chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A medical assistant inadvertently administered a dose of Fluzone Quadrivalent High-Dose to a 63-year-old patient/no AE; A medical assistant inadvertently administered a dose of Fluzone Quadrivalent High-Dose to a 63-year-old patient/no AE; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician and non-health care professional via Global Medical Information (GMI) - 00812680 in the United States.  This case is linked to case 2021SA344205 (same reporter).  This case involves a 63 year-old female patient who inadvertently received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and overdose)  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given  On 13-Oct-2021, the patient received 0.7 mL (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported; frequency-once; strength- High Dose) via an intramuscular route at the deltoid for prophylactic vaccination.  It was reported "Administrative agent reported that two patients under the age of 65 received a dose of Fluzone Quadrivalent High-Dose. She requested information on the use of the vaccine for this population."  It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events).  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  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.  There will be no information available on batch number for this case.
This is a spontaneous report from a 46 year old nurse referring to himself. On 7/16/99, he experienced fatigue with decreased vigor. On 7/22/99, he developed pain in his heels, the right more so than the left heel. The recent information received on 8/2/99, reports the fatigue is slowly improving and the heel soreness lasted 5-6 days.
Two days after an infusion, (five days after the shot), I got light jaw swelling at night and pain. It would last about a week or two. In April, they did a ten day course of dexamethasone
Information has been received from a physician concerning a 16 year old female patient who on 21-MAY-2007, was vaccinated with the first dose of GARDASIL (Lot # and Batch # not provided). Date of second dose not reported. On 03-APR-2008, was vaccinated with the third dose of GARDASIL (Lot # and Batch # not provided). On 02-JUN-2008, about two months after completion of the GARDASIL series, the patient experienced seizure. The patient sought for medical attention at physician's office. On unspecified date, the patient recovered from seizure. Upon internal review, seizure was considered to be other important medical event. Additional information has been requested.  8/26/08 Reviewed ER medical records of 5/31/2008. FINAL DX: new onset seizures Records reveal patient experienced an initial seizure w/LOC, dizziness, nausea, weakness, blurry vision while in restaurant.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit) outcome was unknown.        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.   No concomitant products were reported.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.  No treatment drugs were reported.   This case was linked to MOD-2022-474599, MOD-2022-479993, MOD-2022-479969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received contain significant information: narrative and date of vaccination were updated.
Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2017, the patient was administered the ZOSTAVAX vaccine (lot # and route not specified) by a pharmacist. On an unspecified date the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Heart Attack; Didn't feel good; Tested and I had Covid; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (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 had the first vaccine, 5 days later, patient didn't feel good and then 6 days later patient went to ER (not clarified) and had heart attack, patient wasn't came home and next day got tested and had Covid. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. The event outcome was unknown. Reporter seriousness was unspecified.   Information on the lot/batch number has been requested.
Vesicular rash, widespread including palms, arms, chest and site of injection. No fever or other Sx. No treatment offered, resolved on its own.
Patient described a red circular area near the site of injection on the left arm. Patient stated that it was itchy and irritated. She stated that this rash developed after the second dose of her COVID-19 Vaccine (Pfizer).
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with AGENCY concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Agencies were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Healthcare Resolution Specialist and AGENCY, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient experienced moderate flu like symptoms. The reporter did not agree to follow up from GlaxoSmithKline.
Within 15 minutes of 2nd dose, I felt chest tightness & increased angina symptoms which lasted 5 days post-injection.  Hives/urticaria developed bodywide on day 5 and have continued since (this is week 5); itchy red papules in groups on extremities, torso, back & face.
This spontaneous report was received from a registered nurse and refers to a 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 08-JUN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (dose, route of administration were not reported; lot # M040412, expiration date 30-JUN-2019). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1708USA010049: US-009507513-1708USA010050: US-009507513-1708USA010051: US-009507513-1708USA010047: US-009507513-1706USA002146:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (strength, lot#, dosage and frequency), orally. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 103.9, shaking (not seizure type), shallow breathing. Took to the ER followed up 1/26/05 with private physician. Doctor said she had an inner ear infection and URI and possible asthma, gave antibiotic and instr. to alternate Motrin and Tylenol every 4 hrs.
