chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
Information has been received from a physician concerning a 23 year old female patient, allergic to neomycin, who on 18-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot number 663452/0671Y). Concomitant therapy included DESOGEN. On 20-AUG-2009, the patient complained of swollen glands and difficulty swallowing. The patient sought unspecified medical attention. Additional information has been requested.
pt states that she developed headache, chills, and could not move.  She stayed in bed in 48 hours.  Headache and chills subsided in 24 hours and fatigue that for 48 hours.  She says had the coronavirus in Sept 2020.  She says she still has fatigue that comes and goes since getting the vax.  Pt will contact PCP regarding getting the 2nd dose.
52 -yo Female came Center vacc.site July 05, 2021.Received Janssen vac. at 10:35am in L arm. Directed to observation area. 10:39 am she reported some discomfort in her chest area, anxiety, some flushing in her face and diaphoretic. 10:40am V/S HR 76,BP135/70, RR26,02Sat % 99%RA.11:03am - Attendee stated she felt better, feeling maybe due to anxiety. She remained sitting. No liquids. No longer diaphoretic, or pale. Attendee's skin warm/dry. Attendee's respirations were not tachypneic/dyspneic. V/S HR64,B/P126/66, RR22, 02Sat%100%.11:09am HR54BP120/58RR17,02Sa100%RA.Went to restroom w/Admin. laughing/talking.11:15am. Educ. given on home discharge/adv reaction. Left clinic independently.
64 YO received Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 64-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA859A, expiry date 31st January 2024) for prophylaxis.   On 2nd February 2023, the patient received Menveo. On 2nd February 2023, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The pharmacist called to inquired that any complications to look for. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Menveo at inappropriate age, which led to inappropriate age at vaccine administration.
a 13 years old patient received FLUBLOK QIV vaccine/ No AE; Initial information received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a physician via consumers via regulatory authority number: 00793359.  This case involves a 13 year old male patient who received a dose of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and Human papillomavirus (HPV) VACCINE for prophylactic vaccinations.  On 30-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (pre-filled syringe, lot number: UJ725AA, expiry date: 30-Jun-2022, frequency: once, strength: standard) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Office Manager stated FLUBLOK was given to a child and wanted to know what needed to be done. States the child received the product yesterday and they notified the mom who did not report any issues."  Product used: Used and First time product used: Yes.   Adverse event (AE) symptoms or no AE.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
First vaccine given on 5/22/2021  no adverse reaction at that time.   Second Vaccine given on 6/12/2021 no adverse reaction at the time of injection.  On 7/20/2021 came home from work around 10:30 PM when wife noticed the drooping in face like a stroke.   Was taken to Hospital emergency room by private vehicle.  Bloodwork and CT scan was preformed.  Diagnosed with Krames Bell's Palsy  Prescribed Acyclovir and Prednisone.  Released from emergency room
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 at 13:30 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 31May2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Mar2021 at 13:00 as dose 1, single (Lot number: 001B21A), in left arm and on 08Apr2021 at 13:00 as dose 2, single (Lot number: 016B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: Jan2020; ALLEGRA, start date: Jan1994; XYZAL, start date: Jan2012; NASACORT AQ, start date: Jan1998. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "recovered" (Jun2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive; (07Jun2022) Negative; (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid, treatment start date-01Jun2022 and treatment stop date-05Jun2022. Rebound/recurrence of COVID symptoms with concurrent positive COVID test on 10Jun. He tested positive for COVID with symptom onset on 01Jun. He started taking Paxlovid on 01Jun. Symptoms disappeared by 06Jun. He tested negative for COVID on 07Jun. Mild symptoms returned on 10Jun, and he tested positive again on 10Jun.
Case number PHEH2016US028432, is an initial spontaneous report received from a pharmacist on 27 Oct 2016. This report refers to a 64 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618621) at a dose of 0.5 ml intramuscularly on 27 Oct 2016. It was reported that, the patient received more than once FLUVIRIN in the season (year) on separate occasions, by mistake. No adverse event was reported following this administration error.
has not stopped bleeding or passing clots; anemic; weak; depressed; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A registered nurse patient received bnt162b2 (COMIRNATY), administration date 09Sep2021 (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 patient reported that since the vaccination has not stopped bleeding or passing clots. She had 2 surgeries and has been prescribed different medications to stop the bleeding. However, nothing has worked and she was still bleeding. As a result of this, the patient was anemic, weak and depressed. The reason is bringing this to the attention is because no one knows what's in the vaccine that triggered the body to start bleed. The outcome of the events was not recovered.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
An initial report was received from a nurse on 01.Mar.2012 and concerns a female patient of unspecified age who, on an unspecified date, received oral typhoid (batch no: not reported). The patient's medical history and any concomitant medications were not reported. On an unspecified date, at an unspecified time following the oral typhoid administration, the patient experienced hives on her arms. No further information was available. At the time of reporting the outcome was unknown. The event was considered non-serious.
