chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 YO F / was / administered the 1st(Jul-10-2021) / 2nd dose (Aug-4-2021) of the Pediarix; administered the 1st(Jul-10-2021) / 2nd dose (Aug-4-2021); 9 YO F / was / administered the 1st(Jul-10-2021) / 2nd dose (Aug-4-2021) of the Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number MK9444, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On 4th August 2021, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that, the 9 years old patient was inadvertently administered the 1st and 2nd dose of the Pediarix vaccine, which led to inappropriate age at vaccine administration. Also, the 2nd dose of Pediarix was given earlier than recommended time, which led to shortening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172397:same reporter
User error.   Patient received an initial dose thought to be vaccine through new syringe set that had been set up that was predominantly air (and not vaccine as intended). The air was palpated in slender deltoid  upon administration an raised curiosity in vaccinator who determination that adequate dosing was not given . It was confirmed that her dose was noted in vial of COVID vaccine (eg 6 doses had not been administered with hers remaining)  and patient was paged back  immediately to receive her actual 3mm dose of vaccine and received without any difficulty
My lips started to feel tingly and started to swell. A couple of hours later I developed blisters on the sides of my tongue as well as tongue swelling.
I have experiencing swelling and extreme hives that began less than two weeks after my booster.  I have since been extremely uncomfortable, itchy, and worried about any other side effects that may appear in the future.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
After 30 minutes of getting the vaccine, she felt burning sensation on the injection site, and felt dizzy and at home she developed chest tightness and had to use albuterol inhaler 2x that night and today one time after getting up this morning. Complaints of body aches, sore throat, and eye pain to both. Noted on the left deltoid, injection site with redness, swelling and complaint of pain on palpation.
9/20/2016 12:30p Patient received flu vaccine and reported a rash on chest and neck, no hives, no swelling. Pt declined treatment with BENADRYL. VS were normal. Pt took own supply of ZYRTEC and oral BENADRYL and stayed with nurse for 30 more minutes without further issues. Pt reported back at 2:40p 9/20/16 that rash improved.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 15-AUG-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L017138, expiration date 13-AUG-2016 (dose, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD lot # M006104 and expiry date 01-AUG-2017 for prophylaxis (incorrect product storage) which was reconstituted with sterile diluent (manufacturer unknown). No adverse effects reported (no adverse event). This is one of the two case from the same reported. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014450: Original Case : 1704USA014450.
Patient developed a rash at injection site. She felt as though her throat was itchy and tight. She went to the urgent care and was prescribed Keflex to prevent infection.
About 20 hours after the vaccination, I had pain and weakness in my left arm.  I couldn't lift even a cup of coffee.   I also felt very tired. I spent about 3 hours lying in bed and then felt much better; still a little tired and pain/discomfort at the injection site.  By evening (about 27 hours after the vaccine, I was totally fine and back to normal.
