chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing and feel congested; Coughing and feel congested; This is a spontaneous report from a contactable consumer (husband of patient). This is a spontaneous report from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced coughing and feel congested on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
A pediatric dose of HepB was accidentally administered to client instead of an adult dose. Client was contacted and informed of the incident. Staff also explained that because it was a pediatric dose, it would be considered invalid and he would need to receive an adult dose of HepB to complete the series. Staff scheduled client an appointment on 1/18/23 and an adult dose of HepB was administered.  Second, the HPV9 was pulled from the inventory and it should have been taken from the private vaccine inventory.  Due to client's age, he does not qualify for program. This dose will be replaced with private pay and private vaccine loss report will be completed by my supervisor.
Mother states child turned purple and would not respond to her. Child did have a fever of 102.2. Mother took child to ER.
Within 10 minutes post vax, this patient developed extreme pain in her arm and cried "hysterically." The pt self-medicated with Benadryl and Tylenol; she self-treated with applications of ice. The pt recovered within 12 hours.
PATIENT WAS OBSERVED FOR 15-20 MINUTES IN THE PHARMACY POST INJECTION, AND HAD NO SYMPTOMS.  PATIENT ALSO HAD BROUGHT ALONG HER EPI-PEN TO THE APPOINTMENT AS SHE WOULD BE PREPARED IF SHE HAD ANY PROBLEMS.  ON HER WAY HOME, APPROXIMATELY 30 MINUTES AFTER HER VACCINATION, SHE HAD SOME MILD CHEST PAIN AND FELT SOME THROAT TIGHTNESS.  SHE DID ADMINISTER 1 DOSE OF HER EPI-PEN 0.3 MG INJECTION AT THAT TIME.  SHE EXPERIENCED RELIEF OF HER SYMPTOMS, AND APPROXIMATELY 1 HOUR AND 30 MINUTES LATER WHEN I CALLED HER, SHE WAS STILL FEELING UNUSUAL SENSATION IN HER THROAT, BUT WAS MUCH BETTER.  I ENCOURAGED HER TO TAKE SOME HYDROXYZINE , WHICH SHE HAD AVAILABLE AT HOME, AND TO CONTACT THE EMERGENCY ROOM IF HER SYMPTOMS DID NOT RESOLVE COMPLETELY OR SEEM TO BE GETTING WORSE.
Body aches and low grade fever of 99.2%. At 1:00 PM I was experiencing frequent diarrhea. At 3:30 PM I started to vomit fluid and food. I continued to vomit every two or three hours until 5:00 AM the following morning. The diarrhea frequency increased to every 30 minutes until 1PM on 10/21/2016 after which decreased to an hour and a half. This continued until the morning of 10/22/16. Eating: I had eaten breakfast on 10/20/2016 but was unable to eat anything again until 7:00PM on 10/21/2016 and that was chicken soup with crackers and Sprite. As of 10/23/16 the bowel movements have not returned to normal baseline. I am on no medications and a very active healthy individual other than when I receive the influenza vaccination annually as required by my workplace.
C/O right sided numbness and tingling was transported to Hospital by paramedics. Was released that same evening
Had my second moderna civid vaccine on 3/2/22 Ended up in hospital with PE ( pulmonary embolism)  on 3/13/21. hospital
This spontaneous case, was received on 12-Oct-2017 from a pharmacist, concerning a 63-year-old adult male patient. This was a quality complaint report (PTC number: 1025294). The patient's medical history and concomitant medications were not reported. On 12-Oct-2017, the patient was administered FLUCELVAX QIV (dose: less than 0.5 ml, batch number: 195234, expiry date: 31-May-2018, anatomical location: left deltoid, route of administration: intramuscular). It was reported that, on the same day, the patient received less than a 0.5 ml dose of vaccine due to leakage from the PFS (explicitly coded as vaccine under dose and product leakage). It was reported that, part of vaccine leaked between the needle and the syringe where needle tip fastens into the syringe. Although the reporter concedes that it was hard to tell, from where the leaking took place. As per the reporter, she securely fastened the needle tip into the syringe before administration. No defects were identified on syringe or any other syringes in box. Based on the investigation performed, it can be concluded that FLUCELVAX batch 195234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringe or stopper components, and no trends were identified for the batch. However, a trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial season for leaking syringes due to using the easy point needles, but the needles are not supplied or controlled by Seqirus. The most likely root cause can be attributed to improper handling by the user. It was reported that, no adverse effects were noted. The reporter assessed the events as non-serious. Follow-up received on 16-Oct-2017: Non-significant information received. PTC reference number (1025294) was updated. Follow-up received on 01-Dec-2017: Expiry date: 31-May-2018 was updated. Event "no adverse event" exists no longer. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringe or stopper components, and no trends were identified for the batch. However, a trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for leaking syringes due to using the easy point needles, but the needles are not supplied or controlled by Seqirus. The most likely root cause can be attributed to improper handling by the user. Amended narrative accordingly. Non-significant case correction received with 16-Oct-2017: PTC reference number (1025294) was added.
