chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CAME INTO THE STORE AND SAID SHE PASSES OUT EVERYTIME SHE IS GIVEN A SHOT.  LESS THAN A MINUTES AFTER ADMINISTERING THE SHOT HTE PATIENT PASSED OUT IN THE CHAIR THAT SHE WAS SITTING IN AT THE TIME OF ADMINISTRATION.  SHE KNEW IT WAS GOING TO HAPPEN AND WARNED ME AHEAD OF TIME.  I TOOK PATIENTS BLOOD PRESSURE / HEART RATE AND OFFERED PATIENT WATER AND A SNACK.   SHE SAT IN CHAIR FOR AN ADDITIONAL TWENTY MINUTES BEFORE SHE FELT WELL ENOUGH TO STAND UP.   I DID NOT LET HER DRIVE HERSELF AFTER THIS.  HER BOYFRIEND CAME DOWN AND GAVE HER A RIDE HOME,
This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), FATIGUE (fatigue), SENSORY LOSS (loss of sensation on legs), GAIT DISTURBANCE (walking difficulty) and ARTHRALGIA (shoulder pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced NAUSEA (Nausea), FATIGUE (fatigue), SENSORY LOSS (loss of sensation on legs), GAIT DISTURBANCE (walking difficulty), ARTHRALGIA (shoulder pain) and ASTHENIA (weakness in morning). At the time of the report, NAUSEA (Nausea), FATIGUE (fatigue), SENSORY LOSS (loss of sensation on legs), GAIT DISTURBANCE (walking difficulty), ARTHRALGIA (shoulder pain) and ASTHENIA (weakness in morning) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from the health worker refers to an unspecified number of patients of unknown age and gender. On an unspecified day, the patient were vaccinated with improperly stored (Oka/Merck) VARIVAX (Strength, dose, route and lot number were not reported) for an unknown indication. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pain in left arm for 3-4 days, couldn?t lift arm. Hives on torso that lasted 3-4 weeks that created scabby sores with intense itching, lightheaded spells 1-2 after shot, fatigue.
Case number PHEH2013US024188 is an initial spontaneous report received from a pharmacist on 14 NOV 2013. This report refers to a 10-years-old male patient. His medical history and concomitant medications were not reported. It was reported that this patient under 16-years of age received a 0.5 ml intramuscular dose of FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) on 13 NOV 2013. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 14 NOV 2013. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Patient says that he broke out in red bumps on both arms 1 day after receiving his first dose. He says that the effects lasted for 1 week then went away.
been sick like 2 and half days now/ He's so sick after the first.; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; NDC number/ UPC number: unknown; Batch/Lot Number: EW0176; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 04May2021 as 1st dose, single for covid-19 immunisation. The patient did not have medical history. There was no investigation. Patient did not take any concomitant medications. Reporter stated that the patient took the first dose of vaccine and experienced side effects like one does during a 2nd dose and wanted to know what people do regarding the 2nd dose if they had side effects from the first dose. He was fine until Thursday evening and he has been sick like 2 and a half days now. When probed for treatment, reporter stated, he took Ibuprofen after the shot, when he got sick 2 days later. Not the day of the shot, 2 days later when he got sick. Reporter was provided with the contact for Pfizer Medical Information. Reporter stated that her husband is still sick. Patient had no lab test. There was no product complaint to report. There was a medical information request. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Pt received Pfizer booster.   Was asked to wait 30 minutes d/t numerous allergies.   After 30 minutes pt felt her heart was racing. HR 88, regular rhythm.   Pt asked to wait an extra 16 minutes.  Given small bottle of water.   Within 10 minutes pt stated she felt better, HR 75.   Pt was instructed to push fluids today.   Pt stated this happened while she had active covid infection, EKG through PCP was normal.
Itchiness all over.  No visible rash, just feeling itchy all over with no redness.  It feels like I'm itching from the inside.
Patient was immunized with vaccine that has beyond-use-date (BUD) of 7/15/22; MFG: 11/2021; EXP: 10/31/22. No temperature excursion during this time period. We have reached out to Pfizer for additional information regarding the vaccine viability past the BUD, currently waiting on response.
