chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound COVID 3 days after finishing course of paxlovid.; Rebound COVID 3 days after finishing course of paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes; "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Rebound COVID 3 days after finishing course of paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (28Jun2022) Negative, notes: Tested negative for 2 days; (29Jun2022) Negative, notes: Tested negative for 2 days; (01Jul2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment: Paxlovid, start date: 22Jun2022, stop date: 27Jun2022, Indication: Treatment of COVID-19.Other medication in 2 weeks includes Insulin and Levothyroxine. Adverse event: Rebound COVID 3 days after finishing course of Paxlovid. Tested negative for 2 days then positive with return of more severe symptoms. No hospitalization required. Other medical history: Type 1 diabetes, hypothyroidism. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, Drug ineffective and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
fainted after the administration; Information has been received from a field representative, referring to a female teenage patient between the age of 11-12 years of old. The patient's concomitant medication and drug reactions/allergies were unknown. The patient had no pertinent medical history.  On an unknown date, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTap), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as unspecified meningitis vaccine) and final dose of unidentified Merck hpv vaccine (name, strength, dose detail, route of administration, lot number and expiration date of all suspect drugs were not reported) for routine vaccination.  On the same date after the administration, the patient fainted. It was unknown whether any lab diagnostics or studies were performed or not. The patient did not seek medical attention. It was reported that the vaccines were not discontinued. The outcome of faint was reported as recovered after resting on the exam table. The causality assessment was not provided.  Upon internal review, the patient fainted was considered as medically significant. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA003051:
Patient calling for Acute IUD  Check, COVID-19 Vaccine, and VAGINAL BLEEDING Symptoms started 7/29/21. Symptoms include: Constant Moderate vaginal bleeding. Patient Has not attempted treatment at home.. Pertinent negatives include: No abdominal pain. No breathing difficulty. No injury. No symptoms of allergic reaction.                Pertinent Medical History: Patient received the second dose of the Pfizer COVID vaccine and later that day started having moderate vaginal bleeding. She has not had a period in 5 years due to mirena IUD. She does report she had a fever in the first 24 hours after the vaccine but has been afebrile since. She also is not having any abdominal pain or cramping.   Patient wanted to report the vaginal bleeding as it occurred after her 2nd covid shot and she wondered if that was related. She had to change tampon every 2-3 hours initially but has slowed down some  No chest pain or SOB No lightheadedness or dizziness.  Patient will call office tomorrow with progess  Patient has IUDin place and has not had a period in 5 years..
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. Follow up information has ben received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if the information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old (reported as 1-year-old) patient of unknown gender. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L003775. The vaccine was purchased with public funds as a part of vaccine program. This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
Approx 8pm began to have Fever of 104  lasted thru the night unrelieved by Tylenol 650 x3 doses, and cool compress, chest palpitations, high heart rate, severe body aches, left shoulder pain, nausea, diarrhea, severe left leg pain could not stand or walk, Chills and sweats, and severe migraine,  went to emergency room, ordered  EKG, left leg ultrasound, chest X-ray, blood cultures, blood work and urinalysis.
Febrile seizure after a MMR. The follow up states, "I filled out my report because I want to be reimbursed for my costs. My daughter had a febrile seizure and we had emergency bills. I was told if I sent in the forms we would be paid back for our pain and suffering."
Rapid heart beat, difficulty breathing, itching, rash, clamminess, cold sweats, nausea
a dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report has been received from a pharmacy technician by a nurse at one of their facility's clinic, referring to a patient of unknown age and gender. The patient's concomitant medication, historical condition and current condition were not reported.   On 04-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (1 dose, lot# U028179 with expiration date: 08-MAR-2023, route and strength were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, lot# U024221 with expiration date: 04-AUG-2023, strength and route were unknown), both for prophylaxis (overdose). It is unknown to caller if any product confusion occurred. No further information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004906: US-009507513-2204USA004990: US-009507513-2204USA005095: US-009507513-2204USA005731: US-009507513-2204USA005733: US-009507513-2204USA005079: US-009507513-2204USA005255:
SLIGHT TENDERNESS AT THE SITE OF INJECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced slight tenderness at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight tenderness at the site of injection was not reported. This report was non-serious.
p/vax both legs turned cyanosis w/a distended vein lasted 30 seconds on legs & then disappeared;child did fine rest of day & no problems;
Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
BODY ACHES; MIGRAINE; FEVER/BURNING UP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 10:40 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021 14:00, the subject experienced body aches. On 18-MAR-2021 14:00, the subject experienced migraine. On 18-MAR-2021 14:00, the subject experienced fever/burning up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, migraine, and fever/burning up. This report was non-serious.
During the evening for two nights after the second one I just start not feeling well. The second day I had very body aches and I became very fatigue.
The patient received a booster dose of Moderna when it should have been a full dose. Following CDC guidance, the patient was advised to repeat the dose.
Dose leaked during administration of vaccine; did not receive the full dose of the vaccine; vaccine leaked down arm; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced the syringe connection issue, vaccine underdose, and exposure via skin contact.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    On 14-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    While receiving the vaccine, the patient said the vaccine leaked down her arm and did not receive the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events,syringe connection issue, vaccine underdose, and exposure via skin contact were recovered.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 011M20A), reporting Underdose, device connection issue, and exposure via skin contact without any associated adverse events.
Pregnancy at time of vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in December 2020 and the estimated date of delivery was 18-Oct-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy at time of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Treatment information was not provided.
This spontaneous report as received from a consumer via Clinic refers to a currently 74 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
AS OF 02/27/2012 I HAVE PAIN IN MY RIGHT ARM, CANNOT LIFT ARM OVERHEAD OR REACH BEHIND MY BACK.  UNABLE TO SLEEP ON RIGHT SIDE.
