chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an expired dose of PENTACEL was administered today, to a 5 month-old boy,with no reported adverse event; Initial information received on 27-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 months old male patient for whom  an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered today.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Dec-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (lot number: UJ622AAA, expiry date: 07-Dec-2022) via intramuscular route in unknown administration site for immunization, which is an expired dose of pentacel administered with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was 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 guidelines. 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.
Received Heplisav-B and Developed COVID; Initial Report Received on 18-OCT-2022  This is a spontaneous report, received from a patient, who received HEPLISAV-B for hepatitis B immunization.  Medical history was reported as unknown.   Concomitant medications were not reported.  On 02-SEP-2022, dose 1 of HEPLISAV-B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunization.  The patient subsequently developed COVID after a trip on 11-OCT-2022.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fever started 12 hours after 2nd dose and stopped 24 hours later. Then approximately 45.5 hours after 2nd dose I started to have a hot flash and fainted and was sent to the ER with a concussion. Treatment required rest and ice.
Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain; Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain; Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain/I can hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Previous immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset 07Apr2022, outcome "unknown" and all described as "Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain"; GAIT DISTURBANCE (non-serious) with onset 07Apr2022, outcome "unknown", described as "Upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain/I can hardly walk".  Additional Information: Consumer stated, "I had my second booster yesterday and I woke this morning and the upper part of my leg is so sore and weak that I can hard, I am using a cane to walk with as I can barely walk, it's in acute pain."  Comment: Reporter type could not be probed as the consumer was unwilling to share any further information, hence captured by default as consumer or other non-health professional in tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 4 (booster), single (Lot number: GH9697) at the age of 27 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 31Mar2021 as dose 2, single (Lot number: ER8732), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 3303080), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "generalized anxiety" (unspecified if ongoing); "acne" (unspecified if ongoing); "eczema" (unspecified if ongoing); "benign breast tumors" (unspecified if ongoing); "ankle arthroscopy surgery" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL, start date: 15Feb2023, stop date: 17Feb2023; SERTRALINE, start date: 02Feb2023, stop date: 21Feb2023; MINOCYCLINE, start date: 02Feb2023, stop date: 21Feb2023; CETIRIZINE, start date: 02Feb2023, stop date: 21Feb2023; ACETAMINOPHEN, start date: 13Feb2023, stop date: 13Feb2023. Past drug history included: Known allergies chorhexidine, reaction(s): "Known allergies chorhexidine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Dayquil (brand: Kroger CO), Sertaline (brand: Aurobindo pharma), Minocyline 100mg (Sun pharmaceuticals), cetirizine (brand: Kroger Co), Acetaminophen 500mg (brand: Kroger CO). The patient received Paxlovid from 16Feb2023 to 20Feb2023 for treatment of COVID-19.
Phlebitis, Fever, I had the second COVID vaccine on Wed, Sept 15th and as with the first injection the arm was super sore but was additionally very, very edematous for 3 days, with heat and erythema down the arm all the way to about 2 inches above the elbow. There was a  Narrative:
Rash over entire body, severe itching. Raised red bumps, first symptoms started 2 hrs after receiving the vaccination.
Seizure episode. Eyes rolling in back of head. Body fell backwards on to table. Not responding for approx. 2minutes. Pale face & pale body.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO (batch number 15C801, expiry date unknown). On 20th March 2018, the patient received the 2nd dose of BEXSERO. On 20th March 2018, less than a day after receiving BEXSERO, the patient experienced injection site erythema. The patient was treated with BENADRYL and Cold Compresses. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be almost certainly related to BEXSERO. Additional details were provided as follows: The health care professional reported that patient was experiencing erythema on the right arm that was below the site of injection after 2nd dose of BEXSERO. On 23rd March 2018, the patient came to the physician and was still experiencing the same symptom at that time. The physician gave the patient BENADRYL and cold compresses as of 23rd March, 2018. The patient required emergency room visit. No additional information was provided.
SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced sore arm. On JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and sore arm was not reported. This report was non-serious.
Erythema, induration, edema of skin involving 2 x 12 cm distoly of administration site. Erythema extended at medial aspect of forearm and preps right hand. Few hives at abdomen.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Day 1- headache Day 4-swelling, rash and itching at injection site.  Initial size when noticed about 3 inches in diameter. Day 5-14- rash and itching spread down arm. Final size 4 x 7-8 inches oval.
