chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route of administration, lot# and expiration date were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion (temperature and time frame were unspecified). A Digital Data Logger was involved. There were many multiple previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.; Sender's Comments:  US-009507513-1705USA002847:
This is a Solicited report refers to a 45 year old female patient. The patient current condition includes non smoker, and Crohn's disease. The patient is allergic to ceclor, Asacol, Pentasa and an unknown medication and was manifested by itching and respiratory problems. The patient's medical history included sinus allergies, itching, respiratory problems and bowel resection. On 12-JAN-2014, the patient experienced sinus problems, anemic, arm was little red and low grade temperature/fever off and on. The patient reported from starting to have sinus problems on 12-JAN-2014. The patient stated she saw her physician on 13-JAN-2014 for check up. She was given a vaccine, PNEUMOVAX 23 and had blood drawn. Other suspect therapies included HUMIRA (40 mg, Solution or injection in pre-filled pen). Concomitant therapies included FLINTSONTES MULTIVITAMIN and CALCIUM (UNSPECIFIED). The patient stated that after getting the PNEUMOVAX 23 her arm was a little red and she ran a fever off and on ever since. The patient was treated with ferrous sulfate. She felt a little better but still had a low grade temperature. The patient stated sinus issues had persisted as well. The patient stated the physician called her that day to report that her blood was low. The outcome of sinus disorder was reported as not recovered/not resolved. The outcome of redness was reported as recovered/resolved. The outcome of anemic was unknown. The outcome of fever was reported as recovering/resolving. The outcome of blood low was unknown. This is linked to 1402USA012998 due to same patient link. Additional information has been requested.
Severe Rash/Hives with severe swelling,  began apprx 2 hours after receiving injection.  covering chest/arms and face
Extreme dizziness, blurred vision, tight chest passed out, severe uncontrollable chills, fever 102 + Severe Upset stomach almost threw up, head ache and joint pains, sporadic pains in legs and head, sore swollen arm. Had to go to Emergency room, I?ve fluids pain meds ultrasound and xrays
tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Blood in stool within 1-2 hours of vaccination, 5 episodes total, last episode was 2 days ago.
Headache, Myalgia, CoughWheeze, Developed fever,chills, HA,myalgias, cough, and fatigue 14 hours post 2nd Moderna COVID vaccine causing loss of 1 day of work. Narrative:  Developed fever,chills, HA,myalgias, cough, and fatigue 14 hours post 2nd Moderna COVID vaccine causing loss of 1 day of work.  Other Relevant History:
Diarrhea; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Due for second dose on 24-AUG-2021 but having diarrhea from 23-AUG-2021 No concomitant medications reported. No treatment information was reported by reporter   Reporter did not allow further contact
Severe headache when tried to think; Tiredness; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Severe headache when tried to think) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Antihistamine therapy, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Tiredness) and PAIN IN EXTREMITY (Arm soreness). On 14-Mar-2021, the patient experienced HEADACHE (Severe headache when tried to think). At the time of the report, FATIGUE (Tiredness), PAIN IN EXTREMITY (Arm soreness) and HEADACHE (Severe headache when tried to think) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication not reported.  The patient stated that they have three other prescription medicine that he's taking daily.
Spoke with RN with Pfizer and staff regarding pfiizer vaccine that was administered to pt on 1/3/22 per immunizations due to vial was expired as of 12/31/21. Per RN there is a 32 day max on vials that are refrigerated. Medical information told nurse  to contact cdc to discuss 2nd step. Also contacted CDC and spoke with staff and recommended for pt to get re-vaccinated due to expired vaccine. Spoke with mom of pt and pt has no c/o adverse effects at this time.  mom will schedule an appt, told mom to ask for nurse
Tennis ball size hive that was itching and warm to the touch. This hive came and went 2-3 times over the course of 1 week, each time it got bigger and hotter and more itchy.
Patient reported redness and soreness around injection sight that presented on 8/1/2016.
I had 102 fever for 2 days, I was fatigued and the following Monday, I could not walk I had a lot of excruciating pain on my left leg. I went to the emergency room, and they said it was muscles. I came home saw my primary a couple times then I saw an orthopedic doctor and she did an injection on my knee.  I went back to the emergency room because my pain was so severe, I was crying at night, they gave me prednisone, it did not work. I went to pain management, and he ordered an MRI of my back and he put me on prednisone, it did not work. I went back to the emergency room. I took multiple trips to the emergency room due to pain. I went back to my primary doctor they put me on a pain medicine for nerve pain. I went back to pain management they changed my medication to a muscle relaxer and 3 other medications. Then these medications started helping me. I started recovering around the end of May. I was still walking with a cane. I could not work or drive for 2 and 1/2 months.
