chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose in2019, hasn´t had 2nd; This case was reported by a other health professional via call center representative 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 in 2019).   On an unknown date, the patient did not receive 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: 24-JAN-2023 Reporter's Comments:  The patient had first dose of Shingrix in 2019 and yet second dose was not administered. The reporter consented to follow up via email. Healthcare professional (HCP) was asked about patient information, vaccination date and batch number for the vaccine, information was declined. HCP looked in their system and couldn't find anything. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023010238:same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (26Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Oct2023 to 24Oct2023.  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-202300351409 same patient different drug/event;
Patient was given the wrong vaccine, she should of been given the Meningococcal B (Bexsero) second dose and not a third dose of Meningococcal Conjugate (MenQuadFi)
Angioedema of eyes. Eye (L) started swelling 3 hrs after flu vaccine. Both eyes swollen by morning - (no redness and no discharge).
Patient had Itching, Coughing, Difficulty Breathing, Headaches, Fatigue, about 6 hours after vaccination
The morning after vaccination, she felt extremely  and unusually fatigued. After getting up from bed and eating her usual breakfast, she was returning to her bedroom when she became dizzy and fainted, falling to the floor, hitting her head and suffering other effects, including rhabdomyolysis from being on the floor for a long time after the fall as she was unable to get up. She was transported to the ER and was admitted to the hospital for 3 days. She was treated with IV fluids, Tylenol and a short course of antibiotics. While hospitalized, she had a repeat of a rash/swelling at injection site that began about 48 hours after vaccination.  The hospital treated the rash with some barrier cream and within 48, the redness, rash and swelling abated.
Vaccine leaked down the patient's arm, received only 3/4 of the dose; Vaccine leaked down the patient's arm, received only 3/4 of the dose; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incorrect dose administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 06 Jan 2021 in the deltoid intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, a pharmacist called to report a nurse administered the Moderna Covid-19 vaccine to a male patient today. The male patient received the first dose of the vaccine today in the deltoid muscle of unknown arm and the vaccine leaked down the patient's arm. The nurse that administered the vaccine thinks that the patient might have received only 3/4 of the dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, incorrect dose administered, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of male patient who experienced vaccine leaked down the patient's arm, received only 3/4 of the dose (incomplete dose administered) for mRNA-1273, lot # and expiration date unknown. There were no reported AEs associated with this case of vaccine leaked down the patient's arm, received only 3/4 of the dose.
This is a 44-year-old female who presents to the emergency department today because of right arm pain redness. He was seen in primary care clinic yesterday and had a flu shot and a tetanus shot in her left arm and had Pneumovax placed in her right arm. At 8 PM last night her arm became more red swollen and painful. This discomfort when into her right breast as well. She states that she had a little bit of tingling in her mouth at that time and decided that she would take some Benadryl and use her EpiPen. They have 3 hours later she started feeling a little bit better. Saying she woke up and her arm was quite painful hurts to move. Still has some discomfort into her right upper chest wall. Prescribed Percocet, Keflex, Septra DS.