Appendicitis symptoms started on 12/3/2021.  We went to the ER on Saturday, Dec. 4th.  It was confirmed that I had appendicitis and the next morning, Dec. 5th I had surgery to remove my appendix.
12/26/2022, he had croup and cough in the early morning. We took him to urgent care that morning and they did a nasal swab. They prescribed a steroid to help with breathing and his condition worsened throughout the day. Our doctor recommended we go back to urgent care that evening. They did two breathing treatments. When the strider returned they sent us by ambulance to the emergency room, where we had another breathing treatment. He was admitted and discharged on December 28. We went back on December 29 and he was discharged on December 31. We continued steroids at home.
This spontaneous report as received from Certified Medical Assistant refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 16-SEP-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J006921 expiry date 09-AUG-2014 (dose and route not reported). Concomitant medication was not reported. No known adverse effects. Additional information has been requested.
Severe muscle and joint pain, headache, extreme chills.  Started around 12 hours post-vax and continued for nearly 24 hours.  Naproxen helped after dose #2 but not after the booster.
Initial report received from a consumer (patient) on 01 Oct 2010: This with medical history of severe allergy to some antibiotics especially penicillin, was vaccinated with INFLUENZA (manufacturer unknown, and batch number unknown) on 24 Sep 2010. The patient was vaccinated with no warning that the vaccine was grown in an antibiotic medium. On 24 Sep 2010, the patient experienced a rash, intense itching, swelling, extreme fatigue and slight asthma (within 24 hours), necessitating intervention treatment including hydrocortisone. The patient was not fully recovered.
FLUAD was given first followed by PNEUMOVAX given one inch below per protocol. Patient experienced swelling and pain due to what was later determined by Dr. as a calcified thrombus formed because injection passed through the Cephalic vein. Patient went to Urgent Care twice where she was misdiagnosed both times. Later Dr.,  her primary care physician discovered the thrombus. He had her treat with heat, employed medicine for the pain and referred her to physical therapy stating it was only way to resolve the issue.
A non-serious spontaneous report of stridor and laryngeal tracheal bronchitis has been received from a nurse concerning a 24-month-old male, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age. The patient's past medical history included an upper respiratory tract infection the week prior to FLUMIST administration. At the time of the vaccination, the patient had a "croupy cough". On 01-Oct-2009, the patient received FLUMIST and Hepatitis A vaccination. On 01-Oct-2009, the patient developed stridor and laryngeal tracheal bronchitis. The outcome for stridor and laryngeal bronchitis was not reported. The reported indicated the events of stridor and laryngeal tracheal bronchitis were secondary to FLUMIST.  Vaccine number 1 is not a MedImmune vaccine.  Information not available. 22-Feb-2010.
rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number T9KE4, expiry date 25th September 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix (intramuscular) and PREVNAR. On 6th July 2019, 12 days after receiving Shingrix, the patient experienced rash. The patient was treated with triamcinolone, hydroxyzine hydrochloride (Hydroxyzine) and methylprednisolone sodium succinate (Solu Medrol). On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and prevnar was administered in the right arm. The patient received Shingrix and Prevnar concomitantly and developed a rash on both arms, back and trunk.  The patient had the rash about two weeks before he went to the emergency room on 20th July 2019.  He was prescribed hydroxyzine, triamcinolone, and solu medrol. The rash was getting better but still not resolved.  The reporter consented to follow up.
Staff member received TD by Intrathecally injection to LFA rather than PPD. Staff member developed moderate induration only x 1 week.
COVID-19 I tested positive for Covid on July 31. I was tired, & weak, on the 3rd day I had a really bad headache, on the 4th day I was nauseated with diarrhea. I was prescribed PAXLOVID for my symptoms. I was prescribed prednisone for breathing and I was also prescribed antibiotics for chest phlegm.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L044694, expiration date: 04-FEB-2018, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 49 degrees Fahrenheit for 6.5 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
15 mins after vaccination I began to have a scratchy throat, which gradually got worse and became thick mucus in throat, wheezing, sinus inflammation, fatigue, racing heartbeat. Symptoms became under control after 50mg of Benadryl. Thick mucus lingered until the next day. Increased heart rate leveled off after Benadryl took affect. Fully recovered by the following day.
