chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired DAPTACEL being administered to a patient with no adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] being administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 31-Aug-2022, the patient was administered with an expired dose 4 (0.5 ml) (1x) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5765BA: Expiry date. 28-Aug-2022) via intramuscular route in the right vastus lateralis for immunisation with no adverse event (expired product administered) (latency: same day)  Action taken : not applicable.  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 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.
Patient reported rash the next day following vaccination. No report of anaphylaxis. Patient went to primary physician clinic. Then, called us to obtain 1-800 number for compensation.
Expired Moderna Covid-19 vaccine administered to 100 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to 100 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to 100 patients). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to 100 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly, The Nurse had a temperature high alert for vaccine stored in the refrigerator. 600 doses were affected. No patients had received any of the vaccine. The vials were closed and were stored in their boxes.   Lot 034C21A had 200 doses  Lot number 008C21A with expiration date 31-OCT-2021 had 400 doses. The vials were placed in the refrigerator on 10-MAY-2021.  Doses were administered to approximately 100 patients since 10-JUN-2021 from Moderna Covid-19 vaccine that had been stored in the refrigerator since the beyond used date passed on 10-JUN-2021.  Generalized Adverse event had been reported. No patients information was available.  Nurse and physician had granted permission for Safety to contact her with e-mail or telephone.  Concomitant product use was not provided.  Treatment product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow-up  received on 14-Sep-2021 and contains NNI.
I had a fainting spell, confused, fatigue, not oriented x3. Soreness all over my body and needed to be hospitalized for stroke like symptoms.
Received Moderna Vaccine 1st dose on 2/24/2021.  Went for a cystoscopy and biopsy on 3/8/2021.  On 3/9/2021 was sent to the ER and admitted for acute renal failure, UTI, and dehydration.
mom called 410PM 29OCt stated pt was crying non-stop-temp 100 ax;cry became high pitched @ times;MD talked w/mom p/1hr & 15min the pt slept;next day there was redness & ecchymosis @ both sites;
GARDASIL 9 used for the treatment of condyloma acuminata (off label use); Literature report:   This literature marketed report has been received from the authors of the published article, and refers to a 79-year-old female patient with severe Parkinson's disease. On an unknown date, the patient presented with numerous massive coalescing verrucous papules and plaques in the groin and inframammary folds (extensive verrucous papules and plaques in the pubis, inner thighs, and left inguinal fold). Lesions had been present for years and were accompanied by itching, maceration, and malodor. Biopsy from a few lesions demonstrated papillomatosis and acanthosis of the epidermis, together with koilocytic cells in the upper parts of the epidermis. In situ hybridization detected positivity for high-risk HPV 16 and 18 and low-risk 6 and 11 but was negative for HPV 31 and 33 types. No atypia was found in the epidermal cells, and histopathological diagnosis of condyloma acuminata was established. Surgical treatment was considered but was deferred due to the extensive lesions and possibility of long recovery. Additionally, the patient was wheelchair bound and was not able to take care of the wounds. Few applications of imiquimod caused significant irritation, and the patient stopped it. Off-label treatment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine was discussed.  On an unknown date, the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was injected intramuscularly (exact dose, lot # and expiration date were not reported) (off label use).  The patient experienced dizziness, headache, and fatigue in the evening after the injections and was admitted to a hospital. Although unable to prove that the episode was directly related to the vaccine and not caused by other reasons (exacerbation of Parkinson's symptoms, vasovagal, other medication effect, etc.), she refused to have additional doses of the vaccine in the future (only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered). The patient was followed during the year and was only given supportive topical medications (topical hydrocortisone and antifungals) to treat maceration and itching in the folds as well as superimposed intertrigo. With every subsequent visit, it was noticed that condylomas were diminishing in size and completely disappeared 1.5 years after the initial visit.  A copy of the published article is attached as further documentation of the patient's experience.
Within 30 seconds a burning sensation at injection point. Followed by funny taste in mouth, upper teeth felt numb. Left arm became heavy with a burning rash type itch. Quarter size welt at injection point. flu like achy joints on left side. Symptoms lasted 3 days. Follow up: Paresthesias in left forarm and 3rd, 4th, 5th digits of left hand. Symptoms subsided in January 03 without additional evaluation or treatment. Arthralgias of the left arm. Described as "shootingpain." Symptoms subsided January 03 without additional evaluation or treatment. Patient received anthrax no. 4. He did not have pretreatment with NSAIDs as recommended. He did receive the injection IM in his right arm. Ohter than burning at the vaccine site, he did not have recurrence of his previous symptoms. Since receipt of anthrax vaccine 4 in July 2003, patient has had an unexplained 25-30 pound weight gain and has noted a significant change in his short teerm memory.  No evaluation of these changes has been initiated. When patient returns from abroad, another VAERS report will be filed regarding these new symptoms associated with vaccine 4.
