chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed a rash and tingling on both legs about 90 to 100 minutes after administration.  I administered 50 mg of Chewable Diphenhydramine and observed patient for 30 minutes.  the rash started to improve and I followed up this morning and patient continues to improve
nausea, fever, vomiting, dec appetite, diarrhea, leg pains, dec activity level (sleeps more than usual), h/a, stomach aches, periods of unconsolable crying, gen does not feel well;didn't want to play;
This spontaneous report as received from a other health professional refers to a 4 month old male patient. On 06-AUG-2018 the patient was vaccinated with ROTATEQ lot # N030364 dose 2, oral for prophylaxis. Other suspect therapies included PREVNAR 13 and PENTACEL. No adverse event reported. Patient didn't have reverse reactions to the vaccines.
he feels wiped out; Shaking; Vomiting; rigidity in his upper body; he started getting cold and having chills; he started getting cold and having chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 24Feb2021 at 06:30 AM (age at vaccination: 79-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of COMIRNATY with lot no EL9261. On 24Feb2021, at 06:00, the patient started to feel cold and was having chills. He was never cold. By 9:30PM he started vomiting and he had rigidity in the upper part of his body it was almost like he was having a seizure but he was still talking to her and that lasted about an hour with the vomiting, shaking, and rigidity. She told him to take a hot shower, he couldn't stop shaking and he did take a hot shower then he got fully dressed and went to bed fully clothed to try and get warm. He had no fever but it was terrible and she said to him do you want to go to the hospital or take some Benadryl and he said no. She confirmed that, the next morning when he woke up, shaking vomiting and rigidity was gone but he felt wiped out. Outcome of the events shaking vomiting and rigidity was recovered on an unspecified date in 2021 and outcome of the events getting cold, having chills and feels wiped out was unknown.  Follow-up attempts are completed. No further information is expected.
Recieved Prevnar on 7/28/09, on 7/30/09 was seen in this office due to erythema around injection site, area continuuing to spread and is hot and tender. Afebrile
Information has been received from a physician's assistant concerning a 19 year old female with no pertinent medical history and no drug allergies, who on 27-NOV-2006 was vaccinated with the first dose of GARDASIL, the second dose in January 2007 and her third dose in June 2007. There was no concomitant medication. The patient was not sexually active at that time. The patient became sexually active in September 2008. In December 2009, the patient had abnormal PAP test. The patient sought unspecified medical attention. At the time of the report, the patient had abnormal PAP test. Additional information has been requested.
Pt was vaccinated with her 2nd covid 19 vaccine on 2/19/2021. she presented to the emergency room on 7/23/21 with her daughter c/o abdominal pain, persistent nausea and poor appetite and a 20 lb weight loss since May along with new, progressive shortness of breath and fatigue. She also mentioned noticing in the last few months that her left breast seemed sore and more firm than before. She was found to have a large L sided pleural effusion. CT abdomen and pelvis revealed no significant findings to cause her symptoms other than the large pleural effusion. multiple sclerotic lesions were seen on the chest CT suggesting metastatic disease.  She underwent thorocentesis. cytology revealed  ADENOCARCINOMA likely of breast origin. she was discharged home on 7/27/21 to follow up with oncology.
chest pain, started 1 day after the vaccine and persisted for 3 days until presentation in the ED. chest pain was substernal, constant and non-radiating. No associated SOB
2am - 3am:  Uncontrollable shaking, muscle spasms.  Legs and arms involuntarily convulsing. 3am - 5am: Lucid dreams/ hallucinations.  Difficulty determining sleep/awake state.  Was convinced he had been ambushed/shot with an AR15 rifle. Muscle spasms continue. Restless. 5am - 7am: Dizzy, foggy head,headache, muscle soreness in arm, lower back, and both legs 7am - 10pm: Dizzy, bodyaches especially in legs, radiating pain through arm and neck.
No additional AE; Caller reported AE for inadvertent administration of PROQUAD following a TE.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information on the patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 12-JUN-2023, the patient inadvertently received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (rHA) (PROQUAD) 0.5 milliliter (strength and route not reported, lot # X011437, expiration date: 18-JUL-2024) for prophylaxis (product storage error). The vaccine was exposed to 6.4 degrees Celsius for 191 Hours 0 minutes 0 seconds. There was no prior excursion. No additional adverse events were reported.
pt recv vax & was adm to ER then to ICU w/sz on 7JUL95 by MD; pt was transferred to another hosp; CTS: abn; sm hemorrhage & edema assoc w/small insult; no evidence of neoplasm; CXR; upper lobe pneumonia;
Light headed, weakness, heart palpitations, fainting,  Has been 2 months and continues
Child reported experiencing right sided "poking" chest pain immediately after receiving vaccine. Child rated discomfort at a 4 out of a scale of 1-10, 10 being the worst pain. After about 15 minutes, child reported pain moved to right elbow. No other symptoms reported. No visual symptoms observed.
