chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the shot, still got shingles/ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot, still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
began having numbness to face, tingling to hands and legs and dizziness with movement and that her legs were going to give out
Extreme fatigue and sleepiness. Slept for 20+ hrs beginning 8/10/2021 Mild to moderate heaches Difficulty in concentration Rash and swelling of face Inability to fully raise arm where the injection was. Symptoms still ongoing
Patient reported a history of lightheadedness with immunizations. Gave patient his influenza immunizationin his right deltoid. Patient seemed fine and was talking. About a minute later while still talking to patient, patient put his head in his hands. When asked if he was feeling OK, he responded he was feeling lightheaded. He then slumped forward in the chair, fell forward, and fell onto the ground. I rushed to his side to see if he was OK. He was unconscious for approximately 10-15 seconds on the ground, then regained consciousness. I then noticed he had a large gash on his forehead and was bleeding from it. An off the clock EMT was in the area and came over to help. I called 911 and had paramedics come to the pharmacy. The EMT, myself, and management stayed with the patient until the paramedics arrived. The paramedics said he seemed fine except for his gash, and recommended going to the hospital if he began to not feel well. He was doing better by that time and the paramedics offered to walk him to his car and assess him along the way. Nothing else is known about the patient or the situation at this time.
This spontaneous report was received from a pharmacist and refers to a 69-year-old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 16-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection via intramuscular route, lot # N022703 with expiration date on 27-FEB-2019 (dose was not reported).  On the same night, the patient experienced pain with no redness or swelling. At the time of the report, the patient did not recover from the event. The relatedness between the event and PNEUMOVAX 23 was not reported.
Minor headache, stomachache, resolved in less than 30 minutes. Vital signs measured, blood pressure 163/117, repeat in 15 minutes without intervention on a different blood pressure measuring device was 150/87.
I63.81 - Other cerebral infarction due to occlusion or stenosis of small artery R29.810 - Facial weakness I63.81 - Left sided lacunar stroke
Redness and swelling at injection site, 9 days past injection. Overnight, the red area has enlarged and become warmer to the touch. Nurse Practitioner has diagnosed swelling as cellulitis and prescribed triamcinolone acetonide .5% and doxycycline 100mg x 7 days.
Chest Pain, Headache, Dizziness, Arm Pain, Nausea, Fatigue
Patient received a second Bivalent booster for COVID-19. CDC only recommends one bivalent booster. MD on site evaluated the patient, no current harm. Will continue to follow and monitor. Dose 0.5 ml. Moderna manufacturer.
pt rcvd vax; inconsolable crying for 5 hrs; high pitched cry; fever between 100;
Day 7 post vaccine: Coughing, chest congestion, fatigue Day 8 post vaccine: Coughing, chest congestion, fatigue, wheezing, injection site became red and hard and was hot to the touch; was tested for COVID-19 and given a topical steroid for the injection site. Day 9 injection site reaction was larger and arm was swollen in the area of the injection and was still hot to the touch and hard. Day 10 injection site reaction was larger again and was still swollen and hot but was less hard.   Day 11-15 continued to use steroid cream, did not get larger, perimeter of reaction could still be seen but started to get less red and less swollen. Day16-20 no longer swollen still a red area Day 27 (today) still slight discoloration still exists around the injection site
Kinrix given to a 6 months-old; Received 3 doses of IPV; wrong vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap vaccine (received 2 doses of Dtap vaccine) and IPV vaccine (received 3 doses of IPV vaccine).   On 28th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered were 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: 28-Feb-2023 Reporter's Comments:  Medical assistant reported on 28th February 2023, patient 6 month of age received by mistake Kinrix.  The patient received 2 previous Dtap doses and 3 doses of IPV. The reporter asked how to proceed. the reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received Kinrix by mistake at the age of 6 months of age, which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered, and wrong vaccine administered.
Pt developed swelling, redness of arm from site of injection to his fingertips almost immediately after the shot.  Pt also reports the shot being painful upon injection.
Fever,  serious lethargy - I slept for 8 hours at a time and woke only to eat and went straight back to bed. Had fever of 101 and chills. Body aches. All sx x 48 hours and then gone.
Patient reported that they normally feel fatigue, but after receiving the vaccine they have felt the fatigue become even more pronounced, to the point that she feels like she will pass out when she stands up.
Patient called and said her left arm hurts to life, touch, and that it is warm on top. She tried advil 3 times daily, then iced it. Patient advised to follow up with doctor next week.
fever; chills; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial cancer, Ovarian cancer, Bone pain since 23-Oct-2020, Back pain since 23-Oct-2020 and Pelvic pain (Lower pelvic pain on 8/10 scale) since 01-Nov-2020. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 23-Oct-2020 to an unknown date for Endometrial cancer and Ovarian cancer, PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Renal impairment: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment reported in the source document.
