chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IT WAS DISCOVERED LATE AFTERNOON THAT PATIENT'S DOSAGE MAY HAVE BEEN UNDER DILUTED RESULTING IN A DOSE THAT COULD HAVE BEEN BETWEEN 10-30MCG.  PATIENT'S PARENT WAS CALLED AND NOTIFIED ABOUT POTENTIAL SIDE EFFECTS AS A RESULT AND TO MONITOR FOR FEVER , EXCESSIVE SORE ARM.  IF PATIENT'S FEVER GOT OVER 102F TO CHECK IN WITH THE MD.  PATIENT'S PEDIATRICIAN WAS NOTIFIED ON 6/21/22.  SPOKE WITH MOTHER ON 6/21/22 AND SHE STATES THAT HE FEELS FINE, HOWEVER FELT A LITTLE WARMER, AND WILL CONTINUE TO MONITOR HIS CONDITION.
11/8/99, parents called office approx. 6 hrs. post/DTAP, EIPV, & HIB administration. Pt. was very fussy and temp was 102 (rectal). Instructed to use Tylenol & sx's to monitor for. On 11/10, pt. was afebrile, no further symptoms.
Narrative: Patient died on 9/8/2022 of unknown cause & circumstances, unknown place and time. Patient had received a covid EUA vaccine (J&J) on 8/25/2021. Pt left medical care and moved in DEC 2021. NO INFORMATION IN MEDICAL RECORDS since close of care notes in 12/2021 & 1/2022. Likely covid vaccine is not related to this death given long length of time in between date of vaccine and date of death. Last problem list in chart: 25 Active Problems PROBLEM LAST MOD PROVIDER Diverticulitis (SCT 307496006) (ICD-10-CM 06/27/2019 K57.32) Spinal stenosis of lumbar region (SCT 18347007) 04/29/2019 (ICD-10-CM M48.062) Sleep apnea (SCT 73430006) (ICD-10-CM G47.33) 03/04/2019 Benign prostatic hypertrophy with outflow 01/07/2019 obstruction (SCT 236646007) (ICD-10-CM N40.1/N13.8) Polyp of colon (SCT 68496003) (ICD-10-CM K63.5) 01/07/2019 Pain of left hip joint (SCT 316781000119100) 06/25/2018 (ICD-10-CM M25.552) Dyspnea (SCT 267036007) (ICD-10-CM R06.00) 03/19/2018 Impotence (SCT 397803000) (ICD-10-CM N 52.9) 03/19/2018 Insomnia (SCT 193462001) (ICD-10-CM G47.00) 08/29/2016 Chronic neck pain (SCT 1121000119107) (ICD-10-CM 05/16/2016 R52.) Low back pain (SCT 279039007) (ICD-10-CM M54.5) 05/16/2016 Chronic neck pain (SCT 1121000119107) (ICD-10-CM 05/16/2016 R52.) Low back pain (SCT 279039007) (ICD-10-CM M54.5) 05/16/2016 (ICD-9-CM 599.00); UTI (ICD-9-CM 599.0) 07/05/2013 (ICD-9-CM 787.91); Diarrhea * (ICD-9-CM 787.91) 07/05/2013 (ICD-9-CM 842.09); Wrist sprain (ICD-9-CM 03/12/2013 842.09) (ICD-9-CM 472.0); Chronic rhinitis (ICD-9-CM 03/05/2013 472.0) OPIOID (ICD-9-CM 799.9) 11/07/2012 1. Agreement signed 09-07-12 2. consent signed 11-07-12 (ICD-10-CM F39.); Depression (SNOMED CT 10/28/2019 35489007) (ICD-10-CM F41.9); Anxiety (SNOMED CT 48694002) 05/16/2016 (ICD-9-CM 414.9); CAD * (ICD-9-CM 414.9) 03/19/2012 (ICD-9-CM 715.90); Osteoarthritis * (ICD-9-CM 03/19/2012 715.90) (ICD-9-CM 530.81); Gastroesophageal Reflux 03/19/2012 Disorder * (ICD-9-CM 530.81) (ICD-9-CM 786.59); Atypical Chest Pain (ICD-9-CM 03/19/2012 786.59) (ICD-10-CM F17.200); Tobacco user (SNOMED CT 05/16/2016 110483000)
Patient says that 2 days post vaccination that she was having difficulty breathing.  They admitted her in the hospital and she said she had inflammation around her heart.
Near immediately, within 5 minutes of injection, my tongue swelled up. I also had extreme fatigue and slept for 20 hours over the next two days I took  Generic Benadryl/Antihistamine the night of the vaccine, followed by 3 more nights by 4 days after injection the reaction had stopped.
