chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Vocational Nurse (LVN) via a Field Representative refers to a female patient in her late 70s. In approximately 2013 (about one year ago) the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date and dose unspecified), Injection. On an unknown date in 2014 the patient had developed shingles "recently". The event outcome was unknown. The patient had sought medical attention via visited clinic. Additional information has been requested.
Breakthrough COVID infection on 6/14/2022. Symptom of fatigue with unknown symptom onset.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 28-SEP-2013, 13-NOV-2013, 09-OCT-2014, the patient was vaccinated with the first, the second and the third doses of RECOMBIVAX HB (strength, lot#, expiration date, dose and route were unknown) (inappropriate schedule of drug administration). No adverse events were reported. Additional information has been requested.
Soreness in left lateral upper chest. Confusion. Soreness in left arm at injection site.
pt recvd vax & w/in 24hrs post vax exp sore throat,fever (100) & malaise;sx resolved w/in a couple days;
Confirmed Breakthrough 1st - 02/06/2021  Moderna 007M20A   2nd - 03/09/2021 Moderna 023M20A   3rd - 10/26/2021 Moderna 049C21A   4th -- 05/04/2022 Moderna 048L21A
She states they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 19, 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: She states they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-OCT-2023 The pharmacist was calling to report that a patient had dose 1 Shingrix.  She stated they picked up dose 2 in May 2023 from the pharmacy but dose 2 was not administered.  The Shingrix vials that the patient brought in today to be given have an expiration date of October 12, 2023, so they were not administered.  They did not get dose 2 yet and pharmacy is asking for replacement of expired Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The case is linked US2023150323, by same reporter.; Sender's Comments:  US-GSK-US2023150323:1 of 2 report
Patient was given two PREVNAR doses 4 months apart by accident. Patient was notified.
Felt bad upon awakening, on Saturday morning (3/27/21) left arm sore at injection site and in joint of  left shoulder and elbow, developed fever of 101.5, took acetaminophen and returned to bed. Fever broke about 8 pm, awoke Sunday felling drained, tried and sore all over.
Third booster of Moderna (0.25ml) given in error. Patient had no adverse events at time of injection or 2 hours after.  Facility will monitor patient for side effects in accordance with regular facility protocol after vaccination.
pt recvd vax;cont crying,afebrile; saw MD;no apparent reason, clear exam;7mar95 began crying;apap given prior to clinic apppoint;dad said crying spell not as long this pm 7mar95;
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age. On 03-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date, the patient experienced nausea, headaches, malaise and flu like symptoms. The outcome of nausea, headaches, malaise and flu like symptoms was reported was not recovered. The patient sought medical attention. Additional information is not expected.
On 06/20/2003, pt. received a TD immunization for facial burns.  On June 25th, she presented to ED fpr a recheck of the burns, but also c/o flu-like symptoms (muscle aches).  Injection site with a 2 cm nodule, mild erythema and warmth.
her fever still at 102.4; Ache in the body; Chills; This is a spontaneous report from a contactable consumer or other non hcp (Parent) reported for patient (Daughter). A female patient of an unspecified age (Age:12, Unit: Unknown as reported) received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 26Jul2021 as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The reporter stated her daughter just turned twelve she had her COVID vaccine, Pfizer just the few days after she turned twelve, previous night she had her second shot because it was three weeks already and the first dose she did not have no problem. She cannot get her fever and chills to stop. That morning they started around like 1 or 2 o'clock in the morning and her fever still at 102.4. The reporter asked should I take it to the ER. Because the Motrin and the ice pack on her head and washing her down with cold water is not doing that. Is that a side effect like the Covid vaccine. The chills, the ache in the body because the reporter did not have the Pfizer, she did not have the same symptoms like her. The patient underwent lab tests and procedures which included body temperature: 102.4 fahrenheit on 27Jul2021. The outcome of all the events was reported as not resolved.
