chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to clinic requesting HBV vaccination. Patient stated that his work sent him to complete his HBV series. Records reviewed in records which showed one 3-dose series HBV given on  9/23/2019 and one Heplisav dose given on 10/23/2019. Reviewed records with another nurse to verify patient's need of a second dose of Heplisav. Heplisav dose administered in clinic on date of occurrence to complete Heplisav series per PHN protocol.  It was later found that the patient had received a Heplisav on 9/23/2019, not a 3-dose HBV vaccine, but that coding in records was incorrect, displaying the incorrect vaccine formulation. Patient's immunization screen was fixed in records and system, to reflect 3 doses of Heplisav. Patient informed of error. This nurse will view all previous orders on patient before administering vaccines in the future to assess formulations of previous vaccinations.  Reviewing coding and immunization screens at the end of every clinic day to ensure vaccinations given are accurately recorded in records is already established in this clinic site. Patient's immunization screen was fixed in records and systems to reflect 3 doses of Heplisav. Patient informed of error. This nurse will view all previous orders on patient before administering vaccines in the future to assess formulations of previous vaccinations.  Reviewing coding and immunization screens at the end of every clinic day to ensure vaccinations given are accurately recorded in records is already established in this clinic site. Patient's immunization screen was fixed in records and systems to reflect 3 doses of Heplisav. Patient informed of error, patient denies any adverse symptoms or side effects of vaccination.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last year on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last year on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last year on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.).    No concomitant medications were reported.  It was reported that patient received the Monovalent expired dose of vaccine, it was first booster dose of Moderna COVID-19 vaccine. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 12-Nov-2021. The vial did not undergo any temperature excursions.  No treatment details were reported.
Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-357255 (Patient Link).
Headache, NauseaVomiting, Sore arm Narrative:  Other Relevant History:
high fever, severe chills, severe headache, severe body aches, sensitivity to light and noise, nausea. Treated with Tylenol with minimal effect.
On day 2 after first vaccine in the middle of the night I developed a burning itching rash on the bottom of my feet and the palms of my hands that got me up out of bed to apply cold water and as that didn't help, I tried witch hazel which helped enough that I was able to get back to sleep.  The next day I had a rash on both sides of my torso, on the backs of my hands and at the base of the upper side of my toes.  Also from my armpits on both arms past my elbows.
At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excessive chattering of my teeth.  I had trouble getting warm and had to utilize multiple blankets to gain heat, which is not normal.  I was very warm and most likely developed a fever.  I did not eat until 2 PM that day and the started feeling better later that night.  I was forced to miss work to recover.  I returned to work today, 1/28 but I remain tired and a little lethargic.
Employee reports swelling and redness day after vaccination. Two days after vaccination, increase swelling, pain, redness and itching around injection site. Ice to area as needed.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K002991 with expiration date 12-DEC-2014, oral, dose unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning 4 patients (ages and gender no reported) who on 13-JUL-2007 were vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  No adverse events were reported.  The physician reported that the wrong container of medications were picked up from the pharmacy and it was not a product confusion.  Additional information has been requested.
Approximately 9 hours after receiving MCV4 and Tdap vaccines my son began vomiting and continued vomiting hourly for ten hours, then it tapered off over the next 8 hours.
I had congestion, burning in my left side of nasal cavity, sore throat, cough, lot of body aches, headaches, restless, also extreme fatigue. I lost my taste and smell.
12OCT91 @ 4PM t102.6, not eating, irritable given APAP tepid bath; to ER dx probable OM, meds given; @ 730PM t104.8 & convuls; to ER; new meds given; 14OCT91 went to hosp for spinal tap, blood cultures; @330AM 103T had urinaylsis & IVs;
Inj. site hot to touch deltoid with pain from top deltoid to elbow local reaction (L) arm (-) symptoms improving.
