chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The mother refers the patient presented redness, inflamation and heat in the left deltoid, area of the vaccine administration.
On 9/7/2021 at approximately 21:30 the patient experienced an out of hospital cardiac arrest while driving with a friend. He was resuscitated by EMS and transported to hospital. His tox screen was positive for cannabinoids. No cause could be found for this event. He suffered severe anoxic brain damage. Patient is still in hospital on life support at the time of this report. High chance of death. Almost certain to have permanent severe disability if he survives
Patient presented to the ER with fever, chills, dry cough, mild SOB, diarrhea and mild nausea. Patient was diagnosed with sepsis r/t Covid-19 infection. Patient received IV steroids. Patient was discharged home. Home health refused by patient.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        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-2021-395985 (Patient Link).
Sore shoulder for 3 days. Used ice pack which helped pain. Arm was stiff enough to miss work for 1 day. Headache for 2 days.
Increased seizures activity starting day after, and is now 4th day after and continued increased strength and number of partial seizure activity. It my be linked to the mild fatigue still felling that started after first vaccination shot.
Shortly after being given her 11yr old vaccines, Patient fell weak and dizzy. She was sitting on the exam table. She subsequently fell and hit the left side of her head. I heard the mother scream. MD was next door. MD immediately went to the next room. MD found her mother on the floor with her child in her arm who was uncounscous. MD checked her pulse which was in the 90's. MD called out her name and immediately woke up and opened her eyes. She was in a bit of daze. She was able to recognize me and her mother. MD have her an alcohol swab to smell as a noxious stimuli. MD activated EMS. We brought in the crash cart. MD asked the child to sit on the chair. She said she felt dizzy. MD performed a mini mental exam. She passed the test without any errors. Her GCS was 15. Shortly there after EMS and I gave them an update. We repeated the vital signs which were WNL. A bedside ECG was done which was normal. Given that she was feeling dizzy, MD counseled the mother that she should be evaluated in the ER. The EMT agreed to take her to ER.
Developed very large red bump, about 4" in diameter, and red rash encompassing entire area from my elbow to almost my arm pit.  Sharp throbbing pain at area.  Shooting pain in my armpit down thru my body.  Arm painful to move. Hurts badly to touch.  Red area swollen as well.
Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; congestion; sore throat; loss of smell; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.   A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient experienced patient had both doses of the pfizer covid vaccine and tested positive for covid (medically significant) on an unspecified date, congestion, sore throat, loss of smell on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.   Information about lot/batch number has been requested.
This case was reported by a nurse via call center representative and described the occurrence of tonic clonic movements in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tonic clonic movements (serious criteria GSK medically significant). On an unknown date, the outcome of the tonic clonic movements was unknown. It was unknown if the reporter considered the tonic clonic movements to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The nurse reported patient had tonic-clonic spasms in the arms and legs after receiving the SHINGRIX vaccine. The health care professional did not have vaccine or patient information.
A hour after the vaccination, I had a lot of numbness and couldn't stand up with someone holding me. When I had the vaccination it set off the nerves in my face. I did take a Benadryl and have to get help to move around. My facial neuralgia begin to become worse.
48 Hours after vaccine, patient experienced extreme fatigue and neurological motor control issues.  She was in bed and unable to walk or lift anything for a week.  Lingering fatigue and motor control issues lasted approximately four weeks.  Fatigue persisted for approximately 8 weeks.
It was a solid red surface, today now more like a rash and not as itchy; Itching really bad around the injection site; Became very red around the injection site; Slightly raised, 2inch diameter around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching really bad around the injection site), VACCINATION SITE ERYTHEMA (Became very red around the injection site), VACCINATION SITE SWELLING (Slightly raised, 2inch diameter around the injection site) and VACCINATION SITE RASH (It was a solid red surface, today now more like a rash and not as itchy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE for Blood pressure, NADOLOL (CORGARD), VITAMIN B COMPLEX and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching really bad around the injection site), VACCINATION SITE ERYTHEMA (Became very red around the injection site) and VACCINATION SITE SWELLING (Slightly raised, 2inch diameter around the injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (It was a solid red surface, today now more like a rash and not as itchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 04-Feb-2021, VACCINATION SITE PRURITUS (Itching really bad around the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Became very red around the injection site), VACCINATION SITE SWELLING (Slightly raised, 2inch diameter around the injection site) and VACCINATION SITE RASH (It was a solid red surface, today now more like a rash and not as itchy) outcome was unknown.        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 for the event included Ibuprofen, cetirizine and diphenhydramine cream.
fever of 100.6°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.6°F) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PYREXIA (fever of 100.6°F). At the time of the report, PYREXIA (fever of 100.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever of 100.6°F.         No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
hives started approximately 1 week post vaccine and continue to have hives off and on daily,   itching,  some swelling of joints,   some throat itching.
