chrisvoncsefalvay/vaers-outcomes huggingface dataset:
axillary lymphadenopathy; This is spontaneous report from a non-contactable consumer reporting for himself. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL324), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no known allergies. The patient experienced axillary lymphadenopathy on 24Jan2021. No treatment was received. Outcome of the event was recovering. The reporter assessed the event as non-serious.  No follow-up attempts are possible. No further information is expected.
Patient was asked twice regarding if patient had received previous COVID vaccines before the vaccine (Moderna) was administered.  The vaccine was given and patient was given multiple opportunities to inform us of previous vaccine history.
Initial report received from a healthcare professional on 26 AUGUST 2013. A 49-year-old female patient had received intramuscular first dose of ADACEL (batch number: C4385AA and expiry date: 17 SEPTEMBER 2015) in the left deltoid on 14 AUGUST 2013. The patient had no illness at the time of vaccination and no known allergies. The patient was diabetic. Concomitant medications were not reported. On 17 AUGUST 2013, the patient developed pain on left arm radiating to shoulder, neck area and to bottom of the shoulder blades. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none. Follow up information received on 04 NOVEMBER 2013. Concomitant medications included Metformin hydrochloride 500 mg,   Glimepiride 1 mg; Simvastatin 20 mg and Lisinopril 5 mg. The outcome of the patient was reported as unknown.
red rash noted to trunk area, swollen lymph nodes behind both ears, on 7/16/05 temperature of 102.6
Fever to 104, nausea, lethargy within 1 hour of vaccine. Previously well.
ENT doctor found loss in the right ear. Took the shot on the right harm.; Experiencing ringing and throbbing in the right ear.; throbbing in the right ear.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: ew0185) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=ew0185,, prev dose lot unknown=False,, prev dose administration date=28Jul2021,, prev dose dose number=1), administration date: 28Jul2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 01Dec2021, outcome "unknown", described as "ENT doctor found loss in the right ear. Took the shot on the right harm."; TINNITUS (non-serious) with onset 01Dec2021, outcome "unknown", described as "Experiencing ringing and throbbing in the right ear."; EAR DISCOMFORT (non-serious) with onset 01Dec2021, outcome "unknown", described as "throbbing in the right ear.". The events "ent doctor found loss in the right ear. took the shot on the right harm.", "experiencing ringing and throbbing in the right ear." and "throbbing in the right ear." were evaluated at the physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus, ear discomfort. Patient had not received any other vaccine within four weeks. She was not tested COVID positive prior to vaccination and was not tested positive post vaccination.   No follow-up attempts are possible. No further information is expected.
Red, swollen, painful injection site - no treatment at this time. Patient to return to clinic for further monitoring.
Woke the following morning tired with an upset stomach. I suffered fatigue with stomach pain the remainder of the day.  Ate very little. The following day I had the same symptoms plus I was feverish (100.6). and I had a headache. Unable to eat all day. Drank only a little. Stayed in bed the entire day.  The third day (today) the fever is gone. Fatigue and mild stomach upset only remaining symptoms.
My son reported that he woke up in the middle of the night with diarrhea, and all of a sudden he fell down (fainting/lost conscious). Second episode: 1/1/13 He had a dizzy spell in the bathroom once again, and passed out hitting his forehead on the wall.
Within 12 hours, the site was painful, toxic reaction. Within 15 hours, prostration incapacitated. The patient had tense induration, left deltoid vaccination site, fever. 48 hours after vaccination, Lymphamgenic streaking, pain, clear cellulitis ; requiring antibiotics. The pain lasted for 6 weeks. Induration (fat necrosis) golf ball size x 90 day.
Patient complains of significant burning at injection site during injection.  Similar reports received recently from other patients receiving Prevnar 13 vaccine.
The afternoon of the 6th, I noticed I had what looked like a pimple or a blister on my left nostril. I looked at it more closely when I got home, and it resembled a cold sore with multiple blisters. The next morning, I contacted my doctor. They suggested I go to Urgent Care because they couldn't see me for a few days. The other option was to wait and see. I decided to go to Urgent Care on the 7th because it was itchy and painful. The provider looked at my nose, throat, ears, and eyes. He said it could be a cold sore or a shingles lesion, but they couldn't tell the difference. He sent a prescription for an antiviral to start that evening due to the proximity to my eyes and the concern of spreading. I started the prescription immediately. Within a day or two, the symptoms had lessened, and they continue to get better as I finish the prescription.
