chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 17th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
No adverse event; Non case: No stability data available in temperature excursion case no adverse event with no medication error case
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-SEP-2014, the patient received the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his (Conflicting information, as patient was a female, with a female first name) body. The patient did not have a Shingles outbreak until 20-DEC-2016 and a return outbreak on 02-FEB-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his (conflicting information) condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the event was unknown. The reporter considered the events to be related to ZOSTAVAX. The event of shingles outbreak and Return outbreak of Shingles were considered disabling. Additional information has been requested.
severe rxn w/itching, wheal all over trunk & back;went to ER where given adrenalin;
Three pts who recv vax subsequently in 1991 exp mumps.  Vaccine failure has been attributed to outbreak in pts high school; possible waning vax-induced immunity.
began feeling like there was a large lump in throat. Slight difficulty breathing, eyes watering, nose congested, sore throat. Lasted 2 days. Have previously taken influenza shot, no H1N1.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 29-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAZX (1 dose form (DF), lot #, expiration date and route unspecified), which was reconstituted with expired sterile diluent (Merck Sterile Diluent) (lot # L003601, expiration date 24-JAN-2016) (product preparation error and expired product administered). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Rash on half upper right thigh, patient will try hydrocortisone 1% and BENDARYL 25mg to suppress symptoms.
Patient reported feeling dizzy, nervous and diaphoretic Patient provided with water and seen by medical team Patient refused medical transport and signed AMA form  Patient?s symptoms improved and will be driven home by mother
HOSPITALIZATION, CHEST PAIN, SHORTNESS OF BREATH, DECREASED APPETITE, ANOSMIA, COVID-19 INFECTION Narrative:  Patient is a 71 yo MALE with PMHx significant for malignant tumor of urinary bladder, obesity, osteomyelitis of foot/ankle, T2DM (c/b DM foot ulcers), HTN, and HLD. Patient received the COVID vaccine (Pfizer dose #1) on 1/30/21. Of note, patient received Tdap vaccine on 1/29/21; ok-ed to receive COVID vaccine by MD and patient declined offer to reschedule COVID vaccination. Patient presented to emergency department on 2/15/21 with c/o fever, loss of taste, anosmia, decreased appetite, nausea, dry cough, chest pain, and SOB; symptom onset was 2 days prior to presentation to ED. Reported that he was exposed to daughter who is COVID positive and lives with him. In ED, patient was afebrile, BP 140s/60s, pulse 80-90s; initially came in with 6L O2 via nasal canula, reduced to 4L with wean (85% on RA). Patient tested COVID positive and 2/15/21 chest x-ray suggested bilateral pneumonia; patient admitted on 2/15/21 for acute hypoxemic respiratory failure 2/2 Covid-19. While hospitalized, patient enrolled "Controlled Trial" and completed 5-day course of that treatment and discharged 2/20/21 with home O2 (2L NC), home PT/OT, and increased insulin doses. Patient received his 2nd Pfizer COVID vaccine when he was no longer symptomatic, on 3/3/21, as per Infectious Disease consultation. Reporting to Regulatory Authority given patient's hospitalization s/p Pfizer COVID-19 vaccine as required by the Emergency Use Authorization of the PFIZER-BIONTECH COVID-19 vaccine.
On October 9, 1999, post vax, pt experienced a severe rash and itching to the point where he was bleeding.  The rash was more on the lower extremities. The pt also experienced dermatographism.  The rash increased in redness as the pt scratched.  Antihistamines were administered.  The symptoms persisted for three weeks.  The itching persisted at the time of the report although not as intense. No further information is available.
10 cm local symptom at site after 24 hours. Entire upper arm swelling, redness, itch extending up back to neck. Down volar forearm.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 18-NOV-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 64 hours with 48 C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 C, 264 hours with 33 C, 88 hours with 30 C, 40 hours with 34 C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist via company representative refers to a 17 year old patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose and frequency was not reported). It was reported that the 17 year old patient has been receiving PNEUMOVAX23 every three years since an unspecified date. No adverse effect reported. Additional information has been requested.
tingling in her right arm; a hard time making a grip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her right arm) and GRIP STRENGTH DECREASED (a hard time making a grip) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 27-Dec-2020.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PARAESTHESIA (tingling in her right arm) and GRIP STRENGTH DECREASED (a hard time making a grip). At the time of the report, PARAESTHESIA (tingling in her right arm) and GRIP STRENGTH DECREASED (a hard time making a grip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Developed severe conjunctivitis and itching following administration of Shingrix. Due to vigorous rubbing of her eyes, developed corneal abrasion requiring ER visit and ophthalmologic consultation
Vaccine given at 12 noon at 3:00 school called Dad patient had fever, dad got there and took her to ER.
When contacted patient stated the arm the vaccine was administered in (left) started hurting and was sore. It got progressively worse and pt. had trouble twisting, lifting, and moving her arm. It is still bothersome, but not red, swollen, or require any emergency care. (continues to hurt).
Loss of taste and smell; Loss of taste and smell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2022 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pacemaker" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "known allergies: Ceftin". The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 22Sep2022, outcome "not recovered" and all described as "Loss of taste and smell". Therapeutic measures were not taken as a result of anosmia, ageusia.  Additional information: Facility type Vaccine was reported as Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. Patient did not have covid prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial arm soreness resolved after two days but a week later redness, itchiness and slight hardness noted at the injection site. Redness and itching increased the next day but not the hardness.
