chrisvoncsefalvay/vaers-outcomes huggingface dataset:
33 year old healthy man presented with seizure to Hospital ER on 5/7/2021. He required intubation. CT scan and MRI of brain showed dural venous sinus thrombosis along the anterior to mid aspects of the sagittal sinus.  CBC was normal at presentation with WBC 13.9, HGB 16.1 and PLT 367k. He was admitted on unfractionated heparin. Repeat platelet count on 5/8/2021 was 153k.  HIPA was negative. Patient was extubated and continued to improve. He was put on warfarin and sent home. He has some mild personality change in the immediate weeks of discharge.  Hypercoagulable workup had normal Prot S & C activity, normal ATIII activity. The Factor V Leiden and Prothrombin Gene were negative. The homocysteine level was elevated at 16.3.
Approximately 1 hour after administration, dry, "choking like" cough developed.  7 hours after administration, patient developed a fever(101.5), dizziness, mood changes, racing heart-rate, weakness and "odd breathing - felt like something in my chest".  Experineced no hives. No treatment sought.  Following day had fever and body aches.  Third day had only a low grade fever (99).  Felt fine on the fourth day.
normal tiredness and head ache for two days. Extended irradic blood sugar readings 87 to 326 from vaccine to present. no apparent patern.
Fever of 103.4. High fever for 4 hours before treated with tylenol/Motrin.
severe muscle fatigue; little cough; chills; little out of breath; couldn't eat; high fever over 102; body aches; extreme headache - intense; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (high fever over 102), MYALGIA (body aches), HEADACHE (extreme headache - intense), FATIGUE (severe muscle fatigue) and COUGH (little cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (high fever over 102), MYALGIA (body aches), HEADACHE (extreme headache - intense), COUGH (little cough), CHILLS (chills), DYSPNOEA (little out of breath) and FEEDING DISORDER (couldn't eat). On 09-Jan-2021, the patient experienced FATIGUE (severe muscle fatigue). The patient was treated with PARACETAMOL (TYNELOL) at a dose of UNK, q6h. On 10-Jan-2021, PYREXIA (high fever over 102), MYALGIA (body aches), HEADACHE (extreme headache - intense), COUGH (little cough), CHILLS (chills), DYSPNOEA (little out of breath) and FEEDING DISORDER (couldn't eat) had resolved. On 12-Jan-2021, FATIGUE (severe muscle fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: positive (Positive) (took antibody test 3 weeks after the first dose and was Positive for antibodies).     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.
I woke up with a tremendous headache and I just felt bad. It escalated from that. I was very nauseous with a stomachache. I was also short of breath. I could not keep anything down. I either vomited it up or had severe diarrhea sometimes it was both. This lasted about 2 weeks. I was also having upper respiratory issues. On 02/11/2023, I completed a home COVID-19 Test and it was positive. I reached out to my doctor who prescribed Paxlovid. I did not have any improvement in my symptoms. I almost felt like I got worse. The metallic taste in my mouth made me sick. I completed the full 5-day regimen. I was taking Tylenol, but it did not seem to help as I had a tremendous headache. I vomited so much until I am certain if my prescribed medication would be effective. I was still tired for an additional 2 weeks. After that the headache finally went away and I was finally able to eat.
I developed a debilitating  migraine headache  on day 2 and 3. day 4 fatigue, body aches  which have continued off and on are still occurring today on day 7.  In addition, i developed a slight dry cough. around day 4  and it is still present today on day 7th.
5 minutes after, lips tingling and swollen tongue/ tongue continued to be bigger than normal, doctor onsite administered 2.5mg of epinephrine, felt relief within mins, however, after 15 minutes my tongue was tingling and swelling again. My throat, too was  feeling swollen and scratchy. Was taken by the ambulance to the er where they gave me more medication to help with the swelling.
Since having been administered the vaccine, patient has experienced hives (waist down), severe abdominal pain (slightly below navel, right side), vomiting, etc.  Severe acute abdominal pain continues, under supervision currently of PCP.
1st dose 06May2022, 2nd 30Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440).   On 30th July 2022, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 30th July 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 29-DEC-2022 Reporter's Comment: The pharmacist called to report that a patient was erroneously given the second dose of Havrix, only 2 months after the first dose, which was given on 6th May 2022.  The patient looked up information about the recommended schedule and insisted that they needed a second dose.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received the second dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
This spontaneous report was received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The patients' had no medical history, concurrent condition, drug and allergy history to be reported. On 12-JAN-2017, an unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ lot # M016238 expiration date  07-DIC-2017, (strength, dose were not provided) for prophylaxis. The patients' concomitant medications were not reported. On an unspecified date ROTATEQ was exposed to a temperature excursion of 32° Fahrenheit (°F) to 35°F (31°F) during a time frame of 1 hour, with no previous temperature excursion (incorrect product storage). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested; Sender's Comments:  US-009507513-1706USA000994:
This spontaneous report was received from a physician referring to a patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 23-JAN-2019, the patient was vaccinated with a dose of improperly stored VARIVAX, lot # R022113, expiry date: 02-AUG-2020 or lot # R017639, expiry date: 20-JUN-2020 (strength, dose number, dose, units, route and anatomical location were not reported) for prophylaxis which was reconstituted with properly stored diluent. The vaccine with the lot # R022113 and lot # R017639 experienced temperature excursion from 6ºF to 14ºF (7ºF) for 30 minutes. Previous temperature excursion was reported to be from 6ºF to 14ºF (12ºF) for 8 hours and 15 minutes. The call was not due to digital data logger. At the time of the call it was unspecified which lot # of the vaccine was administered to the patient. No adverse effects were reported. The outcome of product storage error was unknown. No product quality complaint (PQC) was involved.
