chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breast seroma Narrative: Employee reports symptoms of injection site swelling and redness x 3 days. Additionally, employee reports development of a seroma beneath the left breast. Employee reports went to PCP and breast augmentation doctor, who both performed an ultrasound, where seroma was confirmed. Employee reports is subsiding, however is still present. No medications reported by employee.
Left arm where COVID Booster was given became painful and tigh in day 3 following injection. Area developed rash and was warm to the touch. Patient applied an ice pack to area. Redness, pain and warmth has resolved on day 6 post injection.
Covid 19 infection/SARS-CoV-2 infection; Lack of effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid 19 infection/SARS-CoV-2 infection) and DRUG INEFFECTIVE (Lack of effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced COVID-19 (Covid 19 infection/SARS-CoV-2 infection) and DRUG INEFFECTIVE (Lack of effect). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 milligram. At the time of the report, COVID-19 (Covid 19 infection/SARS-CoV-2 infection) had not resolved and DRUG INEFFECTIVE (Lack of effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, SARS-CoV-2 test: negative (Negative) negative. On 15-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was reported. Patient decided to take the Binax Now rapid test. It was negative and to herknowledge administered correctly. On Oct 15, Patient  repeated the Binax Now rapid test because her symptoms  were not better. This time there was a very faint pink line indicative of a positive test so she went in for a PCR test on the same day.   This report concerns a female patient of unknown age, with no relevant medical history, who experienced the non serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 8 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This report concerns a female patient of unknown age, with no relevant medical history, who experienced the non serious unexpected AESI of COVID 19. Additionally, Drug ineffective was considered as an event. The events occurred approximately 8 months after receiving the second dose of Spikevax. Rechallenge is not applicable since it is a COVID 19 case. The benefit-risk relation of Spikevax is not affected by this report.
Complex febrile seizure approximately 5-6 hours after flu vaccine. Medical Records received on 2/7/2005 states apnea and AE to Ativan.
Chest pain issues have resolved mostly. The most debilitating thing to come after the vaccine was the onset of ringing, buzzing persistently in left ear, comes and goes in right ear. Started 2 weeks and 2 days after second dose of Pfizer vaccine, and after flying multiple times and started when I got back on the 13th of April 2021. It has remained constant but has improved slightly from where it was in the beginning, have been doing Hyperbaric Oxygen Therapy (five 1 hour sessions, spaced about a week-week and a half apart over the last 2 months to see if things improve). Things I would say have improved but I am running out of patience and financial means to keep going to a doctor. I feel helpless, depressional, work performance is awful, and lastly very suicidal than I have ever been. Just want to die.
Child received influenza vaccine on 1-11-06. On 1-13-06 mother phoned in stating since 4 am on 1-13-06 child vomiting. Small diarrhea stool noted. Mother instructed to call family physician due to concern of dehydration.
TIRED; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, Expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (dose number in series 1).  The patient experienced tired when treated with covid-19 vaccine ad26. cov2. S (dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, Expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested.   No concomitant medications were reported.  On an unspecified date, the patient was tired (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case involving the same patient is linked to 20211244564.
Adverse reaction was not to the immediate vaccine.  The adverse reaction being reported is that  patient has tested positive for COVID-19 on 3/10/21, almost 1 month after second vaccination. Pt has been hospitalized since 2/20/21 for 1. Suspected acute toxoplasmosis 2. Severe sepsis with encephalopathy, transaminitis and acute respiratory failure d/t #1.   He had tested negative for COVID per NP PCR tests twice prior to testing positive for discharge to SNF with associated chest pains. This has prolonged his existing hospitalization
Tingling in hands and feet. Balance and equilibrium were off. Guillain Barre Syndrome.
Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd January 2023).   On 01-MAY-2023, the patient received the 2nd dose of Twinrix. On 01-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than Recommended Interval). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-JUL-2023 The pharmacist would like to know how to proceed for the 3rd dose in the series. The reporter consented to follow up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
pt recv vax & p/exp soreness & heat @ inj site devel redness @ the inj site & exp muscle aches to a point where they could not lift their arms;
Pt called pharmacy AM of 8/19 to report and get advice on her injection site reaction. Her left upper arm is bruised, swollen and painful to the touch. She has not noted any fevers or chills and will contact her physician if that should occur. Pt was advised to ice the area, take TYLENOL &/or ibuprofen and to keep an eye on the bruised area to watch for any growth or continued swelling.
