chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a dose of PENTACEL was administered prior to reconstituting with ActHib portion of vaccine/ no AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2-year-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] prior to reconstituting with ACT-HIB portion of vaccine (product preparation error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 02-Oct-2020, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ343ABA, expiry date-22-Jun-2021) via intramuscular route in the thigh for prophylactic vaccination prior to reconstituting with ACT-HIB portion of vaccine (product preparation error).  This was a case of actual medication error due to active ingredient not added to diluent (latency same day).  At the time of report, 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 holders 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.
Erythema, swollen 24 hours after shot given.  Indurated, warm 11 x 6 cm.  No fever, temperature 98 degrees.
Got covid with mild symptoms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Got covid with mild symptoms) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included MS and Living in nursing home.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid with mild symptoms). At the time of the report, COVID-19 (Got covid with mild symptoms) had not resolved.            No concomitant medication information was provided. Events dyspnea and cough are subsumed under the event Covid19. Patient had coughed for a month and went away and had no cough after 3rd dose, now patient had long haul COVID.   Treatment information included patient on oxygen due to breathing problems.  Company Comment: This spontaneous case concerns a 71-year-old male patient, with relevant concurrent medical condition multiple sclerosis and living in a nursing home, who experienced unexpected, non-serious AESI Covid19, after receiving a second dose of mRNA-1273.  Onset latency of Covid19 from time of vaccination could not be determined due to limited information.  It was reported that after the second dose, he developed breathing problems and got Covid19 with mild symptoms.  He also had cough which lasted for a month.  It was further reported that after a third dose of vaccination, he now had long haul Covid19 with need for oxygen.  The ongoing Covid19 pandemic could be a contributory factor.  The patient's concurrent multiple sclerosis could also be a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-642170 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old male patient, with relevant concurrent medical condition multiple sclerosis and living in a nursing home, who experienced unexpected, non-serious AESI Covid19, after receiving a second dose of mRNA-1273.  Onset latency of Covid19 from time of vaccination could not be determined due to limited information.  It was reported that after the second dose, he developed breathing problems and got Covid19 with mild symptoms.  He also had cough which lasted for a month.  It was further reported that after a third dose of vaccination, he now had long haul Covid19 with need for oxygen.  The ongoing Covid19 pandemic could be a contributory factor.  The patient's concurrent multiple sclerosis could also be a confounding factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Got rash, like dry skin, from shoulder to elbow of left arm. Sometimes it was itchy, sometimes burning. Put aloe vera on it and that helped it after a few minutes.
3 days p/inject pt experienced aching throughout lt arm w/same tingling & numbness of index & middle fingers; P/20NOV90 pain inc & is now severe; Turning neck seems to initiate pain;
At 3pm resident was taken by EMS to local hospital.  She had complained of respiratory distress (hx of COPD).   Property manager reported that paramedic said she was "in cardiac arrest".   We do not have more information at this time.
I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest; I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat; Diarrhea; Nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) and OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Has body aches from that) and Chest pain - cardiac (Cardiac history: Has chest pains sometimes (1-2x/month, or every 3 months).).    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) and OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Company comment: This case refers to a 29-year-old female patient with a medical history of rheumatoid arthritis and cardiac chest pain who experienced the unexpected events of Chest Discomfort and Oropharyngeal Pain approximately 1 day after the first dose of Spikevax. No causality assessment was provided by the reporter. The past medical history of chest pain remains a confounder.The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a 29-year-old female patient with a medical history of rheumatoid arthritis and cardiac chest pain who experienced the unexpected events of Chest Discomfort and Oropharyngeal Pain approximately 1 day after the first dose of Spikevax. No causality assessment was provided by the reporter. The past medical history of chest pain remains a confounder.The benefit-risk relationship of Spikevax is not affected by this report.
