chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a "15 year old" female who on an unspecified date was vaccinated with a second 0.5ml dose of GARDASIL (lot # 663453/0249Y) IM. The physician stated that "a patient developed a vasovagal reaction, including staff hands and her eyes rolled back into her head after receiving GARDASIL on 06-OCT-2009." "The nurse stated that she did not believe GARDASIL was the cause of this, but rather the patient had been very nervous about receiving the vaccine, the patient did not eat anything that day before receiving the vaccine, and she was just recovering from the flu." The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who on 04-AUG-2009 at 3:30 pm was vaccinated with the first dose of GARDASIL (lot # 663451/0216Y) IM and on 06-OCT-2009 at 4:30 pm with the second dose (lot # 663453/0249Y) IM. The father stated that the patient had been sick with "flu" the week prior to the vaccine. On 06-OCT-2009 at 4:30 pm to 4:45 pm, the patient appeared to have a vasovagal response. She got pale and her eyes rolled back. Her teeth clinched and she was unresponsive for 3 to 5 seconds. It was noted that the patient had not eaten all day and had been sick with "flu". The patient was also very nervous about the shot. PHENERGAN suppository was given due to nausea. There were no labs and diagnostic tests performed. The patient was watched for 45 minutes with the doctor present. Subsequently, the patient recovered on 06-OCT-2009 and left with her father. No further information is available.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, 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.   On 6th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th 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: 13-JAN-2023 Reporter's Comment: The pharmacist reported that a patient inadvertently received an expired dose of Twinrix. The expiration date was 1st JAN 2023.  The lot number available.  The reporter declined to provide additional information. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Spotting after first dose, have not had a menstrual cycle since before my first shot. Ive had period symptoms but no bleeding. I am 10 days late for my cycle as of 5/16/21
pt recvv ax 27MAY97 & 27MAY97 pt exp soreness @ the inj site;
Her arm is red, warm, itchy and hard. It is sore to the touch. It started at injection site and it spread over arm. The MD diagnosed cellulitis.
Information has been received from a pharmacist concerning a 15 year old female with eczema who on 15-JUL-2009 was vaccinated with the first dose of GARDASIL. On 15-JUL-2009 the patient experienced extreme fatigue and an exacerbation of pre existing eczema after her first dose. The patient sought medical attention. Severe fatigue was considered to cause a disability because the patient could not get out of bed. At the report time the patient had not recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Pt received Bivalent Pfizer dose when patient should have received monovalent 2nd dose.
This spontaneous report was received from a Licensed Practical Nurse referring to 7 patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with M-M-R II lot # K022284 with expiration date of 12-NOV-2016; lot # L003858 with expiration date of 05-FEB-2017; lot # L015280 with expiration date of 30-APR-2017 and lot # L034731 with expiration date of 09-SEP-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was stated by the reporter, that the vaccine was exposed to a temperature excursion of 9 degrees C for 35 minutes. The vaccine has not been exposed to any previous temperature excursion and a data logger was stated. Furthermore, no adverse events were reported due to M-M-R II vaccination and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
DIZZINESS, LIGHTHEADEDNESS, ITCHY ALL OVER BODY (NO HIVES), BLURRED VISION.
A 9 year old white female presents complaining of a rash on her lower abdomen and legs. The patient got a Hepatitis B injection, Monday morning. The same day she broke out in that rash. She describes an erythematous pruritic ash initially over her trunk. She he has been taking Benadryl since then. Over the last several days the rash has migrated slowly down her body. Now it is present on her lower abdomen and lower extremities. The patient is well nourished, well developed, no apparent distress. The patient had a pulse of 128, BP 120/82, respiration's 22, temperature is 101.8. Examination of her skin reveals an erythematous rash with raised edges over the trunk and both legs. No excoriation's. Allergic reaction to Hepatitis B shot. Recommend for the patient to continue Benadryl, prescribed Prednisone taper for seven days. To follow up if any significant worsening or if no improvement in one week. Recommend that they not continue the Hepatitis series.
