chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details were reported.  Vial size was reported as 10 dose vials. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at this time. The second potential lot was confirmed to not be used. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Pt stood up after receiving second vaccine (Boostrix) and stated she felt a little light headed.  Pt sat back down then lost consciousness after about 15 seconds.  Pharmacy placed ice pack on the back of her neck, called her name, checked breathing, and called 911.  After 15 seconds, pt briefly regained consciousness but was incoherent, pt lost consciousness again for about 10 seconds.  Then pt regained consciousness and was given some water.  The EMTs arrived within 10 minutes and evaluated the patient.  Pt refused to go to hospital and left the pharmacy at about 10:30 am under her own power with her husband.
On 2-18-13 Patient had achiness on left arm with flu like symptoms in the evening on 2-19-13 in the am had redness and swelling 8"x 4" and itchiness. Took CLARITIN 2-19-13 saw MD on 2-20-13.
Inadverently administered M-M-R- II vaccine instead of an M-M-R-II vaccine titre test; His daughter is not experienced any additional side effects; This spontaneous report was received from a veterinarian referring to a 29 year old female patient. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 29-NOV-2021, the patient was going to do an measles, mumps, and rubella (MMR) titer test, but was inadvertently administered with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin (rHA) or human serum albumin (HAS), only leave one after receiving validation result of therapy type) (M-M-R II) for prophylaxis (accidental exposure to product) (strength, dose, vaccination scheme, route of administration, anatomical location were not reported; lot number U006487 has been verified to be a valid lot number, expiration date was 26-FEB-2023). The patient was not experiencing any additional side effects at the time (no adverse event). The reporter stated that he did not believe the patient was pregnant, but the patient was worried about since her and her husband were trying to become pregnant.
This 73-year-old male subject was enrolled in a study. The subject received the 2nd dose of Zoster VZV-gE-AS01B (intramuscular) on 8th April 2015. The subject received the 1st dose of Tdap vaccine (intramuscular) on 17th December 2014. Concurrent medical conditions included polycystic kidney. In May 2015, 30 days after receiving Zoster VZV-gE-AS01B and 152 days after receiving Tdap vaccine, the subject developed severe - grade 3 polycystic kidney. Serious criteria included hospitalization and GSK medically significant. The subject was treated with Acetaminophen-Oxycodone and fentanyl. The outcome of polycystic kidney was recovered/resolved on 2nd July 2015. The investigator considered that there was no reasonable possibility that the polycystic kidney may have been caused by Zoster VZV-gE-AS01B and Tdap vaccine. Relevant Tests: No relevant diagnostic tests. Investigator comment: Patient was admitted on 30 Jun 2015 for evaluation of possible acute cholecystitis. Patient was made NPO with intravenous fluids. Abdominal ultrasound imaging showed cholelithiasis and necessitated follow-up HIDA scan, which showed no acute cystic obstruction. Patient's diet was slowly advanced, which he tolerated well. Upon discharge on 02 Jul 2015 he no longer had any abdominal pain. The likely cause of his pain is due to his known polycystic kidney disease. No, discharged diagnosis is worsening of pain from polycystic kidney disease and acute cholelithiasis was ruled out for this admission.
Chills; Tiredness; Nausea; Low grade fever; Pain at the site of the injection (upper left body); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Tiredness), NAUSEA (Nausea), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left body)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced CHILLS (Chills), FATIGUE (Tiredness), NAUSEA (Nausea), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left body)). At the time of the report, CHILLS (Chills), FATIGUE (Tiredness), NAUSEA (Nausea), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left body)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Sore throat, runny nose, headache, fatigue, low-grade fever, extreme and frequent urge incontinence through the night (23:00 to 07:00) with resulting weakness, headache, dehydration and no appetite but moderated late on 10/29/00 PM. Coughing, wheezing, weakness and fatigue continued but nearly normal on 11/2/00 PM.
I experienced a severe migraine, inflammation, swollen lymph glands, and stiff jaw. I have also experienced difficulty swallowing and chewing, weakness on the right side of body, leg pain, severe fatigue. I got inflammation in the muscle around my eyeballs. I went to eye doctor for treatment for my eye and was diagnosed Ocular Myositis and was prescribed 800mg of ibuprofen 3xday for the inflammation. I walked to my PCP to try to be seen but they were so busy they couldn't see me. I was able to do the virtual the appointment but the MD couldn't do anything virtually. I had a neurologist appointment on 9/21/21 @ 9:45AM and he advised me that I do need to see my PCP in regards to the issues that I am having.
Takes promethazine for nausea and took Excedrin Migraine for her headache, has history of migraines. Low grade fever ranging from 100.1F to 100.5F
Father brought his daughter, patient, for her latest Pediatric Pfizer Bivalent Booster and instead one of the nurse at our clinic administered her Adult Pfizer Bivalent Booster. I called the father as soon as the error was discovered but could not reach him until the more than 24 hours later. Father assured me that patient was doing well and only experienced mild soreness of the arm where the vaccine was given.
