chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I try to push through it I feel like I'm going pass out and weak; When I try to push through it I feel like I'm going pass out and weak; I have been feeling off; I slept the whole time. I will sleep 18 hours at a time.; My fatigue is out of control.; Every week 2-3 days a week I'll have various colored vaginal spotting; This is a spontaneous report from a contactable consumer. A 32-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EN6204) dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:00 (at the age of 32-years) as dose 2, single dose for covid-19 immunisation. The patient medical history included HIV, bipolar, anxiety, PCOS, fibromyalgia, liver disease, asthma, obesity, periodic limb movement disorder, hepatic adenomas, fatty liver disease on an unspecified date. The patient past drug therapy included BNT162B2 (Dose: 1, Lot no: EM9809, Time: 02:15 PM, Vaccine location: Left arm) for COVID-19 immunization on 08Mar2021. The patient had allergies with penicillin, cefuroxime adhesive tapes. The patient's concomitant medications included duloxetine, topiramate, lithium, lamotrigine, bikta for unknown indication on an unknown date. The patient had tested covid post vaccination. The patient has been feeling off and feeling like I did before I was put on medicine for HIV since I received my second shot. I was put down for 4 days after the 2nd vax shot, I slept the whole time. I will sleep 18 hours at a time. My fatigue is out of control. When I try to push through it, I feel like I am going pass out and weak. I have also had continuous spotting since May. Every week 2-3 days a week I will have various colored vaginal spotting on 29Mar2021 07:00 PM. The patient underwent lab tests and procedures which included nasal Swab (SARS-CoV-2 test) was negative on 02Aug2021. The outcome of the events was not recovered.
nurse mentioned that quadracel was meant to be given to the patient but nurse ended up getting and giving the menquadfi with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves a 4 years old male patient and nurse reported that diphtheria-15/tetanus/5 Hybrid Ac Pertussis/IPV (Mrc5) Vaccine [Quadracel] was meant to be given to the patient but ended up getting and giving the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad); Hepatitis B Vaccine Rhbsag (Yeast) (Recombivax) And Hepatitis A Vaccine Inact (Vaqta) for Prophylactic vaccination.  On 25-Oct-2023, the patient received a unknown (dose 1) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength: standard, frequency: once, lot U7903AC, expiry date: 31-Dec-2025) instead of diphtheria-15/tetanus/5 Hybrid Ac Pertussis/IPV (Mrc5) Vaccine Suspension for injection (strength, lot number, expiry date: unknown)via intramuscular route in the left deltoid as Immunization (wrong product administered) (latency: same day). Information on the batch number was requested.   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.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 02-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (lot # N013992 with an expiration date in 27-JAN-2019), for prophylaxis, (dose and frequency were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003769.
Extreme redness and rash starting in the groin area and spreading over entire body. After the doctor visit and taking Doxycycline 100 mg for 10 days the redness and rash cleared up. My hands were swollen and later the skin pealed from both hands.
Patient had a red, itchy, large spot at injection site. Redness started going down, but it's still itchy. Also developed a rash on torso. Doctor not sure, maybe shingles-> gave Acyclovir and topical steroid. Taking ibuprofen for pain.
Inflamed red circle (approximately 2 inch) at injection site. No pain at injection site (only sore to touch). Patient will take BENADRYL by mouth.
Information has been received from a Registered Nurse referring to ten patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. On 10-MAR-2016 doses of VARIVAX (Merck) (lot# L043619, expiration date 02-NOV-2017) were improperly stored to -2.2C for 8.25 hours. Then on unspecified dates since 10-MAR-2016 the patients each received a dose of the improperly stored VARIVAX (Merck) (dose and route unknown) (incorrect product storage). There were no known adverse effects. Additional information has been requested.
swelling in legs, SOB, loss of 20 lbs; seen in ER received 1 L of fluids. labs showed AKI and anemia.referred for inpt for further management.  DX with COVID 19 w/out hypoxia.
Muscle/joint pain and chills lasting for about 10 hours beginning about 9 hours after injection.  Redness at injection site - about 6 inch circle.
itching; redness; welts; raised around the injection side; Pain around injection site; arm feels warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness), INJECTION SITE MASS (welts), INJECTION SITE SWELLING (raised around the injection side) and INJECTION SITE PAIN (Pain around injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain around injection site) and INJECTION SITE WARMTH (arm feels warm). On 21-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness), INJECTION SITE MASS (welts) and INJECTION SITE SWELLING (raised around the injection side). At the time of the report, INJECTION SITE PRURITUS (itching), INJECTION SITE ERYTHEMA (redness), INJECTION SITE MASS (welts), INJECTION SITE SWELLING (raised around the injection side), INJECTION SITE PAIN (Pain around injection site) and INJECTION SITE WARMTH (arm feels warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient experienced fever, chills, vomiting and watery diarrhea throughout the night. Patient continued to experience diarrhea through next day.