pt recv vax;4 days later noted a bump in mouth & in genital area; seen by MD & tested pos for herpes;took acetaminophen;
Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 29-Jan-2021 and dose 2 on 05-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2022-540720 (Patient Link).
fatigue, headaches, nausea, tingling in left arm after 24 hours, dyspnea within 72 hours prescribed Prednisone for 3 days Within 96 hrs dyspnea under control, no longer tingling in left arm, fatigue and headaches persist
Broke out in rash over entire body including arms, legs, belly, back, face. Rash lasted 6 days
Thrombosis on left arm and chest; "you can see all of the veins"; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis on left arm and chest) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuralgia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced THROMBOSIS (Thrombosis on left arm and chest) (seriousness criterion medically significant) and VASODILATATION ("you can see all of the veins"). At the time of the report, THROMBOSIS (Thrombosis on left arm and chest) and VASODILATATION ("you can see all of the veins") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product include an unspecified neuralgia medication.  No treatment information was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sore shoulder for about 3 days, and started having bloody nose when i blow my nose sometimes.
The patient describes a feeling of "sore pain" from armpit radiating down to pinky and ring finger and palm of the left arm. The patient states the symptom started on 12/6/18 the day after her vaccination.
Pt stressed concerns about getting shots pale before or after shots given got sick or vomitted after shots given. After getting sick patient laid down was given juice (No dr on between times before seen by provider ) and ice was seem by a provider after 30 minutes only no other symptoms vomitted x 2.
didn't want to eat anything; aching feeling; 1st dose - I had fever; feel tired, laid around in bed for 2 days (for 3-4 days); chills (cold chills); This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (didn't want to eat anything), PAIN (aching feeling), PYREXIA (1st dose - I had fever), CHILLS (chills (cold chills)) and FATIGUE (feel tired, laid around in bed for 2 days (for 3-4 days)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DECREASED APPETITE (didn't want to eat anything), PAIN (aching feeling), PYREXIA (1st dose - I had fever) and FATIGUE (feel tired, laid around in bed for 2 days (for 3-4 days)). In January 2021, the patient experienced CHILLS (chills (cold chills)). At the time of the report, DECREASED APPETITE (didn't want to eat anything), PAIN (aching feeling), PYREXIA (1st dose - I had fever), CHILLS (chills (cold chills)) and FATIGUE (feel tired, laid around in bed for 2 days (for 3-4 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication detail were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-036083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Reporter's contact details updated, patient demographic updated.
patient requested the bivalent covid vaccine and was given, in error the monovalent covid vacccine
temperature excursion for GSK vaccines; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and HAV (Havrix) for prophylaxis.   In November 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Havrix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 16-JUN-2022 Reporter's Comment: The reporter stated that a previous temperature excursion for GlaxoSmithKline vaccines(Kinrix, Pediarix, Engerix-B and Havrix) and that those products had been administered to patients since that excursion in November of 2021. The reporter also stated that multiple patients had received multiple vaccines and that the vaccines had been evaluated by GlaxoSmithKline and determined to be supported by GlaxoSmithKline's stability data. The reporter provided the names of the vaccines involved.  The reporter unable to provided additional details. The reporter consented to follow-up. Additional supportive information: The patients received doses of Kinrix, Pediarix, Engerix-B and Havrix vaccines which were previously temperature excursion, which led to Incorrect storage of drug.
Information has been received from a pharmacist concerning a 70 year old male physician with no known allergies who on 11-MAR-2007 was vaccinated SC with a 0.5 ml dose of Zostavax (lot # 656606/0033U). Concomitant therapy included cetirizine hydrochloride (ZYRTEC), polyethylene glycol 3350 (MIRALAX), niacin (NIASPAN) and ezetimibe (+) simvastatin (MSD). Within 24 hours of vaccination the patient had a rash that started at the injection site and then became a generalised body rash which was "very itchy." It was reported to be "like an allergic (hive) type rash and not a VZV rash." Medical attention was sought, the physician gave himself a steroid injection for the itching.  There was no product quality complaint involved. No further information was provided. Additional information has been requested.