Left side of face started drooping on Thursday afternoon. Was diagnosed with Bells Palsy on Thursday evening.
10MAY92 t102 w/APAP, listless took to MD t104.5; strep neg; MD doesn't think it is rxn to vax recvd 6MAY92-11MAY92 remains listless;
Developed large rash a few days after 3rd vaccine at injection site. Developed Raynaud's syndrome a few months after 3rd vaccine Developed skin rashes later diagnosed as eczema during same time frame Autoimmune panel bloodwork done, elevated RA factor, ANA  positive.  Not diagnosed with autoimmune disease
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in the freezer and one to two vials were taken out and placed in fridge each day  as needed. No concomitant and treatment drugs were reported.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 71 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. In 2017, the patient was treated by a healthcare provider at an urgent care for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Pneumonia; Fainting; Vomiting; Fever; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SYNCOPE (Fainting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), VOMITING (Vomiting), PYREXIA (Fever) and MYALGIA (Muscle aches and pains). On 23-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PNEUMONIA (Pneumonia) had not resolved and SYNCOPE (Fainting), VOMITING (Vomiting) and MYALGIA (Muscle aches and pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: revealed pneumonia (Inconclusive) Revealed pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
seizure; He also had a flu shot on the same day; He also had a flu shot on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5,Gray cap), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Epilepsy" (ongoing), notes: Had been seizure free for a couple of weeks; "Sinus Tachycardia" (ongoing). Family Medical History included father has high sugar, bypass surgery in 2007, and high cholesterol and Mother High Blood Pressure. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization; Bnt162b2 (Dose 3), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 04Oct2022, outcome "unknown" and all described as "He also had a flu shot on the same day"; SEIZURE (medically significant) with onset 05Oct2022, outcome "recovered" (05Oct2022). The event "seizure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Vital signs measurement: Unknown results; X-ray: Unknown results, notes: Blood work, they did a X-Ray of his Right Shoulder because he wasn't sure if it was injured, and monitored his vital signs. Therapeutic measures were taken as a result of seizure.It was reported that patient received the Pfizer-BioNTech Covid-19 Vaccine, Bivalent, on Tuesday 04Oct2022. One day after that, on 05Oct2022, he had a seizure evening time and went to the ER on 05Oct2022 after 7pm ,he was not admitted to the hospital, he was treated in the ER and discharged early this morning. He also had a flu shot on the same day. He has a history of seizures, but he had been seizure-free for a couple of weeks. He wanted to know if the seizure could be related to vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I received the Pfizer Bivalent booster on 9/28/2022. Sometime in late September or early October 2022, I noticed that I was beginning to get much more frequent headaches, which occurred nearly daily. This problem lasted for about 3 months. In October, I then began to periodically take my BP at home for the first time since getting the bivalent booster. The first time I took my BP, I noticed my BP was elevated and did not decrease with subsequent readings. This continued throughout October into mid-November 2022. On 11/16/2022, I saw my PCP. The PCP prescribed me candesartan, which I have been taking ever since. As of now, my BP is fine and within the normal range. Not only that, but my headaches are now pretty much gone.
