chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 hours after receiving vaccines, patient had altered mental status and had 2 seizures without returning to her baseline. She was brought to the Er where she was found to be in status epilepticus and hypoxic. So, she was intubated and transferred to NeuroICU. She was also loaded with IV keppra 2 grams and ativan. In the NeuroICU, she was hooked up to continuous EEG and was continued on high dose versed drip and propofol drip. We continued vimpat at her home dose and added keppra. She was also found to have persistent tachycardia and fever. She had worsening renal function with Cr peaked at 2.51. EEG didn't show any seizure like activity. So, propofol and versed were weaned off. Even after stopping propofol and versed drips for more than 36 hours, she is still encephalopathic.
Patient reports painful, red, swollen armpit, no rash and no fever. Patient had taken Advil morning of 10/11/16. Patient reported the reaction started at 2 to 3 pm the afternoon of 10/11/16.
local injection site erythema for 2 weeks, then appearance of non-itchy viral exanthematous rash without fever.
He has been running a fever of 101-102, tired, loss of appetite, thirsty. Called nurse line traced back to shot.
experienced stiffness and body ache after the 1st dose and the caller mentioned that he also experienced the same thing yesterday; experienced stiffness and body ache after the 1st dose; This is a spontaneous report from a contactable consumer reporting for a patient (wife) received from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that on an unspecified date, his wife has experienced stiffness and body ache after the 1st dose and the reporter asked if his wife can take a Tylenol. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetanus, reaction(s): "Known Allergies: Tetanus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 21Aug2023 to 26Aug2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I had a fever and sore arm for about two days. I have a history of my hands and toes change in presentation with cold weather. Now it happens at any temperature. My right foot big toe is still swollen and purple since January. I have referred to a rheumatologist.
Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician reported that patient developed pelvic inflammatory disease after being vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
This spontaneous report as received from a consumer refers to a patient of unknown age with prophylaxis. On 12-JUL-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. On 12-JUL-2017 the patient experienced vaccination error. On an unknown date the patient experienced no adverse event. The outcome of vaccination error and no adverse event is unknown. The reporter considered no adverse event to be not related to ZOSTAVAX and sterile diluent. The reporter considered vaccination error to be not related to sterile diluent and ZOSTAVAX.
Received IM injection in left deltoid muscle. Pt complaining of muscle pain in arm of injection site and soreness not allowing pt to lift arm up all the way even after 6 weeks from receiving vaccination.
55 years old female, seen and examined on July 19, 2021 1:00 a.m., with history of asthma, CAD, hyperlipidemia, hypertension, myasthenia gravis.  Here for evaluation of progressive short of breath, dry cough, generalized weakness for which she believes might having a  MG  flare up, started about 5 days ago, per patient she received Johnson & Johnson vaccine back in March.  She also developed subjective fever, palpitations. 7/23/21: intubated due to increased fatigue while on BiPAP 7/30/21: transferred to Hospital ICU  8/15/21: remains intubated, not tolerating weaning of sedation, afebrile 8/22/21: awaiting Trach/PEG
On 2/3/21 I woke up around 6am with a swollen arm, red, itchy and warm to the touch.  I went to Patient First that evening, after consult with my primary care. The doctor at Patient First prescribed: Cefdinir 300 mg, Triamcinolone Acetonide Cream 0.1% and Hydroxyzine HCL 25 mg.  My symptoms are improving but are still there.
Information has been received from a consumer concerning her 26 year old daughter who in 2007 was vaccinated with the three doses of GARDASIL third dose was in August 2007. There was no concomitant medication. On approximately 09-Sep-2008, the patient had a Papanicolaou test positive and revealed mild dysplasia. As of 30-Sep-2008, the patient had not recovered. The patient sought unspecified medical attention. No additional information is expected.
At 7:30 PM 7 hrs after shot fever 103.8. Eyes rolled back fully, foaming, 1 min and 5 min post ictal. Went to ER. UA positive, CXR negative. WBC increased 21000, Got Rocephin and Tylenol/ Motrin. At 5am 12/15/04 fever 104.3 jerking and eyes rolling.
45 year old female presents with cc of left axillary pain and swelling since yesterday 6/29/2021 s/p J&J Covid19 Vaccine on 6/28/2021 to left deltoid. Pt reports pain is moderate, nonradiating, constant, minimally relieved despite use of tylenol and ibuprofen. Pt denies trauma to affected region. She denies fever, chills, cough, chest pain, SOB, palpitations, weakness, numbness, tingling, headaches, neck pain, back pain, rash, dizziness. Pt offers no other complaints.
