 1/23 I woke up at 2am and had welts on my legs. I got up in the morning, welts were over whole body. Within next 24 hours, spread out every day; very very itchy. I took Benadryl. Rash spread from tips of ears down to my toes.  Saw PCM who referred me to dermatologist.  1/27 Steroid cream, Claritin and Benadryl. Started to calm the rash down.  2/3 Allergist and Dermatologist appts.  Biopsy of rash; rash from something on 'the inside'.  Allergist advised NOT to take 2nd vaccine as it may affect my immune system.
Within 15 minutes of vaccines, became very tired, lethargic and appeared slumped over, drooling some, unresponsive except to painful stimuli. With painful stimuli, would withdraw, open eyes slightly, say brief phrase, like "no", but then appear to go back to sleep. After about 5 minutes seemed more lucid, sitting up, looking around, but then had another 3-5 min episode similar to above. After second episode, remained normal thereafter. Was observed in ED. She did develop onset of fever around same time as symptoms, initially low grade 100.3, then rose to 101. 3.  Ibuprofen given and no further sx once fever resolved. No hives, oropharyngeal swelling, seizure like movements. BP was normal. HR was elevated to 160s during event.
All symptoms from my first vaccine continued-swollen arm, redness, and not able to move arm below the elbow properly.
Patient right upper thigh had a red, hard, lump 6cm by 3cm. Patient showed signs of streaking and rash on chest and face. Patient had temperature of 101.6.
Used incorrect needle tip size for administration. Used a 5/8" instead of 1" but still gave in an IM fashion.
Fainting episode after receiving FLUMIST vaccine. Episode occurred while student was walking back to class therefore fell hitting head on the side walk student was taken to the emergency room to be monitored for severe had injury.
About 45 minutes after vaccine was administered, patient reported severe muscle pain in her left arm (injection site arm). The pain became so intense that patient couldn't breathe  well (pain was taking her breath away) and made it difficult to walk. She also reported elevated heart rate and blood pressure along with shaking/shivering. No redness and moderate swelling  at injection site was also reported. The reaction was severe enough that she went to urgent care.
Information has been received from a physician concerning a female patient who was vaccinated with three doses of Gardasil (dates not reported). Subsequently the patient was diagnosed with cervical intraepithelial neoplasia II. The patient was treated with a Loop Electrosurgical Excision Procedure. It was reported that the patient was not recovered at the time of this report. Additional information has been requested.
A rash that developed on the back of my right leg between the knee and hip. The rash went away completely after about 2 weeks. I had not had a rash like that previously, and the rash did not appear on any other part of my body. No treatments were applied.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pruritus. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shots and got shingles now. The patient had a light case, but still burned and itched.  The patient took the antiviral five pills a day for a week.  The patient stated that they (shingles) did not spread and were going away.  The patient stated that it would had been awful if he/she not had the shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 09:30 as dose 1, single (Lot number: FE3592), in left arm and on 08Jun2022 at 12:00 as dose 2, single (Lot number: FJ1611) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Prevacid, reaction(s): "Allergy:Prevacid"; Prilosec, reaction(s): "Allergy:Prilosec"; Protonix, reaction(s): "Allergy:Protonix". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medications in two weeks and treatment received from 01Jul2022 to 06Jul2022. Patient took Paxlovid for 5 days and tested negative on 08Jul2022 for Covid, on Sunday woke to have the Covid symptoms.  No follow-up attempts are possible. No further information is expected.
4mins post vaccination pt reported dizziness.  Pt was was pale, mild sweating and blackened vision.  Pt appears to have had a moderate vasovagal event.  Vitals: 106/59, 58, 16, 99% on RA Pt stable and released from the vaccination site at 17:09.  NAD and feeling 100% better
In February I had swelling in my glands. A couple days I tried to get the swelling down. I decided to see one of my colleagues and they order lab work. My lab work as fine. It has since then gone down on its own. On June 22nd I developed severe pain in my abdominal and nausea and vomiting. I went to the ER, and I was diagnosed with a kidney stone. I had an appointment today with the urologist and I still have the kidney stone, and I am being treated for them.