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 0038B21A and 0038B21A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea and Headache. Previously administered products included for Product used for unknown indication: Vaccine, Influenza (Series 1, 05-NOV-2019 Series 2 and 21-OCT-2021). Past adverse reactions to the above products included No adverse event with Vaccine and Influenza. Concurrent medical conditions included Sclerosis multiple (Calvarium, Facial bones and cervical spine), Amnesia transient, Diverticulitis, Clostridium difficile infection, Diverticulosis, Vitamin D deficiency, Splinter hemorrhages, Hypothyroidism, Plantar fasciitis (bilateral), Venous insufficiency (Chronic), Arthralgia, Chest discomfort, Hyperlipidemia, GERD, Prostate cancer, Lung cancer, Colon cancer, Coronary artery disease and Drug allergy (CEFDINIR (CEFDINIR) (Severe)). Concomitant products included LEVOTHYROXINE SODIUM, VITAMIN D3 (VITAMIN D3 2000 UNIT ORAL CAPSULE), ACETYLSALICYLIC ACID (ASPIRIN LOW) and VANCOMYCIN HCL for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: abnormal (abnormal) Screen skin cancer, abnormal. On an unknown date, Blood thyroid stimulating hormone: abnormal (abnormal) Thyroid stimulating hormone, abnormal. On an unknown date, Colonoscopy: abnormal (abnormal) Screen colon cancer, abnormal. On an unknown date, Computerised tomogram thorax: abnormal (abnormal) Screen lung cancer, abnormal. On an unknown date, High density lipoprotein decreased: low (Low) Low. On an unknown date, Investigation: abnormal (abnormal) CAD , abnormal. On an unknown date, Physical examination: abnormal (abnormal) Physical exam routine, abnormal. On an unknown date, Rectal examination: inconclusive (Inconclusive) Screening prostate cancer, abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported  VANCOMYCIN HCL dosage was reported as  one three times a day for one week then one twice a day for one week then one daily for one week then one every other day for 2 weeks then one every 3rd day for 2 weeks  Services Due were reported as TD BOOSTER, BP DIASTOLIC, BP SYSTOLIC, HEMOCCULT or SIDMOID
Pt with enlarged smallpox site with heaped up edges also with papulovesicular rash on extensor surfaces of arm & neck very pruritic. Pt responded well to oral Prednisone taper & CALAMINE lotion. Resolution of vesicles over 5 days.
Patient received the vaccine and while sitting down within one minute he fainted and fell on the floor. He remained on the floor until paramedics arrived. Paramedics took his vitals and observed him for a period of time. They said it was fine for him to leave with someone else to drive him. While waiting for family to arrive the patient began to have a seizure. Paramedics returned and this time they took the patient for further care.
Dizziness, sweating, shortness of breath, lower abdominal pain, vomiting.
Moderna booster was given today. After the vaccine was given, items were being documented and found to be that this lot was expired. No ADE reported from patient.
Pts arm was red, slightly swollen, hot to touch - Down whole arm. Pt took BENADRYL said it helped. Pt did not go to MD office. Rxn was in arm Pneumovax was adm. in.
mom reported that pt devel t104.6 afternon 14JAN93 accompanied by a sz described as shaking & twitching, eyes rolling; taken to ER;
resting heart rate elevated; heart was pounding a little bit/ slight spluttering on the chest, a little bit, a mild case; This case was received via an unknown source, no reference has been entered for a health authority on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of resting heart rate elevated and PALPITATIONS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced resting heart rate elevated and PALPITATIONS. On 26-Aug-2021, resting heart rate elevated and PALPITATIONS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No Concomitant medication was reported.  No treatment Drug was reported.
The one time I got the flu shot, I was deathly Ill; Initial information received on 18-Oct-2023 regarding an unsolicited valid social media non-serious case received from a patient.  This case involves an unknown age and gender patient who was deathly ill after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient was deathly ill (illness) (unknown latency) following the administration of Influenza Vaccine.  Reportedly, The one* time I got the flu shot, I was deathly I'll, like; c0V!* ill*..   It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Fever: onset ~7.5 hours post injection.  Peaked at 101.8 °F ~13 hours post injection.  Overall duration ~24 hours.  Headache: accompanied fever  Sore arm in vicinity of injection site: roughly same time as fever as well.  Made it almost impossible to lie on my left side.
