chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary Embolism (blood clot) left lung; Pulmonary Embolism (blood clot) left lung; Also had to have an appendectomy 01May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LANSOPRAZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: APPENDICECTOMY (medically significant) with onset 01May2022, outcome "unknown", described as "Also had to have an appendectomy 01May2022"; PULMONARY EMBOLISM (hospitalization, medically significant), PULMONARY THROMBOSIS (hospitalization, medically significant) all with onset 01May2022 at 04:30, outcome "not recovered" and all described as "Pulmonary Embolism (blood clot) left lung". The patient was hospitalized for pulmonary embolism, pulmonary thrombosis (hospitalization duration: 2 day(s)). The event "pulmonary embolism (blood clot) left lung" required emergency room visit. The patient underwent the following laboratory tests and procedures: nasal swab: (06Jul2022) Positive, notes: rapid antigen.  Clinical course: The event did not results in death, or life threatening. The event caused/prolonged hospitalization. The event did not cause disabling/Incapacitating or congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Vaccine suspected by doctor as cause of both AEs. Device Date : 21Jul2022.  Follow-Up (25Jul2022): Follow-up attempts are completed. No further information is expected.
Circular itchy rash, 6ish days after injection. No other symptoms. Reporting because online said report it.
Potentially gave 5th dose to patient due to incorrect documentation in medical record  from Rehab facility(patient was marked down as having only received her first and second doses of vaccine and consented to being vaccinated)
History of large red spots, not seen on ER exam. History of prolonged crying 5-6 hours.
Within a week after this she started her period. She states she just finished her period prior to this and is on birth control so her cycle is very regular; break through bleeding; Stiff neck; Pain in arm; Nausea; Neck pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0191and Expiry date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 15:00 as 1st dose, single dose for covid-19 immunization.  Relevant medical history was not included. The patient had no prior vaccinations within last 4 weeks. The patient experienced within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular on an unspecified date while break through bleeding experienced on 29May2021. Patient also experienced stiff neck, pain in arm, neck pain and nausea on 26May2021. The caller stated that patient had her first Pfizer Covid vaccine dose on 25May2021. Within a week after this she started her period. She states she just finished her period prior to this and was on birth control so her cycle was very regular. Within a few days of getting the shot, she has had some major breakthrough bleeding. She normally did not have that the only thing that changed in her life was that she got the COVID shot. She believes the breakthrough bleeding started Saturday night. It has gotten progressively worse. At first, it was just like a little bit of bleeding but, she full blown had her period. She didn't take her pills late or anything like that. She did not really know what she should do because this was really odd. she was still taking her birth control pills and takes vitamins. Caller mentions at first, she had the normal side effects like a stiff neck and pain in the arm. She also felt nauseas the next day. It was pretty normal stuff, then the breakthrough bleeding happened. The neck pain, pain in arm, and nausea started the next day after receiving the vaccine and lasted like 24 hours. Caller stated just out of curiosity, has anyone else had this issue. She was not asking for people personally if it is a side effect, but she believed everyone should be told about if this was one of the side effects. She wants to know if this had a side effect of the Covid vaccine. Therapeutic measures were taken as a result of events, patient took Advil. The outcome for event within a week after this she started her period. she states she just finished her period prior to this and is on birth control so her cycle is very regular and stiff neck was unknown, while the outcome for pain in arm, neck pain and nausea were recovered on 27May2021. The outcome for break through bleeding was not recovered.
When she was of school age, tests taken. Mentally handicapped, Speech impaired. Symptoms of Autism.
Pt became diaphoretic & pale when receiving Pfizer vaccine.  Moved to Observation area per w/c.   BP118/76  P72.   Rested until syncope symptoms subsided.  Left without assistance with daughter.
This is a spontaneous report received from contactable pharmacist/consumer or other non-HCP. A 28-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 28, on Aug 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had visual impairment (changes in vision), onset Aug 31, 2021, with outcome of unknown; and blurred vision (blurry vision), onset 2021, with outcome of recovering. Additional Information: Patient experienced changes in vision immediately after vaccine administration. While he was sitting in the waiting area, he said he couldn't read the apps on his phone, but didn't mention anything at the time to the pharmacy staff. Now patient presented back to the pharmacy to report his symptoms. He has been "experiencing blurry vision, so he went to an eye doctor and got it checked." The doctor could not find anything out of the ordinary. The patient reported the blurry vision "seems like it's getting better" as more time passes. The patient has worn glasses since 2014, and reported "getting new glasses a couple of months ago." No other side effects reported. Follow-up (Nov 15, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Pt. has mall raised bumps to both shoulders and lower legs, along with dry patches to lower legs. Reports started 5/25/2012. No treatment other than lotion. Also has bumps on right cheek of face et neck.