In general, ability to lift legs when stepping up ltd to 3". That day, was unable to lift when attempting to step into be using a smaller singular step.  Foot caught underneath and slid downwards onto lower legs (from knees down to both ankles -- including shins); no strike of hip joints incurred. Unable to rise to standing position; transported by EMS to Hospital ER.   Final ER diagnoses listed: [W19.XXXA] Fall, initial encounter [M79.604] Right leg pain  Later at home that evening, bruising noted on both knees, extending down both shins noted.
Three weeks after vaccination woke up with aching pain in legs and feet. Within 48 hours it progressed to roaming pain in arms, legs, hands, and feet which includes general aching pain, occasional muscle cramp, numb sensations that come and go - hours at a time, some tingling, very significant pain in feet when trying to walk barefoot on sand. About 10 or 11 days after that onset, I developed vertigo, having the feeling of being tipped to the left nearly constantly. Symptoms are interfering with my ability to go about daily activities, slowing me down, especially the vertigo. The pain persists even in the night.  It has been 18 days with no improvement and I am waiting for an appointment with a neurologist.
Woke the next day with terrible body aches, unable to lift left arm at all due to severe pain, fatigue, then later developed a headache, slight chills. Lasted for about 36 hours total. I took ibuprofen and acetaminophen for pain.
PT HAD TRANSIENT GLOBAL AMNESIA AS PER NEUROLOGIST THAT LASTED FRIDAY AND OVER THE WEEKEND
pt recvd vax;on 17oct had a work injury,approx 24 hrs later awoke w/ fever of 102.9; c/o redness & soreness at site;tx w/ ATB;still c/o severe pain & tenderness at site;in er;tx w/ motrin,11jan95 area still tender touch,area black & blue;
Did not get the second dose, "first dose early this year: he was unable to go get the second dose"; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get the second dose, "first dose early this year: he was unable to go get the second dose") in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the second dose, "first dose early this year: he was unable to go get the second dose"). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get the second dose, "first dose early this year: he was unable to go get the second dose") outcome was unknown.            Reporter did not allow further contact
This spontaneous report as received from a physician refers to a 19 months old male patient. The patient had no pertinent medical history and no history of drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX (reported lot number h011072, expiry date 07-JUN-2014) on 24-JAN-2013. The patient used no concomitant medications. On 28-JAN-2013, four days after the vaccination, the patient developed red, edematous bumps, pruritus and vesicles all over his body. The patient sought medical attention and visited the doctor's office. The patient was diagnosed with chickenpox. No lab diagnostic studies were performed. The event was treated with BENADRYL, TYLENOL and hydrocortisone cream. At the time of report the patient was recovering. The reporter did not provided a causality assessment. Additional information is not expected.
PT recd vax (1cc, IM deltoid) JAN91 & FEB91; 10 days p/JAN91 dose, exp proteinuria; event reoccurred p/FEB91 dose, but persisted longer; rx: prednisone & cytoxan (?); event resolved; reporter indicated PT exp proteinuria p/JUN91 vax;
Side effects from COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects from COVID-19 Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION COMPLICATION (Side effects from COVID-19 Vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects from COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
pain at the site of the injection; lymph nodes that are inflamed; Stiff neck; swollen lymph nodes; This is a spontaneous report from a contactable other hcp (patient). A 32-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 16Jul2021 (Batch/Lot number was not reported) at the age of 32 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient did not receive other vaccines 4 weeks prior to COVID vaccine. The patient received her COVID vaccine in July 16th of this year and that was the first vaccine shot. Her question was, one of the side effects is pain at the site of the injection on 16Jul2021. She asked how long that pain would last for. Immediately after the vaccine, same day as vaccine, there was definitely lingering pain for the pain, so the immediate reaction was the pain obviously and that was normal and the lymph nodes was a week after, the one week after the vaccine (Jul2021), her lymph nodes were inflamed and her neck was completely stiff. The patient had lymph nodes that were inflamed and swollen in her neck on Jul2021. This is a non-serious report. There was no treatment taken by the patient for the events. Outcome of stiff neck was unknown, while outcome of the remaining events was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt. noticed "shingles" outbreak starting after taking the vaccination - pt. uncertain if she should take acyclovir which has proven beneficial in past   states physician not giving her confidence regarding take/do not take medication after vaccination due to limited data
