chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports that she got her 3rd covid vaccine on Thurs 09Sep2021; Patient reports that she got her 3rd covid vaccine on Thurs 09Sep2021; has not been feeling well since; diarrhea; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Sep2021 (at the age of 56-year-old) as dose 3, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication from 01May2020 to 13Sep2021. Patient previously took two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 56-year-old) as dose 1 and dose 2, single for covid-19 immunisation. On 09Sep2021, the patient experienced patient reports that she got her 3rd covid vaccine on Thursday. On an unspecified date in Sep2021, patient experienced has not been feeling well since, diarrhea. Patient believed she was not feeling well due to covid vaccine and not missed doses of Xeljanz. Discussed missed doses and returning to regular dosing schedule. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient was accidentally given adult Pfizer gray cap vaccine instead of the pediatric formulation. Dose was 0.2 mL given but out of the adult vial and not pediatric. Patient experienced fever up to 101.7, insomnia, and stomach pain. Patient missed school and mom missed work due to illness.
Itchy rash with bumps, lasted for about 4 -5 days and then regressed.
Patient tested positive for COVID 19 on 03/21 after a symptom onset of 03/19/21. She was admitted to the hospital on 03/24 and passed away 04/19. Cause of death is listed as multi-organ dysfunction secondary to hemorrhagic shock, other contributing factors: COVID-19 pneumonia.
According to mom, received 4-year-old vaccines on Thursday.   On Friday, patient developed redness and swelling.  Patient was seen at clinic, started on Augmentin. Swelling and redness worsen.  Patient was seen by radius urgent care 2 days ago was started on clindamycin and Benadryl. Seen at ER 6/25 overall, redness has lessened.  However extending towards the distal portion of the upper arm. Ultra sound reassuring.  No abscess formation.  Labs overall reassuring.  We will continue on clinda.    At follow up today 6/28 no redness, mild crusting to popped blisters near injection site
Information has been received through the pregnancy registry from a physician concerning a female teenager who was vaccinated with a first dose of Gardasil without the knowledge that she was pregnant. It was found out that the patient was pregnant after the administration of the vaccine. Later the patient had a miscarriage. As per the reporter, the miscarriage happened "last month or so." Medical attention was sought. The patient was recovering. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Pt states that 2 days after the tetanus shot that her arm swelled and was warm at the site. Five days later - it is still swollen and a little hardened. Ice packs applied periodically. She said this happened on her last tetanus shot - over 10 years ago.
Monderna COVID Vaccine was drawn on 08/24/21 @ 12:41pm and was given outside the 12 hour period recommended by manufacture.  Vaccine was given on 08/25/21 @ 4:28pm.
Developed shingles starting on 1/30 with initial rash and 1/28 with pain. Previously had covid arm (reported separately)
Red, hot, painful and raised/swollen area around vaccination site that began shortly after receiving first shot and has gotten larger/redder since receiving the shot. I am now about 21 hours after receiving the shot and the area is approximately 2.5 inches long by 1.75 inches wide
This spontaneous report as received from a Medical Assistant refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # reported as K004552, expiration date 19-AUG-2015 (dose and route were not reported). No adverse effects reported. No product quality complaint (PQC) was reported. This is one of several report received from the same source. Additional information has been requested.
2am 2/14: vomiting, severe shaking/shivering, body hot with cold nose and feet, possible fever 2/14: nausea, body aches; 2/15: abdominal cramping, pain at base of skull, radiating to shoulders and both arms, headache; 2/16: nausea, pain at base of skull.
Immunization documents not available before physical exam (7/23/12). Later that evening documents showed patient had received a previous dose of MENACTRA in 2009.