No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 23 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccines were discarded after excursion developed (reported as discarded vaccines that were no longer usable). On 14-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (lot# U011995 with expiration date: 15-APR-2023, route/site: subcutaneous/"triage", single use vaccine) at public health clinic hospital. The vaccines purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccines were not available for return/evaluation. The vaccines used according to the instruction leaflet.  This is one of four reports from the same reporter.
Received 4 mon. shots on 4-14-08 but started early yesterday a.m with increased fussiness & fever up to 103 degrees.  About 7 A.M. yesterday morning had episode of getting stiff, eyes rolled back in head.  15 min later fell asleep.  Came to office at 9:10 A.M.  CBC obtained increased leukocytes.  LP done.  Pt. transferred to hosp. 6/12/08-records received for DOS 4/15-4/17/08- DC DX-Fever. One day history of fever and 2 spells concerning for seizure activity. Fussy. Fever 102.7. Eyes rolled back, hands turned blue.
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 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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 70.11.  Concomitant products were not provided.  Temperature Excursion at 9 AM, 10 AM, the temperature was 29, 32 respectively. Total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 5-Oct-2021 vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were sent to clinic on respective dates. Vaccine BUD date was 29-Oct-2021 and 7-Nov-2021.  Vial was stored in cooler 1, on 27-Oct-2021, Excursion duration, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 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.  Treatment medications were not reported.
Tired; Headache; Chills; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6202; Expiration Date: Jun2021), via an unspecified route, administered in Left Arm on 23Feb2021 (at the age of 66-year-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302, Expiry date: May2021), via an unspecified route, administered in left arm on 02Feb2021 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation and experienced headache for 48 hours. No other products. No Patient history. No Investigational assessment. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient states that with both vaccines first and second dose, experienced a strong headache for about 48 hours after, that each time it resolved in 48 hours. States with the second dose of the vaccine, had chills as well for about 48 hours, clarifies it was more that he was tired (on 23Feb2021) than chills. States first does was on 02Feb2021, and second dose was on 23Feb 2021. The adverse event did not require emergency room and Physician office visit. Outcome of event headache and chills was recovered in feb2021 and outcome of event tired was recovered on 25Feb2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021229933 same patient and drug, different dose and event
Started with a fever that climbed to 105 degrees by nightime.  Fever lasted 3 days. On the 4th day she developed 2 pock-like spots, one on her upper lip, one on her chest.  5 days after vaccine, she started to have a rash of pock-like marks on her lower legs. On the next day, she woke up with a severe headache (sore to the touch in the back of the head) and a sore right ankle and knee. Throughout the day, the pain and swelling got worse in the leg.  The ankle was the size of a softball, when we took her to the ER.  This got better over the next couple of days, but then re-inflamed and we took her to her physician.  The next day, her other (left) leg began to swell and become painful to the point she could not walk on it. She also had a stomach ache all day and the site of the vaccination swelled into a hard ball under the skin and became very red and inflamed. The next day we noticed several more pock marks on her legs and another one on her chest and cheek.  The pain in the left leg still prevents her to walk on that foot.  That brings us to today.
A report has been received from a Physician concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced expired FLUMIST given which started on 16-Jan-2013. Reporter had reviewed the records and he stated that the product was not expired. The outcome of the event of expired FLUMIST given is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 17-Jan-2013 from Physician: narrative updated.
LUMP C H1N1 WAS GIVEN, ARM SORE AND CANT MOVE
Cellulitis like reaction at site of lower injection (L) thigh 5 x 4 cm likely a reaction to DTaP.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Tested positive for Covid-19 on 11/9. Not hospitalized for Covid-19
flu; Based on information previously received, the following information [Delete Non-Valid classification and the justification product not otherwise specified (NOS) and Influenza Vaccine to be recoded] has been amended.  Initial and additional information regarding an unsolicited non-valid non-serious case received from a consumer (patient) from via social media on 12-Oct-2020 and 17-Oct-2020 respectively (both processed together).  This case is linked to case 2020SA289533(CLUSTER).  This case involves patient (unknown demographics) who experienced flu (influenza), while receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was also reported that Only had the flu one time. The year patient took the Flu shot.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.   There will be no information available on the batch number for this case.  Follow-up information regarding an unsolicited non-valid non-serious case received from a consumer (patient) from via social media on 17-Oct-2020 transmitted to Sanofi on 17-Mar-2021.  Action taken changed unknown to not applicable. Corresponding field and narrative were updated accordingly.
