chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK ANTIBIOTICS WITHIN THREE DAYS AFTER VIVOTIF; This spontaneous case report (PVX2019-1798) was received from a pharmacist on 12-Jul-2019. It describes a female consumer who "took antibiotics within three days after Vivotif" (PT: Labelled drug-drug interaction medication error). The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis and clindamycin (600 mg) for wisdom teeth extraction.  Case report: The consumer took the first dose of Vivotf either on 11-Jul-2019 or 10-Jul-2019. On 11-Jul-2019 and 12-Jul-2019, she took clindamycin for wisdom teeth extraction, which was planned prior to staring Vivotif.  Action taken with Vivotif and Clindamycin was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took antibiotics within three days after Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took antibiotics within three days after Vivotif" was considered as not applicable.
11 x 10 cm area of erythema, induration swelling right upper arm at swollen sites (HIB and PREVNAR).
clots in the patient's system; This is a spontaneous report from contactable consumer via a company representative.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.The  patient was admitted to the hospital within 12 hours of receiving the first dose of the Pfizer COVID-19 vaccine. Hematologist reported two major clots in the patient's system who had to undergo four transfusions.Physicians determined that the Pfizer COVID-19 vaccine was responsible for these clots in the patient.Patient has since recovered, and reported this occurrence only with the Pfizer vaccine.The outcome of the event was recovered on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness; muscle pain; Dizziness; Now having swelling lymph nodes under left arm; pain down entirety of the arm; This is a spontaneous report from a contactable other health care rofessional (HCP) (Patient).  A 33-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular Left arm on 07Jan2021 02:00 PM at a single dose for COVID-19 immunization, Lot number: unknown. Medical history was reported as none. Patient had no known allergies. Concomitant medications were not provided. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 02:00 PM Intramuscular Left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccine within four weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. The patient received purified protein derivative (PPD) within two weeks prior to the vaccination on unknown date in Jan2021 (reported as last week), unknown results. On 08Jan2021 12:00 AM patient experienced fever night sweats, severe anxiety from 12 am -5 am, anxiety subsiding, residual fever, weakness, muscle pain and dizziness for the next 48 hours. Now having swelling lymph nodes under left arm and pain down entirety of the arm. No treatment received for the events. At the time of the report anxiety was recovering and patient had not recovered from the other mentioned events.  Information on the Lot/Batch number has been requested.
Patient described a rash on her Torso along chest and arms.  It was red, bumpy with blisters.  It began soon after the vaccines and continues 2 weeks later.
Will discuss with pt possible side effects such as fever, body aches, fatigue and headache which would be similar to the 2nd moderna dose when pt returns my call
Sore swollen lymph nodes; This is a spontaneous report received from a non-contactable consumer, the patient. A 34-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 20Mar2021 (at the age of 34-year-old) as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left as a dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore swollen lymph nodes on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of event lymphadenopathy was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: arm left was removed from anatomical location since no information was provided for dose 1, AE recoded as swollen lymph nodes and final sentence updated.
Employee reported fever of 101.2. Nausea, Vomiting, and upset stomach. Employee stated that this happened the evening after Immunization.
Pt presented with three healing wounds at injection sites located on upper outer left thigh. Parents reported history of  purulent exudate.
Information has been received from a nurse concerning a 19 week old male patient who on 07-JUL-2009 was vaccinated orally with the second dose of ROTATEQ (lot number 663264/1485X). In July 2009 the patient possibly developed a rotavirus-like infection. Unspecified medical attention was sought. It was unknown if there were lab studies performed. It was reported that the patient was "fine". The nurse's office was certain that this event was not related to ROTATEQ vaccine. No further information is available.
Had varicella vaccine at 08/28/2003.  Local reaction with 6 varicella-like rash/zoets appeared over body and face at 09/08/2003.  Rash started getting more as days go by.
Extreme ache in neck, shoulders, upper back.  Dizziness.  Fingers tingling and numb in both hands.  Heaviness on chest.
Patient was given Zostavax and 2 days after injection patient came down with moderate severe case of shingles.
