chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK VAXCHORA WHILE ON ANTIBIOTIC; 16-YEAR-OLD FEMALE CONSUMER WHO TOOK VAXCHORA; This spontaneous case (PVX2019-1462) was received from a consumer on 06-Jun-2019. It describes a "16-year-old female consumer who took Vaxchora" and she "took Vaxchora while on antibiotic". She was receiving oral Vaxchora (lot no: 7000011 and expiry date: 31-May-2019) for cholera prophylaxis and oral Targadox (doxycycline; 50 mg; twice a day) for acne.  Case report: A 16-year-old, adolescent female consumer took a dose of Vaxchora on 29-May-2019, while she was taking Targadox for acne. She stopped taking Targadox on 29-May-2019.   Action taken with Vaxchora and Targadox was not applicable.  The clinical outcome of the events was unknown.; Sender's Comments: Company's Comment: The causality of the event"16-year-old female consumer who took Vaxchora" and she "took Vaxchora while on antibiotic" was considered as not applicable.
A nurse administered Moderna Vaccine 0.25 ml in the right arm to a minor under 11 years of age, since the minor was with his mother and very restless, at the time of vaccination, the wrong tray was selected and a booster Moderna adult dose of 0.25 ml was administered to the right arm.
Patient called about 9a and stated that she had some irritation at the injection site. Asked her to come to the pharmacy to be assessed (works here). 1030a-Pt presented with redness at injection site -- pink with a red dote in the center about 3" in diameter on Right Arm. It was warm and firm to the touch compared to the rest of her arm. She reported some stiffness and pain. Told pt if the redness grows or the arm get more painful to return to the pharmacy. 520p - Pt returned to pharmacy. Pt and I agreed that the reaction looked better. Pt still experiencing soreness. Advised that she put ice on the site a few times tonight.
Initial report received from a consumer who is also the patient on 09 September 2013. A 55-year-old male patient, had received a dose of FLUZONE (lot number: UH896AA, expiry date: 30 June 2014) intramuscular in right deltoid on 06 September 2013. The patient had no illness at time of vaccination. The patient had COPD (Chronic obstructive pulmonary disease), allergic to FENTANYL and seasonal allergies. Concomitant medications were not reported. On 07 September 2013, 1 day after vaccination, in morning the patient woke up with chest congestion, feeling tired, feels light headed at times, temperature of 98.8 F (oral) and had been as low as 97F, injection site (right deltoid) was sore with no redness or swelling. The patient's wife touched his forehead and felt he was burning up however the temperature was not high when checked and no other symptoms were reported. No laboratory investigations were done and corrective treatments were not reported. The patient outcome was not recovered. Documents held by sender: none.
Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was on 19-aug-2021.  Concomitant medication use was unknown  Treatment information was unknown
The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10.  The pain gradually increased, became more intense, and more constant.  Mild fever and chills started happening, and I took Ibuprofen.  By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night.  Pain was 6-8/10.  I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis.  I underwent laparoscopic surgery and it was found to be perforated.  It was removed.  I am currently recovering in the hospital.  I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.
Patient had a dizzy spell, then on the 15th had problems with both legs. A lot of pain and tingling like needle pricks and water running down her legs. Pt mentioned receiving the wrong dose.
Patient had a cough Friday, 1/7/22. Tested pos Saturday. Feeling weak and some body aches with one episode of vomiting. Nurse coordinator told patient to come to the ED to be dialyzed as unable to get into a COVID accessible dialysis unit.
21 weeks pregnant, di/di mono twins . EDD 01/05/22.   vomiting for a week without any relief.  unable to eat/drink. admission to hospital, blood in urine, sepsis, elevated liver enzymes, heart palpitations, and elongated QT time. Discharged with midline and antibiotics.  Readmitted within a week.  At time of admission, liver enzymes still elevated and now, preterm labor. 3cm dilated & contractions between 2-3 minutes apart. during this admission liver enzymes climbed to 1600 when standard range was between 8-30.  liver stabilized before delivering the twins prematurely.  unfortunately both twins passed.
pt recv vax 4FEB98 & 22FEB98 pt exp burning @ the inj site;24FEB98 pt devel herpes zoster;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time was (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion was (refrigerator/freezer)(R/F) for each time were 40, 34 and R; 136, 33 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
The individual felt neck, back and shoulder pain.    Symptoms started 1-18-2021.  On 1-31-21 she went to hospital and was admitted on 2-1-21 with nausea, chilss, headaches, vomiting, and body aches.  COVID-19 test was reportedly negative.  All tests were normal.
Post vax the patient experienced a headache, abdominal pain, and chills for 3 days.
Mild hives, r/face/neck. No mouth swelling or wheezing. Acting fine. Happened 10-15 mins after immunizations. Tx'd with Benadryl/po 3:50 pm.
