chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed itchy rash along arm, bra line, between the legs, torso; Developed itchy rash along arm, bra line, between the legs, torso; Case reference number US-BN-2021-002300, initially downloaded on 27-Sep-2021, is a spontaneous case received from a consumer via health authority (Worldwide Unique Identifier 1467228-1) and concerns a 20-year-old female patient.  The patient had no current illnesses, no medical history and no known allergies.  The patient did not use any medication at the time of vaccination.   On unspecified dates, the patient was vaccinated with the first and with the second dose of RabaVert (inactivated rabies virus vaccine; batch number was not provided) at unknown dose or route of administration, for unknown indication.   On 07-Jul-2021, the patient received the third dose of RabaVert (inactivated rabies virus vaccine; batch number was not provided) at unknown dose, administered intramuscularly, for unknown indication.   On the same day, the patient developed itchy rash along arm, bra line, between the legs and torso. The patient was seen by a physician, who prescribed steroid shot and cortisone cream as treatment.  On an unspecified date, reported also as by Saturday, the steroid shot and cortisone cream cleared everything up.  At the time of this report, the patient had recovered from the events.   The reporter assessed the events as non-serious. The causality assessment was not provided.  No further information was provided.; Reporter's Comments: Rash and rash pruritic are listed for RabAvert according to the Prescriber Information. The patient developed rash and rash pruritic on the same day the patient received the third dose of RabaVert. Due to plausible temporal relationship and known vaccine safety profile, the causality for the events is assessed as possibly related to the suspect product. This case is considered non-serious.; Sender's Comments: Rash and rash pruritic are listed for RabAvert according to the Prescriber Information. The patient developed rash and rash pruritic on the same day the patient received the third dose of RabaVert. Due to plausible temporal relationship and known vaccine safety profile, the causality for the events is assessed as possibly related to the suspect product. This case is considered non-serious.
Pt recv vax on 4/23/99; on 4/27/99 pt exp rash
This spontaneous report was received from an 84-year old female patient reporting on herself. The patient's concurrent condition included high blood pressure. No drug reactions or allergies were reported. Concomitant therapies included DIOVAN. On 15-JAN-2011, the patient was vaccinated with ZOSTAVAX in the right arm (strength, dose, route of administration, lot# and expiry date were not reported). On 24-JUL-2015, the patient was diagnosed with shingles. At the time of the report, patient was still experiencing nerve pain in back, right breast area and in her arm from elbow to shoulders. The patient received treatment with gabapentin. The patient's initial reason for the call was to obtain reimbursement for her cost. The outcome of herpes zoster was reported as not recovered at the time of the report. The causality assessment between adverse event and suspect therapy was not provided. Additional information has been requested.
Day 5- severe headaches, chest congestion, coughing phylum, flu like aching, dizziness,  Day 6 gastrointestinal pains, diarrheas, fever 99.4-102.8 for 2 days.
Fine erythematous macules on eye lids, frontal scalp with salivation, described at ER as urticarial (sent there for monitoring). Change in breathing patter with occ wheeze at office.
Body and Muscle cramps; Confused; Foul taste in mouth; Foul smell; Severe headache; Couldnt walk, Trouble walking; Black rings developed under eyes; Body burns; Fell asleep while talking; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 16Mar2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as yes, however medical history was unspecified. Concomitant medications were taken within two weeks of vaccination was reported; however, it was unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, at 06:00, the patient experienced body and muscle cramps, confusion, falling asleep while talking, foul taste in mouth, foul smell, unable to walk, severe headache, body burns, black rings developed under eyes, trouble walking. The patient had not received any treatment for the reported events. The clinical outcome of the events muscle cramps, confusion, taste peculiar, smell change, headache, difficulty in walking, dark circles under eyes, body temperature increased and sleepiness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
The following day, 02/07/2021 around 3:30pm I started feeling extreme fatigue, mild sore throat and chills. The following days after I was okay, with a sore throat only occurring in the evening after 4pm, along with vertigo and slight disorientation for approximately 8 days. Starting Saturday, 02/13 around 8pm I noticed a tingling sensation in my right middle finger, that continued to Sunday and through to today. As of this morning, 02/15, I still have the nerve pain in my finger that is now spreading to the palm of my hand.
