chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 20 years 1 month. No concomitant drug reported. It was reported that vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines. No treatment information was provided by the reporter.
Initial report received on 04 September 2009 from a consumer.  A 37-year-old patient, who has medical condition of "GERD" (gastroesophageal reflux disease) for which he takes PROTONIX, had received a first right deltoid injection of DECAVAC; a first left deltoid/thigh/buttocks dose of IMOGAM; and a first dose of IMOVAX on 02 September 2009.  The indications for post exposure vaccination was not provided.  The next day after receiving the vaccinations, the patient experienced body aches, sore throat and a fever.  It was not reported whether the patient required medical evaluation, or if he received any treatments.  At the time of this report, the patient had not recovered.  Documents held by sender:
patient began having hives that continued to spread and then patient stated lip numbness, patient was given PO benadryl, IM epi, and transported to ED for further monitoring and intervention.
vesiculobullous rash - information has been received from a woman in a physician's office concerning a 7 year old female patient who on 28 mar 1996 was vaccinated with a second dose of varicella virus vaccine live (lot 616866/1508b) It was noted that the office did not state which arm.  On 27 mar 2000 the patient developed a vasicular rash on her right trunk that consisted of more than 50 that were 2 inches apart.
Symptoms: Fever 100 to 101, diarrhea, nausea, sinus congestion Treatment: Tylenol, over the counter decongestant Outcome: Return to work on 8/16/2021
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 11-NOV-2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term 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 condition of herpes zoster or shingles. On or about 14-JAN-2015, the patient was treated by the physician for the onset of a vesicular rash 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (arm was red and swollen), erythema (arm was red), pain in extremity (arm is red 4 inches by 3 inches and sore) and pruritus (itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history information was not provided. Concomitant products included lisinopril for an unknown indication. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 4, 2021, patient experienced peripheral swelling (arm was red and swollen) and erythema (arm was red). On an unknown date, patient experienced pain in extremity (arm is red 4 inches by 3 inches and sore) and pruritus (itching). The patient was treated with Benadryl (diphenhydramine hydrochloride) for itching, at an unspecified dose and frequency. At the time of the report, peripheral swelling (arm was red and swollen) and extremity (arm was red): unresolved and pain in extremity  (arm is red 4 inches by 3 inches and sore) and pruritus (itching) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reportedly, patient was scheduled to received the second dose on Mar 31, 2021, however does not know if she should get the second dose since she had a reaction that went away and came back.
On day 8, my arm became more sore than on day 2/3. A red itchy ring appeared and has progressively gotten worse each day. I am taking Benadryl 2 at night and Zyrtec in the morning, using cold compresses and anti itch cream daily.  The redness/fever  is not as bad but the itchy ring is still present. It is over 18 cm across.
Nausea; Spontaneous report received on 13DEC2019.  A nurse reported that a female consumer had nausea (PT: Nausea), following immunization with Vivotif. On an unknown date about 2 years ago, the consumer took Vivotif but missed her last dose due to nausea. Action taken with Vivotif with respect to reported event was vaccine discontinued. At the time of report, the event had resolved.  Company Comment: A consumer who started taking Vivotif doses had nausea and did not take her last dose of Vivotif, and the event nausea resolved.The consumer was not certain if she had nausea prior to the start of Vivotif or not. Considering the potential of Vivotif to cause nausea, and the positive dechallenge, the causality of the event nausea is assessed as possible with Vivotif.; Sender's Comments: A consumer who started taking Vivotif doses had nausea and did not take her last dose of Vivotif, and the event nausea resolved.The consumer was not certain if she had nausea prior to the start of Vivotif or not. Considering the potential of Vivotif to cause nausea, and the positive dechallenge, the causality of the event nausea is assessed as possible with Vivotif.
feeling a little hazy; Blurred vision; general weakness; minor aches; nausea; body aches; slight headache; soreness in injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 08:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic type 2 controlled and Psoriasis. The patient was allergic to cucumbers. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), tiagabine (MANUFACTURER UNKNOWN) and meloxicam (MANUFACTURER UNKNOWN) and seven more medication, all for unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 09Mar2021 at 08:45 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 13:00, the patient experienced slight headache and soreness in injection site(vaccination site pain). On 31Mar2021 the patient experienced headache, nausea and body aches. On 01Apr2021 the patient experienced vision impaired(blurred vision), slight headache, slight nausea general weakness and minor aches. On 02Apr2021 the patient felt slight headache, slight nausea, slight weakness. On 03Apr2021 the patient felt little hazy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events slight headache, slight soreness in injection site, nausea, body aches, vision impaired(blurred vision), general weakness, minor aches and feeling a little hazy were recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
A report has been received from a Health Professional concerning a 17 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 20-Jan-2014. Inadvertently was given expired FLUMIST QUADRIVALENT to the patient. The patient experienced GAVE EXPIRED FLUMIST QUADRIVALENT which started on 20-Jan-2014. The outcome of the event of GAVE EXPIRED FLUMIST QUADRIVALENT is unknown. The reporter was considered to be non-serious by the reporter.
