chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 8/29/21, patient was watching TV when he starting to feel very dizzy and had a fall but denies any loss of consciousness.  Patient denies any chest pain or shortness of breath or palpitations. Patient denies any abdominal pain or nausea or vomiting or constipation or diarrhea.  No fever no chills. Patient was found to have a hepatic mass and CHF. Patient was admitted and COVID was negative on 8/29. On  9/6/21 patient got another COVID19 test done due to spike in temperature and chest xray showed infiltrate. and it came back positive. He also developed COVID 19 infection with pneumonia and was treated with steroids, ceftriaxone and doxy and Remdesivir, off oxygen and off isolation. He was discharged to a nursing home on 10/5/21 for rehab. He will complete antibiotic course with Augmentin 875-125 mg bid for 7 days and Fluconazole 200 mg daily for 7 days.
26 year old male presents to immunizations complaining of itching around the body x 2 weeks after receiving Anthrax #4 on 26JUL04. No SOB, No dyspnea. Except for itching with rash at both legs, thighs back and arms.
Patient became fatigued and irritable. She was having trouble focusing after injection. Injection was hard and sore. It was reddened as well. Both of her elbows became reddened.
Chills, fever, body aches, headache, lightheaded, fatigue. These symptoms began approx.. 3:45am lasting until about 11am. Extreme stomach pain/cramping that radiated into chest and back started at approx. 12:30pm and lasted until 8:15pm on 2/2/21. Vaccine given at 11:30am on 2/1/2021.
No additional AEs were reported; The medical assistant is reporting that a patient received improperly stored vaccine.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not reported.   On 17-MAY-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA)  0.5 milliliter, once, lot #x004813, expiration date: 28-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided), which was improperly stored with a temperature excursion of 46.74F during a time frame of 2 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events (AE) were reported.
SIGNIFICANT LEFT SHOULDER PAIN THAT HAS NOT IMPROVED OVER THE PAST 8 MONTHS PER PATIENT.
itching on forehead and neck, skin slightly pink. Both cheeks red and very warm to touch. began approx 48 hrs after injection. The redness and heat on cheeks intensified through out the night and into the next day. Called my primary care doctor who recommended Zyrtec which eased symptoms.  After 48 hours symptoms had mostly subsided.
Swelling, pain and rash at injection site; itching and slight pain at various points on trunk.
lightheadedness; confusion; This is a spontaneous report from a non-contactable healthcare professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EH9899) solution for injection intramuscular in the left arm on 22Dec2020 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. Pregnancy status was not provided at the time of vaccination. Medical history and concomitant medications were unknown. Past drug history was unknown. On 22Dec2020 during her 15 minutes waiting period after the injection, the patient began to experience lightheadedness and confusion. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient was discharged stable to go home and follow up with PCP (primary care physician). The patient was released at 16:39 with no symptoms at that time. No treatment was provided for the events lightheadedness and confusion. The outcome of the events lightheadedness and confusion was recovered on 22Dec2020.  No follow-up attempts are possible. No further information is expected.
For 3 days under my armpit/lymph nodes like oval. 7 November Sunday night Feet started burning, and on Monday am my feet felt like it's on fire, legs were tingly and itchy, and Wednesday burning on the skin of tummy. Couldn't focus and migraines. I couldn't even work from home. Telehealth on Monday. I thought it was antibiotic and drink lots of water and Benadryl. 10 went to ER. Had the second, I had the same reaction for 2nd dose, and it was worst this time. EKG, Bloodwork, urine test, Pain and uninflammatory Sunday evening.
Approx 15-20 min. following IM administration of INFLUENZA virus vaccine, patient c/o vomiting, floaters in front of eyes, & chest tightness.
Kinrix given not at age 4-6, given at 6 months old; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 31-JAN-2023 Reporter's Comment: If a patient was given Kinrix earlier in the vaccination series, not at age 4-6, could you provide data if that was ok or did the office need to repeat the doses using Pediarix.  This office had patient from another health system that joined their practice that was administered Kinrix this way. The reporter noticed that one patient was given Kinrix at 6 months. Since we got no communication with healthcare professional other than through sales representative , no more information that the one on the description was provided (no Lot number, expiration date, patient's identifiers were provided). The reporter shared she had two patients that transferred to her office from two different offices. The reporter agreed to follow up from GlaxoSmithKline was not asked. Additional Supportive Information: The patient received Kinrix below than the recommended age, which led to inappropriate age at vaccine administration. The case had been linked to US2023015600, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023015600:Same reporter
Moderna vaccination- 1/6/21 and 2/9/21. Diagnosed with Covid July 16, 2021.  Hospitalized in August for 5 days for stomach pain, gastritis, colitis, nausea/vomiting and chills. Release from hospital and dx with covid long hauler. Reported to state and they suggested I make a VAERS report.
