chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt given DTAP in left leg and MMR and IPV in right leg. Parent back in clinic about 16:30 with child. Child's leg without redness and not warm to touch. Both thighs appear swollen. The areas appear soft to touch. No distress seen.
Per family he received the vaccine at the office and on arrival home was fatigued. He woke in the morning with fatigue, muscular aches and headache.
Pneumovax23 was given in error on 7/20/2022. Once it was caught patient and parent were immediately notified. Advised to watch out for signs of local/systemic reaction and to call with any updates. Checked on pt on 7/21, did not report any reaction. On 7/22 pt presented with a small red area below injection site. The area was slightly raised and warm to the touch. Pt reported pain in the area but it had decreased since onset. Encouraged to follow up with a primary care provider if redness/pain increased or did not resolve.
After receiving FLUMIST patient reported chest tightness. When assessed patient was holding chest and breathing difficulty teary eyes, red skin feeling dizzy slow speech mild allergic reaction. One shot of EPINEPHRINE administered. Patient had a relief from the respiratory distress. Dispatched ambulance transferred patient for further evaluation. Later, released soldier with diagnosis of mild allergic reaction.
Patient with dizziness after the booster vaccine. He consulted with Doctor who recommends that he make an appointment with his family doctor.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 23-SEP-2014, the patient was vaccinated with the third dose of ROTATEQ vial, oral route, (lot # J001254; Exp. Date: 19-SEP-2014), oral (strength not provided). Co-suspect or concomitant therapies were not reported. The dose received by the patient was expired. The ROTATEQ did not have any previous temperature excursions and was found to be supported with in-house post-expiry data. No adverse symptoms reported. Additional information has been requested.
This first started 3 days after I received the Moderna shots.  I started having severe itching, burning, pain and tingling in my hands and feet (more severe in my hands).  Then my sleep pattern became very disturbed to endless nights up all night for days.  Swelling in my lower legs to the point they were as thick with Edema it was as thick as my thighs.  Then I started seeing bugs crawling on my skin and feeling like they were digging into my skin, which started about the beginning of the year 2022.  My fiancée called emergency services on one occasion and I went into the hospital on 2 occasions and received no help.  Seeing the bugs and things on my skin, hair and clothing started freaking me out.  As the months went on, I started hallucinating and being extremely paranoid.  I've had unexplained migraines and severe anger episodes.  One minute I'm fine and the next it's an outburst.  Please help.
pt recv vax 14DEC94 & 25DEC94 devel a rash on face & chest; On the lt arm & lt chest area, it was red & blotchy; also had a fever a swollen lt hand;
external and internal swelling/lump at injection site size of softball, redness at area of swelling, fever, itching
flu like sx occurred on 30SEP w/fever, devel into cold; lasted through following wk;
Started as charlie horse in left leg by next day; Saturday left calf was totally knotted up this continued until Monday night when the right calf knotted up along with tingling and numbness upon awakening and muscle knotting in my biceps as well by Tuesday morning. This was very scary and the muscle cramping/knotting is continuing as of 2:00 PM Tuesay; today The 10th of November.
Nausea; Diarrhea; Sleepiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:00 (Lot number: EN6205) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; SOMNOLENCE (non-serious) with onset 24Mar2021 15:00, outcome "recovered" (2021), described as "Sleepiness". Therapeutic measures were not taken as a result of nausea, diarrhoea, somnolence. No follow-up attempts are possible. No further information is expected.  Additional information: After the first dose had sleepiness which went away after 3 to 4 days.
bright red cheeks (circular rash),rash on chest&stomach;no fever;MD office recommended giving DPH;rash subsided p/ 2 days;no further DTAP to be given
Stronger than usual hay fever symptoms: rhinitis, sneezing, runny nose, stinging or burning sensation in side if nose
Muscle pain and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Muscle pain and pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (Muscle pain and pain at the injection site). At the time of the report, INJECTION SITE PAIN (Muscle pain and pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.   Reporter did not allow further contact
Patient and husband at drive thru vaccination clinic on 3/12/21. Vaccination given at 1519. EMS called to vehicle at 1527. RN arrived a few minutes later.  Per EMS report: Patient complained of itching all over, trouble swallowing, throat tightness, legs hurting, and raspy voice.  No hives present and injection site normal. Per EMS report VS- BP:165/81   P:100   O2: 98% on RA   End Tidal CO2: WNL  EMS administered 50mg Benadryl IM at 1541 and IV started. Departed in ambulance.
