chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the SHINGRIX and flu vaccine Sept. 10, 2018. My pharmacist said I may experience some flu like symptoms and headache, which I did. On 9-11-2018 I didn't feel well. On 9-12-2018 I felt better. Then at 9 pm, while sitting on the sofa, I got sudden severe nausea. I had immediate severe projective vomiting for over an hour. It was continuous. I also was, embarrassingly, incontinent of stool at the same time. I told my husband I had to go to the hospital. I was so weak and dizzy he had to hold me up. I felt like a rag doll with no strength. As we made turns or went over bumps I had severe vertigo and nausea. I went to the emergency room about 11 pm. After IVs, an EKG, CT scan and chest x-ray and I believe anti-nausea medicine I was transferred to another hospital via ambulance to their stroke center. Eventual ruling was that I did not have a stroke. After about two days at hospital I realized I could not hear anything in my right ear. Up to this time I had perfect hearing. During my stay in both hospitals I was nauseous, vomited during a CT scan and very imbalanced where I needed a walker or help to get up or walk around. I had numerous tests, inner ear crystal treatment, IVs, meds (specifically meclizine, prednisone) diabetic check and insulin and the regular meds I'm on. I was discharged with vertigo, absolutely no hearing and imbalance. I fell 3 times since I've been home. I started physical therapy yesterday on 10-10-2018. Total time in both hospitals was 9-12-2018 about 11 pm to 9-17-2018 early afternoon.
Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Heart disease, unspecified.    On 15-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2020, the patient experienced PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth). On 23-May-2020, PRURITUS (Patient said 12 hours after Moderna shot in 2020 she got very itchy Even in throat and mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient said 12 hours after Moderna shot in2020 she got very itchy Even in throat and mouth. She never had a problem breathing. It subsided within 12 hours.  Treatment information was not provided.
rash to lower back & itching some pain @ site of injection No swelling, HA, fatigue, fever. Txt with antihistamines
Information has been received from a lawyer regarding a case in litigation concerning an approximately 12 month old male child who on 1/25/95, was vaccinated IM with his third dose of hepatitis B vaccine recombinant (yeast) lot # 611468/0653A given on 1/25/95; lot # 613800/1291A given on 3/27/95 and 5/26/97. An immunization record indicated that the patient was also vaccinated IM with four doses of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) lot #3C51043 given on 1/25/95, lot #4A61098 given on 3/27/95 and 5/26/95, and lot # U031 given 12/19/00; one dose of diphtheria toxoid (+) Hemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid (TETRAMUNE VACCINE) lot # 429 969 given on 1/29/96; and three doses of HIB conjugate vaccine (HIBTITER) lot # 305LF given on 1/25/95, lot # 265LJ given on 3/27/95, lot 005LK given on 5/26/95, lot 005LK given on 5/26/95. It was noted that all of these vaccinations contained the mercury laden preservative thimerosal. It is alleged that due to the accumulation of mercury in his body and the resultant mercury toxicity, the patient at approximately 12 months of age was neurologically devastated and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, and the loss of language skills, motor skills and affect. Upon internal review the patient's mercury toxicity, neurological devastation, withdrawn/unresponsive behavior, inability to speak, repetitive behavior and loss of language skills, loss of motor skills and loss of affect were determined to be other important medical events. Additional information is expected.
Patient developed hives on her chest and neck roughly 2 hours after receiving her second dose of the Moderna vaccine.
HA, hot flashes, clammy skin, feeling faint. Pt recovered and cleared by EMS.
Patient was given an undiluted dose of pediatric pfizer (42mcg) instead of the adult 30mcg dose. Only adverse event she is experiencing is a sore arm.
Hurting all over; Body felt like a ball on fire; Could not drink water because it kept coming back up; A spontaneous report was received from a consumer concerning a 80 year old, female patient who experienced hurting all over her body (pain), body felt like a ball on fire (feeling hot), and vomiting.    The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Vitamin C, Vitamin D, Echinacea, Losartan, lovastatin, baby aspirin (81 mg), metoprolol and pantoprazole.     The patient received the first of two planned doses of mRNA-1273 (Batch number: 011A4N) on 27 Feb 2021.   On 28 Feb 2021, the was hospitalized due to her symptoms like she was hurting all over her body like a ball on fire and vomiting. Treatment for the event included anti-inflammatory shot and acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "colitis" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Dark Positive, notes: by Day 8 I had returning symptoms and a dark POSITIVE result with a follow up rapid antigen test; (01Feb2023) Positive, notes: Took Paxlovid on Day 1 of COVID 19 positive test; (07Feb2023) Negative, notes: I tested negative on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: Paxlovid (Lot number: GF6437) treatment start date was 01Feb2023 and treatment stop date was 06Feb2023, Indication included treatment of COVID-19. Reported that, Rebound. Took Paxlovid on Day 1 of COVID 19 positive test. Did not have symptoms before the positive test confirmed positive COVID, Dr. considered this DAY 1 and Patient began taking the Paxlovid. After completing the 5 days of Paxlovid she tested negative on Day 7 and by Day 8 she had returning symptoms and a dark POSITIVE result with a follow up rapid antigen test. Patient now (at the time of report) at Day 9 and isolating for the required 5 days, with fever, runny nose, body aches, fatigue. Patient just as bad, if not worse, as she was on Day 1. No treatment received for rebound symptoms and not recovered from symptoms.  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.