Woke up on July 26th with a mild headache and mild sore throat. Ate and felt a bit better but hours later the sore throat got worse. Gave him a rapid test and it was negative. Woke up next morning still woke up with same sore throat. Gave him another rapid test and was negative. Called pediatrician office to make sure he didn't have strep. They ran a respiratory panel. My son by this point started to get congestion, was sneezing, headache was back, and as the evening the progressed he got stuffier and the sneezing continuing. He took MOTRIN and felt fine and the sore throat went away and did not come back. But the congestion is really bad, he can't breathe through the nose. He used inhaler and slept well. Had no temperature but woke up the next day with a slight cough, runny nose with mucus and a temperature of 100.4. The doctor office called back this morning and said that he was positive for rhino virus but negative for everything else. His temperature as of right now is really mild and his symptoms are mild except for the mucus.
Extreme soreness (couldn't move my arm fully), as well as fatigue and muscle pain, nausea, and headaches.  I couldn't move half of the day and was in so much pain I could not leave my room.  My joints felt like they were burning and I couldn't stay in one position too long (more than 15-30 minutes) or I would get back pain.  I couldn't sleep due to the pain
PATIENT GOT WEAK AND FELL AND FRACTURED LEG REQUIRING SURGERY AND IS NOW IN REHAB FACILITY DUE TO NON WEIGHT BEARING STATUS FOR 6 WEEKS
Headaches, heart aches, palpitations, short of breath, lightheaded, felt faint, sweat at smallest exertion, jittery and shaky, Ongoing Determined a thyroid issue but not sure what kind. May be acute thyroiditis.
chicken pox; This spontaneous report was received from a lawyer and the patient, reporting on herself. A 5 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unspecified date in 1954 (also reported as "maybe 1954"), the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unspecified date in 1954, the patient was diagnosed with chickenpox (varicella).    The outcome of varicella and the causality assessment between the event and therapy with varicella virus vaccine live (oka/merck) (manufacturer unknown) was not provided.         On approximately 2016, the patient experienced events related to zoster vaccine live (ZOSTAVAX) (Captured in: 2006USA003705).; Sender's Comments:  US-009507513-2006USA003705:
Shingrix 3 doses administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-DEC-2023) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 20th December 2022). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 27-MAY-2023, the patient received the 3rd dose of Shingrix. On 27-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Shingrix 3 doses administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter reported that the patient received 3 doses of Shingrix which led to extra dose administered.  The reporter asked was there any safety data. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
At time of vaccine patient was 14 weeks 4 days pregnant with third baby, due November 9, 2021.  Muscle soreness at injection site, started afternoon of 5/14, lasted through 5/16 Fatigue, started afternoon of 5/14, lasted through 5/28 Aching joints, started morning of 5/15, lasted through 5/16, took acetaminophen to relieve pain Nausea, started over night 5/14, lasted through morning of 5/15 Headaches, started afternoon of 5/15, occurred daily through 5/26, took acetaminophen to relieve pain Red, itchy rash at injection site, started 5/21, lasted through 5/27
Red bump appeared at injection site 9 days after injection. No adverse effects at time of injection aside from sore arm.
Influenza virus vaccine. Seizure. 40 y.o. f presents to ED via EMS 10/19 with witnessed seizure x 2. (received flu vaccine 5PM 10/18, went to bed, seized 00:30 heard by daughter and again in ED 04:00 10/19). PMH: hx normal pressure hydrocephalus, s/p ventriculostomy, 2 brain surgeries after which she developed seizure disorder, currently maintained on NEURONTIN and "as needed" KLONOPIN, last seizure 6 months ago, has had several breakthrough seizures over time. Neuro consult. Prior to coming in, she had a flu vaccine so the exact precipitating cause is unknown, it is possible it could be the flu vaccine, but she has had flu vaccine in past without problems. ATIVAN and fosphenytoin given, admit to hospital, meds adjusted, neuro consult. Discharged 10/20/13. ADDENDUM: occurred prior to admit and was reason for admit. VAERS report. Per neuro: potential triggering or irritating factors could include flu vaccine and intermittent use of clonazepam."