64-year-old male with a PMH of DM type 2, HTN HLD who recently underwent a left knee replacement with an Orthopedics office at an outside facility, he subsequently went to rehab and was released 2 days ago but did test positive for COVID-19 prior to his release on 01/24 and presents today with increasing weakness, cough, SOB and poor appetite.
Started approx 50 hours after immunizations neck pain - sore to touch, hurts to turn head, stiff neck. 1/10/06 Pt saw MD, no treatment given.
The left arm was very swollen and sore and there was a 1.5 inch knot and heat and redness where the vaccine was administered.  It was difficult to move the arm without moderate pain for secure days.  On Sunday, Feb. 8, the knot has grown 2.5 inches.  The redness around the injection site has grown and is spreading down in an oval shape.  There continues to be soreness and swelling.
STARTING ON 1/16/2022 PATIENT REPORTED VERTIGO, DIZZINESS, SPINNING SENSATION, NAUSEA. SHE THEN STARTED WITH BURNING AND PARASTHESIAS IN THE LEFT ARM WHICH IS THE INJECTION ARM FOLLOWED BY PAIN RADIATING INTO THE LEFT NECK AND SCALP REGION
Tremors, allergies, headaches, rashes and diagnosed with mast cell activation syndrome.
A 2 month of age patient received a dose of Kinrix instead of Pediarix; A 2 month of age patient received a dose of Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 2 month old patient received Kinrix instead of Paediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reported batch number was not found in sales data sheet, hence was updated to HB7L7. The reporter consented to follow up.
Patient had second vaccine and having side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient had second vaccine and having side effects ) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had second vaccine and having side effects ). At the time of the report, VACCINATION COMPLICATION (Patient had second vaccine and having side effects ) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
This spontaneous report was received from a physician referring to a 12-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Heart palpitations; chills; fever; body aches; weakness; This is a spontaneous report from a contactable 66-year-old female Other HCP reported for herself (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in right arm on 29Dec2020 05:00 (at the age of 66 years) as dose 1, single for COVID-19 immunisation at hospital. Medical history included heart disease from an unknown date and unknown if ongoing other medical history, known allergies to medications, food, or other products from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020, 20:00 the patient experienced heart palpitations, chills, fever, body aches, weakness. No treatment was received for events. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in right arm on 15Jan2021 04:30 as dose 2, single (at the age of 66-years-old) for COVID-19 immunisation at hospital. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
02/15/21 About 7-715pm injection site red with small raise circle around site (maybe dime to nickle size) developing. Site stayed red for ~48hrs.  Arm was sore, but nothing too bad.  At hour 35 developed fatigue.  Redness started to fade.  Not much activity around site until early morning of 02/22/21 when site started to redden again and rash began to develop.  Site began getting itchy and noticeably hot at 9am.  At 1245pm surrounding skin and other arm surface temps were ~85-86 degrees but area around injection site and on rash was 95.6 to 96.8 degrees.  The reaction is roughly 2/25" (top to bottom)  x 2/5" (side to side) at 1:28pm.
Rash on arm bilateral, thigh, buttocks, swelling around injection site and face.
Fever, cold chills, aching, headache Treatment: Tylenol, ibuprofen Outcome: resolved in less than 48 hrs
I had chills and fever through the night.  On Monday 4/26 morning at approximately 8:20 am I didn't feel good while trying to eat breakfast and thought I was going to faint.   I put my head between my knees and feeling didn't go away.   Vision was blurry and narrowed and my heart started to race.   I knew I needed to lie down and in getting up from dining room table I did faint.
Fine rash forehead, chest, abdomen and back noticed on awakening in a.m. Seen by Dr on 2/12/14. No treatment.
Redness and swelling started 5-24-08 at night; worsened - brought to office on 5-26-08 with redness, swelling, warm to touch, and itching on right thigh - Treatment: advised parent to use BENADRYL, ice, and ibuprofen
Tingling in the left fingers, left arch of foot, left cheek bone on the second day (4/24/2020) after the shot.  Left foot and fingers continue to feel prickly or tingle as of today (4/28/2020).
pt visited hlth dept on 13APR98 to recv next immun;pt had rash that was itchy on back & chest;went to hosp ER;was told rash was allerg rxn d/t recent immun;given some oral med;
Severe pain on L upper back associated with tingling/sharp shooting pain on L arm/elbow which started 3-4 days post pfizer booster. It started of with pain on L upper arm (injection site) then pain started on neck/upper back and gradually gets worse.