Spoke with patient 5/11/04. She noted, incidental to conversation that Td given on 8/6/04 led to a sore left arm and fever x 1 day, then gone. I did not see her for this.
This spontaneous report as received from a Licensed Practical Nurse refers to a 16 year old patient of unknown gender. In 2008 the patient was vaccinated with the first dose of GARDASIL (lot #, dose and route unspecified). In 2013 the patient was vaccinated with the second dose of GARDASIL (lot#, dose and route unspecified). In 2014 the patient was vaccinated with the third dose of GARDASIL (lot#, dose and route unspecified). No adverse effects were noted. Additional information has been requested.
the vaccine caused me to have a very bad exacerbation of my condition, extreme fatigue, leg and joint pain, cannot be up very long, have to rest, also extremely emotional.  This has happened in the past but this time worse and very much caused by the vaccine.
Information has been received from a radiologist reported that a gastroenterologist said he had some patients experience stomach pain after receiving a dose of GARDASIL. No specific patient information was provided. Follow up information was received from a radiologist by phone on 19-MAR-2009 providing the name and telephone number of the gastroenterologist. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of GARDASIL (lot # J006236, expiry date 25-FEB-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Client had a syncopal episode and fell from a sitting position to the floor. Pt was lying with eyes closed and non-verbal for 30 seconds or less.  Tactile stimuli and deep sternum rub done to mid chest wall. Pt eyes open. A/O x3. LCTA. Medium size hematoma noted to left side of forehead with small abrasion noted to bridge of nose.  Pt denies pain. EMS was notified. Once EMS arrived orthostatic v/s was obtained per EMS with  last reading b/p 133/82 HR 72 RR 22 O2 99% RA.  Pt refused further tx . Placed in w/c and pushed to lobby with family and RN at side. No acute distress.
The primary encounter diagnosis was Acute on chronic congestive heart failure, unspecified heart failure type (*). Diagnoses of Anemia, unspecified type, Hypotension, unspecified hypotension type, and Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type were also pertinent to this visit.Patient presented to emergency services on 12/12/21 with dyspnea on exertion and weakness worsening over the last 6 months.  Is also had worsening shortness of breath and lower extremity edema.
Right arm was sore; Felt generally ill; fatigued; joints hurt the day following injection; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL 3247) dose 2 via an unspecified route of administration in right arm on 12Feb2021 02:30 PM (at the age of 36-year-old) as single dose for COVID-19 immunisation at Workplace clinic. Medical history and concomitant medications were not reported. Historical vaccine included received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number EL 3247) dose 1 via an unspecified route of administration in right arm on 20Jan2021 02:00 PM (at the age of 36-year-old) as single dose for COVID-19 immunisation. She had sore and swollen lymph node in neck, she was tired, arm she was injected was sore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Feb2021, her right arm was sore. Felt generally ill, fatigued, and joints hurt the day following injection. Symptoms started to resolve 2 days after injection. No treatment was received for the adverse event. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057929 Same reporter, patient, and product different doses.
pt recvd vax;w/in 24 hrs p/ dose 3,exp fever & body aches;sx resolved w/in 72 hrs;
bell's palsy; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Limited information was provided. No further information was reported. This is 1 of 4 cases, reported by the same reporter.
Client received vaccine at 3:10PM began feeling wheezy at 3:49, client consumed liquid benadryl at 3:50pm. reported feeling improved symptoms at 4:00PM. Offered to call EMS twice, refused and left clinic at 4:00pm.
fever (100.5F); rigors; myalgia; anorexia; headache; painful arm
soreness at injection site; Light headed/dizzy; Felt very anxious and tense; Tense; Heart racing; This is a spontaneous report received from a contactable consumer (reporting on himself). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK9231; Expiration Date was not reported), via intramuscular route of administration in Arm Right on 23Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included prostatomegaly, drug hypersensitivity both from an unknown date and unknown if ongoing. Concomitant medication(s) included finasteride (FINAS-TERIDE); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) both taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. On 23Jan2021 12:30, he received his first dose of the Pfizer COVID vaccine. Patient states he felt fine at the clinic after 15 mins and then after he left he felt lightheaded and dizzy and this continued on. Patient says his reaction was about 20 plus minutes after his injection, which he was fine when he got the injection, he became lightheaded and that has kind of continued on. He says it was pretty bad on the first day, then the second day it went away. He says a couple days later it came back, with his heart kind of racing, and he was still experiencing that though it was getting better. This was not something he had be-fore and he feels anxious and body is tight with dizziness. He says he experiences it periodically, and today it was not bad, but yesterday it came back again. He says he was concerned about that, but he hasn't passed out or anything. He says he went to the doctor and had an EKG and blood work done, which were all ok. He says it has been off and on, and he was kind of very anxious and tense as well, his insides are tight and jittery, sort of. He says he didn't see that listed as a common side effect. He says he had soreness at injection site, that went away, and he had no fever or any-thing, just the lightheadedness. He says he wants to see about the lightheadedness, if it had been reported by others, since he didn't notice it as a common reaction, to see what is going on there, since it has been over a week and it hasn't totally gone away, so he is concerned about having his second dose. Am doing better now. Went to the doctor for tests on 27Jan2021 (Wednesday). Test results were okay. Patient states these are not some of the common side effects he has seen or read about. He would like to know when will his symptoms go away. Patient would like to know if he should receive the second dose that was scheduled in less than two weeks. Patient states he called his doctor had an EKG and blood work done and his tests were negative. The outcome for soreness at injection site was recovered on an unspecified date and for rest events was recovering.
