chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A little bit of fever of 100.1 degrees Fahrenheit; Bad covid arm reaction; Painful/pain is very bad; Itchy; Warm to the touch; Swollen; Was like an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch) and SWELLING (Swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch), SWELLING (Swollen) and HYPERSENSITIVITY (Was like an allergic reaction). On 16-Dec-2021, the patient experienced PYREXIA (A little bit of fever of 100.1 degrees Fahrenheit). At the time of the report, VACCINATION SITE REACTION (Bad covid arm reaction), PAIN (Painful/pain is very bad), PRURITUS (Itchy), SKIN WARM (Warm to the touch), SWELLING (Swollen), HYPERSENSITIVITY (Was like an allergic reaction) and PYREXIA (A little bit of fever of 100.1 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Body temperature: 100.1 (High) 100.1 degrees Fahrenheit.         No any concomitant medications were reported. No any treatment medications were reported.  The patient stated that the reaction circle grew every day.   This case was linked to MOD-2021-417907 (Patient Link).
Severe headache, muscle ache, fever, shivering, acute fatigue, sweating
Fever of 100-102 for two days  Fatigue  Chills Body aches Nausea
Pain after immediately after injection that radiated up into neck and down into arm continued for several months.  Had "a knot" half grapefruit size that started the day after and continued for 4 months.  Pain 6 months.  Improving with massage, chiropractic benefit.
RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 46 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The batch number was not reported and has been requested. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the Janssen COVID-19 vaccine as a booster dose approximately around 0.3mL of dose (captured as: vaccine underdose) and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen COVID-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211209874, 20211209884, 20211210159, 20211210334, 20211210385, 20211210408, 20211210409, 20211210549, 20211210555, 20211210585, 20211210590, 20211210610, 20211210662, 20211210670, 20211210824, 20211212082 and 20211212088.
Pt recd series of 3 Engerix-B doses & it was determined that Pt did not respond;
Infanrix administered and was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st March 2022, unknown after receiving Infanrix and Infanrix 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 details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Infanrix, which led to expired vaccine used. The reporter did not have any patient demographics available at time of reporting. The reporter consented to follow up.
CLIENT DEVELOPED RED RAISED RASH WITH ULCERATION WAS SEEN BY PRIMARY CARE MD X2 VISITS. RECEIVED PRESCRIPTIONS FOR CEPHLAHEXIN 500MG AT FIRST VISIT AND BACTRIM DS AT FOLLOW UP
Fever of 100.6 F; local erythema, swelling 1 cm diameter at injection site.
2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration.    Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too.  Mildly reduced  tongue coordination continues.
It leaked and she is concerned she missed some of the dose; A spontaneous report was received from a nurse concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it leaked and she is concerned that she missed some of the dose.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection, but there was an issue with the needle and syringe. It leaked and she is concerned that she missed some of the dose.  Treatment information was not provided.   The outcome of the even was considered resolved on 05 Feb 2021.; Reporter's Comments: Based on current information the causality of this event was assessed as not applicable.
Breakthrough Case  **Patient pregnant with EDD of unknown ***Unknow if patient was pregnant at time vaccine administration
5 y.o. girl who presented with cyanosis, unresponsiveness, bradycardia HR =40 approx 5-10 minutes after HepA. 1 mg Epi, 4L O2, IVF were given with response.  09/06/2007 Progress note received for DOS 8/31/2007 at 11:35 am. Approximately 10 minutes after receiving Hep A vax (2nd dose) child was returned to clinic floppy and not responding.  Pt was cyanotic, not responding to verbal stimuli, and hypotonic with HR in the 40's.  Was treated with Epi, O2, and IV fluids.  Pt became responsive and back to baseline after ~2 minutes with HR increase to 90's and then 120's. Spoke with RN in clinic.  Child was not hospitalized. DXd with syncope in ER and released.
c/o came back in after being discharged 10- 15 minutes and stated she was dizziness, scratchy throat, heart racing  taken to ER via wheelchair for evaluation
I had the known side effects- headache, myalgia, and malaise. However, I also had joint pains (not muscle aches). All symptoms seem to have resolved after 36 hours
3/10 - 4:00 AM - muscle cramps 3/10 - 8:00 AM - headache 3/10 - 10:00 PM vomiting that lasted till noon on 3/11 3/11 - 4:00 PM - symptoms begin to resolve
1 day post vax developed severe urticaria, & pruritis; Did not seek medical attention;
Symptoms onset approx 10 hours after dose.  Fever of 100.6*F; mild headache; moderate fatigue; elevated heart rate (90-115bpm at rest).  Reports felt like active flu.   Symptoms persisted for approx 12 hours.