PT NOTICED A RED BUMP ON HER BACK THAT WAS INFLAMMED AND HAD A PIMPLE IN THE MIDDLE AND SMALLER ONES IN THE PATCH AREA.  IT SPREAD ALL OVER HER BODY, LESIONS ON HER HEAD, BLISTER LIKE  PLACES ALL OVER BODY.  ITCHES REALLY BAD.  IT BURNS BUT DOESNT HURT. HER HAIR HAS GOTTEN THIN AND HAS LOST HAIR. HANDS PEELED OFF AND CAN'T HOLD ANY OBJECTS. HEELS ARE CRACKED OPEN.  SKIN IS MOLTING OFF OF HER.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 11Mar2021 as dose 2, single (Lot number: EN6208), in right arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Isaacs Syndrome" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "Known allergies: Contrast Dye" (unspecified if ongoing). Concomitant medication(s) included: IMMUNOGLOBULIN [IMMUNOGLOBULIN HUMAN NORMAL], start date: 17May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. It was reported that patient had taken other medication in 2 weeks. Patient had taken Paxlovid for COVID 19 Treatment. Treatment start date was 29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had chills starting on day 2 after receiving vaccine. Also had a large red spot (4" in length) on arm.
Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 08:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, peanut allergy, potato allergy and food allergy (bell peppers). Concomitant medications included sertraline hydrochloride (ZOLOFT) and one a day woman's multi vitamin, both since an unknown date for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 09:00 the patient experienced Injection site pain and headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event Injection site pain and headache was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Feeling weak; Patient doesn't feel good.; Fever of 100; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak), FEELING ABNORMAL (Patient doesn't feel good.) and PYREXIA (Fever of 100) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Shingles.    Patient's concurrent medical conditions also  included bladder issue.  The patient's past medical history included COVID-19 in 2021. Concurrent medical conditions included Panic attacks, Depression and Cholesterol.   On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. In April 2022, the patient experienced ASTHENIA (Feeling weak), FEELING ABNORMAL (Patient doesn't feel good.) and PYREXIA (Fever of 100). At the time of the report, ASTHENIA (Feeling weak), FEELING ABNORMAL (Patient doesn't feel good.) and PYREXIA (Fever of 100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100.         Patient's concomitant medications included pill for Cholesterol, bladder, panic attacks, depression.  Patient took Shingles booster on the same day as Moderna Booster in the other arm. Patient hasn't gone to the doctor.  Patient did not take any treatment medicine.
9 yr old male received 0.2cc of vaccine from vial, essentially 20mcg. No adverse reactions noted during time in clinic.
Patient received FLUZONE HD and PREVNAR 13 on left deltoid on 10/15/15 12:10 pm. On morning of 10/16/15 she noticed red/flush skin and bruised from left deltoid down to almost her elbow. No raised rash, no itching, no pain. Patient didn't take anything for it. She came to report this on 10/17/15 at 12:30 pm.
On second day pt experienced overt fatigue.  He had to increase breathing treatments because he if has extreme SOB.  Describes symptoms of being "wiped-out".  Unable to function.  I referred him to the Emergency Dept.
3 days after immunization, the baby vomited formula after feeding and lay limp for 5 minutes as per mother.
I was slightly overheated after shot but that lessened quickly. My arm hurt and was swollen the first time I got the covid shot but yesterday after the second shot it got really itchy and swollen. It is hard to lift my arm and started to worse throughout today. The injection site is a misshapen red rash that has spread. It started to leak a clearish pus liquid about an hour ago. I am recovering with a bandaid and adding antibiotics cream just in case. I will call my dr tomorrow if it continues to worsen.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.   Additional information has been requested.
Breakthrough COVID-19 case with symptom onset 8/27/2021: Sore Throat, Fatigue or tiredness, Cough.  Wife states Patient continues in the hospital with Covid Pneumonia and trying to get his oxygen levels stable. Wife states they initially suspected Patient had strep or possibly UTI which are common for Patient per Wife. They went to their local urgent care on 8/29/21 and Patient was tested for strep and UTI both results were negative. Tested positive for Covid-19. Wife states PUI was prescribed some meds for symptoms and sent home. Wife mentioned they had several telehealth visits with his PCP to monitor his recovery. Wife states however that Patient had an uncontrollable cough that would not go away with anything that doctor prescribed. Wife went and bought a pulse oximeter on 9/13/21 out of curiosity. When she checked his 02 reading it was in the low 80s. Wife said she was shocked that doctor didn't suggest she get one for Patient initially. Wife said she called PCP and notified him of the reading of the pulse oximeter and he said for her to take him to ER immediately (9/13/2021). Wife states that doctors are still trying to stabilize his oxygen.
Itching began within 24 hours, within 3 days there are severe hives all over the body, swelling and itchiness.