Discharge Provider:  MD Primary Care Provider: DO Admission Date: 12/8/2022 Discharge Date: 12/13/2022 COVID positive Date 12/8/2022 PRESENTING PROBLEM: Suicidal ideation [R45.851] COVID-19 [U07.1]   HOSPITAL COURSE: Pt is a 68 y.o. female with a past medical history of schizoaffective disorder, depression, anxiety, PTSD, hypertension, hyperlipidemia, type 2 diabetes mellitus who presented on 12/13 with acute complain of suicidal ideation. Pt was admitted for suicidal ideation for a plan to ingest her medications at home with the intention to overdose.  Pt was evaluated and called a high suicide risk with need to transfer to a psychiatric hospital.  Pt was put with a 1:1 sitter for the entirety of her stay.  Labs on admission were unremarkable save for a positive COVID-19 PCR and a CXR remarkable for LLL bronchial thickening consistent with possible pneumonia.  Pt had some symptoms of COVID infection that started 2 weeks prior, however they were minor and pt did not need Oxygen, so there was no indication for steroid or remdesivir treatment.  Pt was noted to have some symptoms of possible tardive dyskinesia on admission, however Seroquel was continued as pt has acute disease state with SI.  Pt's stay at hospital was largely unremarkable, save for occasional MSK pain amenable to tylenol and lidocaine, and some treatments with Duo-nebs due to underlying asthma with her COVID infection.  Patient remained stable until 12/13/2022 when she was accepted for further psychiatric care at facility.  She was transferred in stable medical condition for further psychiatric care.
No additional AEs; PEDVAX HIB was diluted with Merck Sterile Diluent and administered to a 4 month old; This spontaneous report was received from an medical assistant and refers to a 4-month-old male patient. The patient had none pre-existing physician-diagnosed allergies, birth defects, medical conditions. The patient had none illness at time of vaccination. Concomitant vaccinations administered on the same day included diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and rotavirus vaccine live oral 1v (ROTARIX).  On 18-APR-2023, the patient was vaccinated with second dose haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in right vastus lateralis, for prophylaxis (exact dose was not provided), with 0.5 ml sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, lot #W014210, expiration date: 27-NOV-2024, administered intramuscularly, added to the vaccine (Product preparation error). The vaccine did not required dilution. The vaccine provider did not realize that was incorrect until after administration. The vaccine provider promptly reported error to physician and supervisor for further instructions. The physician notified parent. The vaccine was administered at public health clinic. No additional adverse events (AEs) was reported. There was no temperature excursion.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 16-MAR-2016, the patient was vaccinated an improperly stored dose of ROTATEQ (Lot number L027070, expiration date 30-APR-2016), dose, route and anatomical location were not provided and the patient was also vaccinated with an improperly dose of PEDVAXHIB), dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses of ROTATEQ and PEDVAXHIB were improperly stored in a temperature of -1.4 degrees C, the time frame was 1 hour. There was no previous temperature excursion reported. The vaccines involved included ROTATEQ Lot # L027070 (exp 30-APR-2017) and Lot # M002252 (exp 28-FEB-2017), and PEDVAXHIB Lot # L033690 (exp 28-FEB-2017). No adverse effects were reported, no product quality complaint was involved. This is one of several case received from the same reporter. Additional information has been requested.
2nd dose in the series was given at 15 days instead of recommended 21 days.  Patient had no adverse events or issues to report.
Moderna COVID-19 Vaccine EUA The child came with his mother to get vaccination. There is no adverse event reported.  Moderna vaccine was administered to him when he does not fall within the age group for EUA. It completely escaped my attention and I had a recollection yesterday evening when I left the pharmacy. The parent telephone number provided was called but no one picked however a voicemail message was left for her to call the pharmacy at her earliest convenience.
Patient describes flushing and face, neck and upper chest, dizziness and lightheadedness that started 45 minutes after the vaccine was administered.  She had already left the clinic at this time.  She did not take any medications or seek any medical attention.  The symptoms resolved 45 minutes after they started.  She subsequently consulted with her primary care provider, who advised her not to get her second vaccine dose and referred her to an allergist for further evaluation and advice.
receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Redness, swelling, itchiness at injection 1 week after getting the shot - got worse the next day - two large red hives at injection site and smaller hives around it
Patient with JJ COVID vaccine 03/26/21 who admitted with complications of COVID.  Provider discharge note below:  "Patient is a 62-year-old female with a past medical history of chronic hepatitis-C, hypertension who presents initially with fall and left femur fracture.  Once discharged to SNF returned with acute hypoxic respiratory failure secondary to COVID and pulmonary embolism.  Also developed C difficile and completed course of vancomycin.  Had episode of encephalopathy which resolved without intervention and had negative MRI."