Pt was described as being weak & spaced out but not unconscious or febrile; Episode lasted about 3 hrs; Pt slept well that night & has been normal since; Pt was not seen @ time of rxn but historically suggests a hypotonic rxn;
received the Covid-19 vaccination Friday. 6 hours later it started bothering him.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (received the Covid-19 vaccination Friday. 6 hours later it started bothering him.) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION COMPLICATION (received the Covid-19 vaccination Friday. 6 hours later it started bothering him.). At the time of the report, VACCINATION COMPLICATION (received the Covid-19 vaccination Friday. 6 hours later it started bothering him.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
1st dose 3 years ago, 2nd dose just received; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's Comments: The HCP (Health care professional) reported that patient just received the 2nd dose.  The date of 2nd dose was not provided.  The HCP (Health care professional) mentioned possible 3rd dose may be given. The HCP declined providing patient identifiers, lot number and expiration date. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Mother notes that approximately 1 month after his 4yr vaccines, he had sudden onset of unilateral hearing loss.
Pt is a 78 year 2 month old, female is here for called stated 9/19 that she had pneumonia and flu shot recently and left arm is inflamed hot and achy plan to give KEFLEX for cellulitis and note that it will increase the pt INR of the COUMADIN so watch this I will set up RTC in 2 wks or sooner if not better.
FORGOT TO TAKE THE LAST DOSE ON TIME; This spontaneous case (PVX2019-2249) was received from a consumer on 03-Sep-2019. It described a male consumer who "forgot to take the last dose on time" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer did not take the last dose of Vivotif on time. The doses were taken on 26-Aug-2019, 28-Aug-2019, 30-Aug-2019, and 02-Sep-2019, respectively.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "forgot to take the last dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the last dose on time" was considered as not applicable.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-JUL-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot # S032591, expiration date 16-AUG-2022).  Administered dose of vaccine was exposed to the temperature excursion of 13.6 degrees Fahrenheit for 12 hours (reported as multiple excursions) and 16 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.; Sender's Comments:  US-009507513-2009USA001256:
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA248540. This case involves a 16 months old female patient who experienced ACTHIB was used with sterile water, while she received vaccines PREVNAR 13, DTAP and ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 16-Aug-2018, the patient received a dose of suspect ACTHIB VACCINE lot U1945AAA via unknown route. On an unknown date, the patient received a dose of suspect DTAP not produced by Sanofi Pasteur lot number not reported via intramuscular route in the right thigh. On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. 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 and Module VI of the 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.
BRAO-branch retinal artery occlusion - October 4, 2022 Event history:  while on vacation in October 2022, I noticed an issue with my left eye.  At first I thought I had something IN my eye, then on the second day, when it was still there I thought maybe I had scratched my eye.  I called my dr. office, described my symptoms to see if flying home was a safe idea.  I knew the symptoms for a detached retina and it was not those.  I was advised that they felt it was safe to fly home on the Wednesday and attend their office on the Friday of that same week for an exam.  When I got up Thursday a.m., I called my optometrist as I assumed I would be referred there for an appointment after the dr. appointment on Friday.  They requested I come in right after lunch, which I did.  I experienced no headache, no blurred vision or other symptoms while on this trip.  We did leave VERY early on our flight out, and had written off any ill-feeling to just being tired.  When I returned home I saw my optometrist on the Thursday, gp on the Friday.  It turns out I?d had a ?stroke? in my left eye and it has left me with some permanent damage ? causing partial blindness.  It may get worse, nobody knows.  I?ve been checking in with my ophthalmologist regularly and have been advised there is no pill, surgery or hope of fixing the damage that has happened.  Apparently, this condition is something they usually see in males - 80 year olds.  It is called BRAO ? Branch Retinal Artery Occlusion.
Seizure - rigid and shaking.  Given glucose gel in mouth and seizure stopped after 6 minutes.  Fingerstick glucose of 62 at that time.  Vomited once and severe headache followed.