Per parent has approximately 20-30 vesicular lesions on trunk and extremities. No known fever.
intestinal gas; loose stool/not having normal stool; red dotted rash that went up the inside and back of his legs; itchy rash that went up the inside and back of his legs; skin became discolored; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (intestinal gas), DIARRHOEA (loose stool/not having normal stool), RASH MACULAR (red dotted rash that went up the inside and back of his legs), RASH PRURITIC (itchy rash that went up the inside and back of his legs) and SKIN DISCOLOURATION (skin became discolored) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FLATULENCE (intestinal gas), DIARRHOEA (loose stool/not having normal stool), RASH MACULAR (red dotted rash that went up the inside and back of his legs), RASH PRURITIC (itchy rash that went up the inside and back of his legs) and SKIN DISCOLOURATION (skin became discolored). In March 2021, FLATULENCE (intestinal gas), RASH MACULAR (red dotted rash that went up the inside and back of his legs), RASH PRURITIC (itchy rash that went up the inside and back of his legs) and SKIN DISCOLOURATION (skin became discolored) had resolved and DIARRHOEA (loose stool/not having normal stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
Mom describes child as being more fussy, less consolable, and less happy. Mom reports the same symptoms with first series of vaccines and that the course of complaints lasted for six weeks. Symptoms began within 24 hours.
coughing; where I got the injection, it is hot and swollen; where I got the injection, it is hot and swollen; her arm is sore; feel really really sick; Nausea / I have Ondansetron that I take for nausea and that's helping a little bit; Stiff neck; feeling worse; severe headache / (Advil migraine) it is not doing a thing for the headache/(Tramadol) That has not even helped the headache; pain that goes across her shoulders/painful joints and muscles; whole body was in pain; painful joints and muscles; fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, strength: 0.3 ml, #lot: FA7484) via an unspecified route of administration, administered in Arm Right on 21Jul2021 (at the age of 67-years-old) as single dose for covid-19 immunization, ibuprofen (ADVIL MIGRAINE, #lot: ER4082), tramadol (#lot: AN627) and ondansetron (ONDANSETRON). The patient's medical history included high cholesterol, acute intermittent porphyria, fibromyalgia and allergic to bees. The patient's concomitant medications included topiramate at 150 mg, atorvastatin at 10 mg, lorazepam at 1 mg, tizanidine, loratadine at 1 mg for allergy, hydroxyzine hydrochloride at 25 mg for itching and hives, albuterol sulfate and epinephrine (EPIPEN). On 21Jul2021, the patient woke up with a severe headache last night and pain that goes across her shoulders. When she woke up this morning, her whole body was in pain, she has painful joints and muscles, and she is running a fever on 21Jul2021. She has taken Advil Migraine and Tramadol 50 mg and now is coughing too on an unknown date. She was feeling worse and her daughter brought over her granddaughter today. When probe for concern, patient stated she got the second COVID shot yesterday and last night she woke up with, well she started getting stiff neck and pain across her shoulders and she woke up with worst headache. She has had and she cannot even say when and today her whole body and her joints hurt so bad, it literally hurts to walk almost and she have been taking Advil migraine and it is not doing a thing for the headache and she has ondansetron that she takes for nausea and that's helping a little bit. The patient stated she have Tramadol 50 mg and she can take one tablet twice daily for chronic pain that has not even helped the headache. When probed the vaccine name as Pfizer COVID shot, patient stated she got the injection, it is hot and swollen and her arm is sore all the way down. She feels really sick. The outcome of the events was unknown.  Information on batch/lot number is requested.
About 2:00 or so I started feeling very hot and sweaty I walked up front and took my temperature. I was not running a fever. I walked back to my desk and sat down. I had a headache and put my head in my hands, I felt nauseous, dizzy and like I was going to pass out. The MAs I work with were asking if I was ok and other questions and I felt as though I wanted to answer them but couldn't get any words out. This lasted a short while and then I was able to answer them. They said I was very pale and my body felt like I could have just slid out of my chair and onto the floor, I also had some chest pressure and fatigue. A nurse came over to my desk to check me out, she asked the infusion room to come over and start and IV of fluids and some Zofran. They checked my glucose (122) after lunch, bp was normal. They got the stretcher and got me into an exam room and ran an EKG and called EMS for transport to the ED. When I got to the ED they ran an EKG, did lab work, continued IV fluids, gave me meclizine. They released me that night around 8pm and advised me to follow up with my PCP the next day. I called my PCP as instructed the next day. Due to the holiday I was set up with a video visit with my PCP on 1/4/2021. By this time my dizziness had improved and I was only dizzy with quick positional changes. The fatigue was worse and I had a sore throat, congested sinuses, loose stools, nausea, headache and occasional productive cough. My PCP prescribed azithromycin 500mg 1 tab daily for 5 days, staying hydrated and following the BRAT diet and COVID testing.  COVID testing was negative. Had follow up video visit with PCP  on 1/7/2021. Still VERY FATIGUED, sinus congestion and headache. Diarrhea, nausea and cough have improved. Due to continued fatigue and headache I called my PCP and she ordered more lab work. Due to resulting elevated WBC PCP ordered chest X-ray and U/A, culture if indicated. I am still very fatigued, it is taking everything I have to make it through the day.
