chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she administered pentacel to a patient instead of the scheduled Daptacel today with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 years old female patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient instead of the scheduled Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Poliomyelitis vaccine (inactivated) (ipol) for Immunisation.   On 18-Oct-2023, the patient received 0.5 ml (Dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ957AB) (strength: standard) (Frequency: once) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation).  On 18-Oct-2023, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient instead of the scheduled Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] today with no reported adverse event (wrong product administered) (latency: same day).  It was reported, Nurse called to notify that she administered PENTACEL to a patient instead of the scheduled Daptacel today, 18Oct2023. Nurse said that patient received Ipol today as well so they're wondering if there are recommendations that can be e-mailed when patients receive an extra IPV dose! Outbound  This situation is reported as an off-label use as per local labelling due to administering PENTACEL to a 5-year-old patient. This situation is reported as a medication error due to administering PENTACEL to a patient who was supposed to receive Daptacel.  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 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.
Information has been received from a certified medical assistant concerning a 4-year-old female who in approximately 2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+0 rubella virus vaccine live.  In approximately 2002, suddenly after the vaccine was given, the patient died.  The child's autopsy was inconclusive.  No other information was available.  There was no product quality complaint.  The event was also considered  to be immediately life-threatening by the reporter.  Additional information has been requested.
Patient reported hives 2 days after receiving 2nd dose of SHINGRIX. OTC topical steroids ineffective. Gave prednisone today and advised to use topical BENADRYL for itching.
When assembling the injection, the cap on the syringe was not secured tightly enough to the end of the syringe. When attempting to attach the needle, the barrel section of the syringe slipped out of the cap. The cap assembly was not tightly secure. And cap assembly was not tightly secure.
PMH:  CAD (CABG), DM, stage III CKD; in ED tests positive for COVID; dx'd with AHRF and AKI; no remdisivir given due to AKI; treated with IV steroids; intubated requiring up to 70 L O2 supplementation; agitation worsened; developed shock; given vasopressors, antibiotics; worsening O2 needs and increase of pressors; transitioned to comfort care and pt died in the hospital
Received vaccine, 12/21/10 everything was fine. Three day later lump showed up and then it spread into a rash look spot. All on the right arm. Vaccine administered 21 December 2010 - varicella - Lot # 0758Z manufacturer - Merck. Client states everything was fine after receiving the varicella vaccine. Three days after she felt a lump on the right tricep area of her arm and it started to itch, she scratched it and the redness and the lump spread. She came in today 28 Dec 2010 to see a Health care provider, area 2.5 x 3.0inch when examined.
SWELLING AND TENDERNESS BELOW THE INJECTION SITE. SHE CALLED ME THE MORNING OF 12/11/19 TO ASK ABOUT REDNESS AND SWELLING THAT SHE JUST NOTICED THIS MORNING BELOW THE INJECTION SITE.  I TOLD HER IT WAS MOST LIKELY A SIDE EFFECT OF THE SHOT AND TO COME IN IF SHE WAS CONCERNED AND I WOULD LOOK AT IT.  I SUGGESTED TAKING TYLENOL AND AN ANITHISTAMINE. SHE CAME INTO THE PHARMACY A FEW HOURS LATER. THE AREA ABOUT AN INCH BELOW AND TO THE LEFT OF THE INJECTION SITE WAS SLIGHTLY SWOLLEN AND RED. I COULDN'T TELL IF IT WAS WARM BUT SHE THOUGHT IT WAS.  I TOLD HER IT LOOKED MORE RED AND SWOLLEN THEN I WOULD EXPECT FROM JUST AN ADVERSE REACTION TO THE  SHOT. I AGAIN SUGGESTED TYLENOL AND CLARITIN BECAUSE SHE DID NOT TAKE IT EARLIER. I ALSO SUGGESTED SHE CALL HER DOCTOR OR GO TO A CLINIC TO HAVE IT LOOKED AT IF IT DOESN'T RESOLVE SOON OR IF IT GOT ANY WORSE. SHE CALLED HER DOCTOR FROM OUR PARKING LOT AND THE NURSE TOLD HER HE SAID IT WAS PROBABLY JUST AN ADVERSE REACTION TO THE SHOT, WHICH IS NORMAL, AND TO TAKE CLARITIN IN THE MORNING AND BENADRYL IN THE EVENING.
mom called 405PM stating pt had t101.5 was having a sz;911 was called & were on the way;
I woke up on Saturday morning (May 8, was vaccinated on May 6) with a mild rash on my hands, feet and butt. On May 10, the rash spread to my entire body and has a measles-like appearance. I?m extremely itchy and can?t sleep due to being uncomfortable. Benedryl doesn?t relieve the itch.
