chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After vaccines were administered, the child stood up abruptly and swayed.  The nurse asked if he felt all right and he said yes, and almost immediately fainted.  He was caught before he hit the floor.  Ammonia salts were utilized and he revived immediately and tried to stand.  Nurse and MA kept the child in a prone position for approximately ten minutes. When asked, he said he ate a little yogurt for breakfast.  Mom stayed on her phone.  When helped to a sitting position in a chair, the child lost color in his face again and dropped something from his hand.  MA and nurse wheeled the child to a sofa in an employee break room.  When given water, he drank it very thirstily and stated he had not had anything to drink all day.  Mom gave child a juice box which he drank completely.  He stayed on the sofa for approximately 20 minutes.  He had some shivering.  As he would drink fluids, he would regain color in his lips and face.  After a few minutes post-hydration, his color would pale again.  Mom remained on her phone, while stating to clinic staff that "he got too many shots."  (The child, a recent immigrant, did not have requisite vaccinations to enroll in school.  He received the five necessary vaccination for enrollment, and Mother requested that HPV be given also.)  Mother was educated about eating and drinking before the next visit and if the child needed further medical attention, to take the child to his doctor or an Urgent Care near their home.  The vaccines were administered at 10;40 and the family departed the clinic at 11:20.
Unable to use left arm after vaccination. Arm was extremely painful and I was unable to lift it.
He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19. He is scheduled for his second dose this weekend (16Jan2021-17Jan2021). He wants more information about his safety. What happens next, the do's and don'ts. He is asking if there is any information on this. The outcome of the event was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
This spontaneous report as received from a pharmacist (also reported as pharmacy student) refers to a 26 year old male patient. Patients medical history, drug reactions and allergies were reported as none. On 12-JUN-2013, the patient was vaccinated with first dose of GARDASIL, intramuscular injection, strength 120 Y, (lot number H015030, expiry date 28-MAR-2015), dose 0.5 ml, intramuscular for vaccination. On 13-DEC-2013, the patient was vaccinated with second dose of GARDASIL, intramuscular injection, strength 120 Y, (lot number H015030, expiry date 28-MAR-2015), dose 0.5 ml, intramuscular for vaccination. Concomitant medication was reported as none. Approximately on an unspecified date and month in 2013, the patient developed genital warts after receiving the first dose of GARDASIL. No product quality complaint was involved. No lab diagnostics studies were performed. On an unknown date in 2013, the patient went to see pharmacist. The outcome of the event genital warts was unknown. The reporters causality assessment for the event genital warts with the therapy of GARDASIL was not reported. Additional information has been requested.
pt recvd vax 26MAY95 & cried high pitched screaming for 1/2 hr during the day immunized;no fever or local rxn reported;
I lost mobility of my left arm, then my right shoulder and now low back and neck damage due to over usage from not being able to use my left arm.   I have spent money and time. I have been in constant pain. I can not reach over my head or behind my back. It is affecting the rest of my body.  It has been so long. I can not keep living like this.
Pain relievers for reaction to shingles shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. The patient was treated with analgesic, nos (Pain Reliever (Drug Name Unknown)). On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient experienced adverse event after shingle shot and asked whether it was ok to take pain relievers for reactions to the shingles vaccine.
It started off as a slight fuzzy/ cloudy feeling and then turned into heavy brain fog the next day. Then for the next 5 or so days the brain fog continued along with dizziness, lightheadedness, fatigue and a little bit of vertigo. It was so bad on that Thursday that I ended up missing work. It is mostly gone now but I still have some slight symptoms.