This case was reported by a nurse via call center representative and described the occurrence of alopecia in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was not reported. It was unknown if the reporter considered the alopecia to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The HCP (healthcare professional) reported information through chat, however the HCP was no longer responding to the chat so this was the only information that was provided.
The patient reported that she  started having lymph node swelling in January.  She also reported that her physician told her that shingrix could be a cause of it.  She is currently undergoing testing for it.
swelling of eyes & lips 2hr p/vax taken to ER & given DPh & Epi & poss Decadron;
Patient had a seizure and the father caught the patient. He was still sitting on the chair he received his vaccine on so he did not fall or get injured. By the time I got back to the patient he stopped having the seizure and was complaining of dizziness. He felt weak and was going to fell if his father was not by his side. I sat across him and took over supporting him. After asking what he had that day, I decided to give the patient some cookies, water and then orange juice. After 15 minutes of eating and drinking his juice, he was starting to feel better. He then felt well enough to stand and go to the cafe to get some pizza. When I checked on him while he was eating, he felt better and was active/functional. I recommended the parents take him to the ER to get checked for the seizure.
Severe aching and nerve pain in legs, back. hips Cramping in ovaries Polymenorrhea, menorrhagia, increasingly severe dysmenorrhea
Admission Date: 10/6/2022 Discharge Date: Oct 17, 2022  PRESENTING PROBLEM: Pneumonia due to COVID-19 virus COVID-19   HOSPITAL COURSE: 69-year-old male with a past medical history significant for metastatic prostate cancer as well as chronic kidney disease stage 3 with bilateral nephrostomy tubes in place who presents due to generalized weakness as well as cough and fevers and was found to have COVID-19.   Although patient briefly required oxygen on admission the hospital, he was quickly able to wean off of oxygen.  His presentation was thought to be related to his COVID-19 infection the setting of his chronic comorbid conditions.  On admission, patient and family had already expressed consideration for hospice in the future but there hope was that the patient would have some improvement in his symptomatology and that he would be stronger to allow for him to return to home which is where he wanted to be.   As the patient had presented with acute on chronic kidney injury, IV fluids were provided and with this, patient's renal function did improve.  Off of fluids his renal function continue to improve.  Consult was placed to IR for consideration of exchange of his bilateral nephrostomy tubes as he normally does undergo monthly exchanges.   Although the patient initially presented hypertensive requiring addition of amlodipine morning 10/10 he was notably more hypotensive.  Etiology behind this was uncertain.  All antihypertensive agents were held and with 1 L of fluid provided, patient's blood pressures began to trend up.  Hemoglobin was stable.  Lactic acid was normal.  Patient was eventually able risk to be restarted on Imdur, hydralazine.  His Coreg continue to be held.   After being seen by PT/OT, patient was thought to warrant transition to subacute rehab.  Transition to subacute rehab was thought to be complicated by his COVID-19 status but eventually, a facility was found that was willing to accept the patient with his isolation precautions in place.  However, this facility was hours away from home.  Patient and wife also did not approve of the ratings the facility received on the Internet.  The refused the transfer to this facility which was the only accepting facility for the patient.  They decided to appeal the discharge initially.  However, they did not want this appeal.  Instead of going to rehab per our recommendations, they decided to go home instead and sign on with hospice in the outpatient setting.
Development of erythematous, indurated area at (L) deltoid approximately 1 day after administration of MMRV. Reaction site-approx. 8x10 cm induration and erythema with central vesicular eruption. Tx'd with PO antibiotic and BENADRYL.
flu like symptom; shortness of breath (diagnosed with lung damage early 2019); fatigue; headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Lung disorder since 2019, Allergy, Diabetes and Blood cholesterol abnormal.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medication reported were unspecified diabetic medication, blood thinner and cholesterol medication.
Myalgia Chills Narrative: Employee reports body aches, chills, has taken Tylenol. Employee left work early. Condition improved, not yet resolved.
Dosing error. FLUZONE (6 months-36 months) given to pt instead of 3 or older FLUZONE formulation. Pt. contacted another dose of 0.25 mL FLUZONE given to make immunity of 0.5 mL dose.
NO ADVERSE EVENT WAS NOTED.  ADMINISTERED EXPIRED VACCINE.  VACCINE EXPIRED ON 4/1/2022 AND WAS ADMINISTERED ON 04/19/2022.
Tachycardia; fever of 101.6; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number C47FY, expiry date 16th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2020, 1 days after receiving Shingrix, the patient experienced tachycardia and fever. On 20th October 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in right deltoid and the day after vaccination experienced fever of 101.6 degree C, which resolved the same day and tachycardia (increased heart rate noted on her apple watch). The patient was concerned due to the side effects she experienced after her 1st dose and till the time of reporting, patient did not receive 2nd dose of Shingrix due to covid 19 vaccine timing. The reporter asked about the efficacy of single dose vs two doses of Shingrix. The reporter consented to follow up.