Red area about the size of a quarter on both legs (thighs), small knot on each leg as well.
12/30/2020 - Pt c/o  low-grade fever about 20 hrs after vaccine dose given.  3 hrs later, c/o temp. 101.6 F.   12/31/2020 - Pt c/o fever, dry cough, fatigue, nausea, light H/A.  Referred her to PMD.
Acute necrotizing appendicitis - appendectomy........doing well Nausea, vomiting, abdominal pain, mild fever
He is diagnosed with autism. Cried for first two years of his life. Nothing would console him. Many sensory issues. Anxiety, overwhelmed, caused horrible meltdowns. 7 years old and still isn't potty trained with bowel movements. Shows he must be struggling with a guy issue caused from vaccinations.
Narrative:  Developed "penny sized" erythematous rash around injection area that he noticed on the same day of the initial vaccination, which persisted for about a week before resolving. Associated with pruritus and fatigue, but no warmth to touch, induration, swelling or sloughing. He denied any other adverse effects. No therapies tried or applied.
Woke up with fast heart rate; Tingling sensation; Fatigue; Chills; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Woke up with fast heart rate), PARAESTHESIA (Tingling sensation), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Sore muscles) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 023M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Dehydration. Concomitant products included DOXYCYCLINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced TACHYCARDIA (Woke up with fast heart rate) and PARAESTHESIA (Tingling sensation). In November 2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Sore muscles). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Woke up with fast heart rate), PARAESTHESIA (Tingling sensation), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Sore muscles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had receiver her vaccine on left non dominant arm.   This case was linked to MOD-2021-386967 (Patient Link).
Patient reported today that 1-2 hours after receiving a flu shot she developed headache, dizziness, fever and nausea that lasted 24 hours.
Ulcerative Colitis flare ups due to covid vaccination; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4166223.  A 39-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 01Jan2021, outcome "not recovered", described as "Ulcerative Colitis flare ups due to covid vaccination".  The reporter's causality for the event(s) of Ulcerative Colitis flare ups due to covid vaccination with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Regulatory Authority opinion was that the causality for the event(s) of Ulcerative Colitis flare ups due to covid vaccination with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported event colitis ulcerative .Case will be reviewed further on receipt of FU information . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a physician via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. Physician reported several patients from internal medicine practice had missed receiving 2nd dose of Shingrix within recommended dosing window due to the COVID-19 pandemic which led to social problem. Reporter did not have patient information or details of 1st vaccine dose. The reporter did not consent to follow-up. Health care professional (HCP) did not want to be contacted for follow-up. HCP declined to provide mailing address or email address.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-OCT-2011, a healthcare provider at a medical facility/hospital administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 08-NOV-2016, the patient was treated by a physician (The address that was provided is a physician's office address, however, a hospital name (not at same address as office) was also provided. It is unclear if the pt was seen on 08-NOV-2016 in a hospital (ER) or at the physician's office.) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Extreme vomiting leading to dehydration requiring 3 L of IV saline; headache; nausea; chills; woozy feeling; all beginning 11 days after shot, leading  to ER visit 14 days after shot.  Still ill 15 days after shot but now have meds for symptoms.
Injection site became red, warm, painful and swollen soon after vaccination. Ten days after first vaccination, site began to improve.   Recommended warm compress, measure and monitor swelling and Tylenol.  No medical care needed.
Starting towards the end of May 2021, itching at injection site on left arm with no other known explanation and no other vaccines since January 20th 2021. No rash or redness is visible.
Pt's throat and tongue and jaw felt like it was swelling. She had extreme pain in her arm and her hands started swelling. She got a rash on her arms and on her hands. I took her to the urgent care facility and they gave her a shot of Decadron and a shot of Benadryl. They also Prescribed steroids. She was very sick like she had a severe flu. I was very worried as her mother. She was weak and slept constantly. Her arm could barely move and It almost appears as if she had had a stroke. She had brain fog and she wasn't remembering her days like she was missing memory. After five days, the reaction started up again so we took her to the emergency room. They did a variety of tests including a urinalysis, CT of the brain, ECG 12 lead, peripheral venous duplex of her upper arm. Everything checked out OK so they put her on more steroids and sent her home. Pt is still having arm pain a month later but finally feels better.