Patient received 1st dose of moderna on 3/3/21, when giving 2nd dose Janssen was inadvertently given to patient
YF-VAX was reconstituted with sterile water instead of the sodium chloride diluent/ NO AE; Initial information received on 22-Jun-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Medical Information (reference number- 00651985).  This case involves a patient of unknown demographics who was vaccinated with 0.5 mL YELLOW FEVER VACCINE - [YF-VAX] (lot number and expiry date not reported) via an unknown route in unknown administration site which was reconstituted with sterile water instead of the sodium chloride diluent (product preparation error) on an unknown date for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).   Reporter was asking information about YF-VAX reconstituted with sterile water instead of the sodium chloride (NaCl) diluent. Asking information about what to do when given to a patient. Facility was trying to determine how best to mitigate a dose that was reconstituted with sterile water and then was administered to a patient.  At the time of reporting, no adverse event was reported.  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 available on the batch number for this case.
She been feels ill slightly ill ever since the shot. Always short of breathe. Now she died of a blood clot / heart attack while at night in her chair.
No additional AE; the HCP administered a 1 ml adult dose of the hepatitis B vaccine to her son instead of the pediatric formulation of the 0.5ml dose; This spontaneous report was received from a consumer and refers to her son, a currently 36 years old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  The reporter informed that her son received an adult formulation dose of possibly hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) at the age of 17 years old back in May 2005. Caller is unsure of the name of the hepatitis B vaccine that he received but stated that it could possibly have been hepatitis b vaccine (recombinant) (RECOMBIVAX HB). The reporter stated that the healthcare professional (HCP) administered a 1 ml adult dose of the vaccine to her son instead of the pediatric formulation of the 0.5ml dose because the HCP stated that "his weight is heavy enough for the adult dose" (Incorrect dose administered). No additional adverse events reported.
Pt seen in the office on 04/19/2021 for x/o pain and swelling in right wrist, within 72 hours of receiving Covid vaccine in right arm, on 04/16/2021 and states: "Friday evening I got #2 Moderna; woke up in middle of night with right sided pain 9/10 in my wrist, hand and thumb." Pt has no pain on left side. Denies pain or s/s at injection site. Has taken Advil and Tylenol pm, and iced and elevated and applied heat, all without improvement. States overall the same constant pain as of today (04/19/2021).
Fever 101 degrees1:57 am. Ache pain, fatigue x 10 days (Hx of COPD)
Patient received dose 1 of the Pfizer COVID vaccine (lot FD0809) on 9/8/2021. Patient felt blurry vision and brain fog immediately after injection that resolved in 5min. Patient did not report symptoms to medical staff. Upon return to vaccine POD for 2nd dose, patient reported symptoms to Pharmacist vaccinator who relayed information to PHN. Patient reported no allergies, no medications, no medical conditions. Patient did not follow up with provider after 1st dose. Patient reported eating and drinking fluids prior to vaccination and feeling anxious about COVID vaccine. No previous similar reaction. History of ateriovenous malformation with open brain surgery in 2016 and Cesarean section in 2015. At 1730, vital signs: respirations 16, O2 97%, pulse 84, blood pressure 136/94. PHN texted medical consult to medical team at 1733. PHN received approval for Pfizer 2nd dose with 30min wait at 1737. Patient received dose 2 of the Pfizer COVID vaccine (lot FF8893) at approximately 1750. At 1801, patient reported feeling dizzy and brain fog to Pharmacist. PHN and Paramedic approached to assess. Vital signs: blood pressure 136/92, pulse 84, 99% O2, respirations 18. Patient transferred unassisted to zero-gravity chair and laid supine. Patient reported eating and drinking fluids prior to 2nd dose vaccination. PHN offered Benadryl but patient declined. PHN encouraged patient to stay for 30min monitoring period after report of symptoms, to follow up with provider, and when to call 911. Patient drank water, offered applesauce but patient declined. At 1816, vital signs: blood pressure 126/78, pulse 68, O2 100%, respirations 16. Patient reported symptoms had resolved. Patient sat up, continuing to report no symptoms. At 1810, patient stood up closely monitored by PHN, patient continued to report no symptoms. Patient left walking with steady gait at 1827, patient left against medical advice.