This spontaneous report as received from a health care worker refers to a 55 year old female patient. The patient was allergic to latex. The patient's pertinent medical history was unspecified. On 21-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 (Dose 0.5 ml) (lot # K007826, expiry date: 03-FEB-2016) in an unspecified arm. Concomitant therapies included prednisolone (manufacturer unknown), ACTIVELLA, LATISSE, levothyroxine sodium (manufacturer unknown), PAXIL, SINGULAIR, ULTRAM, WELLBUTRIN and RESTASIS. On the night of 21-NOV-2014 the patient developed fever of 102 F, felt achy all over, her arm swelled from the shoulder to the elbow and it was bright red and tender to the touch. The patient sought medical attention and no treatment was provided (also reported as treatment given was unspecified). The patient called the physician's office on 21-NOV-2014 to report the adverse experience, but she was not seen in the office. The outcome of the events was unknown. The causality of the events was not provided. No product quality complaint was reported for PNEUMOVAX 23. Lot check was requested. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Additional Details: PATIENT STATES HEADACHE ONSET 4 DAYS AFTER ADMIN OF VACCINE, HAS HAD HEADACHE EVER SINCE (STATES DOES NOT GET HEADACHES), ARM STILL SWOLLEN AFTER ADMIN
I began having off cycle vaginal bleeding on September 26, 2022.  It has continued to this date - so far 18 days.  I visited the doctor on October 10 to check for reasons for the bleeding including checking the position of my copper IUD and checking for other uterine issues.  I had an ultrasound on October 10 that revealed a small cyst on my left ovary and good placement of my IUD.  Not determined to be a cause of my bleeding.
The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023; No reported symptoms; patients received doses of vaccine after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD), PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023) and NO ADVERSE EVENT (No reported symptoms) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 29-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023) and NO ADVERSE EVENT (No reported symptoms). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD), PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023) and NO ADVERSE EVENT (No reported symptoms) 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 reported symptoms) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients received doses of vaccine after BUD) and PRODUCT STORAGE ERROR (The vials have been taken out of the Freezer on 25-MAY-2023 and were placed in Fridge on 05-JUN-2023 with a timed out date for 23-JUN-2023).    Concomitant medication details not reported by the reporter.  Reporter stated that on the day of report it was discovered that 2 vials of Moderna Bivalent Lot# AS7185B that were injection into 6 pts on 29-Jun-23.  The vials were taken out of the freezer on 25-May-2023.  The vials were placed in fridge on 05-Jun-2023 with a timed-out date of 23-Jun-2023.  It was reported that 2 patients had received their 6th doses and rest were 5th doses in this error.  Dosage text was reported as unknown.  Treatment details was not reported by the reporter.  This case contains information for the 4th patient out of 6 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732158, US-MODERNATX, INC.-MOD-2023-732468, US-MODERNATX, INC.-MOD-2023-732470 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732158:Master case US-MODERNATX, INC.-MOD-2023-732470:Patient 1 US-MODERNATX, INC.-MOD-2023-732468:Patient 1
WITHIN SECONDS OF RECEIVING THE FIRST DOSE OF PFIZER VACCINE PATIENT APPEARED TO HAVE A SEIZURE. HE BLACKED OUT, BECAME PALE, SWEATY, HUNCHED OVER WITH TREMORS.  IT ONLY LASTED A FEW SECONDS. WHEN PATIENT CAME TO, HE WASNT SURE WHAT HAPPENED TO HIM.
Diarrhea, headache, flatulence, stomach pain, fatigue, blurry vision, localized pain at injection site
This spontaneous report as received from a healthcare worker (office manager) refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccination with improperly stored VARIVAX subcutaneously, lot # L026407, expiration date 15-JAN-2017 (dose was not reported). There was no adverse effect reported. Additional information has been requested.
27FEB92 lt thigh muscle swollen below inject site; uncontrollable crying; advised to notify pts MD; 28FEB92 tc to home pt improved same instructions for comfort measures as clinic;
Entire left arm and hand began to swell within a short time after receiving injection, then became painful and client lost significant range of motion. Was evaluated by his PCP, treated for pain only.
I had running nose, sore throat, congestive, and cough. I had a fever and lethargic. I started having an earache.
Event occurred after 2nd dose. Patient was diagnosed with COVID-19. Tylenol, In-patient.
Sore ,pain after 2 hours later of the injection. in about one week, my upper arm started to get itchy and has some rash
No additional AE reported; an expired GARDASIL 9 was administered to a patient.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient. No concurrent condition, medical history, or concomitant therapy was reported.      On 19-JUL-2021, the patient was vaccinated with a expired dose (expired product administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (lot # R029515, has been verified to be a valid lot number, expiration date reported as 08-JUL-2021; strength, route of administration and anatomical location were not provided)  for prophylaxis. The vaccine did not experience any temperature excursions. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
1 inch x 1 inch abscess on left arm, currently being treated with cephalexin, may need I and D if doesn't clear up with antibiotic. Cephalexin dispensed 9/15/16.
Individual raised red bumps on trunk and neck. Minimal itching/no treatment @ this time.