I received the vaccination on Friday and on Sunday my bleeding increased. I already had some mild bleeding that had been constant since Feb 23rd or 24th. But I had an appointment on Feb 26th that confirmed I had a baby with a healthy heartbeat. I was also diagnosed with a very small uterine cyst. They told me the cause of the bleeding was pro ant implantation bleeding.  I had light bleeding (bleeding just needing one or two pant liners each day) until Sunday the  7 when I saw an increase in bleeding. I called my doctor on Tuesday (I decided not to call Monday because I felt I would get the same answer I had already gotten, which was that everything was fine) and they had me come in die an urgent same day appointment. At that appointment I learned my baby did not have a heartbeat. The baby was measuring at just over 8 weeks.  The due date given to me based on my last period was October 12th. So I was exactly 9 weeks when I went into the appointment Tuesday to find out the baby didn?t have a heartbeat.  I officially miscarried the embryo and the placenta on Friday March 12th.  This would have been my second baby. My first is a male and he is 18 months old. My first pregnancy didn?t have any complications. I do not have a history of miscarriage in my family, and this was the first one I have had.  I did have to take 150mg of Clomid to get pregnant with this baby.
Patient experienced slight facial drooping and it went away after 2 hours. Cleared for second vaccine by site MD
66 y/o female presents today with complaints of fatigue and decreased appetite X 7 days ago. Pt states she is still having cough. Pt states she is having tingling to her upper body, but states she has a history of anxiety and has had the same tingling sensation when she gets anxious. Pt states she feels slightly anxious. Pt states she had 2 negative covid tests at home.
A 46 year old female patient experienced an allergic reaction with associated symptoms of shortness of breath, an urticarial lesion and the sensation that her throat was closing, after receiving post exposure treatment with RabAvert following questionable exposure to a bat. The patient reported to a bat on 07/29/04 but it reportedly disintegrated before the brain could be studied. On 09/17/2004 she was started on post exposure therapy (PET) and received the first dose of RabAvert 1ml intramuscularly along with Rabies Immune Globulin. Approximately 10 minutes after receiving the first injection she complained of a slight sensation of shortness of breath (SOB) developed on urticarial lesion on her left shoulder, and the sensation that her throat was closing. She was driven to the local Emergency Room(ER) where thy physician administered Benadryl, Pepcid, and Prednisone. She was placed on Prednisone 60mg daily. The events resolved that same evening and she contacted her private physician who advised continuing the RabAvert series, However, due to the questionable bat exposure and the reaction following the first treatment, she will not receive continued treatment.
Initial paresthesia left arm  to fingers - began @ 3P (5 hours after injection). Tenderness @ injection site.  Decreased paresthesia left arm  -  2/26/21. Tenderness @ injection site persists 2/26/21. At 12 hours post-injection - feeling generalized weakness, muscle aches, nausea, low grade temperature, chills. Slept thru the night and awoke @ 8a the next morning with the same aforementioned symptoms. Extreme weakness - able to get only 10 feet to bathroom. Slept / rested in bed throughout the day. Able to get up and get something to eat ( broth, dry toast) and start increased fluids @ 6p 2/25/21.  2/26/21 - 8am:  decreased weakness, increasing soft diet, increasing fluids; low grade temp continues. Overall feeling much better.
Pain, swelling, itching, rash  at injection site. Used ice pack and triamcinalone ointment Headache . Took aspirin General tiredness, fatique
After I received the Pfizer Dose 2, I had extreme fatigue and lot of body aches. All during the time after I had the vaccine but the symptoms got a lot worse April 25th. I had to go twice for 2 COVID-19 TEST. I  had my test at facility. I tested positive twice for COVID-19 on the week of April 25, I was really sick till like May 11th. I lost my sense of smell and taste, and extremely fatigue, and body aches everywhere, terrible cough, headache, hard time breathing, I had an oxygen monitor, but I did not get a high fever. May 10, 2021, and the Dr. diagnosed me with a sinus infection and prescribed cefdinir 300 mg, 1 capsule a day for 10 day.
