chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 19-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
big red lesion around injection site. 3-4 inches in diameter. soreness. Hardness.
Pt reported 1 week after receiving vaccine developed red rash with small speckled dots 1/8-1/4 inch in diameter. Rash on the upper chest about 12 inches across and 8 inches tall. Pt stated rash developed overnight and did not heal for 6 weeks. Only complaint from pt was that it was very itchy. Rash did not spread, was not painful, and did not scab.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with GARDASIL lot # L012190 for prophylaxis. On 21-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL.
Red sore tingling sensation of upper arm into axilla and left shoulder 8 x 8.5 cm blotchy rash on (L) upper arm. X-ray of (L) shoulder ordered.
This patient received a 3rd dose of Moderna. 1st dose on 1/13/21, 2nd dose on 2/10/21, and 3rd dose on 4/16/21.
Information has been received from a nurse practitioner concerning a female with no known history of needle aversion, who was vaccinated with the first dose of GARDASIL possibly one year ago. Before leaving the office the patient felt dizzy. After lying down for 15 minutes, she went home. The patient fainted upon getting out of the car on arrival at home. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered. Additional information has been requested.
The patient had diarrhea, vomiting, severe chills, headache and whole body aching all afternoon and all night on 12/07/00. The next day all of the symptoms were gone.
Patient who received ENGERIX-B is under the age of the adult dose (1 ml) he received. He should have received the pediatric dose (0.5 ml) at his doctor's office or hospital.
On 12/11/2019 I developed severe facial pain later diagnosed as Trigeminal Neuralgia of the 5th trigeminal nerve.  My neurologist gave me OXcarbazepine and Gabapentin which has stopped the pain
Severe, incapacitating headache w/mild moderate neck stiffness. No Kenng's or Brudzinski signs present.
Itching and hives to chest, back and face, redness to face and scalp. No wheezing or airway compromise. BENADRYL was given.
the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies, drug allergies and concurrent condition were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S020241, expiration date 23-AUG-2020; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursion included 12.1 Celsius degree for 16 hours and 11 minutes. There was no preciously temperature excursion. There was a data logger involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever x 2 days, muscle ache upper arms, redness, warmth and tenderness at site of injection.
Red, swollen and soreness. Receive the shot on a Thursday and today Monday injection site if very red swollen and warm to the touch. Put ice on my are yesterday but it doesn't seem to have helped much
Extreme and continuing vertigo, went to doctor and was diagnosed with BPPV. Vertigo comes and goes, paired with fatigue.
he was down for the afternoon; This is a spontaneous report from a contactable consumer or other no-health care professional.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot: not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for covid-19 immunization. The patients medical history and concomitant medications was not reported. Patient reported that on unspecified date after the second Pfizer Covid 19 vaccine he was down for the afternoon but then he picked up. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
My arm was sore pretty much from the beginning and is still sore today, February 9th. It's not terribly painful but uncomfortable, and I have lost strength in this arm.
Patient received Tdap vaccination at student clinic required for attendance.  Took Acetaminophen, reported that he felt OK. Came back to clinic at 11:55PM the next day and stated that he had a headache, soreness in his left arm (received immununization in left deltoid), some intermittent nausea.  He was seen by a nurse practitioner.  He was given Ibuprofen for the soreness and advised to return to student health services.
dizziness; Headache; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), HEADACHE (Headache) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (Headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form and DIMENHYDRINATE (DRAMAMINE) at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Action taken for Moderna COVID-19 Vaccine was not applicable..
Noticed pain and swelling in lower right leg early June and seen by a dermatologist, referred for an US of the lower extremity and was called to go to the ER immediately following as the US indicated acute embolism and thrombosis of deep veins of lower extremity. Blood tests were performed and was placed on Xarelto 20 mg.  Referred to Hematologist for f/u and treatment.
Patient developed a rash over left arm, chest, and neck about 2 days after receiving the vaccine. The rash did not itch or cause any other symptoms. Patient talked with a doctor friend and was advised to report reaction when she received the 2nd dose. No treatment was needed and the rash resolved within 2 to 3 days.