Pt fainted, slow response to ammonia caps BP-130/80 @ 117pm, 80/60 @ 122pm ; diaphoretic; evaluated by EMS; c/o nausea on d/c;
Red (30mm) and tender at injection site; sore to touch; states was "puffy" on 8/26 and 8/27/08. Temp. 98.2
She started waking up at night jerk movements a week after vaccine. Then on August 29th 2013 she had her first seizure.
both doses of SHINGRIX 1 month apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 19th November 2021, the patient received the 2nd dose of Shingrix. On 19th November 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Pharmacist reported that the patient received both doses of Shingrix 1 month apart, which led to shortening of vaccination schedule. Pharmacist would like to know if they need a 3rd dose. Pharmacist was unsure if the patient was immunodeficient or immunosuppressed. Spoke from content. No further information reported. The reporter did not consent to follow-up.
This spontaneous report as received from a physician via field representative refers to a male patient of unknown age. The patient's pertinent medical history and drug allergies were unspecified. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Dose/Frequency: 1 injection). Concomitant medications were unspecified. On an unknown date, the patient still had a mild case of shingles. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
patient contacted pharmacy and reported that both arms hurt and stated to experience body aches and flu-like symptoms last evening (02/11/2020). Patient contacted pharmacy 02/12/2020 about these symptoms. She was experiencing a fever (felt like she was burning up) but did not take temperature. Also reported body aches and arms hurting, feeling lethargic. Patient took extra strength Tylenol. Advised rest and fluids also. Contacted patient back a few hours later and she said she was feeling better but still had some nausea. Told patient I would check on her again 02/13/2020
Initial report received from a healthcare professional on 17 October 2013. 20 patient, whose medical history was unknown and concomitant medications was not reported, had received an intradermal dose of FLUZONE ID, batch number, anatomical site of administration and dose number were not reported on 07 October 2013. On 07 October 2013, same day after vaccination, the patient experienced redness, swelling, hotness and burning sensation. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
nausea, headache, achiness through the night, dissipating by noon the following day
patient came in and requested to get moderna bivalent shot, but was given the flu shot. Patient stated he had received his flu shot from his primary care doctor a month ago, I tried to call the doctor's office to confirm , but doctor;s office was closed for the day. So i called insurance to confirm, and the agaent i spoke with told me that based on  his records patient had not received any flushot during this flu season apart from the one he received today 12/09/2022 at our location. and that if patient had received any previous flu shot, the insurance won't allow us bill for the flushot the scond time
Normal sore arm the evening of vaccine, the next day it was red, hot and itchy.  As of today, 3/29/2021,  it is still red, hot and itchy and seems to be extending farther down my arm and is slightly swollen/puffy.  The only other side effects seem to be a continuing slight headache and there was also tiredness the evening of and for the first day after the vaccine..
temporal arteritis; severe headaches; near syncope; chest pain; dypsnea on exertion; weakness/fatigue; weakness/fatigue; This is a spontaneous report from a contactable Other HCP (other health professional). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in May2021 at the age of 67-year-old for COVID-19 immunization. The first dose was in Apr2021 at the age of 67-year-old. Medical history included COVID-19, had covid prior vaccination. Concomitant medication was not reported. The covid test post vaccination was no. In May2021, patient experienced temporal arteritis, severe headaches, near syncope, chest pain, dypsnea on exertion, weakness/fatigue. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and treatment received. The treatments included steroids. Patient underwent CTA chest, cardiac cath, CT chest and CT head, all unknown results. The outcome of events was not recovered.   The seriousness criteria were hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (lump), VACCINATION SITE PAIN (felt like someone socked me in the arm/sore) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no adverse events were reported). Concomitant products included DUPILUMAB (DUPIXENT), IRBESARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING (lump) and VACCINATION SITE PAIN (felt like someone socked me in the arm/sore). On 15-Jan-2021, the patient experienced FATIGUE (Tired). On 15-Jan-2021, SWELLING (lump) and VACCINATION SITE PAIN (felt like someone socked me in the arm/sore) had resolved. On 16-Jan-2021, FATIGUE (Tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-057867.
Left arm was very hot, swollen and brusied.  Left arm had pain from shoulder to elbow.  Pain, swelling and bruising lasted several days. Patient also experienced vomiting starting the evening of the injection which continued for 3 days.  vomiting subsided after receiving medication for the it.  At the 6th day, the arm was only a little sore.
States she had swelling that has increased over the last 48 hrs. Currently warm, red, size of fist per patient. She is calling her MD and treating with ice and TYLENOL.
Double intussusception (ileoileal, ileocecal), developed 5 weeks after vaccinations.
Information has been received from  a registered medical assistant referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 12-MAY-2015, multiple unspecified patients were vaccinated with unspecified doses of improperly stored LIQUID PEDVAXHIB (lot # K004541, expiry date 04-DEC-2016) (dosage, strength and route were not reported). At the time of the report, there was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed rash on neck, superior to clavicles bilaterally.  Treating with Triamcinolone 0.025% cream topically
Within 1-2 hours of vaccine, pt became lethargic and difficult to arouse. Vomited once.
Headache, Myalgia, Fever, injection site pain Narrative: Employee reports symptoms of fever (102 F), chills, headaches, body aches, upset stomach, and injection site pain/discomfort in the middle of the night, after receiving second dose of COVID-19 vaccine. Reports took Tylenol (no dose or frequency provided).
pt recvd vax 1SEP95 & lab eval on 14NOV95 revealed complement fixation studies neg;no further details were provided;
Moderate tinnitus in both ears.  Developed about a week after second dose.  No change a month later.
gen rash & urticaria over body;taken to PMD dx immunization rxn to vax;given DPH & not to have 3rd vaccine in series