chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired ActHIB diluent was used to administer ActHIB to 2 patients, no AE; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two patients of unknown demography, who were vaccinated with a dose of (PRP/T) VACCINE [ACT-HIB] (lot number: UJ055AA, expiry date of the vaccine is 17-Nov-2020 and expiry date of the diluent is 22-Apr-2020) via an unknown route at an unknown administration site for prophylactic vaccination on an un unknown date, which was reconstituted with expired diluent.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It was an actual medication error case due to expired product administered. It was reported that the nurse called and inquires expired Act-HIB diluent was used to administer Act-HIB vaccine to 2 patients and if would it be valid.  At the time of this report, the patient had no 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 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.
pt stated her mouth tingly, VS taken and WNL. Pt self administered epi pen. Rapid Response team called. O2@2L given to patient to help calm her down. RRT transferred pt to ER for further treatment.
arm sensation / "feels like the liquid went into muscle and just sat there; This case was reported by a pharmacist via call center representative and described the occurrence of arm discomfort in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 29th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2020, less than 3 months after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a sensation in his arm. The pharmacist describes the arm sensation stating feels like the liquid went into muscle and just sat there.  The pharmacist also stated it was a sensation was always aware of. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, headache, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the fever, headache, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had 1st dose of SHINGRIX in May 2018 with no side effects and received 2nd dose in late July 2018 in right arm, with dose 2 the patient experienced fever and headache, which began the same day, but resolved the next day. The patient reported that she had a sore arm, which began on the day of the injection, but at time of reporting had not resolved. She could not raise her arm. The call was completed with an interpreter, the dates of vaccination were not known. The patient had denied permission to contact their physician.
Starting mid afternoon I had what seemed normal for possible side effects: an incredibly sore arm and a little bit of a headache. Both continued to worsen as the day went on. I had moderate swelling at the injection site. The pain spread from my arm across my chest to midline, and across my back to the spine & up my neck. At 8pm, almost all at once, everything escalated dramatically. I was experiencing severe chills causing me to shake so much I couldn't sleep but also couldn't safely hold my baby to breastfeed. I laid down under lots of warm blankets, but could not improve the situation. After about 45 minutes, I could not move without intense pain - not turn my head, not roll over - it was every part of me, hair follicles ached, my teeth, my joints. I had a headache so severe I couldn't sleep, joint pain and stiffness, swollen glands, blurred vision. At 3:45am I made a small amount of vomit (enough to catch in mouth). I was able to sleep on and off from 3:45am-5am. The shivers waned by 8am, but I was still very achey, swollen glands, sore arm, raging headache. By late afternoon on 12/1 nothing had improved further. I went to bed early, but struggled to sleep from aches, arm pain, glands in my neck causing discomfort, and a raging headache. It is now 4 days later and I continue to ache and have a meaningful headache.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II of lots L034737 with expiry date 09-SEP-2017, L040960 with expiry date 05-MAR-2021, L036851 with expiry date 23-SEP-2017, L049455 with expiry date 03-DEC-2017 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Thickening of flem and strange feeling in my throat. Had to keep swallowing. Not sore but swollen. Possibly a little sob. I was driving and about 20 min out in a rural area. I took an ibuprofen and kept drinking lots of water. By the time I got near a medical facility it was better.
dizzy(light headed); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2022 at 11:00 as dose 1, single (Lot number: FK9894) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 12Mar2022, outcome "recovered" (28Mar2022), described as "dizzy(light headed)".  Additional information: On 11Mar2022 at 10:00 am (pending clarification), the first dose of the Pfizer vaccine was administered in to patient's left arm. The morning of 12Mar2022 running thru 20Mar2022, the patient found himself very dizzy (light headed) for eight days. The dizzy feeling slowly began dissipating on 21Mar2022 until by the sixteenth day, the morning of 28Mar2022, it was gone.
