chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; joint muscle pain; joint muscle pain; fever of 100; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (joint muscle pain), MYALGIA (joint muscle pain) and PYREXIA (fever of 100) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), ARTHRALGIA (joint muscle pain), MYALGIA (joint muscle pain) and PYREXIA (fever of 100). At the time of the report, HEADACHE (Headache), ARTHRALGIA (joint muscle pain), MYALGIA (joint muscle pain) and PYREXIA (fever of 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up received on 13-MAY-2021, no new information
Patient is a 79 y.o. male with a history of A fib on chronic anticoagulation, DM type II on insulin, HTN, GERD, obesity and OSA on CPAP who is transferred for after worsening respiratory status despite Remdesivir and dexamethasone treatment for recently diagnosed COVID-19. He arrives and is on high flow O2 80% at 40L/min. He tells me his symptoms began about a week ago. He noticed that he was fatigued despite using his CPAP at night. He also noticed he had lost his appetite. He denies any loss of taste or smell. He says his cough has been ongoing about a week. He denies any N/V, fever or diarrhea. He says he has been eating now, but not as much as normal. His breathing he t
Patient was inadvertently administered an expired dose of Daptacel, no AE; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional .  This case involves a 15-month-old female patient who was vaccinated with an expired 0.5 mL fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] once (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 11-Sep-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and INFLUENZA VACCINE (FLU) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of this report, no adverse event was reported.  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 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.
Itching and painful shingles. I had only 1 or 2 shingles per year prior to receiving the shingles vaccination. I now have 8 or 10 and more painful.
Resp. Depression, Tachycardia and Cardiac Arrest. Epinephrine 1 MG Other, Dopamine 10 MCG Other.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a two-years old patient of an unknown gender who received a first dose of 0.5 ml instead of 0.25 ml FLUZONE QUADRIVALENT (lot number, expiry date, dose, route and site of administration were not reported) on 20-Sep-2018. The patient's past medical history included iron deficiency anemia. The patient's medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose and extra dose administered. It was reported that patient came in for the first time to get a flu shot and the child was administered 0.5 ml instead of 0.25 ml of FLUZONE QUADRIVALENT. Later on an unknown date, when the child came back to the medical office to check/monitor for iron deficiency anemia, the nurse misread the chart and the child was administered another 0.25 ml of the vaccine. The pediatric patient received 0.75 ml total dose. It was not reported if the patient experienced any adverse event following the vaccination or not. 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. List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-DEC-2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.18.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.    The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient stated having round redness around injection site that is slowly getting larger and warm to touch. No pain, tenderness, and itching. Recommended seeing PCP and letting them take a look at it just to be safe. Pt. stated having an appointment scheduled.
Impaired speech, stuttering, insecure and constantly wanting to be held. He was very independent prior to shot. Cries a lot now. A follow up report received 10/25/2002 adds: From follow-up mailed correspondence received on 08/27/2001, the pt's birth weight, number of siblings and the pt's history was provided. From follow-up correspondence received on 12/03/2001 it was reported that the pt recovered from this experience. The correct Facility Name where the vaccine was administered was also provided. This case is closed.
painful infection in her left molar that was beginning to abscess; painful infection in her left molar that was beginning to abscess; her face was swollen; eye was twitching; she had intense pain at night due to the molar infection.; fever; chills; tiredness; achiness; painful infection in her left molar that was beginning to; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (painful infection in her left molar that was beginning to abscess), TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess), SWELLING FACE (her face was swollen), THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to) and BLEPHAROSPASM (eye was twitching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental abscess. Concomitant products included BENZOCAINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (achiness). On an unknown date, the patient experienced TOOTH INFECTION (painful infection in her left molar that was beginning to abscess), TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess), SWELLING FACE (her face was swollen), BLEPHAROSPASM (eye was twitching) and TOOTHACHE (she had intense pain at night due to the molar infection.). On 13-Mar-2021, TOOTH INFECTION (painful infection in her left molar that was beginning to abscess) had resolved, TOOTH ABSCESS (painful infection in her left molar that was beginning to abscess) outcome was unknown. On 15-Mar-2021, PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (achiness) had resolved. At the time of the report, SWELLING FACE (her face was swollen), THERAPEUTIC RESPONSE UNEXPECTED (painful infection in her left molar that was beginning to), BLEPHAROSPASM (eye was twitching) and TOOTHACHE (she had intense pain at night due to the molar infection.) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-069996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069996:case for first dose
This spontaneous report as received from a registered nurse refers to a 17 months old male patient with drug reactions/allergies to milk and with no pertinent medical history. The patient was vaccinated with M-M-R II (Lot#, dose/frequency, duration unspecified) on 08-JUL-2008. No other co-suspects were reported. Concomitant medications included DTaP (unspecified), HIB (manufacture unspecified), PREVNAR 13 and IPV (unspecified) also on the same day 08-JUL-2008. The nurse reported that the patient developed purple spots on the face (described as vasculitis of the face) on 08-JUL-2008, "the same day he received M-M-R II". The physician associated with the case was retired. It was unspecified whether the patient had sought medical attention or not. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as recovered/resolved (date unspecified). Additional information is not expected.
" Per proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes."
