chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient of unknown age and gender with no information reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacist reported that an unspecified patient received one dose of an unspecified HPV vaccine (manufacturer unknown) in approximately 2012-2013 (reported as "about 4 to 5 years ago") (lot number, dosage, and route of administration not provided). The pharmacist reported that the patient received a dose of GARDASIL 9 on 20-APR-2017 (reported as "last Thursday") as the second dose in the HPV vaccination series (dosage and route of administration not provided) (lot # M032650, expiration date 31-MAR-2019). No adverse effects were reported. No additional information is available. Additional information has been requested.
Expired Twinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received an expired dose of Twinrix vaccine. The reporter stated that the vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-MAY-2014 the patient was vaccinated with ZOSTAVAX (lot # J001003, exp. date 24-APR-2014) 0.65 ml subcutaneous. The patient received an expired dose of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post shot painful lymph node pain under left arm and side of breast
States that she receieved influenza vaccine on 10/06/04 at 0753.  At 1600 noted hives on trunk.  States that at 2000 had about 15 pruritic maculopapular lesions on trunk mostly on back.  Took Benadryl 25mg at HS and stated that by 10/8/04 rash is mostly gone except where she scratched lesions.   States she did not make any changes in her diet or take any new foods or use any new skin care products or soaps or laundry detergent.  States that she had varicella as a child and has a positive titer.   States that she does not have a history of an egg allergy and that she has taken the flu shot regularly in the past.
Injection site on arm swelled up and was red. It was hot to the touch and tender. This symptom start around 20 hours after injection and lasted a little over 24 hours.
Undiluted Pfizer 5-11 y/o vaccine injected directly to pt.
Discharge Date: Sep 17, 2022 Discharge Provider: MD Primary Care Provider:  MD  Admission Date: 9/15/2022  PRESENTING PROBLEM: Respiratory insufficiency   HOSPITAL COURSE: 79-year-old male with past medical history significant for chronic obstructive pulmonary disease, chronic arthritis, hypertension, history of stroke, BPH and GERD.  Presented to emergency department on 09/15 with generalized malaise, headaches, shortness of breath and cough.  He had been feeling symptoms since 09/04 and has a positive for COVID-19 on 09/07.  He was recently given a short course of prednisone but did not improve so presented emergency department.  He is found to be hemodynamically stable placed on 2 L of nasal cannula.  Labs appeared relatively stable.  CTA thorax was negative for pulmonary embolus but did show ground-glass opacities favoring multifocal pneumonia, findings of bronchitis and emphysema.  He is started on increased dose of steroids, DuoNebs and admitted to Medicine Service for further management.   As far as acute hypoxic respiratory failure, this is likely secondary to COVID-19 pneumonia as well as a mild chronic obstructive pulmonary disease flare.  This was treated with DuoNebs, Symbicort, azithromycin and steroids. Procalcitonin and Influenza PCR were negative. Patient was on 2-3 L nasal cannula. He is subjectively feeling better. He had stable oxygen requirement of 2-3L for 48 hours. Patient was discharged home on home oxygen. He will continue to monitor his O2 sats at home and present back for re-evaluation if he develops increasing oxygen requirement and symptoms. He will finish 2 more days of azithromycin and finish a prednisone taper
The patient reported to me a worsening of left side lower facial paresis originally experienced about 11/2020 as idiopathic Bell's Palsy.  the worsening occurred after the second Moderna vaccination.  He also reported right lower facial weakness which was a completely new symptom.
no adverse event on patient; temperature excrusion; This spontaneous report was received from an office manager and referred to an 11-year-old patient of an unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 07-MAR-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration date: 1775811, 07-DEC-2023; or 1775827, 27-JUN-2024; or W009829, 19-OCT-2024; or U032681, 26-OCT-2023; or 1780876, 09-NOV-2023 (administration site, and route of administration were not provided) administered for prophylaxis (product storage error). Temperature excursion total time was reported as 25 minutes. There were 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day. The vaccines was purchased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice. No additional adverse events (AEs) were reported (no adverse event).  This is one of several reports received from the same reporter.
Muscle pain; Numbness; Lightheadedness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness), DIZZINESS (Lightheadedness), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness), DIZZINESS (Lightheadedness) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, HYPOAESTHESIA (Numbness), DIZZINESS (Lightheadedness), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: The Non significant follow up case received on 27-APR-2021.Email information was added.