12/16/22 presents to ED for "extremity weakness" "cough/congestion". PMHx of "DM, HTN, CAD s/p stents"
She started feeling aches in her body the next day (2/26/2021). The aches started getting worse and eventually moved to her arms, legs and neck. She started to feel a burning sensation in those same aching areas. She waiting until her yearly physical (10/1/2021)  to mention it to her Dr.
After baby received Dtap/IPV/Hep B, Hib, PCV and Rotavirus vaccines yesterday AM (5/15/07) in the afternoon baby started to swell up in her thighs, shoulders and then generalized "looking like a marshmallow".
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacy intern (other health professional). This case involves a 43 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 10-Sep-2018, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AB in the left deltoid. It waa a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown whether adverse event occurred or not. 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.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-FEB-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. She was prescribed VALTREX and prednisone for management for her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Itching on both arms and lower back/buttocks, hives and rash. Rash then extended over entire body (except for below the knees and only mildly on face). Extreme itchiness, hot to the touch, red,  raised.
heaviness; lethargy; Soreness in arm; soreness in hips; This is a spontaneous report from contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 19:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and was allergic to penicillin. The concomitant medications included MULTIVITAMIN, VITAMIN C, OSTEO BI FLEX, calcium (MANUFACTURER UNKNOWN), VITAMIN E for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 06:00, the patient experienced soreness in arm, heaviness in arm, lethargy, soreness in hips. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of soreness in arm, heaviness in arm, lethargy, soreness in hips was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Severe nausea, vomited, extreme fatigue, dizziness/lightheaded disoriented. Yesterday and today. Stomach pains moderate
NO adverse event.  pt would like to have 1st dose of shingle. I gave Varivax.
productive cough, fever 101 yesterday, chills, body aches, nasal congestion. starting 11/4/21
fever, soreness at injection site, body aches and chills.  These began approximately 6:30pm night of injection, continued into the next day.  Taking advil every 4 hours and this has helped to stop the fever but the rest of the symptoms continue
Patient developed soreness and redness at the site of the injection on 4/20/15. The area did improve the next day, but then patient developed hives on 4/22/15 and patient denied any additional symptoms. He was advised to take BENADRYL, advised to monitor for side effects from the BENADRYL, and to continue to monitor for additional allergic reaction side effects. He will continue to monitor his symptoms and follow up with our office as needed. Provider was notified and agreed to the plan of action as well.
numbness & tingling rt arm & hand & down leg & face-tightness tingling intermittant x 2 wks;mostly rt side-1 day in lt hand
Hep A vaccine given IM L deltoid. Red flushing occurred across back and L ear and chest. No hives - No SOB. No coughing. No swelling. No wheezing BENADRYL no liquid given per M.D. order. M.D. office advised child be taken to ER. Child taken to ER and observed by physician. No further treatment required and all S/S resolved within 30 minutes.
numbness and tingling in both hands, pain in muscle at injection site, worse at night, unable to sleep
Information has been received from a nurse practitioner concerning a 47 year old female with an allergy to sulfa drugs and quinolones who on 20-JAN-2011 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot number 664864/1365Y, expiration date 24-MAR-2011). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown), CYMBALTA and VERAMYST. On 21-JAN-2011 the patient experienced left arm redness, soreness at the injection site. Additionally patient experienced chills, body aches, fatigue and a "fever". The patient sought unspecified medical attention and was taking KEFLEX for treatment. At time of report, the patient was recovering. Follow-up information has been received from the nurse practitioner reporting that the 41 year old (previously reported as 47 years old by the same nurse) patient with asthma and no illness at the time of vaccination was vaccinated the first dose of PNEUMOVAX 23 at left upper arm. On 20-JAN-2011 PM (previously reported as "21-JAN-2011"), the patient began to experience pain at injection site, had a fever, chills, body ache for 2 days. Soreness at site recovered. All symptoms recovered on 22-JAN-2011. There were no diagnostics tests and laboratory data. No further information is available.
