chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administerd an expired pentacel vaccine with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old of an unknown gender patient who was administerd an expired pentacel vaccine with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jul-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ504AAA and expiration date: 29-May-2022) at a dose of 0.5ml via unknown route in unknown administration site for immunization.  On 26-Jul-2022 (latency: same day), the patient developed a non-serious events of administerd an expired pentacel vaccine with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown   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.
Pt's first dose of COVID vaccine was Pfizer on 8/9/22 and the second dose should have also been Pfizer. Instead was given Moderna on 9/20/22. No reaction or treatment required. No adverse side effects.
Hazy; Felt Weird; Sweating Profusely; Red; Sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red), INJECTION SITE PAIN (Sore), DIZZINESS (Hazy), FEELING ABNORMAL (Felt Weird) and HYPERHIDROSIS (Sweating Profusely) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red) and INJECTION SITE PAIN (Sore). On 24-Jan-2021, the patient experienced DIZZINESS (Hazy), FEELING ABNORMAL (Felt Weird) and HYPERHIDROSIS (Sweating Profusely). On 25-Jan-2021, INJECTION SITE PAIN (Sore), DIZZINESS (Hazy), FEELING ABNORMAL (Felt Weird) and HYPERHIDROSIS (Sweating Profusely) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient fainted at 1 am, experienced dizziness and slight nausea into the next day.
Warm to the touch; Injection site redness; Very tender; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Very tender) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Very tender). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Very tender) outcome was unknown.        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.   No relevant concomitant medications were reported.   No treatment information was provided.
Hot and cold flashes all night. Sweating. Probably a fever (didn't have a thermometer). Light headed. Feel like going to pass out. The headache, hot/cold lasted for around 20 hours into the next day.
3/14/04-Swelling, sore, itching at site. 3/15/04 noticed swelling and itching around lips and on face. Injection site continued to itch. Face soon became quite swollen. Saw physician, given Omnicef 600 mg. Opposite arm also has red blotching. 3/16/04 lips still somewhat swollen.
Shoulder Injury Related to Vaccine Administration Signs and Symptoms: decreased ROM, persistent left shoulder pain, Positive Neer's and Hawkins tests Treatment: Left subacromial bursa corticosteroid injection on 01/22/2021.
Congestive heart failure exacerbation; pneumonia; flu like symptoms; Coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure exacerbation) and PNEUMONIA (pneumonia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030-M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure. Concomitant products included CARVEDILOL, THIAMINE (VITAMIN B1 [THIAMINE]), AMLODIPINE, LOSARTAN, FOLIC ACID, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FUROSEMIDE and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and COUGH (Coughing). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure exacerbation) (seriousness criterion hospitalization) and PNEUMONIA (pneumonia) (seriousness criterion hospitalization). The patient was hospitalized from 09-Apr-2021 to 13-Apr-2021 due to CARDIAC FAILURE CONGESTIVE and PNEUMONIA. On 13-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and COUGH (Coughing) had resolved. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure exacerbation) and PNEUMONIA (pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Multiple inhalers.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Aches, low grade fever throughout the day; Nausea and vomiting would occur sporadically throughout the day, only after my system removed everything it could from the third time vomiting did the nausea subside;
Chills, sweats, nausea, headache, chest pain with deep inspiration, contacted 1 week after vaccination. Continued for another week, contacted clinic. Recommended ER, patient did not go. Reached out to her cardiologist who ordered labs and chest xray. CMP, CBC and Chest xray all normal on 4/12/21. Reached out after she returned from vacation and reported lingering cough. Rx'd Cheratussin and Albuterol inhaler. Patient was recommended respiratory clinic, instead she made her own appt to go to ENT.  Patient had also reported worsening GERD symptoms- upset stomach and throat clearing- referred to her GI specialist who manages her GERD/Hiatal hernia. ENT saw patient on 4/30/21- dx'd with cough, reactive airway, GERD, globus sensation. Rx'd- Advair- 2 puffs BID, Nasal saline spray, Allegra 180 mg- daily, continue Protonix and referred back to GI. Called 5/5- reported mid right back pain that woke her up on Saturday AM (4 days prior). Recommend ER due to pain awakening her and also to follow up with her GI MD.  She reports her GI ordered an Ultrasound but couldn't see her until August. Went to ER on 5/5 with dx of right sided thoracic pain. Sent home with no Rx, recommend NSAIDs, ice/heat, lidocaine patches.  Patient reached out on 5/18 to discuss US results- informed there was mild splenomegaly. Continued with cough, upset stomach, back pain. PCP received US results on 5/24.  Patient recommended to come in to see PCP for further management. Saw PCP on 6/2/21- Labs ordered today are ANA screen, BNP, CRP, CMP, COVID IgG, UA macro/mirco and culture, CMV antibody, EBV panel, D-Dimer, CBC, hepatitis panel, HIV, LDH, lipase, Quantiferon, TSH, RF and ESR. Referred to respiratory clinic- informed patient it was Pertussis- placed on Azithromycin. PCP switched RX to Levaquin. Healthline reached out to patient for elevated D-Dimer- patient refused ER. 6/9/21- CT- renal infarct, splenic infarct 6/10/21- Admitted. Bacterial endocarditis, renal and splenic infarct,  ended with open heart surgery, valve replaced,  replaced pacemaker
a patient was administered an expired dose of ROTA TEQ on 4/9/2020; This spontaneous report was received from a licensed practical nurse referring to a 6-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication was not provided.     On 09-APR-2020, the patient was administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R021065, expiration date 01-APR-2020; dose was unknown) via oral for prophylaxis (expired product administered).