Patient was given the MENACTRA vaccine, he then passed out about 2 minutes after getting the injection.
pt recv vax & devel mouth rash-white like along teeth in cheek one side (DOSE #1); pt recv vax & devel 1 spot (rash) lower lip w/#2 dose;
Received PREVNAR 13 on 11/28/16 and hematoma formed shortly after and has not gone away. She was treated by her HC provider on 12/23/16 - warm compress to area - nodular calcification noted.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-DEC-2012, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-DEC-2014, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin and VALTREX for management of her painful breakouts. 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.
A report was received from a vaccinees daughter on 09Dec02 regarding a 90 year old female vaccinee who experienced a fingertip size swelling at the injection site 2 days after receiving Fluvirin on 04Dec02. On 06Dec02 the vaccinee experienced a fingertip size swelling at the injection site. The vaccinee had no decrease in arm mobility and no pain was experienced. The event had not resolved at the time of reporting.
23Oct96 pt recv 1 dose vax. 20Feb98 pt devel 50 varicella-like lesions on head,face,neck,torso,arms,groin & legs. Pt is afebrile. 26Feb98 pt recovered.
injection site redness; injection site rash; sore arm again; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PAIN IN EXTREMITY (sore arm again), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (injection site rash) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE RASH (injection site rash). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, PAIN IN EXTREMITY (Arm sore), PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not reported.  Treatment information was not provided.   Reporter did not allow further contact
Fever above 100. Chills, muscle aches, fatigue,  light headedness, headache,  all lasting approximately 24 hours
This case was reported by a physician and described the occurrence of fever in a 2-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Act Hib vaccine Merck, TRIPEDIA, PREVNAR, IPOL and ROTATEQ all given on 3 July 2008. There were no concurrent medications. On 3 July 2008 the subject inadvertently received 1st dose of HAVRIX at 0.5 ml. There was considered to be a medication error as HAVRIX is not indicated for use in subjects under the age of 12 months. Immediately following vaccination with HAVRIX, on 3 July 2008, the subject developed a fever that resolved one day later on 4 July 2008. The physician considered the events of fever to probably related to vaccination with HAVRIX. Follow up information was received on 27 October 2008, via physician who reported the subject was a female who experienced the fever and medication error. The physician reported the subject's earliest sign or symptoms were experienced on 03 July 2008 and resolved on 04 July 2008. The physician stated the events were possibly related to HAVRIX or one of the other administered vaccine. It was reported that the immunization series with HAVRIX was delayed until the appropriate age.
Pt received IPV, Dtap and Hep a on R upper arm (deltoid region) developed red(erythema about 1 1/2" on L upper arm pt received Varicella and MMR. 24 hours later she came back with sup. vesicular lesions and serious discharge from few vesicles.
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Pt reports 'itching all over and difficult to work'. I suggested Benadryl but pt at work and makes her drowsy. No swelling or any other issues per pt.
Dizziness, loss of equilibrium.... on and off for 10 days.    Could not drive for two days.  Nausea also.
went in for her second dose on Tuesday she also got shingles; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported same events for two patients (patient himself and his mom). This is the second of two reports.  A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 78 years of age), via an unspecified route of administration, administered in arm right on 13Apr2021 (Batch/Lot Number: ER8729) as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included BNT162B2 dose 1 on 22Mar2021 (lot number: EN6208) (at 78 years of age) for COVID-19 immunisation. The patient went in for her second dose on Tuesday, she also got shingles. It was mentioned that the patient recently got diagnosed today (unspecified) so she was not taking anything currently but she takes some antiviral (not sure exactly what it was). It was clarified that the patient had not yet taken treatment for the event but the reporting other healthcare professional was sure that she will be. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381912 same reporter/drugs/events; different patients
Hives with itching on chest which appeared day following vaccine.  No cough, wheezing, N/V/D,  Benadryl prescribed
74 y.o. female admitted 1/11/2022 with PMH significant for COPD on 2 L home O2 continuously, diastolic CHF, chronic cor pulmonale, OSA, HTN, and dyslipidemia who presents to ED with complaint of shortness of breath.  Patient notes she started feeling more tired and short of breath 2 or 3 weeks ago, similar to how she felt when she was diagnosed with CHF in 2002 with dyspnea on exertion and orthopnea.  Yesterday, patient became increasingly short of breath and her daughter called her PCP to have her seen today.  On the way to her appointment patient became extremely short of breath and her daughter brought her to the ED.  Patient denies any known exposure to COVID-19 or other illness, cough, change in taste or smell, fever or chills, or N/V/D.  Of note, she states she got her COVID booster yesterday, 1/10/2022, at pharmacy.   In the ED, patient was placed on a nonrebreather at 10 L.  No documentation of O2 sat on admission.  CT angio was negative for PE, but did show mid and lower lung opacifications of bronchopneumonia superimposed upon interstitial pulmonary edema, trace left pleural effusion.  Patient's COVID test came back positive.  Of note, patient's creatinine is elevated at 1.24 beyond baseline of 0.95.  She also has a low H&H, 9.6/31.8.  During physical exam, patient desatted into the low 70s after talking and had to be placed back on nonrebreather after being on 5 L NC.  She will be admitted to hospital medicine for further evaluation and treatment.
