chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 82 year old male with a PMH/PSH as noted below. The patient states he was Covid+ about 2 weeks ago and had been at home. He had been weak, tired with cough. Denied SOB. Had poor appetite and intake at home. Stated he had a fever at home. Today he was feeling weaker and tired prompting him to come to the ED for further work up.  In the ED, patient was found to have bilateral infiltrates confirmed by CT scan of chest. Labs noted elevated AST/ALT, WBC was 1.9 with platelet 74, DD 451 with negative CTA for PE, LA 2.23. HR was 109 afib BP stable and saturation 96% on 3l/m. Patient was vaccinated.
The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022; Expired Vaccine Used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergy or had no food and medication allergy patent had no acute illness.   On 20-Apr-2022 at 11:39 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:39 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Dose administered past the 30 day storage on the refrigerator Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant medications were not provided. On 28-SEP-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L021612, expiration date: 10-OCT-2016, 0.65 ml, subcutaneously). No adverse effects were reported. Additional information has been requested.
This spontaneous report has been received from a 59 year old female patient reporting on herself. Patient's concurrent condition included an "issue with a nerve in her elbow". Patient's concomitant therapies included: gabapentin, nortriptyline and Tizanidine. In 26-SEP-2017, the patient was vaccinated with ZOSTAVAX, (lot #, expiration date and concentration were not provided) dose of 0, 65 ml, route administration unknown, for prophylaxis. On the same date, about an hour later after vaccination, the patient experienced headache which "was not as bad as when it started but it was still there". The outcome of headache was reported as recovering. The causal relationship between ZOSTAVAX and the events was not reported. No product quality complaint was involved.
back of tongue swelled up; throat swelled up; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (back of tongue swelled up) and PHARYNGEAL SWELLING (throat swelled up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced SWOLLEN TONGUE (back of tongue swelled up) and PHARYNGEAL SWELLING (throat swelled up). On 11-Feb-2021, SWOLLEN TONGUE (back of tongue swelled up) and PHARYNGEAL SWELLING (throat swelled up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment related information was reported.
Approx 1 week after influenza vaccine patient developed pain in left arm and reduced range of motion. Patient complains that the pain is getting worse. Patient had had an xray of the L shoulder done. Seen by ortho and will follow up with PCP on Monday.
fever of 100.4,achy feeling all over, nausea,sleepy ness
I am unable to regulate my body temperature. I fluctuate between shivering from chills to sweating profusely. I have a mild headache and joint pain. I am heavily fatigued to the point that walking to my kitchen is laborious. My temperature is only slightly elevated to 98.8 degrees F. My normal temperature is 98.1 degrees F.  I have been drinking Gatorade when I?m able to make it to my kitchen and taking acetaminophen.  The events started approximately 7 hours after vaccination and have been constant to this point.
Patient has continued pain and now numbness and tingling down entire right arm after injection which has not gotten better.
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, chills and fatigue Narrative:
Received An Expired Dose; Initial Report Received on 24-Mar-2023  This spontaneous report was received from a medical assistant regarding a 19-year-old female patient who received an expired dose of HEPLISAV-B.  The patient had no known drug allergies.  Other medical history was reported as unknown.  Concomitant medications were not specified.    On 24-Mar-2023, a dose of HEPLISAV-B (Lot # 937253, expiration date 11-Mar-2023, and NDC 43528000301), was administered intramuscularly in the right deltoid.  On 24-Mar-2023, the patient received a dose of HEPLISAV-B which was 13 days past the expiry date.   The reporter indicated that the patient has not complained of any side effects following the injection.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. On 10-JUN-2013, the patient was vaccinated with first dose of GARDASIL (Lot unknown, Expiry date unknown) for prophylaxis. The nurse reported the patient received her second dose of  GARDASIL 9 (Lot unknown, Expiry date unknown) on 21-NOV-2016 at 19 years of age (inappropriate schedule of drug administration)(interchange of vaccine products) and received her third dose of GARDASIL 9 (Lot unknown, Expiry date unknown) on 25-JAN-2017 at 19 years of age. No adverse effects were reported. No additional information provided.