SAW OBITUARY FOR PATIENT IN PAPER SHE HAD JUST RECEIVED VACCINE NOT TO LONG AGO SO WANTED TO MAKE SURE THIS WAS REPORTED
the patient received the pfizer covid 19 vaccine with an expiration of 31oct2021, she was given an expired dose; fevers/ She has a fever which is causing her to be very flushed; She has a fever which is causing her to be very flushed; cold sweat; she is shivering and she was shivering so bad her teeths were shaking; She has a 'sore arm' on her arm from the shot area; She has body ache from the fever/her whole body started hurting."; she is feeling some numbness in her right leg and; Discrepancy of lot number on the vial and the insurance records; This is a spontaneous report from a contactable consumer (patients aunt) via Medical Information Team.   A 13-years-old female patient received bnt162b2 (Pfizer BioNTech COVID-19 mRNA Vaccine , Formulation: Solution for injection, Batch/Lot Number: FC3181, Expiration Date: 31Oct2021, NDC number:), via intramuscular route of administration, administered in left arm on 12Nov2021 (at the age of 13-year-old) at 12:30pm as DOSE 1, SINGLE for COVID-19 immunization at Pharmacy. The patient medical history was reported as none. The patient concomitant medications therapy were reported as none. The patient did not received any prior vaccinations within 4 weeks. On 12Nov2021, the patient received the pfizer covid 19 vaccine with an expiration of 31oct2021, she was given an expired dose, On Nov2021, fevers, she has a fever (unit not provided) which is causing her to be very flushed, cold sweat, she is shivering and she was shivering so bad her teeths were shaking, she has a sore arm on her arm from the shot area, she has body ache from the fever, her whole body started hurting, she is feeling some numbness in her right leg, she told that when she stood up on her right leg that her whole body started hurting and discrepancy of lot number on the vial and the insurance records. She said she took a video to record the vial to make sure her daughter received the right lot number. However, when she went to her car and looked back at the video, she noticed that the vial given to her daughter was expired. She said the lot number was FC3181 with Oct2021 as the expiry date. She said she went back inside the Pharmacy to inform them, but they called security on her. Then yesterday, she noticed that the lot number recorded on withheld was different from what the withheld gave her daughter. It was different from the one withheld Pharmacy submitted online and to CDC. She said withheld has this record since the hospital is the consumer's insurance company. She said the lot number on the record was FA6780 instead of FC3181. Consumer said she called to report and notify Pfizer about the discrepancy. Therapeutic measures were taken as a result of fevers/ she has a fever which is causing her to be very flushed, she has a fever which is causing her to be very flushed, cold sweat, she is shivering and she was shivering so bad her teeths were shaking, she has a sore arm on her arm from the shot area and she has body ache from the fever/her whole body started hurting includes administration of  medication Tylenol. The clinical outcome of the events was unknown for all.
Patient developed Covid-19 infection with a positive test on 05Aug2021. Symptoms included fever (up to 103 F), chills, congestion, and cough.; Patient developed Covid-19 infection with a positive test on 05Aug2021. Symptoms included fever (up to 103 F), chills, congestion, and cough.; This is a spontaneous report from a contactable consumer (Pfizer employee). A 39-year-old male patient (Pharmacist) received bnt162b2, dose 2 intramuscularly on 22Jan2021 (Lot Number: EL3246) as dose 2, single, dose 1 intramuscularly on 30Dec2020 (Lot Number: EH9899) as dose 1, single, both at the age of 39-year-old for covid-19 immunisation. No relevant medical history. No known allergies. No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Patient developed Covid-19 infection with a positive test on 05Aug2021 03:00. Symptoms included fever (up to 103F), chills, congestion, and cough. No treatment received for COVID-19. No Covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab: positive on 05Aug2021. The outcome of COVID-19 was not recovered.  No follow-up attempts are needed. No further information is expected.
Sunburn-like rash on upper-inner arm extending to just above middle of arm. (Off of injection site.) Next day, the rash turned tan-brown, like a very large bruise. The yellow hue lasted 3 days, then started fading. Area of rash got smaller and stayed, mostly, near the bicep. The color turned to a flesh-colored red. During the early days of the rash, I took Benadryl. (Not sure if it helped.) No fever during this time. No fu-like symptoms.
A report was received from a health care professional on 1/28/04 concerning a female vaccinee of unspecified age who developed redness and soreness at the injection site after inadvertently receiving a sub-optimal dose (0.1ml) of Fluvirin ID on 1/26/04, instead of Tuberculin skin test. On 1/26/04 the vaccinee received 0.1ml Fluvirin ID instead of Tuberculin skin test. The vaccinee has complained of redness and soreness at the injection site. There was insufficient information to determine the reporter's causality assessment. Update 3/12/04: Further information was received from a health care professional indicating that the vaccinee experienced redness and soreness at the injection site on 1/28/04 which lasted for 2 days. The vaccinee did not experience any further effects. Follow up pending.
