chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fully vaccinated and boosted against COVID-19 (4 shots). Last shot was 04/07/2022. My daughter and wife (also fully vaccinated) tested positive for COVID-19 first and I tested positive on 06/20/2022 (although I'm pretty sure I had symptoms etc the day before).  Symptoms: very minor but included sore throat, runny nose and nasal congestion.  Went to a pharmacy Test to a Treat Clinic at the local pharmacy and was given Paxlovid (3 tables / day for 5 days). Symptoms persisted (but improved) over the next 2-3 days. No symptoms by day 5. Ended isolation but worked from home anyway.  Tested negative on 06/26/2022 (by self-test at home) and again on 06/28/2022 (at a laboratory). Both tests were nasal swab antigen tests.
Pt developed probable herpes zoster dermatitis, T12-L1 on left about 2-3 days after vaccine. Under treatment on 7/31/01.
This initial report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in May 2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L003216 with expiration date on 30-APR-2016 (dose, strength and frequency were not provided). On an unspecified date in July 2015, unspecified number of patients received improperly stored VARIVAX, lot number reported as L015416 with expiration date on 01-AUG-2016 (dose, strength and frequency were not provided). On an unspecified date in October 2015, unspecified number of patient received improperly stored VARIVAX, lot number reported as K002918 with expiration date on 26-FEB-2016 (dose, strength and frequency were not provided). On an unspecified dates, unspecified number of patient received improperly stored VARIVAX, lot number reported as L006384 with expiration date on 25-FEB-2017 and lot number as J014812 with expiration date 20-FEB-2016 (dose, strength and frequency was not provided). According to the reporter, there were no previous temperature excursions and the temperature and time frame excursions were reported as: -11.2C for 360 hours, -11.1C for 480 hours and -10.7C for 1296 hours. Lot numbers L015416, L003216 and J014812 were verified as invalid lot numbers for VARIVAX. At the reporting time, the patients outcome was unknown. Additional information has been requested.
patient fainted within 30 seconds of administering hpv vaccine. was given influenza 5 minutes before and did fine with that
Lump around injection site size of a baseball followed by a rash that extended from injection site to elbow.
I received the moderna vaccine at 7pm on 1/19/21, this was the first shot I received. I have not had covid and have not been sick since pandemic started. The following morning I woke up with a fever of 101 and extreme arm pain. As the morning progressed, I continued to have increasing fever even after taking Tylenol 500mg every 4-6 hours. My fever peaked at 104.7 by 3pm on 1/20, then started to come down after taking 400mg of ibuprofen. By 9pm on 1/20, my fever started to spike again and then I took more inbuprofen. As of 1/21, I am still having symptoms of being unwell and nausea, as well as low grade fever of 101. I do not have any covid symptoms (no cough, no loss of taste).
On 10/25/06 Flu Vaccination given. Patient noted rt arm (deltoid) more tender then usual and has remained for over three weeks. Pain has improved but still present and bothersome with movement. No pain at rest. No weakness or numbness and tingling.
Arm all red at and around injection site. Pt said she felt nauseous, feverish, headache and body aches starting the evening of the immunization. Pt told to put ice pack on arm and to rest.
muscle pain; fever/well last night it was like the whole night with temperature; chills; Headache; Body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported), second dose via an unspecified route of administration on 03May2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as single for covid-19 immunization. On 04May2021, the patient had fever/well last night it was like the whole night with temperature and she woke up with so much pain like body ache, muscle ache and had really bad headache. So, she was just wondering whether she could take Tylenol or what medication she could take. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Expired Twinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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.   In January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In January 2023, 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: 9-Jan-2023 Reporter's comment: The specialist requested initials and date of birth, but only gender was provided at the time of call. The reporter consented to follow-up from safety. Additional supportive information: The patient received an expired dose of Twinirx, which led to expired vaccine used.
A few minutes after giving ADACEL on patient's right deltoid, she stated she felt some itchiness and there was a small bump forming at injection site. Dr. was informed and took a look at site. He advised to put ice on injection site. Ice was given to patient.
Left arm swelled up a couple days later. Became red Itchy, painful & stayed like that for about 2 1/2 weeks!!