Patient complained of feeling "dizzy and seeing black" at 1200. Patient assisted to zero gravity chair. Vital signs taken at 1200 (Blood Pressure 116/70, heart rate 65, SPO2 99%). Patient appeared diaphoretic. Patient offered water. Vital signs taken at 1210 (Blood pressure 116/74, Heart rate 72, SPO2 99%). Patient stated "I am feeling better." Vital signs taken at 1215 (Blood Pressure 110/64, Heart rate 74). Patient advised to follow  up with primary care provider. Patient stated at 1230 that she is "feeling much better." Patient left facility unassisted with a steady gate.
Arm hurt and swollen; Arm tied; Dizzied; Sick; Difficult of breathing; Difficult to fallen sleeping; Cold hands; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm hurt and swollen), LIMB DISCOMFORT (Arm tied), DIZZINESS (Dizzied), ILLNESS (Sick) and DYSPNOEA (Difficult of breathing) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disorder NOS, Drug allergy (Allergic to Penicillin) and Asthma. Concomitant products included CLONAZEPAM;ESCITALOPRAM, AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (ADVENT [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) and LEVOTHYROXINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm hurt and swollen), LIMB DISCOMFORT (Arm tied), DIZZINESS (Dizzied), ILLNESS (Sick), DYSPNOEA (Difficult of breathing), INSOMNIA (Difficult to fallen sleeping), PERIPHERAL COLDNESS (Cold hands), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Arm hurt and swollen), LIMB DISCOMFORT (Arm tied), DIZZINESS (Dizzied), ILLNESS (Sick), DYSPNOEA (Difficult of breathing), INSOMNIA (Difficult to fallen sleeping), PERIPHERAL COLDNESS (Cold hands), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medicines included Bolta and inhaler for asthma. No treatment information were reported.
high fever, diarrhea, fussy, all over rash from head to toe, first flat & red for 3 days then turned bumpy & red for 5 to 7 days-looked like measles rash;
Chills; headache; body aches; This is a spontaneous report from a contactable other health professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, intramuscular in the right arm, on 12Jan2021 17:00 at a SINGLE DOSE for covid-19 immunization. Prior vaccination, the patient had COVID-19 on an unspecified date.  Concomitant medications included venlafaxine hydrochloride (EFFEXOR), rosuvastatin calcium (CRESTOR), colecalciferol (VITAMIN D), ibuprofen, paracetamol (TYLENOL).  Patient was not pregnant during vaccination. The patient previously took Tetracycline and Wellbutrin; she experienced allergy to both on unspecified dates. On 13Jan2021 17:00, the patient experienced chills, headache and body aches. outcome of events was recovered. The patient did not receive any treatment due to events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
pt received immunization around noon, and by 6pm then 9pm very bad pain in all of her muscles (back, shoulders, neck, legs) and very intense headache
joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating.    I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough).  it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
Sharp pain when breathing after having her first dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (Sharp pain when breathing after having her first dose of the Moderna vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAINFUL RESPIRATION (Sharp pain when breathing after having her first dose of the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, PAINFUL RESPIRATION (Sharp pain when breathing after having her first dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient experienced sharp pain when breathing with Moderna vaccine even after having it.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
3-4 hours after the jab, she developed new joint pain, low fever, which progressed by hour #4 hour to hypoxic respiratory failure due to acute asthma exacerbation, with symptoms of chest pain, shortness of breath, difficulty breathing, wheezing. She spoke to her PCP and was told the symptoms were covid vaccine related when the runny nose and sneezing started about a day later.  She thought she had covid-19 and kept testing negative. October 23rd, 2021 she had another asthma attack and she went to EMERGENCY ROOM for evaluation and was given nebulizer, inhaled steroids, and albuterol, as well as monteleukast(singulair).  She developed a bronchitis and started OTC mucinex. She was tested for COVID-19 in ER and was negative October 23rd, 2021 . She was sent home with inhalers and nebulizer and epi pen. Symptoms persisted for a month.
