chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stuffy nose; has colds; allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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: NASAL CONGESTION (non-serious), outcome "unknown", described as "stuffy nose"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "has colds"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller would like to know if she can get the new covid 19 shot, because the caller had a stuffy nose and has colds. Confirmed question with caller. She mentioned she took a COVID-19 test in the morning and tested negative, but he wanted to be sure because of her stuffy nose. Caller added she really wants the vaccine because she's had all the previous vaccines and she doesn't want to have COVID again. The caller said that she has an appointment for the new COVID-19 vaccine in about 45 minutes. The caller just has a preliminary question. The caller mentioned that she has mild congestion and a stuffy nose. The caller stated that she gave herself a COVID test at home and was negative this morning. The caller said that it could be allergies. The caller also said that she got the Pfizer vaccines and had no side effects. The caller would like to know if she can get the new Pfizer COVID-19 vaccine. Seriousness was reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UNIT HAD AN EXCURSION THAT WAS NOT CAUGHT DURING TROUBLESHOOTING. VACCINE WAS CLEARED BY MANUFACTURER. NO TREATMENT NEEDED. PATIENT WAS CONTACTED BY PROVIDER AND MADE AWARE.
Once mother arrived at home she noticed rash on cheek, arms, legs, and right side of face. On 9/8/00, when child awoke in am, mother noticed child's lower lip and left eye were swollen. Mother applied Cortisone 10 cream to relieve itching. Mother sent child to school so the school nurse could examine her. School nurse stated it appeared to be a spider or bug bite. Mother states she didn't believe it, because no other children were bitten.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in hands
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 08-FEB-2013, the patient was vaccinated with a dose of VARIVAX (merck), (lot number, expiry date and route was not reported) instead of ZOSTAVAX. No adverse event was reported. The nurse felt that the medication error was due to product confusion between VARIVAX (merck) and ZOSTAVAX and provided that the two names were similar, they both and in VAX and they were kept side by side in the freezer and it was easy to get them mixed up. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: DEXILANT; FINASTERIDE; SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (unspecified date) Negative; (13Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: patient received other medication in 2weeks. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 06Jul2022, Treatment stop date: 11Jul2022, Indication: Treatment of COVID-19. AE: had a rebound in symptoms and tested positive again after testing negative for a period of time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fatigue; muscle pain; chills; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
they only gave the dtap/polio part of the PENTACEL because it was not mixed with ACTHIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00715707) and transmitted to Sanofi on 09-Aug-2021.  This case involves a 5 month old female patient for whom they only gave the dtap/polio part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] because it was not mixed with ACTHIB  (product preparation issue).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 06-Aug-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot U6940BA and expiry date: not reported] via an unknown route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue (Latency: on the same day).  It was reported that, Caller stated they only gave the dtap/polio part of the PENTACEL because it was not mixed with ACT-HIB. AE symptoms or no AE (adverse event). ActHIB lot: UJ472AA expiry date: 21-May-2022.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  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 the 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.
2nd has been awful; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 3rd January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had zero issues. The patient received 2nd dose of Shingrix and had been awful. The patient enquired if he/she could get monoclonal antibodies treatment after getting Shingrix vaccine, would it be harmful.
had a rash all over her body; developed full blown shingles on the right side of her body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 03Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had a reaction to her first dose that she received on 03Jul2021 and stated that on an unspecified date in 2021 the patient had a rash all over her body and after a week developed full blown shingles on the right side of her body and 8 weeks later today, she was still recovering. The doctor told her not to get a second dose until she is well, and she does not consider herself well, so she asks for any information on getting a second dose after these events. The patient was recovering from the events at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Swelling, erythema Rt. deltoid, warm to touch. 9 x 9 cm.
C/o HA, mid abd pain, vomited X 1. Advised rest, fluids and supportive care.