This spontaneous report was received from a physician, concerning a 4 year old patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was inadvertently vaccinated with GARDASIL 9 1 dose, for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of two reports received from the same reporter.
Minimal swelling, erythema, warmth, slightly rough on central area without actual vesicles; tenderness. Child is ambulatory and afebrile.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 23-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Covid19 breakthrough.  1st vaccine received on 01/26/2021.  75 y/o with PMHX of myasthenias gravis, Whipple, pancreatitis, HLD Gerd took a home Covid test on 12/30 that was positive.  Pt attempted to treat self at home but presented to ER when home O2sat 88%.  Upon arrival, room air sat 69% and pt c/o fever, body aches, cough, congestion, chills, night sweats.  Pt placed on BIPAP and admitted to ICU.  Started IV steroids, Remdesivir and Tocilizumab.
Frequent and severe vomiting, hourly from 0100-0400, resulting in mild dehydration, resolved without intervention
@1135 Pt's granddaughter called out because pt felt dizziness upon getting up. Pt is 30 mins post vaccination, Pfizer 1st dose. C/O dizziness and tingling sensation to L hand.    @1135 VS sitting 128/69 (103) 74 with dizziness @1136 VS standing 151/82 (109) 82 with increased dizziness, wobbly upon getting up. Needs to be supported by nurse and granddaughter.   Water provided. Encouraged patient to finish bottle of water.    Daughter arrived, was able to translate better. Per pt, she has pressure to R eye and was feeling dizzy post vaccination. Pt didn't tell granddaughter and nurse these symptoms. Tried standing patient up, complained of dizziness and nausea. Was gagging. Nonpharmacologic interventions provided, effective. Pt stated that her nausea is better.   @ 1153 VS sitting 68 98%RA 122/74 (94)  @ 1154 VS standing 120/84 (96) 76HR 100% Denies any dizziness. C/O very mild nausea. Pt refused to stay longer, wants to go to get some food. Daughter agreed to patient's plan and is confident to take pt home. Instructed to have pt follow up to her PMD and to go to the ER if symptoms worse or new symptoms arise. Encourage increased fluid intake as tolerated. Pt, daughter verbalized understanding.
Mother had shingles 2 weeks before; child seen with probable dg of varicella on 7/10/2007
Patient received vaccine and after checking on her in about 10 minutes, she reported that her tongue felt weird, kind of tingly. I said I wanted to give her benadryl and patient refused. Sat with patient and she reported no changes, just felt different and tingled a little. Patient stated that it did not feel like allergic reactions she has had in the past. Checked tongue and lips for swelling, no sign of anything like that or other signs of anaphylaxis. By the end of allotted 30 min waiting period, patient said she felt normal again. She stayed in the store for another 30 minutes and reported back that she was fine.
On 4/24 - 4/26  : 8 - 10 days after receiving my second shot of the Pfizer vaccine, I broke out in hives on my legs, hips, sides (near ribs), chest, and lower back. The hives were much more pronounced at night, becoming more prevalent after 7:00 pm. After the third night, they were gone. I did not show any side-effects at all until day 8
Patient was given the vaccine on Friday 8/8/08 and I noticed hives all over his body on Sunday 8/10/2008.  He was given Benadryl and Predisone.  Today is Monday 8/11 and I still notice some hives on him.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K006681, expired date 21-OCT-2015), (dose and route unspecified). On an unspecified date in 2014, the patient only experienced slight pain at the injection site, which quickly resolved, without treatment. This is one of several reports received from same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9269), in right arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 67 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID, start date: Jan2021; METHENAMINE, start date: 23Jun2022, stop date: 27Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks stop date: 27Jun2022, Adverse event: Within an hour of the first dose, I had a horrible taste in my mouth that wouldn't go away no matter how many times I rinsed my mouth, brushed my teeth, or ate or drank something. Hard to describe - metallic, bitter - totally disgusting. Since my symptoms were mild it wasn't worth continuing to take the medication. Discontinued after 1 1/2 days.  No follow-up attempts are possible. No further information is expected.
No adverse effects; the patient received an adult dose of VAQTA instead of pediatric dose of VAQTA; Information has been received from a registered nurse referring to a pediatric patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 08-JUL-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R032910, expiration date: 18-NOV-2019; strength, frequency, route were not reported) for prophylaxis. No adverse effects was reported for the patient.