WEIGHT LOSS; LOW ANTIBODY COUNT; This spontaneous report received from a patient concerned a 60 year old male of mixed race .The patient's weight was 158 pounds, and height was 182.88 centimeters. The patient's past medical history included: foot surgery, and hives, and concurrent conditions included: heart valve defect, impetigo, boils, food allergy, seasonal allergies, alcohol user, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 24-JUL-2021, the patient was tested with antibody test- IgG which showed low antibody level 36- 38 (partial responder to therapy). The patient also experienced weight loss from 165 lbs to 142 lbs. According to the patient, the vaccine increased his metabolism. The patients stated that he takes ice-cream daily at bedtime to gain weight. The patient's physician would test him for T-cell count.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low antibody count and weight loss was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000189642.; Sender's Comments: V0: 20210829077- Covid-19 vaccine ad26.cov2.s- Low antibody count. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Had it 2 times, got the vaccine, and got it one more time/ suspected vaccination failure; Had it 2 times, got the vaccine, and got it one more time.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 times).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got the vaccine and got shingles one more time. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease(shingles) and laboratory test confiding shingles were unknown at the time of reporting.
Dizziness starting  less than 24hrs after.  Chills,  arm pain and fatigue.  On 2/16/21 arm became red, swollen, firm, warm to touch.
Large raised area at injection site, accompanied by redness.  Did not start until 7 days after the dose.
Patient developed shingles on left temple/scalp 6 days following administration of Shingrix #1. Subsequently developed vesicular lesions on torso. Swab of vesicular lesions by dermatologist positive for VARICELLA.  Patient had known history of childhood varicella at age 10 yrs.
Information has been received from a physician concerning a male in his 40's with a past medical history significant for a thyroid disorder treated with "thyroid hormone" since the age of 15 years old. There was no history of immuno compromise or drug allergies. There was no other concomitant medication. In May 2008, the patient was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed mild "flu-like symptoms" including cold symptoms and muscle acne. In June 2008, the patient was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced mild "flu-like symptoms", rash described as purple patches (1/2-2 cm firm macules) on his face, arms, back, neck that were itchy, fever , a mouth felt inflamed and swollen without lesions, red/ chapped lips that bled when touched, redness around the eyes and joint pain. On approximately 11-Aug-2008, "last week", the patient experienced fever and redness around the eyeballs. On approximately 15-Aug-2008, "last Friday", the patient was seen by a dermatologist. Rash was biopsied with results showing "fixed drug reaction". The healthcare physician questioned possible HSP or vasculitis. The patient currently continued with the rash, although the rest of the symptoms had subsided. Additional information has been requested.
Developed fine rash, vaccine given 5/27/08. Rash is itchy, face and neck - rash onset June 7, felt heart racing. Swollen glands - glands behind ear and 2 at base of skull - onset June 7. Rash on face, neck, chest and back. Rash fading 6/10/08.
Patient is fully vaccinated. COVID + on 11/24/2021.  Hospitalized from 11/24-11/30, 2021.  71y.o. female with PMHx of HTN, OSA, Back pain with recent L4-L5 decompressive laminectomy presented to beaumont trenton 2/2 to hypotension, with post op infection.  Patient reports she had her back surgery November 8th.  Following the surgery she was told it was not healing well, and states she took keflex for 7 days.  She states it continued to not heal appropriately and has since been taking augmentin.  She has been at rehab where she was found to be hypotensive.  Patient reports earlier today she had a 4-5 hour period where she felt she lost her vision, and felt like she was going to pass out. In the ED initial BP 81/54.  Patient was found to have Cr 3.41, baseline 0.61, Lactic acid 2.1.  During her time in the ED she was given 3.5L fluids, and her BP improved. CT lumbar spine showing post op changes, in addition to gas and fluid extending along incision site.  Patient also had a covid test done which was positive.She denied any sick contacts. Denied chest pain, difficulty breathing. Patient was saturating appropriately on room air. Denied loss of taste or smell. Patient asymptomatic with covid.  Afib:  Patient takes xarelto for anticoagulation at home. DVT Prophylaxis: heparin sub Q. Discharged to home.
Approx 30-60 seconds after immunization, infant became limp and pale and within 5-10 seconds had return to crying. Infant was monitored with nomral HR, RR, pulse ox, and mental status x45 minutes, and was discharged home with strict return precautions.
The Flu shot was given at approx. 12:30p.m. on 12/10/03. Within just a few minutes she got very pale, dizzy, sweaty and felt clammy & nausea. She said she heard a buzzing sound in hear head. She heaved a few times, but nothing came up. The nurses there said it was probably from waiting in line for so long and it was warm and she needed to raise her blood sugar level. She fell asleep in the car on the way home, but when she awoke, had to throw up, which she did several times through out the evening, had a low grade fever until around 10:00a.m. 12/11.
The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.; No adverse event; Patient received vaccine after 30-day Use by Date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.  On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.). Concomitant drugs were not reported. Number of doses/vials: around 50 doses from 5 vials. Date of Vaccination was from 07-Aug-2022 to 11-Aug-2022. The vials were initially refrigerated on 08-Jul-2022. The vial did not undergo any temperature excursions.  Treatment details were not given.
