chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a 11 year old patient of unknown gender.  Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 26-JAN-2007, the 11 year old patient was vaccinated with M-M-R II, (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (considered an inappropriate schedule of drug administration and drug administered to patient of inappropriate age). On 18-JUL-2011 and 04-APR-2017,  the patient was vaccinated with M-M-R II, (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (considered  overdose). No adverse symptoms were reported. Additional information has been requested.
Patient was given his 2 month vaccines today.  He was given the Rotavirus vaccine first and then his 3 shots.  Pentacel, Prevnar 13 and Hep B.  The child started crying like kids normally do after receiving their shots but patient's whole body turned red.  His head was the most noticeable.  It was like the color of a cherry tomato.  He was not crying that hard at the time and did stop crying shortly after.  His body remained that red for several minutes.  He did not have any sort of rash or hives or breathing issues, just the change in color.  His color gradually went back to normal over the next 2-3 minutes.  The child was monitored for any signs of further reaction.  He was kept in the clinic for 30 minutes.  The incident was reported to Dr.  Dr. did re-evaluate the child and everything was back to normal.   Patients mom instantly got concerned.  Patient has never turned that color even when he is crying really hard.  She is also a nurse and right away assumed it was a reaction to his vaccines.   We are unsure if this is related to his vaccines but are reporting this just in case.
24 hours post vaccination pt experienced erythema and heat that spread to elbow and up through chest and armpit. Painful to move extremity. She is treating with acetaminophen and ice. (This is regarding her Pneumovax vaccination)
Headache, feels like swelling and pressure in brain, and pressure in eyes. Can't keep eyes open. Body aches, especially back Stiffness Fever 99.9F  given ibuprofen to manage pain symptoms have not yet subsided
Two hours, post vax, pt felt light-headed which lasted about 1/2 hour. At the same time, pt's right arm and leg felt tingly, lasting about 3 hours. In the AM of 12/28/00, woke up with right arm and leg feeling tingly, progressing to numbness in the right hand and foot. Numbness persisted until around 12/31/00. Pt still has periodic numbness on top of right foot.
1 day after COVID vaccination, began to have chest pain, palpitations, brain fog, and severe fatigue. Also had fever. Fever resolved within 48 hours after vaccine administration. However, other symptoms continued. Sought care at emergency room on 9/20 for chest pain, headache, dizziness, and altered mental status. Subsequently have followed up with cardiologist who discussed likely symptoms may represent mild pericarditis. Treating at home with ibuprofen and will follow up with additional studies if symptoms do not resolve in expected timeframe of 2 weeks.
Patient presented to the ED on 10/3/21 for weakness and diarrhea. Patient was hospitalized on 10/6/21 as a result of bacteremia. These visits are within 6 weeks of receiving COVID vaccination.
Approximately 4 hours after receiving Zostavax, patient develeoped sever headache & L visual field defect. Diagnosed with subacute hemorhage R occipital lobe, subdural and subarachnoid hemorhage aong the R cerepbral convexity. No ischemic changes, no acute injury, no abnormal enhancement. Normal CT angiographic study. Pt's BP e;evated in hospital but no previous history of hypertension. TReated with observation, BP and pain medication.  9/18/07 Reviewed ER medical records which reveal patient experienced HTN (228/110 at home, 189/108 in ER), head pressure & lightheadedness, seeing spots. Transferred to higher level of care. 9/25/07 Reviewed hospital medical records which reveal patient experienced headache w/left sided visual defects.  Admitted 8/10-8/15/2007.  BP in outlying ER high.  Neurosurgery, ophthalmology & neurology consults done.  Medically managed & HTN controlled at time of d/c.  HRT was d/c'd & patient started on Synthroid & Paxil FINAL DX: right occipital intracerebral hemorrhage w/adjacent SAH & SDH.
Tinnitus in both ears.  Started 10 days after second dose.  Pretty bad and constant. Never experienced tinnitus before.