Information has been received from a 60 year old female nurse practitioner who on 24-OCT-2007 ordered and vaccinated herself with a dose of zoster vaccine live (Oka/Merck). On approximately 26-OCT-2007, the patient experienced sensitivity, rash and redness around area. The patient wanted to know with this going on was she contagious and could she cause harm to a woman who was pregnant. No medical attention was sought. There was no product quality complaint. Additional information has been requested. 06/24/2008 Initial and follow-up information has been received from a 60 year old female nurse practitioner who on 24-OCT-2007 ordered and vaccinated herself in the abdomen with a dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. On approximately 26-OCT-2007 the patient experienced a red, raised, painful lesion (also reported as rash) around the injection site. The patient wanted to know with this going on was she contagious and could she cause harm to a woman who was pregnant. No medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Client had received Moderna primary series in January 20 21 and February 2021. At the time client was 16 years old. Client presented today for Moderna booster and it was identified the patient was not eligible for Moderna due to being under 18. However Pfizer is approved for under 18 Pfizer was administered as a booster and patient is still not eligible for a booster due to age under 18 .
On 08/17/2022 at 7:00PM I had chills, fever, headache and tiredness. On 08/18/2022 I took a home test which was positive. I called my doctor  in the morning who prescribed me Paxlovid for 5 days.  It took me  17 days to test negative. I felt better in 3 weeks in total.
shot hurt more than usual shotsSOB x 1 1/2 days HA, muscle aches, swelling and redness at site x 3 days
patient came in on 3/2/21 and reported having blurred vision since the day he received the vaccine on 2/24/21. he said the blurred vision came hours after receiving the vaccine on the same day
I had an unexplained fever of 102.3F that went on for eighteen days, stomach upset, headaches, off and on diarrhea. I had many doctors visit, trips to the emergency room, trips to the urgent care. My blood work that my primary care physician ran came back negative. I ended up going to the emergency room, I was still not feeling well. They did a CT scan of my head because of the headaches, it came back negative, the chest x-ray came back clear. The test for COVID-19. RSV, Influenzas A and B came back negative. Eventually I started to feel better.
mom called clinic 29DEC94 to report that pt had had high pitched cry & screamed 9-11PM on 17NOV94 p/obtaining DTP/HIB & OPV; mom had called own PMD @ that time & reported situation;
No adverse effect reported; a male patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 19-JUN-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R030612, expiration date 23-OCT-2020 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion from -14 to -10 degrees Celsius (-13.3 degrees Celsius) for 30 minutes and from 9 to 25 degrees Celsius (17.8 degrees Celsius, multiple) for 32 minutes. The data logger was involved. There were no previous excursions reported. There were no adverse effects reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008340: US-009507513-1906USA008121:
Rheumatoid arthritis flared up; Lack of drug effect; Early morning stiffness; Nodule on extremity; Headache; Very tired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), DRUG INEFFECTIVE (Lack of drug effect), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nodule since 2019, Teetotaller (Abstains from alcohol.), Drug allergy (Associated manifestation for the sulfa drugs allergy was rash and for the ACE inhibitors allergy was chest tightness), Peanut allergy (Associated manifestation for the peanut allergy was rash) and Non-smoker.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) to be not related. No further causality assessments were provided for RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect).    Treatment information were included prednisone and acetaminophen.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.   This case was linked to MOD-2021-096000 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.
patient came in for "updated" pfizer booster and received regular booster; pt advised to come back in 2 months for correct booster.  The new booster is not available at this facility at this time.
Patient was on a conference call and the other participants noticed some facial drooping. Patient felt better following the call and did not seek care until the following morning (10/19/21). Patient was evaluated by primary care provider and determined that he had experienced a TIA (mini stroke). Patient is currently back at home and will be following up with cardiology and neurology to look at long-term issues/damage.
Arthus reaction manifested by local erythema and edema to just above the elbow that slowly improved over the following 6 days.
Type 1 Diabetes- discovered by repeat urogenital infections with glucose in urine. UTIs started in late July 2021 and diagnosis was early August 2021.
48 Hours after immunization seen and had apprx. 7 x 10 cm erythematous, warm, indurated area not painful. No treatment given. Labs NL. Did not come for followup and seen again 2 moths later for sick visit and no evidence of lesion.
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 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE  1; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE  3 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no known allergies. Paxlovid taken from 18Oct2023 to 23Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352143 Same patient, different product, different event;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-APR-1994, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were not provided). On 06-JUN-1994, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. The reporter stated, that the patient received the dose of GARDASIL 9 a few weeks to early and they would give the correct dose soon (inappropriate schedule of drug administration). At the time of the report, the patient had not been re vaccinated. Additional information has been requested.