Patient was administered an undiluted dose of Pfizer Vaccine.  PCP was notified. Mom was called and informed of error and given instructions on what to monitor for.
This client received a dose of J&J on 5/24/21, after having already received a dose on Moderna on 1/7/21 unbeknownst to the vaccinator.
Swelling, soreness at injection site just after shot. Uneasy sleep, awoke the following morning in a sweat, with overall discomfort and nausea, began to retch and vomit for nearly 13 hrs. throughout the only comfort was to sit in a hot shower till the hot water ran out sometime falling into a deep sleep, I did this many times through the day, Accompanying this was a general fog and complete loss of equilibrium, extreme weakness. this made it difficult to move from bed to bath or anywhere in my home. I am writing this at 5:13 am Mar  6 and find it hard to gather thoughts.
pt recv vax & exp numbness in arm;also exp local induration & sore & swollen nodes;pt also exp a tingly feeling;
04/30: Patient got pneumo vaccination and states 2 hours later had redness and swelling at injection site. 05/03: Patient states had sore throat and burning, increased trouble swallowing.
Woke up with Pulsating Tinnitus 24/7.  No treatments.   Saw PCP, Neurologist, ENT, Immunologist.
Spontaneous nose bleed approximately 24 hours after the injection. Lasted for approximately 30 mins and resolved with pressure.  Other expected side effects he has are fatigue, muscle cramps, body aches, headache.
This patient had soreness at the site of injection, 12/07/00. The she began to develop  muscle soreness, tightness in legs, that moved into her arms beginning 12/07/00. This continued through the end of January 2001. The patient was off of work from 01/02/01 to 01/19/01, due to severe fatigue, and weakness. The patient was never really evaluated by MD. She saw a hygienist for holistic treatment at the end of Jan 2001. Completely recovered as of 03/06/01. This report was completed only after the patient was relaying the problem to the school nurse.
she is not feeling well; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (PFIZER COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she is not feeling well".  Additional Information: The patient was supposed to get the second dose of the vaccine today, 19Apr2021. However, she was not feeling well. The reporter wanted to reschedule the appointment and was asking what will happen if the patient did not follow the 3 weeks time frame.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HYPOXIA 11/5/2021 MALIGNANT NEOPLASM UNS PART UNS BRONCHUS/LUNG
Information has been received from a physician concerning a 12 year old female patient with asthma and no known drug allergies, who on 03-MAY-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# not provided). Concomitant therapy included AUGMENTIN. On 09-MAY-2008 the patient experienced nausea, vomiting, fatigue, dizziness and weakness. The patient was seen by the physician. At the time of reporting the patient was feeling better. The patient was recovering. Additional information has been requested.
slightly swollen in bicep area; sore arms; lymphnode in her armpit started to hurt; arm was itchy; felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNE-MEDIATED MYOSITIS (slightly swollen in bicep area) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNE-MEDIATED MYOSITIS (slightly swollen in bicep area) (seriousness criterion medically significant), PAIN IN EXTREMITY (sore arms), LYMPH NODE PAIN (lymphnode in her armpit started to hurt), PRURITUS (arm was itchy) and FATIGUE (felt tired). At the time of the report, IMMUNE-MEDIATED MYOSITIS (slightly swollen in bicep area), PAIN IN EXTREMITY (sore arms), LYMPH NODE PAIN (lymphnode in her armpit started to hurt), PRURITUS (arm was itchy) and FATIGUE (felt tired) outcome was unknown.
pt recv vax 19APR96 & 21APR96 pt devel scattered varicella-like lesions;22APR96 presented to a MD;23APR96 pt had more than 50 lesions & was cont to break out;pt devel full blown varicella w/over 200 chickenpox lesions all over body;
Narrative:  Patient received COVID 19 vaccine in Mar/Apr 2021. The patient tested positive for COVID 19 on 9 Sep 2022. The patient presented to the ED with shortness of breath, and cough. The patient was admitted with sepsis and treated with remdesivir and steroids. The patient was discharged on 19 Sep 22 in stable condition. Reported per EUA.