Rapid severe onset of nausea, vomiting, diarrhea, chills - approximately 70 hours after second vaccine Migraine - onset approximately 72 hours after second vaccine, lasted approximately 36 hours Vertigo and dizziness - onset roughly 4 days after second vaccine, intermittent and ongoing still (10 days post vaccine)
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 31-OCT-2014 the patient was vaccinated with and expired dose of ZOSTAVAX lot # J006156, expiration date: 30-AUG-2014 (strength, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
The evening after receiving her BEXSERO number 1 she started to get a red mark around the injection sight, by Saturday it was 3 inches, warm to touch, painful, then today it was 1 and 1/4 inches. She's had a headache since then.
Approximately 11 PM on the same date as the vaccine, I developed a severe headache and my body was sore. I woke up at approximately 5:30 in the morning on 12/30 with severe chills and bodyaches. No fever however. Ibuprofen helped very little. It?s an hour 24 hours later and I still have a severe headache and profound muscle and bone aching along with fatigue. My arm, at the injection site, is very tender and I?m not able to lift my arm above shoulder level without severe pain.
The patient had difficulty tolerating hemodialysis from a hemodynamic standpoint given her poor left ventricular function.  She had hypotension with dialysis precluding significant ultrafiltration and continued to have evidence of volume overload with respiratory compromise.  She also continued to have difficulty with encephalopathy.  Multiple medications were tried to help with intermittent agitation without success.  Family conference was held with the family and ultimately she was changed to DNR comfort care and expired with family at bedside on September 9th.
After receiving the vaccine, I woke up the next morning with constant ringing in my left ear, which I am still experiencing.  Visited my PCP on 10/25/21 and discussed my experience with the ringing in my left ear. My PCP referred me to an ENT Specialist.  Appointment in progress. Please advise if I will need to follow up with results of ENT Specialist visit to VAERS, when  completed.
9:00 - swollen arm & hurting 11/29 - 9:00 am vomiting & swollen arm       - 5:00 pm  chills & achy 11/30- all day achy-chills not feeling well. Monday 4:00pm swelling of all joints very painful to move & rash on legs.  Feet & wrist of hand of injection swollen the most. Tuesday visited allergy dr and started pred for swelling.  Took bloodwork only 7 days after blood work for yearly check up was all good.  Couldn't explain why patient had reaction.  Also was a little stuffed up and in a lot of pain hard to move & sit and sleep.
5 days after I had the second dose of the Pfizer Covid vaccine, I had blood clots that caused several strokes.   I have normal cholesterol, normal blood pressure, normal A1C and other diabetes measures, and my blood was tested for multiple things to identify what caused the clotting. Every single test came back within normal limits.   The ONLY thing that changed was that vaccine. And it was 5 days after the second dose.   The doctors cannot figure out why I had a stroke.
Pt recv vax on 11/12/97; on 11/13/97 pt exp rash on neck & vax site, throat closed; tx=Benadryl On 11/13, Morning after FLUZONE, when patient showered she developed a rash just on neck, then at site of vaccine.  Throat started to close about 3:30pm, 24 hours later.  Went to Emergency Room.  They gave BENADRYL and resolved.  She was monitored there for 4 hours.  No additional information was provided from correspondence received at agency on 20-Apr-200.  This case is closed.
About 40 hrs after immunization, right deltoid became erythematous, swollen, warm but bot pruritic or painful. No decreased range of motion. Pt was seen 8/20. No treatment. Rash resolved within 48 hours.
Fever to 103 for 2 days. Treated with acetaminophen, ibuprofen.
Day 8, a hard, red bump appeared at the injection site. It is itchy. Around 1-1.5 inches in diameter.
Gritty eyes, progressing quickly to overall body pain, eye pain, excessive eye watering, within 6 hrs face was completely swollen, eyes bright red, extreme fatigue and lethargy greater than 48 hrs. Out of work 2 days.