Intermittent parenthesis of right cheek; covid test date Sep2021, covid test result Positive; covid test date Sep2021, covid test result Positive; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old non-pregnant female patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, via an unspecified route of administration, administered in Left Arm on 23Mar2021 at 12:00 AM (Batch/Lot Number: ER2613) as Dose 2, Single (age at vaccination:70-Years-old), via an unspecified route of administration administered in Left Arm on 26Feb2021 (Batch/Lot Number: EN6198) as Dose 1, Single, both doses for Covid-19 immunisation. The patient medical history was not reported. Other medications in two weeks as Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine hydrochloride (CYCLOBENZAPRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously took bnt162b2 for covid-19 immunisation, amoxicillin and experienced hypersensitivity. The patient was not diagnosed with covid-19 before and tested post vaccination. On an unspecific date in Sep2021 the patient experienced covid test date sep2021, covid test result positive (vaccination failure). On 10Jun2021 patient experienced intermittent parenthesis of right cheek. On unspecific date in Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test as positive. The patient had not received treatment for the intermittent parenthesis of right cheek. The outcome of the Intermittent parenthesis of right cheek was not recovered, and unknown for the other event.  Follow-up (15Nov2021): Follow-up attempts are completed. No further information is expected.
Chest warm and tingling sensation. EMS evaluated. Stayed for40 minutes sensation transient  went home
9.8 pain rating after receiving the first; Lupus acting up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 18:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). Concomitant medication(s) included: NORCO taken for systemic lupus erythematosus; TRAMADOL taken for systemic lupus erythematosus. The following information was reported: PAIN (non-serious), outcome "unknown", described as "9.8 pain rating after receiving the first"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Lupus acting up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  Additional information: Caller (over 65 years old) calling regarding her daughter who had Lupus and had received her first dose of Pfizer COVID vaccine on 20Mar2021 and would be getting her second dose tomorrow, 10Apr2021. She was told by her doctor not to take methotrexate. She had a 9.8 pain rating after receiving the first shot, but the caller was not sure if it might have been due to the Lupus acting up. After the first dose at 6 pm, her daughter complained of a 9.8 rated pain, so the caller gave her Norco and offered Tylenol, but her daughter did not want to take Tylenol. What really helped her was the Diclofenac (Voltaren) gel, but it was only temporary relief. Caller states her daughter normally has Lupus in the morning and normally takes Norco or Tramadol in the morning. Caller was asking if it is ok for her daughter to take Norco or Tramadol in the morning when her second dose was scheduled in the afternoon at 2 pm Caller also asking if her husband should not take his Aspirin that he normally takes at night before he gets his vaccine Caller also asking if her husband could continue to take his blood pressure medication for his heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. received MENVEO on (L) deltoid as well as TDAP after 24 hrs MENVEO site had slight cellulitis. Told to do cold compresses to site and BENADRYL. marked area with pen; no fever; told if site got bigger to be seen in office. Mom understood plan.
Patient informed immunization clinic staff that she was unaware of pregnancy at time of vaccination on 12/11. She is having labwork done today to determine if she is indeed pregnant.
12 hours after the yellow fever vaccine he developed joint pains, fever, shortness of breath and just felt like he had the flu. It lasted 1 1/2 days. He didn't call the office or go to the ER. He states he is fine now.
Breakthrough case admission after 3 vaccines Moderna 3/6/21 Lot# 029A21A;  Moderna 4/3/21 Lot# 045A21A;  Moderna 10/28/21 Lot# 071F21A
Pt reports ongoing difficulty with knees, fingers difficulty walking - stiff fingers (developed Hepatitis after vax, treated)
pt had 1-2cm raised, flesh colored bumps devel on rt leg;approx 8 bumps on 19JUL96;mom noticed 5 bumps on lt leg on 22JUL96;also noticed 3 bumps on forehead, 3 on back & 4 on rt arm, mom states pt fussy, afeb, bump not going away, non-pain
Systemic: Seizure-Mild, Additional Details: *Patient did not receive COVID vaccine. unable to proceed without selecing covid vaccine. *less than a minute after receiving FLUZONE vaccine, patient fainted to the floor with body tremors lasting less than 1 minute. pale palor. no recollection of fainting. numbness reported.. bp laying was 118/82 sitting up 92/70. stated  no food today and decreased appetite prior to vaccine. blood sugar check declined.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 22nd March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 25th March 2019, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient provided limited information, as he did not want to answer question regarding his experience. The patient did not consent to follow up.