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number unspecified). The patient experienced syncopal episode after received GARDASIL and passed out immediately. The patient had not recovered after 25mins. An ambulance was called and the patient was taken to a local emergency room(ER). The physician did not hear any follow up information from the hospital or the patient. The outcome of the patient was unknown. Additional information has been requested.
Developed almost immediate red, itchy swollen area at injection site. About 1 hour later developed chest tightness and several hours later developed hives.  Seen by allergist who completed PFTs and diagnosed immediate type I hypersensitivty reaction. Treated with epinephrine, Ventolin and steroid dose pack.
Rush in different parts of my body, some like shingles and some like chicken pox , very itchy for about a week
Within 12 hours, I experienced muscle pain, soreness and fatigue especially of the larger muscles of my thighs and pelvis. This has progressively worsened over the 3 weeks. At this point I am unable to do my daily exercise/stretching routine or walk any distance, especially with speed. My leg muscles hurt when I stretch them,contract them and even lay/sit (ie;gluteals). It has impacted my sleep because laying on the muscles hurts and my activity level is severely limited now. I was advised to stop my statins to see if that was a contributing factor but the symptoms continue to worsen.
just wasn't with it; arm was sore; she begun to have the chills this morning and every part of her body was cold; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (just wasn't with it), CHILLS (she begun to have the chills this morning and every part of her body was cold), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026620A and 027620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (she begun to have the chills this morning and every part of her body was cold) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (just wasn't with it) and VACCINATION SITE PAIN (arm was sore). At the time of the report, FEELING ABNORMAL (just wasn't with it), CHILLS (she begun to have the chills this morning and every part of her body was cold), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore) outcome was unknown.            No concomitants or treatment medications were reported.
Pt devel a sterile abscess @ inject site p/receiving TTOX; Pt was seen in ER on 5JUN91, & was treated w/Keflex;
Patient developed Pityriasis rosea. It started on day 3 after the shot. Just a bump or two on his trunk. Over the span of a week it spread over his trunk and started to show up on his arms and legs. After three weeks the bumps are still noticeable but are drying up.
Information has been received from a physician concerning a patient who was exposed to "natural varicella" 11 days prior to vaccination and was vaccinated with one dose of varicella virus vaccine live on 07/24/2000. Subsequently, the patient "started to develop some scattered chickenpox" accompanied by a 99.8F fever. The patient was formally diagnosed with chickenpox on 08/03/2000 and placed on Zovirax. The patient has recovered.
Rapid heart rate within 5 minutes of injection. Lightheaded. Shortness of breath.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The information about allergies, acute illnesses, chronic or long standing health conditions, information about other medications (prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was initially stored in refrigerator on 03-Nov-2021 and moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were reported.
Patient received one dose of Fluad on 10/11/21 at another location and then received a second fluad at our location on 10/27/21
Sore muscles, joints, strange tingling down the arm, nausea, chills, fatigue
Activity change, appetite change, fatigue, fever, cough, SOB, chest pain and myalgia.
Loss of appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) and HEADACHE (Headache) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since December 2020.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and HEADACHE (Headache). On 10-Feb-2021, HEADACHE (Headache) had resolved. On 17-Feb-2021, DECREASED APPETITE (Loss of appetite) had resolved.            Concomitant product used was not provided by the reporter. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05-May-2021 will be submitted at the same time as the initial report. Follow-up information included patient's demographics and medical history updated. Events updated to headache and loss of appetite.
No additional adverse events reported.; Nurse stated 3rd dose of GARDASIL 9 was given 3 weeks too early in the series; This spontaneous report was received from a nurese refers to a 41 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. Concomitant therapies included lidocaine and lisdexamfetamine dimesylate(VYVANSE).   On 15-OCT-2020 (reported as "3 weeks too early in the series"), the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml  intramuscular in deltoid (strength was unknown) with lot # 1659422 and expiration date reported as 24-SEP-2022, but upon internal validation established as 04-SEP-2022 for prophylaxis. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
I would like to register an adverse reaction to the vaccines my child has received. I cannot give you a form which states 1 vaccine and it's reaction, due to my belief that my son's autism was caused be the inclusion of thermisol preservative contained in most of his vaccines, MMR and DPT, due to their load on his immune system. Here is a list of his vaccines: 1st Hep-B on 12/30/95; DTP-HIB #1 on 3/8/96; OPV/IPV #1 on 4/4/96; #2 DTP-HIB on 5/6/96; #3 DTP-HIB on 5/6/96; #2 OPV/IPV on 6/3/96; #3 DTP/HIB and #3 OPV/IPV on 7/8/96; #3 Engerix-B/2129A2/IM/RL on 9/25/96; #1 MMRII/0473D/SC/LL and #4 HIB-Titer/Praxis/M270PA/IM/RL on 3/12/97; #4 Acel-Imune/444258/IM/LA on 6/13/97; and Fluzone/Pasteur-Merieux/7F81852/IM/RL on 11/25/97. Doc 204161, 60 Day follow up states that patient has autism spectrum disorder, immune disfunction, and many others related biological disorders.
Pt had a CBC done to evaluate weight loss and possible celiac dz since December. Labs  6/18/21 WBC count was low 2.62 with ANC of  843, platelets low at 171. Referred to hematology/oncology who rechecked labs on 6/22/21 and WBC normalized to 4.63 but plts still low at 159.  normal physical exam no new symptoms.