chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered 3 days after the expiration date of 8/8/2021.  No noted petient reactions.  Concern about efficacy and integrity of expired vaccine. Vaccine manufacturer medical information department contacted. Per GSK manufacturer there is no data available for patients who receive expired vaccinations. Advised to follow CDC guidelines. Per CDC expiration date of vaccines must be observed. Doses of expired vaccines should be repeated as soon as possible.  Patient's mother informed and patient scheduled to receive repeat TDAP vaccine 9/27/2021.
Received well check and vaccine at approx. 10:30 AM. Well check normal. First vomited at 19:30 PM the same day and continued through the night for a total of 7 times. Refused to ear or drink. Only wanted to lay down. Complained of "tummy hurt". Last time to vomit was 07:00 AM next morning. 5 hours later, he sat up from bed and got up. No fever. The whole time.
injection was below the ideal site for deltoid injection; A spontaneous report was sent by physician concerning a patient, unknown age or gender, who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced injection below the ideal site for deltoid injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  A physician reported that a patient received the vaccine injection below the ideal site for deltoid injection. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Right arm pain, redness, muscle aches, headache. 1/22 Ibuprofen, NORCO, BENADRYL. 1/23 and 24 ibuprofen.
Patient is a 6 year old ex 28 week twin male with hx of grade 3 IVH and VP shunt  (last revised 8/2020) with recently diagnosed focal epilepsy, well controlled on Keppra.  He received his first dose of Pfizer vaccine on 11/6 around 9:30 am. The next day, dad states he c/o headache and some stomach upset.  On 11/7 in the evening, he had 1x episode of emesis just prior to bed.  After this episode, per dad, he was staring into space and not responsive.  Denies eye deviation or extremity shaking.  EMS was called and was intermittently sleepy and not back to baseline for ~1 hour.     Patient was seen initially at where he had a reassuring BMP, CBC.  They gave him his evening dose of Keppra via IV.  He was then transferred to for further management given VP shunt and concern for seizure.   No fevers, headache, diarrhea, rash, URI symptoms within the week leading up to the vaccine.   Last (and first) seizure was in January 2021.  Takes daily Keppra.  Last medication change was around March 2021.
Starting one day after Moderna dose 2, patient developed severe night sweats, which have persisted nightly for the past month.  Also has noted diffuse on-going hair loss.  More recently over past 1 week, developed some yellowish discoloration of her palms with some palmar petechiae, which resolved over 1 week.  Has also noticed some bruising on her thighs without obvious injury. No fever.
pt recvd vax & exp visual disturbances, "optical neuritis", neuralgia in arms & muscle weakness;
Pt states she found a hard red spot where she got the shingles vaccine. She said it doesn't hurt or itch.
pt states the same day after her 2nd covid vax that her left arm started itching really bad between the wrist and elbow.  This itching continued to spread up the entire arm and then spread to her right arm.  She then developed red, hot lumps on both arms.  She went to PCP and was prescribed a steroid cream which did not help.  She went back and was then put on antibiotic and prednisone that did not help.  She went to a dermatologist. She was prescribed Triamcinolone that has not helped.  She went back yesterday 7/5/22 and was told to take a antihistamine which she has already tried but it did not help.  She now is putting ice on the lumps and using calamine lotion.  So far nothing has helped with her symptoms.
Patient expressed that after the vaccine and during the 15 minute observation period that she was feeling nauseous and dizzy. Patient explained previously that she had tested positive for COVID recently and was still experiencing lingering effects since. Patient was advised to remain in the lobby for observation for an additional 15 minutes for any worsening or new symptom development. Patient eventually left without additional reportings.
Patient was to receive her 4th dose of DTaP.  A TDap vaccine was pulled in error and given to patient.  Patient did not have any adverse effect from the administration of the TDap vaccine.
Severe itching behinning on scalp, ears and base of neck. Next morning proceeded to chest, trunk and arms, as well as developing severe hives covering entire body. Recieved a steroid for 2 weeks and told to take antihistamine 3x a day. After week/week and a half turned into dermatographia.  Have been on antihistamines since 2x a day to 4x a day as well as montelukast for the past 3 weeks.