ActHib portion of Pentacel was administered to patient more than 5 years old with no adverse event; patient received the ActHib portion of Pentacel reconstituted with sterile water with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00420275) and transmitted to Sanofi on 07-Jan-2021.  The case involved a 5 years 10 months old female patient who received the ACT-HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product administered to patient of inappropriate age) (lot: powder UJ220AA, diluent U6540AC, expiry date not reported, dose 4), but it was reconstituted with sterile water (product preparation issue)once via intramuscular route in the left thigh, for prophylactic vaccination, on 23-Oct-2020.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was a case of actual medication error due to product preparation issue and inappropriate age at vaccine administration (latency same day).  It was reported that the liquid DTaP-IPV portion was not administered.  The reporter discovered this on an audit.  Their electronic system contributed to the error because the easier way to enter a Pentacel order was by separating the two components. Reporter stated the system would allow it to be entered another way as a single product, but it was more difficult to enter it that way in the system. The reporter had already notified someone about the electronic order entry issue. The patient had an appointment this coming Monday and the office might have an opportunity to give the Pentacel dose properly at that time. The reporter asked if it hurt the ActHIB component and was the ActHIB portion was considered a valid dose.  No adverse event was reported, at the time of reporting.  This suspected adverse reaction report was 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 was 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 had contributed to or was to be held liable for the occurrence of this medication error.
Patient received 4 year old vaccines - Dtap, MMR,IPV, and Varicella.  PPD placed.  Child experienced an area of erythema approximately 6 inches in diameter - ?Dtap.  Unable to verify which vaccine due to glich in computer system.
Post Vaccine 5 to 7 minutes, swelling, red arm, temperature on site, applied ice pack, arm was better after ice pack
Per patient, "Right after the shot I experienced tingling sensation going up my neck and then had tingly and some numbness in the left side of my face, which is the same side I received the shot.  These sensations lasted for about 2 1/2 hours after the shot and then I was fine, however my arm still hurts a bit.  My heart rate did also increase, but I think this was mostly because I was extremely nervous of the other symptoms."  Today feels okay, just some soreness of the arm.  Patient is monitoring
Headache & SkinRash Narrative:  Received vaccine at approx. 1030. At approx. 1040 employee developed h/a and noted beginning phase of a rash. Sent to ED for eval. Noted to have diffuse erythematous, non-blanchable macular rash across forearms, trunk, and LE. Given Methylprednisone 120 mg IV, Benadryl 50 mg IV, Famotidine 20 mg IV, LR 1L Bolus, observed for 2 hours with improvement, discharged home.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medication were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Vomiting for 2 days, first day around 10 times, second day 4-5 times. Muscle weakness overall body 5 days, lower back muscle pain, ongoing. Nausea (bloating, gas, etc.) ongoing. Headache ongoing.
Information has been received from a nurse concerning a 65 days old male patient with no pertinent medical history reported who on 20-DEC-2004 was vaccinated with a first dose of RECOMBIVAX HB (route and lot number not reported) (manufacturer unknown). On 18-FEB-2005 and 22-APR-2005 the patient was vaccinated with a second and third dose respectively of RECOMBIVAX HB (routes and lot numbers not reported) (manufacturer unknown). It was reported that on 22-JUN-2005 the patient received a fourth dose of RECOMBIVAX HB (route and lot number not reported) (manufacturer unknown). The nurse reported that the patient had a negative hepatitis B surface antigen after 4 doses of unknown hepatitis B vaccine. Hepatitis B titer was performed on 10-MAY-2010 and the result was negative. At the time of the report the outcome of the patient was not recovered. It was unspecified if the patient sought medical attention. Follow-up information was received from the registered nurse who reported that the 5 years old patient, with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions, on 10-MAY-2010 was stuck with a needle that has been contaminated while he was receiving a MMR II (Merck). Laboratories were done on the employee involved on the incident and also in the patient. The patient's labs revealed negative hepatitis B surface antigen and negative hepatitis B surface antibody, complete blood count were within normal limits. RPR with reflex titer was non-reactive and HIV 1/2 screen reflex WB was not reactive. No further information is available.
Rash around injection site.  Took allergy medicine before going to bed.  Rash improved somewhat 3/19/21.