ADMINISTERED HIBERIX BOOSTER DOSE TO CHILD 1 YEAR OLD NOT 15 MONTHS OLD.
Rash of body, scattered, lesion on lip, back and torso, vesicular lesion on lip. No Tx.
Pain in joints and especially elbow. Red and hot at site of vaccine. Hoarse voice - could barely speak for 1-2 days.
Case number PHHY2014US092090 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517845) website on 24 Jul 2014. This report refers to an adult female patient. Her medical history included sore arm in 1993 and 1994 post vaccination with FLUVIRIN (see cases: PHHY2014US092088 and PHHY2014US092089 respectively). She was vaccinated with FLUVIRIN (batch number: unknown) in 1995. Post vaccination she experienced sore arm. Seriousness, outcome and causality of the event were not reported.
Patient falsified DOB when registering for vaccination, stating the minor was 12/01/2005. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 12/01/2005 which made the vaccine a contraindication.  No known adverse reactions noted.
After the vaccine I was really fatigued and had a sore arm.  My BP elevated and got a really bad ocular migrane which caused vision changes.  I reached out to my PCP who had me admitted to medical center for  2 days d/t elevated protein in my urine, the bad migrane and elevated BP.  All labs were negative for preeclampsia.  EDD-8/1/2021
56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX, 10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions of 48 hours each. For one excursion the lowest recorded temperature was 34 F (1.111111111 Celsius) and for the other excursion the lowest recorded temperature was 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Woke up in middle of night with left shoulder feeling of internal burning sensation and extreme pain and discomfort. This has been felt since day 1 after the vaccination, but it finally reached a point to where it was extremely painful, instead of gradually subsiding.
Hot flush starting from feet.  Tingling and numbness in feet. Little tingling in fingers.  Blood pressure rose to 170-190 over 110 and would not go down.  Doctor advised I go to the E.R. for assessment, which I did. Blood pressure remained elevated for days . Noted the systolic was higher , mostly in the 80's.  I do not have hypertension BP this morning  in the 120's over 70.  Needed Alprazolam to calm my anxiety since.  Not every day. Very concerned about having the second dose. Doctor has advised me to only drink water the day of shot, take a tranquilizer an hour before and has given me BP med to take if my BP goes over 150.
Pt had drooping of right side of the face. Went to the emergency department with concerns of stroke. Ended up with diagnosis of Bells Palsy.  Hospital treating with prednisone and antiviral (name unknown by wife).
I just started having a bad headache & it continued for hours & then it was everyday for about 2 or 3 hrs. at a time so I went to the dr. and he put me on migraine medication & I'm still having them then I got covid in Dec 2021 & the headaches have gotten worse.
I had the vaccine on 4/5 and on 4/8 I experienced sudden sensorineural hearing loss, unilaterally left ear... I am now profoundly deaf in my left ear. Suffering tinnitus and vertigo.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX. On 10th October 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 10th October 2018, the patient was diagnosed with Shingles.
inadvertent adm.inistration of PROQUAD and Varivax on the same day; This spontaneous report was received from a nurse and refers to a 16-month-old patient of an unknown gender. On 11-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# reported as T021644 has been verified to be valid lot number, expiration date 21-DEC-2021, albumin status :rHA (formulation, strength, exact dose, frequency and route of administration were not reported) for prophylaxis and with varicella virus vaccine live (oka/merck) (VARIVAX) lot# T012552, expiration date: 10-APR-2022 (formulation, strength, exact dose, frequency and route of administration were not reported) for prophylaxis. On 11-NOV-2020, the patient experienced inappropriate schedule of product administration. The outcome of inappropriate schedule of product administration was unknown. Causality assessment was not provided.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 08-SEP-2016 the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (route and dosage unknown; lot number reported as M001200 EXP 28-AUG-2016). Additional information has been requested.
Significant muscle/body ache and soreness, headache, ear ache, fever, lethargic. Two days after vaccine and symptoms are lessening but have not entirely gone away.
Extreme pain at site of injection radiating to neck and shoulders. Loss of ROM and loss of strength. My dominate hand.
I started having Covid-19 symptoms headache, fatigue, sinus congestion in the nose, and a low fever on 08/15/2021 and on the third day, 08/18/2021 I went to urgent care to test for Covid-19. My test results came back positive. I did not receive any medicine from the urgent care. I was told to stay in bed and stay hydrated. The fever lasted 4 days from 08/15/2021. Two weeks after I lost taste and smell for two days. I don't remember the doctors/nurses name from the urgent care.
Pfizer/mcg/.03/mg  age 5 to 12 years given in error.  Pfizer contacted instructed nurse to give full dose 30mcg/.3  for proper immunity.  No adverse reaction occurred . Pfizer Covid lot# HG7557  given in Rt Deltoid.  Pt was observed for 30 minutes after second administration.   Dr medical officer was contacted about the error, no new instruction give at this time.