The Flu Vaccine (Flumist) was administered to the patient by his X-pediatrician and his Brother's current pediatrician on Wednesday, September 12, 2012 at around 3:45 PM. On the morning of Thursday, September 13, 2012, we noticed that he was coughing. On Thursday night the coughing was bad and the patient also had Temperature (about 100 deg F). On Friday, September 14 the cough was worse and we got an appointment with the nurse practitioner at his pediatrician's office. Upon examination, his Lungs, ears and throat were clear. We did not even think about the FluMist and did not remember to mention the same to the nurse. Nurse prescribed the patient with Mucinex for cough and Tylenol for temperature. We did not see any improvements all Saturday. Upon talking with some friends and neighbors on Saturday night, we realized that this might be an immune reaction due to the Flumist. The condition was getting worse and we rushed him to Urgent Care around 10:00Am on Sunday morning. We did mention about the Flumist to the pediatrician. Dr. diagnosed it as an Asthma attack and asked to start the breathing treatment immediately. We started treating him with Albuterol Sulfate through nebulizer (inhaler). On Monday, September 17, 2012 we took him back to see his current pediatrician and she confirmed the Asthma attack and the immune reaction due to Flumist since he has a Wheezing history. She asked us to treat him with the mixture of Albuterol sulfate and Budesonide (Pulmicort) through nebulizer. She also mentioned that if the condition does not improve then we will have to give him Oral Steroids else it will lead to pnuemonia. On late Tuesday night, we noticed that he was breathing very heavily, had Chest congestion and also had temperature (about 100 deg F). We visited his pediatrician again on Wednesday (September 19, 2012) morning at about 8:45 AM. She administered Steroids orally and levalbuterol tartrate (Xopenex) through nebulizer in her Clinic. She asked to increase the breathing treatment frequency to every 2 hours and continue with Albuterol sulfate through nebulizer.
No adverse event; Improperly stored PROQUAD was inadvertently administered; Information has been received from a medical assistant concerning to a 4 year old female patient. No medical history nor concurrent conditions were reported. On 21-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S012536, exp. date 20-OCT-2020) (rHA) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015996:
Mid afternoon this employee noted itching of both eyes with the Left eye being more affected, lids appeared to have red "whelps" on the upper Left lid.  The whelps resolved and then the upper eyelids were red and puffy when she went to bed on 9/29/09.  Upon awakening on 9/30/09 the swelling was still present, but more pronounced on the Left lid.
This spontaneous report as received from a 63 year old female with Diabetes Mellitus reporting herself. In approximately 2013 (reported as two years ago), the patient was vaccinated with a one shingle shot of ZOSTAVAX (dose, route, lot number and expiry date were not reported). Concomitant therapies included metformin, INVOKANA and LANTUS. In approximately 2013 (reported as two years ago after I received ZOSTAVAX, the patient experienced a rash on her face. Recently (unspecified date), the consumer developed a rash on her legs and after seeking medical attention from an unspecified local physician she was diagnosed with shingles (herpes zoster). The patient received "balacyclovir" (dosage/frequency/manufacturer unknown) as a treatment. There was no laboratories diagnostics performed. The outcome of herpes zoster and rash was reported as not recovered. The relatedness between the events above mentioned and ZOSTAVAX was not provided. Additional information has been requested.
Started with fever that day, not measured by family. Fever lasted 1.5 days. Patient vomited everyday since the shot and last vomited 3/28/18. Also has watery diarrhea since 3/24/18 which is now thickened up as of 3/29/18.
2nd shot was  little achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: 2nd shot was  little achy). The outcome of the pain was resolved (duration 2 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got his/ her second shot was a little achy for two days but it's all good now. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Diagnosed with Guillian Barre Syndrome (GBS); paresthesia in all extremities; falls x3; memory loss; weakness; pain; This is a spontaneous report from a contactable Other Healthcare Professional (patient) reported for herself. A 31-year-old female patient (not pregnant) received bnt162b2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 08Aug2021 at 31 years old (Lot Number: FC3181) as single dose for covid-19 immunization. Medical history was none, no known drug allergy, no COVID prior to vaccination. Concomitant medication in two weeks included omeprazole taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient experienced diagnosed with Guillian Barre Syndrome (GBS), paresthesia in all extremities, falls x3, memory loss, weakness and pain on 22Aug2021. The patient underwent lab tests and procedures which included Nasal Swab for COVID: negative on 09Oct2021. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. Treatment received for the events included PT, OT, IVIG, pain meds, lyrica, gabapentin. The outcome of the events was not recovered. The patient received the second dose of bnt162b2 (Lot number: FC3184) administered in Right arm on 02Sep2021.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Gullian Barre Syndrome, Paraesthesia, Fall, Amnesia, Asthenia, Pain and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented with generalized weakness and shortness of breath her pulse ox was 89%, she was placed supplemental oxygen.  Patient's labs within acceptable range, COVID-19 PCR came back positive.  Patient improved on Decadron with doxycycline.  Patient was able to weaned to room air within approximately five days.