This spontaneous report was received from a Medical Assistant concerning a 39 year old female patient. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route, Lot # and expiration date not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The Medical Assistant called regarding the accidental administration of PROQUAD (Merck) to an unspecified 39 year old female patient on 30-AUG-2013. Patient had titers drawn on an unspecified date for measles, mumps and rubella. The measles titer results came back as equivocal on an unspecified date. It was unknown if the patient ever received the full series (2 doses) of MMR in the past. The patient should have been administered MMR. The outcome of the events was unknown. Additional information has been requested.
Vertigo 3 days after vaccine, lasting 1-2 days self-resolved.
developed heart pain down both arms; myocarditis, every time his heart beat it hurt and he felt pressure; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (developed heart pain down both arms) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDITIS and PAIN IN EXTREMITY. At the time of the report, MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: high (High) high protein numbers. In 2021, Electrocardiogram: abnormal (abnormal) diagnosis of myocarditis. In 2021, Scan: abnormal (abnormal) diagnosis of myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was not given. No concomitant medication information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Very limited information has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
Pain in arm where inject given Flu like symptoms the next day in the morning. Relieved by tylenol.
Giving vaccines to 15mo. female-inadvertently drew up and was given 2 HIB vaccines along with her other routine DTAP, PCV and flu.
Patient got overheated, lightheaded, dry heaving.  EVerything started about 10 minutes after injection. Patient ended going with EMS to hospital upon her request.
Patient started having a severe nose bleed almost instantaneously after receiving the Spikevax vaccine in her left deltoid. Bleeding continued and I was not able to administered the second vaccine the patient had requested as a result (Flu vaccine). Patient continued bleeding for a few minutes despite her attempts to pinch her nose and lean forward. Blood spilled on the floor in the IMZ panel and some also splattered on IMZ cart. Emergency services and code white was called. Maintenance and club management assisted with the clean up of the blood spill and EMTs administered Afrin to patient and stretchered her out of the facility to the ER. Called patient at 3:19 pm, patient was home and doing well. She said she was informed at the hospital that the nosebleed was most likely the result of a combination of seasonal allergies which dried out her nasal membrane lining and high blood pressure. She was discharged after providing instructions on what to do if it happens again. Patient was very grateful for the follow up and all the assistance the pharmacy and  the store management and associates provided her and calling emergency services in a timely manner.
Fever, fatigue, headache, body aches, weakness the day after injection. Fever lasted for two days. Arm soreness and fatigue was present for three days following injection.
Pt returned to pharmacy on 2-24 and rph advised patient to apply ice pack to lessen swelling. Pt returned on 2-27 and stated that he had gone hiking and the arm continued to get worse and redness spread down his arm. He went to the hospital and was given IV antibiotics, then oral Bactrim DS (per record). He stated on 2-27 that it was beginning to resolve. I observed for the first time and redness was throughout lower arm starting at the elbow. Patient had been to PCP and she said it was getting better.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 30-MAY-2019, the patient was vaccinated with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R015745, expiration date 02-DEC-2019; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Report 20003415-1 describes hepatitis B in a vaccine of unspecified age and gender who received Engerix-B.  Allergies, medical history and concomitant medications are unspecified.  On an unspecified date, the vaccinee received the forth dose of Engerix-B. Following the forth dose of Engerix-B, he was found to be in a nonresponder, and subsequently the vaccinee contracted hepatitis B. As of 28-NOV-00, the outcome of the event is unknown
Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hospital 4/14/2021 with chest pain, upper abdominal pain and ongoing melena.    1. Melena: Ongoing for 6 weeks per patient. Underwent colonoscopy 4/7/21 with polypectomy, no inflammation or bleeding. CT A/P 4/14/21 with mild esophagitis, mild colitis, no other acute finding. IV PPI BID. GI followed, pt is s/p EGD 4/15/21 with normal esophagus, large hiatal hernia with multiple Cameron ulcers and erosive gastropathy with no stigmata of recent bleeding. Biopsied. H&H stable at discharge. Avoid NSAIDs. Discharged on PPI  2. Colitis: Mild on CT A/P. Stool PCR discontinued as diarrhea resolved. Patient is s/p cipro/flagyl in ED. Transitioned to Unasyn with end date 4/15/21.  3. Acute Blood Loss Anemia: Baseline Hgb ~ 12-14. Down to 5.8 on admit in setting of GI bleed. Transfused 1 unit pRBC 4/14/21. Trend H/H Q6H. Transfuse for Hgb < 8 given cardiac diease. Iron studies with evidence of iron deficiency. s/p IV iron. H&H stable at discharge 4. AKI: Baseline creat ~ 0.7-0.8. Elevated to 1.35 in the setting of bleeding/anemia. Held ACEi and diuretic. She did receive IV contrast. Colloid resuscitation with blood transfusion. Resolved 5. Chest Pain w/ Elevated Troponin: Troponin T 16 on admit in setting of severe anemia and poor clearance with AKI. ECG non acute on admit. CT PA negative 4/14/21. Suspect demand ischemia. Negative delta troponin. No further workup.  6. Hx COVID 19: Positive testing 12/2020. Repeat testing ordered in ED 4/14/21 and remains positive. She desaturated only after receiving IV fentanyl in ED. Asymptomatic, CT chest 4/14/21 without GGO. Given > 90 day, patient remain in isolation per OhioHealth Policy.  7. CAD: LHC 9/28 with diffuse disease DES to OM1 and BMS to Circ/OM1. Held ASA/Plavix on admit due to GIB, resumed at discharge. Continued home statin, imdur, BB.  8. Chronic HFrEF: due to ischemic cardiomyopathy. LV 45% on LHC. Continued BB, Imdur. ACEi and Maxzide held initially with GIB and hypotension. PCP follow up 9. HTN: Soft BP on 4/15/21. Continued Imdur and BB with hold parameters. Norvasc, Maxzide, and ACEi discontinued at discharge. Follow up with PCP   10. IDDM2: A1c 7.8% on 3/2021. Continued home regimen.  11. Essential tremor: Follows with Dr. (Neurology). Continued home Propranolol.  12. Pulmonary Nodule: Ct chest 4/14/21 with 6mm pulmonary nodule, repeat in 6-12 moths.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-JAN-2019, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Non-febrile seizure, only post ictum witnessed.  10/19/07 Reviewed ER medical records which reveal patient experienced diarrhea, sleepiness, slurred speech, difficulty walking, diaphosesis & seizure like activity.  Seen in ER 10/12/2007.  Exam & labs all WNL.  PCP to see next day. ER Diagnosis:  possible seizures.
Patient fainted after receiving injection. Apparently had been apprehensive prior to injection - twin sister always faints, had nasal spray today. Patient transported to first aid. Laid on conf feet elevated until color returned, blood pressure and pulse normal.
Fatigue; scar tissue; rash at the injection site with itchy; arm  hurt; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INJECTION SITE PAIN (arm  hurt), INJECTION SITE RASH (rash at the injection site with itchy) and EXCESSIVE GRANULATION TISSUE (scar tissue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (arm  hurt). On 12-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the injection site with itchy) and EXCESSIVE GRANULATION TISSUE (scar tissue). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue), INJECTION SITE PAIN (arm  hurt) and EXCESSIVE GRANULATION TISSUE (scar tissue) had resolved and INJECTION SITE RASH (rash at the injection site with itchy) outcome was unknown. Not Provided          patient received the treatment includes: hydrocortisone   This case was linked to MOD-2021-045102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI: AE contact information was updated
Day 8 after first moderna dose, I have redness at injection site. It is red and hot and hard. Some itchiness. I hadn?t had any site redness before this. My arm was sore for the few days after and my left axillary lymph nodes are swollen.
