chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 08-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unkonwn number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Pt recv vax on 11/9/98; on 11/14/98 pt exp fever (99.8), dec appetite, macular rash-general & vesicular rash at vax site
my arm was sore; i was very tired.but feeling good today; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 1st shot of Shingles vaccine and experienced arm sore and was very tired. On the day of reporting, the patient was feeling good today. The patient will get 2nd dose in November and asked if not going through that pain of shingles.
Pt recvd vax on 7JAN92 & exp joint pain in rt shoulder & lt elbow; also tingling in hands & swollen fingers; seen by MD; PE nl; lab eval revealed no evidence for pt's sx;
- weakness in my body - muscle aches - headaches - fever of 101.3 lasting for almost a full day after - confusion -chills - soreness around injection site - redness around injection site (all the above lasted almost 24hrs, from 7pm the day of the shot until the next day around 7pm) I also have a hardness under the skin at the injection site that has persisted  a week after. It?s a hard lump, shallow and it?s sore to the touch, it used to be hot and red, now it?s just tough.
Threw up at least 4 times; Diarrhea; Cold chills; Real tired; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Apr2021 at 14:00, the patient threw up at least 4 times, diarrhea, cold chills and was really tired. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of threw up at least 4 times, diarrhea, cold chills and real tired was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
heart disorder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart disorder".  Additional information: The reporter also had a nephew and a niece that had heart damages because of these shots, so no comments needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel severe aches & fever for several days;hx included rheumatoid arthritis;pt eventually recovered & also recv addtl med for arthritic flares;this is one of 3 patients from this site who exp above rxn,p/vax
right side of face was "nummy; my eye was watering a bit; I felt warm and cold; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history was not provided. Concomitant product use was not provided.  On an unknown date, approximately 3 weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold). Treatment information was not provided.  At the time of the report, HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold) outcome was unknown.    The outcome of the events, HYPOAESTHESIA (right side of face was "nummy), LACRIMATION INCREASED (my eye was watering a bit) and FEELING OF BODY TEMPERATURE CHANGE (I felt warm and cold) were unknown.   Action taken with mRNA-1273 in response to the events was not provided.
pt recv vax 10NOV98 2PM & hoarseness occurred around 4PM;salt gargles, throat/cough drops condition lasted approx 4-5 days;
Initial unsolicited report received from a consumer on 23 September 2016. This case involves a 70-year-old female patient who was vaccinated with first dose Fluzone HD (batch number, expiration date, site of administration were not reported) intramuscularly on an unknown date in 2014. Any other vaccinations within 4 weeks of vaccinations was not reported. Patient illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included no specific medication. Concomitant medications were not reported. On an unspecified date, within 15 minutes following the vaccination, the patient experienced full blown anaphylactic reaction. It was reported that patient was wheeled to the emergency room. Lab data was reported as none. The patient received corrective treatment with intravenous (IV) Benadryl steroids and breathing treatments. On an unspecified date after few hours after monitoring patient was fine and the outcome was reported as recovered. List of documents held by sender: none. Sender's Comments: This case concerns a 70 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and within fifteen minutes after vaccination developed full blown anaphylactic reaction. Time to onset of event was compatible. However details regarding medical history, concurrent conditions, patient immune status at the time of vaccination and other etiologies would be helpful to further assess this case.
Inadvertently gave patient a 2nd dose of Arexvy after his doctor advised him to get RSV shot. We found out later the insurance called the patient and explained that he had been billed for the shot on September 6, 2023.  Patient has no issues, but called to report to the pharmacy. We will continue to monitor patient.
Information has been received from a physician concerning a female employee who in October 2002, was vaccinated with a first dose of varicella virus vaccine live. She experienced an injection site reaction with swelling and numbness of her upper arm area. The physician reported that the patient did not show it anyone, and she did not treat it. There was no prescription drug required. The physician also reported the patient did not return for the second injection. The physician indicated there was no additional information available at the time and reported that he or his staff would call back with it. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Pain of muscles surrounding (L) shoulder including biceps/trapezius, supraspinatus; levator SCAP,  SCM, latissimus on (L) pain inhibiting mobility of shoulder on exam normal rom passive.
Initially bump and soreness directly at Injection site. It went away within 4-5 days. On day 7-9 (I cannot remember which day exactly. I believe it was day 7 though) I developed an itchy red, warm, bump lower on my arm than where the Injection was. It progressed into a circular type ring-rash. I went to urgent care in fear of lyme, but he said it was likely Moderna Arm. No fever, mild itchiness now. Swelling has went down.
