chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On unknown dates, the patients were administered PROQUAD (Merck) (0.5 ml, subcutaneous, lot number, expiration date unknown). The nurse mentioned that she had noticed an increased incidence of injection site reactions when PROQUAD (Merck) (0.5ml, subcutaneous) was administered in the same arm as KINRIX (route, dose, lot number, expiration date unknown). The injection site reactions varied in intensity and could include erythema, induration, warmth, and tenderness. The patients sought for medical attention by office visit. Some patients had required unspecified oral antibiotic therapy and some patients had been advised to apply cold compresses to the reaction. The outcome of the events was unknown. Additional information has been requested.
Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.
4 days post 2nd vax the pt developed face, neck,and eye swelling. The pt's allergist placed her on prednisone. Was unable to go off of prednisone until 10/5/99. The pt was diabetic and had terrible problems. Blood sugar went up to 508, vision problems, lost muscle in legs to the extent that she couldn't go up two steps. If she knelt down to get something off of the floor she couldn't get up. Arms were full of large ecchymosis. The pt was terribly ill for 4 months and then in November her hair started falling out. It has now all grown back but she had to wear wigs for 6-8 months. Missing vaccine information not available.
Pt received vaccine around 1400.  At 1415, pts mother returned to clinic with pt in her arms.  Pt had reported dizziness so his mother picked him up and brought him to RN.  RN noted pt had sleepy appearance but was awake and responsive.  Pt stated he had no difficulty breathing.  Pt placed in supine position with feet elevated.  VS at 1416 BP 88/57, HR 67, O2 97%.  Pt continued to report improvement in symptoms and gradually moved to seated position in chair.  VSS.  Final VS at 1438 BP 92/68, HR 76, O2 99%.  Pt awake, alert, sipping water, and chatting.  Pt left with mother at 1440.
I had extreme burning pain over a large area of my body.  Both arms, both legs, my chest, and head.  I had some word confusion and a sense of dislocation and a sense of doom.  I felt lightheaded and nauseous.  I have seen several doctors, and have had many tests, but no help for the pain
no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hours and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000958: US-009507513-2108USA000973:
A pharmacist reported that a female received Tetanus Toxoid adsorbed, 25 years ago and subsequently, developed and unspecific reaction. The patient recovered. As of 03/09/00, no further information was available.
Patient experienced a rash and itching on her neck and face and returned to the pharmacy about 1 & 1/2 hours after getting the vaccine. No shortness of breath was present. Pharmacist gave diphenhydramine 50mg  to patient with water. Since her husband was with we recommended that he take her to the hospital (short distance away) for further observation.
Temperature of 104. 6 hours after vaccine. Seizure 6hrs. after vaccine. Admitted 7/5/10 to hospital for seizure recurrence.
Cutaneous reaction at site of BCG vaccine.  I was born in Russia and received a BCG vaccine as a baby, it left a scar.  I received my Covid-19 vaccine in the same arm.  Today (2 days after me vaccine) I noticed that my BCG scar is bright pink and very itchy.  My COVID vaccine site is not pink.  I did not have this reaction to my first dose.  I put some topical  cortisone on it, and it?s helped.  It?s a mild reaction and doesn?t bother me, I just found it interesting since I haven?t heard of this side effect before.
Itching, Peticiae rash under the skin - back, shoulders, upper arms, and upper legs, arms & shoulders became red. Self treatment with CALAHIST liquid
Moderna 2023-23 12 yr+ SYR use for COVID-19 under Emergency Use Authorization (EUA): mimic heart attack, chest comfot, nausea, vomiting, BP 219-73 elevated troponin and d-domer, profuse sweating, headache
10-15-14: Sudden hearing loss (R) ear. 10-16-14: Hearing loss (R) ear and swelling face/throat -> urgent care visit that day: epi-shot given and 40 mg prednisone prescribed. 10-17-14 visit to ENT. 10-19-14 visit to ER: sudden hearing loss continued and increased swelling at face: increased steroids to 60 mg. CT scan of brain (-). Blood work taken and referred to internal medicine MD for specific MRIs as follow-up. 10-22 MRI of brain, steroid taper ordered by MD. 10-23 and 10-24 episodes anaphylaxis - treated with steroid, albuterol and BENADRYL. 10-24: Bladder control changes and trunk weakness, muscle twitching, paresthesias, hand swelling, decreased motor control, decreased short term memory, blurry vision, heart palpitations, bowel control changes -> 4 additional ER visits, 2 by ambulance for allergic reaction and anaphylaxis. Increased BP, med changes. MRI spine: T-L-S, more blood work. Referral to ENT, allergy/immunology MD, neurologist. Testing ongoing for continued problems.