pt recv vax that evening & devel a fever of 100 & an inj site rxn characterized by warmth, swelling & a rash;
Post vaccine pt became dizzy, sweaty and experienced nausea. Pt transferred to med obs. Accompanied by parents. Pt reports immediately feeling better after lying down on stretcher. Vitals obtained and monitored. Per on site physician - pt experienced classic non syncopal vasovagal reaction - resolved.  Pt released at 0857 with parents. Vitals as follows:  0845 LYING BP 120/83 HR 65 RR 18 SpO2 97% 0840 SITTING BP 113/67 HR 78 RR 18 SpO2 100% 0850 STANDING BP 130/75 HR 93 RR 18 SpO2 96%
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 (oral solution, strength, lot#, expiration date and dose were unknown) orally. The temperature excursion ROTATEQ was supported with in-house stability date. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Appeared to be leakage out of the hub of the needle; A spontaneous report was received from a pharmacist, concerning an 83-years old male patient, who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced incorrect dose administration.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 15-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for COVID-19 infection.    During the vaccination, the vaccine appeared to be leaking out of the hub of the needle. However, the reporter stated that most of the dose was believed to be successfully administered to the patient. No additional information was reported at the time of this report. Reporter provided consent to follow-up. No treatment information was provided for the event.   Action taken in response to the events were not reported.  The outcome of the event, incorrect dose administration was considered to be resolved on 15-Jan-2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Dizzy, thick tongue, racing heart, red ears. Benadryl 50mg im given.
No additional AE; Aphysician reported a patient (teenager) inadvertently received GARDASIL 9 instead of the flu vaccine. The four dose was administered on 03-MAR-2022; Aphysician reported a patient (teenager) inadvertently received GARDASIL 9 instead of the flu vaccine. The four dose was administered on 03-MAR-2022; 1st dose 03-DEC-2018, 2ND DOSE 05-FEB-2019, 3RD DOSE 07-JAN-2020, 4TH DOSE 03-MAR-2022; This spontaneous report has been received from a physician, concerning to a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-DEC-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number validated as R008164, expiration date reported and stablished as 12-NOV-2020), the second dose on 05-FEB-2019 (lot number validated as R011630, expiration date reported and stablished as 12-DEC-2020), and the third dose on 07-JAN-2020 (lot number validated as R030453, expiration date reported and stablished as 23-JUL-2021) (inappropriate schedule of product administration) all three doses as prophylaxis (strength, dose, route of administration and anatomical location were not provided). Moreover, on 03-MAR-2022 inadvertently the patient was administered a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliters (mL) (lot number validated as U007667, expiration date reported and stablished as 23-MAY-2023) instead of a flu vaccine (wrong product administered, extra dose administered) (strength, route of administration and anatomical location were not provided). No additional adverse events (AE) reported (no adverse event).
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/06/21Lot#EL3246 2nd dose 01/27/21,lot#EL9262 Diagnosed covid positive:08/06/21 Symptom onset:08/04/21 Exposure:community Symptoms:cough, sore throat,runny nose, congestion.
"2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Unlike the first dose, at the time of injection of my second dose, my arm immediately started stinging, turned hot, and began to swell. 48 hours after the injection, the injection site on my arm continues to stay hot and swell 1-2 inches.
Discharge Provider:  Primary Care Provider:  Admission Date: 7/22/2022 Discharge Date: Jul 25, 2022   PRESENTING PROBLEM: Shortness of breath [R06.02] Acute pulmonary edema [J81.0] Acute respiratory failure with hypoxia [J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: 84-year-old man with past medical history of chronic diastolic heart failure, hypertension, type 2 diabetes, peripheral artery disease who presented to the emergency department due to concern for worsening shortness of breath and wheezing.  His symptoms of shortness of breath and upper respiratory infection started 1 week prior to this presentation.  In the emergency department patient required BiPAP and on lab work his creatinine was consistent with 2.24.  His troponins were elevated along with elevated BNP.  COVID PCR was positive.  Chest x-ray was consistent with central vascular congestion and moderate CHF and pulmonary edema suspected foot bilateral small pleural effusions were seen. Patient symptoms improved significantly with IV Lasix diuresis.  He was eventually weaned off the roommate.  He was also started on Decadron as he was requiring oxygen but COVID positive status.  He was not a candidate for remdesivir due to the timing and creatinine at the time of presentation..  Echocardiogram was obtained which did not show any wall motion abnormalities.  Patient also felt significantly better just with diuresis however after performing multiple doses of IV Lasix patient's creatinine went back up to 2.0 hands Lasix was held at the time of discharge and patient was asked to follow with his PCP with repeat BMP within 3 days from discharge.  During this admission patient on to have gross hematuria for which he underwent renal ultrasound was negative for any abnormality.  Neurology was consulted who plans to follow up with patient as outpatient to perform cystoscopy.  Patient was encouraged to follow heart failure diet and follow up with his primary care physician after getting discharged.  Decadron was held at the time of discharge as patient is significantly improved in terms of symptoms.  Patient was offered to enroll acute care program at the time of discharge but patient refused this. Since daughter is very actively involved in his care I spoke to her and gave all the instructions at the time of discharge.  Patient was also instructed to check his blood sugars as they were slightly elevated in the setting of Decadron use in the hospital.  If his blood sugars remain elevated then he will benefit and increasing dose of his home medications.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022. Vial was placed into fridge on 12/28/2021. Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered. Manufacturer's expiry date is March 25, 2022. Provider informed. Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration'. No adverse effects noted or voiced.
