chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered dose, expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 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.   Concurrent medical conditions included transgender (male at birth but identified as female at the time of reporting).   On 4th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th March 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 details were provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up. Note- Healthcare professional reported that, the patient's gender was male at birth, but identified as female at the time of reporting, hence gender was selected as female in Argus.
Clammy, sweaty, low blood pressure of 92/45. Patient recovered to normal after about 20 minutes
fatigue; Soreness in injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection site left arm) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injection site left arm). On 15-Jan-2021, the patient experienced FATIGUE (fatigue). On 15-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness in injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-265396 (Patient Link).   Reporter did not allow further contact
pt vax w/ 1 dose varicella live @ 12 months of age;  UNK if HIV sero positive then; diagnosed w/ HIV at 15 months of age; @ 2yr of age pt vax w/ flu + developed shingles on L leg same day; pt on AZT and prescribed ACV p/ diagnosed w/ shingl
Nausea and vomiting for about 12 hours.  I was not able to keep down any food or drink.
The patient received her second dose on Sunday and her symptoms started around 11:30 AM on Monday.  She reported stabbing cramps, she felt like she was going to pass out, and reported tingling in her fingers.  She went home from school and tried to  lay down.  She also took ibuprofen and the cramping went away.
Erythema of 17 cm with 6 cm induration extending over lt deltoid region from just below shoulder to above lt elbow at injection site in lt arm.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 42 year old female patient who received hepatitis B vaccine recombinant Engerix B. On 3/24/2005, the patient received the first dose of Engerix B in the left arm (lot ENg5595B). Almost immediately following the first dose of Engerix B, on 3/24/2005, the patient experienced an injection site reaction characterized as tingling. the injection site tingling was ongoing at the time of initial reporting, 3/28/2005. The nurse considered the injection site reaction to possibly be related to vaccination with Engerix B.
Subconjuctival hemorrhage of right eye.  Entire white of eye very very red.  Resolved over a period of weeks.  After second vaccination on 2/18/2021, lot number 030M20A, blood vessels in eyes are very red and prominent (unlike ever before in my life).  Scared to look at in mirror.
pt recv vax 25OCT96 & on way home was involved in auto accident & taken to hosp & released;26OCT96 began w/diarrhea, vomiting & t101;seen by pvt MD sent home on ATB w/OM;adm to hosp w/sz;put on respirator & IV fluids;tx viral meningitis
This spontaneous report was received from a licensed practical nurse and refers to seven patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L023232, expiry date 25-FEB-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of VAQTA underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 1/29/99; on 1/30/99 pt exp vax site sore, swollen, red
Grandma had said patient got her shot on Monday. She had a knot there. She stated she called on Wednesday and was told to take BENADRYL. She came in on Friday. Still had knot, arm was red and she was favoring her arm. Patient's arm was tender, warm and a little erythematous.
2 hours later, throat tightness and itching, stomach pain. Lasted 3 hours. Did not recur with second injection.
She stood up after her vaccine.  She looked at me with sort of a blank stare and I asked her if she was ok and she just sort of folded to the floor.  Instructed  someone to call 9-1-1, checked on Mary.  She was breathing and started talking to me.  I found out her parents were outside the store in the car and I had someone go get them  They said this is a frequent thing.  Probably not related to her getting the vaccine.  Paramedics got here, monitored her for about 30 minutes and it was jointly decided between them and the parents to take her.
6 x 4 swelling R/upper arm, lasting more than 6 days. Started 24 hrs after DTAP, 1/12/00.
Body aches and cramps, headache, fever, chills, sweats, dizziness, loss of appetite, unable to eat, brain fog, extreme fatigue.   I was dysfunctional for 4 days and had to stay in bed.  The fatigue continued for 3 months.,  My chronic migraines, digestive problems, insomnia, and light sensitivity all got worse.  My migraines became twice as frequent and I had to double my dose of migraine pain medication for each migraine event.  I am still recovering.
A MA reported that an 8 month old female received her 4th dose of Prevnar on 8/21/01. On 8/23/01, the infant developed an abscess at the injection site. The infant was treated with cefaclor for 10 days. No additional information is available as of the date of this report.