felt dizzy 30 minutes after the shot , sit down for  another 30 minutes and felt fine
Friday morning when i left i had a little sore throat and thought it was from sleeping on my back but on my way home it was getting worse and i got some drainage and my eys are bother me so i stopped to get some food and did a test before i went it. The test was weakly positive and i got worse and worse as i was going home. And i stopped at the er and got them to see me and they swapped for COVID-19 and flu i came back positive for both and they gave me Thermoful and Paxolvid.
hoarseness in her voice; swollen glands in the neck; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Elderly female patient who experienced swollen glands (lymphadenopathy) in the neck accompanied by hoarseness in her voice (dysphonia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, The patient developed a non-serious swollen glands in the neck (lymphadenopathy) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious hoarseness in her voice (dysphonia) 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was hoarseness in her voice and swollen glands in the neck.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for swollen glands in the neck and as Unknown for hoarseness in her voice.  Information on the batch number was requested.
Received vaccines 7/15/08 on 7/16/08 site of Hep A left was red; On 7/17/08 9AM site red, warm to touch and rash and swelling toward right site. No pus/drainage, No fever and no significant apparent discomfort.
At the right subcutaneous injection site where Varicella was administered there was a 3 inch area that was red, raised, hard, and itchy. Cortisone cream was recommended to treat the area.
Mom reported baby to "bolt out of sleep"-screaming approx. 2-3 hrs after vaccines given. T 100. Consoled about an hour after TYLENOL given. Baby then also started with diarrhea, having up to 10 stools/day. Parents and gm also with stomach bug s/s. Child had red lump (L) leg.
( R ) deltoid  - two visible wheals with central clearing. ( + ) erythematous macule 12cm X 9cm from deltoid region to elbow and warm to touch. ( + ) fevers of 102-103 since IZ admin. Tx MOTRIN, BENADRYL.
This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot Number: EM9809), dose 1 via an unspecified route of administration, administer in arm left on 16Feb2021 14:15 as single dose for covid-19 immunisation. The medical history not reported. known allergy to Wheat. Concomitant medications included Vitamin D, Biotin, Alpha Lipoic Acid, MSM (methylsulfonylmethane), Vit B12 (cyanocobalamin). On 16Feb2021 20:00 approximately 6 hours post injection she became extremely tired, having difficulty sitting or standing upright and having to make an effort to speak clearly her speech was slowed, she had lay down and went to sleep about 1 1/2 hours later she woke up, feeling much more normal then she went back to sleep and slept through the night. The next morning on 17Feb2021 she went pole walk in her hilly neighborhood, she removed her mask to breathe better and was audibly wheezing no pain and no inability to walk at her usual, rapid pace. she had some tiredness that day but not to the degree of the day before. There was no wheezing on 18Feb2021, and no tiredness so far. No other vaccine in four weeks. No COVID-19 prior vaccination and No COVID-19 tested post vaccination. Patient did not receive any treatment.  The outcome of the events was recovered on 18Feb2021.
pt devel welts all over but not the face;feet were so swollen that could not wear shoes;had red rash between welts;no fever;no resp distress;rash around mouth;welts move to face;
Immediately after receiving his covid vaccine patient started feeling nauseaus/dizzy, and threw up. After throwing up he felt better.
Pain & swelling in her arm, also per husband appears to be a knot, she is going to dr today.
Muscle pain in arm injection was given (left arm). Bruising starting below injection area and extending to inner arm to the elbow.
Started 1/11/21 at work. I am a medical professional. Left arm tingling and numbness. Floaters and flashers mostly in left eye. Scattered ones in right eye. Elevated blood pressure 147/79 (normal for me near 120/70) Pulse 106. My normal is in 60's. R:20  POX: 95% RA. Worked full shift 2P-10:30PM. Got good night sleep. Still had symptoms on 1/12/21 so went to urgent care.  I still have these symptoms.
