chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse outcome at time of injection on 8/15/21. Tested positive for COVID on 2/3/22.
See medical record note dated 12/31/20. Itching, discoloration of both arms.
Patient had decreased feeding and activity from the day after vaccines until calling 911 on 12/13/19  at 5pm and being taken by rescue to the ED due to non responsiveness.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date between 12-JAN-2015 and 05-JUL-2015, the unspecified number of patients were vaccinated with GARDASIL 9 lot # K026246 exp. 28-JAN-2017 (dose, route of administration not reported). The GARDASIL 9 was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
This spontaneous report was received from a nurse (L.P.N.) refers to unspecified patients. The patients were vaccinated with improperly stored VAQTA in May, 2011. It was reported that the first excursion occurred in May 2011 where VAQTA were exposed to 31 F for 4 hours and the second excursion occurred on 29-MAY-2012 where VAQTA were exposed to 30F for 12 hours. No adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Patient fully vaccinated (Moderna) and boosted, admitted to the hospital on 02/02/22 with COVID-19 and associated hypoxia. Patient was discharged on 02/07/22.
Caller reporting temperature excursions. One dose had been administered to a patient.; No additional AE; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # W003819, expiration date on 02-FEB-2024, for prophylaxis (strength, dose, route of administration and anatomical location were not reported) which had a temperature excursion (product storage error) at 44°F during a time frame of 672 hours. No previous temperature excursion were reported neither additional adverse events (no adverse event).
Whole body urticarial progressing to several bullae.  Symptoms beginning 16 hours after vaccination with initial lesion noted at vaccination site.
This spontaneous report was received from a pharmacist via company representative and refers to a 23-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly (concentration, exact dose, lot number and expiration date were not reported) for human papillomavirus (HPV) prevention. At an unspecified time after administration, she "fainted and experienced seizure like activity". The outcome of syncope and seizure was reported as recovered. The causal relationship between the event and the vaccine was not reported. Upon internal review, the events of syncope and seizure were determined to be medically significant.
CHIEF COMPLAINT:   Per EMS family states that he has been having pain due to his back as well as a cough. 80%  RA. 6 LPM NC satting at 96%. Patient severly demented at baseline. Patient known COVID positive. Unsure of when.   HISTORY OF PRESENT ILLNESS:     Patient is a 87-year-old man, history of hypertension, dementia, brought in by EMS from home for upper back pain and cough.  He is known to be Covid positive, it is unclear what that test was.  Patient is unable to give history or review of systems due to advanced dementia, he has no complaints at this time of chest pain, or shortness of breath, states that he does have upper back pain and feels thirsty.
Stomach ache; sharp pain in his chest; couldn't breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22 year-old male patient received bnt162b2 (BNT162B2), administration date 21Feb2022 (Batch/Lot number: unknown) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; CHEST PAIN (non-serious), outcome "unknown", described as "sharp pain in his chest"; DYSPNOEA (non-serious), outcome "unknown", described as "couldn''t breathe". The events "stomach ache", "sharp pain in his chest" and "couldn't breathe" were evaluated at the emergency room visit.Reporter had to call the 911 and they came and they took patient to the hospital and that was like around probably 06:30 pm. They took him to the hospital and was released like 11 or 11:30 pm. Reporter stated that when they took him to the hospital, they gave him something to drink medicine but reporter was not sure what it was.  The lot number for bnt162b2 was not provided and will be requested during follow up.
2-2-01  Tachycardia began-Cardiology workup and appts.   Continues with Tachycardia, fatigue, headache
In reviewing patient information, she marked she has fainted in the past from vaccines. She clarified during the pre-examination that she fainted after getting a flu shot  2 years ago. She said she has not gotten a flu shot since and she had not had one prior to that since childhood. She said he thinks she fainted because she did not wait to be monitored after her shot and left immediately. She was informed that she should wait 30 minutes after her COVID vaccine to have proper monitoring. Patient received shot at 5pm, sat out in the waiting area outside pharmacy. Pharmacist checked on patient at 5:09pm and she was slumped over against the body of her friend. Pharmacist asked if she was okay and friend said she is beginning to faint. Friend was advised to lay friend on the ground, legs elevated, and a cold compress pack was giving to apply to patient's neck and face.  At 5:14pm, patient was awake and alert. She remained seated on the ground for the remainder of her 30 minutes of monitoring. Patient left alert and well.
left shoulder was the injection site- very swollen, red, the size of a fist, hot to the touch, very sore- a lot of pain.  Hot, cold, chills, extreme body aches, blinding head ache, loss of clear site in left eye, vomit, nausea, tired, loss of taste, sores on the inside of mouth.