very hard lump in area of injection; hot in area of injection; itchy in area of injection; red in area of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (very hard lump in area of injection), VACCINATION SITE WARMTH (hot in area of injection), VACCINATION SITE PRURITUS (itchy in area of injection) and VACCINATION SITE ERYTHEMA (red in area of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L201A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (very hard lump in area of injection), VACCINATION SITE WARMTH (hot in area of injection), VACCINATION SITE PRURITUS (itchy in area of injection) and VACCINATION SITE ERYTHEMA (red in area of injection). On 15-Feb-2021, VACCINATION SITE MASS (very hard lump in area of injection), VACCINATION SITE WARMTH (hot in area of injection), VACCINATION SITE PRURITUS (itchy in area of injection) and VACCINATION SITE ERYTHEMA (red in area of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included cold water. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
24 hours after administered, right deltoid had quarter sized red spot and I started to have general achiness. 48 hours after administered, red spot has doubled in size and deltoid is quite swollen. Last 3-4 days, I have had severe pain to right shoulder, deltoid, pain in my chest and ribs and back. Yesterday, my right hand started turning purple at times and I am having heaviness to hand and arm. Today, I?m having great difficulty moving right arm due to numbness and pain. I have had to call in sick today and for tomorrow. My deltoid is still swollen and slightly red. I am taking Prednisone.
Headache, Myalgia, Rash & NauseaVomiting Narrative:
Extreme hip/joint pain in left leg (glute Med area extremely sensitive to touch) Extreme Pain experienced with sitting on the left hip/side and also when attempting to stand.; Walking around slowly seemed to warm up the muscle with less discomfort; Any rotation at the hip brought on sharp pain as well though (around that glute med,TFL area, around hip); Pain also radiated down to toes; some neck pain; Extreme hip/joint pain in left leg (glute Med area extremely sensitive to touch) Extreme Pain experienced with sitting on the left hip/side and also when attempting to stand.; injection site pain; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EW0153, expiration date: not reported), intramuscular, administered in Arm Right on 30Apr2021 12:30 (age at vaccination 44-year-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included Iliosoas (hip) injury from 2013 to an unknown date, Exercise induced bronco-spasms from an unknown date and unknown if ongoing, Pre-Diabetic from an unknown date and unknown if ongoing. Patient previously took Pfizer COVID-19 vaccine on 09Apr2021 12:15 PM (lot number: EW0170) administered via Intramuscular route in Right arm (age at vaccination 44-year-old) as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. Since the vaccination the patient had been tested for covid-19. Prior to vaccination the patient was not diagnosed with Covid-19. The patients concomitant medications were not reported. On 02May2021 at 12:30, the patient experienced extreme hip/joint pain in left leg (glute med area extremely sensitive to touch) extreme pain experienced with sitting on the left hip/side and also when attempting to stand, walking around slowly seemed to warm up the muscle with less discomfort, any rotation at the hip brought on sharp pain as well though (around that glute med, tfl area, around hip), pain also radiated down to toes, injection site pain, some neck pain. Patient was self-treated with ice packs, compression, elevation & Biofreeze (topical menthol pain reliever) PRN as a therapeutic measure for all the events. The clinical outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm, as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing), notes: Other medical history: High bp; "diagnosed with diabetes (no meds)" (unspecified if ongoing), notes: Other medical history: diagnosed with diabetes (no meds). Concomitant medication(s) included: AMLODIPINE; OXYCODONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Brand-Paxlovid Treatment start date- 14Jun2022, Treatment stop date- 20Jun2022  Clinical course: After onset, seemed to recover, tested negative on a Thursday. The following Tuesday felt bad, tested positive. Bad cold like symptoms, getting chills on wed. Cannot work. Adverse event start date: 27Jun2022 Adverse event start time: 08:00 AM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
about 5 min after receiving the vaccine patient started to feel upset to her stomach and nauseous, patient was moved into an examination room and she then had complaints of a painful headache. Patient was given Zofran 4 mg tablet, Ibuprofen 200 mg 2 tablets after about 20-25 min patient reported that the nausea was gone, the headache pain had decreased but pain not gone
no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 10-APR-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R022879, expiration date 02-AUG-2020) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008551: US-009507513-1904USA008553: US-009507513-1904USA008542:
3JUN93 noticed to have inc redness around vaccination site w/inc tenderness; had 7x6.5 cm area of tenderness, swelling & warmth @ lt deltoid area; given Kelfex for cellulitis;