his pressure went up to 168/90; headaches; This is a spontaneous report from a contactable consumer.   An 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for hypertension and carvedilol hcl taken for hypertension. Patient reported that he had his vaccine on 08Feb2021 and 2 days later his pressure went up to 168/90 and it has stayed up. Caller reports that he usually takes Carvedilol and Lipitor for his blood pressure and asks if elevated blood pressure is a side effect of the covid vaccine. Caller states he got the Pfizer vaccine on 8Feb2021, everything was great and the next day it was good, on the second day after the vaccine, clarifies 10Feb2021, states his blood pressure went up and got headaches. States tomorrow he has an appointment with cardiology. States Second dose is scheduled on 3Mar2021.Caller wants to know if this is normal. The caller gave additional Information for Concomitant Products Lipitor as couple years. The caller provided the dates for blood pressure went up and has headaches as 10Feb2021 to Ongoing. The patient underwent lab tests and procedures which included blood pressure measurement: 168/90 on 10Feb2021 Caller reports that he had his vaccine on Feb 8th and 2 days later his pressure went up to 168/90 and it has stayed up. The outcome of the events was not recovered/not resolved.  Information of lot/batch number have been requested  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX (lot # 660685/0619X). The patient experienced pain, swelling and unable to lift arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the events were not reported. This is one of several report received from the same source. Additional information has been requested.
Became very dizzy within moments after administration.  Sudden onset.  Reported to attending medical staff who held me for evaluation.  During evaluation BP was found to be elevated (160 or 180+/100+ approximately (don't recall exact numbers).  Within an hour subsided enough for me to return to work, and dizziness subsided over the next several days.  Similar reaction to booster dose on 2/16/21; less acute but dizziness continues 1 month later.  Severity is not debilitating at this time.
Pain, swelling, and redness right calf for 2 days. Diagnosed with acute DVT.
The pt's symptoms were observed at company health care on 11/30/01 on her left upper arm. There is a 7mm area of induration and redness centrally with 3cm redness and slight induration peripherally at the site of vaccine. No drainage, open lesions or lymphangitis. No systemic symptoms.
After getting vaccine patient stated her arm was very sore, patient stated that 2 days later she could not sleep, and kept waking up throughout the night, experiencing sweating, nausea, and body weakness. Patient has not recovered from adverse events.
It has been almost 24 hours since the vaccination. Headache, starting to abate, fever of 100 still persists, severe chills all night long, joint pain (hands, wrists, neck, nausea last night - no vomiting. I checked my blood pressure and it is normal.
I received a Pfizer booster at pharmacy. My arm was extremely sore following the shot and has continued to feel sore. Recently, I have felt more soreness down my arm and fingers. I just called the pharmacy and they recommended I report it to you all. I have made an appointment with a primary care doctor to help identify what to do.
Sore & Hurting; Loss of taste; Difficulty sleeping on the side; Felt injection of the vaccine down in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore & Hurting), AGEUSIA (Loss of taste), INSOMNIA (Difficulty sleeping on the side) and SKIN BURNING SENSATION (Felt injection of the vaccine down in her leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore & Hurting), AGEUSIA (Loss of taste), INSOMNIA (Difficulty sleeping on the side) and SKIN BURNING SENSATION (Felt injection of the vaccine down in her leg). At the time of the report, PAIN (Sore & Hurting), AGEUSIA (Loss of taste), INSOMNIA (Difficulty sleeping on the side) and SKIN BURNING SENSATION (Felt injection of the vaccine down in her leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
I am breastfeeding and on the second day after vaccine I developed a serious mastitis in my right breast. I had fever of 38,5, which beaded after a day and a half of intense sweating.