Information has been received from a physician concerning a male patient in his late 40's to late 50's who was vaccinated with PNEUMOVAX (lot # 658449/0989U). Subsequently the patient experienced injection site reaction which included redness, induration and swelling. Physician states "It was almost like it was a cellulitis reaction". It is unspecified if the patient received PNEUMOVAX in the past because the patient could not recall their vaccination history. The patient was told to take BENADRYL, CLARITIN, PEPCID, MOTRIN or TYLENOL and to elevate his arm. No hospitalization required. Subsequently the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
started to have soreness of the arm after the vaccine and then the pain progressed over the course of 2 weeks and now cannot lift her right arm.
No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 09-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001779: US-009507513-2007USA001780: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001778: US-009507513-2007USA001777: US-009507513-2007USA001781:
Pt c/o of irritation on left arm at injection site. Upper left arm slightly warm to touch with red raised area approx 1inch in diameter. No c/o itching or difficulty breathing.
No additional AE; The patient was administered an expired dose of ROTATEQ; This spontaneous report received from an office manager and refers to a 06-months old patient of unknown gender. The information about patient's pertinent medical history and drug reaction and allergy, and concomitant medications were not reported.  On 15-DEC-2021, the patient was vaccinated with expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (Lot No. 1691302 has been verified to be a valid lot number for [Rotavirus Vaccine, Live, Oral, Pentavalent], expiration date reported as 12-DEC-2021, but upon internal validation established as 23-JAN-2022) (frequency and exact dose were not reported,) as prophylaxis (Expired product administered). No additional AE reported. No PQC reported.
Hospitalization for COVID-19 symptoms on dates  4/25/2023- 4/30/2023. Treated with hydrocortisone PO, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
immunization reaction 24hrs p/vax-fever 102.8;rx APAP
The patient presented today at counselling for an antibiotic. The patient stated she was seen today in the ER today for a rash she developed on her arm where she received the Moderna Covid-19 vaccine 2 weeks ago. The patient stated she started itching on her right deltoid 4 days ago and since then the rash has progressed down and around her bicep. The patient stated that the rash was not painful and therefore, the doctor did not think it was cellulitis but prescribed the antibiotic just in case. I thanked the patient for letting me know and I informed her that I would be reporting the reaction to Vaccine Adverse Event Reporting System.
Arm (right) swollen and could not move for a couple of days (hurting). Ran fever of 102.7; Right arm is still red and swollen from shot.
This spontaneous report as received from a nurse refers to a 65 year old patient of unknown gender. No medical history provided. On 06-MAY-2013 the patient was vaccinated with ZOSTAVAX (dosing, frequency, indication; lot # H018510, exp 15-JAN-2014). The vaccine had been improperly stored at minus 5C since 14-FEB-2013. Unknown whether the patient had been using any concomitant medications. No adverse event was reported. Additional information has been requested.
As the vaccinator proceeded to to administer the vaccine, she injected the needle into the site. As the vaccinator began pushing down on the plunger to administer the dose, the vaccine exploded out of the sides of the syringe and began to drip down the patient's arm. The patient did not receive the full dose.
Circumstance or information capable of leading to medication error; not administered, but will vaccinate with 1 mL dose; not administered, but will vaccinate with 1 mL dose; This case was reported by a physician via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 19-year-old female patient who received HBV (Engerix B) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B 1 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error, adult product administered to child and overdose. On an unknown date, the outcome of the circumstance or information capable of leading to medication error, adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not have history of hemodialysis. Physician stated that, 19-years patient was in clinic and needed to receive 2n dose of Engerix-B.   MD stated that, they only had 1 mL doses on hand.   Physician thought she had read this dose was ok for a 19-years-old but wanted to make sure before it was administered. She was administering it based off the alternate schedule in the PI. At the time of reporting, 1 ml was drawn up but was not administered but based off the alternate schedule healthcare professional stated that she would vaccinate using the 1 ml dose which would led to circumstance or information capable of leading to medication error as adult product administered to child and overdose.  The patient received 0,1- and 6-month schedule of Engerix B.  The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Sweating; This is a spontaneous report from a contactable consumer (patient mother). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was sweating for 2 days. Outcome for the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Rash all over, irritable, reddened sore vaccine site (L) thigh where PROQUAD given.