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck.  She reported feeling faint and began to have mild hyperventilation.  Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement.  Pt was treated with PO bendryl.  Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
Spoke with Pt mother and she stated that the Pt was not ill prior to receiving the vaccine (no fever, diarrhea, or vomitting). She stated that she started throwing up around 9pm 09/06/2017 and her fever reached 100.5. She stated that all three vaccines were red and the leg that had 2 vaccines on them (R leg) had bumps. The vaccine on the upper R thigh was the size of a dime and the vaccine on the lower R thigh was a nickel. She denied any rash. I advised her to return to UC if symptoms persist and she is always welcome to call our office and speak with me regarding any vaccine questions. Pt was evaluated by UC, but no treatments were given on 09/06/2017. They returned to UC on 09/08/2017 for vomiting and an US was ordered to r/o pyloric stenosis.
2/15/22 - 2/17/22 : fever, chills, achiness to all joints and armpits, nausea and diarrhea.  2/18/22 - present Right upper quadrant pain with radiating pain to right shoulder, and epigastric area,  consistent belching.
approx 2hr p/vax pt devel hives;DPH given;hives resolved;
Systemic: Allergic: Difficulty Breathing-Medium, Additional Details: mother reported that son was allergic to an ingredient in the vaccine and that he was not feeling well and was having difficulty breathing.  vaccine was administered  on 08/05/21 and incident was reported on 08/09/21.  mother stated son was taken to see the doctor
Patient called the retail pharmacy on 9/04/08 to let us know that she developed quarter-sized hives 24 hours after her pneumococcal-23 vaccine that was administered 8/19/08.  No treatment was given.
Information has been received from a physician concerning a 15 year old female who on 17-MAR-2009, 15-MAY-2009 and 30-DEC-2009 was vaccinated with a first, second and third dose of GARDASIL (Lot # 661841/0653X, expiration date: 25-FEB-2011, Lot # 661841/0653X, expiration date: 25-FEB-2011 and Lot # 663558/0819Y, expiration date: 10-OCT-2011, respectively). The physician reported that the patient on 20-FEB-2010 started to experiencing recurrent syncope after receiving 3 doses of GARDASIL. The patient was examined by a cardiologist who prescribed FLORINEF. At the time of this report, the patient had not recovered. Additional information has been requested.
I noticed that I wasn't able to fall asleep one night because I was itchy all over my body. I would look and see hives, then the itchy spot would move to somewhere else when I put anti-itch cream on it. I noticed when my skin was scratched it would raise up into a red welt that would stay for a few hours. My dermatologist recommended that I take a Zyrtec every day and that has relieved my symptoms. However if I forget to take it the symptoms will still persist.
Approximately 7PM - chills, body aches.  Midnight - headache, nausea, vomiting, diarrhea Took Pepto Bismol and Tylenol overnight.  took Phenergan about 7AM Tuesday and finally rested
very light cold like something; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (very light cold like something) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NASOPHARYNGITIS (very light cold like something). On 11-Apr-2021, NASOPHARYNGITIS (very light cold like something) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.    This case was linked to MOD-2021-106412 (Patient Link).
This spontaneous report was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-MAY-2016, one unspecified patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L0048848 (expiry date: 19-AUG-2018) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
first dose of the shingles vaccine on 11/3/21; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose on 3rd November 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: This case was reported by a consumer via Chat. The patient had my first dose and asked if it was okay to get the second dose, even though it has been longer than 6 months. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
soreness in arm/shoulder; soreness in arm/shoulder; Unable to lift arm properly without pain; This is a spontaneous report from a contactable consumer or other non HCP.   A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 2021 (at the age of 51-years-old) as dose 1, single, and dose 2 intramuscular, administered in Arm Right on 2021 (at the age of 51-years-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was not reported whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported, whether prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in 2021, the patient experienced soreness in arm/shoulder. She was unable to lift arm properly without pain. She indicated her doctor put her on steroid to help. Has not been effective. Indicated going on 8 weeks not with little improvement. The adverse event result in doctor or other healthcare professional office/clinic visit.  Information about lot/batch number has been requested.
