chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative and refers to a patients of unknown age and gender, described in the article entitle "Shingles Vaccine May Pose Eye risk in some people". There was no information about patient's pertinent medical histories, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with ZOSTAVAX injection (lot #, expiration date, dose, anatomical location and route of administration were not reported). On an unknown dates, the patients experienced a shingles flare-up. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
AMR Transport due to high P/P, Patient requested transport to ER by medic unit.
Pediatric dose to adult patient; Pediatric dose to adult patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 29-year-old female patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 26th January 2022, the patient received Havrix pediatric. On 26th January 2022, unknown after receiving Havrix pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: Medical assistant reported to have administered one pediatric dose of Havrix to an adult patient, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the patient received the second dose of GARDASIL (route, lot number and expiration date not reported) one year after the first dose in series of an unspecified date. No adverse were reported. Additional information has been requested.
Dizzy, light headed, felt faint, low blood pressure, called 911 and they transported her to hospital. Patient notified staff 15 min. after receiving shot that she needed 3 nitroglycerin night prior to feel any relief, did not seek medical attention
HEADACHE STARTED DAY AFTER VACCINATION (20JULY2021) , CONTINUED UP UNTIL TODAY (23JULY2021) NAUSEA 2 DAYS AFTER VACCINATION PAIN IN MUSCLE OF THE ARM OF SITE DAY OF  AND DAY AFTER VACCINE. ICE APPLIED TO SITE, INDUCED MOTION, IBUPROFEN FOR HEADACHE AND ARM PAIN
Patient reported the day after receiving the vaccination that she woke up during the night with nausea and aching.  These symptoms persisted upon awakening.  She took acetaminophen and that helped to resolve the symptoms.
she becomes, like she is paralyzed; Panic attacks; Psychiatrist puts her on drugs (Unspecified Medications); but she suffers from fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete;), for COVID-19 Immunization. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "she becomes, like she is paralyzed"; PANIC ATTACK (non-serious), outcome "unknown", described as "Panic attacks"; FATIGUE (non-serious), outcome "unknown", described as "Psychiatrist puts her on drugs (Unspecified Medications); but she suffers from fatigue". Clinical course: She was living on her own, working, doing just fine. She did not have COVID, but she had the Boosters and the Pfizer (Pfizer COVID-19 Vaccine) and this is the only thing reporter can think of. So, then in the last year and a half, she going through, she has panic attacks which are she becomes, like she is paralyzed. Reporter think it is like she is paralyzed. She is unable to work. She has been in 2 different places, one here in Withheld, Withheld a institute she was up north. She was in a place for like 26 days (Further information was not available over the call). She now has been in Withheld for year and half but anyway she was in her place here for a week because the Psychiatrist puts her on drugs (Further could not be clarified over the call hence suspect captured as Unspecified Medications) but she suffers from fatigue and reporter just want to, the only thing reporter can think of that happened in her life that was different than anything else was the fact that she had the vaccinations that up until that point she did just fine. You know she lived on her own, worked and everything and she is not capable of working. So, reporter just want to, the only thing reporter can thing of that happened was that she got the vaccinations and there is nothing else that reporter can think of that could have happened that would cause her and reporter did not know whether you have had any, anybody had these symptoms or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient received full dose 9-19-22.
8cm X 8cm patch of pink papules on right arm, inferior aspect of deltoid. Referred to an Allergist.
1/24/22 I had my shot that afternoon. I had severe arm pain in my upper left arm immediately. Later it became swollen, red, and it was a hard knot. My fever went up to 101 for one day. I felt nauseated and had a headache. The main symptoms lasted a few days and my arm hurt for around 5 days.
My Appendix exploded inside me and almost killed me . They had to gut me like a Pig from bottom of my chest to my waistline . They removed my appendix and had to leave it open to drain. I am permanently scared for life. I was in the hospital for 8 days and couldnt work for three weeks
Squeezing sensation in chest and SOB about 3 hours after injection lasting about 24 hours.
first Shingrix vaccine / two years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from the date of reporting).   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 details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if needed to restart the series or just get the 2nd shot.
Patient presented to ED on 02/04/2022 with ongoing and progressive SOB and cough.  Patient endorsed weakness and intermittent chill.  In ED patient tested Covid Positive.  CXR consistent with ill-defined opacities in the right lung base and peripheral left lung, atelectasis versus airspace disease.  Patient admitted to hospital with acute hypoxic resp failure.  Palliative care consulted and patient agreed to DNR code.  Patient expired on 03/06/2022.
