chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt reported that after the first dose she experienced swelling of he hand 3-4 days post vax. The pt presented to her MD and was dx with rheumatoid arthritis. The pt noted that her rheumatoid factor is presently 741 and that she was been unable to work since. This is in follow-up to report(s) previously submitted on 03/07/2001. Information has been received from a female consumer who was vaccinated with hepatitis b vaccine recombinant (yeast). Subsequently, the patient experienced rheumatoid arthritis which she indicated was "from the hepatitis b vaccine." Additional information has been requested. It has been determined that WAES # 00091017 is a duplicate of WAES #'s 99102341 and 01011360. Therefore, WAES #'s 00091017 and 99102341 are being deleted from our files and the reports consolidated into WAES # 01011360.
Mother of vaccine recipient called clinic 3/19/2015 @ 5:00 PM to report erythema and swelling to left upper arm radiating to left axilla. Client counseled to come into clinic to have provider examine area; offer was declined. Mother stated adult client would go to ER after work. Attempt was made to contact client on 3/20/2015 morning to follow-up with client; no answer. Message left by clinic FNP to call clinic with questions or concerns.
Patient was scheduled to for a Pediatric Pfizer Booster instead was given Pfizer Booster Adult dose his left arm.
3 weeks later I'm noticing hair loss on both legs that has no other likely cause.  V-safe check-in app does not allow me to add this 3 weeks after vaccine, but I wanted to share it.  I did not find this listed on side effects and want to know if this is a concern and if I should get checked out by physician.
first dose on 2020 forgot to get second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The patient received 1st dose on 26th October 2020, forgot to get the second dose. The reporter stated that it was 17 months since the first dose. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (Lot L031274 expiry 19-NOV-2016), ZOSTAVAX (Lot L024997 expiry 06-OCT-2016). No adverse event was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
arm pain near injection site; ringing in ears lasted 1 minute; pressure in ears lasted 1 minute; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears lasted 1 minute), EAR DISCOMFORT (pressure in ears lasted 1 minute) and VACCINATION SITE PAIN (arm pain near injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TINNITUS (ringing in ears lasted 1 minute) and EAR DISCOMFORT (pressure in ears lasted 1 minute). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm pain near injection site). At the time of the report, TINNITUS (ringing in ears lasted 1 minute) and EAR DISCOMFORT (pressure in ears lasted 1 minute) had resolved and VACCINATION SITE PAIN (arm pain near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Diagnosis: Inflammation around the heart; This is a spontaneous report received from a contactable consumer (patient). A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route in right arm on 06May2021 as single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0182) via an unspecified route on 06May2021 for covid-19 immunisation. The patient 's medical history included Covid-19 on unspecified date. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jun2021 at 11:00, the patient experienced and diagnosed inflammation around the heart. Patient visited emergency room and received treatment for event. The patient had hospitalization for 7 days. The outcome of the event was unknown.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
At time of injection, the "Vanishingpoint" syringe needle did not retract first time I pressed plunger. Pressed a second time and it retracted. Soreness developed next morning. Progressing discomfort and weakness until saw family Dr 10/19/2011. Diagnosis of "nerve inflammation". Treated with anti-inflammatory OTC medication and ice packs. At this time is recovering and most of discomfort is gone. She reported a previous tetanus vaccine had caused severe discomfort a couple years ago.
Information has been received from a physician concerning a female with one genital wart before vaccination who was vaccinated with a dose of GARDASIL.  Subsequently the patient developed a whole colony of genital warts.  The patient's outcome was unknown.  The patient sought medical attention in the physician's office.  Additional information has been requested.
This spontaneous prospective pregnancy report has been received from a medical assistant referring to a 38 year old female patient. The patient had nausea and vomiting with SULFA. The patient also had angioedema with penicillin. On 19-OCT-2015, the pregnancy patient (pregnancy onset date unspecified) was inadvertently administered VARIVAX (dose, strength, lot # and route were not reported). Concomitant therapy included extended released metformin hydrochloride. There was no treatment for drug exposure during pregnancy. The reporter stated that the patient was currently 15 weeks pregnancy as of 03-DEC-2015 (reported as today). So the last menstruation period (LMP) was estimated on approximately 20-AUG-2015. The estimated delivery date (EDD) would be on approximately 26-MAY-2016. The reporter also reported that the patient had routine unspecified blood work, an ultrasound and panorama genetic testing performed on 03-DEC-2015. The result of ultrasound was normal and the results of unspecified blood work and panorama genetic testing were pending as of 03-DEC-2015. No adverse effects were reported. The patient had sought medical attention by seeing the physician in office. Additional information has been requested.
