chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient ws vaccinated with a dose of ZOSTAVAX (lot#, dose, frequency and route unspecified). On the unspecified date two days later, the patient "developed shingles" The outcome of shingles was unknown. A VZVIP packet would be faxed when the correct fax number was available. Additional information has been requested.
3 seperate fever blisters confusion/loss of memory elbow pain/ armpit pain extreme chills but no fever congested nose extremely weak and tired nausea/vomiting abdominal pain off and on woke up with thick film to tongue,teeth and lips difficulty sleeping
Myalgias and low grade fever on first day.  Chest pain requiring ER visit on second day.  Exam, ECG, lab work, echo consistent with pericarditis
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 39 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: Sulfa drug" (unspecified if ongoing), notes: Allergy. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: No other medication received in 2weeks. Received treatment Paxlovid start date=23May2022 stop date=27May2022. Reported as COVID rebound symptoms extended to day 17. Felt well at day five and then poorly again on day 10. Felt better on day 12, then back to original symptoms on day 13. Patient received urgent care. Follow-up attempts are completed. No further information is expected.
Sore arm at injection site, nausea, chest and head congestion, headache, personality change, shortness of breath, coughing, excessive mucous, watery eyes: 10 days
12/18/08, received Varciella Vaccine Lot # 0720U on left upper forearm.  Immediately area swelled to size of half dollar and painful to touch. On 1/10/2008 blood work drawn for yearly exam. Normal thyroid TSH/T4. On 1/10/2008, began developing allergies to multiple insulins that was being used to treat type 1 IDDM. (Humulin R, Humalog and Novalog allergies after above Varicella vaccine.) Epi-Pen Jr. prescribed and currently maintaining. Changed rapid acting insulin to Apedria.  On 1/18/2008 blood work drawn for follow up regarding allergies and found TSH 6.01/T4 1.0.  On 2/7/2008, diagnosis of Hashimotos thyroid disease and started on Synthroid po daily, which currently is maintained.  02/15/2008 Vax and medical records recd from PCP showing WCC 12/18/07 with Varicella Vax (Merck 0720U) given.  OV 1/16/2008 due to allergy to insulin. Referred to Allergist.  OV 1/31/2008 due to anti-thyroid and anti-gliadin antibodies. Referred to endocrinologist. DX:  Thyroiditis and Celiac Disease. Referred to immunologist.  4/18/08 MR received from allergy/immunology consult from 1/17-2/14/2008 with DX:  Insulin Hypersensitivity, Recent Hashimoto's Disease and Autoimmune Polyglandular Syndrome. Pt developed possible adverse reaction/allergy/hypersensitivity to insulin injections following Varicella vax.  Insulin injections sites with significant redness, swelling and induration, as well as facial redness. Pt also with recent increase in TSH from 1/10/08 to 1/18/2008.
15:08 - Attendee received second dose Pfizer vaccine in the left arm.  Lot# ER8734. Attendee was directed to observation area.   15:10  Attendee voiced complaints of dizziness and darkened vision.  Attendee's skin was pale and clammy. Attendee denied that anything like this had ever happened to him before. Attendee assisted to the cot to lie down.  911 called. HR:  96   BP:  100/59   RR:   24   O2Sat%:  96 15:15  EMS arrived. Attendee's brother who had come with him, called their mother.  15:22 - Attendee symptoms had not changed.  EMS caring for attendee. HR:  92   BP:  108/70   RR:   24   O2Sat%:  98
Pt stated having  nauseating from the evening on 09/18/21 and still not feeling  better. Had his 3 rd Chemo 09/15/21. No swelling , fever or chills except little sore on injection site. I adviesed him to contact his Cancer provider
flare-ups where my eyes get completely puffy; underneath my eyes there's splotches of red patches; Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; 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 48-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I'm allergic to Penicillin" (unspecified if ongoing), notes: I'm allergic to Penicillin, So I'm not sure if the vaccines have penicillin in them. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization.  The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), EYE SWELLING (non-serious), outcome "unknown" and all described as "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At the time of the needle stick (prior to the serum being injected) I stated to the nurse that she must have hit a nerve.  She asked if I was in pain and I said, "Not pain, but there is an achey feeling from my shoulder to my fingertips."  She continued with the injection and withdrew the needle and at that time asked if it was still hurting.  I stated no, not at the time.  Later that evening, the left shoulder and arm was in severe pain and I was not even able to lift my arm away from my body.  I treated myself with over the counter Tylenol and was still in severe pain the next day so I sought treatment from the Occupational Health doctor on 10/7/2014.  DX was Left deltoid pain after annual flu vaccination.  I was told to ice as I could for 15 minutes at a time and to take Aleve as directed on the bottle.  I returned on 10/9/14 for the scheduled follow up and was feeling better and range of motion was improving as I was using Aleve and ice to treat.  I was told to follow up as needed.  I never improved beyond that point and the following week the pain began to get worse.  I called to see Dr. again on 10/21/14 and was told the next available appointment was on 10/23/14.  I again saw Dr. that afternoon and was given the same instructions and was recommended therapy, which was denied by Workers Compensation.  As of 10/29/14 I am still experiencing pain in my left shoulder and upper arm.  I am scheduled to follow up on 11/6/14 if allowed by workers compensation.