Pt presented to emergency room because of hematuria and blood in her suprapubic catheter bag, also the patient has generalized abdomen pain for last 3 days, nausea and she did have vomiting , no blood with the vomiting, the patient has had multiple hospitalized admissions for UTI, she denied any fever or chills but she has general weakness, low appetite,  In emergency room blood pressure 129/65, heart rate 79, respiratory rate 18, temperature 97.8°, O2 sat 99% room air, her covid test came back as presumtive positive. Otherwise she was asymptomatic. She received monoclonal antibodies on 3/18/22 .
Chronic urticaria. Started almost 2 weeks after booster. It persists to this day. At first, it was extremely severe. I was put on Prednisone. After month on Prednisone it has stabilized but hives appear daily. First two weeks, condition was extremely severe and debilitating.
One day post vax, lab tests were drawn for a routine employment physical. They showed elevated liver function tests. The most recent information received report the condition of the pt is ongoing.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Fever /seizure. Patient received the above vaccines on 10/27/09 in the afternoon. Per ER notes, pt. had low grade fever all afternoon and evening on 10/27. In the morning of Oct 28, pt. felt very hot (per mom T 105), per ER T 101.9, and noted to have seizure. Physical exam normal (please see attached ER notes).
Slightly swollen red warm to touch left upper arm. Advised pain reliever BENADRYL; warm/cold compress, FU pvt MD.
This is a spontaneous report from a non-contactable consumer (a Pfizer employee). A female patient of an unspecified age received TRUMENBA (batch number and lot number were not reported), via an unspecified route of administration on 10Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was headed off to college so it was the requirement. The patient reported that she received a meningococcal group b rlp2086 vaccination on 10Jul2018 through her primary care doctor and she asked were there any side effects to the shot because she said she got it today (10Jul2018) and she was not feeling well. The outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
mom states pt slept for 40min p/vax & woke up cranky-while pt was trying to feed pt remained cranky & felt hot about 1PM & seized;pt taken to ER/amb dx w/febrile sz tx w/APAP & Ibuprofen & released;3AM fever went up again & seized;
Fever (100+) and chills vomiting.  Fever has persisted through following morning.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
booster; Arm pit pain 24 hours after 3rd booster; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; AXILLARY PAIN (non-serious), outcome "unknown", described as "Arm pit pain 24 hours after 3rd booster".  Additional information: Arm pit pain started 24 hours after 3rd booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness at injection site, fever, pain up the arm to the neck and down the arm to the hand, pain with shoulder movement.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5218), in right arm, on 22Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 301308A) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary Artery Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 30Jun2017, stop date: 18Oct2022; ALFUZOSIN HCL, start date: 15Jan2017, stop date: 18Oct2022; ASPIRIN 81, start date: 29Jan2007; CETRIZINE; TOPROL, start date: 15Jul2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Apr2022, outcome "unknown", described as "vaccine brand other=Moderna/vaccine brand=Pfizer/BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 incldued Paxlovid.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19, and interchange of vaccine products and BNT162B2.
Six days after my first dose of the Pfizer COVID-19 vaccine, I woke up in the middle of the night and had watery diarrhea, vomiting (at least three times), fever of 100.4, chills, headache, and a heart rate of 132bpm. The vomiting lasted for 8 hours, the fever/chills and fast heart rate lasted about 24 hours, and the diarrhea and headache (most likely due to dehydration I would think) lasted about four days. It should be noted that I did test positive for COVID-19 on February 11, 2021, about six weeks before my first dose of the vaccine. When I had COVID, I had about a week of mild/moderate symptoms of fever/chills, headache, and extreme fatigue, with some lingering fatigue for weeks after.
Patient was signed up for the bivalent Pfizer COVID19 vaccine.  Pharmacist did not review the database to see that they had never received any COVID vaccination.  Patient should have received the initial monovalent dose series to start.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored, Oral ROTATEQ, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.