On Tuesday 10/18/22, I had that raspy feeling in my throat that a cold was coming on. By Wednesday, 10/18/22 I awoke feeling really bad, my temperature was 102.7F and my blood pressure was really high for me. I had an extremely sore throat and a cough that would not stop, very foggy brain. I could only get out of bed to go to the bathroom or get something to drink for twenty-four to thirty-six hours. I used a home COVID-19 test that came back positive, called my doctor to let her know I was positive. My doctor called and suggested that I rest and allow my immune system fight the infection. By Thursday my fever broke, my head is no longer foggy I did spend most of my time resting in bed on Thursday. I do feel so much better today, I showered, shaved, a little bit of a cough, sore throat, runny nose, but my head is clear. I can do some of my work as I do work from home.
Patient developed itchy, maculopapular rash on the palms 2 days after Gardasil was administered.  Sje also had temp of 102 which lasted less than 1 day duration.  Po benadryl given.
diarrhea; still running a slight temperature, feverish; body aches, ache every where; feels tired and not having fun; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (still running a slight temperature, feverish), MYALGIA (body aches, ache every where), FATIGUE (feels tired and not having fun) and NAUSEA (nauseous) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), PYREXIA (still running a slight temperature, feverish), MYALGIA (body aches, ache every where), FATIGUE (feels tired and not having fun) and NAUSEA (nauseous). The patient was treated with NAPROXEN for Myalgia, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), FATIGUE (feels tired and not having fun) and NAUSEA (nauseous) outcome was unknown and PYREXIA (still running a slight temperature, feverish) and MYALGIA (body aches, ache every where) had not resolved.            Concomitant medications were not provided. The patient received unspecified treatment medication for diarrhea.
Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/ Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR117937).   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown.   It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. For tolerance of last dose refer case US2021AMR118023. This case is one of 3 cases, reported by the same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR117937:Same reporter. US-GLAXOSMITHKLINE-US2021AMR118023:Same reporter.
Patient received their first dose of Pfizer COVID-19 vaccine.  Patient was instructed to wait in the waiting area. Patient was sitting on the floor at the time. He was conversing with his brother (whom also received a Pfizer covid vaccine). He began to say that he wasn't feeling well, then the patient collapsed. The patient came to in about 15 seconds. He reported that he began feeling really dizzy and next he knew he was on the floor.
developed covid infection; This is a spontaneous report from a contactable consumer. This consumer (Parent) reported for 22-Years-old patient (son) that.  A 22-years-old male 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 immunisation. Medical history and concomitant medications were not reported. It was reported he received first dose of pfizer covid vaccine and then 5 days later, he developed covid infection. He was in quarantine. He got his first dose on a Saturday and the following Wednesday he felt sick, had a fever and went to the doctor and tested positive. He still has a lingering cough, but he is better now. It was further stated that he is due to get second dose this Saturday of Pfizer Covid-19 vaccine and asked 'should he even get the second dose'. Reporter stated that 'the doctors don't know, pharmacist wasn't sure, and further stated that I don't see the point of getting the vaccine because he should already have anti-bodies. The events were assessed as Non serious by reporter. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of event was unknown.  Information on the lot batch number has been requested.
Low grade fever, pain throughout arm, injections redness, redness throughout arm- Pt monitored temperature, went to bed early and resolution within 24 hours of symptoms.
I also made a report for my first vaccine (J&J). The problems started with that vaccination, but they began to accelerate a lot faster after getting this booster. Increase in tremor strength, and faster spread. More pressure on my heart. Raynaud's worsened. I can no longer write. I can't exercise anymore, because my heart feels like it's going to explode. At all hours of the day, it feels like my internal organs are vibrating. I don't know if it's a coincidence, and it was caused by my J&J vaccine, and Pfizer booster has nothing to do with this or not. I just thought I'd send in information about this stuff. I've been wanting to for a while, but I don't know. I haven't been able to find any information about people who have mixed J&J with Pfizer.
approximately 10 minutes after receiving her first COVID vaccine, the pt developed dizziness, palpitations and feeling "out of it".   heart rate regular at106 bpm, bp 131/69.  the pt drank 8 oz of , her vitals were monitored every 5 minutes.  she developed tremors to bilateral upper extremities, chills, and chest pressure substernally that was worse with deep inspiration the pt has a history of anxiety however she states that the symptoms were not her "typical anxiety.  the pt was feeing worse and ER was recommended, the pt accepted and 911 activated.   bp was 134/66, hear rate 96, pulse ox 99%, resp rate 20
Developed rash on upper arm about 24 hours after vaccine.  In area of injection and surrounding.  Rash is slightly raised, red, and bumpy.   Rest of arm is not swollen.  Applied cold compresses.  No MD visit.  Still has rash but is improving.
Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 168 doses/vials were given for LOT 048C21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information.
Fatigue; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (23Dec2020), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional. A 23-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), first dose via intramuscular on 22Dec2020 15:00 in left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fatigue on 22Dec2020 18:00. The outcome of  the event was unknown. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Started feeling woozy and nauseous within 15 min.  Spike in pulse O2 good  thought it was poss. hypoglycemic reaction Provided with Orange juice.  Daughter came to drive me home. At her house started extreme tremors beyond chills lips tingling  confusion and heart racing.  Extreme urination . beyond fluid intake for morning. Daughter called ambulance and was  taken to hospital > EMT administered nausea med IV.  In ambulance had extreme left ear, neck, and jaw pain. extreme headache and uncontrolled shakes tremors esp on left hand arm.  Er admit and treatment until released to daughters care.  24 hrs nausea even with meds. Severe headache and body aches as of this time-frame  3:20 PM 3/7/2021
Information has been received from a lawyer regarding a case in litigation concerning a male (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Hypotensive - 106/62, 98/57; Lightheadedness; Flushed Monitored for 35 minutes total  Placed in Trendelenberg position.  BP 121/74.  HR 85  Released from clinic.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient as recently as 1 month ago (AUG-2021) tested PCR positive (COVID-19 PCR test) for Covid (confirmed covid-19 and confirmed clinical vaccination failure). He was only having mild case and reported that it was not the kind that puts patient in the hospital, some mild fatigue and coughing were his chief complaints.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210949780-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a healthcare worker concerning a 79 year old female with no drug reaction/allergies, who on 15-FEB-2008 was vaccinated SC with a 0.65 mL dose of Zostavax (Oka/Merck) (lot number: 659324/1835U). On 15-FEB-2008 the patient had an injection site reaction after receiving the vaccine. The patient developed blisters the size of "the palm of the hand" at the injection site. The patient was given a diagnosis of cellulitis. The patient also had an elevated temperature of 103 degrees F and was treated with unspecified antibiotics and corticosteroids. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested. Follow up information has been received indicating there was no additional information at this time. This is a consolidated report of two reports (WAES# 04913) for the same patient.
6 months after the last vaccine I experienced vertigo, nausea, fatigue, GI distress
Two days after first dose of vaccine. Welts and severe itching occurred all over patients body.
Nausea & Vomiting of stomach contents and bright red blood, multiple times prior to seeking treatment in ER. Treated with Zofran 4mg every 8 hours as needed for nausea. Also diagnosed with UTI and treated with an antibiotic.
Pt recvd 3 doses of Engerix-B & 2 wks ago was discovered to be a non-responder when tested;
Patient had fever above 101. Went to PCP whom found a knot on pelvis.  Patient states PCP tested for Monkey pox. Patient waiting for results.
Dose #2 given on 3/1/2023 Dose #3 given on 4/19/23
COVID 19 Treatment; COVID 19 Treatment; Dose 1 and 2: Pfizer, Dose 3 and 4: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), in left arm and on 14Apr2021 as dose 2, single (Lot number: ER8735) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 037C21A), in left arm and on 03Mar2022 as dose 4 (booster), single (Lot number: 066h21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: DULERA, start date: Jan2015; SINGULAIR, start date: Jan2010; RABEPRAZOLE, start date: Jan2010; ZYRTEC ALLERGY, start date: Jan2010. Past drug history included: Naproxen, reaction(s): "Known allergies: naproxen", notes: Known allergies: naproxen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and 2: Pfizer, Dose 3 and 4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Rebound with worse symptoms 4 days after completion of Plaxovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 01Sep2022 to 05Sep2022. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH Covid-19 Vaccine lot ER8732, ER8735 was investigated. The investigation included a review of packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot ER8732, lot ER8735 fill lot EP8684 and fill lot EP8687 and bulk formulation lot EP8571 and lot EP8574. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.