chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient ID:  73 y.o.  Admit Date:  8/6/2022   Discharge Date:   8/9/2022   Discharge Diagnosis:  Principal Problem:   Acute hypoxemic respiratory failure due to COVID-19 Active Problems:   Hypokalemia   Pulmonary embolism associated with COVID-19   Chronic systolic CHF (congestive heart failure)   Essential hypertension   Atrial fibrillation     Hospital Course:  73 year old male on Trilogy at home was admitted with Covid-19 pneumonia and associated PE. He was started on anticoagulation and switched to Eliquis yesterday. He will be discharged home today in stable condition. He will have to be on Eliquis for 6 months. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.4 °F (36.3 °C) Heart Rate (Monitor): 83 Pulse: 100 BP: 130/78 Respirations: 14 SpO2: 95 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: irregular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone    Consults:  IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   CT chest   Operations: none   Disposition:  Home    Discharge Condition:  Fair
PARTIAL EPILEPSY, INTRACTABLE TRANSIENT CEREBRAL ISCHEMIA
Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Vaccine was expied on 19-May-2023, the vial was initially stored in the refrigerator thawed and injected on 31-May-2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine was expied on 19-May-2023, the vial was initially stored in the refrigerator thawed and injected on 31-May-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expied on 19-May-2023, the vial was initially stored in the refrigerator thawed and injected on 31-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine was expied on 19-May-2023, the vial was initially stored in the refrigerator thawed and injected on 31-May-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was expied on 19-May-2023, the vial was initially stored in the refrigerator thawed and injected on 31-May-2023).    No concomitant medications were reported. They were all in intact carton. Vial size was 2.5 ml and the vial did not underwent any temperature excursions. No treatment medications were reported.  This case contains information for the 6 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Patient 3 out of 20 (Master case)
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On17-SEP-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, for prophylaxis lot number R006466 and expiration date of 24-OCT-2019. The administered dose of the vaccine experienced a temperature excursion of 47 degrees F to 77 degrees F during 1 hour and 6 minutes, as recorded by a data logger. There was no adverse effect reported.
12 days after booster I developed swollen lymph nodes (occipital, supraclavicular) and neck tenderness on L side (side I received the booster) I had a low grade fever. I went to urgent care and they thought I may have a virsu. The next day I developed cellulitis up the L side of my face and had a fever of 100.4. The L side of my face was red, inflamed and painful.  I was seen at urgent care and they prescribed antibiotics. After a week and as .the cellulitis improved, I noticed a hard, painful vein on the L side of my neck. I went to see my NP , was sent for a STAT ultrasound and eventually was diagnosed with a superficial venous thrombosis. I have been on aspirin therapy.
became more sick; 104 temperature and constantly throwing up; Initial information received on 28-Nov-2020 regarding an unsolicited valid non-serious social media case from non-health care professional.  This case involves a patient of unknown demographics who became more sick (Illness) and 104 temperature and constantly throwing up (Pyrexia), while he/she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, family history and concurrent condition were not provided. Concomitant medication was not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route on unknown site of administration for prophylactic vaccination.  On an unknown date, the patient reported got a flu shot when I was 21. Shortly after that became more sick (Illness) than  had ever been. 104 temperature and constantly throwing up (Pyrexia). For 44 years after that patient have refused to get the shot. gotten sick maybe 4 or 5 times with light symptoms. was take chances, non-serious) (Unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for sickness,fever at the time of reporting.  There will be no information available on the batch number for this case. No further information was reported.
arm soreness; rash on the injection site; redness; swellling; hard to move the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swellling) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Acid reflux (esophageal) and Low back pain. Concomitant products included ALENDRONATE SODIUM (FOSAMAX), ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) and TRAMADOL.    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swellling) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move the arm). At the time of the report, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swellling) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
States had a local reaction to tetanus vaccine in 1994. Wanted to get another as update. Was advised in 1994 to get in half doses. On 11/20/2003 given 1/2 dose. One week later 11/28/03, right upper arm swollen and tender. Status and swelling from earlier in the week. Postponed next dose.
Adacel was given to a 4 year old with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 years old male patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was given to a 4 year old with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 02-Aug-2022, the patient received a  fifth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, with an unknown formulation and strength, at dose of 0.5 ml (frequency: once) ( lot: U7271AA ; expiry date: 12-Jan-2024) via intramuscular route in the right thigh for immunization.  It was reported that Adacel was given to a 4 year old with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
AREA AROUND INJECTION SITE WAS RED, LITTLE SWOLLEN AND ITCHY FOR FIRST FEW DAYS, WHICH I ASSUMED NORMAL.  I DIDN'T NOTICE ANY ISSUE UNTIL A WEEK LATER ON 4/3/21, LOT OF ITCHING AND INJECTION SITE AND UPPER ARM AREA ARE ALL RED AND SLIGHTLY PUFFY.   I WENT BACK TO PHARMACY AND THE PERSON THERE SAID I SHOULD REPORT TO YOU BUT DIDN'T GIVE ME ANY OTHER ADVICE.  I MENTIONED ONE OTHER TIME I HAD A SIMILAR EXPERIENCE WITH A FLU SHOT AND THAT PHARMACIST TOLD ME TO TAKE BENADRYL, WHICH I DID AND THE ISSUE WENT AWAY.  I BOUGHT BENADRYL AND HAVE USED IT FOR LAST 24 HOURS BUT THE ISSUE HASN'T CLEARED UP.