Redness and swelling to left thigh at vaccine site on 05/10/2003.  Afebrile, administered Tylenol throughout day.  High swelling and redness at site on 05/11/2003 to 4in diameter.  Site was arm to touch and itchy.  Tylenol and regular intervals on 05/11/2003.  Site was smaller and pink on 05/12/2003.  Child was irritable throughout the weekend but was better on 05/12/2003.  No itching on 05/12/2003.
2/6/03 - Mother phoned and noticed daughter's right thigh swelling under injection site the size of a dinner plate. Red and warm to touch. Denies general discomfort; only when pressing on it. Phoned physician at home last evening and advised Benadryl and ice. Mom states left thigh still swollen, but breaking up to small welts now. No fever; child playful and walking normal.
Initial report received from a nurse on 17 Feb 2010: This patient (a child under the age of 4 years) inadvertently received a 0.5 mL IM dose of S-OIV FLUVIRIN (batch no 102138P1A) on 16 Feb 2010. No adverse effects were noted after administration.
A report was received from a health professional on 10/23/2002, concerning a female vaccinee of unknown age who inadvertently received frozen Fluvirin vaccine on 10/23/2002. The vaccine did not experience any adverse event. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200585, PJP200200629 and PJP200200774. Update (1) 12/23/2002: A follow up report received from a health care professional indicated that the event was resolved on an unspecified date.
Tingling sensation (R) ear eyebrow, cheek & side of face & back of head starting 2.5hrs after Shingrix given. Seen in ER on 9-30-20. CT head, CT angio neck & head with perfusion Also Labs - Covid test, CBC, CMP,
Pt called 10/13/12 to report that she had a serious reaction to the flu shot given 10/10/12. She reported she called 911 on Wed. pm with a high fever, weakness and nausea. She was transported from home via ambulance to Hosp and Tx with IV meds. Released early Thurs. am. She states she feels better but not 100%.
sore arm; redness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pain in extremity (1st dose received on an unknown date, patient experienced redness and swelling, refer link case US2021AMR073688).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm, erythema and swelling. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the pain in arm, erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm, erythema and swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: Office manager reported the case for her daughter. The age at vaccination was not reported. The patient had had sore arm, redness, and swelling for approximately one week following a dose of Bexsero. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073688:same patient
next day- fever, headache, aches (flu like symptoms for 36 hours) breakthrough covid for 4 weeks (dec 28 2021 even after booster)
This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with dose of GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 31°F (degrees Fahrenheit) for 10 minutes. No previous temperature excursion was done. The call was not because of a "data logger".
I experienced extremely itchy all over for no reason and the doctor prescribed me Zyrtec to combat the itchiness (helped a little but did not resolve the symptoms). I started taking  Benadryl  at night (do not know how much it's helping) and am continuing to take Zrytec even though I'm still experiencing the same symptoms. The doctor recommended that if the Zyrtec is not working to make an appointment with my normal PCP since I did a tele appointment with Kaiser. I have not been able to get an appointment with the doctor yet.
12 hours post injection: Fever, overall body ach 24 hours raised rash throughout body ,headache, fever, tired
POTENTIALLY EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the subject experienced potentially expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potentially expired vaccine administered was not reported. This report was non-serious.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five months old female patient who was vaccinated with a 0.5 ml second dose of ACT-HIB lot UI913AA and Exp. Date 22-NOV-2019 via intramuscular route in the left thigh on 29-Nov-2018. The patient's medical history not reported and concomitant medications included PREVNAR for Immunization. It was reported that, reporter received an email from Sanofi stating their shipment of ACT-HIB was delayed in transit and the vaccine should not be used once received at their facility; and shipment arrived on 29 Nov 2018 and it should have been delivered by 28 Nov 2018 to avoid any shipping excursions. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hours, and slightly shortened breath is still present 5 days later.
husband  reported swollen axillary  glands later that day after she was vaccinated. She also had throat pain and body aches. She took some advil  for her pain
10:00 am 10/06 hands started itching. No sign of rash or hives at this time, just itching. Starting in the evening approx. time 7:00 pm had started itching. Continued into Thursday morning. After 10:00 am started itching on various parts of body. No signs of rash or hives. Thursday night 10/7 about 6:00pm saw hives around waist. Itching incresed. Called doctor 8:00pm, told to start taking 25mg Benadryl. Friday morning 10/08 started itching intensely,more hives appeared. Called the doctor, was given a prescription for Predenisone 10mg to be taken on a tapered method, six the first day-five the second day-four the third day etc.   During the night Friday 10/08 the hives and rash started spreading all over ..eyes started swelling...at 8:00 am Saturday morning 10/09 went to the emergency dept.  Given three shots by IV.benadryl-zantac-don't remember the third. Was told these three injections help for hives. Given a prescription for 150mg of Zantac to be taken twice daily for five days. Released from hospital at 10:30am and told to make appointment with family doctor.