Computer EMR was down so paper documentation was used.  On review of the paper documentation for entry into the computer when it was back up and working, it was noted that the lot number for the vaccine administered was for Flublok and not for Flulaval.  There was no adverse effect noted at the time of vaccination.  A message was left for the patient's mother.
11/18/07 Neck and right shoulder pain, difficulty lifting right arm.  Determined to be acute right brachial neuritis.  Treated with physical therapy.  Is still not back to pre vaccine status, is begining to get some use back.
C/O L arm pain post flu shot. Took Motrin without relief. Referred to neurologist. Dx=myalgia. Ordered PT with relief. Thinks shot was given "too high."
Call made to vaccine unit who informed us that over the next 5-10 days after the vaccine was given a chicken pox rash contagious could occur and fever. Mom informed of what has happened and what could happen. Mom will be in touch with our office if any symptoms occur.
Itchy rash; Bumps/rash popular/raised rash; skin lesions; hot rash; Red rash; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th March 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. In April 2019, the patient experienced itchy rash, raised rash, skin lesion, heat rash and red rash. On an unknown date, the outcome of the influenza-like symptoms and skin lesion were recovered/resolved and the outcome of the itchy rash, heat rash and red rash were unknown and the outcome of the raised rash was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, itchy rash, raised rash, skin lesion, heat rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at his physician's office, on his right arm, deltoid muscle, intramuscularly. The batch number was not reported. He did experience flu-like symptoms the same day which resolved by the next day of vaccination. The patient states after about a week later, he started to experience lesions red, raised, hot, itchy on his right upper torso, shoulder, and back which went away and came back later.  At the time of reporting he has bumps on his left shoulder and left scapula area. He reports also having these skin lesions, which look like insect bites on his right knee which has resolved. Patient has been referred to infectious disease for follow up. The reporter consented to follow up.
Raised red bump right thigh were vaccine injected. Itchy, irritated appeared at injection site 12 days after varivax.
Employee had tingling sensation in Right upper extremity, and heaviness in bilateral lower extremities 5 minutes after receiving vaccine. These symptoms resolved approximately 2 hours after they began
Initially had arm soreness day after second dose of vaccine. Had increasing nausea, headache, severe fatigue, and developed swollen lymph nodes during week following second dose
Patient admitted on 9/8/21 with increased generalized weakness and falls x2 in last 72 hours.  COVID swab performed as precautionary anticipating admission resulted positive.  O2 SAT STABLE ON 3L/M N/C, no steroids given
second COVID vaccine was on 31Mar2021 and it "kicked my butt" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute; second COVID vaccine was on 31Mar2021 and it "kicked my butt" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute; first COVID vaccine was on 15Mar2021, second COVID vaccine on 31MAR2021; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN: LRN4535447, 7793-2123331565.  A 39-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: Patient's concurrent condition included: Multiple Sclerosis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 15Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "first COVID vaccine was on 15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric"; The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Mar2021, outcome "unknown", described as "first COVID vaccine was on 15Mar2021, second COVID vaccine on 31MAR2021"; HEART RATE INCREASED (medically significant), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "second COVID vaccine was on 31Mar2021 and it "kicked my ass" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute". The patient underwent the following laboratory tests and procedures: Heart rate: 140, notes: his heart rate was 140 beats per minute. Clinical course: On 15Mar2021, patient started therapy with Pfizer COVID-19 VACCINE for unknown indication On unknown date , it was reported that patient experienced: No immune response to COVID vaccine, first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric, second COVID vaccine was on 31Mar2021 and it "kicked my butt" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o feeling tired/fatigue, usually feeling exhausted during evening time on/off since she got her 2nd dose covid vaccine Pfizer on 05/22/2021. Also stated she got low grade fever this morning but did not check temperature. She stated she is checking her O2 sat and PR regularly at home,O2 sat remains >95% and HR between 70s-90s. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. urgent care provider visit scheduled for consultation.
5/26 38 y/o female with persistent cough post COVID-19 infection presented with pleuritic CP.
Information has been received from a nurse practitioner concerning an 18 year old female patient with several bug bites who on 18-MAR-2008 was vaccinated with the first dose of GARDASIL (lot # 659655/1486U) 0.5 mL, intramuscular route, and on 16-JUL-2008 was vaccinated with the second dose of GARDASIL (lot # 660555/0279X) 0.5 mL, intramuscular route. There was no concomitant medication. It was reported that on 16-JUL-2008 the patient developed hives several hours after administration of second dose of GARDASIL. The nurse indicated that at the time of the administration the patient had several bug bites and the hives caused the bug bites to intensify in appearance. On approximately 30-JUL-2008 the patient recovered completely from both the hives and bug bites. The patient did not seek medical attention. Additional information has been requested.