Woke up Saturday and couldn't lift arm up.  Pain from shoulder to elbow.  No real redness or swelling, just painful.  Took Tylenol.  Called PH on Monday.  Advised cool compress, Tylenol or Motrin, call PMD if persists.  Saw PMD on 10/22/2009.  Given Vicodin for pain.  Had CT scan, x-rays and blood tests.  Saw PMD x 3 visits.  Also given antibiotics in case of infection but told by PMD to stop before completed.  As of today, 11/2/2009, still painful and cannot raise arm.  Hurts to touch where injection was given.  Also reported immediate pain at site after injection.  Continues to take Vicodin at night for pain.
Patient came into pharmacy for scheduled vaccine appointment. They stated they were nervous about needles but that they wanted to get vaccine today. Patient was able to have a normal conversation about travel plans while I administered vaccine. Right after administration I turned to get band aid and patient fainted out of chair. His companion and I got him seated again right after and he resumed normal behavior. I gave patient cold compress and observed him for about 20 minutes.
Couldn't sit up or stand up. Pressure in head, room spinning.  Had to hang on to something to get to bathroom.  Had to stay in bed. Extreme nausea. Sip of water made it worse. Temperature 3 degrees higher than my normal.
Injection stung at site. Arm was sore in the evening. Nausea throughout the following day, along with growing pain in my lower back. I vomited my dinner in the evening. Then next day, my lower back pain increased and I was bedridden. I figured my kidneys were hurting me. I couldn't stomach anything until about mid-day. Finally, just a piece of toast. I have no issues with urination, but I noticed a decrease in urination especially for the next following days. It took me about a week to get back to my normal routine.
This vaccine was used after BUD.  Patient did not report any adverse reaction after receiving this vaccine.
This vaccine was given outside of the approved age range related to the Moderna COVID-19 vaccination.  The patient is only 15 years of age and did not meet the minimum requirement of 18 years old.  The patient has not demonstrated any abnormal outcomes related to this vaccination.  We will follow current CDC recommendations to give the second dose at the appropriate interval of 28 days from the first dose since this child is between 12 and 18 years of age.
Patient called today stating she experienced an allergic reaction to the Pfizer BioNtech vaccine which she received on 1/4/22 at 9:18am. Patient went home, and around 10:40am when she got home. She began to have facial swelling. The patient called me today 1/5/22 at 2:15pm to report that her eyes and face were still swollen since yesterday. The patient was instructed to go to emergency room as this is where her primary care physician is located. The patient agreed to go to the ER immediately.     Medical Provider who was on site was notified of incident.
From telephone encounter notes: Had FLUMIST vaccine yesterday (1/10/2019). Today woke up feeling itchy this morning. Now rash (little red raised bumps, like freckles) over upper chest, upper back, neck, chin and right ear. Right ear, soft tissue is slightly swollen. Feels warm and itchy over rash area. No SOB or difficulty swallowing. No headache, dizziness or difficulty speaking. No fever. No nausea, vomiting or diarrhea. Has had the flu vaccine in previous years with no reaction, first mist vaccine. No change in diet, soaps, lotions or laundry detergent.
As of disease investigation date of 8/24/21 case reported symptom onset of 8/14/21 which included sore throat, new olfactory disorders, headache and cough which resolved 8/21/21.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored doses of M-M-R II (lot # L032182, expiry date 25-AUG-2017) (strength, dosing details, anatomical locations were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Fever of 102. Body aches. Headache. Dizziness. Blurry vision. Confusion. Chills. Fatigue. Malaise. Extreme thirst. Sudden extremely painful sharp pains in ears, temple area, and left hip.  These symptoms lasted 3 days. I still have the same sharp pains in my ears and temple area daily but not as frequently now.
I got a flu shot one time it have me the flu; Initial information regarding an unsolicited valid non-serious case received on 15-Dec-2020 from a consumer (patient) via social media.  This case involved a patient of unknown demographics who got a flu shot one time it had patient the flu (Influenza), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got a flu shot one time it had patient the flu (Influenza), following the administration of INFLUENZA VACCINE.  Patient hadn't had a shot since and haven't had the flu Either.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was reported as Unknown for reported event.  There will be no information available on batch number for this case.
One week subsequent to receiving one dose of varicella virus vaccine live the pt experienced a mild illness with a rash and a fever of 100F. The rash started on her face and spread to her back and feet. There were only a few spots and no other symptoms. The pts experience was felt to be a post vaccination rash.