delusional; paranoid; intense and sudden unwarranted anger; more easily agitated; This is a spontaneous report from a contactable Non-healthcare Professional reporting for a patient.   An 84-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 13Jan2021 as SINGLE DOSE for covid-19 immunization.  Medical history included cardiac failure congestive (CHF), severe tricuspid valve regurgitation, renal failure. Concomitant medications in two weeks included Apixaban (ELIQUIS), Simvastatin (SIMVASTATIN), Levothyroxine sodium (LEVOTHYROXIN) Atenolol (ATENOLOL), Spironolactone (SPIRONOLACTONE), Losartan (LOSARTAN) Torsemide (TORSEMIDE). On 15Jan2021, the patient was delusional, paranoid, intense and sudden unwarranted anger, more easily agitated. There was no treatment for the events. The outcome of the events was not recovered. It was reported that patient has become delusional and paranoid, intense and sudden unwarranted anger, more easily agitated. The patient underwent lab test Possible exposure to virus before vaccination although tested negative (weekly testing for about 4 weeks prior, every 2 weeks prior to that). The vaccine was administered at nursing Home/Senior Living Facility. No other vaccine was in four weeks. Prior to vaccination, patient has not had covid. It was unknown whether patient was tested for covid post vaccination. The patient had known allergies to Pneumonia Vaccine.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient received Janssen COVID vaccine on 3/14/21. On 10/5/21, patient admitted to our facility with acute on chronic hypoxic respiratory failure and COVID pneumonia (COVID positive). As of 10/12/21, patient is still admitted in med/surg unit on higih flow oxygen and dexamethasone. She already received tocilizumab.
ALMOST DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient had been previously vaccinated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total was administered for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse event following vaccination with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized (date unspecified) and was in the hospital for 3 weeks on a respirator and almost died (Dose number in series 2). Number of days hospitalized was 21 days and discharge information was not reported. As per the consumer, "another friend was fully vaccinated and boosted and spent 3 weeks in the hospital on a respirator and almost died". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20221222696, 20221222719, 20221222695 and 20221222669.; Sender's Comments: V0: 20221222717-almost died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Small, red rash developed at injection site 6 days after receiving vaccine. Each day it has grown in diameter. It was very sore to the touch for the first three days but now is feeling more itchy. It is slightly raised and warm to the touch. It currently has a diameter of roughly 4-5 inches.
Increse in sense of smell (mostly disgusting odors) for 2 days. Back pain (the whole spine for 3 weeks predominantly in the morning and relieved with daily activity). Chills (3 days) Pain in the site of the injection with a radius of about 8 inches.
Initial report received from a physician on 05 Jan 2010: On 13 Nov 2009, the patient was vaccinated with Influenza A H1N1 (batch # 102045P1). Four days later, on 17 Nov 2009, the patient experienced right facial nerve palsy (Bell's palsy). On 18 Nov 2009, the patient met his primary care physician, and he was started on VALTREX and CEFTIN (details unspecified). However, the patient had no Zoster lesions and no other signs or symptoms of Lyme disease (the patient lives in an area where Lyme disease is relatively common). Blood tests for Lyme disease were negative. On an unspecified date, the patient was referred to a neurologist. On an unreported date the patient underwent a brain MR and was found to be negative. The outcome of the event was reported as no significant improvement in the condition. The causality of the event was not reported. Follow up received from physician on 02 Mar 2010: This polymedicated patient had medical history of diabetes mellitus, increased cholesterol and seasonal rhinitis, received influenza virus vaccine on 13 Nov 2009. On 17 Nov 2009, the patient experienced facial numbness and contacted the reporting physician with Bell's palsy on 18 Nov 2009. The outcome of the event was reported as dense Facial palsy present.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient received improperly stored GARDASIL (strength, dose, frequency and route unknown). Reporter reported GARDASIL with Lot # L024993 and expired date 17-AUG-2017 which was not valid for GARDASIL. However, Lot # L024993 was valid for GARDASIL 9. Concomitant therapy was not provided. The vaccines was stored under 30F for 15 minutes. There was no previous temperature excursion. Digital logger was not involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea; Irritability; just overall  been a breath and that is not like her; This is a spontaneous report from a contactable consumer (mother) reported for a female patient (daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's mother stated that her daughter got the COVID shot yesterday. She was literally having a reverse reaction, irritability and just diarrhea and just overall been a breath and that is not like her and she was a teenager so, the doctor said to call you guys to report the side effect. The outcome of the events was unknown.  Follow up attempts are needed, Information on lot/batch number has been requested.
This is a spontaneous report from a physician referring to a 56 year old female who received her 1st dose of Lymerix on 5/5/99 and shortly thereafter, she experienced joint pain and her knee pain increased. Outcome is ongoing. On 6/5/99, she had her 2nd dose of Lymerix and subsequently, she had swelling in her hands and wrists. The physician stated that the pt has been given a tentative dx of rheumatoid arthritis. The pt plans to see a rheumatologist. The most recent information, received on 8/25/99, reports the condition of the pt as ongoing.