WITHIN 26 HOURS, PATIENT HAD A PRURITIC 7CM X 9CM ERYTHEMATOUS AREA OF INDURATION (LOCALOIZED REACTION).
Case number PHEH2016US023842, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 47-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. Medical assistant reported that 8 patients received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this maladministration (expired vaccine used).
OFF LABEL USE; VACCINE GIVEN TO 15 YEAR OLD PATIENT; This spontaneous report received from a health care professional concerned a 15 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known drug allergies, no known medications and no known medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number:1820095 expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced off label use. On 06-AUG-2021, the patient experienced vaccine given to 15 year old patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine given to 15 year old patient was not reported. This report was non-serious.
Client when rising from bed in AM was very "dizzy" falling back onto the bed. States she felt this way all day. Saw chiropractor for neck adjustment later in the day. Was still feeling "unwell" several days after receiving vaccine. No local reaction. Also complained of body aches, fever, and diarrhea. Came into health department 11/14/17 to verbalize complaint.
On July 26, 2021 I had a mild sore throat and fatigue, did a home test and was negative.  At 3 am on the 27th of July, I woke up and felt worse, achy, hot, took a home test and was positive.  I also took a PCR test and was positive.  For the next few days I slept a lot, had a mild  fever of 99-100 degrees, achy, fatigue.  I contacted my doctor and she prescribed Paxlovid, which I took the full course.  It caused some nausea and mild diarrhea.  After 5 days I was cleared to go back to work, still felt tired and fatigued, but no other symptoms.  I tested positive on a home test on day 6, and negative on a home test on day 8.  I am now feeling well and have my energy back.
I had a full grand mal seizure on the 15th. I followed up with my PCP who referred me to neurology immediately. The neurologist ran tests and autoimmune tests. The blood work was normal. EEG was normal. MRI was normal except for some black matter that has been there forever. They put me on antiepileptic drugs because I have had 2 seizures since then. I am still having some seizures and I am still on medication, which seem to be helping but it has not resolved entirely.
pt recv vax; infant inc T Fri., Sat., Sun. ; to er, mom states MD told her that it could have been vax; at home 100 & higher; apap given in er;no d;returned to MD 27jun95 for recheck;
Information was received from a physician regarding a 69 year old female patient who 5 years ago "in 2007", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not provided). The physician reported that the patient went back to her office last week "in June 2012" with shingles. The physician stated that the shingles were mild and the patient had no symptoms. At the time of the report, the patient recovered. The patient sought medical attention, by office visit of physician. Additional information has been requested.
Pt. received MMR, Kinrix, Varicella, and flu vaccines.  Within minutes she complained her throat hurt and she squated downa nd then went into a fetal type position, and vomitted (no blood).  Vomit was thick and color of her breakfast cereal.  Patient was talking and responsive during entire episode.  No loss of consciousness.  Pulse ox 98%, pulse 90-105, skin color pale.
Bell's palsy left side of face; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202) at the age of 71-years-old, intramuscular on left arm on 28Feb2021 at 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies, blood cholesterol abnormal (reported as cholesterol), and allergies to penicillin which were all ongoing. The patient was not pregnant. She has no COVID prior to vaccination and has no prior vaccination and other vaccines in four weeks. Ongoing concomitant medications included zileuton (ZYFLO CR) and budesonide, formoterol fumarate (SYMBICORT) for asthma; levocetirizine and azelastine hydrochloride, fluticasone propionate (DYMISTA) for allergies; immunoglobulin human normal (HIZENTRA); and atorvastatin (LIPITOR) for cholesterol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264) at the age of 71-years-old, intramuscular on left arm on 02Feb2021 at 14:30 at single dose for COVID-19 immunization. The patient previously took aspirin and experienced allergy. The allergy was reported to be ongoing. The facility type where the vaccine was administered as reported to be other and mega-site. The patient experienced Bell's palsy left side of face on 01Mar2021 which required physician office visit. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event and included treatment with valacyclovir 1g, 3x/day. The outcome of the event was not recovered. The event was assessed as non-serious by the reporter.
HPV9 ADMINISTERED TO PT'S LEFT DELTOID AT 1PM. PT VERBALIZED IT WAS PAINFUL. 30 SECONDS LATER. PT DROPPED HER HEAD. TRYING TO WAKE UP PATIENT AND GOT EPINEPHRINE INJECTION FROM THE CABINATE. PT WAKE UP ANXIOUS. ASKING" WHAT HAPPENED?" BENADRYL 1TSP GIVEN. MONITORED PT FOR 15 MINUUTES. PT WAS ALERT AWAKE ORIENTED PLEASANT AMBULATING OUT OF THE CLINIC AT 115PM.