I received the 2nd shot Friday, 4/23 at 10:05am. I had previously started my period cycle on Thursday, 4/22 (the day before). By Friday between 3-4pm I had completely stopped bleeding. I continued up until present day with no menstruation bleeding or spotting at all. I have taken pregnancy test on Monday, 4/26 that was negative. This is VERY unusual for me and my monthly cycle. I track every symptom, every sign, etc. leading up to my cycle each month. I know exactly when my body ovulates and when my body will start the cycle over again. This has never happened before.
The RN selected the Pfizer primary vaccine vial instead of the Pfizer Bivalent vaccine vial and administered a 0.3 ml dose to the patient.
Following administration of vaccine patient started to have difficulty swallowing and tingling in mouth and tongue.  Patient was given liquid diphenhydramine and water and stated the difficulty swallowing improved but his mouth still had the tingling sensation.  Patient never reported facial swelling or difficulty breathing and declined an EpiPen.  After 30 minutes or so patient reported improvement and left our facility.  We reached out to the patient later that day and they had continual improvement, but felt they had experienced a possible allergic reaction.
Unknown-patient died at home on 5/15/13.  Time of death not indicated on death certificate.  Manner of death indicated as natural and pulmonary aplasia listed as cause of death.
Pt sat down after he got his vaccine. He stood back up to accompany his wife while she got her shot. He said he started to get light headed and we helped him to the ground.He was cold and clammy and he had no difficulty breathing.   He stayed conscience. He sat with us for 1/2 hour , had some water. Said he felt better and then he left. He did not with us to call Paramedics.  To the best of my knowledge he was recovered. He said he was recovered.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (rHA, lot # L023386, expiration date 25-JUN-2017; dose and route were unknown) for prophylaxis. The vaccine was exposed to 22.7 Celsius degree for 45 minutes. Temperatures were recorded with a data logger and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. Since unspecified dates in October 2014, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) injection (unknown strength and route). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chills the night I received the shot. Then fever of 99.6, rotated from very hot to chills and very cold. Muscle aches and tingles from fingers to toes. Overwhelming tiredness.
screaming p/DTP for 4 hrs uncontrollably; lethargy for 3 days;
Rash started Saturday 7/9/11 & spread all over body. Also had fever for 48 hours after vaccination.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 12/26/2022 Discharge Date:  1/7/2023 COVID positive date: 12/26/2022 PRESENTING PROBLEM: Confusion [R41.0] COVID-19 [U07.1]   HOSPITAL COURSE: DETAILS OF HOSPITAL STAY:   HOSPITAL COURSE: Patient is a 75-year-old male with history of type 2 diabetes mellitus, hypertension, bipolar disorder, BPH, hyperlipidemia, chronic back pain and GERD who presented with cough, shortness of breath and generalized weakness.  In the emergency department, he was febrile and tachycardic.  Labs showed sodium 133, mildly elevated LFTs and lactic acid of 2.6.  COVID PCR was positive.  Chest x-ray showed no acute cardiopulmonary process.  CT abdomen/pelvis was obtained, showing incidental finding of right renal mass and mild hepatic steatosis.  He was hypoxemic in the emergency department, and placed on 2 L of oxygen.  He was given Tylenol and 1 L of saline.  He was admitted to the hospitalist service for further care.   Upon admission, the patient was continued on supplemental oxygen and started on Decadron. He also received a three day course of Remdesivir.   He required up to 5 L oxygen, but was then able to gradually be weaned.  He was able to be weaned to room air by time of hospital discharge.   He was seen by Physical and Occupational therapy, who recommended subacute rehab at discharge.   Admission CT abdomen/pelvis revealed incidental finding of right renal mass.  This was further evaluated with MRI abdomen with without contrast, which confirmed 3.3 cm right renal mass, concerning for renal cell carcinoma.  Urology was consulted, and recommended outpatient follow-up in 1 month.   Pt was discharge when medically stable to SAR.
