chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While entering dose into WIR, Health Department staff found that the patient had already completed a full series of Moderna in Feb/March despite indicating she hadn't on her vaccine administration form. This means the dose she received on 4/20/2021 was the 3rd she had received.   Staff was vaccinating at an independent apartment and when interacting with the individual had no reason to believe she wasn't lucid, trustworthy.
From initial information received on 8/2/04 from a health care professional regarding an adverse event occurring in the USA it was reported that a 20 month old male patient received an ACTHIB vaccination, lot number X0185 (US lot number UE100AA), administered IM in the right thigh, a DAPTACEL vaccination, lot number C1679AA, administered IM in the right thigh, an IPOL vaccination, lot number X0771-2, administered SC in the left thigh, and a PREVNAR vaccination, lot number 495703, administered IM in the left thigh on 7/28/04. After leaving the office on 7/28/04, the patient developed a high fever going to 105 degrees F. He was taken by ambulance to the hospital emergency room where he experienced four seizures. The patient was treated for febrile seizures and held for 24 hours. The patient recovered from this event.
This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL, injection 120 Y (lot#, expiration date, route and dose not reported). The healthcare worker stated that he was contacted by an unknown television station to respond to an adverse event where a patient developed fibromyalgia after receiving GARDASIL. The healthcare worker also mentioned that the television station would be airing a story on the adverse events that occur with GARDASIL, possibly on 30-JUL-2014("tonight"). The outcome of fibromyalgia was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
At 1:20pm pt. C/o scratch throat,SOB and chest tightness and asked for water to drink.Dr. at chairside. V/s163/94 pulse 85 resp 20 o2 sat 98%RA   1:38 team alert activated 1:41 EMS activated 1:42 epi pen given 0.3mg subq  1:49 ambulance arrived unit 586 report given to EMT. V/s before transported 156/86 pulse 84 resp 20 98% o2 sat RA Pt. Requested to be transported to the nearest/ED hospital
The next morning I woke up not being able to hear out of my right ear. My Doctor said to use Flonase and then for over two weeks I had ringing at night and popping constantly (eating, drinking, yawning, talking, elevators etc). Finally after a few weeks my ear returned to normal.
Maternal exposure during pregnancy (Delivery Date 15Dec2021); First night of second dose I was fatigued; had a headache; body aches; fever; violent chills; My whole body was shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 11:15 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Date of last menstrual period: 14Mar2021. The patient was 27 weeks pregnant at the time of exposure to bnt162b2. The patient was 27 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 15Dec2021. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Proprietary medicinal product name: Pfizer   , Batch/lot number: Unknown    , Anatomical Location : Arm Left   , Dose Number : 1, administration time=10:30 AM), administration date: 24Aug2021, for COVID-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "Maternal exposure during pregnancy (Delivery Date 15Dec2021)"; FATIGUE (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "First night of second dose I was fatigued"; HEADACHE (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "had a headache"; PAIN (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "violent chills"; TREMOR (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "My whole body was shaking". Therapeutic measures were not taken as a result of maternal exposure during pregnancy, fatigue, headache, pain, pyrexia, chills, tremor.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ate lunch  and vomited shortly after, decreased wet diapers since morning, sleepiness
cont crying p/vax;pt seen 10/13/99;did resolve w/APAP ATC overnoc;
pt recvd flu vax & devel a wheal which was characterized as near necrosis w/deep bruising & swelling for 3-4 days; pt also exp pain & heat in the arm of inject;
I was advised by the provider to administer the Shringrix vaccine due to the patient being Immune compromised being HIV positive and a type 2 diabetic. I advised the provider of the patients age but he reassured me that he was eligible due to being HIV positive and Immune compromised.
Swelling on right side of face, tingling, numbness up to Right  eye and into Right side of neck  (started 1/4 - lasted approximately 10 hours)
Pt recvd 3 Hep B vax doses  on 26JUL89, 29AUG89 & 23JAN90; 13MAR90 titer was neg; pt was given a 4th dose of vax on 9AUG90; 19SEP90 titer=11; 6AUG91 1 yr later, titer was negative;
Customer walked up to pharmacy requesting the J&J shot at our walk up clinic.  Did not want Pfizer under any circumstances. We did not look in our system for a previous dose given.  Will from now on and check the CDC website for previous dose given before giving any J&J shots.  Discovered while customer was waiting 15 minutes after his shot given that he had previously gotten a Pfizer vaccination in March 2021 from pharmacy.  Consulted with customer and he still denied that he had gotten any Covid shot previously.  Told him that he had gotten a Pfizer vaccination.  He said no no Moderna.  We told him he had gotten Pfizer.  That with the Janssen shot he was fully covered and that he should not under any circumstances get any more shots for Covid 19.  He kept telling us he had gotten Moderna and we said no in our system he had gotten a Pfizer.  Advised him that he may have more side effects since he had gotten a different vaccine previously.  When he left the our site he was fine and without any side effects.  Customer speaks very little language so when contacting you will need a interpreter.
