chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The whole body was red and swollen, including the face and eyes. Some cough (+) but no difficulty with breathing.
Started with shaking body then began pain in waist, toe and ankle joints, knuckles/fingers wrists. Then hands because numb as I started to lay in bed. Then numbness in feet, toes, hands, face, nose, chest and severe stiffness to the point I could not move.
pt recv vax 20AUG98 & 21AUG98 pt exp inj site rxn which was described as 50 cent to 4 inch red, swollen, warm area @ the site of vax;3SEP98 thigh felt warm to touch, red, swollen;
administered an expired lot for ACTHIB with no reported Adverse event; Initial information received on 06-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient who was administered an expired lot for HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Jul-2022, the patient received a dose 1 of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via intramuscular route in unknown administration site, on 16-Sep-2022 also received a Dose 2 of the same vaccine, on 19-Nov-2022 also received a dose 3 of the same vaccine. On an unknown date patient also received a dose 4 Booster dose 0.5 ml of the same vaccine lot UJ787AA expiry date: 11-Aug-2023 via intramuscular route in the left thigh for immunization.  On an unknown date the patient administered an expired lot for acthib with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired lot for acthib with no reported adverse 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 is a spontaneous report from a contactable consumer (mother). This is a clone reports are created to document the first daughter's experience. This is report two of three. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Aug2021 for COVID-19 immunization. The patient age at the vaccination is 22-years-old. The patient medical history were not reported. The patient concomitant medications were not reported. No Prior Vaccinations within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect was not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect was not provided. Second dose was Tuesday 24Aug2021. On 07Aug2021, It was reported that weekend after 03Aug2021 her daughter went to emergency room the following weekend for abdominal pain, but she had no fever, no chills. They didn't treat her but released her. On unknown date in 2021 outcome of event was recovered. Information about lot/batch number has been requested.
After receiving Pfizer vaccine, Husband began having weakness in his legs to the extent that it was hard for him to walk. No pain just major weakness. After booster shot in November he appeared that he was having a stroke as he could not put one foot in front of the other and legs gave out, had the shakes and could not walk.
inc c rying w/in 3hr of vax-fever up to 101R, emesis x 2;APAP pt calm (mild, swelling, firm nodule lt thigh inj site;
Hives.  Still have as if this date.  Benadryl,  prednisone
This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot #'s, expiration dates, doses, frequency were not reported). No adverse effect were reported and no product quality complaints (PQC) were involved. Additional information has been requested.
within 4 hours i had a headache, nausea, fatigue, and then next day I was  lightheaded and almost passed out 3x in a couple hours (this was 24 hours after the shot).  Felt feverish and unable to get off the couch but worst part was feeling like my vision was clouding over, nauseated,  and i was about to pass out.  Every time i tried to get up or walk, i felt like i was going to faint. This lasted about 2-3 hours and then i was just fatigued.  Arm was very sore day 2 and i had a rash about 3 inches below vaccination site.
lt deltoid sore almost immed p/vax localized reddness & tenderness w/whelps & rash developing w/in 24hrs;low grade fever;
Patient was given a Tdap injection previously on 04/03/08 and another Tdap injection today 06/05/08.
After vaccine of #2 dose varicella on 18 March 03 noticed small redness on thigh (am 20Mar 03) apprx. 1 in diameter- Increased to hand size by 1300. red area with yellowish center-no lesons. No fever. instructed to see MD. 24 Mar 03- site improving. Still tender.