This spontaneous report was received from a physician and a pharmacist via VZV questionnaire concerning a 60 year old female patient with allergy to codeine and latex, asthma, hypothyroidism, irritable bowel syndrome (IBS), migraine and hypertension (HTN). The patient's medical history included migraine, chickenpox (exact date unknown) and an episode of herpes zoster in the left upper arm in 2010. It was reported that the patient had no prior history of herpes zoster ophthalmicus. On 25-OCT-2016 the patient was vaccinated with an unspecified dose of ZOSTAVAX (strength, dose, lot # and expiration date were not provided), subcutaneously in the left arm at another facility. Other concomitant vaccine included FLUVIRIN (strength, dose, indication, lot # and expiration date were not provided). Concomitant therapies included losartan potassium (+) hydrochlorothiazide (manufacturer unknown), VENTOLIN, nortriptyline, levothyroxine sodium (manufacturer unknown), QVAR, SINGULAIR, cyclobenzaprine hydrochloride, desonide, FLONASE, METROGEL and AMBIEN. The physician reported that, on 26-OCT-2016 (also reported by the pharmacist as at noon of 27-OCT-2016), approximately 24 hours post injection, the patient experienced a blistered rash at injection site which was diffuse, macular with elevation warm to touch; in addition, it was reported an area of redness of 22cm x 15cm elliptical around the injection site with an area of 6cm x 4.5cm bright, slightly elevated and tender. The physician reported that, on 27-OCT-2016, date in which the patient was seen in clinic, the patient had a temperature of 99.7 (units not provide) on the forehead and a temperature of 100.6 (units not provided) over rash. It was reported that the patient did not developed other systemic symptoms and had no recent exposure to chickenpox or shingles. No product quality complaint was involved and it was informed that no sample of VZIP specimen was collected. On 02-NOV-2016, the patient recovered from the events of injection site vesicles, injection site pain, injection site warmth, injection site erythema, rash maculo-papular and injection site macule. The causality between ZOSTAVAX and the events of injection site vesicles, injection site pain, injection site warmth, injection site erythema, rash maculo-papular and injection site macule was not assessed. The reporting pharmacist considered that the adverse events were no life threatening. Additional information has been requested.
I've taken a flu shot every year for the past 5 years + or minus, but this is the first time that I've taken the FLUZONE QUAD. It was administered in my left arm and there was no issue with the injection site. About 2 hours after the injection my entire arm hurt; to the point that I couldn't sleep that night. It was over a week before I could even attempt to sleep on my left side. To date, my arm constantly aches and feels heavy; I have muscle weakness and severe pain with certain attempted movements. At times, there is a tingling all the way down my arm to my fingers and across my back to my shoulder blade and up my neck; which leads me to believe that there's a nerve issue. It's been over 3 months since the injection and I need to know if this is something that I need to consult a doctor about of if it's something that will remedy itself.
pt recvd vax OCT94 & devel eczemoid rash;biopsied showing papulosquamous drug eruption,unusual contact dermatitis;condition is continuing & is being treated w/hydrocortisone cream;
23Jan98 recv 1 dose vax. 04Feb98 pt exp "head to toe rash of small bumps" No fever. Lesions were "tiny,reddish, slightly raised bumps which did not bother her". 06Feb98 pt recovered.
feverish; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Patient had no history of COVID-19. Patient had no history of Pericarditis or myocarditis.  The patient's past medical history included Shortness of breath (not diagnosed with Myocarditis or Pericarditis).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 ( Linked Report). This case was linked to MOD-2022-659965, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:crosslink case - MOD22-026769
sudden onset of lt sided facial paralysis 3MAR97 dx w/bells palsy;no tx;improving as of 10MAR97;
Patient was given #3 booster dose, about 15-20 minutes later patient report symptoms of "whooziness" and feeling off balance. Vitals were stable but after 30 min of continued observation symtoms did not improve. She was stagging while attempting to walk. Patient was taken to ER for futher evaulation and treatment. Patient was found to have an acute ischemic stroke and admitted to hospital.
felt very dizzy; severe headache for 2-3 days; lips turned blue but returned to normal color an hour later; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:15 (at the age of 23-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced felt very dizzy, severe headache for 2-3 days, lips turned blue but returned to normal color an hour later. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received as a result of events. The outcome of the events felt very dizzy, severe headache for 2-3 days were recovering, lips turned blue but returned to normal color an hour later was recovered on an unspecified date in 2021.    Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Left deltoid area appears red, swollen, and hard to the touch. Pt. appears to be doing well, no other s/s of adverse reactions.  Mother advised to apply cold/warm compress periodically and to administer Tylenol for pain. Mother verbalized understanding.
Began fever on 24th gave APAP-fever would drop, then inc; spoke w/MD who told to cont APAP; finally took to ER on 25 about 9PM w/t105.5 w/APAP;
have a lot of redness on site and a little bit of swelling; have a lot of redness on site and a little bit of swelling; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; This is a spontaneous report from a contactable consumer or other non hcp.  A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), administered in Arm Left single dose, via intramuscular route on 03Feb2021 for COVID-19 immunization. Medical history included hypertension. The concomitant medications were not reported. In the morning after her shot, her arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching. It has been going for 3 days now as of the moment. The patient stated that she still have a lot of redness on site and a little bit of swelling. Patient asked it was considered normal and this was like the third day. The patient was just put on a wet compress for the events. The patient stated that she received the 1st dose on 03Feb2021 (Wednesday) and 2nd dose scheduled after 18 days and she was asking is the timing of the 2nd dose of vaccine. At the time of this report event application site swelling and application site erythema were not recovered and other event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Loss of hearing in left ear next morning after -very high temp started next night around 5pm with chills- passed out going up stairs to bed my husband called 911 thought I had a stroke but didn't. went to bed very weak that night and next day ran high fever bad headache for two more days went to urgent care and ER 3 days after vaccine. Nothing was found to be wrong with  me bus they diagnosed a very bad ear infection which I didn't have prior to vaccine. Unable to eat and was very weak for another week. Had to seek ENT to help with ear, Gave me steroid. still have some hearing loss and crackling in my ear
Fever; chills; headache; nausea; Pain in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included vegetable allergy (Raw carrot allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 01May2021 at 02:00, the patient experienced fever, chills, headache, nausea, pain in arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, nausea, pain in arm was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported swelling, blisters in and out of mouth, whelps on legs with blisters, and itchy hands. Pt used steroid cream and put her hands in cold water to help the itching.  She called her doctor Monday, July 1st in the morning and was waiting on a return call.  She called the pharmacy around 10:30 am on 7/1/19.  I spoke with her again around 4 pm.  Her blisters and whelps on her legs had improved.  She still have blisters on her upper lip and inside her mouth.  She was still waiting on her doctor to call her back.  I suggested she call him again before they closed. Called pt on 7/2/19, blisters on lips and inside mouth are slowly improving.