Swelling and Soreness at the side of injection. Round discoloration and itchy rash.
pt recv vax & w/in 12hr post vax pt exp contractions of the lt side of chest & pain down lt inj site arm;sx resolved by next day;
itchy; raised rash; rash on the injection arm on the under arm, above the elbow; "arm sore for two days",; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("arm sore for two days",), PRURITUS (itchy), RASH PAPULAR (raised rash) and VACCINATION SITE RASH (rash on the injection arm on the under arm, above the elbow) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY ("arm sore for two days",). On 01-Apr-2021, the patient experienced PRURITUS (itchy), RASH PAPULAR (raised rash) and VACCINATION SITE RASH (rash on the injection arm on the under arm, above the elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency; HYDROCORTISONE (topical) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. On 24-Mar-2021, PAIN IN EXTREMITY ("arm sore for two days",) had resolved. At the time of the report, PRURITUS (itchy), RASH PAPULAR (raised rash) and VACCINATION SITE RASH (rash on the injection arm on the under arm, above the elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: The follow up received on 01-JUN-2021. AE  contact information is (email) updated.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster) single (Lot number: FD0809) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received any Other medication in 2weeks, had no known allergies and no other medical history. Patient took Paxlovid for treatment of COVID-19 from 14May2022 to 19May2022. Took Paxlovid for 5 days and Covid symptoms resolved for three days and tested negative on day 5. Symptoms returned on day 9 with dark and fast line on at home test and positive on rapid test st doctor.
PATIENT HAS RAISED RED RASH FROM INJECTION SITE TO ELBOW, MOTHER STATED THAT SHE WAS MADE AWARE OF THE RASH IN THE EVENING.
Redness to right arm, severe edema, right arm , fretfulness, fevers, sore throat, malaise, cough, decrease appetite.
swollen lymphomas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included: TRAMADOL; MELOXICAM; HUMIRA. Past drug history included: Doxycyclin, reaction(s): "Drug allergy". The following information was reported: LYMPHOMA (medically significant), outcome "recovered with sequelae", described as "swollen lymphomas". Therapeutic measures were not taken as a result of lymphoma. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, bump under skin, fever, 3 inch round, raised red swollen area.
administration of expired vaccine to a patient with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had administration of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Aug-2023, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 mL (lot U7092AA, expiry date- 24-JUN-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Pharmacist requested information on what is recommended if a patient was inadvertently administered an expired TENIVAC. He did not know if the patient had received any concomitant vaccines and did not have information on where on the body the vaccine was administered.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
When getting the shot my arm felt norm and the next day severe pain can't stretch out at all.first I thought it was a sore arm of the vaccine. The pain continues. In December I decided to see an orthopedic and was told that the shot was g.j iven in the nerve instead around fatty area and it will take up to 6 months to get back to normal. Here I am now almost six months and still having pain as day one
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
11/20/2001-Patient received a tetantus vaccine after a foot laceration had occurred. 12/07/2001-Patient is seen for a 7 cm area of swelling and rash at the injection site.
weakness; entire arm pain; pain on injection site; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   On 25th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced weakness, pain in arm and pain injection site. On an unknown date, the outcome of the weakness, pain in arm and pain injection site were unknown.   It was unknown if the reporter considered the weakness, pain in arm and pain injection site to be related to Shingrix.  Additional details were received as follows: The patient had pain in injection site,then she experienced entire arm pain and weakness. It was reported that the friend of patient also experienced the same adverse events. This was 1 of the 3 cases from same reporter.
I have difficulty catching my breath from simple tasks such as vacuuming and cleaning. I first noticed it when I walked up my attic stairs to put something in storage and my heart felt like it was beating out of my chest.  My heart rate was over 150 bpm from walking up 5 stairs. My resting heart rate is around 60 and now when I stand it shoots to over 100 and my blood pressure drops.  My blood pressure is all over the place throughout the day. I am light headed when standing, dizzy, blurry vision, constant headaches, my arms get tingly feeling- especially when laying down and brain fog.  My period started 10 days early and only lasted for 1 day. I have been monitoring by side effects and keeping a journal so when I can speak to my primary we can review in detail.
Chronic pain in left shoulder; unable to raise arm; pain when trying to remove a shirt; unable to sleep on left side.
Fluid leaked out of the injection site, pharmacist giving vaccine rubbed in fluid to skin and the skin became very red and irritated.
pustule of skin, progressing to possible cellulitis. treating with bactroban, topical antibiotic. May need oral atb, but attempting tx with topical.
received dose 1 of Twinrix on 11/18/2020 and 2nd dose on 01/20/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HAB (Twinrix) 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.   Concomitant products included HAB (Twinrix).   On 20th January 2021, the patient received the 2nd dose of Twinrix. On an unknown date, the patient started Twinrix Pre-Filled Syringe Device. On 20th January 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 details were provided as follows: The patient received 1st dose of Twinrix on 18th November 2020. The patient received 2nd dose twinrix more than recommended interval, which led to lengthening of vaccination schedule. The reporter wanted to know when the patient could receive 3rd dose.  The batch number and expiration date were asked but were not available.  No further clarifications were performed. The reporter did not consent to follow-up.
COVID vaccine vial was inadvertently diluted with 0.8ml diluent instead of 1.8ml. Error was discovered when 3rd dose from vial was drawn up and it was found that there were no doses left in vial.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. Treatment included Paxlovid from 07May2023 to 12May2023. Patient experienced rebound Covid after 5 days of Paxlovid on 16May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's right hand started swelling and developed a red rash a few minutes after the vaccine. I asked if he was having any other severe allergic reaction symptoms such as trouble breathing/hives/palpitations/throat swelling etc and he said he was feeling fine. I advised him to remain seated for an extra 30 mins just to be safe. I called his PCP just to make her aware.  I had to leave a message since they didn't answer. The patient was feeling better after 30 mins. I advised him to call his doctor right away or go to the ER if he had any of the emergency symptoms/signs or if he wasn't feeling okay. I went over the list of severe allergic reaction symptoms with him too.
Stayed home on 3/2, was very weak. Wed went to work. Friday, menstrual cycle started 12 days early, which she had thick blood clots and noticed greyish color piece of tissue.  Saturday and Sunday, she started to move around after being in bed. Today, she feels about 90% better.
pt recv vax 30APR96 & pt exp a sl case of rash, fever & malaise;pt sibling who was vaccinated w/varicella exp similar sx;