H1N1 Flu a mono 2009 after injection, in 30 minutes later, felt mild chilling for 30 minute. Just mild side effect, but not serious
PATIENT THOUGHT SHE HAD RECEIVED THE MODERNA VACCINE FOR THE FISRT VACCIINE.  TWO DAYS AFTER RECEIVING THE MODERNA VACCINE SHE FOUND HER VACCINATION CARD THAT SHOWED SHE RECEIVED THE JOHNSON AND JOHNSON VACCINE FOR  HER FIRST VACCINATION.  SO SHE WAS GIVEN THE JOHNSON AND JOHNSON VACCINE ON 04/02/21 AND THE MODERNA VACCINE ON 5/18/2021
Redness and itching turning into a rash all over body, starting at 1:00 p.m. today (the day after the vaccine).   I'm wondering if one or more of the vitamins and supplements I took this morning, including Slo-Niacin, fish oil, multivitamins and extra D and C interacted with the vaccine.  I took one Benadryl  tablet at 2:00 p.m. today, which seems to be calming down the redness and itching.
Full body aches. Severe headache. Heartburn. Fever. Joint pain.  Heart pain.
Fever, chills, swelling at site, redness at site, pain at site, nausea. Pain/redness at site began the first afternoon and evening (Tues 8/21). Fever, nausea and chills began the next day (Wed 8/22), worsening to evening. All symptoms remained the next day (Thur 8/23), though lessening gradually throughout the day. Today (Fri 8/24), only remaining is the redness/pain at the site and feels a bit itchy. Could possibly be a little rash, but no blisters or sores are present at this time.
Feeling dizzy; Nauseous; Headache; Body aches; Fatigue; started to get chills / had chills; Fever/ Fever 102/ I had  99.2 fever; dose received: 3/dose number = 3; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Nov2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination was not reported. The patient received other vaccines within four weeks prior to the COVID vaccine which included influenza vaccine (FLU) in the left arm on 04Nov2021 for immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 16:00 (at the age of 43-years-old) both as  single dose for COVID-19 immunisation. On 18Nov2021 at 17:00, the patient started to get chills and a fever and 19Nov2021 to 21Nov2021, the patient had chills, headache, fever 102 (unspecified units), body aches and fatigue. On 22Nov2021 (reported as MON and also as "now"), patient had a 99.2 (unspecified units) fever, felt dizzy and nauseous. It was reported that the patient was still feeling the affects a week after the booster and enquired if that was normal. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the events started to get chills, had chills, headache, body aches, fatigue was resolved on 21Nov2021, however the events fever/ fever 102/  had a 99.2 fever, feeling dizzy and nauseous was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
the patient received the PNEUMOV AX 23 (Lot#Unknown/Exp:Unknown) vaccine five times; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On unspecified dates, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiration date were not reported) five times for prophylaxis (reported as prevent pneumonia) (inappropriate schedule of product administration). The pharmacist reported that the patient "engages in polyphannacy and polyphysicians". The patient's present status was fine.
Fever, chills, injection site hot to touch. Injection site swollen to "size of a grapefruit" in right arm (ZOSTAVAX site) beginning day after shot. Administered.
Infant developed bloody stool (heme positive in clinic on 8/15) on morning of 8/15. Developed vomiting 8/14. Symptoms continued, pt taken to ER subsequently diagnosed with intussusception. Successfully treated with air enema.
ISCHEMIC STROKE WITH  EMBOLISM IN BASAL ARTERY.   SYMPTOMS: HEADACHES, BRAIN FOG, BALANCE EFFECTED, SOME BREATHING PROBLEMS, FATIGUE
Pt mother notice that arm was swollen, red & warm to the touch. Pt. seen by pediatrician, advised to use cool compress, Ibuprofen & continue to observe.
