chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site soreness - ongoing but not as bad as first dose Fatigue, light nausea, and elevated body temperature (fluctuating in the 99 F range) - on day of vaccine and following day.  Took 1 Tylenol on the first night to help with reducing headache and arm soreness for better sleep.
I've had the Shingles shots and still get/Suspected vaccination failure; Still get Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
Fever 100, aches, chills, headache, nausea, exhaustion, sore arm. Today is 48 hours since receiving injection. Ibuprofen helps, but could not go to work.
Localized erythema in rt post-tricep @ injection site;17 x 21 cm. No subcutaneous nodules & no systemic symptoms.
Temperature of 101 degrees, chills and muscle aches for 24 to 36 hours. Not treated with medication.
Headache, Myalgia. Fever, Diarrhea chills, fatigue, arm soreness Narrative: Fever, myalgia, diarrhea, headache, chills, fatigue, sore arm; took ibuprofen; resolved.
BURNING SENSATIONS SHOOTING UP AND ARM WHEN RECEIVING THE VACCINE; BODY ACHES; DIZZINESS; EARACHE; SORE THROAT; CONGESTION; EXCESSIVE THIRST; IMMEDIATE SORENESS; FEVER; HEADACHES; This spontaneous report received from a consumer 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, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced burning sensations shooting up and arm when receiving the vaccine. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced earache. On 13-MAR-2021, the subject experienced sore throat. On 13-MAR-2021, the subject experienced congestion. On 13-MAR-2021, the subject experienced excessive thirst. On 13-MAR-2021, the subject experienced immediate soreness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, headaches, dizziness, earache, sore throat, congestion, fever, excessive thirst, burning sensations shooting up and arm when receiving the vaccine and immediate soreness was not reported. This report was non-serious.
Chest pain; Cough; Hyperhidrosis; Pain in extremity; Pruritus; Throat tightness; Wheezing; This case was received via FDA VAERS (Reference number: 1402783) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain), COUGH (Cough), HYPERHIDROSIS (Hyperhidrosis), PAIN IN EXTREMITY (Pain in extremity), PRURITUS (Pruritus), THROAT TIGHTNESS (Throat tightness) and WHEEZING (Wheezing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Seasonal allergy, Drug allergy (Aspirin), Drug allergy (Ibuprofen), Drug allergy (Zofran), Drug allergy (Pepcid), Food allergy (Kiwi) and Food allergy (Paprika). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion life threatening), COUGH (Cough) (seriousness criterion life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criterion life threatening), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion life threatening), PRURITUS (Pruritus) (seriousness criterion life threatening), THROAT TIGHTNESS (Throat tightness) (seriousness criterion life threatening) and WHEEZING (Wheezing) (seriousness criterion life threatening). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain), COUGH (Cough), HYPERHIDROSIS (Hyperhidrosis), PAIN IN EXTREMITY (Pain in extremity), PRURITUS (Pruritus), THROAT TIGHTNESS (Throat tightness) and WHEEZING (Wheezing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment of the events also included, steroids in ER. Patient under went chest X-ray, results were not provided.  Post vaccination patient experienced, pain in chest, wheezing, uncontrollable coughing, which lead to throat felt like it was closing, sweating and feeling itchy all over body and am hurt super bad.; 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.
VOMITING; SORE THROAT; DIARRHEA; SORE ARMS; MINOR HEADACHES; This spontaneous report received from a patient concerned an 18 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vomiting. On 06-MAY-2021, the subject experienced sore throat. On 06-MAY-2021, the subject experienced diarrhea. On 06-MAY-2021, the subject experienced sore arms. On 06-MAY-2021, the subject experienced minor headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and the outcome of sore throat, diarrhea, minor headaches and sore arms was not reported. This report was non-serious
Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022; Vaccine administered 1 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 1 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     Patient had never been diagnosed with/ tested positive for COVID-19. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  Concurrent medical conditions included Blood pressure, Cholesterol and Coagulation disorder. Concomitant products included METOPROLOL for Blood pressure, ATORVASTATIN for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for Coagulation disorder.    On 27-Jun-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Jun-2022 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 1 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 1 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 27-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Number of doses or vails were reported as 7. The patient had reported no side effects. The vial did not undergo any temperature excursion. No treatment details were provided.   This case was linked to MODERNATX, INC.-MOD-2022-601207 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-601207:
Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient have not received second dose of Moderna Covid 19 vaccice 49 days after first.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.  Reporter  called on 20May2021 and reported that a male patient was currently at their clinic to receive the second dose of Moderna Covid -19 vaccine, but it has been 49 days since patient  got the first dose. . First dose was received on 1April2021.  It was unspecified if the patient was given the 2nd dose.