According to mother, swelling and redness to right deltoid started in evening on 05-17-07, was warm to touch, and child had temp. of 99.2 F. States at 0930 this AM (05-18-07) center of redness was blistered and leaking and was hard to touch. States temp 103 F at 1100. Mother brought child to clinic at 1220. Right deltoid hard and hot to touch. 90mm W x 72mm L erythema and hardness. Center of area blistered and scabbed, clear fluid emitting from tiny blisters. Child denies pain when touched. Mom states child c/o soreness at 0930. Referred child to PCP. Mother states is taking child there now.
Pt's mom phoned clinic stating pt had fever 101.2 on 29JUN91; fever exhibited periodically til 3JUL91; rash was noted all over pt body 30JUN91;
This spontaneous report as received from a pharmacist via a company representative refers to a male patient over the age of sixty years old. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) in the forearm that caused an injection site reaction "last week", on approximately 16-OCT-2012. The reaction was described as a large deep bruise. It was also stated that the patient was administered ZOSTAVAX in forearm rather then in the deltoid region. Patient returned to his physician (unspecified by reporter) and was prescribed an antibiotic (product and manufacturer unspecified). The outcome was unknown. Additional information is not expected.
"Breakout" on face, muscle stiffness, pain in L. shoulder and neck. On 7/27/12 began feeling tingling in neck, L. shoulder, forehead, and face. Has continued.
30-day Use By Date or after manufacturer date of expiry; No adverse event; 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (30-day Use By Date or after manufacturer date of expiry).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial size was reported as 2.5 mL The vial was initially stored in the refrigerator on 30-Mar-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718108:same reporter US-MODERNATX, INC.-MOD-2023-718009:same reporter, patient 3
Mild alergic reaction in face. After 30 minutes of taken the vaccine my face started to get swollen. It was not severe so I decided to take benadryl as instructed by the nurses in rhe site and stay home till it calmed down.
Fainted:  Patient in sitting position and dropped head and started falling forward. Patient came to with 1-2 jerking motions in about 10-25 seconds.  Patient was slightly pale but did not complain for feeling faint. Continue to sit for 7-8 minutes longer.   Did not want anyone called for assistance and mother was with patient.  She left prior to the recommended time.  (Hospital is very close and they stated would head to the parking lot to be closer in case needed.)  Phone f/u call said patient tired but no further issues noted.
she was supposed to take Infanrix but instead gave ADACEL with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 months old female patient who was supposed to take infanrix but instead gave diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Prophylactic vaccination.  On 03-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- U7624AA and expiration date- 06-Dec-2024) via intramuscular route in the left thigh (strength: not provided) for Immunisation (wrong product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patients were vaccinated with LIQUID PEDVAXHIB. Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored LIQUID PEDVAXHIB was administered. No adverse effects were noted. This is one of several reports from the same source.  Additional information has been requested.
Moderna COVID-19 Vaccine Very high fever, bad headache, body aches everywhere, joint pain, disoriented, nauseous, exhausted, but unable to sleep well.  This is the sickest I've felt in decades, maybe my entire life.  Oh, and my injection site hurt too.  The night of the shot, and the day after, were the worst.  I'm writing this on the morning of day 2.  Today, the fever, body aches, and joint pain are gone.  I still have a headache (but it's better than yesterday), fatigue, and injection site pain.  After my first Moderna shot, I had a slight headache and fatigue the following day, but this second shot really kicked my ass.
Pediatrician ordered Dtap, PCV13, HepA, MMR, and Varicella vaccines for child visiting the clinic. During preparation the wrong vaccine was taken out, prepared, and administered. Instead of Dtap by itself, Pedarix (Dtap, HepB, IPV combo) was given in it's place by this RN.  Child had NO adverse reaction, and had already received Hep B and IPV vaccines on a prior date. Pediatrician was notified within 10 minutes of administration mistake and mom was called immediately but was not able to talk to her until the next morning. Mom was notified of the incorrect vaccine given and mom reported child had no adverse reactions overnight and child slept well, drank, and ate as usual.
pt recvd 2nd dose of vax & six hrs p/dose exp fever, chills, & joint pain; pt's sx resolved p/approx 24 hrs;
was administered a 3rd dose of MMR II intramuscularly; no adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose 3, intramuscular, lot # R035700 with expiration date on 09-DEC-2020, for prophylaxis (dosage schedule and anatomical location were not reported) (incorrect route of product administration). No adverse event was reported.
twenty six hours after vaccine, hands started itching. Progressed to hive type rash from waist up. Also arms from elbows to hands. Face and eyes turned red. Fifty mg of Benadryl taken every six hours times three. This morning went to a walk in clinic . Was put on a Prednisone taper over 5 days.
