chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant (also reported as "nurse practitioner") concerning an approximately 26 year old female with no pertinent medical history and no drug allergy or reaction who on 11-NOV-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot number: 662404/0312Y; expiration date: 03-APR-2011). There was no concomitant medication. At an unspecified time after the injection the patient reported that she developed redness, swelling and tenderness at the injection site that lasted for two months. Medical assistant reported that the patient reported that she did not experience a reaction to the first dose of GARDASIL. No lab diagnostics study was performed. The patient did not seek medical attention. At the time of the report, the patient's present status was unknown. Additional information has been requested.
patient passed out after vaccination given. Patient stated she felt nauseous then loss of consciousnes thereafter. Nurse practitioner informed and assesed patient. patient recovered
The patient was administered a flu shot on 11/18/2022 and 12/21/2022.  He was administered two within the same flu season.
Client seated next to nurse, HPV #2 given in left arm, IM. After injection, client stated that she thought she was going to faint. While seated, she began to fall back and was caught in arms of nurse giving injection. Mother was told that nurse would ease client to the floor, at which time client sat up and said, "did I go to sleep?". Client was unresponsive from 3-5 seconds. Cool packs applied to back and neck for about 10 minutes. Client very pale and stated she was hungry. She ate an apple and the color returned to her face. Client observed for 15 more minutes.
a big red circle  came up on arm around the injection spot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (a big red circle  came up on arm around the injection spot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a big red circle  came up on arm around the injection spot). At the time of the report, VACCINATION SITE ERYTHEMA (a big red circle  came up on arm around the injection spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Pain and redness at injection site followed by body aches, head aches, nausea, fever, vomiting starting approx 2 hours after vaccines administered treated with TAMIFLU and TYLENOL. Pt to return to clinic in one week.
Information has been received from a medical assistant concerning her 18 year old daughter with family history free from abnormalities who in August 2006, was vaccinated with Gardasil (lot # not reported) injection, IM. Concomitant therapy included varicella virus vaccine live (lot # not reported) given in September 2006). The patient sought medical attention. At the time of reporting, the patient was 4 months pregnant (estimated last menstrual period 03-NOV-2006 and estimated date of delivery 10-AUG-2007). Her unborn child has fetal abnormalities which were detected shortly after vaccination with Gardasil and varicella virus vaccine live. On an unspecified date, the patient had ultrasounds and amniocentesis  performed. Additional information was received from the patient's mother via telephone call who reported that her daughter is currently under the care of perinatologist. Additional information has been requested.
Bruising to LUA, red and warm to touch localized reaction noted to be approximately size of RN's hand. No streaking, no fever. Client plans to follow up at walk-in clinic.
Per patient started to have heavy bleeding, halt on menstruation then ongoing menstruation for 3 weeks  after receiving pfizer vaccine
Swelling and redness to left shoulder down to mid upper arm, hot to touch, child complained of area itching.
was "not right" 6 days after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "was "not right" 6 days after receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt states the site was red, streaky, hot to the touch, swollen and that the ancillary lymphnodes were very swollen. PT was seen by Urgent care provider and was prescribed antibiotics.
increase in tinnitus in both ears within an hour of each dose. an audiogram indicated no loss of hearing.
Patient received Pneumovax injection on 9/3/03. Returned to PCP office 9/4/03. Complaints of left upper arm pain and swelling. LUE ultrasound showed left bascilic vein clot. Patient admitted to hospital; started on Heparin and Coumadin. Discharged from hospital 9/5/03 on Coumadin.
ON 7/13/2021 PATIENT PRESENTED TO THE CLINIC FOR HIS BEHAVIORIAL HEALTH FOLLOW UP APPOINTMENT.  AT THIS TIME HE STATED "i think i maybe allergic to Moderna due to my reaction on 06/16/2021 after his second Vaccination here at clinic. I felt  fine for a few hours, got home and about 4 hours after my vaccine I lost all control of my movements. I fell to the ground and could not move for roughly 20 hours. I finally was able to crawl to phone to call my sister who came to assist me."  Patient shared that he didnt eat or drink or take his medications during this time.
Moderate vertigo, dizziness, nausea, can stand up, symptoms still there at 10 a.m., does not need treatment at this point.