8/19/04: 4:15 pm later in day. 8/19/04. Pink area from knee down to ankle on right leg. Gave Tylenol 0.4cc drops. Benadryl 1/2 tsp. Mom called at 4:15pm.
Mother called to report pt had fever of 103 degrees F, body aches at the onset of symptoms at approximately 3:00 pm yesterday.  Mother called health department and was unable to reach due to after hours so she contacted family physician instructed patient to alternate Tylenol/ibuprofen to reduce fever and body aches and monitor for anaphylaxis.  Mother states fever is under control but returns after medication wears off.  Pt woke up at round 3:30am and 5:00am this morning vomiting.  Instructed mother to continue monitoring patient, continue to rotate Tylenol/ibuprofen as needed, also drink fluids to reduced risk of dehydration.  Mother to follow up with health department this afternoon.
Patient presented with abnormal loss of weight, nausea and vomiting in July 2021 and passed in August 2021.
Case number PHEH2016US029801, is an initial spontaneous report received from a consumer on 10 Nov 2016. This report refers to a 25 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) as a dose of 0.5 ml intramuscularly on 20 Oct 2016. On the same day after vaccination, the patient experienced soreness in his right arm. It was reported that the patient received FLUCELVAX QUADRIVALENT 02 to 03 weeks ago and was still experiencing soreness in his right arm. He recently visited a health care professional at a clinic to address the issue, however had not yet taken any medication for it. The patient described the soreness as non severe. The final outcome of event was reported as condition unchanged. The seriousness and causality of the events were not reported.
The patient received her first Covid-19 immunization on 1/26/2022 and her second dose on 2/8/2022, only 13 days after her first dose. She tolerated the injection well without adverse effects. Per CDC recommendations, have notified parent, we will re-administer her second dose, and am completing a VAERS report.
pt recvd vax & 2 days later devel aches, chills, swollen joints in all four extremities; tongue had a burnt-like sensation; pt was treated w/steroids & non-steroidals (Anaprox); pt cont to have joint stiffness in the fingers;
suspected vaccination failure; 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 patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine years ago from the date reporting. After receiving Shingles vaccine, the patient got shingles, but just a light case. The patient still went ahead and got the two shots they now suggested. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Vaccination site (lt thigh) immediately after giving the vaccination turned purple all the way down to leg, foot spontaneously spread to extremity, face and rest of the body. Also turned pale and  discomfort on face. 05/29/2003 Admission- diagnosis "Probable anaphylaxis" secondary to vaccination. Treated with Solu Medrol Epinephrine and Benadryl. 05/31/2003 Re-admitted for fever 100.50-100.8 and diarrhea. Sepsis was ruled out. Diagnosis was gastro enteritis. Discharged 06/04/2003. The ER records and hospital discharge summary received on 1/6/04 states sudden onset of urticaria. Admission note states reaction "close to anaphylaxis." The final diagnosis was stated as gastroenteriris. Additional symptoms noted were fever, tiredness, sleepiness and diarrhea. There was an ER visit 2 months after onset of AE that was for vomiting.
Patient received vaccine 10/21/21. Within a couple of days she developed a large area indurated erythema  (shoulder to elbow). Patient reports growing in size daily.
02/02/2022 Half of my right arm was red, hot, tingling, throbbing and itchy. I went to the health center where I work. I was put on antibiotics. My arm kept getting bigger. After five to six days later, it was all better.
Patient came to the pharmacy to get seasonal flu vaccine and Shingrix first dose, and after she got the shots she started feeling dizzy, and very pale, and she told me she will passed out .She told me she gets very nervous every time she has to get any medical procedure, I gave her alcohol pads  to smell but still dizzy and she passed out, lost consciousness for about 4-5 minutes, and also peed her pants. We tried to reanimate her, but she did not respond so we called 911.After at least 5 minutes, she became responsive but still very sweaty and pale, fire fighters showed up in about 10-15 minutes and did vitals and blood sugar for her, and everything was fine, she did not want to go to the hospital, and she went home.