COVID Arm; delayed injection site swelling; delayed injection site redness; itching and erythema; itching and erythema; ongoing rash on chest; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling), VACCINATION SITE ERYTHEMA (delayed injection site redness), RASH (ongoing rash on chest) and PRURITUS (itching and erythema) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Obesity. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Thimerosal Allergy (rash) and Tylenol (rash)) and Allergy to vaccine (Tetanus Vaccine (Anaphylaxis)). Concomitant products included MULTIVITAMINS;MINERALS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (ongoing rash on chest). On 16-Mar-2021, the patient experienced PRURITUS (itching and erythema) and ERYTHEMA (itching and erythema). On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling) and VACCINATION SITE ERYTHEMA (delayed injection site redness). On 02-Apr-2021, VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling) and VACCINATION SITE ERYTHEMA (delayed injection site redness) had resolved. At the time of the report, RASH (ongoing rash on chest), PRURITUS (itching and erythema) and ERYTHEMA (itching and erythema) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: (Positive) Positive.     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.   Treatment Medication included topical Ointment.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up information was received on date 13-APR-2021: Added Medical History, Concomitant medication, lab data. On 14-Apr-2021: Nonsignificant follow up appended
9:30 client became lethargic, diaphoretic, pale and taken via w/c to triage area. Oriented x 4 - drowsy. States the symptoms occurred immediately, that he felt too warm, felt clammy and light headed. States he has problems with claustrophobia. Cooled area by opening doors, patient removed layers of shirts. EMT personal at vaccine site in attendance. BP 136/78; HR 79; O2 sat 99% on r/a.  9:32 EMS activated 9:36 EMS cancelled per patient request.  9:50 states he feels much better and wants to leave, ambulated down hall and turned back stating he still felt lightheaded. Sat back in chair. States he last ate last night. provided juice. declined cookies.  10:00 States he feels much better, trial ambulation tolerated will without lightheadedness, gait steady. Left with wife to personal vehicle.
Adverse event: 12-15 moderately-severely painful vaginal aphthous ulcers, duration 1 week  [Negative HSV culture, no response to antivirals (valacyclovir)] Treatment: Sitz bath, NSAIDs Outcomes: Self-limiting in 7 days
Bell's Palsy on left side of face as diagnosed and confirmed by ER doctors on 12/23/2021.  Strength and dexterity testing plus CT scan concluded that it was not a stroke.  Was prescribed Prednisone 20mg tablets to be taken 3 at a time once per day for 7 days.  Also prescribed eye lubricating drops.  Then, was released with instructions to come back if symptoms worsened and schedule a follow-up with Physician. As of 12/30/2021, I have regained ~70 % of normal function.  Left eye still doesn't close tightly, both forehead and cheek are still noticeably uneven.  Mouth won't close firmly while drinking, brushing teeth and using mouthwash.  Food still gets stuck below the gum-line on the left-hand side.  Biting inside of cheek while chewing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not received other medications in two weeks. Anti-viral details: product=COVID 19 Treatment, Brand: Pfizer, treatment start date: 31May2022, treatment stop date: 04Jun2022, Indication: treatment of Covid-19. There were no known allergies and other medical history.  No follow-up attempts are possible; information about lot/batch can not be obtained. No further information is expected.
Two red welts. One at the injection site, one about 1/2 inch below.  1 inch and 2 inches respectively.  Hard, hot, itchy.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccine on 2/09/21, 3/09/21, and 8/31/21.  Covid + 1/09/22. Previously admitted for  covid19 (10/2021 tx remdesivir and dexamethasone), leukopenia,  presented 12/26-12/30/21 with fevers, cough and mass like left upper lobe consolidation found. New right lower lobe nodules 1.6 cm, multiple ground glass opacities present. Underwent bronchoscopy on 12/30/21, fungitel negative. Tx'd w/cefepime and vancomcyin.  D/C'd 01/03/2022.  Presented with fevers, tx'd x10 days of abx, completed 1/16/22. Presented to ED 1/26/22 with fatigue, fever, and malaise, admitted for PNA, UTI, thrombocytopenia, mild neutropenia, dehydration and malnutrition.  CT chest showed increased left upper lobe mass, new left sided effusions, increased nodules, all worrisome for metastatic disease.  CT guided bx of lung mass via IR 1/27/22, negative for malignancy. Continued to deteriorate, transitioned to comfort care. Tx'd w/Vancomycin, Cefepime, flagyl, Zosyn, and  isavuconazonium. Expired on 2/9/2022