chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had DTaP immunizaiton on 10/5/04. Mom states that leg started swelling and getting red later on and preceded to get worse. Mom in to immunization on 10/7/04 seen by commander nurse on staff now will be seen as walk in.
Initial misuse report received from a healthcare professional on 07 November 2014 and follow-up information received on 10 November 2014. A 61-year-old female patient had received first dose of FLUZONE HD, (batch number 45063BA, intramuscularly in left deltoid) on 06 November 2014. The reporter denied any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions include autism, hypothyroidism, lupus, RA (rheumatoid arthritis) and allergy to bee stings. The patient's concomitant medications were not reported. The patient received vaccine at an inappropriate age. On 07 November 2014, one day after vaccination, the patient presented with site reaction of 14 cm erythema, redness and 7cm induration. The patient was sent to emergency room for evaluation. Laboratory investigations were not reported. The patient was prescribed KEFLEX as corrective treatment. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow up information received from a healthcare professional on 20 February 2015. It was confirmed that the lot number of the suspect product was 45063BA. The patient had no laboratory investigations. As corrective treatment the patient received BENADRYL. It was reported that the patient recovered within 24 hours of onset of the event.
Upper body achy ness & headache. Symptoms started around 5:00 PM & subsided overnight & by following morning headache diminished. Sore upper arm the following Thursday evening,
Initial report was received from a patient on 28 October 2011. A male patient (date of birth and age not reported) had received a FLUZONE injection ( lot number, route, site of administration not reported). On an unspecified date, the patient experienced chest, ear and nasal congestion and sore joints. The patient declined to provide contact and vaccination information. No further informational was available at the time of the report. The patient treatment and outcome were not reported. Documents held by sender: none.
Pt Received Japanese Encephalitis Shot. Pt stated that he felt dizzy and nauseated. Pt became limp and lost responsiveness. Pt was put in Trendelenberg position and immediately gained responsiveness. Ten minutes later he began vomiting. PT had vitals taken.
Only a slight sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received Shingles vaccine and experienced only a slight sore arm. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.  Note: Case kept conservatively valid since no contact details available for follow up.
1.5 inch in diameter, round swelling; 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward); 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 19Apr2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension (HTN). It was unknown whether the patient had any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), valaciclovir (VALACYCLOVIR) and acetylsalicylic acid (ASPIRIN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 21:00, the patient experienced a 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a 1.5 inch in diameter, round swelling and, itching and sore to touch (slightly forward) was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Kinrix administered to a 7 YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 14th November 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 Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. The case is for 2 of 2 linked patients reported by same reporter. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022185120:Same reporter
Mother states Pt developed a rash, fever (104), and a lump in his legs following vaccination.
her arm got red 5 days after the vaccine; This is a spontaneous report from a Pfizer-sponsored program via Medical Information team. A contactable reporter (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration in arm on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, peanuts. The patient's concomitant medications were not reported. The patient's arm got red 5 days after the vaccine on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
a 16 year old male patient received first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old male patient received first dose of Moderna Covid-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old male patient received first dose of Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old male patient received first dose of Moderna Covid-19 vaccine) outcome was unknown. Not Provided      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.   No concomitant medications were mentioned. No treatment drugs were reported.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient returned to pharmacy 3 days after vaccine to report 1 x 2 inch red/swollen/painful area below the vaccination area. Started 1 day after vaccination administration and worst on 2nd day after, starting to improve but not resolved on day 3.
10/8/05:  Aching noted at left deltoid area. 10/10/05: Fluid-filled blisters appear on left deltoid area.  States she also had fever so she took tylenol and an antibiotic she had at home. 10/14/05:  increase in blisters.  Skin reddened and swollen down to left wrist.  Seen by MD.
01/10/22 presents to Medical Oncology for "inpatient chemotherapy". PMHx of "recurrent metastatic uterine leiomyosarcoma"
Information has been received on 06-MAR-2017 from a pharmacist regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 05-MAR-2017 the patient was vaccinated with a dose of ZOSTAVAX lot # L044529 expiration 09-FEB2017, 0.65 ml, subcutaneous for prophylaxis which was expired. No adverse effected reported. No further information was provided. Additional information has been requested.
RASH AROUND INJECTION SITE.  ITCHING. APPLIED TOPICAL ANTI ITCH CREAM.  LASTED 36-48 HOURS
Day 1: aching in back first, then aches in all joints, then aching everywhere, soreness at injection site, tired, chills, fever. All started within 3-6 hours of shot. Day 2: all of those symptoms remained plus started getting congested! Day 3: No fever, but all other symptoms remain, congestion getting worse, soreness in ribcage or lungs (not sure which one) should be getting better but not feeling better.
Initial s/s were swelling and stiffness at the left vastus lateralis and left knee (10/23/2001). By late that  evening rest scattered blotches were appearing on the left leg extending down to toes. After a number of doctor appt it was determined that Jena had inflammation of the blood vessels diagnosis a strep infection. The hemorraghic, area extended over most of her body and there is a possibly that chronic arthritis may localize in her joints.