Narrative: Veteran received Covid-19 vaccine 3/8/2021. He called VA on 3/9/2021 reporting that he had chills, headache. and temperature of 102f after taking acetaminophen (dose unknown) an hour prior. He also stated that he had tingling in lips and increasing difficulty breathing. Denied itching. rash, nausea, vomiting, or diarrhea. Instructed to report to emergency department, though no documentation of follow up. It should be noted, veteran received second dose of Moderna Covid-19 vaccine on 11/3/2021. NO documentation of slide effects or reactions noted at this time.
There is blue discoloration at the center of my tongue. It is painless, I would not even know it was there were it not for sticking my tongue out to brush it in the mornings. It only happens overnight, now 2 consecutive mornings since the 2nd dose of moderna. No edema, sore throat, or swelling. I have photos that I can send. It looks like I ate a blue colored candy, but I didn?t. I wake up like this from sleep.
Cellulitis at injection site (+) erythema/edema. Given Keflex 200mg po q 6 hrs x 7 days.
improperly stored administered ROTATEQ; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 for prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023); no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:Original Case # (no patients' identifiers)
After the first shot had mild hot flash like symptoms; soreness at injection site; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 36-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in Arm Right on 30Apr2021 09:00 (age at vaccination: 36-year-old) as first dose, single for covid-19 immunization. (Vaccination facility). Patient had no Medical history. The patient concomitant medications were not reported. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was not diagnosed with COVID-19. It was reported that After the first shot patient experienced mild hot flash like symptoms and soreness at injection site. Since the vaccination, patient has been not tested for COVID-19. outcome for the events was reported as unknown.   No follow-up attempts are possible. No further information is expected
Pregnancy with no AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a physician..  This case involves adult female patient who was pregnant (Exposure during pregnancy) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   Data regarding this pregnancy were received prospectively, i.e, before pregnancy outcome was known.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient medical history included cardiac disorder, sexually transmitted disease and earning difficulties, congenital malformations, and environmental exposures.  At the time of the event, the patient had ongoing thyroid disorder, asthma, and hypersensitivity.  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On 11-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7315MA and expiry date: not reported] via an intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date, for the patient reported a non-serious event pregnancy (Exposure during pregnancy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was unknown to consent to be contacted patient and patient physician.  It is unknown if the patient experienced any additional symptoms/events  Action taken with QUADRIVALENT INFLUENZA VACCINE was not applicable.  At time of reporting, the outcome was unknown for the event pregnancy.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
chronic spontaneous urticaria; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (chronic spontaneous urticaria) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drug information was provided.
Exaserbated the ringing in my head from the Pfizer vaccine that I received on April 14th.  I previously reported this event.  The Pfizer number is ER8727.   The ringing in my head is persistent and louder.
She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder); Lack of effect with Moderna Covid-19 vaccine; you get dizzy; flip flopped; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder)), DRUG INEFFECTIVE (Lack of effect with Moderna Covid-19 vaccine), DIZZINESS (you get dizzy) and PALPITATIONS (flip flopped) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 027A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose twice a day. On an unknown date, the patient experienced COVID-19 (She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder)), DRUG INEFFECTIVE (Lack of effect with Moderna Covid-19 vaccine), DIZZINESS (you get dizzy) and PALPITATIONS (flip flopped). At the time of the report, COVID-19 (She has Covid-19 (Dyspnoea , diarrhoea, asthenia, taste disorder)) and DRUG INEFFECTIVE (Lack of effect with Moderna Covid-19 vaccine) outcome was unknown and DIZZINESS (you get dizzy) and PALPITATIONS (flip flopped) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Shortness of breath: with the Moderna shot, It lasted three months and not all the time. Caller said that her blood pressure is not high.  Lack of effect with Moderna Covid-19 vaccine. Patient has Covid.  No concomitant medication was provided by reporter.  Company Comment: This is an spontaneous case concerning a 65-years-old female patient with medical history of co-suspect product PAXLOVID for COVID-19 disease who experienced the unexpected events of Covid-19 (AESI), Drug ineffective, palpitations and other expected event unknown days after  2nd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 65-years-old female patient with medical history of co-suspect product PAXLOVID for COVID-19 disease who experienced the unexpected events of Covid-19 (AESI), Drug ineffective, palpitations and other expected event unknown days after  2nd.  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Cough, abdominal pain, sore throat, chest pain, headache, nasal and chest congestion
One week after the first shot a Red, hard, very itchy  circle developed at injection site.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 31-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000593: US-009507513-2109USA000594: US-009507513-2109USA000595: US-009507513-2109USA000596: US-009507513-2109USA000591: US-009507513-2109USA000590: US-009507513-2109USA000589: US-009507513-2109USA000588: US-009507513-2109USA000592: US-009507513-2109USA000674: US-009507513-2109USA000675: US-009507513-2109USA000673: US-009507513-2109USA000672: US-009507513-2109USA000671:
Caller stated the first day her husband's arm bothered him and he felt sick the next day; Caller stated the first day her husband's arm bothered him and he felt sick the next day; slight headache; This is a spontaneous report from a contactable consumer (patient's wife) via the medical information team. This consumer reported for 2 patients. This is the second (husband) of 2 reports.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history included COVID-19 from 2020. Caller stated that she and her husband had COVID-19 around thanksgiving last year. He spent 6 days in hospital. The patient's concomitant medications were not reported. On an unspecified date, the reporter stated that the first day her husband's arm bothered him and he felt sick the next day and he felt sick the next day. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299440 same drug, different patient and event.
Swelling of lip and part of tongue, hive on chest.  Symptoms lasted about 2 hours.