I was out walking and I suddenly felt vertigo and severe pain in my neck, shoulders, and back. I went to the closest friend's house and he stated that I was dropping things/wasn't clear...rushed me to the hospital ER where the doctors thought I was having a heart attack; therefore, they ran some tests to find out. I was discharged with information about signs to look for in reference to heart attacks and asked that my PCP refer me to a Cardiologist for further evaluation.
I had the same rash reaction but only in my chest/she had the same reaction but on her chest, neck and face; Caller states she has a lot of scars on her chest, it looks like red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "I had the same rash reaction but only in my chest/she had the same reaction but on her chest, neck and face"; SCAR (non-serious), outcome "unknown", described as "Caller states she has a lot of scars on her chest, it looks like red". Therapeutic measures were taken as a result of rash.  Additional information: Patient had the Pfizer Covid vaccine 5-6 months ago. She had no new events to report. Start date and Stop date for covid vaccine was Unspecified. Investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate swelling and itching of the injection site. Area of erythema approximately 3 inches in diameter.  Tachycardia to 120 bpm. Ice applied. Swelling and itching subsided by the next morning (20 hours later).   Area of induration still palpable 44 hours later.
red rash spreading down the arm then a dark welt for 24 hrs patient took Benadryl and symptoms lessened after 24hrs leaving dark skin patch wher welt had been
Information has been received from a consumer concerning her daughter who in approximately June 2007, was vaccinated with the first dose of GARDASIL. The patient received the third dose of GARDASIL on 15-JAN-2008. On 16-JAN-2008 the patient experienced pain around the injection site. The pain began escalating since then, and radiated down to her elbow. The mother did not know which arm the reaction occurred. The mother also reported that the patient almost fainted after receiving her first dose of GARDASIL. There were no reported reactions after receiving the second dose. No further information is available.
After administration of the gardisil my 12 year old had an intense splitting headache, an intense stomach cramp, and passed out. The doctor had to monitor his blood pressure and make him lie down for a while. Even after we left the doctors office, he was having muscle spasms in his arm that lasted almost 3 hours after we left the doctors office.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 13:00 as dose 1, single (Lot number: HH7595) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Other medical history: Type 2 diabetes; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Oct2023) Positive, notes: tested positive again; (Oct2023) Negative, notes: This after 2 negative tests; (Oct2023) Negative, notes: This after 2 negative tests. Therapeutic measures were taken as a result of covid-19 treatment included paxlovid from 15Oct2023 to 19Oct2023.
pt recvd vax 16JUN93 & devel a red generalized rash, fever & arthralgia; It was felt that exp was coincidental, & not due to the vax; No further details were provided;
Onset of Pain in vaccination arm starting 19 March @ 6 days S/P innoculation.  COntinued pain and eventual reythema and swelling of affected arm, classic for cellulitis.  Patient placed on parenteral antibiotics times two days and continued on po ciprofloxicin with good resolution of symptoms.  No cutures done (no abcess)
slight nausea; "brain fog" (like a disconnect with her thinking and speech); "brain fog" (like a disconnect with her thinking and speech); aches; chills; This is a spontaneous report from a non-contactable consumer, the parent. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified birth control medications from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food or other products. On 10Apr2021 at 17:00, the patient experienced "brain fog" (like a disconnect with thinking and speech) in approximately 8 hours after shot and under 12 hours the patient had some aches and chills, took a tylenol and went to bed. On 11Apr2021, patient woke up next morning with aches/chills which lingered through part of day and also reported some slight nausea morning after shot and took tylenol a day in the morning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the aches, chills which included treatment with tylenol and hot shower. The clinical outcomes of the events  "brain fog" (like a disconnect with her thinking and speech), aches, chills and slight nausea was recovered on an unknown date of Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Warm flushed feeling, racing heart, dizziness that started about two minutes after injection. It dissipated after about 3-5 minutes.
None; Received PNEUMOVAX on 29-APR-2016 and then on 14-OCT-2019; This spontaneous report was received from a 62-year-old female patient referring to herself. The patient's historical and concurrent conditions, as well as her concomitant medications were not provided.  On 29-APR-2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, anatomical site of vaccination, lot number and expiration date were not reported). On 19-OCT-2017, the patient was vaccinated with zoster live vaccine (ZOSTAVAX) and experienced herpes zoster and post herpetic neuralgia (both captured in 1911USA011081). Then, on 14-OCT-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). It was reported that the patient did not experience adverse events with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (reported as none).; Sender's Comments:  US-009507513-1911USA011081:
pt cried hysterically almost 3 hrs normally a very good child; was given APAP q 4 hrs;