She screamed 75% of day for over 1 1/2 years, thrashing in sleep and while awake, violent anger trying to hurt you, inflammation of brain according to her doctor, very large head had x rayed, sensory processing disorder, she missed all her milestones at the pediatricians office, no eye contact, wouldn't respond to name at 9 months, extreme anxiety, food allergies, very similar symptoms as autism. Our family was debilitated by what happened to her. We stopped vaccines, found a Dr who actually helped us with extensive tests and supplements, we changed her diet to all organic and dairy, gluten free and she was in occupational therapy for sensory and speech and developmental delays. She has improved very slowly over time as we have put countless hours in research and with doctors who have helped her. She is currently on several supplements that help her through the day and is extremely improved. I don't know what would happen if we took her off the supplements though. She still struggles with sleep and mood and allergies and anxiety but great improvement has occurred since we've taken these measures but it's been a slow traumatic process.
Pfizer COVID 19 vaccine given 01/22/21.  Patient reports severe arm pain the following day.  She presented to ED and was seen by a provider who believes she may have bursitis or tendonitis secondary to the vaccine.  I followed up with her 02/16/21 and she is still experiencing severe pain and unable to use that arm. She has an appointment scheduled with an orthopedic specialist 02/18/21 for further evaluation.
Patient came into clinic for follow-up appointment with Dr. on 03/09/2023 at 11:00. Writer asked if patient would like to get Pfizer bivalent vaccine as system had no record of patient receiving it. Patient agreed to receiving vaccine. Writer gave vaccine in right deltoid then patient left clinic after appointment was finished. Patient called office at 1422 to inform that she received the Pfizer bivalent vaccine at Therapy in 01/2023. Writer asked patient if she was experiencing any adverse effects. Patient stated she is not. Per Dr., it is fine and call office if she starts having adverse reaction.
Left arm red and swollen for 2 days.  Warm compress-cold compress, tylenol as needed.
First dose of Pfizer covid vaccine (0.2 mL 5-12 year old dose) was obtained from Clinic 6 and administered to patient. Label was removed for charting. After administered it was noted that the dose had been drawn up on 6/27/22 and expired on 6/27/22 at 2200. Contacted pharmacy, infectious disease and patient's physician for recommendations. Per infectious disease, the dose is considered void as the effectivity is unknown. Will administer another dose at next clinic visit and consider it as first dose of vaccination series.
Patient said that starting early evening of 11/4 (date of vaccination administration) she felt flu like, aches and fever. She said that starting early morning 11/5 she started to also have dizziness and it has not gone away like the flu like symptoms have. She said it's mostly when she changes position. I recommended trying  otc meclizine and see if that helps improve anything.
skin rash to all of his body; inflammation to genital area; This is a spontaneous report from a contactable consumer (patient). A 27-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA7484), via an unspecified route of administration on 29Jul2021 as dose 2, single for covid-19 immunization (age at vaccination 27 years). Medical history and concomitant medications were none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an unspecified route of administration on 08Jul2021 as dose 1, single (age at vaccination 27 years) for covid-19 immunisation. The patient was very healthy before the vaccine. The patient experienced skin rash to all of his body and inflammation to genital area on an unspecified date in 2021. The patient stated that, he has had a side effect after getting the second dose of Pfizer-BioNTech COVID-19 vaccine of a skin rash and inflammation to genital area that has lasted more than two weeks and was not going away. He said that the doctor said they cannot understand what it was and how to treat and told him to take allergy pill which he took Benadryl for two weeks and it was not working and it was not going away. Caller clarified that it was a skin rash to all of his body and inflammation to genital area are the same, they are not better or not worse. He says that the problems were not going away. Therapeutic measures taken as a result of events included treatment with Benadryl. The outcome of the events was not recovered.
administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022 at 2:02 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-581769, MOD-2022-581743, MOD-2022-581765 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Follow-up  received with non significant information On 01-Jun-2022: Significant follow up received contains: Patient details updated, Hcp reporter updated, suspect dosage details updated and Product coding updated.
Pt vaccinated with DT in lt arm using sterile technique 18DEC90. Seen 26DEC90 c/o lt arm reddened, painful, edematous w/drainage. I&D done by PMD drainage of green liquid noted. Seen again 27DEC90, no change, wound I&D cleaned, IV ampicill.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 26Mar2023 to 30Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
FACE STARTED GETTING A LITTLE ITCHY AFTER ABOUT AN  HOUR.  THEN IT WENT AWAY.  AT 2 AM I WOKE UP SWEATING..  MY PULSE WAS IN THE 90'S FOR ABOUT 24 HRS. BECAME DEHYDRATED AND VERY THIRSTY. THEN THE NEXT 24 HRS IT WAS IN THE 80'S.  NOW ITS BACK TO NORMAL.