No adverse event; The patient received her first Moderna Covid-19 bivalent vaccine booster dose on 15-Jun-2023 lot number is 023H22A expiration date is 05-Jun-2023/42-year-old patient received expired Bivalent dose of Moderna COVID-19 vaccine on 16-Jun-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received her first Moderna Covid-19 bivalent vaccine booster dose on 15-Jun-2023 lot number is 023H22A expiration date is 05-Jun-2023/42-year-old patient received expired Bivalent dose of Moderna COVID-19 vaccine on 16-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 16-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received her first Moderna Covid-19 bivalent vaccine booster dose on 15-Jun-2023 lot number is 023H22A expiration date is 05-Jun-2023/42-year-old patient received expired Bivalent dose of Moderna COVID-19 vaccine on 16-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received her first Moderna Covid-19 bivalent vaccine booster dose on 15-Jun-2023 lot number is 023H22A expiration date is 05-Jun-2023/42-year-old patient received expired Bivalent dose of Moderna COVID-19 vaccine on 16-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient received her first Moderna Covid-19 bivalent vaccine booster dose on 15-Jun-2023 lot number is 023H22A expiration date is 05-Jun-2023/42-year-old patient received expired Bivalent dose of Moderna COVID-19 vaccine on 16-Jun-2023).    No concomitant medications were reported.  It was reported that the vails were in intact cartons. The vial size was 2.5 ml. It was reported that the vial was initially stored in the refrigerator on 16-Jun-2023. The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2023: Live Significant follow-up appended: Suspect product details updated, event details updated and narrative updated.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On unknown date, the patient was inoculated with ZOSTAVAX at pharmacy center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 20-SEP-2013, the patient was treated by an Optometrist for the onset of rash, which was diagnosed as herpes zoster. He was prescribed Valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 14-Jul-2022). No concomitant medications were reported. The patient received half dose. The vial was initially stored in the refrigerator on 04-Jun-2022. Total 35 vials were affected. Reportedly, the vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
Pt developed facial rash on 6/2/19.  Was seen in ER on 6/3/19 and diagnosed with questionable varicella.  On 6/6/19 she was seen in clinic and case was discussed with infectious disease and they suspected attenuate form of measles secondary to recent vaccination.  Varicella Igm, Measles Igm, and Rubeola Ab was drawn.  Measles and varicella were negative, but measles nasal swab was positive.  Pt currently has DNA typing pending.
Case number PHEH2014US020477, is an initial spontaneous report received from a nurse on 09 Oct 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with men A lyophilized conjugate vaccine component on 26 Sep 2014. No adverse event was report following this administration error.
Pt received Menomune and Flu vaccine on 11/28/00 at 15:45. About 16:00, pt began experiencing shortness of breath, wheezing and chest tightness at about 22:00. Pt presented to health center at 08:00 with wheezing. Pt was given epinephrine, Benadryl and a nebulizer treatment with Proventil. Symptoms resolved and improved.
Mom noticed fine rash on child's face on Friday, 11/20/2009. Described as a "viral looking rash, not hives." Rash spready to back on Saturday, 11/21/2009. Completely resolved by interview date of 11/25/2009.
Patient was given the vaccination and then felt like she was drowsy, patient then leaned her head up against the wall and was falling asleep, patient's boyfriend picked her up out of the chair and laid her on the exam table were the patient looked like she was sleeping and then she started to gag like she was going to vomit, patient then started to vomit into the trash can. Patient was also sweating and very flush to the face, patient was given water and ice pack to put on back of her neck to help cool her down. Provider was notified of this all happening too.
presented to ED complaining on weakness, pt also disoriented, O2 sats dropped to 88% in ED so placed on 4L O2 also with elevated troponin - per cardio consult "Type II myocardial infarction in the setting of chronic kidney disease, anemia, Covid pneumonia" pt started on decadron 6mg PO qday and remdesivir
From History and Physical on 12/26/21:  Patient is a 82 y.o. female with history of hyperlipidemia, interstitial lung disease, hypertension who presents with shortness of breath, dyspnea with exertion.  Patient states that on Tuesday 12/21 she started having symptoms of runny nose, decreased appetite.  She has a mild cough but nonproductive.  She saw her primary care doctor who tested her for Covid and she was positive so he put her on steroids.  She did receive monoclonal antibodies on 12/22/2021.  She denies any fevers.  She does have decreased appetite but denies any loss of taste or smell.  She does have some diarrhea for which she took something over-the-counter and is now more constipated though she does say she had a bowel movement this morning. she is vaccinated but has not had the booster.  Patient was noted to have oxygen sats in the low 90s at rest with desaturation with ambulation so hospital medicine was called for admission
Developed  fatigue, lower back pain, facial puffiness and headache.  Did not report to work the day after the vaccine.  Symptoms resolved
The injection (left) arm is damaged in that I could hardly move the entire arm without severe pain even 6 months after. I waited this long to report because I had thought within 6 months, everything will resolve and I will be OK
Nov 1, 2021  8 hours sore arm, L hip pain Nov 2  stiff arm, L hip pain severe  feels like orthopedic concern Nov 3 hip pain severe Nov 4 red area on lower back Nov 5 red blisters, slight itching  shingles suspected Nov 6 urgent care   Shingles  (056.9, B02.9)   prescribed acyclovir 800 mg; prednisone 20 mg; gabapentin 300 mg Nov 7 multiple areas of blisters remain,    hip pain has resolved
Fatigue, starting   3/07/21. Reduced activity, rest; Fatigue persists thru 4/11/21.
