chrisvoncsefalvay/vaers-outcomes huggingface dataset:
massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (massive stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not have allergies to medications, food, or other products. Treatment information was not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Starting hours after the injection on 03/22/2021 my right upper arm became hot & swollen around the injection site.  By the next morning (03/23/2021) I had a fever of 101.3 and it stayed at that level for nearly 24 hours. I had to stop work halfway through my normal work day. Triggered a massive migraine headache.  Groggy, lethargic, minimal appetite, diarrhea, arm more swollen now, extending beyond injection site, swollen lymph nodes in neck & left armpit.  Took 600mg ibuprofen every 5 hours.  Drank lots of water.  rested.  Went to bed by 9pm.  Woke up the following morning (03/25/2021) covered head-to-toe in a red rash.  Assume this to be a heat rash, as my fever had broken by then & I've had a heat rash reaction post-fever in the past.  However, never one to this extreme.  Rash intensified throughout the day, despite multiple cool showers.  Dressed as lightly as possible. Itchy.  Took only ibuprofen during day to allow me to work.  Took 2 Benadryl approaching bedtime to stop the itching & try to sleep.  Left upper arm still swollen, sore, and hot to the touch.  Woke up this morning (03/26/2021) with rash still covering body, but reduced to a much lighter pink. Still quite itchy. Left upper arm still quite swollen & sore; definitive difference in how left arm feels vs. right arm that was not injected.  Arm is still quite hot in that area.  Rash in that area is much redder, extending several inches outward from the original injection site.
Vertigo; Minimal soreness at injection site; A spontaneous report (United States) was received from other health care professional concerning a female patient of an unknown age who received Modena's COVID-19 vaccine (mRNA-1273) and experienced minimal soreness at injection site (vaccination site pain) and vertigo.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 02 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch unknown) on left arm for prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient called on behalf of her mother, who received Moderna COVID-19 vaccine and experienced minimal soreness at injection site.  On 04 Jan 2021, the patient experienced vertigo. Treatment information not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The event minimal soreness at injection site was resolved on 02 Jan 2021. The outcome of the event vertigo was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
severe cough; left nostril swelling; generalized hives throughout abdomen and hips; lower lip swollen/upper lip on left side swelling; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 13:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included allergies to dust, pollen, and dog and cat dander. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on 17Dec2020 at 13:00 on the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Jan2021 at 21:00 (five days after second vaccine dose, for clarification), the patient had lower lip swollen. Second episode occurred (on an unspecified date) with severe cough, upper lip on left side swelling, left nostril swelling, and generalized hives throughout abdomen and hips. The patient took Benadryl for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Patient developed a localized oval shaped 2in x 1in area in the left arm. This area was red, warm and increased in size 2 days after vaccines were given. Patient was prescribed Triamcinolone Acetonide 0.1%.
Information has been received from a caller concerning her daughter who missed her menstrual period after receiving the second dose of GARDASIL (lot# not reported). The caller did not want to report any additional information.  Additional information is not expected.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, Drug reactions or allergies and concomitant therapies was provided. On 29-JUL-2016, the patient was vaccinated with improperly stored dose of PROQUAD (dose, route of administration and injection site were not provided) (lot # M004892, expiration date: 25-JUL-2017). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed erythema, moderate swelling and warmth at site of intramuscular injection, proximal anterior aspect of right leg.  Prednisolone 15mg/5mL 3cc per mouth 3 times a day was received for 4 days.  Complete resolution of problem.
Seizures and fever and vomiting; then 11 hours later Febrile seizure
MENACTRA and MENQUADFI being administered within a week of each other on accident with no adverse event; Initial information received on 30-Sep-2022 regarding an unsolicited valid  non-serious case via other health professional.  This case involves a 12 years old female patient who had MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] being administered within a week of each other on accident with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 22-Sep-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation. On 26-Sep-2022, the patient received, 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7447AC, expiry date: 20-Sep-2024) via intramuscular route in the right deltoid for immunisation.  On 26-Sep-2022, menactra and menquadfi were being administered within a week of each other on accident with no adverse event (extra dose administered) same day latency following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
No additional AE; was due for MMR and Varicella, and was administered Proquad and Varivax; This spontaneous report was received from a pharmacist and a registered nurse, and refers to a 4-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  The patient was supposed to be vaccinated with a measles, mumps, rubella (MMR) and a varicella vaccines, however on 04-AUG-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, in the right arm for prophylaxis  (lot # T038830 was verified to be valid, expiration date reported and established as 17-NOV-2022), and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, in the right arm for prophylaxis (lot # T001190 was verified to be not valid, expiration date provided as 29-AUG-2022), (route of administration was not provided for both). The patient's mother was informed about the inappropriate schedule of the vaccines administration (overdose).  The patient did not experience any additional adverse reactions.
Pt recv vax on 8/10/98; on 8/18/98 pt exp lacy rash on legs & sore throat; tx=antibiotic
VZV Ophthalmicus. Valacyclovir 1gm TID PO.
Patient complained of dizziness and lightheadedness about 10 minutes after receiving vaccine, had visible tremors. Requested a cool cloth, was feeling hot. No complaints of problems breathing or swelling. No 'racing heart.' No EpiPen given. EMS arrived and took her to local ER. Patient was conscious and oriented entire time.
Parent signed child up to receive a flu vaccine at school. Parent took child to pediatrician to receive a flu vaccine on 12.09.22. Parent did not inform school or clinic child had received a flu vaccine for this year. Child received a second flu vaccine on 12.12.22 at school. Per parent, child has not experienced any side effects or adverse events.
Site swelling, itching and pain  12 days after the vaccine lasting 3 days so far
Initial report received from a healthcare professional on 19 June 2013.  An over the age of 65-years male patient (exact age was not reported), had received an intramuscular dose of ADACEL Vaccine (batch number, dose number and anatomical reported) on an unspecified date. The reporter refused to provide information about illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions. Concomitant medications were not reported. On an unspecified date, after vaccination, the patient developed swelling of hand and arm. Corrective treatment was not reported. The reporter refused to provide information about laboratory investigations. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Patient received Novavax dose #1 today at 12:00pm.  12:18pm I noticed patient clearing her throat and  then she stated that immediately after vaccine injection she had itchy throat and tongue tingling. Patient had Epi pen and Benadryl with her.  Patient took 25 mg Benadryl. Vital Signs @ 12:20pm: Pulse ox =100% / HR=75 / RR=16 /BP=136/92. Patient states she has an allergy to 1-Latex, 2-all antibiotics 3- Flu vaccine. 12:30pm patient states she is feeling back to normal. I had patient wait an additional 30 minutes more for monitoring.  Patients vital signs @ 1:00pm:  O2 sats =99% / HR= 63 / BP= 124/90 / RR =16. Patient advised to contact PCP or call 911 with any changes or concerns. Patient stated that she will notify her doctor regarding Novavax Rx.
Case number PHEH2012US012340 is an initial combined spontaneous report received from a consumer on 20 Jun 2012 with a follow up information received on 21 Jun 2012. This report refers to a 51-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1101201) through unspecified route and site on 26 Feb 2012. On the same day a few minutes afterwards she passed out after standing up to walk out. The pharmacist administered EPIPEN and the called an ambulance for the patient. It was reported that she was hospitalized twice on unspecified dates following immunization. She also had an injury claim for the injury received following immunization. The outcome of the event was not reported. No further information was available.
This spontaneous prospective pregnancy report was received from a physician refers to an approximately 27 year old female patient with no pertinent medical history, drug reactions or allergies. On 04-NOV-2013, the patient was vaccinated with MMR II for routine vaccination. No concomitant medication reported. On 01-NOV-2013, the patient had a negative "blood pregnancy test". The patient was then seen by the physician, on 04-NOV-2013, at which time she received MMR II. The patient went to an unspecified Urgent Care facility, on 20-NOV-2013, due to the fact that she was experiencing nausea. The patient "took a pregnancy test" while at the Urgent Care facility which tested positive. The patient called the physician, on an unspecified date, to report this information. The physician stated she had not seen the patient since 04-NOV-2013 and stated she did not know the patient's current gestation or if she was still experiencing the nausea; "I guess she could be 3 weeks pregnant but I don't know". The patient became pregnant with last menstrual period (LMP approximately on 31-OCT-2013 and expected delivery date (EDD) approximately on 07-AUG-2014. The pregnancy outcome was pending. At the time of the report, the outcome of pregnancy test was positive was unknown. Additional information has been requested.