This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to an unspecified number of patients of unknown demographics. No information regarding patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, patients were vaccinated with VARIVAX, subcutaneously (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. The medical assistant reported that the office ran out of the sterile diluent (manufacturer unknown) and used a sterile water (manufacturer unknown) to reconstitute the VARIVAX, on unknown dates. No adverse event was reported. Product quality complaint (PQC) was not involved. The outcome of the reported event was unknown. This is one of four reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010521:
101 fever, chills, brain fog, injection site red and swollen.  All side effects started 14 hours after vaccine.  All effects subsided after 12 hours except the injection site swelling, soreness and redness.
Soreness at site of injection progressed to pain in left shoulder joint. Arm is no longer sore at injection site.
Hives reportedly started shortly after Moderna COVID-19 vaccine in R arm at 8:05 this morning. She said they kept her for > an hour after the vaccine due to itching of neck and back, dry mouth, headache.   She started driving home, felt short of breath and turned around and came to same day clinic.  She was brought into clinic with complaint of hives over neck and chest. Neck and chest were erythematous. Lungs clear. She was immediately given loratadine po. Chest tightness subsided before epinephrine could be given. She was observed for another hour. Has her epipen with her. Discharged to home after about an hour.
Vomiting from 4am until 10am and diarrhea from 4am continuing into today, Saturday 2/13
A couple of days following my first dose of Pfizer, I developed eye flashes/sparks in my eye - up to 100+ per day. Over a period of two months the flashes/sparks subsided, but new symptoms began. The other symptoms include floaters, after images, trailing vision/palinopsia, visual static, BFEP, hypnopompic hallucinations, closed eye hallucinations, and frequent pain in the back left side of my head. I believe I have developed a condition known as Visual Snow Syndrome, which encompasses many of these symptoms. I did not have any of these symptoms prior to vaccination, and my experience started just a couple of days after my first dose on 2/26/21, and still remain to this day (with the exception of the eye flashes/sparks which have mostly subsided).
Patient received only first dose of COVID vaccine and presented to ED and was diagnosed with COVID infection leading to hospitalization
Administration error.  Patient needed an MMR today as their last dose was given a day too early.  RN was used to giving MMR and Varicella to all other patients and pulled those vaccines to administer.  RN prepared the varicella, but instead of reaching into the MMR box, RN grabbed from the Proquad box.  Patient received a Proquad after 12 years of age and 2 doses of varicella.
Headache; Muscle pain for 36 hours; Fever over 100; chills; joint pain for 36 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 21Jan2021 11:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included ulcerative colitis and lactose intolerance, both from an unknown date. Concomitant medication included minerals nos, vitamins nos (CENTRUM) daily vitamin received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Ded2020 10:30 AM in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Fever over 100, chills, muscle and joint pain for 36 hours after second dose on 21Jan2021 10:00 PM. Headache has persisted and not subsided since second dose on 21Jan2021 10:00 PM. The patient underwent lab tests and procedures which included body temperature: over 100 on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The treatment was not received for the adverse event. The outcome of the events was recovering. The case was reported as non-serious.
ER visit on 8/2/2017 for patchy raised macular papular rash to torso, extremities and cheeks. No fever, playful and drinking a bottle at ER visit. Benadryl liquid 12.5 mg PO X1 ordered at 2336- continue to give benadryl as needed every 6 hours.
Within 15 minutes after administration, patient loss consciousness in the chair, still breathing, with weak pulse and tongue was sticking out a little. Patient was non-responsive, even after EMT arrived. Patient was taken to the hospital.
SEVERE SHOULDER/UPPER ARM PAIN -PHYSICAL THERAPY- SEVERAL VARIOUS PHYSICIAN CONSULTS
Muscle aches localized to right upper extremity, shoulder and neck muscles; Significant tenderness to right deltoid (injection site); This is a spontaneous report from a non-contactable health care professional (other HCP; patient herself). A 26-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EL3248; Expiration date: Unknown) via an unspecified route of administration in the right arm on 28Jan2021 14:15 (at the age of 26-years-old) at a single dose for covid-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (Batch/Lot Number: EL1284; Expiration date: Unknown) via an unspecified route of administration in the right arm on 08Jan2021 10:00 (at the age of 25-years-old) at a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. On 30Jan2021 09:00, the patient experienced muscle aches localized to right upper extremity, shoulder and neck muscles and significant tenderness to right deltoid (injection site). Injection site was also reported as right arm. The events were reported as non-serious. No treatment was given for the events. The outcome of these events was recovering.  No follow up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA fatigue, arm pain  patient took tylenol
I had a headache for two days, Tylenol helped. I felt cold and or feverish most of the time. I was very weak and tired. My nose ran a little.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 12-Jan-2009. As of 18-Mar-2009, 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.