Pt. received IM flu shot in (L) deltoid and PNEUMOVAX subcutaneously in (L) posterior arm lower triceps area, on 10/2/10. Presented to clinic today with large red tender erythematous macule posterior upper arm in triceps area 12x13 cm, and low grade temp reported.
2nd dose not administered yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 15th June 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter did not provide patients initials, DOB (date of birth) or vaccine lot number. The second dose of Shingrix was not administered yet. The reporter consented to follow up. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
pt recvd vax devel t103.5 ax x 3d; local react @ inject site 2 1/2 x 1 1/2; area painful, very red, swollen, tender to touch; also had elbow & waist painw/o redness or swelling; had cough, sneezing & runny nose;
COVID VACCINE VIAL WAS DILUTED WITH ONLY .8 DILUENT INSTEAD OF 1.8
pt recvd vax 22nov94 at 9:45am;mom states pt down for nap;difficult time waking up,t was 102 R & was pale & listless; apap given;mom said pt listless & t inc for rest of day;advised to see MD & cont apap;next am t 98.9 R & playing;pt better
12/03/21 presents to ED for "lower extremity edema, decreased urination and lethargy". PMHx of "HTN, HLD, DM2, CKD 4, OSA"
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 03-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
same affliction in different past of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "same affliction in different past of the body". Caller said just as caller got around a little better and his physical therapist apologized for papooing reporter in regard to complaints about the neuropathy. The therapist informed caller four other patients had the same affliction in different past of the body.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case, was initially received on 13-Oct-2017, from a consumer, concerning a 40-year-old adult female patient of 22 weeks pregnancy. The patient's historical medications included unspecified IVF (intravenous fluids). The patient had no relevant maternal or paternal medical history, congenital anomaly in previous pregnancy, defect in prenatal test, adverse pregnancy outcome, spontaneous abortion/still birth. The patient previously had 2 pregnancies and one miscarriage. It was reported that the patient was not using contraceptives at that time. The concomitant medication included prenatal vitamins. The last menstrual period (LMP) was reported as 13-May-2017. On 11-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XF30907, expiry date: 30-Jun-2018). The patient was administered with the vaccine at 22 weeks of pregnancy (explicitly coded as vaccine exposure during pregnancy). No adverse event was reported in foetus and the patient. The EDD (estimated date of delivery) was reported as 17-Feb-2018. The reporter assessed the report as non-serious. Non-significant case correction received 13-Oct-2017: Batch number (XF30907) was captured in the case form and narrative was amended accordingly.
Allergic to Polysorbate; Little pain where the shot was; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic to Polysorbate) and VACCINATION SITE PAIN (Little pain where the shot was) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Percutaneous endoscopic gastrostomy. Concurrent medical conditions included Allergy to chemicals (Allergic to polysorbate.) and Allergic reaction to drug (Allergic to Cartia XT (diltiazem).).   On 09-Mar-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic to Polysorbate) and VACCINATION SITE PAIN (Little pain where the shot was). At the time of the report, HYPERSENSITIVITY (Allergic to Polysorbate) and VACCINATION SITE PAIN (Little pain where the shot was) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Initially no issue, didn't really feel the injection.  It was painless, didn't feel it in the muscle which was pleasant, unlike injection #1.  As the day went on the site became a painful, red lump around the injection site.  I began wondering if it was injected more as a subcutaneous vs. intramuscular injection.   Today the site is swollen, warm to the touch, painful, itching and red.