Severe acute respiratory dristress.  Patient initially treated at pediatrician's offce, then transported by ambulance to emergency room.  Emergency room physicians and staff administered treatment for approxmately 5 hours before patient discharged.
Developed a mass in my scrotum. Now developed Bursitis in my elbow , had to be on antibiotics for both. Had elbow drained now they believe the blood clotted.
pneumoccocal polysaccharide PPV23 on 26-OCT-2017 and pneumoccocal conjugate PCV 13 on 10-OCT-2018; This spontaneous report was received from an adult female patient, concerning to herself via medical record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 2103USA001618). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 26-OCT-2017, the patient was vaccinated with pneumococcal polysaccharide PPV23 (manufacturer unknown) for prophylaxis with a dose of 0.5 mL, administered in the right deltoid , lot number N020502, expiration date 08-FEB-2019 (strength and route of administration was not provide) .It was reported that another doses of pneumococcal conjugate PCV13 pneumococcal vaccine, polyvalent  for prophylaxis, with a dose of 0.5 mL, administered in the left deltoid, intramuscular, lot number W33491 (strength and expiration date was not provided) was administered on 10-OCT-2018 (inappropriate schedule of product administration).   This is one of two reports received from the same patient. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: N020502; expirationdate: 08-FEB-2019; deviceage and unit: 0 ; operatorofdevice: Licensed Practical Nurse; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2103USA001618:
Pt. reports 2 days after receiving the vaccine she started to have mild 2/10 pain in her right arm. After about 1-2 weeks the mild pain started to progress down her arm. At this time also noted some stiffness in her thumb. Notes it causes mild 2/10 pain to move her thumb. Has tried ibuprofen, but the pain has not improved. No other symptoms noted. States she will follow-up with her PCP if the pain worsens.
After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days.  Second dose given 04/23/21 and by 04/28/2021 I started bleeding again And by the second day I was soaking through pads and huge clots were coming out. This has never happened to me before.  After 7 days of bleeding heavily I woke up on May 5th at 4:00 a.m. with intense abdominal cramping The only way I can describe was labor. I felt back labor, pelvic pressure, frequent urination and intense pain. I reached out to my gynecologist And he immediately told me to remove my estrogen patch and later that morning he started me on progesterone treatment for 10 days to stop the bleeding. After 7 hours of pain on May 5th, I went to the emergency department and an ultrasound revealed a blood clot. From ultrasound results "there is a complex area in the area of the cervix measuring 5.7 x 3.6 x 2.6 cm."   After several hours I was released from the emergency room taking toradol for pain. That evening I passed a huge blood clot!  I'm very grateful it was where it was and I could expel it.  But there's no doubt the second vaccine caused this issue that has never happened to me before. I still get my periods though irregular and very light. So this event was highly unusual and very painful
Immediate arm pain (reports injection site was too high--about only 1 fingerbreadth down from acromion), numbness down to left 5th finger. Continued worsening pain radiating into neck. Obtaining MRI tomorrow for possible dx of SIRVA. PT ordered.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patient were vaccinated with improperly stored GARDASIL (lot # K06966, expiration date 10-MAY_2017; dose, route and dose number were not reported; temperature/time frame: 49.1 Fahrenheit / 4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
7" area of erythema, skin hot to touch, itching, pain, and induration.