Customer said products may have been administered after a temperature excursion.; No other AE.; This spontaneous report was received from an office manager referring to herself, a female patient of unknown age. The patients' medical history, concurrent conditions, concomitant therapies, previous drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (strength, dose, lot#, and expiration date were not reported), and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient said that products might have been administered after a temperature excursion (product storage error). She also said that she did not feel comfortable providing information, and refused to provide any further information. No other adverse event (AE) or product quality complaint (PQC) were provided.
Patient had first Pfizer-BioNTech dose 2/12/2021 (Lot #EM9809). She contracted SARS-CoV-2 shortly after and also received monoclonal antibody therapy. She was instructed to wait to get the second dose of vaccine per her provider based on then available CDC guidelines. When she returned to the HCF to continue the series, she stated that she was told to restart the series and received an additional dose that day, 5/16/2021 (Lot #EW0179), which was registered as another first dose. She returned 21 days later on 6/6/2021 for the 'second' dose appointment and was administered another dose, which was actually her third dose (Lot #EW 0182). Additionally, the patient returned to the site on 1/15/2022 and received a booster dose (Lot# FL3209) based on the dates of the repeated in error primary series. As a result of these events, the patient received an additional dose of vaccine prior to CDC guidelines allowing third doses and outside of the third dose window for people who are not immunocompromised.  The patient also received a fourth dose (registered as booster) on 1/15/2022 which constitutes an additional misadministration given that second booster doses are not yet authorized. The patient did not report any adverse reactions as a result of the extra doses.
Patient received her first Pfizer COVID-19 vaccine.  Approximately 25 minutes later she developed a feeling of throat swelling, hoarse voice and difficulty swallowing. She was unable to swallow water. She was treated in the ED  with EpiPen, Solumedrol and Benadryl. Patient was admitted to ICU for airway monitoring.
Dizziness, Chills, Fever, Headache, nauseous, whole body malaise
This spontaneous report as received from a pharmacist refers to a 90 year old male patient. The patient's pertinent medical history included dementia. On 30-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency unknown) (lot number, expiry date was unknown) in the right deltoid. Concomitant therapies included PERCOCET (unspecified medication) for dementia. On 30-APR-2014, the patient fell and broke his hip (hospitalization, life threatening, disability and medically significant) after he received ZOSTAVAX. It was reported that the patient lived at home with his daughter and he was brought to hospital by ambulance. It was reported that the patient would be admitted to the hospital and the doctor was scheduling to do a bi-polar right hip replacement on the patient. The outcome of the event was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
2-25-08 Zostavax vaccine administered SQ arm. 3-3-08 Pt called and said 2 days after vaccine administered, pt report arm started to itch that evening and got hot, raised and reddened about "the length of a hotdog" at injection site. No hives, SOB, etc. Reaction at injection site only. Pt stated someone told her she should report this to the clinic.
Fever, headache, chills, redness, soreness and swelling at injection site.
Pt. c/o lightheadedness and blurry vision following vaccine. Upon exam pt. vs not within normal limits. Pt. transferred to  hospital. Pt. stated this has happened before following a vaccine in the past.
He was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (He was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced MYALGIA (He was sore). At the time of the report, MYALGIA (He was sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
This case was reported by a nurse via sales rep and described the occurrence of herpetiform lesion in a elderly female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced herpetiform lesion. On an unknown date, the outcome of the herpetiform lesion was unknown. It was unknown if the reporter considered the herpetiform lesion to be related to SHINGRIX. Additional details were provided as follows: The registered nurse (BS, BA) who was nursing supervisor reported this case. The patient had no history of herpes virus previously. The age at vaccination was not reported but could be 70 years or 71 years. The patient went to practice on 6th May 2018 with herpetic lesion on her finger. The nurse and provider were unsure if it was related to vaccine. The lot number was provided. The reporter did not agree to follow up contact.
3/19 c/o reaction {chest pain treated in ER costochronditis; 5/21 no reaction per patient; 9/21/07 c/o reaction{SOB, nausea, jittery, generalized body pain 24 hours - resolved 3 doses given to patient
had a sore arm; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included disabilities which patient will be miserable from an unknown date and unknown if ongoing (patient's mother clarified patient had disabilities before taking the Pfizer Covid vaccine). The patient's concomitant medications were not reported.  It was reported that patient had the first Pfizer vaccine couple of weeks ago (unspecified date) and had no side effect except only had a sore arm. It was also reported that patient will have the second one next Wednesday (unspecified date). It was further reported that the next day (unspecified date), there was no soreness. Patient's mother stated that she read that it is not safe to take Ibuprofen or Tylenol because it will decrease effectiveness. Wanted to know if this is true. Outcome of the event was recovered.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107036 same drug/event/reporter, different patient.
Fever of 103.8. Heart rate of 120 beats per minute. Severe joint pain.  Severe chills. These symptoms started roughly 12 hours after vaccination and lasted for roughly 8 hours. After that, the symptoms were somewhat diminished with Tylenol and later Aleve.  Had the symptoms not been slightly diminished or gotten worse with medicine, medical care would have ben sought.