every time I got a vaccine or a booster, my PSA readings go up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "PSA increase"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up". The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "every time I got a vaccine or a booster, my PSA readings go up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that he had 2 vaccines and 2 boosters and then the paxlovid, every time he got a vaccine or a booster, his PSA readings go up because he contracted Covid 19, he have a chart. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. He took Paxlovid took 2 months ago, on 12Aug2022 also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/13/2008, child developed fever and was fussy after receiving 2 month vaccines.  Parents both called nurse advice line at clinic reported symptoms - advised Tylenol.  Went to ER later that next a.m.  8/14/08 baby seems fine now.
As the vaccine technician was administering the shot, I immediately felt a pain in my arm and I felt it moving up into my neck and then my head as she was giving me the shot. It didn't go away and I had a terrible headache for 3-4 days. I don't know if it?s possible that the needle maybe hit a nerve??? In any case, it was awful, but I'm ok now and there were no other symptoms out of the ordinary, which were like as if I had a flu shot.
Patient had dizziness, pallor/sweating. Given 8 oz water and 3 oz juice -- improved after drinking. Stable & released from vaccination site.
No additional AEs; HBP with responsibility for vaccine storage calling to report a temperature excursion. Product administered. No additional AEs. No PQCs.     ?    Names of vaccines involved (including lot/exp) VARIVAX W025273 08/10/2024        ?    Temperature: -; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-APR-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose and route of administration not reported) lot number W025273, expiration date 10-AUG-2024 for prophylaxis (product storage error). No adverse event was reported.  The temperature excursion of the vaccine was of -10 degrees Celsius for 59 minutes. No other excursions were detected.
Information has been received from a physician concerning an 11-15 year female who was vaccinated with a second dose of VARIVAX (Oka/Merck). Subsequently the patient experienced chickenpox type lesions after the second dose of VARIVAX (Oka/Merck). This is one of  two reports from the same source. Additional information has been requested.
Loss of Taste/Smell, one day after vaccine administration.  Follow up Covid PCR negative,  36 hours after symptoms started.
The morning after the injection I woke up to severe tenderness and pain in my left hand, mostly in the palm of my hand .  After approx 3 days it decreased to a more mild constant ache, slight tingling sensations that radiated towards my elbow, and occasional jolts of pain multiple times throughout the days.  Once I returned to my regular work week on 12/27/21, I also developed a similar aching pain in my left knee, ankle, and foot.
This case was reported by a pharmacist and described the occurrence of a facial rash in a pt who received hep B vaccine recombinant (Engerix B). On an unspecified date, the pt received the first dose of Engerix b. At an unspecified time following the first admin of Engerix B, the pt experienced a full body rash. The event resolved on an unspecified date. On an unspecified date, the pt received the second dose of Engerix B. At an unspecified time following the second admin of Engerix B, the pt experienced a facial rash. The event resolved on an unspecified date.
Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 83-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 04:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Jan2021 at 04:15 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm, on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 06Dec2022 at 09:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Rapid Antigen Test is Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received COVID-19 treatment with Paxlovid from 16Aug2023 to 21Aug2023 (lot number GF7316).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure, Covid -19, interchange of vaccine products  cannot be ruled out.
This spontaneous report as received from a Nurse refers to unspecified number patients of unknown age. The reporter stated that GARDASIL, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of the several reports. The case is linked to 1309USA013801, 1406USA007117, 1406USA007118, 1406USA007120, 1406USA007121, 1406USA007076 (same reporter link). Additional information has been requested.
This is a patient with transfusion dependent beta thalassemia major who had a known warm autoantibody that had intermittently caused hemolysis in the past. She was transfused as scheduled on the day of her vaccine. About 10 days after receiving her first dose of Pfizer vaccine, she was noted to be more fatigued and labs showed an acute drop in hemoglobin to 4.9 with elevated markers of hemolysis. She was also febrile at the time, though our in-house respiratory viral panel did not yield any viral pathogens (including Sars-CoV2). She was transfused and started on IV steroids, transitioned to oral steroids for presumed autoimmune hemolytic anemia. She continues to have low level hemolysis despite continuing on steroids, though the hemolytic rate has slowed and she is clinically doing well. We plan to taper steroids over the next few weeks and continue to monitor hemoglobin closely. We do plan to give her a second dose of pfizer vaccine.