Loss of appetite; Diarrhea; Headache; Chills; Initial information regarding an unsolicited valid serious case was received from a Consumer/non-hcp (healthcare professional) via Medical Information (MI) (Reference number- 00349229) and transmitted to Sanofi on 06-Nov-2020.  This case involves a 65 years old female patient who experienced loss of appetite (decreased appetite), diarrhea (diarrhoea), headache (headache) and chills (chills), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatments, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported) via unknown route in the left arm for prophylactic vaccination.  The patient did not get any other vaccines that day.  On an unknown date, the patient developed a non-serious headache and chills, three weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed a non-serious loss of appetite (decreased appetite), diarrhea (diarrhoea), a couple of days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: On an unknown date SARS-CoV-2 test was negative.  It was not reported if the patient received any corrective treatment or not.  The patient was recovering from the events at the time of reporting.  There will be no information on the batch number for this case.
I received my 2nd vaccine and My period came 5 days early and I am bleeding heavy and clotting quarter size clots. Started about 8:30pm on 5/13/2021.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.   No treatments medications was reported.  Patient name Bascom Branbdon, phone number 8018304343, Rx Number 804147.
Mild dizziness & muscle spasm in first 10 minutes of injections. On 4/24, muscle spasm returned & found rash on right arm. I began having joint/muscle pain mainly in knees and in my hands. On 5/3, I struggled with dizziness and nausea as well as the joint/muscle pain so I decided to go to urgent care. They ran some tests and I scheduled a follow up with my doctors office.
Pt received the vaccine on the 7th of May. 1 week later she noticed a red, mildly raised rash at the injection site. Pt denied any pain itching or burning at the site. Pt denies any prior similar reactions to vaccines. She has not had the rash for 4 days with mild improvement. No other associated symptoms to include difficulty of breathing, SOB or diffuse rash other than injection site were noted by the Pt.
The day after the vaccine, patient had nausea and diarrhea, fatigue, muscle pain and weakness.  I checked the CDC site to see if these were common side effects, and it said that they were and they would clear up in a day or two.  Two days later, patient felt stronger, but he had a couple of red patches of skin on his chest.  He did not want to go to a doctor, so we waited for them to clear up.  It took a few days, but they went away.
right after getting the injection I developed hives on arms, legs , back, neck, my tongue turned bright red and lips swelled. My throat was raw and very irritated also tight, extreme hot flashing felt like I was on fire. All of this occurred with in the first 5-15 minutes after the shot. The hives were immediate. I had taken 25 mg benadryl  1 hour before the shot because I always have a slight dizziness when I take the flu shot, but NEVER like this, I made sure the shot did not contain eggs because I have an intolerance to eggs.  After developing the hives and the other symptoms occurring especially tongue and mouth I took another 25 mg benedryl,. I reported to Occupational Health where I was monitored and needed more help, can't take pepcid (allergic), Dr. ordered a Jr. does of Epinephrine which with drinking a large amount of water my tongue started to reduce and become less red. I was released from the clinic and went home took another 25 gm benedryl and later that night before bed I took and additional 25mg benedryl was extremely itchy the entire afternoon and evening.  the next day about 28hr after the vaccination I had more itching and took benedryl. I have had headaches since the injection and hives at various times since the injeciton like today, Unsure of what has triggered them.
No adverse reactions. Pt was given Pfizer 5-11 when pt should have received Pfizer for 12+
2 days after my second Pfizer vaccine I experienced lung pain when breathing, pleurisy, fever, dypsnea, shortness of breath, extreme fatigue.
Fever in the 100.5-101.5 range.  Headache, chills. sweats.
Patient presented to the ED and was subsequently hospitalized for sepsis within 6 weeks of receiving COVID vaccination.
My daughter got the flu shot. She is a type 1 diabetic the nurse gave her the shot in the fat  and not the muscle she swelled up right after. she has a welt the size of a apple red hard and very painful. It is sat the clinic is closed but i may bring her in to ergent care.
Vaccine was mislabeled with the frozen expiration provided on Moderna's website which was 11/01/2021 rather than the refrigerated expiration date of October 3, 2021. Unknown at time of administration, employee received expired vaccine
This spontaneous report as received from a physician refers to an immunocompetent patient of unknown age or gender who developed zoster like rash 24 hours after received a dose of ZOSTAVAX. The rash developed along the dermatome down the arm. Patient route of administration and lot no information were not provided. The outcome of zoster like rash is unknown. Additional information has been requested.
Several dizzy spells started 24 hours after the booster. Mostly while lying down and changing sides or standing up. Possible acute vertigo.
Nausea since 4/10 fever on 4/10  chills since 4/10  headache on 4/11 and 4/12  Arm pain since injection   I have taken Tylenol a few times for the pain and headache. Nothing for the nausea.