Initial Side effect -only headache a few hours after vaccine and then for 48 hours following  Delayed effect - 1 week after vaccine a raised itchy and painful rash appeared at injection site  along with swelling of the arm.  This  lasted about 48 hours,
Heart palpitations, continued for about 2 weeks after each dose. I would be sitting quietly and have a pulse of 130-160 beats a minute for most of the day.
Can not move the left arm; HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the left arm), VACCINATION SITE PAIN (HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 006B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the left arm), VACCINATION SITE PAIN (HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot) and CHILLS (Chills). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the left arm), VACCINATION SITE PAIN (HCP moved the needle in his arm while administering booster shot/Painful left arm immediately after booster shot) and CHILLS (Chills) was resolving.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-367625 (Patient Link).
Approximately two weeks post vax pt developed a rash with 30 - 40 skin lesions. Pt was afebrile. Physician feels the rash was due to the vaccine rather than exposure to wild type virus. Follow up states unspecified medical attention was sought. The patient's sibling had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Only received the first dose of Shingrix in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date in 2019).   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 information was provided as follows: The case was reported by patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter declined to provide health care professional information. The reporter did not consent to follow up. This case is linked to case US2021112519 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021112519:Same reporter. Husband's case.
Right after vaccines patient developed recurrent shaking in both legs at different times 30-60 seconds. Fast full leg shake. First in one leg and then the other. Continued 2-3 times a week for a full month.
Chest pain approximately one week later.; Back pain approximately one week later; headaches; Pain at injection site for 2 days.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 14:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have any allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM) , buspirone hydrochloride (BUSPAR), buspirone (MANUFACTURER UNKNOWN) and eszopiclone (LUNESTA) from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 14:30 the patient experienced pain at injection site for 2 days. chest and back pain approximately one week after the vaccination and headaches. Therapeutic measures were taken as a result of AE and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and Tylenol (MANUFACTURER UNKNOWN). The patient was advised to follow up with doctor. The events resulted in emergency room/department or urgent care. The clinical outcome of the event pain at injection site for 2 days was recovered on 04Apr2021. The clinical outcome of the events chest pain, back pain  and headaches were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
died because of BNT162B2 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died because of BNT162B2 vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter also said he knew 3 clients of his who died from the Pfizer vaccine. The reporter was very irate and did not want to provided further details without a medical refund and did not want to be contacted any further if there was no refund evolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112856 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died because of BNT162B2 vaccine
after giving the vaccine to patient . after 2 min patient felt tired & fainted for 5 minutes then she felt okay patient said she had anxiety about needles & vaccines
Initial unsolicited report received from health authority (under the reference number: 725697) on 03-Apr-2018. This case involves 33-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1703) and PNEUMOVAX (manufacturer: Merck) (Batch number: N022303) (expiration date, dose was not reported) via intramuscular route in the left arm on 02 Nov 2017. The patient's medical history and concomitant medications were not reported. On 03 Nov 2017, one day following the vaccination, the patient experienced redness (erythema), pyrexia (fever of 104 degree C), swelling and diagnosed as cellulitis (reported as patient reported to urgent care and diagnosed with cellulitis). Lab data and corrective treatment were not reported. On an unspecified date, patient recovered from the events. Upon internal review, the company decided to consider the event serious due to important medical event cellulitis. List of documents held by sender: none.; Sender's Comments: This patient developed cellulitis with erythema, fever and swelling following vaccination with FLUBLOK QIV. Time to onset was compatible. Additional information including condition at the time of vaccination, medical history, previous vaccinations and tolerance, lab test ruling out other infectious etiology is needed to confirm the causality. Moreover the patient had also received Pneumovax concomitantly, hence the role of individual vaccine cannot be assessed separately.