lost taste; lost smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 16:00 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple myeloma" (unspecified if ongoing); "Reaction: Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZOMETA. The following information was reported: AGEUSIA (non-serious) with onset 31Aug2021 02:45, outcome "recovering", described as "lost taste"; ANOSMIA (non-serious) with onset 31Aug2021 02:45, outcome "recovering", described as "lost smell". It was unknown if therapeutic measures were taken as a result of ageusia, anosmia.  Additional information: The events did not result in doctor or other healthcare professional office/clinic visit; The most recent COVID-19 vaccine was administered in Workplace clinic administration facility.The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No Known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
Diarrhoea; missed dose; This is a spontaneous report received from a contactable consumer or other non hcp. A 84-years-old female patient received 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 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea and missed dose on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
She received a COVID vaccine at the conclusion of her appointment.  As she was walking out she felt lightheaded and sat on the ground. The staff who witnessed the episode say she might have loss consciousness. There was no direct impact or true fall.  Vital signs at the time showed no tachycardia, normal blood pressure and good saturations.  Point of care glucose was 117, although this was checked shortly after she was given some orange juice.  She was evaluated by the rapid response team here and remained hemodynamically stable
At site of injection area became swollen immediately, ice pack applied swelling went down. Next day individual came area still swollen with ecchymotic areas at site of injection. I to call MD with any further concerns.
Severe unrelenting anxiety with uncontrollable mostly hand and arm intention tremors, The anxiety and intention tremor still exist today but reduced from date of presentation
Second day had rapid rise and fall of my  heart rate    68 to 115  in seconds and then back whether I was sitting, lying down or walking. this continued through the day until Jan 8 morning then it went back to nornal
Within approx. 2 min after administration, pt began to have dizziness and experienced tingling to feet. Soon after experienced heaviness to head that she describes 10x heavier than how she came into office. Approximately 15 minutes later patient began to experience difficulty swallowing. Pt was assessed by MD. Throat was clear. Pt was advised to take Benadryl but refused.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JUN-2008, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 658023/0824U with expiry date 25-MAY-2009. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given vaccines and when he received last vaccine HPV patient felt his lips get tight and his arms went close to chest and eyes rolled back and patient was laid on exam table. Patient did awake to his name and was alert and oriented. Blood pressure was taken, and pulse ox was placed on pt. Patient was given crackers and juice.
Patient requested to receive Covid 19 vaccine; completed screening per protocol, As provider talked to him about vaccine and what to expect per Morderna vaccine guidelines. Patient was given  Moderna covid 19 vaccine; without any complication he was discharged home  after being observed for 15 minutes. As protocol we started entering vaccine in the health features and find out that patient had already received both 2 series of  Covid 19 vaccines; also noted on the needle injection sign that he was given in the past after he had already left the clinic. I called patient on the phone to check how he was doing,  state to be safe, felt well, Also confirm that he had received vaccine at health department, he state that he was confused about 2 series of shingle vaccine and covid 19 vaccine, and state that he was fine. Advised patient to call us or seek urgent care in case of any reaction. Planning to call patient again in the next day to check on him.
Pt reported severe pain when vaccine was administered. Pt was visibly uncomfortable. I treated the site with a cool pack. Pt decided to take ADVIL that she had in her bag.
CHILD'S DATE OF BIRTH AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS FATHER. CHILD IDENTIFIED IN DATABASE WITH DIFFERENT DATE OF BIRTH.  CHILD IS TOO YOUNG TO RECEIVE VACCINE ON 5/15/2021. VAERS TO FOLLOW FOR SECOND DOSE RECEIVED ON 6/9/2021.
Vaccine recipient experienced nausea and vomiting after receiving the vaccine. At the end of the observation period of 15 minutes he developed nausea and vomited once. After he vomited, the symptoms resolved. He was sent to the ED for follow-up and observation. Vaccine recipient stated that they drank a lot of juice. He improved and was subsequently discharged. The next day vaccine recipient reported that they felt sluggish and had arm pain around the site of injection. On a follow-up call today 1/11/2021; he reported that his symptoms have resolved.  Pfizer-BioNTech COVID- 19 Vaccine EUA.
PATIENT WAS GIVEN THE INCORRECT VACCINE WHEN DTAP WAS ADMINISTERED ON THIS DATE.  PATIENT WAS TO RECEIVE TDAP(BOOSTRIX) AND WAS GIVEN DTAP(INFARIX) BY MISTAKE.