PERSISTENT MODERATE HEADACHE OVER EYES; MILD FEVER; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage and no past medical history of medicines to prescriptions herbal supplements. The patient experienced drug allergy when treated with levofloxacin.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. Concomitant medications included lansoprazole. On 09-MAY-2021, the subject experienced persistent moderate headache over eyes. On 09-MAY-2021, the subject experienced mild fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild fever on 14-MAY-2021, and had not recovered from persistent moderate headache over eyes. This report was non-serious.
Fever (102), severe headache and drowsiness since the day after getting the vaccine. This is the 9th day of these symptoms with no significant improvement. Medication taken: Advil and Tylenol.
blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a 51-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced THROMBOSIS (blood clot) (seriousness criteria death and medically significant). The patient died in December 2020. The reported cause of death was blood clot. An autopsy was performed.            No concomitant drug details were reported. No treatment details were reported.  Company comment: This is a spontaneous case concerning a 51-year-old male patient with no medical history reported, who experienced unexpected, fatal  event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The patient died in December 2020. The reported cause of death was blood clot. An autopsy was performed. No information about the first dose was disclosed. Clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 51-year-old male patient with no medical history reported, who experienced unexpected, fatal  event of thrombosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The patient died in December 2020. The reported cause of death was blood clot. An autopsy was performed. No information about the first dose was disclosed. Clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Blood clot
This spontaneous report as received from a pharmacist refers to an elderly male patient of unknown age. In August 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. In August 2017, the patient experienced injection site pruritus and injection site erythema. The outcome of injection site pruritus and injection site erythema was reported as recovered/resolved.; Sender's Comments:  US-009507513-1708USA013584:
I started thinking I had light Bronchitis on June 19th, I had a headache, and two days later the symptoms got worse June 21. On June 22nd I started getting sick and I was very tired 100.4. June 23, I took an at home test which is came back positive I sent information to my doctor, and they told me to go to the urgent care. When the doctor took my temperature, it read 101.4. The doctor started me on PAXLOVID after rearranging some of my other medications. I took the medication and isolated for 5 days. Then after.
Sudden pain throughout child's entire body. Could not move. Could not walk. Entire body sore and immobile. Had child rest in an elevated position on bed with pillows behind head and back. Thick blanket under knees to cushion legs. Heating pad on entire back. Gave Motrin every eight hours. Pain eased slowly, took 48 hours to recover completely.
FluLaval given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 5M2H2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comment: The reporter reported that 2 male patients received a FluLaval Quadrivalent administration after a below temperature excursion.  HCP called in yesterday 14th February 2023 to report a similar situation that involved Engerix B, but they realized that Flulaval QIV was also involved.  The reporter consented to follow up via email. Additional supportive information: The patient received FluLaval Quadrivalent vaccine after a below temperature excursion, which led to incorrect storage of drug. This case is linked with case US2023025429, US2023024476 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023025429:Same reporter - other male patient US-GSK-US2023024476:Same reporter - Engerix B case
Patient received entire vial of undiluted vaccine.  Patient being monitored for adverse effects while inpatient.  Patient received vaccine while admitted for other medical conditions.  Currently experiencing weakness and generalized pain.
This spontaneous report as received from a nurse practitioner refers to a 24 year old female patient. The patient's medical history included anemia, anxiety, depression, allergic rhinitis and condyloma. The patient also had a history of hives after acetaminophen (manufacturer unknown) use (dates unspecified) and had recovered from the hives (linked case 1311USA009438). On 19-JUL-2013, the patient was vaccinated with GARDASIL (dose sequence unspecified) (dose unknown, lot # H105859, expiry date 26-JUN-2015) intramuscular to prevent HPV. On 01-OCT-2013 the patient was vaccinated with GARDASIL of same lot and via same route (dose sequence unspecified). Concomitant medications were none. On 08-OCT-2013 (reported as starting about 2 weeks before 22-OCT-2013), the patient developed bruising at the site of injections. On about 22-OCT-2013 the patient experienced nausea. The outcome of events was unknown. No treatment was given for the events. No lab test was performed. The patient had called the nurse practitioner to seek medical attention. This case is linked to 1311USA009438 (same patient). Additional information has been requested.