just had fever for about 3 times; Covid symptoms are very mild; This is a spontaneous report from a contactable consumer (reporting for herself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with 1st shot of the Pfizer Covid Vaccine last 24Feb2021 and thinks that he was already infected with Covid even before getting his 1st shot. He said that this is because on 04Mar2021 he started experiencing some symptoms of Covid. He went to the hospital and had a Vamlanidimab infusion today and was advised not to have the vaccine within 90 days. Wants to know if it's safe for him to get the vaccine because he was already scheduled for his 2nd dose. Mentioned that he still has 4 days of required isolation left and his Covid symptoms are very mild and just had fever for about 3 times. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
5 cm by 7 cm area of erthyema and redness at the injection site.
infection aggravated; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (infection aggravated) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), PARACETAMOL (TYLENOL 8 HOUR), PROPRANOLOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFECTION (infection aggravated) (seriousness criterion hospitalization). On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was hospitalized on 30-Mar-2021 due to INFECTION. On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFECTION (infection aggravated) outcome was unknown.            No laboratory details was given. Treatment information was mentioned as the patient undergo a "sural" to right ankle as her infection did not get heal on 13 Apr 2021. Before the first dose of vaccination she was hospitalized as she felt and broke her ankle. She was admitted on 19 Feb 2021 and get discharged to a nursing home on 25 Feb 2021. During the first dose of vaccination she also received two antibiotics for her wound infection. She received second dose 7 weeks later as she had to go back to hospital on 30 Mar 2021 due to the infected hardware that they put in.  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. However the patient has a history of broken ankle, wound infection with hospitalization right before the first dose which is a potential confounder.; 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. However the patient has a history of broken ankle, wound infection with hospitalization right before the first dose which is a potential confounder.
1 week after the second dose, 32 week ultrasound shows an isolated, unspecified pleural effusion in the fetus. Previous ultrasounds were normal.
White urticarial and redness and swelling surrounding injection site 10 minutes after administration.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 21-NOV-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 18-DEC-2013, the patient was treated by a nurse practitioner at a family health center for a painful rash which was diagnosed as shingles. Although shingles is an incurable viral condition, the patient was prescribed acyclovir, gabapentin, and ZORIVAX for management of his symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
I immediately got a sore and swollen arm, them my face swelled, and I got hives all over my face. After a week the swelling and hives moved to both arms. I went to a doctor in on vacation and they put me on medicine and antihistamines.  The hives have now turned to hard bumps like cottage cheese on both arms.
Immediate metal taste in mouth, severe muscle pain, explosive diarrhea lasting for days, vomiting, chills, severe headaches (still suffering from HA), chronic fatigue (still suffering from), fever, shortness of breath, rapid heat rate.   I was too weak to even care for myself.  My diarrhea was so explosive and lasted for days, I was too nauseous to keep fluid or food down.  I missed approximately 1 week of work.
Pt developed pain and redness in right upper arm 5/22/03 at 6:30-7:00 PM. Tender to touch. Low grade fever. Now red, warm about 2" diameter.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 20-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 25-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
This spontaneous report as received from a registered nurse refers to unknown number of patients. The patients were vaccinated with M-M-R II (lot number unspecified), PNEUMOVAX 23 (lot number unspecified) and ROTATEQ (lot number unspecified) in the year 2010 that were exposed to 47 F for 72 hours. No concomitant medications were reported. The patients were not experiencing any known symptoms. It was unspecified if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Achy; tired; body aches; headache; chills; arm hurt around shoulder; This spontaneous case was reported by a consumer and describes the occurrence of body aches, PAIN, HEADACHE, CHILLS, and AXILLARY PAIN in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, METOPROLOL, SOTALOL, ENTRESTO, CLONAZEPAM, PRAVASTATIN, VITAMIN D, ALLOPURINOL, FLOMAX, and FARXIGA for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (body aches), HEADACHE, CHILLS, and AXILLARY PAIN. On 14-Feb-2021, the patient experienced PAIN and FATIGUE. The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, body aches, PAIN, HEADACHE, CHILLS, AXILLARY PAIN, and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I experienced flu-like symptoms with a slight headache and body aches for about 24 hours.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 2:35 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that vaccines went into 2-8 degree Celsius on or about 20-Dec-2021.  It was reported that the MFG Expiry date of vaccine was 04-April-2022.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).