This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration were not reported). On an unspecified date in 2008 (reported as 7 years ago), the patient had post ZOSTAVAX shingles. The patient's outcome was unknown. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Pt states had chills and fever, the night of the injection of pneumonia and flu vaccines. Right arm was red and swollen the morning after injection but no fever.
Hepatitis B vaccine that was given to patient on 1/24/22 expired on 12/6/21.  There were no know signs or symptoms reported by the patient or seen by the staff as a result of vaccine administration.
vial used was from previous day and had been punctured 15-16 hours prior to administration.
Extremely sore upper left arm - 5 hours in Fever - 13 hours in Body aches Extremely tired Chills Runny nose Headache Stomach ache Took Tylenol & Ibuprofen alternately every 4 hours Sore arm & headache lasted until about 32 hours in
MD visit 6/7/99 acyclovir 100/5 1/2 tsp tid x 5d;atarax 10/5 3/4 tsp po q 6hr PRN;
Body aches, stiff neck, sore muscles, headache, leg cramps, diarrhea, loss of appetite, fatigue.
Viewed pictures of painful red swollen upper arm (right) following vaccine GARDASIL #2 that took 1 week to resolve. Small reaction after GARDASIL #1.
Bell's palsy/Facial Droop; stroke; Neuro deficit; This case was reported by a lawyer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for product used for unknown indication.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). The action taken with Shingrix was unknown. 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.  The initial information was received on 10 Dec 2020 via medical record (case is now medically confirmed). As per pharmacy record, Patient ingested with shingrix vial from 31 October 2019 to 15 January 2020. On 03 feb 2020, CT of head without contrast performed which shows patient had facial droop and storke, Neuro deficit.
Admission Date: 10/4/2022 Discharge Date: 10/6/2022   HOSPITAL COURSE: Patient is a 30 y.o. female G3P1021 underwent an uncomplicated cesarean delivery and was discharged home in stable condition.  Delivery complicated by COVID Edinburgh Edinburgh Postnatal Depression Scale Total: 0   ESTIMATED DUE DATE: Estimated Date of Delivery: 10/10/22 GESTATIONAL AGE AT DELIVERY: 39w1d  G3P1021  FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  boy      Delivery Date/Time:    7:36 AM           WEIGHT: 3.27 kg  APGAR:  1 minutes 5 minutes 10 minutes  1  4    7
Seven hours after vaccine given patient become irritable and spiked fever to 102.2 and hallucinated worms all over the place.  Hallucinations lasted approximately 20 hours. Telephone report on 12/6 5pm: hallucinations resolved.  Spiked fever in late afternoon.
Patient indicated 2-3 hours after she received a flu vaccine she started to get very cold, felt like she was freezing then patient was shaking like chills. She said she felt disoriented like she was in shock and could not think clearly enough to push her medical alert button. It subsided in 3-4 hours.
Nine days after my first injection of?Moderna COVID-19 Vaccine EAU?, I awoke with severe itching and redness at and around my injection site. I called my PCP and he told me Advil at morning and night and use warm compresses on it. If no better two days later, I am to see him in his office.
Within 10 minutes of receiving her 3 vaccines, while exiting the clinic, patient collapsed, caught by parent and lowered to floor. Momentary unconsciousness, revived immediately when supine.
Patient reported during second dose that she miscarried at 4 months pregnant. Patient reported receiving another vaccination as well, not given at our facility. She did not blame the vaccine, but thought it was worth mentioning. Other vaccine not reported to IMPACTSISS, vaccine likely to be Tdap booster.
Infectious mononucleosis and hepatitis 12 days after vaccine (fever, vomiting, dehydration, sore throat, tiredness) Fever lasted 10 days) ER visit for dehydration. IV administered.