Hospitalized 11/11/2021; COVID-19 positive 11/11/2021; fully vaccinated  BRIEF OVERVIEW:   Admission Date: 11/11/2021 Discharge Date: Nov 17, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Acute respiratory failure with hypoxia (HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 77 year old woman who presented for evaluation of cough, shortness of breath and diarrhea x 5 days. She was found to be COVID-19 positive despite being vaccinated. In the ER, she was found to have hyponatremia (126) and hypoxia. She was given fluids and started on Decadron + Remdesivir. Patient required 3 L o2 via NC to maintain saturations. It was later felt that bronchospasm from COPD-E was contributing to her symptoms. Decadron was transitioned to IV Solumedrol, nebs were given and Spiriva was added to her home bronchodilators.  Throughout her stay, she was clinically stable but was unable to be completely weaned from oxygen.  By the day of discharge, Patient was eager to go home. She will need 2 L of oxygen at the time of discharge. She has transitioned to PO Prednisone and will continue a taper. Glucose levels were well controlled on insulin during admission. She may transition back to her home oral anti-hyperglycemic regimen at discharge. BP was intermittently elevated- recommend follow up with pcp to determine if anti-hypertensive medications are needed. Discharge instructions were printed and explained. All questions were answered.  Please note that Patient had mild hyperkalemia that was improved on labs today.  Probiotic/Fiber sent to help with diarrhea.
Pruritic progressive hive like to maculopapular to vasculitic type rash at face neck upper torso arms hands legs. Treated otc benadryl, and hydrocortisol cream then Medrol dose pak on 03/19/21. Not fully resolved by day 5 of dose pak. Treatment handled over phone.
mom of child indicated had T99.9;swelling along both sides of neck;more so on rt side than lt yesterday evening 9/26/99;temp is nl; today but swelling persists;child denies sore throat;no rash apparent, per MOC;
chills; numbness inside mouth and face; numbness inside mouth and face; This is a spontaneous report from a contactable consumer (Patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734, Expiration date: Unknown), via an unspecified route of administration on 12Apr2021 at 10:00 (at the age of 45-year-old), as 1st dose, single in deltoid Left, for COVID-19 immunisation. The patient's medical history included sensitive to medication. Concomitant medications were not reported. The patient's historical vaccine included flu shot administrated on an unspecified date in 2021, and experienced pain in joints for like a couple of weeks. On an unspecified date, after the administration of the first dose of vaccine, the patient experienced chills for like a week, numbness inside mouth and face. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Nausea, projectile vomiting, diarrhea within 15 minutes of vaccine; muscles aches/weakness the following day and some continued N/V/D--- patient self treated with Gatorade and lots of fluids.
Developed excessive crying for more than 2 days. Was seen at office and admitted to the Hospital for one day. Recovered next day.
Patient tested for COVID-19 on 8/17: 61yo physician with h/o MM s/p ASCT on daratumumab/pomalidomide, HCV cirrhosis / HCC s/p OLT 5/2019 c/b incisional hernia s/p hernia repair with mesh 6/4/20, c/b infected mesh and abdominal abscess s/p ex-lap, washout and mesh removal on 8/5 with OR cx +listeria monocytogenes, now with fever and shortness of breath. He was discharged on 8/11 on augmentin, then over the weekend developed fever to 102 on 8/13 and progressive shortness of breath. Reports nonproductive cough as well and has been using nebulizer with partial improvement. No chest pain. No significant change in abdominal pain - mainly feels sore with using the incentive spirometer. Also reports nasal congestion and sore throat intermittently since having NG tube recently. No known sick contacts. He had recent parainfluenza virus infection prior to his last admission. He also complains of asymmetric RLE edema. Tested positive for COVID-19 on 8/17 and received compassionate use casirivimab-imdevimab, remdesivir, dexamethasone. Tocilizumab not given due to neutropenia. Received zosyn then unasyn for intra-abdominal infection.  Patient remains in ICU on HFNC 100% Fio2 and 40 L.