She got her vaccine, about 2 weeks after the vaccine she got her flu shot. 2 weeks later she noticed an area on her neck she could see the capillaries in a little cluster. A week after that she started to develop chronic hives, which started on the legs when she heated up at night. Then they continued a couple of nights after that. She went to UC ON 12/15/21 and they could not figure out why she has been getting them, and they have continued to this date.  She was given Prednisone, but didn't take it. They go away in some places and come back in other places. They would vary in size, there would be a patch where she was especially warm, the whole top leg in spots, sometimes in-between her knees. Now they are down to a few areas. She would get them on her neck, more wide areas on her legs and arms. Saw her NP on 12/17/21, and started on prednisone 20 mg, she was also prescribed Atarax which she started taking as well. With the Atarax it has calmed down some, but still has the issue. If she stops taking the Atarax she will get some breakout, and if she heats up more she will get some breakout as well. She got hot last night and woke up with quarter size areas around her body. If she goes and shovels snow and sweats they were break out. She saw allergist/immunologist who told her to continue with the Atarax and Zyrtec. She was aware of the number of people getting chronic hives within 4-6 weeks following the vaccine. She saw her PCP 2/7/22 for a physical. She had 2 FU with the NP at her PCP's office. Right now she is at a wait and see. Her PCP wants her to FU with blood work in about 3 months to see where she is at.
vaccine given on 04/21/2023 pt waited in clinic for 15 min after vaccineS was administered by the CMA -Vaccine Adm was not the correct dose for booster Bivalent. 05/08/2023 T/C with mom and explained that patient was administered a lower Moderna dose than the CDC recommends. Recommendation is to have this dose re-peated appt schedule on 05/23/2023 for booster vaccine. Mom reports patient doing fine and no concerns or reactions after vaccines.
Patient was diagnosed with Bell's Palsy 2 days after receiving shot. She started noticing symptoms the day after her shot
muscle weakness in her legs; pain in her legs; blood pressure shot up; pulse was high; queezy; dizziness; 4 inch diameter red rash; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), INJECTION SITE RASH (4 inch diameter red rash), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs) and BLOOD PRESSURE INCREASED (blood pressure shot up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE, FENOFIBRATE and FEXOFENADINE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE RASH (4 inch diameter red rash). On 29-Jan-2021, the patient experienced DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs), BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse was high) and NAUSEA (queezy). At the time of the report, DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs), BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse was high) and NAUSEA (queezy) outcome was unknown and INJECTION SITE RASH (4 inch diameter red rash) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 100/60 (High) Patient's blood pressure is around 100/60.. On 29-Jan-2021, Heart rate: 80 (High) Patient's pulse rate was around 80..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
One week later, I started experiencing abdominal cramping. The next week I started seeing blood in my stools. My colon is now inflammated.
Pain in armpit of arm where shot was given, body aches (shoulders,back), fever 101.0, fatigue
This case was reported by a pharmacist via call center representative and described the occurrence of hoarseness in a 74-year-old male patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, less than a day after receiving SHINGRIX, the patient experienced hoarseness and speech disorder. On an unknown date, the outcome of the hoarseness and speech disorder were not recovered/not resolved. It was unknown if the reporter considered the hoarseness and speech disorder to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX in the left deltoid. Within 24 hours after receiving the vaccine the patient developed hoarseness and could barely speak. When the patient first woke up in the morning, his voice was almost normal. However, within five minutes after waking up, he became hoarse again and could not speak. The patient gave permission for his physician to be contacted.
Hives appeared on my body a few days after the vaccination shot. My body itching and hives are moving around. I have visited my primary care doctor who prescribed me some anti-histamine medication. The medication helped briefly, but the symptom persists. Now I have also been referred to the specialist, with my next appointment on Dec 13, 2021.
This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A 24-year-old male patient of an unspecified ethnicity started to receive TRUMENBA (lot# s26985; Exp: 31Jan2019), via an unspecified route of administration on 12Aug2017 at 0.5 ml, single for immunisation. Medical history included allergy and exercise induced asthma; had history of high fever when gets a fever. The patient's concomitant medications were not reported. Given 12Aug2017 and worked out after vaccination. Patient experienced high fever of 104 Fahrenheit, body aches, headache, chills, skin sensitivity, Flu like symptoms. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Patient had hives and had difficulty breathing. Called 911 and paramedics administered IV benadryl
Tuesday, 12/14/2021 patient developed cough, shortness of breath, and constant chest pain. Patient also endorses loss of taste and smell at that same time.