I felt light headed, dizzy and I almost passed out approximately 20-25 minutes after the injection. I then took 1 tablet of Claritin in order to counter the reaction. I sat down outdoors, removed my mask and jacket so I could breathe better. I also ate a sandwich since I thought maybe I felt dizzy because I didn't eat a full breakfast. I stayed outdoors sitting down for 2 hours before getting up. I felt better after about 1 to 1.5 hours. However, as of March 6, 2021, sometimes I have a drowsy feeling like I'm on cold medication. However, I did not take any medication today. Also, for the 1st COVID vaccine I took on 11 Feb 2021, I took 1 tablet of Benadryl, which countered the allergic reaction which is why I did not have symptoms to report for the 1st dose.
Information has been received from a registered nurse concerning a patient who on 13-NOV-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse events were reported. Nurse stated this was not a product confusion, but the physician wrote down the drug name in the chart. No other information was available from the nurse. There was no product quality complaint. Additional information has been requested.
Sedation, Myalgia, Fever, Chills, Swelling @ injection site  Narrative:   Other Relevant History:
pt recvd vax & exp rxn at inject site(redness/swelling-size of a golf ball) & high fever;
Received vaccines 4/21/09. That night he had chills and temp of 100 degrees. Stayed home from school on 4/22 AM. Had been treated with MOTRIN. 4/23/09 c/o bad headache and soreness R underarm. 4/27/09 TC to mom - she report s/s resolved now.
Soreness/sensitive near the area I was given vaccine (after 8 days, still feels a bit sore and ?strange?). Muscle stiffness (felt when stretching). Headaches. Very itchy around the area on my arm where I was given vaccine.
First couple days, arm painful and headaches.  Plum sized area of redness and hardness. right arm has some roughness. Last two night horrible leg cramps.
Administer Hep A vaccine in Rt deltoid, immediately after pt had LOC, with arms and legs rigid. Episode last approx. 20-30 secs. Kept pt in lying position. Upon waking pt appeared confused and jump up yelling "where am I" "What happened?" Pt mildly combative, but easy to calm/reassure. Pt became weak again and was sat in a chair with assistance. MD notified. held in office for observation x 15 min.
Case number PHEH2014US003966, is an initial spontaneous report from a pharmacist received on 24 Feb 2014 with a follow-up received on 01 Apr 2014. This report refers to a 15-year-old female patient. Her concurrent condition included asthma. Concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX (batch number: 004011A, 006001A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly into left deltoid on 31 Dec 2013 at 3:20 pm. On an unknown date, 10 days after vaccination, she experienced an asthma attack. Seriousness, outcome and causality of the event were not reported. Follow-up received from a pharmacist on 01 Apr 2014: New event (asthma attack), concurrent condition, site and time of vaccination updated. Date of vaccination amended.
L shoulder 3cm Round warm indurated, no fluctuance, mildly tender L shoulder cellulitis.
Almost immediately after vaccination the recipient felt faint. She was helped to lay on the ground, vitals were checked and monitored, and remained stable. She quickly felt better and stayed in observation a total of 25 minutes. She reported that she has experienced this in the past when getting a blood draw or vaccine. She returned to her work unit with a colleague. We checked in with her a few hours later and she was completely fine.
Yf-Vax that was administered intramuscularly instead of by the recommended subcutaneous route, with no reported AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a patient of (unknown demographics) who experienced YELLOW FEVER VACCINE - US [YF-VAX] that was administered intramuscularly instead of by the recommended subcutaneous route (incorrect route of product administration).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to subcutaneous injection formulation administered by other route (same day).  It was reported "Physician reports a nurse gave YF-VAX by the intramuscular route instead of subcutaneous route. Do we have to re-dose it. Will it still last for life, or would a booster be needed."  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported 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 the 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 on the batch number for this case.