1st shot sore arm 2nd shot sore arm, fever, chills, body ache, migraine
Hepatitis B surface antigen positive.  This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject's medical history included hemodialysis.  On an unspecified date the subject received unspecified dose of Engerix-B. On an unspecified date between 01 October 2006 and 16 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antigen test was positive.  The outcome of the event was not reported.
a pediatric patient who received a possibly expired DTAP vaccine/No AE; Initial information received on 22-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a child patient (age and gender unknown) who received a possibly expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number and expiry date not reported via unknown route in unknown administration site on an unknown date for prophylactic vaccination.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting, adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Chest pain starting two days after first injection persisted through second injection for 1 month. Reduced ability to perform high cardio exercise.  Both new and not previously experienced.
I had a TDaP Vaccine on 7/13/17 at around 10 am in the morning. Early on Friday, 7/14/17, I started having issues with my vaginal area and my labia majora, feeling swollen, itchy and tender, very engorged. I just thought it was a yeast infection starting and didn't think it was related to the TDaP. Friday evening around 5 pm in the evening, I became very ill, nausea, vomiting, diarrhea, complete body aches, not just on the right upper arm area. I felt like I had the flu ten times over. My face was a bit swollen and so was my jaw area on the right. I had tingling on the entire right side of the body down to my feet. I could not lay on that side because it was very uncomfortable. At the time, my highest temp was 101.7. However, I started feeling worse, and took Aleve and Zofran for nausea. This helped a little, not much. I developed a headache and continued having such issues until July 18th or July 19th. Tingling in the entire right side of my body down to my feet, not like the "falling asleep sensation", face swelling on the right side-mainly jaw and cheek/lip area, and I also took Benadryl didn't make a difference. I also kept insisting that there was a rash on my arm but my spouse stated there was nothing there. I also ended up with a full-blown yeast infection, which I did some research and it can happen, apparently depending upon the ingredients in the vaccine, it can cause an over production of yeast as an immunity response. I had planned to see my GYN on 7/19 when my wife was having surgery with him and ask him about it. However, I forgot and mentioned it to him on 7/21/17 prior to going into surgery of my own with him. He stated he had never heard of it happening however he would not rule it out, given my history, and also because my body has went through changes, with recently carrying and losing triplets in 2016. I still have upper right arm tenderness, but no discoloration at the sight of injection. I do have an issue with lying on this side still from time to time that I did not have prior to this vaccine.
Narrative: Patient received one dose of covid vaccine. 5 days after patient was found deceased in his home. Patient was with active metastatic, terminal lung cancer. No other details of death reported. Entered per facility instruction.
This spontaneous case reported by a nurse, describes the occurrence of cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue and nausea in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011J20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Dec 31, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue, nausea, vomiting, pyrexia (fever after 2nd dose) and chills (shivering chills). At the time of the report, cluster headaches, vaccination complication (general side effects), peripheral edema (edema in both legs from feet to knees), fatigue, nausea, vomiting, pyrexia (fever after 2nd dose) and chills (shivering chills) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-338654 (patient link).
102 degree fever, muscle pain all over body treated with over the counter pain medication resolved in 48 hours, at day three a swollen lymph node on the left side of neck where neck and collar bone meet , went to doctors office and have not heard results back
had vax 22APR96 on 25APR96 devel fever 102 & was taken to hosp; had blood work showed inc WBC-hosp x 1 day;told was rxn to vax;seen by MD in hosp
Patient came in for a well child check today and the provider ordered the administration of Vaxelis, PCV-13, and Rotavirus vaccine. While I was taking these out of the fridge, I got distracted and pulled out Hep B by mistake instead of rotavirus. I administered Vaxelis, Hep B, and PCV. Within one minute of administration, I realized that I gave Hep B by mistake and forgot to administer the rotavirus vaccine. I immediately informed the provider, and she spoke with the patient's mother. Patient did not experience any symptoms or signs while in the office, and the provider advised mother to monitor for any concerning signs or symptoms.
First I got really sluggish and clumsy, I kept bumping into things and forgetting what I was about to say. My legs felt really weak and I was kinda just going through motions without thinking about what I was doing. I started spacing out towards the end of the night, according to friends I got super quiet. I got home and fell asleep right away. I woke up twice that night, the first time I woke up and I was sweating, my head was pounding, my ears were ringing super loud and I could barely see. I couldn't move any of my muscles and I couldn't speak. Then the ringing stopped and everything became muffled, I couldn't breathe and my vision turned to black. I went from a state of extreme panic to just being numb in a way, I didn't feel like I was in my body anymore I felt separated. I can't put the feeling into words I've tried but I can't. In the moment I 'knew' i was dying, all these thoughts of people I love and things that I want to do came rushing through me and I got this soul-crushing feeling of disappointment that everything was over. I tried calling out because I didn't want to die by myself but I couldn't get any words to come out. Then something snapped and I told myself I wasn't going to let myself die and I focused all of my energy into breathing and staying awake. Then I felt like I was back in my body and I could move again, i kept my eyes open and just breathed for I don't know how long. Eventually I let myself fall asleep again. I woke up again three hours later drenched in sweat and shaking. I got up,  went downstairs and got water and cheese and focused on staying steady and breathing. The above is in my daughters words. She was feeling better the next morning (the 12th) but was very shaken up. She had difficulty falling asleep the next 2 nights because of fear. She is still shaken up from the incident.  No treatment other than time.
Narrative:  Pericarditis. On steroid orally. Had Covid 19 about 1 month prior to vaccine and had fully recovered to getting J&J vaccine. HYPERtension Pericarditis
Patient is 46 years old (under 50 yrs old) and was given fourth dose of Moderna 4 months after his 3rd dose. Patient is not immunocompromised. 2nd booster has been only approved for patients who are 50 years or older or immunocompromised. 2nd booster shot has not been approved yet for healthy individuals under 50 years old.