Shot received in left arm. As of today's date 1-27-12, I am unable to use this arm as needed. It has a pain, similar to a tooth ache. I can not sleep on my left side. I have tried heat, aspercreme, and used my TENZ unit! Still hurts.
I was diagnosed with COVID-19 on 12/23/2021. I had extreme fatigue. I loss my taste but not sense of smell. I felt as if I have a very bad cold.
Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved. In follow up information, the medical assistant reported that she does not have patient information or lot number information. She reported that she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes offered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Sudden onset of shortness of breath, the use of asthma inhaler, severe cough, disorientation.
Rash located on left upper arm in area where she received COVID vaccine. Patient reported incident. Appeared initially after vaccine last Wednesday; cleared up over the next several days; but then suddenly reappeared today. No fever. Reports mild fatigue today. Area is hard, itchy and painful.
Patient fainted after receiving vaccines- Menactra, Tdap, Hep A#2
Information has been received from a health care worker concerning a 29 year old female medical assistant with drug hypersensitivity to cefuroxime axetil (CEFTIN), morphine, and cyclobenzaprine hydrochloride (MSD), (WAES # 0703USA03178), who on 26, Jan 2007, during the patient administration of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot# 656551/1532F) was inadvertently sprayed with the vaccine into both eyes. The medical assistant immediately experienced burning of the eyes. The eyes were flushed with saline. The burning continued in her eyes and on the skin around the eyes. At the time of the report the burning in her eyes and skin around the eyes continued, and she was reported to be not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
swelling, redness & inc warmth @ site of immun; onset 5-6 days p/vax; gradual improvement w/ice packs & ibuprofen;
morderna 2nd shot, sore and achy all over body, very painful injection site, mild headache, very tired, gastritis symptoms, stomach cramps, gas
patient received 1st dose of Pfizer Covid-19 vaccines. within 5 minutes post-injection patient began to have nausea, lightheadness, headache, and hot flashes. Patient vitals signs remained stables, patient began to feel better after 20 minutes.
Fatigue, followed by chills. Next morning 12/20 temp 101.0 with headache, muscle aches, entire upper arm very sore with red splotches. Symptoms lasted all day. Next morning 12/21 same symptoms, temp 101.8. Stayed in bed both days. Left message w/Doctor's office; call not returned. Next morning woke covered with sweat but temp 98.0 (my normal) and felt fine. Arm still very sore and nasty looking.
vaccine was drawn up the day before and given after the 12 hour mark, per the vaccine provider the vaccine is still viable. patient called to see if any side effects 3 times with no answer
Chills, nausea, headache, sleepy Started 11:00 am  Slept fine thru night and fine the next day
dizzy immediately after shot; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy immediately after shot) and VERTIGO (vertigo) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (dizzy immediately after shot) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizzy immediately after shot) and VERTIGO (vertigo) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT MEDICATION WAS REPORTED , NO TREATMENT MEDICATION WAS REPORTED .   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional info received ON 24-MAY-2021 NON SIGNIFIVANT INFORMATION WAS REPORTED .
The injection site felt warm in the evening (after dinner) and started to swell and become hardened. By the next morning, I had a low grade fever (99.5-100) and felt exhausted. Over the next two days, the hardness around the injection site was only slightly raised, but was about 3.5" in diameter. I continued to feel run down and tired with a low fever (99) for the next three days (about 5.5 days after the shot), then started to feel better. I had been told to expect some pain or swelling at the site and suggested that I alternate Tylenol & ibuprofen every few hours, starting as soon as I got home.
Fever, flu like symptoms, muscle aches, fatigue and pain redness swelling in arm which spread over a large portion of my upper arm. Area on arm looked like 13 bee stings attacked and this swelling and redness lasted until  today, 6 days after the vaccine. I have photos of my arm it was severe.
at 37 weeks into pregnancy developed hypertension.  sent to the ER for observation, blood pressure improved.   Three days after delivering the baby blood pressure went up again.
This spontaneous report was received from a certified medical assistant regarding a 2 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours. No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.