chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hours after 4 month vaccines given, pt with fever, multiple episodes of emesis and several cyanotic spells. 1 spell lasted 30-60 seconds - patient went limp, unresponsive, blue in color, other shorter episodes followed. Patient admitted to hospital overnight for observation. No treatment needed. Bright red streak in vomit.  6/10/09 ER record received for DOS 3/4/09 with dx: ALTE. vomiting, dehydration. Pt presented after several episodes of cyanosis, pallor, unresponsiveness and limpness after vomiting, lasting ~1 minute. Multiple vomiting events with one blood streaked emesis. No further events in hospital.  Observed o/n and d/c.
Presented to the ED on 4/25 with severe R calf swelling and pain x4-5 days. Found to have ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT FEMORAL, POPLITEAL, POSTERIOR TIBIAL, PERONEAL VEINS  and ACUTE THROMBOSIS IN THE DEEP VEINS OF THE RIGHT CALF. Admitted for systemic anticoagulation and possible catheter-directed thrombolysis given extent of clot burden and symptoms.
Ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included detached retina and melanoma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine besilate and benazepril hydrochloride (LOTREL), venlafaxine hydrochloride (EFFEXOR) and atorvastatin calcium (LIPITOR), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 08Feb2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 05Mar2021 at 15:00, the patient experienced ringing in ears. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
9/25/09 C/o "When I lift my left arm it feels like ripping off tape, not every time just once in a while.  C/o slightly numbness to ankle area.  9/28/09 status symptoms are now gone.
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/15/2021.
Pt recvd flu vax & pt devel low grade fever, malaise, runny nose & cough;
Arm pain starting within hour. Extreme dizziness staring at 6 hours. Falling down, Falling into walls and furniture. Inability to walk more than 50 feet without stopping to let head spinning stop. Unable to walk without holding walls, rails, etc. No pain or any adverse effects with does one and two.
Approximately 7 - 7.5 hours after vaccine administered developed "mosquito bite" like itching bumps on neck and both inner elbows. Lasted one hour or so, then would disappear, then re-occur off and on - last episode 3/23/2005 PM.
This is a spontaneous report from a contactable consumer who reported for himself. A 68-year-old male patient received a single dose of PREVNAR 13, in Jan2016 at about 10am, in left arm for immunisation. Medical history included high blood pressure for about 2 years and ongoing, cholesterol for about a year and ongoing, vitamin D deficiency for about 2 years and ongoing, enlarged liver from Aug2015 and ongoing, gallbladder stones from Aug2015 (found on an ultrasound). Past drug event included hives with penicillin about 10 years before the report. Concomitant medication included lisinopril tablet at 20 mg daily  oral from about two years and ongoing for blood pressure high, pravastatin at 20 mg 1x/day oral from about a year and ongoing for cholesterol, amlodipine at 5 mg, 1x/day oral from 2015 and ongoing for blood pressure high, precautionary BABY ASPIRIN at 81 mg 1x/day  oral from about two years and ongoing, VITAMIN D3 softgel 2000 IU once a day from about two years and ongoing for Vitamin D deficiency.  The patient got pneumonia shots every year for the last 2 years, in Jan2014 and in Jan2015 (unsure if they were PREVNAR 13). In Feb2016 he had a persistent cough that he associated with bronchitis. He went to went to urgent care (not hospitalized) and was placed on unspecified antibiotics. The patient recovered from the event in Feb2016.
Second dose on 4/18 with high fever, chills, body aches that evening. Fever broke early AM on 4/19 then on 4/20 around 8 PM hiccups started and have remained persistent and still occur at the time of this writing.
vertigo; Eyes dizzy; Very unbalance/My body goes to the left; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Eyes dizzy), BALANCE DISORDER (Very unbalance/My body goes to the left) and VERTIGO (vertigo) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced OCULAR DISCOMFORT (Eyes dizzy) and BALANCE DISORDER (Very unbalance/My body goes to the left). On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, OCULAR DISCOMFORT (Eyes dizzy), BALANCE DISORDER (Very unbalance/My body goes to the left) and VERTIGO (vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Normal.         No concomitant medications were reported.  No treatment drugs were reported.  The patient does not take any regular medications but, they gave her something for the vertigo for some time. Patient done some tests on her legs, that seems to be fine.
Initial unsolicited misuse report received from a non-healthcare professional on 28-Dec-2016. This case involves a female patient (age not reported), who was vaccinated with ADACEL via intradermal route (batch number, expiry date, dose not reported) instead of TUBERCULIN PPD (batch number, expiry date, route and dose not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had a lesion. It was also a case of wrong vaccine administration and inappropriate route of vaccination. Lab test and corrective treatment was not reported. Outcome of the event was not reported. Documents held by sender: none.