Incredibly sore arm, could not move it after 3 hours since getting the vaccine. The pain was so strong I took ibuprofen that relieved it for a few hours,  but it was back again.  After around 12h from getting the vaccine, I started having body aches, had strong chills, a terrible headache, and it got only worse at night.  Since I could not sleep to do body aches, it hurt especially in my back and thighs,  and I decided to take a muscle relaxer I was prescribed before for my back pain. It helped me fall asleep
devel high fever 105 p/vax;MD wrote order for subsequent ped TD;parent reported to hlth dept
Became weak and progressed into a constant cough, migraines that needed Tylenol with codeine. High blood pressure and pulse at 160/113 and pulse at 100 was constant. After tons of various medical tests an mri was done on my heart in sept 2021. Scar tissue was found on my heart from Myocarditis
bruise then knot at injection site with large painful spreading redness; extreme fatigue, tachycardia, wheezing, weakness
Information has been received concerning a pt who was vaccinated with varicella vaccine. On 06/07/00 the pt's father developed shingles. Subsequently the pt developed chickenpox consisting of approximately 50-100 lesions. It was noted that the lesions were in the pt's mouth, on her head and generalized. The lesions reportedly went through the full progression from blisters to scabs. Additionally, it was noted that the pt's chickenpox appeared more mild than natural chickenpox and that it seemed to resolve quicker than wild type disease. Unspecified medical attention was sought.
My supervisor, and staff came to get me from my department because they had a speaking patient that "needed a Hep B vaccine" and they were unable to communicate with her. I walked down the hall to where the patient was and spoke with her. She told me she was getting the shot due to being put at risk at our dental clinic. After verifying she needed a third Hepatitis B vaccine, I asked my supervisor if I could pull the vaccine from the fridge in my department. She said yes. It wasn't until after that it was brought to my attention that I had given her a pediatric dose of Hepatitis B.
Coughing; Wheezing; Vomiting; Loss of appetite; This is a spontaneous report from a contactable consumer (daughter) reported for her mother that a 95-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm, on 20Jan2021 at single dose for covid-19 immunization. Medical history included atrial fibrillation in last 2 months in 2020 and ongoing; pacemaker inserted from 2020 to 2020, inserted about 2 months ago, also mentioned approximately Oct2020. She just had her second follow-up related to this day before getting first dose of Pfizer COVID-19 Vaccine. No notable results or information from that follow-up appointment. broken hip in Oct2020 and surgery for broken hip performed on 27Oct2020. The patient's concomitant medications were not reported. This daughter is the caregiver for her mother but is not a healthcare professional. She reported her mother was administered the first dose of Pfizer COVID-19 Vaccine on 20Jan2021. Starting 22Jan2021 around 08:45 she had onset of coughing; wheezing; vomiting; and loss of appetite. She wanted to know if these events could be related to the Pfizer COVID-19 Vaccine. Events outcome described as improved; the patient's nurse reported to daughter that they have subsided at this time. No adverse events required a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer suspect. Patient did not have any vaccinations within four weeks prior to the first administration date of the suspect vaccine. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Itching legs and red raised welt Friday night Saturday morning face swollen and red hard welts generalized.
pt devel hives that evening p/vax;required steroids & atarax to control the itching;the hives lasted 9 days;
9-11-15 at 7:24 pm reports red, warm swollen arm where flu shot was given-Rec cool compress and Ibuprofen-telephone mess 9-13-15 8:21 am see in E.R. for (L) arm swelling Dx cellulitis-given BENADRYL and KEFLEX.
Patient is 29yo, 14 weeks pregnant, and has a hx of fainting with vaccine administration. Patient fainted after administration. EMS was called, but patient eventually left on her own accord.
Patient reported that later that night developed redness, swelling, and pain on anterior portion of upper left arm with extension onto his chest. Rash and redness, swelling, and pain.
PATIENT RECEIVED VACCINE FRIDAY 4/9/21 AROUND 4 PM. PATIENT STATES WHEN HE WOKE UP SATURDAY 4/10/21 HIS RIGHT EYE WAS RED AND HURT. PATIENT STATED PAIN WAS RESOLVED BUT THE REDNESS REMAINED. PATIENT DID NOT SEEK MEDICAL TREATMENT.
Cold like symptoms and very tired. I did not contact my doctor and it went away after sixteen hours.
A spontaneous non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a six-year-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-20098). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are 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 09-Apr-2009: Product Complaint Investigation results.