Pain in right arm began within days of SHINGRIX vaccine. Pain continues currently, radiates down right arm, through elbow. Pain disrupts sleep and daily activities.
Initial report received from healthcare professional on 19 December 2013. A female patient whose age, medical history and concomitant medications were not reported, received IMOVAX intramuscularly in right deltoid, TYPHIM VI in left deltoid, PNEUMOVAX in right deltoid and TWINRIX in right deltoid (lot number, expiration date unknown) on 16 December 2013. On 17 December 2013, Patient reported that redness on the right arm from injection site up to shoulder. Laboratory investigations and corrective treatment were not reported. As of this report, the patient was recovered from the events. Documents held by sender: none.
Moderna 3/22/21 and 4/19/21. Positive on 1/23/22
pt recv vax on 16APR97;17APR97 pt refuses to bear weight on rt leg & rt leg & rt thigh edematous (not warm);
Maculopapular rash face, neck upper chest c/o feeling hot, T 97.4; decreased redness of rash approx 15-20 min after BENADRYL 50mg IM.
Fever of 100.0 F to 101.8 F without a fever reducer. Fever down to 99.0 F after taking ibuprofen. Bad aches from head to toe, including chest aches (front and back) in my lungs. Specifically I have had joint pain and lots of pain in my left armpit.
The next day I had and still have inflammation of my fingers and shoulders several days later I had a rash on my arms which has not returned  I regret taking the booster
On Thursday,1/21, I felt fine and was working.  At 1530, I began having rigors and SOB and called 911.  At the ED my temp was 103.
This spontaneous report as received from a Physician refers to a 12 months old female patient. Patient's historical vaccines included VAQTA and PREVNAR. The patient was vaccinated with dose 1, M-M-R II on 17-JUL-2012 (Lot number was reported as 1577AA). No other co-suspects were reported. On 23-JUL-2012, the patient experienced seizure (medically significant). The patient was sent to neurology. On an unknown date, the patient was given DIASTAT as a treatment for seizure. On an unknown date in 2012, the patient recovered from the event. Upon internal review the event seizure is considered as medically significant. The patient also experienced febrile seizure when on therapy with VARIVAX (Merck) (1209USA005990). Additional information has been requested.
6 days after bivalent vaccination admitted to hospital for subdural hematoma after syncopal fall -  and then readmitted 11/3 for continued subdural hematoma
severe widespread uticaria.  minimal control with antihistamines.  steroid dose park required.  vasovagal response produced a fall with fractured ankle
He developed malaise, swelling and redness of R arm 5x6cm red indurated area with tenderness developed 18 hrs after vaccine.
DTaP-IPV component of PENTACEL was administered without the Hib component with no reported adverse event; DTaP-IPV component of PENTACEL was administered without the Hib component with no reported adverse event; Initial information was received on 25-Jan-2023 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 months old male patient, the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered without the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a booster 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine without the hib component (lot number: UJ841AA, expiry date: 19-Feb-2024) via intramuscular route in the right thigh for immunisation with no reported adverse event (product preparation error) and (incorrect dose administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown 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 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.; Sender's Comments:  01462770:
Nothing happened after the vaccine. The problem is that I have a growth in my mouth (Adenoma), it was confirmed by a 2nd physician, in a regular visit to the dentist. They sent me to a specialist, and I will have an extraction next month.
Received 100mcg dose of Moderna COVID-19 vaccine instead of approved 50mcg dose.
pt resides in Rehab Center; 6/27/22 pt had a positive COVID test in the rehab center; increasing cough; entered  Medical Center with COVID dx from 6/29/22 - 7/16/22; treated with Decadron, Zosyn, Remdesivir; required stay in CCU; on BiPAP; eventually removed BiPAP and went to 7L O2 via NC, then weaned appropriately; found to have a UTI, tx with ABX; dc'd back to SNF on 7/16/22; on hospice; pt passed away in the SNF