Open polio vial experienced two temperature excursions (warm temp) totaling 35 minutes. One on 6/27 for 26 minutes at 9.0 degrees C and one on 7/13 for 9 minutes at 8.9 degrees C. Polio deemed non viable per manufacturer immunization consultant. Dose given on 7/28, which was non viable at the time due to temperature excursions. Parent to be notified that child will need revaccinated. No adverse reactions have been noted at this time.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
Patient was given two shots 11/18/19. Patient came back to clinic 11/19/19 with complaint of intense right arm pain, patient was seen for a clinic visit and  patient was given a Right Should Immobilizer, and given pain medications along with an antibiotic.
Large swollen, tender lymph node in Right axilla 6 days after first shot  2/2/21 confirmed by ultrasound 2/9 second shot, in opposite arm, no adverse events, but right axilla lymph node still large and swollen
Sore arm, pain, no visible mark or redness/swelling, no temperatures pain worse over time, can not put on deodorant can't lift arm over head. MD ordered ALEVE & Heat.
Headache, Myalgia, NauseaVomiting, flu sx: chills Narrative:
Patient came in looking for a Janssen vaccine. He came in asking if the vaccine can make him vomit because he recently broke his jaw and was worried about vomiting with his mouth wired shut. I informed the patient that it is unlikely, but a possibility and asked the patient if he still felt comfortable getting the vaccine. Because his jaw was wired shut, I asked if he's gotten anything to eat today and described to me he had some yogurt and blend fruit, but that is it. Asked how he is feeling today and he said he "felt good" and isn't sensitive to vaccines in the past.  After Administering the J&J vaccine into his right deltoid, I asked him to sit in a chair for 15 minutes to make sure he is feeling okay. As I was helping other customers, the Patient said loudly that he wasn't feeling good. As I walked over he repeatedly said he felt like he was going to faint. 5 seconds later he fainted in the chair. I positioned myself so he wouldnt fall out of the chair. and a technician called 911 right away. The patient was unconscious for roughly 10-15 seconds then woke up and appeared very sweaty. A technician and I stayed by the patient's side until paramedics arrived less than 5 minutes later where the patient appeared wake and oriented to where he was.  Paramedics thought the reason for the fainting after the vaccine was due to not having enough food in his system due to recently having his jaw wired shut. Pharmacy provided the patient with Gatorade, Ensure, and applesauce to help. Paramedics were here monitoring the patient for 25 minutes Patient stayed for about 1 hour until a friend came and picked him up.
first dose of vaccine administered after excursion; bone pain,bone ache; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and BONE PAIN (bone pain,bone ache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and BONE PAIN (bone pain,bone ache). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and BONE PAIN (bone pain,bone ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-250491 (Patient Link).
The patient experienced swelling/redness/tenderness in the injection site and a mild fever. She presented to the pharmacy on 9/16/2018 to inform me about the injection site reaction. The patient received both vaccinations (FLUZONE HIGH DOSE and PNEUMOVAX 23) during the same visit on 9/14/2018 and states that she was fine before leaving the pharmacy and continued to be fine upon returning home. She stated that hours later, she began to experience swelling at the injection site and a fever that went as high as 102 degrees. The patient then self-medicated with TYLENOL to reduce her fever and she reported a tmeperature reading today of 97 degrees and states that she feels much better but the injection site is still a bit swollen and red. The patient mentioned that she had a similar reaction last year (2017) when receiving the flu shot along with the PREVNAR 13 vaccine and also the year prior to that (2016) with the flu shot only and stated that she did not mention any of these reactions to the pharmacy staff on 9/14/2018 because she was able to treat herself with antibiotics that she had left over at home last year. She states that last year, she self medicated with amoxicillin 500 mg for 2 days and the reaction resolved itself. The patient's prescriber has been made aware of the reaction. I spoke with the prescriber's medical assistant, on 9/16/2018 at 11:19 AM.
Patient was unresponsive initially, slow breathing , pallid color, called 911, patient came too and felt nauseous and needed to use the bathroom, Paramedics check him out and he left with his wife (did not go to the hospital)
16 yo M h/o anxiety with prior panic attacks, syncopized after vaccine, vomited and had a second near syncopal episode. He was evaluated by EMS. He was discharged home. Mother was with patient and was in agreement with discharge. Appointment with therapist scheduled for later that day.