Could not go to the bathroom on his own; "fecal matter had gotten in a crease of his butt and he was deathly ill."; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Could not go to the bathroom on his own) and FAECALOMA ("fecal matter had gotten in a crease of his butt and he was deathly ill.") in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Could not go to the bathroom on his own) (seriousness criteria hospitalization and medically significant) and FAECALOMA ("fecal matter had gotten in a crease of his butt and he was deathly ill.") (seriousness criteria hospitalization and medically significant). At the time of the report, CONSTIPATION (Could not go to the bathroom on his own) and FAECALOMA ("fecal matter had gotten in a crease of his butt and he was deathly ill.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient went to hospital and had surgery. No relevant concomitant medications were reported. Treatment includes colostomy. Patient date of birth reported as 08-Aug-2021. Reporter informed her friend who was also getting a colonic and She states he could not go to the bathroom on his own. It turned out "fecal matter had gotten in a crease of his butt and he was deathly ill." He went to the hospital and had surgery. He had a colostomy. Company Comment: This case concerns a 61-year-old, male patient with no medical history reported, who experienced the unexpected serious events of Constipation and Faecaloma, for which the patient required hospitalization and a colostomy. The events occurred at an unknown day after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition and hospitalization.   This case was linked to MOD-2021-403110 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient with no medical history reported, who experienced the unexpected serious events of Constipation and Faecaloma, for which the patient required hospitalization and a colostomy. The events occurred at an unknown day after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition and hospitalization.
1100.- Vaccine given,  1115- pt. felt dizzy - difficult to breathe  1118- nausea- RN with  patient - 1120- B/P 198/115- HR 82- O2 Sat 99%- MD notified - 1126- B/P 187/112 - HR 80 - O2 sat 100%- M.D. with  patient - eyes red- no itchy throat- no swollen throat - no swollen legs, arms,  or hands- 1130- patient taken to ER via gurney, accompanied by staff
pt recvd 2nd dose of MMR & had a syncopal or vasovagal episode; pt recovered w/o any residual effects; No further details were provided;
Pt developed bump in muscle immediately following shot. Pt reported no numbness or tingling and was able to move arm and fingers appropriately. A cold compress was applied immediately after shot and pt was monitored for signs of allergic reaction. Pt MD was notified and RPH will follow up with pt also.
pt recv vax; devel chicken pox like lesions & urticarial lesions;
Patient was nervous for shot and also did not eat that day. He received shot and was in counseling room still when fell back to the wall and he fainted. His mom was there and caught him.  no Injuries present. He looked pale but regained consiousness immediately. We had patient lay down for a few minutes. He felt better and we gave him some water. The parents stayed with the patient afterwards in the pharmacy to make sure he was ok for about 25-30 minutes. He was fine and the parents felt good to leave.
She became very irritable shortly after leaving the doctor's office. Refused to eat and not herself, crying a lot and wanting to be held..unwilling to sleep. When I tried to put her down in her crib, she completely lost control, screaming violently and throwing herself against the sides of the crib. She continued to so this every time we put her down until I rocked her and calmed her to the point of almost sleeping. She has never displayed this type of behavior before.
PT RECIEVED THE FIRST DOSE ON 8/5/21 THEN THE 2ND DOSE ON 8/20/21.  IT IS MODERNA AND SHOULD HAVE BEEN 28 DAYS
Patient was given the Pfizer COVID-19 vaccine 8 days after the extended expiration date.  The patient did well during the waiting period after the vaccine. PRIVATE Control was called and message was left on the patient's phone to return call to our facility.  We plan to re-vaccinate per guidance from the PRIVATE Control Center.
Patient was given GARDASIL on left - arm, subsequently, given MCV4 on right arm. Patient was fine. I stepped out and 10 seconds later Mom yelled patient had fainted. He quickly recovered. Dr immediately evaluated, was given ice pack and watched over a period of 15 mins. Orthostatics were taken and was discharged by Dr.
Swollen and itchy hands, along with itchy chest, heart palpitations, jitters. PCP recommended BENADRYL.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients. On an unknown date the patients may had vaccinated with improperly stored VARIVAX (strength, route, lot number and expiration date not reported). The vaccines were transported in a brown bag. No adverse effects were reported. This is one of two reports from the same reporter (1405USA009182). Additional information has been requested.
Went for a booster vaccine as was previous one was the Johnson vaccine. Did not have this occur at all with the Johnson vaccine or any vaccine in my life .  Received the Pfizer vaccine and quite fast lips and mouth started burning and a metallic sulfur taste strongly emerged.  Was dizzy next day as well. Most resolved but  It is five days later and the disgusting taste thing is still here.
patient received ADACEL last year and was mistakenly given another dose of vaccine with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 years old female patient who received Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] last year and was mistakenly given another dose of vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jul-2022, the patient received a 2nd dose 0.5 ML (once) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (lot U7266AA, expiry date;11-Jan-2024, strength; standard, formulation: unknown) via intramuscular route at Left deltoid for immunization.  It was reported, the patient received adacel last year and was mistakenly given another dose of vaccine with no reported adverse event (extra dose administered) (onset 14-Jul-2022, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.  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 guidelines. 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.