11:00 tightness in chest started making it difficult to exhale completely. Notified charge nurse around 11:30 - 11:45. Symptoms got progressively worse (more tightness and more shortness of breath). Walked down to ER for treatment. Was given dexamethazone and Benadryl IM injection. Approximately 20-25 minutes later symptoms began to dissipate. Symptoms were gone by time of discharge (around 2:00).
Patient was seen on 10/23/19 for wellness visit and given flulaval; then, he returned on 11/1/19 for immunizations and got a second flu shot before the recommended 4 week break between the two doses
expired ACT-HIB was administered with no adverse event; Initial information regarding an unsolicited valid non-serious case from a nurse via Agency (Reference number- 00651749) and transmitted to Sanofi on 21-Jun-2021.  This case involves a patient of unknown age for whom  it was reported that expired HIB (PRP/T) VACCINE [ACT-HIB] was administered (expired product administered) on 21-Jun-2021 [lot number: unknown and expiration date: unknown] at 0.5 ml once (total) dose via unknown route in an unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to incorrect expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  Outcome of the event was unknown.  It was reported that " expired ACTHIB was administered to a patient yesterday. She has questions about next steps and if the patient needs to be re-vaccinated "  Disclaimer: 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.  There will be no information available regarding batch number in this case.
Moderna COVID-19 Vaccine EUA  10 days after injection, itching, soreness, rash, swelling at injection site
experience scratchy throat/itchy throat; This is a spontaneous report from a non-contactable other healthcare professional. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular, administered in right arm on 26Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, during her 30 minute waiting period after the injection, the patient began to experience scratchy throat/itchy throat. She denied difficulty breathing, difficulty swallowing and throat tightness. No treatment was received. Patient was observed for 65 minutes s/p injection. She states symptom of itchy throat improved. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Hospitalized for temperature 104.7 with hallucinations, headache and nausea Long-term uncontrolled diarrhea since booster injection
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe
Case previously recorded as MA2009-3455. The health care professional reported the following information via MedCom, on 30 OCT 2009: A 42-year-old male patient was vaccinated i.m. with Novartis  H1N1 vaccine (batch no. 101716P1A) on 29 OCT 2009. He developed a temperature of 100 F about four to five hours after vaccination. He recovered on 30 OCT 2009. MedCom Ref. no. NA09-007295.
Diarrhea - over 24 hour period Itchy/sore throat Congestion, runny nose, allergy symptoms Fatigue - in & out of bed 3 full days Muscle, joint and body aches - lasted 4 full days Terrible headache - lasted 4 full days Fever and chills - soaked bed clothes, had to change and bed linens soaked, laid towels on. Chills were teeth chattering, piled on blankets - last 2 full days
I was instructed by another CMA to inject "IM". After completion upon entering into MCIR I was informed this vaccine should have been "SQ".
Around 4:00pm after my vaccine my head, neck, ears started to feel really hot...almost like I was swelling (but no actual edema noted.) I felt like this for the rest of the evening until I went to bed. I woke up in the middle of the night with extreme chills and fever. Chills lasted a few hours. Then I got a HORRIBLE headache in the middle of the night which lasted until around 4:00pm the next day 4/16/21. My fever lasted until around  1:00pm on 4/16/21. fever was 99.9 degrees .
Patient recently diagnosed with lung cancer with metastatic disease to liver, presented to ED with altered mentation secondary to seizure with status epilepticus and subsequently intubated.  Etiology of seizures appeared to be related to metastatic brain disease from lung cancer.  Family wished to make the patient DNR..  Patient also tested positive for Covid-19.  Patient expired on 1/11/2022.
Pain at the site of the injection and fatigue. Tylenol 1g taken on 12/29/2020 at night *** Given 1ml of the vaccine instead of the recommended 0.5ml
Approximately 30 minutes after receiving the vaccine, she started feeling itchy, began developing a rash on her face, arms and trunk. Her lips started swelling and were tingly.