Patient:Age:65 y.o.  Admit Date:  7/5/2022 Discharge Date:  7/14/2022      Principal Diagnoses:  Principal Problem:   Pneumonia due to infectious organism Active Problems:   Acute metabolic encephalopathy   ESRD (end stage renal disease)   COVID-19   Tick bite   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin     Discharge Diagnosis:  Bilateral PNA, Myroides bacteremia, COVID 19, ARF with ATN, HTN, elevated D.dimer. Anemia. Dm2,    Hospital Course:  The patient was admitted with the above. She was treated with 5 days of remdesivir. She was also treated with cefepime for PNA. Blood cultures came back positive for Myroides species. TEE was negative for endocarditis. Her tunneled Dialysis catheter was removed and she had a line holiday. The catheter was replaced and she did well with HD. She was weaned down to 2 liters of oxygen before discharge. She was swtiched to merrem for the blood cultures and was to complete 10 days total of abx. She had 3 days left at the time of discharge. She was debilitated so was sent to emcompas for further treatment.    Consults to: Nephrology, ID, vascular surgery.    Significant Diagnostic Studies:  CT head, CT abdomen, CTA chest, 2D echo,     Procedure(s): Tunneled Catheter exchange, TEE.    Disposition: LTAC.    Discharge Condition:  fair
At time of injection, I immediately had a headache.  When I got home my BP was as 140/90. I'm usually 110/65.  I was very tired and took 2 tylenol and took a 3 hour nap.. was very tired for 3 days
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Swollen testicles; Covid feet; Worn out by it; Edema in my upper and lower legs; Skin rash on my shins and calves in both legs/ skin rash got worse; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Edema in my upper and lower legs), TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet), RASH (Skin rash on my shins and calves in both legs/ skin rash got worse) and FATIGUE (Worn out by it) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 048D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Skin rash on my shins and calves in both legs/ skin rash got worse). On 26-Jun-2021, the patient experienced OEDEMA PERIPHERAL (Edema in my upper and lower legs). On an unknown date, the patient experienced TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet) and FATIGUE (Worn out by it). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Edema in my upper and lower legs), TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet), RASH (Skin rash on my shins and calves in both legs/ skin rash got worse) and FATIGUE (Worn out by it) had not resolved.            No concomitant product information was provided. Treatment medication includes vitamins, frozen water bottles.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document include patient ,facility related details.
Flu shot was given at 4:30 pm and at 9:00 pm I was having chills - fever - headache, all the symptoms of flu with temperature of 101 - had to take an antibiotic to get over flu.
Information has been received from a nurse, referring to a 19 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JUN-2017, the patient was inadvertently vaccinated with a dose of PROQUAD lot # N000336 with an expiration date on 03-JUN-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
12:36:  Vaccine administered 0.5 ml Moderna.  12:46: Patient became, light headed and flushed. Assessed by RN on site. Vitals taken,Vitals :139/80 P:125 02:100%. Patient alert oriented and verbally reported feeling flushed.  Pt given 50mg oral Benadryl and water, elevated legs.   Symptoms relieved within 10 minutes of admin. Monitored patient for an aditional 30 mins, family onsite and availabe to drive patient home for safety.  Advised patient to go home and rest for the the day, provided education to take Acetaminophen for any additional mild symptoms and to call emerency service or any unexpected adverse. V/S after 30 mins BP127/81 P92 02:99% and patient reported feeling back to baseline prior to vaccine administration. Supervisor on site currnetly in vaccination room and aware.
pt recvd vax; titer 0 90 days p/ pre exposure series;19apr94 f/u: returned f/u form; listed vax is ID,but toute is indicated as IM;addtl booster recommended;
Upon administration the patient noted a clear fluid on her deltoid when the needle was withdrawn.  A bandaid was applied and the patient later noted that the bandaid was soaked with clear fluid.  Additionally, the patient noted she had no injection site pain, soreness, warmth, etc. into the evening.  She noted this was atypical , especially relative to her first vaccination in the series.  We are identifying this as an administration error and will re-vaccinate.
arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This consumer (husband) reported for a female patient (wife) that a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number-Not reported) via an unspecified route of administration, administered on unspecified date as Dose 1, single for covid immunization. Patient medical history include Type 1 diabetic. Just wondering if there is a survey I could help with after receiving the first dose of the Pfizer vaccine for COVID. I had arm soreness for about a day, but that is it. The patient concomitant medication were not reported. Patient experienced arm soreness on unknown date. The outcome of event was unknown.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213472 Same reporter/ drug/ event for different patients
severe syncope and fainting, vomiting, lowered BP and lowered heart rate.  First signs about 10 min post injection.  Paramedics attending within 25-30 min of injection
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that vials had not undergone any temperature excursion.  Total of 173 doses were given from LOT 070H21A. It was unknown when the vial was stored in refrigerator.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow Up contains Non-Significant information.
I started feeling fluctuation in my heart/chest and there was slight discomfort but I didn't think anything of it. It was very mild at first but then it got to the point of stabbing pain. I went to the emergency room for the pain. The doctor I saw did detect an irregular heart beat but did not prescribe any medication for the irregular heartbeat but they gave me Iohexol. I also was referred to a cardiologist that did tests as well and there was nothing found either. I also had shortness of breath. Whenever I took a deep breath I had chest pain as well. The pain is still present. I went to the emergency room another two times after that and saw my primary care as well.