Right after the injection had warmth around injection site.  Around 12:00 on 1/27/21, he looked wilted.  Wife checked his temp and it was 103.8.    Was given Tylenol and temp went up to 104.  She called the doctor at 2:00 PM, told her to see the doctor.  Lethargy and weakness.  Tested him for COVID and flu and still had fever.  Was negative for both, told to alternate Tylenol and Ibuprofen, went down to 102.  At 6:30 PM went up to 103.8, at that point she called the doctor, could not speak to him until 6:45 PM instructed to bath down with warm rag, and was told it was probably a reaction to the vaccine.  Was called in a steroid pack.  He went to bed running about 103.6 at 8:30 PM.  Was able to get up, was given more Tylenol/Ibuprofen and his fever finally broke around 101 about 4:00 AM.  Got up this morning and does feel better.  Running around 100-101 temp.  The vaccine is the only thing that has been different in his normal routine.  Still has warmth to the injection site, red.
c/o rt arm being painful, generalized aches, swelling below elbow, inj site hard & hot to touch;notified Md & instructed to use a warm compress to inj site 6NOV98;
9:30 DTaP, HIB, IPV and Hep B #3 given. 1000 Tylenol 0.8cc given. 11:00 felt hot, veins noticeable in hands and legs--pale, asleep. 13:30 Tylenol given by mom. 15.20 mom came back to clinic--temp 103 degrees rectally, pale, oxygen saturation 98%, HR WNL, active, alert Motrin given- Temp V 101.8 rectal. Instructed mom to watch: went home at 16:30; Fever for 2 days: resolved.
pt recv vax & inadvertently recv another inj of pnu imune 23 on 1/7/98;1/30/98 pt devel eczema which resolved as of 2/25/99;
Headache, Myalgia, Fever, CHILLS SORENESS AT INJECTION SITE  Narrative:
Narrative: Per patient: Monday (4/12/2021) received vaccine at Pharmacy Tuesday experienced low grade fever, red flushed face, chills, and was tired Wednesday he stated these symptoms resolved Thursday morning 2am he experienced increased SOB both resting and on exertion Patient presented to ER at 13:10 on 4/15/2021 48 y/o MALE presents to the Emergency Department with complaint of Shortness of breath HPI: Arrives with acute/chronic shortness of breath and weakness worse last night and when he ambulated into building. Per patient he was dx with COVID-19 in 10/20202 and had shortness of breath which did not improve. Patient admits he had 1st vaccine for COVID Monday and last pm he had shortness of breath and fatigue. Patient states denies fever, denies chills, denies chest pain. see above work-up and labs Imaging results: Radiology Impression (2Days) Date Procedure CPT Status Case #04/15/2021 CTA CHEST W/CONT & IMAGE 71275 Verified POSTPROCESSING Massive right-sided pulmonary embolus, occluding the distal aspect of the right pulmonary artery and extending throughout majority of the lobar and segmental branches. There is some peripheral enhancement seen mainly in the upper lobe branches. Smaller embolus on the straddling the bifurcation of the left pulmonary artery. Findings concerning for right heart strain. Critical results discussed with NP Patient stabilized and transferred to local non-facility hospital for cardiac cath procedure and possible embolectomy
On 7-11-2022, I started having a temp of 98.8, chills, fatigue, loss of appetite, runny nose and a scratchy throat. Later that morning, I took a home Covid19 test with positive results. I called the doctors office later that afternoon and left a message with their tele service. The next morning on 7-12, they doctors office called me back and prescribed Paxlovid. I started taking the Paxlovid on 7-12 and have had 2 doses of it. I am not taking anything over the counter for symptoms. I am reporting my breakthru case of Covid.
Headache, NauseaVomiting, chills, shaking, "felt like I had the flu" Narrative:
an area of erythema 5cm x 4cm rt deltoid area site of vax w/induration;no fluctuation;sl tenderness;
Narrative:  Patient reported tingling in fingers following administration of moderna covid vaccine dose 1. No additional treatment noted.