Info regarding Prevnar injection was received from a 36 year old male healthcare professional who experienced flu-like syndrome after Prevnar was accidentally splashed on his face. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in 9/05. Dose regimen was 0.5cc. Pt was not taking concomitant therapy. Event Details: On 9/26/05 or 9/27/05, the physician inadvertently splashed the contents of a syringe of Prevnar on his face (accidental exposure). On 9/28/05, he developed a flu-like syndrome described as muscle and joint aches, low-grade fever, and a sore throat. Treatment included Aleve (naproxen sodium) and the fever had decreased. Outcome is unknown. No additional info was available at the time of this report.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 69 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: "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "CKD stage 3" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; HYDROCHLOROTHIAZIDE. Past drug history included: Penicillin for Hives, notes: Known allergies: Penicillin (hives). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 21Jun2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (14Jun2022) Negative, notes: She previously tested negative on 14Jun; (21Jun2022) Positive, notes: She retested today 21Jun2022 and tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received vaccine. The patient received other medication Levothyroxine, hydrochlorothiazide in 2 weeks. Anti-viral details: The patient received Paxlovid via oral route from 06Jun2022 to 10Jun2022 for COVID 19 treatment of COVID-19.  Adverse event start date: 18Jun2022. Patient experienced rebound covid symptoms on Sunday 19Jun2022. She retested today 21Jun2022 and tested positive. She previously tested negative on 14Jun after finishing course of Paxlovid on 11Jan. The patient was recovering without treatment for AE.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
I had Covid last March, and at approximately 8:30pm of the day (Friday) of the vaccine, I became extremely tired, mild heartache, and developed a 101.1 fever, chills, blood oxygen dropped to 88. The next day (Saturday) I could not get out of bed I was so tired, had chills, mild headache, and fever had fallen to 100.4. The following day (Monday) my temperature dropped to normal and my blood oxygen rose to 97, but still feel tired with a mild heartache.
Within 5-10 min of giving immunizations infant became limp 1 eyes appearing "vacant." No jerking motions/cyanosis - 1 Hr 150-O2 100% monitored for 45 degree - became more alert/responsive after 1/2 hr. Home with mom - instructed to monitor closely.
Developing a cold sore due to sun exposure/broke out with fever blister; Swelling in her armpit that was pretty big; This is a spontaneous report received from Pfizer Sponsored Program. A contactable 50-year-old female consumer (patient) reported for herself.  A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunization. The patient medical history and patient's concomitant medications were not reported. On an unspecified date The patient experienced developing a cold sore due to sun exposure/broke out with fever blister and swelling in her armpit that was pretty big. The patient asked developing a cold sore due to sun exposure. She is scheduled to receive her second dose of the Pfizer-Biontech Covid19 vaccine today. Will the vaccine interact with the cold sore and make it worse. The reporter stated that about 2 days after her first dose, she developed swelling in her armpit that was "pretty big, but went away". The reporter asked she was out in the sun and broke out with fever blister and is asking if she should still get the covax or wait. Reviewed fact sheet for information regarding cold sores with no results. Discussed lymphadenopathy as found in the attached Cons doc, which states, "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days." Referred to HCP for additional guidance. As Per FAQ: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.  Information about batch/lot number has been requested.