Pt reported developing a flushing of the face, shortness of breath, and tightness of the throat within ten to fifteen minutes of receiving this vaccine.  Pt also reported developing a fever, chills, and severe nausea approximately 1 hour after receiving this vaccination.
Pt. called and described muscle soreness of both thighs 3 days after administration of Td and Hep A vaccines. Pt. did not inform provider that she had been taking prednisone 5mg on descending doses for 2 1/2 weeks prior to coming to the clinic for vaccinations. She was taking 5 mg. q o day during week prior to receiving vaccinations. One vaccine given in each arm per pt.
At 10:46, patient reported anxiousness, trouble breathing and diaphoresis. Patient sat down next to EMTs. Patient given water. Patient vitals were blood pressure 144/84 mmHg, heart rate 78 beats/minute, and SpO2 98%. Patient asked to remove mask and take deep breaths. EMTs conversed with patient to lower anxiety. At approximately 10:55, patient had unlabored respirations, decreased anxiety, and decreased diaphoresis. Patient reported history of high cholesterol, gastritis, and unspecified back injury. Patient reassessed at 11:04. Patient vitals were blood pressure 136/90 mmHg, heart rate 96 beats/minute, and SpO2 98%. EMT advised patient to seek emergency care if symptoms return and continue to progress. At 11:10, patient left facility to sister with unlabored respirations and steady gait.
Caller stated that 24 hours after the injection she noticed that her veins "got really blue"; Caller stated that 24 hours after the injection she noticed that her veins "got really blue" and she had soreness/pain in on the underside of her arm that was asministered the vaccine; that her veins "got really blue" and she had soreness/pain in on the underside of her arm that was asministered the vaccine; she might have got the injection intravenously; This spontaneous report was received from a consumer and refers to a 70-year old female patient. The patient's concurrent conditions, medical history, drugs reactions or allergies were not provided. Concomitant therapies included levothyroxine sodium (SYNTHROID),  On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, lot # and expiration date were not provided) for the indication reported as:" doctor has recommended it". The reporter was not 100% sure, but she might have got the injection intravenously. She stated that 24 hours after the injection, on 09-JAN-2021, she noticed her veins "got really blue" and she had soreness/pain in on the underside of her arm that was administered the vaccine. She said that she did not have other reactions and her pain has since dissipated. The outcome of the events was reported as recovering.    The causal relationship between adverse events and  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
While injecting right arm with vaccine - the vaccine fluid squirted out of the syringe an possibly more that half the vaccine did not reach the patient properly. Conferred with HCP and it was ordered to dose the patient with a full dose in the left arm. Orders carried out and vaccine was administered as ordered. Patient tolerated procedure and was understanding.
Two days after shot - chest pain, nausea, headache, full body hives and full body rash where skin turned red like a bad sunburn and mild fever. Administered Tylenol and Benadryl. Hives and rash resolved within a couple of hours, all other symptoms remained. Two weeks after vaccine chest pain, nausea, and head ache remained. Pediatrician sent us to the ER. Determined that she did not have myocarditis. Chest pain has since resolved but headache, fatigue, insomnia, and nausea has continued. Current undergoing treatment by neurologist to treat the remaining symptoms.
Covid19 breakthrough.  1st vaccine received on 01/12/2021.  79 y/o female with PMHx of hypothyroidism, dementia, HTN, GERD, and hx of right breast cancer with possible mets presents to ED from nursing home after testing Covid + on 4/18.  Pt with AMS and hypoxia per NH.  Upon arrival to ED, pt with temp of 102.7, room air sat 95% but placed on 5L NC for resp distress. Sepsis alert in ED. CXR with no focal consolidation.  Pt started on IV ABX, Steroids and Remdesivir.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain) and PARAESTHESIA ORAL (tongue was tingling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Diabetes, Hypertension, Hypercholesterolemia and Allergy (Allergy, Unspecified).    On 01-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 VACCINATION SITE REACTION (covid arm), HYPOAESTHESIA (arm numbness), ADVERSE DRUG REACTION (feeling like it's nerve related), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling), PARAESTHESIA (tingling on her cheek on the left side), VACCINATION SITE PRURITUS (extreme itching on the injection site) and FATIGUE (slight fatigue). At the time of the report, VACCINATION SITE REACTION (covid arm), ADVERSE DRUG REACTION (feeling like it's nerve related), PARAESTHESIA (tingling on her cheek on the left side) and VACCINATION SITE PRURITUS (extreme itching on the injection site) outcome was unknown and HYPOAESTHESIA (arm numbness), PAIN (sharp pain), PARAESTHESIA ORAL (tongue was tingling) and FATIGUE (slight fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.