Pain in legs/Leg pain; pain was also in his joints; 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). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: Had shingles once when he was in his twenties from chicken pox or wherever it comes from. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Jul2021, outcome "not recovered", described as "Pain in legs/Leg pain"; ARTHRALGIA (non-serious) with onset 10Jul2021, outcome "not recovered", described as "pain was also in his joints". The events "pain in legs/leg pain" and "pain was also in his joints" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia.  Additional information: The patient had an unusual reaction to the Pfizer COVID Vaccine. About 3 days after the 1st dose, the patient developed pain in legs like someone beat his legs with a baseball bat from hips down to feet that pain was also in his joints. He had really bad pain in his leg and joint from his hips down to his feet that lasted for 10 days and went away. Was taking a lot of Advil to get rid of it. The patient was taking Advil and Tylenol and all kinds of stuff trying to keep pain under control. The patient was advised to take Gabapentin 100mg at night and 100mg in morning because it needs to turn the pain off so the sensory nerves would die. The patient stated that the Gabapentin was helping. Took Fish Oil to relive inflammation. Took Vitamin C. He stated that this had been going on for 15 weeks and it was getting worse. Everything went good for about a week before he was going for the second shot. The patient had his 2nd shot on 28Jul2021. Doctor and ER did not know what was going on either. Had been going on 15 weeks now. He was seeking a solution and treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report was received from a health care professional on 25 November 2003, concerning a 31 month old female vaccinee who inadvertently received Fluvirin on 18 November 2003. On 18 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. AT the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP100700037, PJP200400036.
Pt developed pain, redness, swelling in left arm, site of injection within 24 hr.
Autoimmune hemolytic anemia, jaundice, syncope vaso-vagal, dehydration, hypertension, DM type I, uncontrolled secondary to steroid treatment, blood transfusion.
On January 12, 20200, Five days after receiving the vaccination, the patient experienced a rash and developed a Herpes Zoster problem. On January 22, 2022 she was admitted into the local hospital with pneumonia and tested positive for Covid.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot#, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Heavy Night Sweats, - Continues every night Chills, - Not as bad now Swollen Knee, - Still swollen and hard to walk or work Joint Pain at hip, knee and ankle, - Hard to walk with hip pain Headache, - mainly at night   tat nigh
pulsing pain in both shoulders which has interfered w/work, recreation & sleep;persisted for 3wk;got rxn for darvocet-N;still taking naprosyn;
Pt called today because in her right arm where she received a chicken pox vaccine it is swollen, red, warm to the touch, and has an itchy rash. Pt explained that it is localized to that area, is not spreading but has been getting worse over the last few days and started on Wednesday. Pt has not taken any medication and is concerned that it could get worse. ASSESSMENT/PLAN: RN advised pt to go to the ER if it continues to get worse, but to try some benedryl tonight to see if it improves tomorrow. RN explained the most serious reactions are typically shortly after the injection and it should be getting better. Pt declined coming to the clinic today, but will call the after hours line this weekend if she needs additional advise. Again pt will follow up at ER if needed.
SOB; lung pain; chest pain; fevers; fatigue; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on (19Nov2021), this case now contains all required information to be considered valid.  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. The reporter is the patient.  A 68-year-old female patient received bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in arm, administration date 24Feb2021 (Lot number: EN6202) at the age of 68 years as dose 1, single and intramuscular, administered in arm, administration date 18Mar2021 (Lot number: ED7534) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (life threatening) with onset 2021, outcome "not recovered", described as "SOB"; PULMONARY PAIN (life threatening) with onset 2021, outcome "not recovered", described as "lung pain"; CHEST PAIN (life threatening) with onset 2021, outcome "not recovered", described as "chest pain"; PYREXIA (life threatening) with onset 2021, outcome "not recovered", described as "fevers"; FATIGUE (life threatening) with onset 2021, outcome "not recovered", described as "fatigue". The patient underwent the following laboratory tests and procedures: body temperature: (2021) fevers. Clinical course: Patient age at time of vaccination was 68 Years. SOB (Shortness of breath), lung pain, chest pain, fevers, Fatigues continues. Vaccine administered at  facility was No.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received on 12-OCT-2016 from a pharmacist who reported that an unspecified female patient (presently 27 years old) who was vaccinated with VARIVAX (Date of vaccination, dose volume, lot number, expiration date were not reported) and MMR (Date of vaccination, dose volume, lot number, expiration date were not reported) "during her adolescence," (age not reported) recently had titers drawn which exhibited low levels for each of the components in those vaccines. The patient's medical history, concurrent conditions and concomitant medications were not reported. The call ended before any further adverse experience (AE) questions could be asked. No further information was provided. Additional information has been requested.