Slept almost the entire day; Headache; Joint pain in legs and neck; Joint pain in legs and neck; Joint pain in legs and neck; Loss of appetite; Chills and Shivers; Chills and Shivers; Sore left arm; Sore arm started at 5pm that day. It has improved, but it is a little itchy now.; This is a spontaneous report from a contactable consumer or other non hcp (patient). The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 15Feb2021, this case now contains all required information to be considered valid. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6021; Expiration Date: Jun2021) via intramuscular route of administration, administered in arm left on 12Feb2021 09:45 (at the age of 73-year-old) at dose 1, single for covid-19 immunisation. Medical history included Retroperitoneal Liposarcoma/Diagnosed 10 years ago with 4 surgeries last one being Aug 2020 and cancer (I am a cancer patient). Concomitant medications were not reported. The patient experienced Sore arm started at 5pm that day. It has improved, but it is a little itchy now on an unspecified date in 2021, sore left arm on 12Feb2021 17:00, chills and shivers on 12Feb2021 22:00, slept almost the entire day, headache, joint pain in legs and neck, loss of appetite on 13Feb2021. Reporter has experienced quite some side effects from the 1st dose of the vaccine and is asking if the side effects of the 2nd dose will be more severe as she's heard it to be like that. She is also asking for any contraindications of the vaccine as she is a cancer patient. Received covid vaccine on Friday. Calling in to report her side effects. Received call from consumer regarding the Pfizer COVID vaccine. She had her first dose last Friday. She would like to report symptoms from that. She did not wish to provide an address or email. There was no prescriber. She is with a Health Service and filled out a questionnaire, and the next day found out she was eligible. Sore arm started at 5pm that day. It has improved, but it is a little itchy now. She was not aware of the joint pain on 13Feb2021 because she was wiped out and was not totally aware. She was not eating and was sleeping all day that day. She is still feeling wiped out since yesterday, but it has improved. She has questions about second dose. She wanted to know if it will be worse with second dose. NO ER or physician's office required. Prior Vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Outcome of the event Sore arm started at 5pm that day. It has improved, but it is a little itchy now was unknown and remaining other events was resolving.  Follow-up (01Apr2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # N020139 with expiration date 14-FEB-2020, for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. At the time of reporting, the temperature excursion and the time frame were unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1803USA000351: US-009507513-1803USA000352: US-009507513-1803USA000353: US-009507513-1803USA000354: US-009507513-1803USA000355: US-009507513-1803USA000356: US-009507513-1803USA000357: US-009507513-1803USA000358:
1.) Had delayed ovulation in cycle immediately following vaccine (3 days late; typically have 28 day cycles); did not attempt to conceive this cycle 2.) Successfully Conceived during my 2nd cycle following my vaccine on June 8th (within 60 days of 2nd dose); due date was March 3rd, 2020. Healthy fetal heart beat was detected at 6 weeks 6 days and normal blood tests; experienced missed miscarriage on July 26th at 8 weeks 5 days (diagnosed via ultrasound on August 11th at 10 weeks 5 days); 3.) Follow-up pathology revealed no chromosomal or cervical abnormalities
05/05/04: Had shots today and he is jerking, starring off, eyes jumping.  05/06/04 @ 9:45am: Spoke with mom. Mom called by myself as she had called answering service last night at 11:00pm to report that child was jerking, starring off and eyes jumping. Stated she was getting ready to put child to bed, when this episode occurred, she couldn't get his attention. She spoke to MD who advised taking him to the hospital ER which she did. She said his behavior was normal en route and at the hospital where his temperature was at 102. She stated that his balance was unsteady prior to the original episode and MD thought he may be dizzy, etc. Mom also states the left thigh continues to be swollen and red area not tight. I told her to continue giving Motrin and Tylenol and use ice as tolerated. Appointment made for 05/07/04 at 10:45am. 07/13/04: Paperwork for adverse reaction to immunizations not sent to VAERS as pt no show for follow up appointment after episode. Pt not seen in office until over 2 months later for sick visit. Temperature 104; vomiting today all day. Came here at 13:00, temperature now 102.2-Motrin 1 tsp given now.  Attends daycare. Ears: red, skin: hot, throat: spots by vulva. Diagnosis: Viral pharyngitis, otitis media. Treatment: Motrin given now 1 tsp, Ibuprofen 1/2 tsp every 6 hours. Ice pops, Oral rehyd soln, amoxicillin 250/5, herpangina handout given. 08/03/04: Talked over with MD about sending VAERS. Agreed should be sent even though mom didn't follow up. Child has had fever over 102 on 07/13/04 and didn't have febrile seizure.