Vomited 3 times in a 24 hr period low grade temp; pt did go to MD;
i am going to get sick; tinnitus; it is getting better however it is still there and annoying; felt like my ears was blocked like, I could not even hear clearly; nauseous very quickly but it went away it did not last that long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FP7150), in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 21Sep2022, outcome "recovered" (21Sep2022), described as "nauseous very quickly but it went away it did not last that long"; EAR DISCOMFORT (non-serious) with onset 22Sep2022, outcome "unknown", described as "felt like my ears was blocked like, I could not even hear clearly"; TINNITUS (non-serious) with onset 22Sep2022, outcome "recovering", described as "tinnitus; it is getting better however it is still there and annoying"; MALAISE (non-serious), outcome "unknown", described as "i am going to get sick".  Additional information: patient just want to report the side effect of the Covid. Patient got the COVID Vaccine with Pfizer on the 21Sep2022 and the day when had vaccine patient just got nauseous very quickly but it went away it did not last that long. However the next day patient woke up and had tinnitus and did not realize that patient felt it but was so busy, so the next day it came and go, it came and go, the next day was very annoying. Patient just thought was going to get sick or you know was going to get a Flu (Further clarifications unknown). Patient felt like ears was blocked like, could not even hear clearly but then was not feeling sick or anything but ears so then patient realized that must be because of vaccine because patient did not had anything else. Patient was not getting sick anything like that, so was still experiencing but it was not bad as a few days after got the vaccine. Patient just want to let you know that and hopefully it will go away. The nausea went away after 15 minutes because patient was in the office from 30 minutes and it went away. Patient thought it just went away. It did not bother that much nausea but that tinnitus yes. Patient considered the COVID-19 Vaccine caused me the adverse event because patient did not had anything prior and was healthy individual, patient usually eat healthy food. Patient exercise did everything possible to keep immunity system healthy and all of a sudden patient had tinnitus which never had. Patient thought it was and thought because it happened the next day and that was why patient was like okay and it is getting better however it was still there and annoying patient thought it is related to that.
Information has been received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 23-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose and route unknown, lot # K010523, expiration date: 25-FEB-2016) for prophylaxis. No adverse effects were reported. Follow-up information has been received on 03-JAN-2017. This report refers to an 83 years old female patient. On 22-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route: intramuscular, left deltoid). Additional information has been requested. Patient information, product information, event information and narrative were updated. Sender's Comments: MERCK 1609USA013565:Mfr number.
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 49-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
PATIENT FELT DIZZY AND FELL AFTER 10-15 MIN BEING ADMINISTERED DOSE 1 OF PFIZER COVID -19.
I have a Band Aid mark on my arm where injection was given to this day. I started to get hives on my wrist. Next day woke up with swollen lips and 1/2 my face swollen. Next day my entire body was covered in hives. It has been almost 7 or 8 weeks that I am having an severe hives.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (really fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced BACK PAIN (lower back pain), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (really fatigue). At the time of the report, BACK PAIN (lower back pain), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (really fatigue) outcome was unknown.            Medications: high blood pressure - cholesterol - prostate medicine, "sisu" for facial convulsions
I had difficulty and painful urination on the 1st, It got worst on that next day I went to the Urgent Care. The saw blood and protein in my urine. I was sent to the hospital for a kidney ultrasound. On that 03/13/2023 I had the ultrasound. I went to the doctor after that, and he suggested I see a urologist. I was treated with Macrobid, and it helped, and my symptoms resolved. I have had a CAT Scan of my heart on 03/07/23, My BUN was elevated, that?s the kidney profile. They are thinking I passed a kidney stone.
Patient has history of Measles and Mumps disease as noted and previous Rubella shot after delivering her son. She needed MMR for 1st responder class. Has had prolonged joint pain starting approximately a week after the shot. Hands, fingers, knees, hips right. Both shoulders very painful at times. Fingers feel creeky and not yet resolved a month after shot.
Patient was seen in the ED at an outside hospital for low oxygen readings at home.  He was found to have a large right pleural effusion and tested positive for COVID.  He was transferred to this facility for IR drainage of pleural effusion and management of COVID-19.  Patent did received casirivimab-imdevimab  on 8/28/2021.  Thoracentesis done on 8/29/2021.  Patient was discharged to home on 8/30/2021
pt came to pharmacy reported he got big bruise on his upper right arm on Wdnesday (8/14). He stated right after pharmacist gave him flu shot on 8/12/2019 the arm became swollen (no bruise) so he came back and spoke with pharmacist. Pharmacist instructed him to take IBU overnight. Pharmacist instructed pt to call her back on Tuesday and see docotor if the situation gets worse. However, pt didn't call her back.  The bruise is about 2 inch wide and 4 inches long beneath the injection site. Appologized to pt and instructed pt to see md for futher check up since the bruise is becoming bigger and bigger per pt. Also instructed pt to stop taking IBU. Check on injection site is corrected, wiped with alcohol, pt's hand can still lift up above hand.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid (Treatment start date:30Oct2023, Treatment stop date: 03Nov2023). Known allergies- None  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-202300377157 same patient, different drug, different event;
None- Menquadfi given when not needed as he had one at 11 yr.