Having pain on the right side of my torso (by Brest); My arm hurts; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Having pain on the right side of my torso (by Brest)) and PAIN IN EXTREMITY (My arm hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Having pain on the right side of my torso (by Brest)) and PAIN IN EXTREMITY (My arm hurts). At the time of the report, PAIN (Having pain on the right side of my torso (by Brest)) outcome was unknown and PAIN IN EXTREMITY (My arm hurts) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   It was reported that the patient arm hurts too but not bad after two days.  Treatment information not provided.
Case number PHEH2013US021321, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to a 17 years old male patient. Past medical history and concomitant medication were not reported. Concomitant vaccine included Tdap (batch number: A652B076BA, other manufacturer) on 25 SEP 2013. He was vaccinated with MENVEO (batch number: M11081 and expiry date: 30 APR 2014), at a dose of 0.5 ml intramuscularly on 25 SEP 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursion was 0 degree Celsius for may be 10-15 minutes and on 09 SEP 2013, the temperature excursion was 0.5 degree Celsius for may be 10-15 minutes. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error. Follow up report from the medical assistant received on 09 DEC 2013. Concomitant vaccine was added.
Fever up to 103,  body aches, loss of appetite, all treated with ibuprofen. Fever did not go under 100 for 40 hours. Also had extreme drowsiness (slept 21 of 24 hours).
Patient received vaccination at flu clinic. Symptoms developed 10 minutes after vaccination of syncope and nausea and blurry vision. Vision became normal after 10 minutes. Patient remained in sitting position while awaiting for paramedics to get there. Blood pressure checked at 130/100, told patient to take deep breaths, 911 was called and paramedics arrived shortly after. Patient refused to go with paramedics for full follow up. Patient educated about reporting this event with primary care doctors and for future flu shots to go to the doctor's office. Patient seemed fine after paramedics left.
Patient is 29 weeks pregnant - high risk pregnancy. Was being seen for routine OB follow-up and wanted Moderna bivalent booster at end of visit.  Patient received potentially up to 3mL of Moderna bivalent COVID vaccine booster instead of indicated 0.5mL dose.  No known side effects aside from  general malaise and injection site tenderness. Fetal monitoring ongoing through remainder of pregnancy.
RASHES (HIVES) ALL OVER THE BODY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, non-smoker, and crohn's disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A214, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included mesalazine for crohn's disease. On 09-MAY-2021, the subject experienced rashes (hives) all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes (hives) all over the body. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
on the day of the vaccination 12/30/20, I experienced an allergic reaction on both of my feet. they both were swollen with red blothches. 1/6/21 I noticed that my arm was swollen and red, I have a big red blotch at the injection site.
Pt received Prevnar and MMR II in office. Family left office and noted that pt was not responsive and was red all over. Brought to ER, hypotensive and unresponsive. Responded to fluids, epinephrine and Benadryl IV. Diagnosed with servere reaction to vaccine.
Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening.  I need more and longer naps than usual.  Because I have leukemia, I do have fatigue normally.; Moderate to severe fatigue; I have trouble staying awake during the day, especially early evening.  I need more and longer naps than usual.  Because I have leukemia, I do have fatigue normally.; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jan2021 09:00 (Batch/Lot Number: EL3249) as single dose for Covid-19 immunization. Medical history included ongoing leukaemia, chronic pain, gastritis, colitis, supraventricular tachycardia, depression, xerostomia, afibrillation, migraines, fatigue, and others. Concomitant medication included ibrutinib (IBRUTINIB) taken for leukaemia. The patient previously had Known allergies for drugs Bactrim, Belladonna, Diclofenac, DMannose, IV contrast media, Mobic, Metoclopramide, Metoprolol, Protonix, and Pyridium. Patient not had other vaccine in four weeks, Other medications in two weeks includes Ibrutinib (for leukemia). On 19Jan2021 on 13:00, patient had Moderate to severe fatigue; "I have trouble staying awake during the day, especially early evening. I need more and longer naps than usual. Because I have leukemia, I do have fatigue normally, but it has gotten Much worse". Patient not had COVID prior vaccination; patient not tested COVID post vaccination. There was no treatment received for the adverse events. Th outcome of the events was not recovered.
Client felt ill at school, 1 day (24 hours) post vaccine was given, That evening 10/31/02. Client ran a temperature of 102 degrees F. Client felt better the next day 11/01/02
Myalgia, SkinRash, Rash & UrticariaPruritus Narrative: