chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; vomiting; Burning sensation in feet; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the arm left on 01May2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included vitiligo. Concomitant medications included naltrexone hydrochloride, bupropion hydrochloride (CONTRAVE) from an unknown date for an unknown indication. The patient previously took LEXAPRO. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 16:30 in the evening, the patient experienced burning sensation in feet. On 04May2021 in the morning, the patient experienced nausea and vomiting. The clinical outcome of the event burning sensation in feet, nausea and vomiting was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Extremely sore arm for 2 weeks, body aches, and 3 days after vaccine both legs started to swell, get numb and burn a little. Googled symptoms to try and reduce and followed those (i.e.: elevating above heart, increased water intake, cut out high sodium foods, wore compression socks daily & even through the night during elevation) but nothing reduced it. Went to urgent care finally and they just told me to keep following what Google recommended, didn't like that response so went to urgent care in the town over from me, they took labs and prescribed me a water pill (can't remember name just know it started with an "F"). That helped for awhile but eventually stopped working and the swelling would come and go. Until yesterday 11/18/2021 both legs were swelled pretty bad but the right leg was larger and hurt to move, put pressure on and was extremely hard. Went to the Emergency room where they highly assumed it was a blood clot...gave me a blood thinner shot and a different water pill and sent me home. Told me a nurse would call me today 11/19/2021 to schedule a better ultrasound.
URI & cough; Seen by MD who prescribed Ceftin & cough suppressant; Recovered;
Administered improperly stored ROTATEQ.  ?; This spontaneous report has been received from an immunization coordinator referring to a 6-month-old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions, any known allergies or reactions or concomitant medications.  On 12-APR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (Dose was not provided,  Lot # 1742429 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ);, expiration date: 11-SEP-2022).  It was reported that the vaccine had underwent a temperature (T) excursion (Product storage error). The immunization coordinator reported that for a time frame of 2 hours (h) and 3 minutes (m) the vaccine was above 48-degree Fahrenheit (F). Additionally, previous temperature excursion was reported as following:  3h,36m, T 34F;  6h,4m, T 34F;  23m, T 34.3F; 21m T 34.3F; 22m, T 34.3F; 18m, T 34.5F; 19m, T 34.7F; 5m, T 34.3F; 18m, T 34.3F; 16m, T34.9F; 19m, T34.7F; and 7h, 31m, T 33.1F
Patient received Janssen vaccine on 03/25/2021. Covid + on 09/14/2021 and hospitalized Per ED Note: Patient is a 61-year-old female with a history of bipolar disorder, right hip fracture with a postop wound infection who presents to the emergency department stating that she tested positive for Covid.  Patient is currently at a rehab facility.  She had a complicated right hip fracture repair with wound infection that has required her to receive IV antibiotic infusions.  Patient states that she was told that she was exposed to another resident or staff member in the rehab facility with Covid so the facility requested that she be tested for Covid.  She denies any symptoms.  No fever, chills, cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain or diarrhea.  She was told that her Covid test came back positive.  Because her rehab facility does not take Covid patients she was required to be transferred out to the next closest hospital.  She requested that she be transferred here as her PCP is associated with this hospital.  Patient admits that she was supposed to be discharged home today with home care nursing to help with her antibiotic infusions.  Patient is visibly upset and anxious.  She denies any new trauma or fall.  No drainage from her wound.  No fever.  She presents for further evaluation.
Information has been received from a health professional concerning a patient in kindergarten who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
5 MINUTES AFTER VACCINATION, SHE REPORTED FASCINT, EXTREME & DIZZYNESS, INCREASED HEART RATE & DRY MOUTH. DID NOT PARAMEDIC INITURLY BUT AFTER "ROOM SPINNING" SHE WANTED 4 PARAMEDIC.
Seizure 5 hours 30 minutes after administration of TD (Decavac) IM.
aches and chills lasting approximately 24 hours; alleviated with Tylenol and Motrin soreness at injection site lasting 5 days to 6 days
I started a low-grade fever about 7 hours after the injection (99.5-100.0 degrees when I'm normally in the 97s) that lasted for about 24 hours. Also I had headaches and achy muscles for that same 24 hours. Still had some fatigue and achyness after that. All symptoms had dissipated after about 48 hours.
This spontaneous report concerning a 65 year old female patient with drug hypersensitivity to sulfas was received from the patient herself. The patient's medical history included a case of shingles (herpes zoster). In September of an unspecified year, the patient was vaccinated with ZOSTAVAX (strength, dose, route, frequency, lot and expiration date were not provided). Concomitant therapies included lidocaine (manufacturer unknown), valacyclovir hydrochloride and acetaminophen, VICODIN. On 11-JUL-2016, the patient experienced shingles (herpes zoster). The reporter stated that she sought medical attention and valacyclovir hydrochloride was given as treatment to the adverse events. No product quality complaint was involved. At the time of reporting the outcome of herpes zoster was reported as not recovered. The causality between ZOSTAVAX and herpes zoster was not assessed. Additional information is not expected as the reporter did not consent for follow-up attempts.
Painful, itchy rash to left lower arm about 13 days after the injection. Need to be treated with steriods.
BODY ACHES; FEVER; EXHAUSTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 body aches, fever, and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and exhaustion. This report was non-serious.
A non-serious spontaneous report of patient received extra dose of FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a total of two doses of FLUMIST. One dose each on 13-Sep-2011 and on 30-Sep-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
patient was given covid pfizer monovalent vaccine in error and was supposed to get the pfizer covid bivalent
- swollen lymph node behind right shoulder (7 days after vaccine injection on 4/12) - extreme fatigue 1 day after injection (4/6) - pain in arm near injection site
Within 1 hour, swelling, redness and warmth at injection site (R) deltoid. Fever of 99.2 persisted for 24 hours. General malaise for > 24 hours.
Infant with onset of high fever (103-104) within 8 hours of her second round of vaccinations.  No other symptoms.  By the next morning not only had high fever but was extremely irritable especially if she was moved or lay down.  Had persistent high fever of 102-104 all weekend and presented to my office on 6/13/2022 for evaluation of irritability and high fever.  Still did not have any other symptoms other than irritability.  Exam did not reveal source of infection.  Had a negative COVID and influenza test in the office and then sent to the hospital for further work-up with concern of possible meningitis. Initial evaluation at the local hospital was negative until she had a MRI of her brain due to persistent irritability that showed evidence of a periauricular abscess/mastoiditis.  Due to her young age she was sent to Hospital for ear nose and throat evaluation who elected to drain this abscess and to place bilateral ear tubes due to the presence of bilateral otitis media with mastoiditis.  She was managed with a PICC line and infusions of Rocephin and oral dosing of metronidazole.  She has improved and is in good clinical condition upon follow-up today 6/24/2020
Headache, Myalgia & Fever Narrative:  STAYED HOME FROM WORK DUE TO SYMPTOMS
Period: 2+ weeks: severe non-stop cough (bronchitis, non- productive, dry), severe migraines (3 continuous days; 5 severe in 7 days, sore throat, weakness, excessive sleep over 2+ weeks, upper respiratory infection  Treated with Z-pac & tussione 2 negative Covid tests over 4 days; no neck pain or fever. No swelling of ankles; negative Streep test
no addtional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a physician and refers to a 2-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 23-AUG-2022, the patient was vaccinated with an improperly store (product storage error) hepatitis a vaccine, inactivated(VAQTA), lot number W003118 with expiration date 13-JUL-2023 or lot number W015191 with expiration date 27-OCT-2023 (the reporter did not specify  which actual lot the patient received), (dose, and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 11.3 degrees Celsius for 34 minutes. No previous temperature excursion were reported. No additional adverse events were reported.
I had my first shot of Pfizer vaccine last Friday morning (March 5). In the evening, I felt fatigued. So I went to sleep early. When I got up Saturday morning, I felt dizzy. The dizziness went away in a few minutes. In the next 36 hours, I had the angina feelings - tightness in the left chest and I felt heart be squeezed occasionally. When I stand up and walk, I felt better. Finally Sunday evening (March 7), I took a walk outside and felt symptom free. Maybe the walk helped, maybe the "thrombosis" had run its course before my walk.   I have not had the severe angina symptoms since my PCI procedure in Feb 2018. I am sure the recent occurrence is related to the vaccine.   Besides reporting the adverse event, I want to get advices whether I should receive the second shot.   Thank you!
Woke up with muscle aches similar to a flu.  Absolutely no energy and feeling tired.  Although I have had no snot, my voice has deepened noticeably. Current temp is 100.8
Patient received 2nd dose of Pfizer vaccine on 07/22/2021. Patient participated in  weekly testing at hospital and tested positive for COVID-19 on 08/26/2021. Symptom onset of a low grade fever also started on 08/26/2021. Patient received Regeneron treatment and then passed away on 09/08/2021.
This spontaneous report as received from a physician refers to a 4 month old patient. On 23-APR-2014, the patient was vaccinated with second dose of expired ROTATEQ suspension 2, lot # H013539, expiry date 28-MAR-2014, dose (unknown) and route of administration (unknown). No concomitants were reported. No adverse effect reported. No product quality complaint was involved. The outcome of events was unknown. No other information was reported. This report is linked to 1405USA001639 and 1405USA006754 by the same reporter link. Additional information has been requested.
Fever, chills, myalgias - onset about 6-7 hours after shots given. Exam on 10-04-15 normal.
pt recv vax 13MAR97 & 24MAR97 pt devel a papular rash located on the anterior & posterior area of the chest, face, & arms which was described as just a little rash;
Fever >100.4,  Subjective fever (felt feverish), Chills,  Muscle or body aches,  New loss of taste or smell,  Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Headache,  Diarrhea (>/=3 loose/looser stools in 24 hr period), eye pain, nostril burning, ear ringing.  Bilateral Pneumonia. 9/1/2021 BiPAP machine at hospital.  Scheduled to move to ICU
Client received her booster dose COVID Moderna vaccine on 12/29/2021 at approximately 1100 in the L deltoid. At 1110, the client reported to EMT in the observation area that she was feeling nauseous. EMT notified Lead RN offered client emesis bag, water, and saltine crackers and assessed the client while EMT took vitals. Clients vitals at 1114 were BP 114/78, HR 72, SPO2 99%, and RR 16. Client denied SOB, dizziness, pain, and altered vision. Client reported that her last intake was a smoothie in the morning. Client reported her nausea onset was approximately 5 minutes after receiving the vaccine and denied experiencing nausea prior to receiving the vaccine. Client denied experiencing an adverse reaction after her 1st dose COVID Pfizer vaccine on 04/15/2021 and 2nd dose COVID Pfizer vaccine on 08/06/2021. At 1124 the client reported to EMT that she wanted fresh air and stated she was going to take a walk in the hallway of the building. EMT advised the client to remain in observation but client declined recommendation. The client returned to observation after approximately 5 minutes later. Client reported to EMT that her nausea had subsided and she "feels fine now". Client stated her husband will drive her home. RN educated on ER precautions and when to follow up with her PCP. Client left vaccine site at approximately 1135.
Sore arm; Systemically she felt bad but not significant; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included Inflammatory bowel disease, Small fiber neuropathy, Diastolic heart failure and Chemotherapy from 2003 to 2004. Concurrent medical conditions included Osteoporosis. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, 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 experienced PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FEELING ABNORMAL (Systemically she felt bad but not significant) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-289133 (Patient Link).
PT PRESENTED IN CLINIC WITH 105.1 TEMP 9/13/11 PATIENT RECEIVING 4 YR VACCINES 9/12/11
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 12:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 12:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 62.75 on 13-Feb-2021 and 62.84 on 20-Mar-2021. No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.   On 13-Feb-2021, at the excursion time 09 AM temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021, 30 vials were sent to clinic, vaccine BUD date was on 10-Mar-2022 for batch number 031L20A.  On 20-Mar-2021, for batch number 031A21A, vials were stored in cooler 1, Excursion duration at 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM 43. On 20-Mar-2021, at the excursion 10 AM temperature was 37 and at 9 AM temperature was 34, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Mar-2021, vial was moved to clinic on 20-Mar-2021, 19 vials were sent to clinic, vaccine BUD date was on 8-Apr-2021 for batch number 031A21A  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided.
unable to get the second shot within 6 months; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked Should now get the second shot or should start with the first again.
I HAD MY YEARLY PHYSICAL ON NOVEMBER 20, MY PSA WAS 0.84. NO ISSUES WITH MY PROSTATE, OR NEVER HAD ANY ISSUES.  ON 2/3/2021, i DEVELOPED A SEVERE PROSTATE INFECTION WAS TAKEN TO THE EMERGENCY ROOM. MY PSA WENT UP TO 39 AND MY WBC WAS 23,000. IT NOW AT 14, BUT STILL GIVING ME ISSUES.  THE ONLY THING THAT CHANGED IN MY LIFE WAS I GOT THE COVID VACCINE FROM MODERNA.
she stated that the injection hurt; coughing a lot; when the nurse pulled out the needle she continued to shoot out some vaccine left in the syringe; from a Pfizer-sponsored program. A contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the injection hurt and when the nurse pulled out the needle she continued to shoot out some vaccine left in the syringe, coughing a lot on an unspecified date with outcome of unknown. She is asking if she should get a third vaccine.   Information of lot/batch number has been requested.
Felt weak; Achy legs; Felt a little short of breath; Felt lightheaded; Headache/head hurt; Sore left arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded) and HEADACHE (Headache/head hurt) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CLOZAPINE and ALPRAZOLAM (ALPLAX) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded), HEADACHE (Headache/head hurt), MYALGIA (Sore left arm) and FATIGUE (Felt tired). At the time of the report, ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded), HEADACHE (Headache/head hurt), MYALGIA (Sore left arm) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported Patient was scheduled to get the second dose on 27Aug2021.