Patient received first dose of Pzifer Vaccine.  Approximately 20 minutes later developed tightness to her posterior neck and shoulders. Encouraged to remain for full 30 minutes, patient continued to report these symptoms. Patient evaluated by RN Observers, denies shortness of breath, mouth/tongue swelling, palpitations, itching, rash.  Patient given 25mg PO Benadryl from Vaccine Clinic RN.  Patient reported she maybe was a little light headed and anxious so she laid down.  About 10 minutes after she reported feeling some better and wanted to go home. Patient counseled by RN, Resource Nurse on signs and symptoms to watch for and when she should call 9-1-1 if symptoms worsen.
Information has been received from a physician as an inquiry concerning a 3 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (No lot number was provided). Subsequently the patient may have potentially developed a case of shingles from varicella virus vaccine live (Oka/Merck). It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Pt developed redness and swelling on right thigh at site of vaccines 3" wide by 2.5" high.
a 65 year old patient had inadvertently been administered the Fluzone Quadrivalent rather than the Fluzone High dose, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via unknown route in unknown site of administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to wrong vaccine administered.  At the time of reporting the patient had no 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.  Information on the batch number was requested.  List of documents held by sender: none.
Body ache fever severe headache shortness of breath arm back and chest pain dizziness nausea Unable to stand or walk more than a few steps
very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.
Employee received #2 varicella vaccine to RUE on 4/27/16 at approx 0900. Today, 4/28/16 approx 0900 employee returned to employee health with noted localized inflammation, approx 40mm x 30mm, erythematous. Employee states she itches and also has a small site to (L) medial wrist approx 15mm x 20mm.
30 minutes of chills; minor hot flash; did not take anything for it (no tylenol); resolved on its own
Abdominal discomfort started occurring around, September 2nd, 2022, which was about three weeks after receiving the first dose of the Jynneos monkeypox vaccine. After I received the second dose of the Jynneos monkeypox vaccine on Friday, September 16th, 2022, the abdominal pain increased then started becoming unbearable, Monday, September 19th, 2022. I had to go to the Emergency Room the morning of Tuesday, September 20th, 2022, due to excruciating pain. I was diagnosed with appendicitis and had an appendectomy, Tuesday, September 20th, 2022.
Patient received shot at pharmacy. He was very nervous of needles.  After shot he became sweaty and said he wasn't feeling well. We fanned him, gave him an ice pack and some candy. He denied having trouble breathing twice, he denied tongue swelling or feeling itchy twice. He did not appear to have any visible signs of an allergic reaction. The technician and I both were convinced this was a panic attack. He was very worried about needles (was pacing back and forth before shot).  He sat there after the injection for about 10-15 minutes with his brother and father.  After this time and denying trouble breathing or tongue swelling, he said he felt better and was "fine".  He left with his father and brother.  Approximately 15 minutes later, the father called and wanted me to call the emergency room.  He said he was on his way there and wanted me to tell them what shot had been given.  He said he was having trouble breathing.
feel like my skin just like on fire like something inside my side that's burning me; didn't feel well; This is a spontaneous report from a contactable consumer. A 76-year-old patient of an unspecified gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for immunization. The patient's medical history included blood pressure abnormal (reported as blood pressure), blood cholesterol, gastrooesophageal reflux disease. Patient had cancer twice and had thyroid removed and had both breast removed but was under control as the patient had exams every 6 months my remission (patient's doctor check the patient's sugar and sodium level) and instructed to watch what he/she eat. The patient's concomitant medications were not reported. The patient didn't feel well and felt like his/her skin was just like on fire like something inside side that's burning him/her. It was further reported that the patient couldn't take any even Pneumonia shot (Captured as suspect), "I have anti-vaccines". The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
sore left arm that lasted less than a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm that lasted less than a week) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (July 2020). Concurrent medical conditions included Hypertension and Joint pain (the patient is having joint aches as reported in current medical condition.).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm that lasted less than a week). At the time of the report, PAIN IN EXTREMITY (sore left arm that lasted less than a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include unknown "hypertension" medication to treat high blood pressure was reported. No treatment information was reported.   This case was linked to MOD-2021-023397 (E2B Linked Report).; Sender's Comments:  MOD-2021-023397:same reporter, different patient