Fatigue, joint pain (whole body) fever an headache.  Start 10 hours post vaccine, lasted about 12 hours
Tested positive for Covid-19 on May 23rd while in country as a school trip chaperone during testing to be able to fly back to the country. Students had begun feeling poorly back on May 19th with symptoms of low grade fever, sore throat and sinus drainage. It was assumed this was allergies and I spent time with those students who didn?t feel well on 19th, 21st, and 22nd. I began feeling poorly on the 20th. I tested daily with lateral flow tests in country from 24-26th and was negative on the morning of May 26th and thus was able to fly home. I tested negative on 26, 27, 28, and 30th of May. While I was still feeling fatigued and had a slight cough, I felt much better overall.   However on June 3rd had a very bad headache and slept quite a bit. I tested again on the morning of the 4th because I felt the same low grade fever, cough, and sinus pressure as before. I tested positive again June 4th and again on the 5th via lateral flow tests.  This second round/relapse has been much more tiring than the first. Coughing up brownish mucus, fever of 100.0 despite ibuprofen, and extreme fatigue. I have talked with my doctor ?s office via phone.
vax recvd 25SEP92 @ 230PM on 25SEP92 w/in 2-3 hrs started w/ inconsolable crying total of 3 to 3 1/2 hrs w/APAP; no temp; leg sl swollen @ DTP site; lethargic & intake was down noc of 25SEP & next day 26SEP92-returned to nl;
EXCRUCIATING ABDOMINAL PAIN; EXCRUCIATING BACK PAIN; EXCRUCIATING KIDNEY PAIN; EXCRUCIATING SPINE PAIN (ACROSS ENTIRE SPINE); SENSATION OF BUBBLE TO HEAD; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lost eyesight, and anaphylactic reaction, and concurrent conditions included: chronic regional pain syndrome, latex allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine, hydromorphone hydrochloride, fentanyl, gabapentin, oxycodone, oxycodone hydrochloride, and pseudoephedrine hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 and expiry: 30-OCT-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced excruciating abdominal pain. On 19-OCT-2021, the patient experienced excruciating back pain. On 19-OCT-2021, the patient experienced excruciating kidney pain. On 19-OCT-2021, the patient experienced excruciating spine pain (across entire spine). On 19-OCT-2021, the patient experienced sensation of bubble to head. Laboratory data included: Pain scale (NR: not provided) 10. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of bubble to head on 19-OCT-2021, and had not recovered from excruciating abdominal pain, excruciating back pain, excruciating kidney pain, and excruciating spine pain (across entire spine). This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment, Paxlovid from 10Aug2023 to 14Aug2023.  No follow-up attempts are possible. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:34 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 85.47 for dose administered on 28-Feb-2021 and 85.55 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 26 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
5 days after first shot, Left breast swelled up, got warm and turned reddish in color.  Breast got hard and large lump around nipple.  Called OB/GYN and was checked by them.  They sent me for a mammogram on left breast and ultrasound as well.  Was told that this was a common adverse reaction to covid shot.  I did not know that.  Would have waited to defer the cost.  After second covid shot same breast was a little sore but not as bad as first shot.
Cough; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Fever) and HEADACHE (Headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COUGH (Cough), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and event outcomes updated.
This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot T3 5 or S 176; Expiration Date 20Jan2020, NDC number 0005-1971-05), via an unspecified route of administration in right deltoid on 19Oct2017 17:30 at 0.5 ml, single for immunisation. Medical history included lupus, gastritis for which she took medications, gastrointestinal distress, allergy to sulfa, narcotics and a flu vaccine. In 1991 she received a flu vaccine and had pain and clamminess so she resulted allergic to flu vaccine. The patient previously took azathioprine, but had not taken that for several months. Concomitant medication were not reported, however she took a birth control pill. The patient experienced bruising line (non-serious) on 19Oct2017. The event was described as not raised or itching. It was tender, bright and intense and went from under her breast towards her navel. It was 4 inches long and it was fading at the time of the report. The outcome of the event was recovering.
day after vaccination, patient had swelling of Left thigh and local erythema surrounding vaccine sight. tender to touch, fever. Mother applied ice regularly. Patient with low appetite, diarrhea, 3 plus fussiness. 3 days after vaccine, thigh swelling and erythema significantly improved
Pt received Janseen vaccine on 05/06/21. Pt presented to the ED on 11/11/21 with flu like symptoms. Pt was found to be COVID positive.