Injection at 12:46, Experienced Tingling on tip of tongue at 1303 took oral Benadryl 25 mg, reported symptoms at 1309- 161/93 sat 100% on room air, P-84, Repeat 1310 135/94 sat 98% P-81, 13:13  152/101 sat 99% P-87, 13:17 145/87 sat 99% P-86, 1330- 141/82 sat 99% P-89, reports tingling decreasing, 13:38 149/83 Sat 98% P-84 13:45 still having tingling transferred to Urgent Care
Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning her daughter a 17 year old female with pulmonary stenosis, cardiac murmur (which were diagnosed when she was only six weeks old) and drug hypersensitivity to codeine who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL (LOT# 661841/0653X). There was no concomitant medication. Subsequently the patient experienced numbness and tingling on her face and fingers. On an unspecified date, the patient sought an unknown medical attention. The patient was prescribed BENADRYL and the numbness and tingling disappeared. The patient's LMP was in May 2009, on approximately 10-JUL-2009 the patient discovered that she was "2 and a half months" pregnant after conducting a home urine pregnancy test. The patient outcome was also reported as recovering. No further information is available at the time of this report. Follow up information has been received which reported that in February 2010, the patient delivered a normal infant with no congenital anomaly. Additional information is not expected.
Headache and mild nausea. Onset started within 20 minutes or so of second dose.  No other adverse reactions noticed at time of submission of this form, approximately 3 hours after second dose.
It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .
Approx. 10 minutes, post vax, had pruritus and redness on left deltoid the size of a baseball progressing to the size of a softball.
Case number PHEH2013US022145 is an initial spontaneous report received from a pharmacist on 21 Oct 2013 with a follow up information received from a pharmacist on 18 Nov 2013. This report refers to a 64-years-old male patient. His medical history included smoking and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 130940) at a dose of 0.5 ml subcutaneously on 21 Oct 2013. He also received ZOSTAVAX (other manufacturer, batch number: not reported) on the same day. No adverse reactions were reported following the maladministration. Follow up information received from a pharmacist on 18 Nov 2013: Patient demographics (date of birth, age and initials), medical history, concomitant vaccination and dose of FLUVIRIN updated.
This spontaneous report as received from a nurse refers to a 23 year old female patient (nurse daughter) with no drug allergies. The patient's pertinent medical history was none. Approximately in 1993 (reported as 21 years ago) the patient was vaccinated with PEDVAXHIB, RECOMBIVAX HB, poliovirus vaccine live oral (manufacturer unknown, reported as unspecified) and Tdap (manufacturer unknown, reported as unspecified). On an unknown date, the patient developed pain in both of her legs a couple of hours after receiving these vaccinations. Lab diagnostic studies performed were none. The nurse reported that she received TYLENOL after receiving vaccinations. The outcome of pain in both of her legs was reported as recovered by the next day. The causality was not reported. The patient did not sought medical attention. The nurse also reported that her grand-daughter was administered TYLENOL prior to and after receiving the unspecified Hib vaccine on an unspecified date and did not had any issues of pain or fever. This case is linked to 1405USA103470 and 1405USA013469 (same reporter link). Additional information has been requested.
Headache, after around 4 hours begin to get worse so took 2 asprin-no help.  After another 2 hours became really bad and after two more hours took two more asprin-no help.  Went to bed a couple hours later it eventually went away.
General malaise escalated to painful body aches, fever, chills, weakness over the next 24 hours. Adverse events ended after 24 hours.
One week after receiving MMR shot, client experienced severe joint pain in arms and legs.  Client saw MD at clinic and was prescribed Vioxx which she took for 1 week and then switched to Aspirin and Ibuprofen and ice.  At this time, symptoms are getting better.
Developed a red warm lump, multiple migraines and developed cellulitis. Have tingling in her which went down to her fingers. Soreness in shoulder and neck. Spoke with a NP and Neurologist
The shot was admininstered in my left arm.  Around noon, I had tingling in the left side of my face and slight numbness and then had tingling in my toungue and lips.  My tongue was tingling until around 6:00pm and the tingling slightly subsided.  The following day, my lips were tingling.  I went to the urgent care facility and they determined that it was an adverse reaction to the flu shot and recommended for me to take Benadryl. The influenza 07/26/2011 shot that I had received was the GlaxoSmithKline lot # AFLLA673AA in my left deltoid via IM.