Cheeks all swollen up; Whole inside of mouth was all blistered up, infected; Whole inside of mouth was all blistered up, infected; Mouth hurting so bad; Arm swelled up; Site hurt; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: unknown) via an unspecified route of administration in left shoulder on 10Feb2021 around 10:10 to 10:15 AM (74-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history included spinal fusion surgery from Oct2020, stated that she had to reach for a pen, she was recovering from spinal fusion surgery, before the shot, in Oct2020. The patient's family medical history mentioned as only one who had a shot. There were no concomitant medications. Vaccination facility was not provided. No additional vaccines were administered on the same date of the Pfizer vaccination or prior to vaccination within 4 weeks.  The patient had no adverse events following prior vaccination. No history of all previous immunization with Pfizer vaccine. On 10Feb2021 (Wednesday), the patient experienced arm swelled up stated it was now not really swollen bad, but still hurts where shot was given. The site started hurting Wednesday night. On 12Feb2021 (Friday), the patient when she woke up in the morning her whole inside of mouth was all blistered up, infected, cheeks all swollen up, mouth hurting so bad had to go to ER and they said it was a side effect from the Pfizer shot. She stated that, she only had two teeth on bottom mouth, the rest was no teeth, so that was how it got so bad, it went from boom everything. She hasn't seen her primary care doctor, he was hard to get into, she went to the ER, she does not had time to contact the doctor, due to the holiday. The ER gave her some special Magic Mouthwash and antibiotics, she couldn't even eat anything, it hurt so bad, so she couldn't, so anything but liquid. She stated that mouth hurting seems to be improving a little bit. She stated that, they didn't write the lot really good on the vaccine card. Lot number could be EL9260 or EL9269, last digit of lot could be 0 or 9, it was down the black part of the paper that divided it. She confirmed it was first dose. Adverse events did not result to visit emergency room.  No relevant tested was provided. She stated that she had spinal fusion surgery before the shot, so she was wondering if it would happen with the second shot, not that much worried, she wanted to say it did occur, so maybe it could be put on the list of possible side effects. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Patient states after receiving Prevnar at MD office, then an hour later receiving Fluzone HD at Pharmacy, developed rash on most of body with itching.  Lasting a couple days.
Tightness in chest, extreme abdominal pain and cramping, numbness/tingling in legs and arms, fast heart beat, dizziness, excessive vomiting, itchy skin, dry mouth.
Large red area on upper arm around shot location.  The upper boundary was rounded on top, vertical on the sides, and a relatively straight line across the bottom.  It is about 3 inches long and 1 1/2 inches wide, and was a little swollen yesterday but not much today.
Information has been received on 03-MAR-2017 from a pharmacist refers to an 85 year old male patient with papilloma viral infection. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 01-MAR-2017 the patient was vaccinated with an expired dose of GARDASIL 9 lot # L001312 expiration 24-FEB-2017, intramuscular related to the "off label indication" of treatment of a HPV (papilloma viral infection) spot on his eyelid. No adverse effects reported. The pharmacist inquired about revaccination if the patient received an expired dose of GARDASIL 9 with no previous temperature excursion. No further information was reported. Additional information has been requested.
1AUG97 pt recv vax 1230PM mom stated pt sneezing & itching 2hr p/vax;mom also reported puffy eyes;no hx of cry other exposures p/shot;went straight home;mom gave DPH as requested;no hx of hive like rash;no hx of resp complications;
Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right deltoid on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. There were no other relevant medical history, no known allergies. Prior to vaccination, the patient was not pregnant, did not have COVID, and did not receive any other vaccines within 4 weeks. The patient's concomitant medications were not reported. On 13Aug2021 23:45, the patient experienced right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included Kenalog intramuscularly. The patient underwent lab tests and procedures which included a COVID-19 nasal swab test on 16Aug2021 which was negative. Outcome of the events was not recovered.; Sender's Comments: Based on the plausible temporal relation, the association between the events of lymph node pain and lymphadenopathy and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
NONE - Other than a slight soreness in the left arm, I had ZERO reaction to the vaccine.  For a second dose this seemed to be very abnormal and I am concerned that this particular vaccine batch might not be effective at preventing Covid.  My first vaccine shot, lot EM9809 on 2/4/2021 generated body wide aches the morning after.  The vast majority of second shots, according to guidance and news reports, seem to generate a greater responses, but to get absolutely ZERO makes me worried that I'm not properly protected.
11/4/2021-Complained of cough, congestion, fatigue, chills and diarrhea x5 days. She denied any fever, chest pain, shortness of breath or headaches. She also denied any loss of taste or smell. Review of Systems: Constitutional: Positive for chills and fatigue. HENT: Positive for congestion, rhinorrhea and sinus pressure. Respiratory: Positive for cough. Gastrointestinal: Positive for diarrhea. Genitourinary: Negative. Musculoskeletal: Negative. Skin: Negative. Neurological: Negative. Hematological: Negative. Psychiatric/Behavioral: Negative. 11/4/2021-Treatment: COVID-19:  Tylenol (acetaminophen) 500mg tablet. Viral illness: Zyrtec allergy (cetirizine) 10mg tablet. Cough: Tessalon (benzonatate) 200mg capsule.