Beginning the second morning after the first shot, I experienced daily bouts of diarrhea. This is still ongoing. I am waiting for test results from Dr. Additionally, on July 3, just prior to my second shot, I experienced breakthrough bleeding that lasted 12 days. I am menopausal and haven?t had a period since October 2020 ( owing to a ruptured cyst) and it had been 8 months before that that I had a regular menstrual cycle.
Sore Arm at injection site and an area of redness on outside of arm surrounding the area of injections,  Patient also reports area of redness on inside of left leg.
Got dizzy. Had to sit down on floor. I 'awoke' and was still sitting on the floor, but was making a kind of funny noise.  I sat their for a few seconds kinda dazed as I couldn't remember what I was doing on the floor. Then I remember and got up.  I was still a bit dizzy.  I am fine now. I hope it doesn't happen again.
Itchy rash appeared on shoulders down to chest and stomach. Was prescribed a steroid ointment by healthcare provider.
The day after (3/11/21) the vaccination at 9:30 PM I experienced shakes, as though very cold.  My pulse oximeter showed low blood oxygen (between 80 and 85%) and elevated heart rate (high 70's/low 80's).  [I took multiple readings to make sure the numbers were accurate.]  By 10 PM my temperature started to increase rapidly.  Max was around 101.5 to 102F.  Sweat profusely.  By about midnight the fever "broke" (dropped back to normal range).  This will sound odd, but I felt like I had been shown what a severe Covid-19 infection/disease would look like if I were to become seriously ill with the disease.  Felt light-headed on Friday (3/12/21).  [I had no reaction, other than some muscle soreness, from the first dose.The same day as and after the second injection I had soreness in my entire left bicep all day.  No other reactions that day.]
Shoulder pain, muscle weakness in arm and shoulder, decreased range of motion, decreased strength in Left arm.
I started to get a sore throat June 6th.  This turned into post nasal drip,  horrible cough, and has been going on for over 6 weeks.  I called the Doctor, she said take flonase and allegra.  These has helped but minimally.    No idea if this is related to the vaccine, some of my friends have also got similar symptoms, but they have all recovered.  There were all vaccinated as well.  All tested negative for COVID.
4/21 - Pain in left arm 4/22 - Headache and chills all day, pain in left arm 4/23 - no head ache, no chills, no pain in left arm, but I woke up with small red bumps on legs and arms. This spread to my mid section and back. The bumps turned into welts, got itchier and more painful until I started taking benadryl. 4/24 - rash is starting to clear up while on benadryl
Local reaction: Leg leg 26cm in diameter, Right leg 22cm, mild erythema - 0 point tenderness or warmth- taking Ibuprofen, cool compress. Also reacted age 6 weeks HIB given at that time.
ITP diagnosed 9 days following vaccination; platelet count 5000. Testing for VIPIT was negative:  brain/head imaging negative for thrombosis, d-dimer and PT/PTT/INR within normal limits, heparin antibody ELISA negative. She was treated with IVIG and corticosteroids with a partial response (platelet count up to 43000), then placed on Promacta.
SWELLING, PAIN, REDNESS, WARM TO TOUCH ON THIGHS BILATEALLY 3 IN X IN CIRCULAR LESIONS ON BOTH THIGHS. TREATMENT GIVEN WAS BENADRYL.
Information has been received from a registered nurse concerning a 74 year old female patient who on 11-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot # 668488/1052Z Exp date 11-AUG-2011) instead of ZOSTAVAX (Merck). No adverse event seen. Additional information has been requested.
Patient was having heaviness in left arm after receiving vaccination checked vitals BP was elevated at 175/128, one minute late they checked again it was 184/109. Patient reported that heaviness on left side was getting worse. Nurse working the clinic got a wheelchair and took patient to Emergency Room. While they were on the way to the ER, patient started complaining of numbness and tingling down left side of arm.
Redness, warmth, swelling, mild pruritis, onset about 20-24 hours after injection
Mother called 9/26/11 and stated patient complained of neck pain Sunday morning, 9/25/11 and back spasms Sunday afternoon, 9/25/11. Mom denies fever or other symptoms. I recommended she take the patient to her primary medical doctor.
After getting the 3rd dose I had swelling and a few days later, there was itching and headache. I developed neck pain and a knot in my arm. I still have itch in the area with the shot. I still am having headache, but not as bad in the beginning. After the 2nd shot, I could not use my left arm at all. It was unable to use because I was in so much pain. I saw the doctor and received Ketorolac Troth shot and a shot of Alopecia from another doctor in the same left arm. The doctor says I may have developed Bursitis.
Vaccine administered on 01/07/2023 after being thawed on 11/5/2022. Per manufacturer, vaccine should be discarded after thawed for 30 days. Vaccine given outside of these parameters. Patient did not report any adverse reactions/symptoms at this time. Patient will be contacted for re-administration of the vaccine.