Welt at injection site, warm to touch. Sore arm, fever, heavy head, neck stiffness and sharp pain, headache, dizziness, nausea. Loss of appetite, fatigue.
Subsequent to receiving one dose of varicella virus vaccine live on 11/6/95, the pt experienced varicella (100-150 lesions) and a fever of 102-103 axillary for 48 hours, on 3/18/99. The pt was treated with Tylenol and Benadryl.  The pt also experienced increased itching, increased restlessness, and headache. Pt was treated with Atarax.
vomiting diarrhea  heat stroke constant chills repeating cycle after that. A few hours where I am fine and al of a sudden it hits me again.
I was experiencing what felt like a toothache. I was having puffiness and numbness in my lower lip. I also had numbness in my lower right jaw. It was swollen as well. This was going on for about 10 days before I went to the ER. They gave me an IV antibiotic and drained some fluid out of my gum. They prescribed clindamycin and I took ibuprofen. I still have numbness in my lower lip, but the puffiness is going down.
Developed alopecia in mid-Feb04 starting on both sides of head above the ears and spreading to approx 20 bald spots on top and back of scalp. Kenalog cream prescribed on 03Mar04. Received injections of 0.4cc of Kenalog in 2 spots on 31Mar04.
very sore throat starting two days after vaccine, with very swollen glands in throat, fatigue
Severe headache, dizziness, nausea, fever, body aches, low back pain
bilateral T; This is a spontaneous report from a non-contactable consumer and a non-contactable other HCP. This report was received via a sales representative.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced a bilateral T and she was on Eliquis after her vaccination. The outcome of event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swollen gland in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications at the time of the 2nd dose of TWINRIX included Antibiotics. On 26 April 2010 and 20 August 2010 the subject received 1st dose and 2nd dose of TWINRIX (details unknown). In April 2010 and August 2010, within 1 or 2 days of each vaccination with TWINRIX, the subject experienced swollen glands and exhaustion. The events occurred after each dose of TWINRIX. The healthcare professional was inquiring as to whether the subject should receive the 3rd dose of TWINRIX. At the time of reporting the outcome of the events was unspecified.
Patient reported running a 104 degree fever and stated she had not taken anything  for the fever and patient was instructed to take tylenol or ibuprofen for her fever and recheck her temperature and if it remained elevated proceed to her physician.
Patient was inadvertently given Moderna booster (0.25 mL) at the age of 17.  After the vaccine was administered, patient had a slight fever to be expected after a booster.  No other adverse events noted.  Patient and mom was informed of this - they had no further questions.
ARM FELT HOT; SWEATY ARM; A BUBBLE OF SOME SORT ON RIGHT ARM AT THE VACCINATION SITE; SORE ARM; A BIG RAISED BUMP ON WRIST ON THE UPPER PART OF HAND MAYBE 2 INCHES; This spontaneous report received from a patient concerned an 80 year old female. 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: 2119211A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced arm felt hot. On APR-2021, the subject experienced sweaty arm. On APR-2021, the subject experienced a bubble of some sort on right arm at the vaccination site. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced a big raised bump on wrist on the upper part of hand maybe 2 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, arm felt hot, and sweaty arm, had not recovered from a big raised bump on wrist on the upper part of hand maybe 2 inches, and the outcome of a bubble of some sort on right arm at the vaccination site was not reported. This report was non-serious.
TC from State Epidemiologist stating that he had received a call from local provider stating possible measles case.  He spoke with child's PCP and was told that the patient presented with rash on trunk, low fever, no greater than 101 degrees.  Child had cough due to runny nose. Provider did draw blood for an IgM. PCP told epidemiologist that child did not have measles. Symptoms presented on 1/24/09, 12 days post immunizations.
palpable node on her left collar bone; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age (age: 61, unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration administered in left arm on 02Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid 19 Vaccine on Wednesday 02June2021. On Thursday 03June2021, she experienced a palpable node on her left collar bone. The patient was asking if the symptom has been reported. The outcome of the event was unknown.
Soars that looks like big mosquito bites located on the upper part of hands, elbows, knees and legs
Around 1520, and while in observation, client stated feeling dizzy. EMS came to the scene, assesed, and cleared her.
7/16/99 rpt via phone several 1/2 dollar sz areas of bruising on upper legs & upper arms.(bilaterally)