MOTHER STATES RED PIN-POINT RASH NOTED ON FACE APPROXIMATELY 1 HOUR AFTER RECEIVING VACCINES. 5--6 HOURS LATER NOTED HIVES ON FACE AND ENTIRE BODY.HIVES GOT LARGER. BABY TAKEN TO E.D AND WAS TREATED WITH ORAPRED AND BENADRYL. RX GIVEN TO CONTINUE MEDS. NEXT DAY BABY DEVELOPPED ITCHING.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The reporter stated that the patient was administered a 2nd dose of PNEUMOVAX 23 (dose, route of administration and anatomical location was unknown) on 08-OCT-2014, while the first dose was administered approximately on 17-SEP-2014 (reported as 2 to 3 weeks ago). Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effect was reported. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Had a breakthrough case of COVID-19 after being fully vaccinated. Which lead to a sinus infection. I was prescribed a Z-pack.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. No concomitant therapies were reported. On 14-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (10mcg/1mL, 10X1DS/VTF) lot number K003533, expiration date of 07-FEB-2016 (route of administration was not reported), which was stored at -3.333 Celsius Degrees; for 472 hours, 1.111 Celsius Degrees for 136 hours, 0 Celsius Degrees for 120 hours, -1.111 Celsius Degree for 1592 hours, -1.666 Celsius Degrees for 24 hours, -2.222 Celsius Degree for 1128 hours, -2.777 Celsius Degree for 208 hours and -0.555 Celsius Degrees for 288 hours. The type of storage was refrigerator. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
My parents tested positive for COVID last Tuesday, I tested Negative myself, but Thursday evening I had nasal congestion, throat felt hard, low fever that night, at the middle of the night I have chills and very high feverish, Friday I continued with congestion and coughing and Friday morning I called the doctor, and they prescribed Paxlovid. Friday night I had fever of 103, I was dehydrated, very bad headache, that was my worst night. Fever went away, this morning I finished Paxlovid but I am taking Mucinex, I still feel congested and tired.
Erythema (20x13cm), tenderness, warmth left deltoid. Treatment-prednisone, Benadryl, cool compresses.
Very ill right now; Have turned red; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill right now) and ERYTHEMA (Have turned red ) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very ill right now) and ERYTHEMA (Have turned red ). At the time of the report, ILLNESS (Very ill right now) and ERYTHEMA (Have turned red ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medication were reported. No treatment information was reported
Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative:   Other Relevant History:
sore liver area; Fever of 101; body aches; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: En6204) via an unspecified route of administration in Arm Left on 18Mar2021 (age at vaccination: 40-Year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't had Covid-19 prior to vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications was Adderall, Vitamin d, Escitalopram within 2weeks of vaccination. The patient medical history was not reported. Concomitant medications included amphetamine aspartate, amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; cholecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: En6202) via unspecified route of administration in Arm Left on 25Feb2021 06:30(age at vaccination: 40 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced fever of 101 on 19Mar2021 10:00, body aches on 19Mar2021 10:00, vomiting on 19Mar2021 10:00, sore liver area on 20Mar2021. The patient underwent lab tests and procedures which included body temperature: 101 on unspecified date Fever of 101. Patient was not tested for Covid-19 to post vaccination. No therapeutic measures were taken for the events. The outcome of the events pyrexia, pain, vomiting, hepatic pain was recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a school nurse concerning a patient who reported to the nurse that 10-15 years ago (approximately 1993), she was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #, dose and route not reported). The nurse reported that 10-15 years ago when the pneumococcal 23v polysaccharide vaccine was given, the patient broke out in hives. The nurse hade no further information. Additional information has been requested.
Loss of voice, difficulty swallowing, rapid muscle mass deterioration, eventual death on 5/21/2021 from acute respiratory failure, and slight pneumonia.
first 24 hours some headaches, fatigue following morning of 2nd injection my upper eye area hurt especially to touch 48 hours post injection more headaches, fatigue, mild bloody nose, eyes slightly swollen  everyday after this my eye was more and more swollen to the point of swollen shut 5x blurry vision  swollen lacrimal gland, pain around eye
Emergency Services to inpatient- Cardio Palm Sx: palpitations, SOB, N, "generally not feeling well" - in ER: afib RVR - chemical conversion but continues to no feel well.
patient administered expired Pentacel/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional. This case involves a 4-months-old female patient who e received 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, lot number: UJ057AAA and expiry date: 07-Nov-2020 via Intramuscular route in the left deltoid) (expired product administered) on 03-Dec-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  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.