no further AE; the dose expired on 16Sep2021 and was administered today 28Sep2021; the vaccine was administered to a patient outside of the age range in the PI; This spontaneous report was received from a nurse, referring to a 14 months old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  On 28-SEP-2021, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S028914, expiration date 16-SEP-2021, 0.5 milliliter one time, therapy type recombinant human albumin (rHA); strength and route were not reported) was vaccinated to the patient outside of the age range in the PI (package insert) for prophylaxis (expired product administered and product administered to patient of inappropriate age). The vaccine has not undergone a temperature excursion. No additional adverse event (AE)/ product quality complaint (PQC) presented.
Still in pain; Unable to perform daily task; Fever of 103 degrees Fahrenheit; Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes), PAIN (Still in pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily task) and PYREXIA (Fever of 103 degrees Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced RASH (Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes) and PYREXIA (Fever of 103 degrees Fahrenheit). On an unknown date, the patient experienced PAIN (Still in pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily task). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form and PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Severe rash that was isolated to the back, abdomen, stomach/rash progressed to all over the body even her toes) was resolving, PAIN (Still in pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform daily task) had not resolved and PYREXIA (Fever of 103 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 (High) 103 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  It was reported that the patient had a severe rash that was initially isolated to her stomach, back, and abdomen but later spread all over her body, even her toes.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
one of the syringes, there is a white I guess it likes white particulate. It looks like a bacterial colony/"bacterial colony" seems to have settled into the needle hub; This is a spontaneous report received from a contactable reporter (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM 197 protein) (PREVNAR 20), as dose number unknown, single (batch/lot number: FJ2602, expiration date: 30Jun2023) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED PRODUCT CONTAMINATION (non-serious), outcome "unknown", described as "one of the syringes, there is a white I guess it likes white particulate. It looks like a bacterial colony/"bacterial colony" seems to have settled into the needle hub".  Additional information: On 27Mar2023 product quality complaint group reported with description of complaint, the pharmacist stated, "I was just, see yesterday we were giving the Prevnar 20 vaccine and one of the syringes, there is a white I guess it likes white particulate. It looks like a bacterial colony. So, I just wanted to call to report that." When paraphrased the concern, pharmacist stated, "I didn't administer that the one with the bacteria in it. It is though just in the box. We need to check up the one without it but there was a syringe in there. Correct. They were not administered." The pharmacist informed product NDC# 0005200001, UPC# 300052000103. The pharmacist was informed to not discard the product, as this report would be forwarded for review to our Pfizer Quality Department. If it was needed that product was required for further evaluation, then a prepaid (withheld) mailer might be sent to you within 3 to 10 business days. The sample status, sample availability was unknown. The pharmacist informed additional information was that on 29Mar2023, a callback to reporter was placed. The reporter stated that "bacterial colony" seems to have settled into the needle hub (where the needle was screwed onto the syringe). The pharmacist stated that he will send pictures and hold syringe for mailer kit. When asked, reporter stated that the other Prevnar vaccines they had on hand were all inspected visually and did not notice any other issues beyond this one syringe.
RASH; ITCHY AREAS ON SHOULDER, EARS WAISTLINES, THIGHS AND ARMS; This spontaneous report received from a patient concerned a 90 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced itchy areas on shoulder, ears waistlines, thighs and arms. On 11-APR-2021, the subject experienced rash. Treatment medications (dates unspecified) included: calamine/camphor/diphenhydramine hydrochloride/glycerol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy areas on shoulder, ears waistlines, thighs and arms, and the outcome of rash was not reported. This report was non-serious.