Moderna COVID-19 Vaccine EUA: three days after vaccination patient hospitalized for volume overload, pulmonary edema, and worsening CKD progressing to ESRD. Patient diuresed and dialyzed with improvement. Discharged to home medically stable with outpatient dialysis in place.
A FAMILY ASKED IF THE MOM, DAD, AND THEIR TEENAGE BOY (AGE 16 YEARS AND 3 MONTHS) COULD GET THE COVID VACCINE AT OUR LOCATION. WE LOOKED ON THE WEBSITE FOR THE AGE LIMITS, AND IT LISTED AGES 16 AND UP COULD RECEIVE THE COVID VACCINE. WE PROCEEDED TO GIVE THE VACCINE TO THE PARENTS AND THEIR SON ON MONDAY, APRIL 12, 2021. UPON FURTHER INVESTIGATION, WE FOUND THAT THE AGE LIMIT FOR THE JANSSEN COVID VACCINE IS ACTUALLY 18 YEARS OLD. WE NOTIFIED THE PARENTS, AND TOLD THEM OF THE SIDE EFFECTS TO WATCH OUT FOR AND IF THEIR SON EXPERIENCED  ANY OF THESE, TO IMMEDIATELY CONTACT HIS PCP. WE ALSO NOTIFIED  THE PCP OF THE EVENT AND EXPLAINED WHAT HAPPENED.
Client reported feeling lightheaded following vaccination, then fainted. Client had LOC approx. 15-20 seconds and regained consciousness spontaneously with verbal prompts. Feet elevated. Client semi-reclined. VSS. HR 72, BP 120/64. Skin initially warm, moist. Skin dry, warm to touch within 2 minutes. Client offered and accepted sips of H2O. Cool cloth applied to back of neck. No change in VS on re-check. Client observed for 15 minutes without further incidence. Client stated, "I always faint with blood draws and other shots."
a 16 year old patient received a dose of Flublok QIV / no adverse event; Initial information regarding an unsolicited valid non-serious case received from a Pharmacist via Nurse on 24-Oct-2019.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591, 2019SA304592 and 2019SA304588.  This case involves a 16-year-old patient (unknown gender) for who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV] (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pfizer second dose 2/2/21 baby tachycardia 2/8 decreased motion noted by mother delivered under c section one month early stiff and no gag reflex
Child immediately showed signs of agitation, regression in developmental mile stones, and behavior changes. He went from communicating his actions, feelings, and foods to pointing and crying/screaming. 1 week from vaccines, child had a 103.4 fever. Low grade fever occurred directly after vaccine. 103 Fever was also displaced 14 days from vaccine , 28 days from vaccine, and a little over 40 days from vaccine. After 5 weeks from vaccine, his fever broke, resulting in extremely red eyes, puffy, and a rash covering his entire skull, parts of his face, inside of his mouth, legs, arms, belly, back, groin area, and feet. Rash appeared to be itchy to the child at times. Rash was very red and puffy. Appetite has been diminished since December 2, 1 day after vaccine. A drastic descrease in fecal matter has occurred and when it does happen, its very hard and clump like rather than it used to be.
I received Pfizer vaccine on: 7/7/21, 7/26/21, and 3/3/22. I've had elevated WBCs since 11/1/21 with no signs of any infection, nor any other cause. I KNOW there's something wrong, and it's been since getting my 2nd vaccine. I've never had elevated wbc when I'm not sick.
Terrible stomach problems after getting the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Terrible stomach problems after getting the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Terrible stomach problems after getting the Moderna Covid-19 vaccine). At the time of the report, ABDOMINAL DISCOMFORT (Terrible stomach problems after getting the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-012577 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012577:Same reporter
ZOSTAVAX given 7/2/08.  Pt developed flu like sx, fever, pustules on lt hand, nose, rt thigh & back, and rt flank pain on 7/14/08.
A non-serious spontaneous report of vomiting was received from a consumer concerning a nine year-old (gender not reported), subsequent to FLUMIST. The patient received FLUMIST on 29-Nov-2008. The mother of the child stated that 6 to 12 hours after administration of FLUMIST the child started to vomit. The outcome of the vomiting was not reported.