Information has been received from a registered nurse (R.N.) and a physician concerning a 13-month-old female with a history of a patent foramen ovale (PFO), macrocephaly (without shunts) and mild congential valvular pulmonary stenosis who on 08/09/2004, was vaccinated subcutaneously in the left thigh with the first dose of varicella virus vaccine live (Oka/Merck) (lot #649739/0121R). Concomitant vaccinations given on the same day included: the first dose of measles virus live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #649672/0774P) given subcutaneously in the left thigh and the fourth dose of Hib conj vaccine (tet Toxoid) (ACTHIB) (lot #UE562AA) given intramuscularly in the right thigh. There was no illness at the time of vaccination. It was reported that 8 days after vaccination, on 08/17/2005, the patient developed lesions. Medical attention was sought and the patient was seen by a physician on 08/19/2005. At the time of the office visit, the patient had less than 50 lesions and she was diagnosed with breakthrough varicella. It was reported that the patient recovered as of 08/26/2005. No product quality complaint was involved. Additional information is not expected.
seizure; sick; genetic mutation; This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced seizure (serious criteria GSK medically significant), sickness and gene mutation. On an unknown date, the outcome of the seizure, sickness and gene mutation were unknown.   It was unknown if the reporter considered the seizure, sickness and gene mutation to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported by the reporter for her youngest grandson. The age at vaccination was not reported. The reporter, her daughter, her daughter's boyfriend, and her 3 grandkids live with her. The patient had 57 seizures from the Hepatitis B vaccine. He was a very sick child.  No patient information provided for the report.  No further information provided for the report. No medical information was requested. This is 1 of the 3 cases reported by the same reporter. Unable to find the link cases due to hidden reporter information.
This spontaneous report was received from a registered nurse regarding a 7 year old patient of unknown gender. Information on the concurrent conditions, medical history and drug allergies of the patient were not reported. On 16-APR-2012 the patient was vaccinated with dose 1 of GARDASIL. On 19-JUN-2012, dose 2 of GARDASIL 1 dosage was given. The reporter stated that the patient was "seven years of age" when the first dose and second dose of GARDASIL was administered (inappropriate schedule of drug administration). The third dose in the series of GARDASIL was not administered. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Company (PQC) involved. Additional information has been requested.
Anthrax #1(18Dec02) - day 2 Headache posterior throbbing, day 3 nausea, vomiting, stiff neck; day 4 cough, congestion (24Dec02) Tx in ER with Toradol, phenergan, MSo4 was dx with pneumonia and Tx with ciproflox and Darvocet, sx's resolved. Anthrax #2 (20Feb02) - day 3 (22Feb02) Bilateral temporal headache. day 4 stiff neck, day 5 nausea/vomiting - dx acute allergic reaction, Tx with phenergan and Darvocet and PO fluids.
Sixteen hours after receiving immunizations, pt developed a fever of 103.9. She had no other symptoms. She was treated with Tylenol and fever resolved.
w/in a few hr p/vax pt devel a rash on the buttocks;next day rash had gen;some areas were papular & some were macular;day p/vax also devel bilat conjunctivitis, fever of 101, hot & mildly swollen rt knee;tx w/APAP;
Facial droop on right side, unable to blink right eye; numbness on right side of lip area.
1MAY98 fever up to 101, sore throat & rash;2MAY98 seen @ immediate care & dx w/chickenpox;by 6MAY98 all pox #30 scabbed over;pt was grumpy & itching;no known exposure;
Increased Fasting Glucose Levels; Initial Report Received on 12-Dec-2019  A Nurse Practitioner called and reported that a female patient who received Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) and HEPLISAV-B had elevated fasting glucose after having received HEPLISAV-B.  No medical history or concomitant medications were reported.   On 02-Dec-2019, the patient received Ixiaro.    On 04-Dec-2019, the patient received a dose of HEPLISAV-B (Lot # 933839, expiration 28-Feb-2021).    On 11-Dec-2019, 8 days after having received HEPLISAV-B, the patient called the Nurse Practitioner and reported that her fasting glucose levels went up after the HEPLISAV-B dose.  No additional information was provided.    Company comment: The company assessed the event of increased fasting glucose levels as non-serious. The event of increased fasting glucose levels is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of increased fasting glucose levels as non-serious. The event of increased fasting glucose levels is unlisted per HEPLISAV-B USPI and IB.
Large welt around area that spread down leg and to inside of thigh. One red sore in back of throat , saying tongue hurts.
Initial report received on 26 SEPTEMBER 2013 from a health care professional. Five patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot # UH898AC and expiration date 30-JUN-2013) intramuscular (site of vaccination was not reported) within the last month.  It was reported that within the last month those five patients have experienced rash, swelling and pain at injection sites.  Patients were given previous does of influenza USP trival a-b subvirion vaccine. As of 25 SEPTEMBER 2013: The outcome of the events was unknown. List of documents held by sender: None.