pt had vax 1JUN93 on 14JUN93 mom brought pt in w/reaction to shot as stated red bump appeared on lt thigh 5 dasy p/shot; took to pvt MD on that day; pt had 15mm area on lth thigh 2 below hip;
Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positive COVID 12/18/2020)  ICU 1/14/2021-1/16/2021, currently hospitalized PCU level of care
Numbness in the upper left site (face, neck and arm) Anaphilaxis Nausea, dizziness, chills asthma exacerbation, headache
27 y/o male called c/o sore arm after MMR vaccine states arm sore all over and hard to move MMR given IM instead of Subque. Initial call 1-17-14 recheck on Tuesday 1-21 states much better 3rd MMR in 1 yr due to losing record (he did not tell RN that at IZ visit).
swollen lymph nodes under the left armpit and into the left breast area, radiating pain and discomfort that has persisted since onset, some numbness in the left arm.
mom reported day p/vax pt cried for 5hr p/vax;pt was afeb APAP was given q 4 hr;
Patient was having trouble sleeping and pain in the her abdomen pain and also severe pain in the vagina. She has had many appointments but still not determined what is the issue
Sore arm day one Day two upper back infamation with knot  Muscle tireness
Felt tightening of the chest; Couldn't breathe; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 01Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Sep2021, the patient felt tightening of the chest and could not breathe. The clinical outcome of the events felt tightening of the chest and could not breathe was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ABDOMINAL PAIN BIHEMESPHERE STROKE TREATMENT LVAD OUTCOME PARALYZED
Information has been received from a 41 year old female patient with an allergy to "cloricidin" and a history of bleeding during pregnancy who on 2-MAR-2009 was accidentally vaccinated with a first dose of GARDASIL (lot number and route not reported) in the arm while she was 10 weeks pregnant. She was supposed to be receiving globulin, RHOGAM. Concomitant therapy included levothyroxine Na. Pregnancy test and ultrasound were performed on an unspecified date (no results reported). The patient saw the physician. It was reported that the patient was 10 1/2 weeks pregnant at the time of this report. Additional information has been requested.
Patient returned to pharmacy 11/5/2021 with a nickel-sized, purple mark at injection site.
On 7/11/01, presented to ER with complaint of left arm pain and redness. She had previously had TD on 7/9/01 in left arm at 12:40. Dx'd with local medication reaction with secondary cellulitis. Treated with Prednisone 50mg po every day; Keflex 500mg po bid; ibuprofen prn and ice to affected area. On 8/1/01, presented to health office at 13:00 today with complaint of pain in left elbow that radiates to left hand. Noted approx. a 2cm in diameter, hardened area in left arm where pt reports she was given her TD shot. Referred to PCP.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic visit with primary care provider 19 days after vaccination to report numbness and tingling on left side of face that started on the drive home from vaccination site. Symptoms resolved without treatment within 24 hours. Since then reports a prickly feeling around the body and within the last four or five days numbness and tingling has returned. The patient's daughter experienced same reaction and the second vaccine dose exacerbated symptoms resulting in follow-up with neurology.
Lower back pain and groin area, Wednesday 1/7/03, 20:30-03:00.
Rash on the chest that spread all the way to the back and neck; Sore; Joint hurt; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the chest that spread all the way to the back and neck), MYALGIA (Sore) and ARTHRALGIA (Joint hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 026L20A and 30M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to some food and medications) and Drug allergy (Allergic to some food and medications). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced MYALGIA (Sore) and ARTHRALGIA (Joint hurt). On 19-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on the chest that spread all the way to the back and neck). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK UNK, qd. In September 2021, MYALGIA (Sore) and ARTHRALGIA (Joint hurt) had resolved. At the time of the report, RASH (Rash on the chest that spread all the way to the back and neck) outcome was unknown.            The patient was also taking high blood pressure medication (unspecified) concomitantly.  The patient was allergic to some food and medications but never experienced a reaction like this, the patient related rash to a possible reaction after taken third dose of the vaccine. The patient consulted to the physician for treatment medication.   This case was linked to MOD-2021-323796 (Patient Link).
This spontaneous report as received from a physician refers to a 16 month old healthy female patient with no allergies. On 30-APR-2013 the patient was vaccinated with a 0.5ml dose of VARIVAX (merck) (lot number unspecified) subcutaneous in the left arm. There was no concomitant medication. The patient presented to the physician office today with a rash at the injection site with red bumps that reportedly started 2 days ago, on 08-MAY-2013. The physician described the reaction as "an area of erythema at the injection site about 1 centimeter, with 3 red spots containing vesicles." There was no lab diagnostic studies performed. The patient used a cold compress for the treatment of the events. The outcome of the patient was unspecified. Additional information has been requested.