Information has been received from a pharmacist referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On 18-DEC-2015, the patient was vaccinated with ZOSTAVAX 19400 plaque forming unit (PFU) (subcutaneous; lot#, expiration date and dose were not reported) and a dose of influenza virus vaccine inactivated (unspecified) at an unspecified pharmacy. The ZOSTAVAX was administered on the back underside of the patient's arm by his elbow (product use issue). The reporter stated that the patient came to the pharmacy for another flu shot. Additional information has been requested.
SORENESS; MINOR FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the subject experienced soreness. On JUL-2021, the subject experienced minor fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor fatigue and soreness was not reported. This report was non-serious.
Developed DVT blood clots in legs and clots in lungs.; Developed DVT blood clots in legs and clots in lungs.; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6198) on 06Mar2021 12:30 PM at left arm for COVID-19 immunisation. Medical history included known allergies: Clindamycin and high blood pressure. Historical vaccine was 1st dose of BNT162B2 (lot number EN6201) on 14Feb2021 01:15 PM at left arm for COVID-19 immunisation. Concomitant drugs included hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), omeprazole, nortriptyline hydrochloride (NORTRIPTYLIN). The patient developed DVT blood clots in legs and clots in lungs on 07Mar2021 08:00 AM. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 3 days and received treatment. The patient had computerised tomogram (CAT) scan, ultrasound, echocardiogram. Event outcome was not resolved.
shakes; She could not move her hands and toes, the back of her legs and arms; She has  lost 13 pounds/She reports she felt like she had no skin on her bones; She was vomiting.; Initial information received on 06-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Elderly female patient who experienced shakes (tremor), she could not move her hands and toes, the back of her legs and arms (hypokinesia), she was vomiting. (vomiting), she has  lost 13 pounds/she reports she felt like she had no skin on her bones (weight decreased), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On 03-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot J536AA via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious shakes (tremor), she could not move her hands and toes, the back of her legs and arms (hypokinesia), she was vomiting. (vomiting), she has  lost 13 pounds/she reports she felt like she had no skin on her bones (weight decreased) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Resolving for all events.
Regarding Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Light headed, dizzy.  Occurs several times during the day, and have also experienced it at night.
Shortly after receiving shot, pt developed a blotchy rash to trunk and limbs. Dr notified. After 10-15 minutes, rash faded.
sudden leg weakness, finding it very difficult to walk; sudden leg weakness, finding it very difficult to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "sudden leg weakness, finding it very difficult to walk". Additional information: The consumer was reporting for his wife. The events happened within 5 weeks of receiving the first dose. On the second dose, the symptoms has increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse administered expired dose of Moderna bivalent. Exp: 06jun2023).    Concomitant medication was not reported. It was unknown that the patient had ever been diagnosed with/ tested positive for COVID-19. It was reported that there were no adverse events following the administration of the vaccine. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728617 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728617:Master case (Patient 1 3 years old)
12 hours after both shots administered, I had fever (90.5), extreme headache, back-neck-leg-arm aches, very sore & swollen upper left arm, uncoordinated walked, very dry mouth & thirsty, very low energy, confused mental state. Took Ibuprofen 600 mg every 4-6 hours, only relief. Slept most the time. An hour aware doing simple tasks made me exhausted. These symptoms lasted through Saturday afternoon, 12/8 (3+ days), when I first noticed a large ca. 4 by 6 in hot to touch, red raised area on left arm below injection site (at bicep muscle); except for red bicep area, symptoms began to diminish on Sunday (4 days), visited Dr. on Monday (day 5, 12/10) who prescribed Doxycycline Hyclate 100 mg (1 ea 12 hrs) and Prednisone 20 mg (1/day). Been on those for 16 hrs and continuing to feel better, but large red hot bicep on left arm still present.
This spontaneous report was received from a 53 years old, female consumer reporting on herself, with no pertinent medical history reported. On 05-APR-2013 the patient was vaccinated with the second dose in the series of (Merck) VARIVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported) for prevention of chicken pox. No other co-suspect therapies or concomitant medications were reported. On an unknown date in April 2013, reported as "shortly following" administration of the second dose of (Merck) VARIVAX, the patient experienced "a large painful bump" at the injection site. The patient reported that she also experienced "a large painful bump" after administration of an unspecified influenza vaccination on an unspecified date. (MARRS 1304USA004699). The outcome for the large painful bump at the injection site was reported as not recovered. The patient stated that no treatment was given for the large painful bump at the injection site. The patient did not seek medical attention. The patient declined to provide healthcare professional information. This is one from several reports from the same reporter. Additional information is not expected.