Local area erythematous area with  no fever, no limping, no tenderness. "Wheal-flare" local reaction.
02-20-04 Mother reported sleep disturbance onset day vaccine rec'd and continued daily. Episodes of 'sporatic movement/seizures' onset evening of 02-17-04. ER visit 02-18. Seen by private physician 02-19. Referred to neurologist; seen 02-23. Dx of Infantile Spasms.  Medications prescribed: Topamax, B6 - 200mg daily
red, swollen, itchy, warmth, raised -doxy med will be given if sx do not improve
Very serious aches and pains in my joints. Fever, sore throat, pain in arm. Swollen glands and stiff joints. All started around 9 Pm
Started developing a rash not near the injection site. The rash started on my face about 15 hours after I received my first shot. The rash burned and itched and I started developing a small rash on my forearm about 26 hours after I received the shot.
This patient had an injection, within 10 - 20 seconds after the injection, she had a large reddened area 3 inches round in size develop. The patient stated this injection was very painful, no swelling noted, only redness. The patient was observed before leaving unit. The nurse was notified. On 11/14/00 the patient called and reported she did not see the MD as was recommended.
Patient incident report Pt: Allergies: Penicillin 14:45 client claims to feel new onset trembling in her legs bilaterally feel trembly with her second dose of the covid Pfizer vaccine Lot ER8732 Ex: 07/2021, denies feeling any reaction with her first dose, nursing staff was altered-------------------------------------------------------------------------------- 14:52 she has history of high blood pressure and diabetes type II, she denies any chest pain, denies shortness of breath, denies trouble breathing, denies itching, denies rash, vitals taken blood pressure 190/85, pulse 97, SPO2 97% , pain scale 0/10, A & O x4 to person, place, DOB, and situation.---------------- 14:55 client was given a simple sugar and protein to eat14:59 reassessed client?s vitals BP- 199/88, Pulse 94, denies pain 0/10, denies shortness of breath, denies trouble breathing, denies chest pain, denies itching, denies rash, client claims she still feels the trembling in her legs-------------------------------------------------------------------------------------- 15:03Emergency services was called, stood by patient while she was in the car to monitor, client claimed to feel an improvement of the trembling, denies chest pain, denies shortness of breath, denies trouble of breathing denies rash, denies itching------------------------------------------------------------ 15:15Emergency Services arrived to the site started to provide treatment to the client, client claims to feel better still has trembling in the bilaterally legs15:23 blood sugar was taken by the emergency service team reported 138-15:31 client was being transported to Hospital
Tested positive for covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid after first dose). At the time of the report, COVID-19 (Tested positive for covid after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Pimply/Scaly Rash across full length of arm- and back, along the under arm near the breast/chest area.
Herpes Zoster - anti-viral and predizone.  Shingles on my face (later called Ramsay-Hunt Syndrome),  Nine weeks on I am still having pain although the initial rash is gone.  Taking gabapentin 4 times a day.
Janssen COVID-19 Vaccine EUA tiredness, a little nausea, muscle aches, occasional headaches
Redness to (L) LE day following vaccine. Pt reports that it is tender. Area measures 1.5" x 1.25". Treated with KEFLEX (250/5) 4 mL PO TID x 10 days. F/U 1 week.
Pentacel was not reconstituted with HIB powder and only the liquid was administered DTap-IPV portion, No AE; Initial information regarding an unsolicited valid non-serious case was received from the Other Health Care Professional via Global Medical Information (GMI) (Reference number- 00370490) via phone via call center and transmitted to Sanofi on 24-Nov-2020.   This case involves a 6 months old female patient who received a 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was not reconstituted with Haemophilus influenzae type B (HIB) powder and only the liquid was administered Diphtheria, Tetanus, Pertussis, Polio (DTAP-IPV) portion (batch number and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination on 09-Nov-2020 (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), INFLUENZA VACCINE (FLU SHOT) and HEPATITIS B VACCINE for prophylactic vaccination.  This was an actual medication error case due to inappropriate reconstitution technique (latency same day).   The caller is needing to know how to proceed since the HIB component was not given at this time. The caller was made aware of the Pentacel.com site and video.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.   There will be no information on the batch number for this case.
Swelling at injection site, mostly swelling; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site, mostly swelling) and VACCINATION SITE PAIN (Pain at injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunization.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site, mostly swelling). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site, mostly swelling) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's medical history was not provided.   Concomitant product use was not provided by the reporter.   No treatment medication was reported.
Approximately 3 days post vax, pts right arm felt like it fell asleep from under the armpit halfway to the elbow.