Symptoms returned 2 days later and testing positive again.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms returned 2 days later and testing positive again.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Shellfish allergy, Blood pressure high and Asthma.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Symptoms returned 2 days later and testing positive again.). At the time of the report, COVID-19 (Symptoms returned 2 days later and testing positive again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         It was reported that the Device Date  is 23-May-2022 Patient had Negative test the day after completing Paxlovid No concomitant medications were provided by the reporter No treatment medications were provided by the reporter Company comment: This spontaneous case concerns a 46-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). The event occurred 181 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. The patient started treatment regimen with Paxlovid on May 12, 2022, it has been reported that patient had a negative SARS-CoV-2 test after the treatment regimen, however the symptoms recurred after two days and again was positive on SARS-CoV-2 test. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 46-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test). The event occurred 181 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. The patient started treatment regimen with Paxlovid on May 12, 2022, it has been reported that patient had a negative SARS-CoV-2 test after the treatment regimen, however the symptoms recurred after two days and again was positive on SARS-CoV-2 test. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient had the Janssen vaccination for covid. In the observation period she sat on the floor and asked for a trashcan in case she vomited. She then vomited and lost consciousness for about 10 seconds
Pres for poss rxn to pneumococcal vaccine given 2-2-10. RUA w/5x3.5" area erythema/warmth. Pain 1-2/10 without arm movement. Pain 4-5/10 w/arm movement. No stiffness noted. Avised rash local, not systemic and will resolve on own. Will pull vaccine from shelf as this is the second poss rxn this week and notify CDC and CDHD. RTC if sx worsen or concerns. +verb understanding. lap
40 YO F PRESENTED WITH A C/O OF  A RACING HEART BEAT A FEW MINUTES AFTER HER VACCINATION. PT DENIES C/P OR PRESSURE.  BP 150/70        HR 125   SpO2 99%    @16:40  PM BP 173/142     HR 129   SpO2 99%     @ 16:44 PM BP 132/78        HR 117   SpO2 100%  @ 16:55 PM BP 134/95        HR 116   SpO2  99%    @17:10  PM  PT WAS FOUND TO HAVE PALPITATIONS AND TACHYCARDIA. HR CONTINUOUSLY FLUCTUATED DURING EVALUATION. BP WAS INITIALLY ON THE HIGH SIDE.  PT WAS NOT GIVEN ANY MEDICATION, BUT ADVISED TO F/U WITH HER PCP FOR BP AND INCREASED HR. PT WAS ALSO EDUCATED ON THE IMPORTANCE OF F/U. PT VERBALIZED UNDERSTANDING. SISTER OF PT PRESENT TO MONITOR  HER/DRIVE. AT 17:13, PT LEFT IN THE COMPANY OF HER SISTER. PT NOT IN APPARENT DISTRESSS.
On 8/17 a hard red lump was noticed at the site of injection of Varicella vaccine.  The morning of 8/18 a hard lump was spotted on her groin and child was brought to the doctor who stated it to be a reaction to vaccine.  On 8/20 another smaller lump appeared on the groin.  All lumps are still present and not presenting any pain.
Patient was accidently given a pediatric dose of Pfizer instead of adult dose. Patient was notified and requested to return to receive full dose of adult Pfizer per CDC guide lines. Patient did return and received full dose approximately one hour after receiving the pediatric dose.
hard knot; red circle; warm; itching; This spontaneous case was reported by a consumer and describes the occurrence of MASS (hard knot), ERYTHEMA (red circle), FEELING HOT (warm) and PRURITUS (itching) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATENOLOL and SIMVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (hard knot), ERYTHEMA (red circle), FEELING HOT (warm) and PRURITUS (itching). At the time of the report, MASS (hard knot), ERYTHEMA (red circle), FEELING HOT (warm) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
17FEB swollen rt knee went to MD referred to orthopedic  was given med;19FEB orthopedic MD swelling, strength test;
The mother of a 33 month old female reported that her daughter received an injection of Prevnar on 7/10/00. That night, the child became fussy and developed an injection site reaction characterized by redness and swelling. In mid-August, the child began having episodes during which she would straighten her arms and legs and appeared to be in a trance". These episodes occurred while the child was sitting or playing. When her mother touched her, she would "snap out of it".