fever; experienced a headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Feb2021 patient experienced fever and headache. He took Advil and Benadryl after. He wants to know if he still needs to take the second dose. The outcome of the event was unknown.  Information about Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
INCREASED HEARTRATE AND SWELLING OF THROAT.  PATIENT CAME TO ME 15 MINUTES AFTER RECEIVING THE VACCINE AT APPROXIMATELY 5:01 PM.   SHE STATED THE THROAT CLOSURE WAS GETTING WORSE AND HEART RATE FELT FAST.  I TOOK BP TO FIND ELEVATION (DON'T REMEMBER THE EXACT VALUE).  HEART RATE WAS 113 BPM AT APROXIMATELY 5:O2.   (EMS WAS CALLED).   5:03 ADMINISTERED EPIPEN 0.3      MEDICS ARRIVED AT 5:05PM.    PT TAKEN TO HOSPITAL BY MEDICS AT 5:10 PM
administered adult dose of Engerix-B vaccines to a 16 year old; administered adult dose of Engerix-B vaccines to a 16 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 08-AUG-2023) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Engerix B adult. On 17-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administered adult dose of Engerix-B vaccines to a 16 year old) and inappropriate age at vaccine administration (Verbatim: administered adult dose of Engerix-B vaccines to a 16 year old). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 Nurse reported that a Medical Assistant administered adult dose of Engerix-B vaccines to a 16-year-old, which led to overdose and inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been linked with US2023099076, reported by same reporter.
within 30 minutes of receiving shot my arm become sore and stiff making it difficult to move.  Within 6 hours I was in a lot of pain and I took a  tylenol 500 and placed a heat pad on the area.  I was extremely tired and by 1am I had flu like symptoms with body aches, and severe shivering and could not get warm.  I was light headed and unable to lift left arm at all.
About 3 days after receiving the vaccine I noticed a pimple on my face and it developed into a rash in a half hour. It spread mostly on the left side, I had a little bit on my right as well. I thought it would go away, it was not bright red but at night around 7AM I noticed it was painful and also started getting darker, like bright red. I could feel it in my face, like a burning, I did not need to touch it and I could feel it. The next day I waited to see if it would go away, I did not apply anything and as it stayed the same, and at night time it would flare up, I decided to go to the Walk in clinic the next morning. I remember now she took Benadryl the first night that it flared up but it did not help.  At the Clinic they could not say exactly what it was but they said they had a co-worker that took the vaccine and had a rash in their chest similar to mine so it probably was a reaction to the vaccine. They prescribed me something, I don't remember now, but it was something to stop the burning.  I started using it (an oral pill) and no improvement. I then texted my PCP and sent a picture of my face. She decided to advise me against taking the second dose.  The rash was gone in about 6 days.
Vaccinations was site on the Left Lower arm, patient came in for the 2nd dose and said it was itching when it was his first one. No sign he said it wasn't bad at all.  1st dose 10/01/22 Time admin 10:15am
Anular erythematous lesion at site of injection 4.5. cm x 5 cm induration
Itching and slight redness around injection site, area around injection is hot and hard to the touch. About 2 inches across. From internet research it sounds like 'covid arm' but is mild and expected to go away in a few days.
Initial admin date 10/09/2021 symptoms were low grade temp 100 degrees F, chills, headache, body aches and right arm pain.  Delayed symptoms started approximately 10/13/2021- upper lip swelling, tongue swollen with bumps, sore throat, upper gum line swollen and rash along hair line that was red and itchy including itchy eyes.  Took Benadryl 25 mg tablet in the morning and evening for about a week hoping symptoms would go away, but still having swollen lip and upper gum line.  Rash is now gone (today's date 11/08/2021).  Tongue still slightly swollen.  Breathing okay, never had to go to emergency room.