Client was vaccinated with the pediatric Pfizer vaccine. Client is 12 years old and should have been vaccinated with the adult Pfizer vaccine. Family has been notified of the error.
Hematuria (bright red blood), pain while urinating, passage of mucus in urine and possible kidney stone over the course of two days.
I noticed a blind spot in my field of vision. I saw my ophthalmologist  who referred mr to a retina specialist. I was diagnosed with a branch retinal vein occlusion .
patient is feeling tired, has redness around injection site, rash below the injection site, arm is warm
After receiving Tdap and MCV4 fainted and fell of table hitting his head.   Ice was placed and head precautions were inforced on the unit where staff and nursing will check hourly.
CLUSTER OF BLISTERS, NON TENDER, NON ERYTHEMATOUS, NON CELLULITIS FROM RUE.
sleepy; she was tired; At night, she didn't feel well after receiving 1st dose; She was shaking; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (At night, she didn't feel well after receiving 1st dose), TREMOR (She was shaking), SOMNOLENCE (sleepy) and FATIGUE (she was tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (At night, she didn't feel well after receiving 1st dose) and TREMOR (She was shaking). On 16-Mar-2021, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (she was tired). At the time of the report, MALAISE (At night, she didn't feel well after receiving 1st dose), TREMOR (She was shaking), SOMNOLENCE (sleepy) and FATIGUE (she was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 200/100 mmHg (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Contact Information Updated
Left upper arm around and below injection site very warm, swollen around top 1/2 of arm, and red.
itching & quarter size knot @ site of inj lt arm w/in 30min;as noc progress, swelling devel in axilla & deltoid area;11OCT95 sx improved 14OCT96 sc improved;
I experienced soreness in the vaccination area and developed a sinus and respiratory infection. The doctor mentioned that I might have had COVID-19. I couldn't remember anything, for example, days of the week.
patient has missed his 5th dose of DAPTACEL when he was about 5 years of age, with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old male patient who had missed his 5th dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] when he was about 5 years of age, with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Immunisation.  On an unknown date, the patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date the patient had missed his 5th dose of diphtheria-15/tetanus/5 AC pertussis vaccine (daptacel) when he was about 5 years of age, with no reported adverse event (routine immunisation schedule incomplete) (unknown latency).  Reportedly, reporter asked for recommendation whether to give a 5th dose of DAPTACEL or first dose of ADACEL to a male patient; caller states the patient has missed his 5th dose of DAPTACEL when he was about 5 years of age, his 4th DAPTACEL dose was given on his 15th month; now that the patient is already 7 years old, they want to know which vaccine or schedule is recommended  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient has missed his 5th dose of daptacel when he was about 5 years of age, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA236781:01713014
Dizziness, Myalgia, Arthralgia & HYPERtension Narrative:
33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the left arm on 3/16/21. She reports associated throat tightening, difficulty swallowing liquids, shortness of breath, nasal congestion, upper extremity/chest tingling, blurring of vision and feelings of anxiety. She denies lip/tongue swelling/tingling, itching or pain at site of injection.   She has h/o allergies to shellfish, cats and bees. No known allergies to medications.   Physical Exam:  Vitals: BP 174/122, HR 78bpm  Skin: non-pruritc erythematous rash of chest, generalized light redness of upper extremities bilaterally. No itching.  Cardiac-regular heart rate and rhythm. Radial pulse 2+   Lungs-clear to auscultation bilaterally   Plan: EMS was contacted immediately when PT reported difficulty swallowing. EMS placed patient in the ambulance at ~6pm and transported patient to Doctor's Hospital.
Patient received 1st COVID Vaccine 3/15/21, then 2nd dose on 4/5/21.  Patient tested positive for COVID on 8/5/21.
fatigue that is still ongoing, migraine for 4 days, vomiting and Diarrhea, chills, fever aches all over body for a week. Bruising that started 7 days after the vaccine, I do not bruise easy and now if you touch me I get a bruise.
Myalgia, numbness Narrative: right side of face numb 30 minutes after injection that lasted for 30 minutes, then 2 hours later the numbness came back and lasted another 30 minutes. soreness at site for 24hours.
Injection given about 10 A.M.   Some slight soreness at injection site but no other symptoms until about 9 P.M.  Then radiating pain in injection arm for entire length of arm.  Moderate chest pain with heart palpitations.  Chills but slightly subnormal temperature (97.1).  Almost called 911 but delayed doing that.  Did not take  BP or anything for the pain.  All symptoms subsided almost instantaneously at approx. 2 A.M.  Jan. 12th.