This is a spontaneous report from a contactable pharmacist. A 68-year-old female patient received PREVNAR 13 on an unspecified date in Jan2017, in upper arm, at 0.5 ml single, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2017 the patient experienced really bad rash, stiffness and skin was like hard and swollen in the upper arm where she received the injection. Events outcome was unknown.
I was given the FLUMIST about 2:30 PM on Thurs. Dec 1st; after that I went home. I knew I had had a reaction from the injection over 10 yrs ago, but I said I was willing to try the nasal mist. Within several minutes, my nose started with allergic symptoms - running & some sneezing. I left about 3 PM, and they got worse on the way home. As the drippage was going down the back of my throat, I could feel the back of my throat.
About 15  minutes after my vaccine I  felt my left side of the face go numb. It fells like after having dental work and your mouth face is numb. It is still felling the same since the time of the vaccine.
I developed a non raised circular rash on each arm in the antecubital space about 10 days after injection.
Sudden loss of consciousness; Claimed one h/x of same episode 1 year ago. H/x of seizures - denied. BP 113/64 - 131/72; HR 75 -- > 92, RR 18, SpO2 100%
hives; lesions on neck and chin; This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included adalimumab (Humira).   On 28th June 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, 17 days after receiving Shingrix, the patient experienced hives and skin lesion. The patient was treated with valaciclovir hydrochloride (Valtrex), hydrocortisone and triamcinolone. On an unknown date, the outcome of the hives and skin lesion were not recovered/not resolved.   It was unknown if the reporter considered the hives and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy intern stated that the patient was on Humira was given the Shingrix and developed hives and lesions on her neck and chin. These symptoms have not resolved till the time of reporting. The patient was prescribed Valtrex, hydrocortison and triamcinolone. The pharmacy intern was not aware of the patient name, administering pharmacy or doctor's information. The pharmacy provides the patient's Humira. The reporter consent to follow up.  Additional information was not available.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
A non-serious spontaneous report of gave H1N1 to person >49 years old was received from a registered nurse/healthcare professional concerning a 57-year-old male. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Treatment of COVID-19/return of Covid symptoms; Treatment of COVID-19/return of Covid symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXIN. Past drug history included: Celecoxib, reaction(s): "Allergy:Celecoxib". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19/return of Covid symptoms ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Positive, notes: Tested positive 6 days after completing Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient experienced a return of Covid symptoms and tested positive 6 days after completing Paxlovid course.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
passed out; dizzy; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 14Oct2021 at 16:30 (Lot Number: F00809) as dose 3 (booster), single for COVID-19 immunisation. Medical history included COVID-19, hypothyroidism, arthritis, migraines, rash, GI upset and known allergies to Nexium, amoxicillin, Duricef, and Monica. The patient was not pregnant at the time of the events. Concomitant medications included levothyroxine sodium (SYNTHROID), pearls probiotics, magnesium, and amitriptyline hydrochloride (AMITRIPTYLENE). The patient previously took the first dose of BNT162B2 (Lot Number: EJ1686) administered in right arm on 30Dec2020 for COVID-19 immunisation. The patient also previously took the second dose of BNT162B2 (Lot Number: EL9261) administered in right arm on 21Jan2021 at 13:15 for COVID-19 immunisation and experienced dizzy and passed out. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Synthroid, Pearls probiotic, magnesium, and amitrpytil. On 16Oct2021 at 07:45, the patient became dizzy and passed out. The patient received treatment (Paramedics came to house) for the events. The patient had COVID-19 prior to vaccination and had not been tested for COVID-19 post-vaccination. The outcome of the events was recovered on 16Oct2021.; Sender's Comments: As there is limited information in the case provided, the causal association between the event  loss of consciousness and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
ARM ATTRACTED TO MAGNETS, SORENESS, LINGERING EAR COLD IN RIGHT EAR.
Narrative: Myalgia, Fever, NauseaVomiting, chills
Client vaccinated with Moderna vaccine x 2 in June, 2021.  Boosted with Moderna vaccine on 12/12/2021.  Symptoms started on 12/19 - chills, headache.
(L) arm 15 x 15 red, warm area in posterior aspect of (L) arm (tricep area).
39yo female patient was here with her 3 kids for well child exam on 6/27/22. They were all there receiving COVID vaccines. Mom had asked provider if she could receive her booster as well since she is here and her kids are getting theirs. So I the patient received her Pfizer COVID vaccine booster on 6/27/22 (4th dose, 2nd booster of Pfizer COVID vaccine) that was signed off by provider.  Patient previously received Pfizer COVID vaccine on 4/9/21, 5/8/21, and 12/18/21. This patient technically does not qualify for a 4th dose (or 2nd booster) because she is under 50 years of age and she's not immunocompromised. So this is an administration error without any adverse reaction.