Shingles.  Started with sore throat and headache. Pain intensified on left side only of back of head and throat/neck. Head swollen. Low fever developed. Went to urgent care twice over the weekend. Rules out strept and mono at first visit. Ruled out Covid at 2nd visit. Finally went to Emergency Rrom at hospital and they diagnosed with shingles. Treated with Acyclovir.
Patient had fever to 103 and febrile seizure (generalized tonic clonic).
Diarrhea-still occurring-getting better abdominal pain-subsided, gas subsided, abdominal cramps-subsided.
She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE on 18-Mar-2021 and Moderna COVID-19 Vaccine on 15-Apr-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine.   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 02-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.). At the time of the report, COVID-19 (She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had COVID in JUN2022 with symptoms of headache, fever, and coughing. Patient's symptoms lasted for 4 days after which she was recovered.   No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
arm pain; diarrhea non-stop; nose has been running almost non-stop; loss of appetite; Swelling in arm with pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), DIARRHOEA (diarrhea non-stop), RHINORRHOEA (nose has been running almost non-stop), DECREASED APPETITE (loss of appetite) and PERIPHERAL SWELLING (Swelling in arm with pain) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Cancer.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), DIARRHOEA (diarrhea non-stop), RHINORRHOEA (nose has been running almost non-stop), DECREASED APPETITE (loss of appetite) and PERIPHERAL SWELLING (Swelling in arm with pain). At the time of the report, PAIN IN EXTREMITY (arm pain), DIARRHOEA (diarrhea non-stop), RHINORRHOEA (nose has been running almost non-stop), DECREASED APPETITE (loss of appetite) and PERIPHERAL SWELLING (Swelling in arm with pain) outcome was unknown.            Patient claimed to have had 7 surgeries in a row, and has "no memory." He took 20 pills a day as regular medication  No concomitant information was provided. No treatment information was provided.   This case was linked to MOD-2021-370097 (Patient Link).
That evening after the vaccine patient was awakened by a sharp burning and tingling sensation in the arm vaccinated which radiated to through the shoulder , back and other arm. Nothing in the stomach area. Took 2 Excedrin tablets and pain somewhat relieved  and gradually got better and as of 5/15/2019 when she stopped in she now had only a pain and a little weakness in the left arm vaccinated. No doctor was called at time of incident but had  a scheduled appointment  with heart doctor and he said all was good. No heart new heart issues.
Prior to vaccinations, patient had a normal bowel movement every other day. The day of his 2 month vaccinations he was fussier than usual but showed no signs of fever. Patient had a small bowel movement the following day, but did not have another until 4 days later, then again 7 days after that. His small bowel movement on 11/13 was the last one he would have for 32 days. At this time, patient was exclusively breastfed with no changes to his diet or mine as his source of breast milk. During the days following his vaccinations, and the 32 days without a bowel movement, patient was fussier than usual. He seemed to eat normally, but his sleep was very uncharacteristically disruptive. We made an appointment with his vaccinating pediatrician to discuss possible reasons why he was not having bowel movements, but the pediatrician simply said that it's common for breastfed babies to go a while between bowel movements. This did not seem common so we saw a new pediatrician at a different practice. This new pediatrician did a physical and said that it could be normal for a breastfed baby to go longer periods of time between bowel movements, but he wanted to make sure there was not another issue so he tried a glycerin suppository. Patient immediately pushed it out, along with a microscopic amount of stool. The pediatrician gave us a prescription for some kind of oral infant laxative to try. We gave patient the laxative 2-3 times, but it seemed to give him cramps and didn't produce any stool so we stopped. The next step the pediatrician recommended was an x-ray to see if there was actually any stool in patient's bowel to eliminate. After the x-ray, the pediatrician stated that he saw no stool, and recommended we take him to a pediatric gastroenterologist. This did not feel right to me, so I made patient an appointment with a chiropractor. On 12/14/18 patient has his first chiropractic adjustment, and had a regular bowel movement the following day. He saw the chiropractor every day for about a week, and his bowel movements became consistent again.
Four cm area of erythema at site of tetanus injection without induration.  Resolved within several days after visit 08/23/2002.
Severe Rash on left arm and left torso / Rash was very itchy; This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th April 2020, 1 days after receiving Shingrix, the patient experienced itchy rash. On 6th April 2020, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had severe rash on left arm and left torso which was the same side as the injection. The rash was very itchy and lasted for one day. The reporter did not consent to follow up. The reporter wanted to know if this was an allergic reaction because the patient was due for her next Shingrix vaccine.