Pt. states 20-30 mins. after injection was given her (L) arm went numb & hurt. She states it hurts in the joint & not the muscle states she waited 2 wks & went to chiropractor then a wk. later she went to her doctor. He rec. she double up on her anti-inflammatory. No external redness or swelling.
vision loss; other zoster-related injuries; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for vision loss and other zoster-related injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of vision loss was considered to be medically significant.
After receiving 3 vaccines (Hep A, Varicella & HPV) pt c/o dizziness. Varicella was given 1st, then Hep A - she was fine denied any discomfort or dizziness. After 2 administered HPV (less than 2 mins after injection) she c/o dizziness without syncopal episode.
After the vaccine I had flu like sickness. I had no energy, and I couldn't think straight. I still get headaches. I had no appetite. I was also very fatigue. I finally went to a doctor a couple days later after feeling sick. This lasted for about two weeks, but I still do get headaches. I haven't experienced headaches until getting the vaccine.
Primary side effects started day after injection: pain at injection site, body aches, chills, fatigue.  Primary side effects went away after one day except for injection site pain which lasted two days from onset. Minor side effects started day after injection: mild nausea and intermittent headache.  The nausea subsided a few hours after onset, while the headache would occur a couple of occasions over a 24 hour period.  Episodes were usually only a couple of minutes in length.
Symptoms similar to days of positive COVID-19 but in 'fast-forward': intense chills/shivering (12:30-2AM), low-grade fever of 99.5-101.1 (3-6AM), moderate fever of 102.1 (7 AM) broke around 9-10AM. Followed by intense headache/migraine, photosensitivity, difficulty sleeping, and mild nausea (until 12PM). Headache finished around 230 PM. Loss of appetite all day. Still not feeling well at time of submission. Treating with Tylenol and forcing fluids.
Had no reaction but soreness for 2 days after injection.  Everything went away and then on day 8 I woke up with a huge knot, redness, swelling, and hot to touch.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805430 was crossed linked to original case 201804863 due to same reporter.
Itching on back, arms, stomach and thighs.  This was my second dose.  I received my first dose on 02/01/2021. I was prescribed Triamcinolone Acetonide Cream USP, 0.5%.  It only gives temporary relief and I am still itching.  It feels like I have sand under my skin.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 23-JUN-2016, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), (by an unspecified healthcare professional) at a public health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed pain on her torso. On 05-OCT-2016, the patient presented to the physician, her primary care physician, and was diagnosed as suffering from polyneuropathy. Shortly thereafter, the patient returned to the physician and was diagnosed as suffering from internal shingles. 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 vaccine, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of the ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. The events of Polyneuropathy and internal shingles were considered disabling. Upon internal review, Polyneuropathy was considered to be a medically significant event. Additional information has been requested.
Within a few minutes, patient's wife came back to pharmacy to tell us she thought he was having a reaction. He hadn't made it far from the pharmacy (he was riding a scooter). He described a warm flushing feeling and chest tightness. I then asked a technician to call 911. He currently uses oxygen for COPD, and he wasn't sure if it was the shot or the oxygen tank causing the problem. I grabbed my first aid kit and offered Benadryl and an Epipen, but the patient declined both. The paramedics arrived shortly after, and the patient stated he was starting to feel better. Paramedics assessed him. Vitals were stable and lungs were clear. He was asked by paramedics if he wanted to go to the hospital to be checked out, but he declined stating he felt like he was back to normal. The paramedics released him into his wife's care.
On-going non-stop spitting headache since vaccine, body/muscle aches since vaccine, off and on fever for 3 days so far
patient felt dizzy and came to pharmacy counter to let pharmacy know that he was not feeling well. He collapsed in chair while trying to sit back down. ended up kneeling  position facing the chair.  Retired sheriff and paramedic from a different county were on site and assisted in asking questions of the patient until paramedics arrived.  Patient contacted his wife.  Paramedics left and said that patient was fine.
Information has been received from a nurse concerning an approximately 20 weeks old male patient who was vaccinated with the third dose of ROTATEQ (lot # not provided) orally a week after receiving the second dose of ROTATEQ. No adverse event reported.