1. Dizziness, slight; 2. Pain in arm muscle and side of neck. Happened right after injection, burning sensation when given shot. No itching. Pt reported these symptoms on 8/28/10.
heathcare provider has told her she cannot have the second dose of the Moderna COVID-19 Vaccine; severe migraine that wouldn't go away for over 24 hours; Shingles; sore arm; tiredness; slept most of the day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSOMNIA (slept most of the day), OFF LABEL USE (heathcare provider has told her she cannot have the second dose of the Moderna COVID-19 Vaccine), MIGRAINE (severe migraine that wouldn't go away for over 24 hours), HERPES ZOSTER (Shingles) and PAIN IN EXTREMITY (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No historical conditions were reported.  Concomitant products included METOPROLOL SUCCINATE for Arrhythmia, DICYCLOMINE HCL for Diarrhea, PANTOPRAZOLE for GERD, Acid reflux (esophageal), Gastritis and Stomach upset, POTASSIUM CHLORIDE for Low potassium syndrome, ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) for Migraine, TOPIRAMATE and RIZATRIPTAN BENZOATE (RIZATRIPTAN ODT) for Migraine prophylaxis, TIZANIDINE for Muscle relaxant, ONDANSETRON (ZOFRAN MELT) for Nausea, TRAMADOL for Pain, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Prevention and Prevention.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERSOMNIA (slept most of the day), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). On 23-Mar-2021, the patient experienced MIGRAINE (severe migraine that wouldn't go away for over 24 hours) and HERPES ZOSTER (Shingles). On an unknown date, the patient experienced OFF LABEL USE (heathcare provider has told her she cannot have the second dose of the Moderna COVID-19 Vaccine). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster, at a dose of 1 gram; PREDNISONE for Shingles, at a dose of 20 mg and CLOBETASOL PROPIONATE for Shingles, at a dose of 0.05 percent. On 22-Mar-2021, HYPERSOMNIA (slept most of the day) had resolved. At the time of the report, OFF LABEL USE (heathcare provider has told her she cannot have the second dose of the Moderna COVID-19 Vaccine), PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown and MIGRAINE (severe migraine that wouldn't go away for over 24 hours) and HERPES ZOSTER (Shingles) had not resolved.        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.   She stated her healthcare provider has told her that she cannot have the second dose of the Moderna COVID-19 Vaccine.
severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products.  other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
PT and 3 family members received same lot # vaccine. Pt developed hives 7-15 and started on Benadryl. On 7/17 not much better started on Medrol dose pack, also with welts on leg. Saw MD in office 7/19. Claritin added.
No adverse effect reported; the patient was inadvertently administered a dose of ROTATEQ, on 01-AUG-2019, that was improperly stored/Temperature: 10.5 °C; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information according the patient's current conditions, medical history, previously past drugs or allergies, and concomitant therapies were not provided.   On 01-AUG-2019, the patient was vaccinated with an improperly dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, as prophylaxis (strength, formulation, dose number, dose, and  anatomical site injection were not reported; lot number reported as S004400; expiration date 14-NOV-2020).   The temperature was of 10.5 degrees Celsius, for a time frame of 5 hours, with a previous temperature excursion. A digital data logger was not used. No adverse effect reported.
fever and fussiness for about one day   She received Hep A earlier this week (5/1).  She was well appearing in clinic, suspect viral process, though given fever occurring recently after vaccines (tmax 103.3)
This case was reported by a nurse via call center representative and described the occurrence of skin irritation in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin irritation. On an unknown date, the outcome of the skin irritation was unknown. The reporter considered the skin irritation to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported.  It was reported that the dose of SHINGRIX caused skin irritation to the patient. The nurse called for assistance on the patient receiving the second dose of SHINGRIX vaccine after reacting to the first dose.
Patient is a 85 y.o. male with a past medical history that includes chronic restrictive lung disease in the setting of kyphosis, CVA with chronic dysphagia s/p G-tube, prior aspiration PNA requiring intubation, incarcerated paraesophageal hernia, osteoporosis, hyperlipidemia, GERD, BPH, osteoarthritis, vertebral compression fractures.  He presented on 5/7/2023 with 4 days of shortness of breath, found to be in acute hypoxic respiratory failure secondary to COVID/aspiration pneumonia. On BiPAP, steroids, remdesivir, rocephin. Overnight 5/10, patient became more somnolent and difficult to arouse with labored breathing. Discussed change with wife, POA, and decision was made to transition care to comfort measures only. Time of death 1017
Temp rose to 104 R pt taken to ER & Pediaprofen given & APAP; temp dec & pt was OK the next day;
No adverse reaction patient tolerated will, dose given out of vial that was in the fridge longer than 30 days.
This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No pertinent medical history were reported. None drug allergies or drug reactions were reported. On 19-SEP-2016 the patient was vaccinated with ZOSTAVAX, (lot, expiration date and dose were not reported) subcutaneously. No concomitant medications were reported. On 19-SEP-2016(reported as the patient began to experience symptoms same evening after receiving the vaccine) the patient experienced burning, soreness and itching at the injection site, face feels like its burning and headache. The patient sought medical attention to the pharmacist. The reporter stated that the patient is still experiencing the symptoms (not recovered). The causality assessment was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.