A few hours after the shot, I developed a headache and my arm was sore at the injection site.  About 15 hours after the shot, I had chills, muscle aches, headache, sore arm, and felt sick. Symptoms woke me up, and I couldn't fall back to sleep because I felt unwell and ached.
Shingles and Hospitalization within 30 days of vaccination.  2/18/21 PCP ordered outpt wound for shingles and unstageable decubitis ulcer (unknown onset date of shingles). Seen in ER on 2/19 and admitted discharged to rehab unit on 2/23/21. reported 1-2 week history of generalized weakness and frequent falls, poor oral intake and shingles. 2/19/21 pt c/o heart racing and irregular.  Found to be in Afib with RVR. 2nd dose of Pfizer given 3/19/2021 went to ER 3/24 for pneumonia.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer (registered nurse). This case is linked to 2018SA250156 (Same reporter). This case involves a 59 years old female patient who experienced fuzzy head, feeling off, heart pounding, feeling weak and received FLUBLOK subcutaneous instead of intramuscular, while she received vaccine FLUBLOK QIV. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2018, the patient received 0.5 mL dose of suspect FLUBLOK QIV lot number was unknown, frequency once, via subcutaneous route in the left arm. On 04-Sep-2018, same day post vaccination patient developed a non-serious fuzzy headed, feeling off heart pounding and feeling weak. It was also the case of actual medication error due to Inappropriate route of vaccination (received FLUBLOK subcutaneous instead of intramuscular). Relevant tests were not reported. Final diagnosis was feeling weak, heart pounding,  feeling off, fuzzy head. It was not reported if the patient received a corrective treatment. The outcome of the events were unknown. 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 and Module VI of the 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. List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In late 2014, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, she presented to a physician. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. ZOSTAVAX and persistent strain of herpes zoster were considered to be disabling. Additional information has been requested.
nausea vomiting headache chills diarrhea exhaustion lasting for 3 weeks  still not recovered stamina.  sore injection site nominal
pt recv vax & exp joint pain & vague neurologic sx;pt exp sl flexion & sl swelling in the rt second digit;sed rate was 15;
Information has been received from a physician concerning a 1 yr old male with an extra chromosome (not Down's syndrome) who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that eight weeks post vaccination, the pt subsequently developed 10 vesicles at the injection site. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the outcome was unk. Additional information has been requested.
Pt. states that after receiving the 3rd Booster of the Phizer 10/27/2021, started experiencing symptoms 10/31/2021 of severe vomiting, nausea, dizziness, and loose stool.  Symptoms have subsided, no noted Primary visit/communications.
Patient may have been inadvertently given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State notified
Received a 3 days expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The medical assistant reported that a patient received a three days expired dose of Twinrix vaccine on the day of reporting. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
pt recv vax 2SEP87 & pt exp fever over 103 & measles-like rash;no further details were provided;
my left arm has been sore at and around the injection site ever since I got the second dose.  It is an on-going dull pain.
have a large redness area with a knot on upper left arm area where shot was given. I had chills for about 12-14 hours started about 16 hours after receiving shot.
The incorrect aged dose was given, thus a higher dose was given. Gave orange dose instead of maroon. Pain in the leg was the only reported side effect to date. No fevers.
MS started after one week of the first dose of BNT162b2; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "MS started after one week of the first dose of BNT162b2". Therapeutic measures were taken as a result of multiple sclerosis.; Sender's Comments: Based on the temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event Multiple sclerosis. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
LOST OF SMELL; LOST OF TASTE; CONGESTION; BODY ACHES; LOW GRADE FEVER; COUGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 01-APR-2021 09:00 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced congestion. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced low grade fever. On 01-APR-2021, the subject experienced low cough. On 03-APR-2021, the subject experienced lost of smell. On 03-APR-2021, the subject experienced lost of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, low grade fever, congestion, lost of taste, and low cough, and the outcome of lost of smell was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
I took a third dose.; Partial dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED BY PRODUCT (Partial dose) and EXTRA DOSE ADMINISTERED (I took a third dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B or D /210A, 026A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 01-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED BY PRODUCT (Partial dose). On 01-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (I took a third dose.). On 18-Mar-2021, INCORRECT DOSE ADMINISTERED BY PRODUCT (Partial dose) had resolved. On 01-Apr-2021, EXTRA DOSE ADMINISTERED (I took a third dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported. The patient was not sure about  3rd dose lot number. She stated that she has willingly taken the third dose as only partial dose was administered during her second dose.