This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose and route not provided). The health care worker reported, the storage compartments that contained GARDASIL were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the unmonitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
Swollen, red arm at site of injection, approx 3x3 inches Extremely itchy No rash
Three days post vax, the pt's skin erupted in rash over most of the body with extreme itching. Treated with prednisone; which took the rash away but it returned within a few weeks.  Information received from medical records state anemia, hyperlipedemia.
could barely walk; headache; body aches; feeling a little tired; she got really bad chills and was in bed and was shaking the whole bed,teeth were chattering; barley even speak; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old 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, administered in Arm Left on 01Nov2021 around noon (at the age of 68-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included fibromyalgia. There were no concomitant medications. She has a recent physical and she was perfect for her age, all her bloodwork and everything. Historical vaccine the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm in Jan2021 around 8am  as dose 1, single patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm in Mar2021 around 8am as dose 2, single for COVID-19 immunization and experienced tired for both doses. The patient did not receive any other vaccine prior vaccinations within 4 weeks. The patient did not have any adverse events following prior vaccinations. The patient received her booster dose of the Pfizer COVID-19 vaccine on Monday 1Nov2021, she had experienced the same side effects with the first two doses and that is 10 hours after she received the shot she started feeling a little tired and as the night progressed she got chills and it started shaking the bed, the patient stated that her husband put an electric blanket on her and her teeth were chattering. She states that in the morning (02Nov2021) she woke up with such a severe headache and body aches she could barely walk herself (02Nov2021) to from the bedroom to the bathroom. And then yesterday she could barely even speak (01Nov2021). She is calling today because it seems with every shot the symptoms are worse, since it looks like and we going to have to keep getting these boosters she doesn't want to have to feel this bad after each one. she got her booster 2 days ago and for the 3rd time she got, she doesn't want to say a reaction, but pretty severe symptoms to the vaccine to the point she had to call her doctor, she didn't know what to do. She states that her fear is the booster every year, does she have to go through this nightmare. The patient had visited for Physician Office for events but did not require Emergency Room for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
p/vax pt noted to have bloody stools; further eval revealed intussusception;required surgery to reduce;Annual follow-up received on 10/13/00 states the pt has recovered.
Elevation of liver enzymes to ALT 630 AST 257 with decrease to ALT 87 AST 45 after 2 months. Then 13 days after next vaccination elevation back up to ALT 549 AST 109. Pt with only vague RUQ pain symptoms.
Minimal adverse effects in January/2022 at the time of the booster. Positive for Covid on September 23,2022. I would consider it a mild case, similar to a common cold with bronchitis symptoms. In December, I had an adverse event that was ongoing for 3 weeks until it worsened at which time I went to the Emergency Room (after normal business hours). I was diagnosed with sinusitis, bronchitis, diverticulitis, and colitis. I was treated with two antibiotics.
A few days after I notice my lymph nodes in the left side of my neck swole which is still swollen to date but doesnt hurt as bad and  my arm at the injection site hurt really bad for a few days but subsided
fatigue, body ache, fever 101.8 the evening of  second day after jab,  and again evening on fourth day after jam.  Treated with 2 Tylenol and over night sleep.  Next day weak, but ok.
Itchy, red circle around shot area, hot-getting a little larger every day.  Using Cortaid and cold compresses.  Only helps a little. I have no systems of the virus. Called Advice Nurse.  Doctor will cal me to discuss.
pt recv vax 6OCT95 & 15FEB96 pt exp varicella rash;no further details were provided;
Post vax, pt's left leg was painful to touch, he was crying and mom did relieve pain every 8 hours. After a week, she took child to MD and was told to apply warm compresses. Two weeks later, leg swelled and became hot. Mom took him back to MD. The labs showed child had Staph and pneumococcal infection and surgery was performed; debridement of skin to bone on 5/19, to remove infection. Now child is in medical foster home for IV antibiotic therapy and leg care.
Patient reports a lot of itching in her L upper arm after the injection.  She noted pain and swelling in her L upper arm when she got home from her MD appt.  Morning of 11/6 pt noticed the redness was going past her elbow, MD recommended inpatient admission for IV antibiotic treatment.  Pt reports no hx of reaction to any vaccines in the past.  12/02/08 Reviewed hospital medical records of 11/06-11/10/2008. FINAL DX: acute LUE cellulitis vx immunologic reaction to pneumovax; sudden onset tachycardia & SOB; HTN; acute left parotitis secondary to dehydration & dry mouth secondary to benadryl. Records reveal patient experienced left arm spreading redness, itching, swelling & pain, nausea, malaise, HA s/p pneumovax injection in LA & flu injection RA.  No reaction to prior vaccinations w/pneumovax, flu or any other vaccines.  Tx w/IV antibiotics.  ENT consult done for left parotitis.  Improved & d/c to home on continued oral antibiotics.
Hospitalized with Bell's Palsy diagnosis on Sunday October 16th, 2022 after stroke like symptoms following headache for two days.
Severe pain radiating into shoulder & neck. Limited range of motion to arm. Plan: Ice, MOTRIN, Physical therapy off work for 1 week.