Mother states area became red with swelling on evening of 8/3/04. Area is warm to touch, slightly swollen, red. Cool compresses advised. (left deltoid)
Information has been received from a medical technical assistance referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was not provided. Concomitant therapies included sterile diluent (manufacturer unknown). On 27-NOV-2017 (also reported as 20-NOV-2017), the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022981 with expiration date on 23-AUG-2017, strength and route unknown) for prophylaxis. No adverse effects reported. The vaccines had been exposed under temperature 6 Fahrenheit (F) to 14 F for 30 minutes, 15 F to 46 F for 64 hours and 47 to 77 F for 3 hours and 30 minutes. A data logger was used. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1712USA004729.
First vaccine 8/25/21.  patient reported decreased vision in left eye on 9/1/21., then second shot 9/24/21, then vision became severely decreased by 9/27/21.  I saw the patient on 10/4/21 and diagnosed an ischemic left optic neuropathy.  Pt had Moderna  covid vaccine.   Patient has reduced visual acuity now at 20/50 and lost the inferior half of her visual field, likely permanent. Discussed with patient this event may or may not be related to the vaccine.
arm swell; arm was hot; Moderna rash / rash on her arm; did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good), PERIPHERAL SWELLING (arm swell), FEELING HOT (arm was hot) and RASH (Moderna rash / rash on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C11A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MALAISE (did not feel good). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swell), FEELING HOT (arm was hot) and RASH (Moderna rash / rash on her arm). At the time of the report, MALAISE (did not feel good) was resolving and PERIPHERAL SWELLING (arm swell), FEELING HOT (arm was hot) and RASH (Moderna rash / rash on her arm) outcome was unknown.            No concomitant medications provided. No treatment medications provided. After the second shot patient did not feel good for 3 days, then started to feel better.   This case was linked to MOD-2021-073004 (Patient Link).
received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.
They found in my blood work that I have a Jak 2 Mutation of the stem cell. It is causing me to produce too much blood and blood cells. They consider it a cancer of the blood. With that comes the diagnosis of Polycythemia Vera. I am having blood taken every 2 weeks. I had my first treatment of having 500 ml of blood from me every 2 weeks. He also wanted me to take a chemo pill, but he referred me to a doctor who specializes in rare blood and bone marrow.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose 6 (booster), single (Lot number: 6L0446) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "On hormone therapy replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid was administered from 25Sep2023 to 29Sep2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Expired Havrix dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   On 24th June 2022, the patient received Havrix. On 24th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: Medical Assistant reported 62-year-old female was administered a dose of Havrix on 24th Jun 2022, which had an expiration date of 17th June 2022. Medical Assistant was not sure which dose in the series this was for the patient.  At the time of reporting, dose had not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient had Havrix on 24th Jun 2022, which had an expiration date of 17th June 2022, which led to expired vaccine used.
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium
Vertigo; Severe dizziness / Light headedness if I get my heart rate up; Nausia; Body flushing if I lay my head down or turn my head quickly; Shortness of breath; Get my heart rate up; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0179) via an unspecified route of administration in left arm on 05May2021 at 15:00 (age at vaccination 54-year-old) at single dose for covid-19 immunization. Patient medical history included Meniere's Disease. The patient's concomitant medications included unspecified medications. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took Levaflozin and had allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0169) on 14Apr2021 (age at vaccination 54-year-old) in left arm as single dose for Covid-19 Immunization. The patient previously took the shingles vaccine and experienced shortness of breath, nausea, light headedness, vertigo, flushing and heart rate increased. Patient have Menieres Disease. Prior to the vaccine, patient not had vertigo or severe dizziness for over 6 months. On 12May2021 at 15:00, one week after second shot patient had 2 bad cases of vertigo within 2 days of each other. Patient was put on Prednisone 2 weeks after the shot to calm the reaction. Patient continued to experience nausea, dizziness, and body flushing if she lays her head down or turn her head quickly. She also experienced shortness of breath, nausea, and light headedness if she gets her heart rate up. Patient experienced this same reaction after the shingles vaccine. It lasted 12 weeks. She was hoping for the same and she was currently 6 weeks out. Adverse events resulted into Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a resukt of events with prednisone. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 13 month old patient. On 03-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
11/02/07 Pt stopped in to show her left arm redness, slight blueness and a knot at 12:15pm. Bruising in center of lumpt- HT 2.5" x Wd 3" Sore and palpable warm to touch. Instructed to use covered bag of ice x 20 minutes and use Tylenol or Advil as instructed.