The patient experienced the following reaction(s) during the immediate   of observation: 1040- pt states she isn't feeling well.  Pt moved to post-vac area vial wheelchair.  1042- BP-90/70 P; 75 R: 16 Sp02 97%.  Pt stated she is feeling dizzy and having a panic attack. Hx of mental health issues that she takes multiple mediactions for.  Pt  stated she did not eat this morning. 1046- pt laying on floor states she is feeling much better, dizziness is going away.  Pulse ox on pt, vitals monitored. 1049- BP: 110/97 P: 63 RL 18 Sp02 98% 1050- p sitting up denies any nausea and states dizziness has almost resolved.  Pt with ice pack and water.  continuing to monitor pt before allowing pt to drive home. 1100- pt released home, ambulating to the door with no issues.  Advised pt to contact family member to come get her or 911 if she gets dizzy while driving. Pt told nurse she was going to a half way house and was withdrawing from drugs currently.  Pt states she is homeless.
CHEST PAIN.  PATIENT HAS AN EXTENSIVE CARDIAC HISTORY INCLUDING CABG AND PAST MI. MD ORDERED PATIENT TO BE SENT TO ACUTE HOSPITAL FOR OBSERVATION. PATIENT WAS GIVEN NYTROGLYCERIN  EN ROUTE. PATIENT DENIES ANY OTHER ASSOCIATED SYMPTOMS. PATIENT DENIES ANY ALLEVIATING OR AXACERBATING FACTORS.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 17-MAR-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number reported as J002646, dose and route were not reported), that had expired on 11-MAR-2014. Concomitant medications were not reported. No adverse effects reported. Additional information is not expected.
The evening of the vaccination when I got home did not feel like myself, extremely fatigued. I went to bed and in the middle of the night I developed shaking chills and had a fever of 101F. Next morning I called Employee health and told them I was having headache, the shaking chills, body pains. They told me to call them back if it got worse. I called them in the afternoon since the symptoms got worse and I also developed a pain in my flank area, like kidney pain (in the back, but not the back). This happened on Sunday 01/10). I took a lot of Tylenol and Ibuprofen that did not help me at all with the fever or the pain (it reached 102F). On Monday, 01/11 the fever broke in the afternoon but I ended up with an extreme fatigue and I slept the whole day. When I woke up on Tuesday, within one hour of waking up I was feeling totally fine.
Pt is a 12-month old girl, was seen in office for the first time for WCC. She only had her 2-month old shots, behind with her IZs, discussed with parents and decided to give her Pentacel, HepB, Hep A, PVC 13, MMR and VAR. I wanted pt to get MMR and VAR vaccines separately. However, MMRV proquad was given by mistake instead of just MMR alone and patient also received VAR alone. I did not verify the vaccine name correctly. Parents were informed that pt received a double dose of varicella, Tylenol was prescribed in case she has a fever. Parents are aware all vaccines have potential adverse reactions with most common being injection site reaction and rarely low grade fever. Parent understood if fever develops, the patient should be given Tylenol to relieve symptoms with ER precautions given. I consulted my supervisor. I also sent an email to the CDC for any recommendations or precautions to take. Per CDC, child might experience a more severe local reaction that usual, but not expecting any other safety concerns.
On December 18, 2021, I started having COVID like symptoms. I was feeling lethargic, weak, coughing, very tired, and I had a very sore throat. That lasted intensely until about December 22, 2021. I was still ill until about December 27th when it got more mild. I was unable to go to work.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was prescribed ZOSTAVAX (dose, route and lot# not provided). However on 27-FEB-2015 the patient was inadvertently given VARIVAX (Merck) (dose, route and lot# not provided) instead of prescribed vaccine. No adverse effect was reported. Additional information has been requested.
Case PHEH2016US025181, is an initial spontaneous report received from a nurse on 18 Sep 2016. This report refers to a 46 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.4 ml intramuscularly on 28 Sep 2016. The nurse stated that, adult patient received partial dose of FLUVIRIN vaccine after syringe became detached from needle during administration. No adverse event was reported following this administration error. The nurse assessed the case was non serious.