Information has been received from a mother concerning her 21 year old daughter with no known drug allergies who on 17-MAY-2007 was vaccinated with her first dose of Gardasil, injection. Concomitant therapy included hormonal contraceptives (unspecified). In the "middle of July" estimated to be approximately 15-JUL-2007, "about two months" after the first dose of Gardasil, the patient experienced paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm. The chest pain extended to her diaphragm area. At first, the physician thought the patient had acid reflux. Further testing showed that she had paralysis of the stomach and a slow down of the gallbladder. The patient started to "get better" about 4 weeks before the third dose, estimated to be 21-OCT-2007. On 21-NOV-2007 the patient received her third dose of Gardasil. The patient's symptoms came back. The patient underwent the following tests: diabetes (results not provided), scleroderma (results not provided), gallbladder (no stones) and liver scan (results not provided). The patient's paralysis of the stomach, slow down of the gallbladder, chest pain and pain in the diaphragm persisted. Unspecified medical attention was sought. OME statement: Upon internal review, paralysis of the stomach was determined to be an other important medical event. Additional information has been requested.
Pt recv vax on 5/5/99; on 5/6/99 pt exp erythema w/ induration at vax site
IMMEDIATELY FOLLOWING VACCINE DEVELOPED A HEADACHE, WITHIN 45 MINUTES DEVELOPED SKIN FLUSHING, SHORTNESS OF BREATH, FEELING OF THROAT CLOSING, AND DIZZINES.
Fever, fatigue, chills kicked in 12 hours after second shot and continued for about 48 hours
Initial misuse report received from a healthcare professional on 23 June 2014. An 11-year-old patient (gender was not reported) had received a dose of DTAP (manufacturer unknown, lot number, dose in series, route and site of administration was not reported) instead of a TDAP on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Swelling of face and eyes.  Itching of eyes, rash on anterior chest and neck symptoms/symptoms occurred 2 days after vaccine treatment.  OTc Benadryl
Would you like to know my side effects from the vaccine/Yes; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION COMPLICATION (Would you like to know my side effects from the vaccine/Yes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced VACCINATION COMPLICATION (Would you like to know my side effects from the vaccine/Yes). At the time of the report, VACCINATION COMPLICATION (Would you like to know my side effects from the vaccine/Yes) 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.   No concomitant and treatment information were reported by the reporter.
I am kind of achy, like my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 02Mar2021 (Lot number: EN6205) at the age of 71 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 03Mar2021, outcome "unknown", described as "I am kind of achy, like my back". Additional information: The patient wanted to know if she could take Ibuprofen. The patient claims she currently have antibodies and does not need convalescent plasma.  No follow-up attempts are needed. No further information is expected.
Dyspnea, oxygen saturation 100% in room air dropped to 77% during albuterol RX-sent via Ambulance to ER -received IV-Solu-Medrol 90mg and Duoneb neb, plus Benadryl and Pepcid.
This spontaneous report as received from a female consumer of unknown age reporting on herself. In 2011, the patient was vaccinated with either 1 or 2 doses of GARDASIL (route and lot # not reported) after the age of 30 years. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
face muscle contractions; numbness; dizziness; continuous fever; This is a spontaneous report from a contactable Pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and Expiry date was not provided), via an unspecified route of administration on 30Mar2021 as a 1st Dose, Single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient had her first dose of the vaccine on 30Mar2021, (as reported) then she developed face muscle contractions, numbness, and dizziness. The right side of her face was contracting, and she had a continuous fever from time to time. She had been seen by a neurologist, but no diagnosis had been made. She stated that, she will report this, but she wanted some help in seeing if there were any case reports similar to this and if anyone had any suggestions and wanted a response ASAP. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
11/6/02 Td 0.5ml IM LUE without problem. 1 1/2 hrs later numb fingers/toes left side and pain shooting down L leg. 5 hrs later had asthma attack not relieved by inhalers. Required two nebulizer tx. 11/7/02 called to inform SHC of reaction that she feels is r/x injection. Saw SHC Dr. diagnosed as having allergic reaction to Td or thimerosal. Rx given for Clarinex and Vicoden. Instructed to avoid Td containing thimerosal.
Pt exp local soreness to lt deltoid, red, no fever x 1 wk;
pt states that rt arm started hurting; nodule appeared below the inject site; pain responded over past six wks to NSAID's but has remained intermittent when using the arm in certain positions;
Day 1-2: Nausea, tricep (Lateral head) cramp, bicep spasm, loss of appetite After 1st week: loss of appetite, migrain headaches, altered homeostasis, decrease energy levels, anxiety attacks Currently: loss of appetite, migrain headaches, decrease mood/energy, anxiety, irritability
High fever - 103; Vomiting; Shakes/chills; Myalgia.
rapid resting heart rate (~110-130 bpm) for a couple of hours.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included congenital/neonatal emphysema. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 10:15, around 15 minutes after vaccination, the patient experienced rapid resting heart rate of approximately 110-130 bpm for a couple of hours. The patient did not experience trouble breathing and relaxed at the store until the heart rate reduced below 100 bpm for a period of approximately 30 minutes. The patient's normal resting heart rate was 60-65 bpm. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the heart rate increased. The clinical outcome of the event heart rate increased was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.