Right upper lip swelling, itchy macular rash to face and bilateral ears began 46 hours after second dose of Moderna.  (This rash also occurred after first dose of Moderna as well but uncertain as to whether this was reported.)  Prednisone twice daily x 5 days, antihistamines, follow up with PCP.
Skin it extremely itchy and no amount of scratching satisfies it. Each itchy episode begins with 1 itch, and lasts 10-15 minutes. Scratching it causes the itch to travel all over the body. There is no rash, just itchiness. This happens 3-5 times a day, every day. I first noticed about 1 week after receiving my 2nd dose.
TIREDNESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious.
PT BEGING HAVING LIPS SWELLING BENADRYL 50 MG IM GIVEN PT HAS EPI PEN WITH HIM TRANFERED TO ER FOR FURTHER EVALUATION
pharmacy has suspended given 2nd dose of Shingrix to patients / not sure how long past the recommended 6 month; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that due to safety concerns the pharmacy has suspended giving 2nd dose to the patients. The reporter stated that they are not sure when it will resume and how long past the recommended 6 months.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 13Sep2023 to 17Sep2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following injection, patient reported redness and swelling of arm around injection site.  Throughout day, worsened and pt went to emergency room where she was treated for cellulitis.
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported RECOMBIVAX HB, (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013. The nurse practitioner reported that GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS # 1401USA000269), 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013. PEDVAXHIB (Lot# J005670, expiration 12/17/2015) was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 (MARRS# 1401USA000276) and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). No adverse effects reported. No further information was provided. Additional information has been requested.
PATIENT RECEIVED A DOSE OF THE MODERNA COVID VACCINE AND HE WAS UNDER THE AGE OF 18. SPOKE TO PATIENT TWO DAYS POST VACCINATION AND HE REPORTED NO ADVERSE REACTIONS AND FEELING WELL
(L) arm painful to touch and hot, 13cmx10cm erythema no induration noted. Dr is aware. Per mom no fever, (L) arm ROM wnl sore at times.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Additional Details: Swelling, redness, pain, and headache have improved significantly, but have not resolved.
1700 on 2/24: headache and fatigue 0400: woke up with chills and nausea
After I gave third Rabies shot and walked out the door, client husband came outside and told me his wife was alittle light headed and heart was racing, and had to sit down.  She also told me she just took her inhaler prior to me coming to the house. After a few minutes she felt better, and proceeded to go shopping with family.  I explained to her when she gets her last shot, if she wanted to she could take some Benadryl before her next shot.  She also told me this happened after her first 2 shots, but just never told me. When client got her last shot, she never stated anything to the nurse.  No reactions noticed.
pt recv vax & devel GBS;pt has been unable to work for 4mo & hosp as of 27MAR98;reporter declined to provide further info;
Patient received Pfizer for first dose (2/27/21) and was accidentally given Moderna for her second dose (3/20/21).
Expired Vaccine Administered. Employee states increased redness at site. No other adverse symptoms reported.
Systemic hive formation/ face/ trunk/ extremities. 48 hours past vaccine dose. DTaP #2/ Comvax/ IPV and Prevnar given 7/13/04.
On Jan 28, 2021 a red rash at injection site developed. Red, tender, itchy.
Shortly after receiving his first COVID shot, he became faint.  Nurse alerted by another parent who had accompanied her son that the patient was dropping his cookie.   0935, as nurse came up behind patient, accompanied by principal, patient slumped to the left and was holding him in place to prevent him from falling to the floor.  Color was pale and dusky as moved hair out of his face.  Stimulated patient and assisted to cot to get blood flow to brain.  BP 120/84, pulse 52 and 97% pulse ox reading.  At 9:43: sitting up in chair and drinking water, 99% pulse oximeter and pulse 61. Patient recovered after 30 minutes and went back to class.  Principal notified his mother and wanted him to return to class.
Significant pain and mild swelling in vaccinated arm. 200 mg Naproxen at 6 PM did not reduce pain significantly, so 600 mg Ibuprofen was also given at 9:30 PM, reducing pain enough to sleep.  Fatigue throughout evening.  Pain continued at decreasing levels at least through date of reporting, with still noticeable swelling.
MEDICATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced medication error. On 13-MAY-2021, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error and incorrect storage of vaccine was not reported. This report was non-serious.