No adverse event; 1 patient who received only 1 vaccine that had undergone a temperature excursion; Information has been received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications.  On 16-OCT-2019, the patients were vaccinated with doses of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot # R030810 and expiration date of 24-OCT-2020, hepatitis a vaccine, inactivated(VAQTA) lot # S007770 and expiration date of 24-JUL-2020, and lot # S021092 and expiration date of 18-MAY-2020 (route of administration and anatomical location were not reported), and doses of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally lot # R033252 and expiration date of 29-JUN-2020 and lot # R033256 and expiration date of 23-JUN-2020, for prophylaxis, which were stored in the range of above 47 Fahrenheit degrees to 35 Fahrenheit degrees or 9 Celsius degrees (9.5 Celsius degrees) for 35 minutes. Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent. No previous temperature excursion was reported. No adverse events were reported.   Digital data logger was not involved.  Follow up information received from office manager on 20-APR-2020.  On 20-APR-2020, a call was placed to the nurse and the call was answered by office manager which made the report valid. The office manager reported that it appeared that there had been only one male patient of 6 months old who received only rotavirus vaccine, live, oral, pentavalent (ROTATEQ) that had undergone a temperature excursion.
Dose administered during temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 03-JUN-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Dose administered during temperature excursion). 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: 05-JUN-2023 The reporter called to inform that dose of Kinrix was administered to a patient while the temperature dropped in a temperature excursion, the minimum temperature of that excursion was 30°F. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. Kinrix was administered to a patient while the temperature dropped in a temperature excursion, which lead to incorrect storage of drug.
Vesicular rash under left breast and left thoracic back around T4-T5 dermatome.
Discharge Provider:  DO Primary Care Provider:  NP Admission Date: 8/19/2022 Discharge Date: 8/22/2022  PRESENTING PROBLEM: COVID-19  Acute kidney injury (HCC)  AKI (acute kidney injury) (HCC)  COVID    HOSPITAL COURSE: Patient is a 97 y.o. male who presents today with a history of hypertension, hyperlipidemia, chronic obstructive pulmonary disease, coronary artery disease, a flutter.  Patient presented to a local emergency department from a residential facility after staff noted patient was somewhat short of breath.  Patient was given a nebulized breathing treatment with no improvement.  When EMS was called they noted patient was not wheezing and found him to have no respiratory distress.  They then proceeded to bring patient to emergency department for further evaluation.  Upon arrival to the emergency department patient was not showing any signs of respiratory distress.  Initial workup showed patient tested positive for COVID-19.  Lab work showed acute kidney injury with decreased GFR of 34 with previous readings normal.  ProBNP was 26 44. WBC 12.8, potassium 5.7.  UA showed large leukocytes, large blood, urine WBC >180.  Patient was then started on IV Rocephin.  Patient was given 20 mg IV Lasix for the elevated BNP and elevated potassium level.  Emergency department provider did talk to patient's daughter and she confirmed patient as a do not resuscitate.  Hospital Services was contacted and accepted patient for admission for acute kidney injury and hyperkalemia.
This spontaneous report as received from a medical assistant refers to a 2 month old, female patient. The patient's medical history was not reported. On 02-AUG-2017 at 8:45 AM, the ROTATEQ vaccine was subjected to incorrect storage. On 03-AUG-2017, the patient was vaccinated with incorrectly stored ROTATEQ (Strength, dose, frequency, anatomical location and expiration date were not reported) orally for prophylaxis. Co-suspect therapies included PENTACEL and PREVNAR. There were no concomitant therapies reported. There were no adverse symptoms or reactions noted. Sender's Comments: US-009507513-1708USA001493.
Aches such as flu - slight headache - low grade fever - Lasted 24 hours.None
7 minutes after vaccination, attendee developed dizziness and a purple circle in her vision.  She was assisted to a cot, lied down and her feet were elevated.  HR 90 BP: 104/58 RR: 18 O2Sat: 100% Temp 98.3.  Nine minutes later she was asymptomatic.  HR: 90 BP: 110/50 RR: 20 O2 Sat: 100 Temp: 98.2. 10 minutes later still asymptomatic.  Assisted to sitting position then vitals taken HR: 84 BP: 112/62 RR: 20 O2 Sat: 98 Temp: 98.2. She remained asymptomatic.  Assisted to a standing position, Asymptomatic. Discharged to home with her mother.  Able to independently walk out of the clinic.