After vaccination on 6/5/08 during routine WCC the patient had inconsolable crying for approximately 24 hours.  On D#5 post vaccine after a second crying bout the mother tried to soothe the child with a warm bath.  The child appeared dusky shortly thereafter and within 10-15minutes became apneic, mottled, and gray.  9-1-1 was called and EMS arrived within 5 minutes.   The child recevied oxygen and stimulation. The patient vomited x2 in the ambulance. Within a few minutes of arrival the patient color returned and the patient perked up.  The patient was obsrved for 48 hours in the hospital with an unknown eitiology for the ALTE. 6/20/08-records received for DOS 6/10/08-overnight stay uneventful. History of several weeks C/O cough worse at night. DX:ALTE.
patient was administered the pfizer covid 19 monovalent booster dose instead of the intended bivalent COVID 19 booster. She was contacted by the provider and was counseled about the nature of the error, potential adverse outcomes, option, if desired to repeat the dose with the bivalent booster, to wait at minimum 8 weeks before returning to clinic.
I developed a profound headache (? migraine?) and fever (101.5F) within 24 hours of the vaccination. The fever continued for two days. The headache continued through and including August 4. On August 4, I also developed Benign Paroxysmal Positional Vertigo (when I turned my head to the right, the room began spinning around me and I would vomit). Repeatedly. Resolved with modified Epley maneuvers.
About 15 min after given vaccine pt passed out, providers notified we laid her down. Put her on 2 liters of O2 she started coming out of it. Rescue was called. Vitals obtained EKG done. Bradycardia with pulse of 44. Transported to ER.
Sudden onset of pain, stiffness and inability to raise right arm over head, pain and stiffness in neck and left shoulder. Pt spoke to physician regarding the same and he said sounded like tendinitis. Pt also consulted a rheumatologist. She was prescribed Motrin an Vioxx.
Received the vaccine last Friday, woke up this morning and the right side of my face was swollen.
Patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022).    The case contains the information of 4th out of 14 patients who had received the vaccine as described by the reporter.  No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15Nov2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquiring the patients need to be re-vaccinated.  The size of the vial was reported as 2.5ml and vial was initially stored in refrigerator on 15Nov2022.  The doses were administered on 16Dec2022, 28Dec2022, 4Jan2023, 7Jan2023, 9Jan2023, 11Jan2023, 13Jan2023, and 18Jan2023. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment medication information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:MASTER  CASE
Systemic: Dizziness / Lightheadness-Medium, Additional Details: pt reported dizzy after receiving moderna bivalent shot; pt also was seeing "evil spirits"; he has history of bipolar and his sister recently passed away
My tongue swelled up about 6 hours after the vaccine was administered.  I went out to eat and had steak and when I returned home I noticed my tongue felt weird and was sitting on my teeth.  It took about 1 1/2 hours to go down but it did so I didn't end up going to the emergency room.   My tongue was soar for the next few days because it was like I had bit it on both sides where it went over my teeth.
Severe swelling in right arm. Hand turned purple, severe pain to touch, redness above elbow to shoulder, elbow swelling.
Patient is turned 12 years old but I had given her the Pfizer from 5-11 yrs. After receiving the vaccine, patient went home.
Headaches, flushed, stiffness & pain low back, hip, shoulders, hands, fingers. 1 1/2" red mark on arm for 14 days.
L arm cellulitis at injection site.  Redness, swelling, itching.   Onset 5-6 days post vaccine.  Treated with warm compresses and Bactrim DS x 7d
woke up with fever and tiredness; woke up with fever and tiredness; he slept until noon; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, refer case US2020AMR039722).   On 2nd March 2020, the patient received the 2nd dose of Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced tiredness, fever and sleepiness. The patient was treated with naproxen (Aleve). On 4th March 2020, the outcome of the tiredness, fever and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness, fever and sleepiness to be related to Shingrix.  Additional case details were reported as follows: The patient woke up with a fever and tiredness and slept until noon after vaccination.
Redness & tenderness, SL induration upper (R) deltoid at site of vaccine. See page 2 of fax for Dr note & treatment plan.
Symptoms began the evening of vaccination, unable to sleep, very restless. When he did sleep, very hard to wake up, out of it. Next morning very weak, could hardly stand. Slightly confused. Temp 100.8 on admission to hospital. Given IV fluids and monitored. Hospital stay was one day. Has recovered completely.