This case was reported by a other health professional via call center representative and described the occurrence of serum reaction in a 4-year-old male patient who received KINRIX (batch number 2439H, expiry date 25th April 2020). Concomitant products included Measles Mumps Rubella and VARIVAX. On 6th February 2018, the patient received KINRIX. On 7th February 2018, 1 days after receiving KINRIX, the patient experienced serum reaction, extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the serum reaction, extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the serum reaction to be related to KINRIX. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be almost certainly related to KINRIX. Additional information was received as follows: The registered nurse called to the call center representative regarding adverse event. The reporter stated that the patient received a dose of KINRIX in his left deltoid on 6th February 2018 and on the same day he also received MMR and VARIVAX which was manufactured by Merck. The reporter stated that symptoms began the day after vaccination and the patient had a follow-up physician's visit on 6th February 2018. The reporter stated that the patient experienced redness, swelling, and warmth which was extended to the elbow and spread to back of shoulder of left arm. The reporter was not aware of any other medical intervention taken and stated that symptoms are now resolved. The reporter stated that the physician diagnosed this as other serum reaction due to vaccination and stated that there were no signs of infection. The reporter stated that she was not aware of any other medication or medical history of patient.
Information has been received from a physician concerning a 73-year-old female with no medical history who on 11-MAR-2008 at 15:34 was vaccinated subcutaneously in the left arm with first dose of zoster vaccine live (Oka/Merck) (lot# 658210/1079U). There was no illness at the time of vaccination. On 11-MAR-2008 at 17:00, the patient experienced 6" welt (red and swollen and warm area) surrounding the injection site. No diagnostic tests were performed. Subsequently, 8 days following the vaccination, on 18-MAR-2008, the patient recovered from 6" welt welt surrounding the injection site. Additional information has been requested.
We arrived on 02/10/2021 to give second doses to residents at Medical center. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.
Left arm was sore until around 6:30pm when soreness changed to pain with any attempt to raise arm. Pain has not subsided and I had a headache upon awaking this morning.
Pain at injection site; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 12:15 (Lot number: EL9262) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1,single, Vaccine Name: Pfizer, Lot Number/ Expiry date: EK9231, Route: Arm Left , Date: 07Jan2021), administration date: 07Jan2021, when the patient was 71 years old, for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Jan2021 05:00, outcome "unknown", described as "Pain at injection site"; DIARRHOEA (non-serious) with onset 29Jan2021 05:00, outcome "unknown", described as "diarrhea".  Additional Information: any AE(s) doesn't require a visit to Emergency Room or Physician Office  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine   On day 9 after injection, began to get itching at the injection site. Now on day 10 with red area ~ 5 cm x 3 cm. Mild fatigue on day 9 as well.
patient come in and asked us to get a flue vaccine and we gave her. then she told us she come for the covid booster and not for the flue after we administered the flue. she wanted the booster and we gave her a moderna vaccine after we administer the flue. she told us she had a flue vaccine
This spontaneous report was received from a physician via a company representative, referring to a 15 year old male patient. The patient's historical drugs included amoxicillin. The patient's concurrent conditions included allergy to amoxicillin. On 13-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9 per intramuscular administration, lot # M04471 with expiration date 19-JUL-2019, to prevent Human Papillomavirus Infection (HPV). It was stated that immediately after receiving the injection, the patient felt light headed. The next day, on 14-JUN-2017, the patient felt lethargic and his arms and legs felt heavy. It was stated the patient contacted his physician and an unspecified treatment was given for the adverse events. Additionally, the patient did not received the second dose of GARDASIL 9 as indicated. At the time of reporting the outcome of the events was reported as recovered (no date reported). The causality assessment between dizziness, lethargy, and limb discomfort with GARDASIL 9 was not provided.
Hotness and stiffness in the arm of the injection; Hotness and stiffness in the arm of the injection; Horrible pain in the arm; Intermittent finger swelling; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE WARMTH (Hotness and stiffness in the arm of the injection), MUSCULOSKELETAL STIFFNESS (Hotness and stiffness in the arm of the injection), PAIN IN EXTREMITY (Horrible pain in the arm) and PERIPHERAL SWELLING (Intermittent finger swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hotness and stiffness in the arm of the injection), MUSCULOSKELETAL STIFFNESS (Hotness and stiffness in the arm of the injection), PAIN IN EXTREMITY (Horrible pain in the arm) and PERIPHERAL SWELLING (Intermittent finger swelling). At the time of the report, VACCINATION SITE WARMTH (Hotness and stiffness in the arm of the injection), MUSCULOSKELETAL STIFFNESS (Hotness and stiffness in the arm of the injection), PAIN IN EXTREMITY (Horrible pain in the arm) and PERIPHERAL SWELLING (Intermittent finger swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
11 month old was administered Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received DTPa-IPV (Kinrix) (batch number uj434aaa, expiry date 17th May 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 22nd February 2022, 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 details reported were as follows: The 10 month old patient received Kinrix, which led to inappropriate age at vaccine administration. The consent to follow up was given.