Pt has a rash (6x7cm oval area of erythema noted (R) deltoid no absEss or depot)
received a second dose of Arexvy today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5, expiry date 28-JAN-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 27-OCT-2023, the patient received the 2nd dose of Arexvy. On 27-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received a second dose of Arexvy today). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 27-Oct-2023 The registered pharmacist reported that the patient received first dose of Arexvy a little over 2 months ago in August. The reporter consented to follow-up. This is 2 of 2 inked patients reported by the same reporter for different patient. The patient received second dose of Arexvy on the day of reporting, which led to extra dose administered.; Sender's Comments:  US-GSK-US2023149472:2nd patient
24hr post vax arm began to hurt-getting increasingly worse-spreading down arm-body aching-flu like feeling-skin sensitive, sweat, cold, h/a, cramps in calves of legs, weak, hurt to lay down, arms & fingers hurt;called MD
Breakthrough case admission after 3 vaccines Moderna 3/6/21 Lot# 010A21A;  Mderna 4/3/21 Lot# 025B21A;  Moderna 11/17/21 Lot# 034F21A
experienced (atypical to me) extremely debilitating cramps; menstrual blood shedding in large clots.; Only slight soreness at the injection site; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in the left arm on 28Apr2021 (at the age of 26-year-old), as DOSE 2, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included depression, anxiety and sunflower seed allergy from an unknown date and unknown if ongoing. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications included Ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unspecified indication and Sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took menthol (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration, administered in the left arm on 07Apr2021 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunization and experienced vaccination site pain (slight soreness at the injection sight). The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced only slight soreness at the injection site and on 03May2021, got first period (5 days after second dose), experienced atypical to her extremely debilitating cramps and menstrual blood shedding in large clots. The patient did not received treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:38 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.93 on 03-Mar-2021 and 42 years on 30-Mar-2021.  Concomitant products were not provided.  On 03-Mar-2021, at excursion time 09 AM, temperature was 51, at 10 AM, temperature was 34, at 01 PM, temperature was 35. total doses given for the day was 200, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 31-Mar-2021, at excursion time 09 AM, temperature was 32. total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I woke up the morning after getting the vaccine feeling total body soreness. I took 3 ibuprofen in the morning. Later in the day at work, I felt shivers, lightheaded, and dizzy. I took my temperature 3 times and it was 99.5, 100.7, and 100.2 degrees Fahrenheit. I felt feverish for the rest of the night. I woke up on 1/20/2021 without a fever.
Red raised 2 inch radius around injection site to Right Deltoid from Influenza vaccine. Skin warm to touch, and reddened, no bruising, swelling, or excudate from site.
Severe body and joint pain, fever (103.1), chills. Fever broke in 24 hours however I developed multiple large fever blisters on my lower lip (2), upper lip (4), corner (right side), and the entire roof of my mouth.
Fever; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site) in an 81-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 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant and treatment medications were reported.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Discharge Provider:  Primary Care Provider:  Admission Date: 9/17/2022 Discharge Date: Sep 21, 2022  PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 (HCC)  COVID-19 virus infection Chronic obstructive pulmonary disease in acute exacerbation (present on admission)   HOSPITAL COURSE: Patient is a 71-year-old man admitted to the hospital with increased shortness of breath and cough.  He has a past medical history of tobacco abuse, peripheral vascular disease, coronary artery disease and diabetes mellitus type 2. He was started on prednisone, Symbicort, Spiriva and albuterol.  He had acute hypoxic respiratory failure upon presentation and was weaned off of oxygen the day of discharge.  Patient has significant peripheral vascular disease which makes it difficult to have a good pulse oximetry reading.  After using a probe on his ear, he was satting at 94% on room air.  He was no longer short of breath and was able to ambulate without difficulty.  He is also no longer requiring isolation for his COVID-19 infection.  Tobacco cessation was recommended and he thinks that he can continue to avoid smoking cigarettes.