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included live, oral ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II and live, oral ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Medical Record # 147563, Rotavirus vaccine date given 11/01/2012. Lot # 0210AE. Additional information has been requested.
In less than 12 hours - fever (temp 102) - body aches/diarrhea - abdominal pain - (lost 10 lbs) TYLENOL did not help - pt in bed for approximately 36 hrs.
Obtained injection into Left Deltoid on Thursday, Friday area firm, by Sunday afternoon area red, firm with edema, measured 6.5inches long by 3.5 inches wide. Stated had a few hives, and felt jittery. Did not inform me until after the fact. Did not seek treatment and symptoms went away. I viewed on Tuesday, no edema, slight red area faded, areas of hives were actually scratched with no raised indication on Tuesday.
SUBJECT RECEIVED SECOND DOSE OF MODERNA VACCINE ON DAY 24 INSTEAD OF DAY 28.. NO ADVERSE EVENTS REPORTED.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVEL QIV Pre Filled Syringe. The patient complained of a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifiers or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the 5 cases, reported by the same reporter.
fever; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 03Mar2021 (at the age of 36 years) as dose 2, single for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient previously received the 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 a dose 1, single for COVID-19 immunization. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 03Mar2021 at 21:00, evening of the second dose, the patient experienced fever which continued for 18 hours. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if any therapeutic measures were taken as a result of the event. The outcome of the event was resolved on 04Mar2021. Follow-up attempts have been completed and no further information is expected.
About 3 days after H1N1 Flu Vax he developed cough sore throat headache, and active fever. He also vomited 3 times with no diarrhea.
Date is approximate. I received a flu shot as well as shingles vaccination (1 of 2 expected) during my annual physical. Have never had either before. A few days later I started experiencing joint pain over my whole body. All blood tests have been negative. Hand XR and ultrasound showed inflammation and I was started on Prednisone (worked well) and Plaquenil to which I developed a severe allergic reaction (known and treated successfully). Rheumatology restarted investigation as to cause of joint pain (worsening). Still not resolved, but tentative plan is to start me on Methotrexate (in spite of negative blood test results for RA factor or anything else). I am reporting as I am highly suspicious of the timing compared to the immunizations and the rapid deterioration. I had some joint stiffness previously, but never any pain. I also have some known osteoarthritis (I am 56) but this has been a very rapid change and pain and swelling are not minor (Sometimes I have trouble holding a pen, or lifting a cup of coffee). It may be that this has nothing to do with the shots, but I wanted to report in case there is a link. Thank you!
Received MMR, Varivax on 2/11/03 over R thigh. Developed urticaria skin rash-target lesions with central pallor, circular raised edges 1-2cm x 4-5 indurated, warm over R thigh at injection site.
Male was administered single dose of Janssen Vaccine on 5/21/21.  Male neglected to inform staff that he had previously been administered both doses of Moderna vaccine on 1/19/21 and 3/3/21. Male has now received a total of 3 doses of covid 19 vaccine.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179301:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
patient did not suffer any adverse affect; the syringe broke at the finger flange while attempting to press the plunger; patient did miss GARDASIL 9 dose; syringe broke at the finger flange while attempting to press the plunger and medication into patient; This spontaneous report as received from a nurse, via a company representative, refers to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 19-JUL-2019, during the administration of one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # 1602283 and expiration date 18-AUG-2021 (strength, dose and route of administration were not reported), for prophylaxis, the syringe broke in two pieces at the finger flange while attempting to press the plunger and put medication into patient (poor quality device used and product quality issue). The reporter stated that the staff did not report having dropped it or any report of mishandling prior to administration. The patient did not suffer any adverse affects, but missed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose (product dose omission) and refused to have another injection administered.  The outcome of product quality issue and the action taken with the suspect therapy were unknown. Causality assessment for product quality issue was not provided.