Patient received second flu shot in 2017-18 season. No adverse effects reported from patient. Corporate policy requires reporting since standing order only covers 1 flu shot per patient per season.
developed rash on my right side one inch above my waste line and is about one inch in size; rash contains individual pustules.
muscles aches and headache 8 hrs after vaccine.  severe left arm/neck pain that night. 4 dizzy spells the following day with increase muscle aches, joint pain in ankles, wrists and shoulders/neck, headache, fatigue.  Overall not feeling well and joint pain, arm pain lasted 2 1/2 weeks.  These adverse reactions has cause me not to get the 2nd vaccine.
My arm hurt about an hour after. I started to get a headache and feel nauseous. I woke up at 2am this morning getting sick, with a big migraine, and not being able to hardly move my arm
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2022, the patient experienced COVID-19 (COVID-19). On 18-Dec-2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. Vaccination dates were provided as 27-Feb-2021, 20-Mar-2021 and 28-Dec-2021. Reporter did not know which vaccines corresponded to which dates. The patient received one vaccination from Moderna and two vaccinations from Pfizer. It was reported that patient had COVID-19 with previous Pfizer COVID vaccinations. Confirmation via a test was not provided. Reporter became aware that the patient had Pfizer COVID vaccinations on 07-Apr-2023. No treatment medication information was reported.
The patient was seen in the ED on 10/10/23 for evaluation of fever, generalized weakness, runny nose, congestion, and cough which started the day prior. A COVID test was done in the ED which resulted positive. Ultimately, the patient was admitted 10/10/23 - 10/15/23 with discharge diagnoses including COVID-19 pneumonia and possible superimposed bacterial pneumonia, among other diagnoses. The patient did not require supplemental oxygen during admission.   Of note, she has received four doses of the Moderna Monovalent COVID vaccine (administered 1/17/2021; 2/13/2021; 11/19/2021; 4/13/2022) and one dose of the Pfizer Bivalent COVID vaccine (administered 10/17/22).
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-JUL-2007, the patient was vaccinated at physician's with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Within the same day of ZOSTAVAX, he was treated for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, he has 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. Additional information has been requested.
Patient diagnosed with Bell's Palsy on 4/20/21, 10 days post-vaccine
joint pain, headache, muscle pain, nausea , fever, body  aches, fatigue
Pain in left achilles tendon and left knee. No swelling, just throbbing pain.; Pain in left achilles tendon and left knee. No swelling, just throbbing pain.; Skin infection under right breast; This is a spontaneous report from a contactable other healthcare professional (patient). This 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 19Feb2021 11:45 (at the age of 45-year-old) (Lot Number: EL9267) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypertension, herpes simplex type II, psoriasis, latex allergy and sulfa allergy. Past drug history included allergy to lisinopril and pethidine hydrochloride (DEMEROL). Concomitant medications included beclometasone dipropionate (QVAR), fluticasone propionate (FLONASE), levocetirizine, amlodipine and olmesartan, all taken for unspecified indications, start and stop dates were not reported. On 27Feb2021, the patient experienced pain in left Achilles tendon and left knee. No swelling, just throbbing pain. On 27Feb2021, she experienced also skin infection under right breast. All the events were considered as non-serious. The events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments taken as a result of the events included "boot on L foot, clotrimazole and betamethasone skin". The patient was recovering from the events. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
I woke up at midnight shivering.  I also have a lot of soreness at the injection site.
Note that DVT or clot is not listed as a symptom to  check above? Nothing really close to signify at VT E, can this be  added??
Patient received flu and RSV on 08/31 and 09/18. No adverse events occurred
Area of injection was red and itchy 2/4/13 she was seen in the ER and reported throat tightness but no difficulty breathing. She had urticarial rash and was treated with 5 day steroid burst. 2/5/13 no symptoms except local redness they held additional steroids. Was seen by allergist w/ prolonged urticaria to vaccine.