Patient fainted/passed out approx 10 minutes after vaccine admin, was shaky and sweating
Suspected vaccination failure; Experienced Flu A; This case was reported by a consumer and described the occurrence of vaccination failure in a 62-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza a virus infection. On an unknown date, the outcome of the vaccination failure and influenza a virus infection were unknown.   It was unknown if the reporter considered the vaccination failure and influenza a virus infection to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu A vaccine and experienced flu. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with US2019AMR154734, reported for same patient for Shingrix vaccine.
Patient passed away related to covid vaccination Narrative: The patient had CHF, cardiomyopathy, A-fib and COPD. Patient received his first dose of Moderna on 1/20. No adverse reaction was reported. Patient was found unresponsive and confirmed dead by Sheriff on 2/10. Cardiologist was notified of his death and suspect patient's death is related to ventricular arrhythmia. He also has a history of noncompliance. Cause of death is not related to COVID 19 vaccination.
Vaccine for Covid rec'd 1/21/21 and 2/10/21  Patient passed away from Covid on 12/10/2021
8/20/11 pt came in to have me look at her arm. There is a red raised area at injection site. She said it is sore to the touch & warm. She said she is putting OH on it. I told her to DC the OH & if not better by Mon call Dr.
pt recv vax & devel inj site pain, crying & fever;no further info was available @ the date of this report;this is one of three pt from this site to have an adverse exp following receipt of vax;
12-10-07 Rc'd Rotateq and other IZ's. Diarrhea started 12-16-07, also vomiting. Seen in office 12-17-07 with dehydration, sent to medical center. + Rotavirus PCR stool culture. No fevers. 1/17/08-records received for DOS-12/17-12/22/07-DC DX: Gastroenteritis. Dehydration. Presented with 3 day history of diarrhea, vomiting irritability and decreased p.o. intake.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL injection (dose, strength, frequency not reported). On an unknown date the patient received incomplete dose of GARDASIL due to leakage from the injection site (no further specified). No adverse effect reported. The outcome of events was unknown. The relatedness between the events and GARDASIL was not assessed by the reporter. Product Quality Complaint (PQC) was not involved. Additional information is not expected.
Minor symptoms happened within an hour like red face, body aches, low energy. More severe reactions on 11/01/12 with dizziness, body aches and fatigue all day. Almost passed out a couple of times while being dizzy. 11/02/12 major severe reactions had all symptoms as noted above with severe dizziness, heart palpitations and racing of the heart.  Several times of near passing out.  Started with an irregular heart beat that I haven't ever had before.
student accidentally received two FLUZONE QIV NP vaccinations from pre-filled syringes instead of the intended FLUZONE QIV NP and Hep B vaccines with no reported adverse event; student accidentally received two FLUZONE QIV NP vaccinations from pre-filled syringes instead of the intended FLUZONE QIV NP and Hep B vaccines with no reported adverse event; Initial information received on 08-Feb-2023 regarding an unsolicited valid non-serious case from a physician.  This case involves a 9-year-old male patient who accidentally received two INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccinations from pre-filled syringes instead of the intended fluzone qiv np and HEPATITIS B VACCINE with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 26-Jan-2023, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose of 0.5 ml twice (lot UT7752MA, expiry date: 30-Jun-2023 via intramuscular route in the right and left deltoid for Influenza (Influenza immunisation).   On 26-Jan-2023 the patient accidentally received two fluzone qiv np vaccinations from pre-filled syringes instead of the intended fluzone qiv np and hep b vaccines with no reported adverse event (wrong product administered, extra dose administered, latency same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
6x6cm indurated, erythmatous, caloric area to right deltoid, well demarcated
Pt devel swelling of the arm of inject, extending from shoulder to elbow, 48 hrs p/receiving vax;
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue,  Symptoms still current after 2 weeks post vaccine.
body aches; fever; This is a spontaneous report from a contactable Other Healthcare Professional (HCP, an x-ray tech who is the patient).   A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 21Dec2020 (reported as ''yesterday'') at single dose for COVID-19 immunisation. Medical history included he had coronavirus in May2020, treated with plasma infusion, and still had detectable antibodies in his system based on lab test administered last month. Concomitant medications were unknown. On 21Dec2020, the patient received the vaccine and has had body aches and a fever.  He wanted to know if this was expected after being vaccinated.  The reporter asked if there are precautions in patients getting the vaccine who have had coronavirus previously and been treated with plasma infusions. Outcome was unknown.  Information on the Lot/Batch number has been requested.
Patient was under-dosed and given 0.25mL rather than 0.5mL.