Shingles; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COPD, Vitamin D deficiency and DVT in 2018. Concurrent medical conditions included Hypertension, Clotting disorder and Hypertension. Concomitant products included MOMETASONE FUROATE (ASMANEX), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) and SALBUTAMOL (ALBUTEROL) for COPD, APIXABAN (ELIQUIS) for DVT, LOSARTAN for Hypertension, VITAMIN D3 for Vitamin D deficiency.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017443 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No new information (NNI) was added On 27-Apr-2021: patient demographic details was updated, medical history information was updated, concomitant medications was updated, events was updated; Sender's Comments:  MOD-2021-017443:same patient, two doses
She needed some air . Stepped out of the store and while talking to her she was dizzy lightheaded and had nausea . no problem with allergies . Just dizzy . takes a few seconds  to respond to questions. Paramedics came and took over.
Flu like symptoms, shaky knees, nauseous, weak. Arm sore after 5 days.
Pt recvd 1st & 2nd dose of Engerix-B on 12MAR91 & 10APR91; About 3 wks ago (from 14MAY91) exp aches in legs, tiredness, knees & legs feel heavy, sleep like never slept a/;
Respiratory Infection; A spontaneous report was received from a 38-years-old female patient (nurse) who experienced respiratory Infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 08-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in left upper arm for prophylaxis of COVID-19 infection.   On 25-JAN-2021, 18 days after receiving the vaccine, the patient had onset of symptoms and was later diagnosed with a respiratory infection.   Treatment information included amoxicillin and broncolin.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), respiratory Infection was recovered/ resolved on 07-FEB-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID Arm for 14 days, delayed reaction reappeared after Day 8. I had nausea and headache/muscle pain and arm muscle tension for two days. It has gone, but the delayed reaction appeared on Day 8. It is still itchy.
Redness, heat, swelling - of left arm, day after given FLUZONE HIGH-DOSE 2016-17 SYR - applied ice, took antihistamine - 25 mg - Redness (heat) lasting 5 days - below injection site - in muscle area.
Patient at Rehab center (who was conducting vaccine clinic at the Rehab facility) that he had received his first Moderna dose but never got the 2nd dose. 0.5ml of Moderna vaccine was administered IM in Left deltoid. When entering information into database, I discovered that his first dose was Pfizer, not Moderna. He received one dose of Pfizer on 4/3/2021. He received Moderna vaccine on 10/22/2021. No adverse reaction was noted at time of administration or for 15 min observation.
Mom called on 11/22/11 said symptoms of rash & red bumps on head neck arms started 11/21/11. Then called again 11/23/11 symptoms got worse supportive care given & Dr. also called pt. at home.
2nd vaccine administered 4/17 and on 4/19/21 he started to have chest pain not relieved by Tylenol and presented to ER with high Troponin.
Described by husband. After 8h. very, very confused, nauseated, dizzy, and feeling hot and cold. Stayed in bed for 2-3 days.
17 Year old patient received 1st Moderna dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old patient received 1st Moderna dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old patient received 1st Moderna dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 Year old patient received 1st Moderna dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The treatment information was not given.
Circle where it looks like the vaccine is sitting there under my skin; My arm is swollen and painfull; My arm is swollen and painfull; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (15 years ago mostly on  face. It was painful) and pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site reaction (Verbatim: Circle where it looks like the vaccine is sitting there under my skin), swelling arm (Verbatim: My arm is swollen and painfull) and pain in arm (Verbatim: My arm is swollen and painfull). The outcome of the injection site reaction, swelling arm and pain in arm were not reported.   It was unknown if the reporter considered the injection site reaction, swelling arm and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the injection site reaction, swelling arm and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date:10-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had shingles maybe 15 years ago mostly on face.  The reporter did not know what it was until he/she went to the doctor. It was painful.  The reporter got the first dose of the vaccine a few days ago.  His/her arm was swollen and painful.  There was a circle where it lookeed like the vaccine was sitting there right under the skin. The reporter felt that he/she had a reaction to the vaccine. The follow-up could not be possible as no contact details were available.
Recipient vaccinated on 12/28/20. On 1/7/2021 the injection site became red, tender, and burning, and the skin was hot to touch.  Patient is being treated with Cephalexin 500mg QID x 7 days for suspected cellulitis.