Dizziness started 2 weeks after first vaccine and then progressed , occurred daily for 4 weeks  had syncopal episode April 16th ,  then developed shingles  on face may 11th
The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion; Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The HCP stated that 3 doses were administered from the opened vial/ Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter reported that 3 doses were administered among which 2 doses were booster and 1 dose was a full dose. Excursion temperature maximum 33.4 degrees Fahrenheit and minimum 19.5 degrees Fahrenheit. Excursion occurred on 07-Feb-2022 with the duration of 612 minutes. Vails were stored at room temperature and were moved from freezer to refrigerator on 04-Feb-2022. Vails looked normal on visual inspection. patient doesn't experienced any side effect 8:00 am Monday (07-FEB-2021) Digital readout on data logger reading -22.5F for freezer and 19.9F for refrigerator. vaccine bottles from refrigerator had no signs of freeze, i.e. no ice or crystallized solids in the vaccine bottle the refrigerator temperature controller dial adjusted to 5 from initial number 7. no water bottles in refrigerator and frozen coolant packs in freezer at this time or any other times. 9:11 am (07-FEB-2021) refrigerator data logger reading is 27.7F freezer data logger reading is -10.3F.  the temperature controller dial is on number 5 9:55 am (07-FEB-2021) refrigerator data logger reading is 32.5F and freezer data logger reading is -0.9F. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Patient demographics updated, product details updated, new Event added.
Pt had extreme swelling around the injection site w/an extrmely red bulls-eye that is hot to the touch.
"covid arm"  7 days post vaccine: vaccine site red, raised, warm, itchy 2.6 inches wide and about 2 inches long
Information has been received from a physician assistant, via a company representative, concerning a 26 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not informed. On an unknown date, the patient was  vaccinated  with  an  unspecified  human  papillomavirus  vaccine  (manufacturer  unknown)  (lot  #,  expiration  date,  dosage  and  route  of  administration  were  not  provided).  On  an  unknown  date,  the  patient  developed throat cancer. No product quality complaint  (PQC) was involved. At the time of the reporting, the outcome of throat cancer was unknown. The causal relationship between throat cancer and the unspecified human papillomavirus vaccine was not reported. Upon internal review, the throat cancer was determined to be a medically significant event. Additional information is not expected as no consent for follow up was given.
Redness; Knot in arm; Warm to touch and growing; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (Redness), SKIN MASS (Knot in arm) and SKIN WARM (Warm to touch and growing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), SKIN MASS (Knot in arm) and SKIN WARM (Warm to touch and growing). At the time of the report, ERYTHEMA (Redness), SKIN MASS (Knot in arm) and SKIN WARM (Warm to touch and growing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
15APR92 nausea, t100; 25APR92 rash on face & body x 2 days;
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K007826, expiration date 03-FEB-2016) (dosage, strength and route not reported). There was no concomitant medication reported. No adverse symptoms was reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to 60 patients of unknown age and gender. No information of concurrent conditions and medical history were reported. Approximately in 2015 (reported as since 23-AUG-2015 til 04-SEP-2015, today) the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (unknown strength, route and dose) lot # L010143 with expiry date 24-SEP-2016. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Friday night I was feeling so tired, I came home from work and just went to bed. I was exhausted my hips hurt, and I was coughing but I had a really hard time sleeping. Saturday I took a home test and then called my doctor since it was positive. I had bad body chills and my hips were aching and just hurting. I did get molnupiravir which did not work the first two days I took it but by the third day I was feeling better.
pt recvd vax 3PM on 14MAY93 about 5PM noticed arm was red & swollen; noticed whelps;
After 8 days, large lump at injection site. Warm to touch. Red rash.
syncopal episode, slurred speech, tremor, facial droop lasting three days upon presentation to the emergency room
1. Hives that break out all over my body. Has occurred approximately 2 to 3 times a week since the second round.  Is currently continuing to occur.   2. Feels like I can?t quite catch my breath at times.  3. Brain fog.
Pt called on 11-29-11 stating he had reaction 2 days after injection - 11-29-11 was day 7. Pt c/o numbness, pain in arm starting at elbow and traveling to pointer and middle finger.
Initial report received from a healthcare professional on 23 October 2012. A 62-year old female patient, whose concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (Batch number: UT4463BA) in left deltoid on 27 August 2012. The patient had no illness at the time of vaccination and had allergy to PCN. The patient had medical history of GERD, diabetes and high cholesterol. On 27 August 2012, on the same day after receiving FLUZONE ID, the patient experienced lump at injection site about half inch in diameter. At the time of this report, the patient had not seen the physician. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None. Follow up information received on 01 February 2013: The patient's concomitant medications included, Metformin 500 milligram, NEXIUM 40 milligram, Glipizide XL 5 milligram, Simvastatin 40 milligram, Chlorthalidone 25 milligram and NASONEX.
arm warmth,redness,irritation level 3 of 10 @ left deltoid & beneath,medially. Started day #8 after vaccine upon awakening in the morning. Day 9 doubled in size,warmth,redness, Contacted Virtual mid level whom deferred to in person aptmt either in office of pcp or Urgent care today April  20th@ 12:26pm
Arm started hurting severe  has not stopped and I have limited use of my arm pain is 24 hrswent