large red, indurated, tender area @ site of DTP vax w/clear blisters on bottom half of red area;
pt recvd vax in lt arm;next day had extreme pain in lt side of head,neck & shoulder & arm
17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (17 patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Concomitant medication not reported by the reporter. No information about previous COVID-19 vaccination doses. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication not reported by the reporter. This case contains information about patient 16th out of 17 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a Medical Center as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUL-2016 , the patient was treated by a physician at a Medical center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I got the inject around 4pm. And by that evening I had trouble sleeping. Everything in my body took turns hurting. At one point even my individual finger hurt. My back started to itch and I scratched it all night. No idea if I had any rash...just kept me from sleeping easily. The next day I felt like I had been run over by a truck. When the pain and itching and weakness finally ended later the following day...I felt very tired. For something like a week or two after the worst symptoms ended I continued to feel dizzy. Sure hope dose two, which I am about to go get soon today, is not as bad. I will take some aspirin before I get hit with any symptoms this time. On the first shot I neglected to take anything until the day after when I was still feeling weak.
Given Hep B #1 10:45 AM, To Medical 12:45 PM with increased edema, increased erythema right side of face - ear/jaw down to chin. Tight/firm, no SOB, no localized reaction, no hives or itch. Painful.
almost died never been so sick; Initial information received on 05-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves unknown age and gender patient who had non serious event "almost died never been so sick" (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "almost died never been so sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got one almost died never been so sick in my life covid was a walk in the park compared to it."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
LOOSE STOOLS STARTED THE DAY THE RTV VACCINE WAS GIVEN.  HAS HAD LOOST STOOLS 5-6/DAY X 1 WEEK SINCE. NO VOMITING.  NO FEVER.
Patient was given covid vaccination (spikeVax). After vaccination patient immediately complained that he was feeling dizzy. Patient was responsive and stated that he feels this way when he gets his blood drawn, but had never experineced it after vaccinations. Patient was being monitored by the pharmacist in the IMZ room while in as he was seated in the chair.  Pharmacist continued to talk to patient for a few minutes. He kept responding and said he was going to be ok. Patient became very pale and sweaty but could hear him talk very faintly. Pharmacist informed Staff to call EMT and notify managment immediately. EMT was notified by staff at 5:42 pm. Patient suddenly lost conciousness, and had unconrolled urination and would not respond back.His symptoms appeared to be seizure like, body shakes and hyperflexion of arms.Shortly after Patient gained conciousness again, and became responsing was able to talk to the pharmacist. Pharmacist measured patients BP 105/65 HR 93 (5:45pm) and Blood Glucose 92(5:47PM) . Emt Arrived at the pharmacy at 5:48 and evaluated patient. Patinet was responsive and answered all the questions emt asked, he was then taken to the hospital for further follow up . Patient was  seated in the IMZ chair the entire time, and there was no incidence of patient falling or injury. Furthermore there was no signs of rash or allergic reaction.
Information has been received from a nurse practitioner concerning an 11 year old female who on 20-AUG-2007 was vaccinated with Gardasil.  On 20-AUG-2007 the patient felt dizzy.  Patient outcome was unknown.  No further information is available.  A 13 year old's experiences were also reported after Gardasil (WAES 0709USA01953).
heart hurts; chest feels bruised; This spontaneous case was reported by a consumer and describes the occurrence of CHEST CRUSHING (chest feels bruised) and CARDIAC DISCOMFORT (heart hurts) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced CHEST CRUSHING (chest feels bruised). On an unknown date, the patient experienced CARDIAC DISCOMFORT (heart hurts). At the time of the report, CHEST CRUSHING (chest feels bruised) and CARDIAC DISCOMFORT (heart hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter. No treatment details were provided by reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
edema in my legs; swelling under my eyes; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 14Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced edema in legs, swelling under eyes on an unspecified date. Caller stated she received her 1st Pfizer vaccine dose the day before this report on 14Mar2021 (yesterday) and had developed edema in her legs and swelling under her eyes. And asked if this was normal. The events were not serious. Clinical outcome of events was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
First dose administered 1 day after BUD (Day 31); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after BUD (Day 31)) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after BUD (Day 31)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose administered 1 day after BUD (Day 31)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.
12/29/10 Symptoms began within 24 hours, had itching,urticaria, excoriations diffusely, significant amount of hives, seen in office, given DEPO-MEDROL injection & oral steroids by ER. Plan to do allergy testing near future.