Information has been received from an unspecified reporter, as part of a marketing research program conducted by agency, referring to an unknown number of patients of unspecified age and gender. In the last 3 months, the reporter had seen or heard that the PNEUMOVAX23 had been used for more pediatric indications (vaccination date, dose, route and lot# were not provided). Additional information is not expected as no reporter's contact information was provided.
High Blood Pressure in the middle of the night 141/101 - night 2 after injection Swollen Armpit Lymph Nodes both sides painful - more so on same side of injection [right arm] day 2 after injection Sore Throat and swollen tonsils day 2 after injection Cold hands/ Feet  day 3 after injection Rapid heart rate day 3 after after injection
15 mins into observation, pt's throat began to feel numb. VS were BP 141/85, O2 95, HR 78, R 20. Denied SOB or airway closing. RN assessed airway with no obstruction. RN felt it was okay to wait to see if symptoms resolved,. 10 minutes later symptoms did not improve & 25mg of Benadryl was given. Pt felt relief within 5 minutes & was instructed to stay an additional 15 mins.
Death; A spontaneous report was received from a reporter concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, 2am the patient passed away. Administrator marked as natural causes. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was fatal. The patient died on 30 Dec 2020. The cause of death was reported as unknown.  The reporter did not provide an assessment for the event, passed away.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 29-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 29-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  The patient's estimated date of conception was 10-Dec-2020.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: ADR and consent form
Patient came to pharmacy with parents to receive both pfizer 5-11 covid vaccine as well as the flu vaccine. The patient received covid vaccine in his left arm and was fine but the once received his fluzone vaccine in the right arm he fainted.  We believe it was from looking at the needle while being injected.  His breathing was ok, we lied him flat opened airway and used ice pack on forehead. He continued to seem dazed, so we called 911 to have him looked at. The paramedics decided it best to transport to the ER.  There the doctors felt it was a vasovagel response to getting the second vaccine, they did not feel it was related to the vaccine itself. He was sent home from er and cleared to participate in his sports activities that day.
patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and was admitted to hospital overnight for observation. He said his temperature hit 107. Was released from hospital and resting . Was COVID + previously where he had to be hospitalized .
Patient with known Syncope reactions to needles answered no on intake form.  Patient administered vaccine and immidiately passed out.  Patient was transitioned to floor.  feet elevated and blood pressure returned.  rested for 25 min.  tried to resume sitting position and passed out again.  transitioned again and ok.  Hydrated and gave sugar.  checked pulse and BP and was normal.  took an exaggerated rest period.  patient left on own power once fully recovered. Then it was mentioned by the patient that we have a needle phobia and pass out.
She got her 2nd booster, immediately after the vaccine she had minimal discomfort, maybe a slight fever, but nothing more than that. Then she developed a very itchy area, then it comes up as a rash as she scratches it. It's all over her body, and when she itches it the rash appears. It is mostly on her abdomen, on her limbs as well and any and every place. It feels like a mosquito bite and then it spreads. She also had this reaction with the 1st booster. She went to the doctor after the itchiness did not go away, she blood work for food allergies and prescribed an antihistamine. She went to the pharmacist this time and got an OTC antihistamine, which has helped. She is still having some reaction to this.
Client complains of rash to left arm, spots the size of quarters down her arm, states it itiches.  Has taken Benadryl and it has helped but is not better.  Encouraged mother to take child to PCP.
Case was hospitalized 9 months after completion of primary Covid vaccine series.  COVID-19 virus infection Assessment & Plan Diagnosed on 10/13. Lives at Facility and there was an outbreak there. Completed vaccine series in late January but it does not appear that he has received a booster (he is not certain). Hypoxic on arrival but some of this may have been from fluid overload. Received monoclonal antibodies at Facility on 10/13. Dexamethasone started on 10/15 after he became hypoxic. - Completed 10 day course of dexamethasone on 10/24 - Remdesivir contraindicated due to ESRD and LFT's >10x ULN - Tocilizumab given on 10/16 - Now back on room air - Off isolation after Nov 1  Acute respiratory failure with hypoxia  Assessment & Plan Secondary to fluid overload and Covid. Unclear what relative contribution was of each though given rapid improvement with dialysis volume overload may have been the bigger contributor. Resolved.
From the neurology consultation notes 3/26/10: Upon waking on 3/20/2010, felt numbness in the left and right toes; toes felt heavy and with decreased sensation but no tingling. No motor symptoms. On 3/21/10, numbness moved to mid-foot. On 3/22/10, numbness moved to first part of her calf bilaterally. On 3/23/10, numbness moved to mid-calf. On 3/24/10 and 3/25/10, numbness moved to below the knees and on the evening of 3/25/10, numbness to the thigh.  On 3/26/10, mid-thigh numbness bilaterally. Had some proprioception difficulty on exam (exam 3/26/10). Decreased sensation in the mid-thigh down. Denied any recent upper respiratory tract infection, denied gastroenteritis, denied diarrhea, denied exposure to Campylobacter. Denied HIV history. Denied fevers, chills, myalgias. She did receive H1N1 and seasonal flu vaccines in fall. The patient was admitted to Hospital on 3/26/10, discharged 3/30/10. LP was done 3/26/10, showed elevated CSF protein (33).