Pt had injection site redness and pain in left arm for several days. Pt also struggled with worsening symptoms of anxiety and SOB and severe headaches.  Pt had several episodes of respiratory distress and confusion and o2 sats dropping into the 60s. Pt a hospice patient and family did not choose to send out to hospital. Pt also had behavioral changes for weeks in addition to the new onset of confusion, pt became agitated and somewhat hostile. Symptoms managed with duo-nebs for SOB as well as morphine and ativan prn for agitation/anxiety/SOB. Pt has lost weight since vaccination and has become very pale. Severe symptoms are subsiding after several weeks, but pt still c/o SOB increased from before vaccine, HA that were new onset after vaccine, and neck pain. Pt did have some issues after first vaccine, but the above symptoms really onset after 2nd vaccine
States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose. No adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse reaction) and WRONG PRODUCT ADMINISTERED (States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose.) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced NO ADVERSE EVENT (No adverse reaction). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose.). At the time of the report, NO ADVERSE EVENT (No adverse reaction) and WRONG PRODUCT ADMINISTERED (states that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided. States that two pediatric patients received the Moderna COVID-19 bivalent vaccine for their 2nd dose instead of the monovalent vaccine dose. They got the correct dosage of the bivalent vaccine but the incorrect product as their 2nd dose. No adverse reactions have been reported by the patients at this time.
815 - flu shot administered, 8:20 throat + chest tightness began. 50mg Benadryl taken at 845, 945 symptoms increased throat swelling. Chest pain and tightness increased heart rate dizziness, short of breath. Sent to ER. IV Benadryl, steroids and anti nausea meds (when vomiting began in ER) given all with good effect. Home w/3 day course of prednisone + orders for Benadryl Q4-6 hours 50 mg
This spontaneous report as received from a registered licensed practical nurse (L.P.N.) refers to a unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with doses of improperly stored (8-9 F for 9 days) VARIVAX (lot number, expiration date, strength, dose, route, indication were not reported.) No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports from the same reporter. Additional information has been requested.
HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 4th of 16 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Within 10 minutes of the vaccine my heart began to pound, I felt dizzy and fearful.  EMT's blood pressure reading was 224/104
This spontaneous case, initially received from other non-health professional on 19-Oct-2018, concerns an 89-year-old, elderly female patient. The patient's current conditions included urinary incontinence and chronic obstructive pulmonary disease (COPD). The concomitant medications included ADVIL, MYRBETRIQ, SYMBICORT and oxygen. On 18-Oct-2018, in the afternoon the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250805 and expiry date: 30-Jun-2019]. On the same day, in the evening after going to bed, the patient got up and vomited the entire dinner which she had earlier. While vomiting, the patient had a terrific or horrendous nose bleed. The patient said that she normally takes this dinner which was 2.5 ounces of rib steak, half of a potato, and fresh asparagus and an ice cream cone and did nothing differently. No treatment measure was taken. On the same day, the patient had recovered from the event. The reporter had assessed the case as non-serious and the causality as related (had an adverse reaction to a flu vaccine).
Chills; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills) and FATIGUE (Tiredness) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Diabetes since an unknown date. Concomitant products included LINAGLIPTIN (TRADJENTA) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Tylenol   This case was linked to MOD-2021-016540 (Patient Link).   Reporter did not allow further contact
PATIENT STATES SMALL RED AFTER PNEUOCOCCAL INJECTION; NEXT DAY WAS"EGGY" FEELING;NOW SWOLLEN SIZE OF GRAPEFRUIT AND WARM TO THE TOUCH. SHE ALSO STATES THAT SHE IS ABLE TO TOUCH THE SKIN WITH LESS PAIN. PATIENT WAS TOLD TO PUT A COLD COMPRESS ON IT AND GO TO ER IF SHE FEELS IT WORSE. PATIENT STATED SHE FELT FINE THEY ONLY THING WAS HER ARM WAS RED AND WARM. SHE TOLD ME SHE"D GO TO ER TOMORROW IF SHE FEELS IT WORSE. I GAVE HER A NAME OF ER NURSE AND PHONE# AND ADVISED HER TO AT LEAST CALL THE ER.
Admitted 8/20/21 with dyspnea, cough for 9 days, fever. Tested positive for COVID. Intubated 8/27/21, compassionate extubation planned for 9/10/21. Baricitib, , Decadron, Vancomycin IV, Cefepime
Spontaneous abortion (miscarriage) on April 15th, approximately 8 weeks pregnant (was due in November). No previous miscarriages and I have 2 healthy children.
Sore arm nausea fatigue 24-48 hrs. after vaccine administration.  Today 1/13/2021- tested covid positive via PCR swab.
GARDASIL 9 potentially administered after the age of 45; patient over the age of 45 wanted the vaccine; She wanted to know if a patient over the age of 45 wanted the vaccine if they would be able to receive the vaccine; This spontaneous report as received from a pharmacist refers to an over the age of  45-year-old female patient (adult).  There was no information about the patient's medical history, concurrent conditions or concomitant medication.  It was reported that the pharmacist wanted to know if a patient over the age of 45 wanted the vaccine of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)( GARDASIL 9) if they would be able to receive HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)( GARDASIL 9)(dose, route of administration, lot number and expiration date were not reported).