I tested positive for COVID-19 on 01/19/2023, 3 days after my husband tested positive. I knew early to test for COVID-19 if there are any new symptoms. I knew that I had caught it early. The symptoms were mild and stayed fairly mild. I felt feverish first and a cough and sore throat. I also felt tiredness. There wasn't too much fatigue, but I did need to rest a lot. Because I'm over 70, I contacted my doctor and was able to do a virtual consultation with the PA and asked about the possibility of PAXLOVID because of my age. I was also fairly sure I was a candidate for that. It was within the earlier days of the infection and it was primarily to avoid complications from COVID-19. Currently, I'm on day 5 of taking PAXLOVID. My symptoms have been decreasing and I've been fever free for 2 days now. I have not tested again and I will wait to test until day 6 at least. My highest fever was 100.9 and the first three days I did have a fever. My temperature did drop for the last few days and I've been fever free. I've been coughing a little bit but not too much anymore. I feel like the PAXLOVID may have helped me get through this faster, but that's not something I know for sure. I'm currently recovering, but not recovered just yet. During my COVID-19 infection (as well as when I got the vaccination), I made sure to stay hydrated throughout with water and tea with honey.
Patient received Fluzone Quadrivalent vaccine instead of Fluzone high dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (MI) (Reference number- 00341763) and transmitted to Sanofi on 02-Nov-2020.  This case involves a 73 years old gender unknown patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination on an unknown date instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered).   Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to wrong vaccine administered (latency: same day).   Reporter states that the caller was asking information on any side effects from a patient receiving Fluzone High Dose after having the Fluzone Quadrivalent vaccine.  At the time of this reporting, 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.  There will be no information on the lot number for this case.
THE MUSCLES THAT I PUMPED WERE SORE FOR 4 DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced the muscles that i pumped were sore for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscles that i pumped were sore for 4 days was not reported. This report was non-serious.
Immediate burning pain, pain worsened the next day with swelling. Developed an indurated mass that ruptured during showering and oozed clear fluid. Swelling and pain resolved. Minor soreness now. No treatment provided.
Information has been received from an unspecified reporter referring to a 13 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011123: US-009507513-1612USA011124: US-009507513-1612USA011125: US-009507513-1612USA011126: US-009507513-1612USA011127: US-009507513-1612USA011128: US-009507513-1612USA011129: US-009507513-1612USA011130: US-009507513-1612USA011131: US-009507513-1612USA011132: US-009507513-1612USA011133: US-009507513-1612USA011134: US-009507513-1612USA011135: US-009507513-1612USA011136: US-009507513-1612USA011137: US-009507513-1612USA011138: US-009507513-1612USA011139: US-009507513-1612USA011140: US-009507513-1612USA011141: US-009507513-1612USA011142: US-009507513-1612USA011143: US-009507513-1612USA011144: US-009507513-1612USA011145: US-009507513-1612USA011146: US-009507513-1612USA011147: US-009507513-1612USA011148: US-009507513-1612USA011149: US-009507513-1612USA011150: US-009507513-1612USA011151: US-009507513-1612USA011152: US-009507513-1612USA011153: US-009507513-1612USA011154.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patient were vaccinated with improperly stored doses of VAQTA lot # L023936, expiration date: 15-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Unknown if any patient experienced itching at the site of injection after administration of Prevnar 20; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Unknown if any patient experienced itching at the site of injection after administration of Prevnar 20". Additional information: Concern: Reporter stated, "I have a question about the Prevnar 20, a pneumonia shot vaccine, Is that common to have an itching in the site of the injection? (Further clarifications Unknown if any patient experienced itching at the site of injection after administration of Prevnar 20) Is that normal ?" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed muscle jerks on entire left arm, pain, headache, and dizziness immediately after getting the HPV vaccine. Symptoms resolved after 1h 45 min. Muscle jerks lasted 45 min. Dizziness lasted 1 hour and 30 min. MOTRIN and BENADRYL given and symptoms resolved.
RESIDENT FIRST TESTED POSITIVE FOR COVID 19 ON 09/01/2020. HAS RECEIVED BOTH DOSES OF MODERNA VACCINE, FIRST DOSE ON 12/30/2020 AND SECOND DOSE ON 1/27/2021. TESTED POSITIVE FOR COVID 19 THE SECOND TIME ON 3/15/2021. RESIDENT IS SHOWING NO SIGNS AND SYMPTOMS.