chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The child was found unresponsive in her crib.  The child was experiencing a seizure (tremors) which involved her right upper and lower extremity and right side of face.  The child was foaming at the mouth.  The seizure lasted approximately 15 minutes and paramedics were called.  Pediatrician was paged.  By the time paramedics arrived, the seizure had ended.  We were advised by pediatrician to take the child to the hospital emergency room.  After that first incident, the child had 11 seizures in the last 3 years.  The child is currently under the care of pediatric neurologist and several anti-seizure medications were tried.  The child is currently on her 3rd anti-seizure medication. Per follow up 01/03/2006 she now has a seizure disorder and is on anti-seizure medication. Follow up received 04/05/2007. Patient has been on seizure meds for over 3 yrs now.
NECK PAIN; SHOULDERS PAIN/ ANKLE PAIN/ POLYARTHRALGIA/ MIDDLE FINGER JOINT ISSUES; PAIN IN HANDS/ FOREARMS HURTING/ SHIN PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included shin pain. The patient was previously treated with gabapentin for shin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain, shoulders pain/ ankle pain/ polyarthralgia/ middle finger joint issues, and pain in hands/ forearms hurting/ shin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in hands/ forearms hurting/ shin pain, shoulders pain/ ankle pain/ polyarthralgia/ middle finger joint issues and neck pain was not reported. This report was non-serious.
Pt had hot flash and increased anxiety with facial flushing.   1625: 168/100, HR 80, SaO2 99%.   1628: 164/111, HR 77, SaO2 100% 16:30: Benadryl 25 mg PO x1 16:40: 170/117, HR 76, SaO2 99% 16:42: Manual BP obtained - 152/92.   Pt feeling better - no signs of throat swelling or tongue swelling.  Released to own care, encouraged considering another Benadryl once at home.  Check BP at home with cuff, if staying > 140/90, must contact doctor.
Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) 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 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced DYSPNOEA (Difficulty breathing). On 02-Nov-2021, DYSPNOEA (Difficulty breathing) had resolved.            Concomitant medications was not reported. Treatment medications was not reported.   Reporter did not allow further contact
Behavior changes all night, vision changes, fainting, dizzy stars first day until today she still make changes with take care or her on the Hospital.
capillary bleed on top of the patient's left hand; bumps over both arms; bruises in patients' left wrist about half an inch size; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (capillary bleed on top of the patient's left hand), VACCINATION SITE MASS (bumps over both arms) and CONTUSION (bruises in patients' left wrist about half an inch size) in a 75-year-old female patient 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). Concomitant products included DICLOFENAC SODIUM (PROFENAC) for Back pain, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SINUS MEDICATION) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced HAEMORRHAGE (capillary bleed on top of the patient's left hand), VACCINATION SITE MASS (bumps over both arms) and CONTUSION (bruises in patients' left wrist about half an inch size). At the time of the report, HAEMORRHAGE (capillary bleed on top of the patient's left hand) and VACCINATION SITE MASS (bumps over both arms) outcome was unknown and CONTUSION (bruises in patients' left wrist about half an inch size) had resolved.            Concomitant medication include supplements.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073125 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent conditions were not reported. On 24-NOV-2015 the patient was vaccinated with VAQTA (lot # L002717, expiration date 02-JUN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
a 7-year-old child was given the daptacel vaccine with no reported Adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 7-year-old and unknown gender patient who was given the diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient had a non-serious event of  7-year-old child was given the daptacel vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-15/tetanus/5 AC Pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  Outcome: unknown.    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 guidelines. 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.
Headache, Arthralgia, Diarrhea, Left arm pain Narrative:
Patient said the evening of vaccination he had redness on his face and right side of body. His arms & legs were sore and he had a decrease in urination. He reported to MD next day.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 5 hours after receiving the vaccine pt. experienced severe body aches and chills. He took ibuprofen, covered with a blanket and went to bed. He woke up the next morning feeling fine.
Tested as Asymptomatic, however had abd cramping, diarrhea N&V, HA, cough
ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/ She had symptoms; ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine/ She had symptoms; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 1st of two reports.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899; expiry date unknown), via an unspecified route of administration, on an unspecified date, at 0.3 mL, single for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The nurse reported on an unspecified date that the patient tested positive after the first dose. The reporter works in employee health at their hospital. The employee ended up testing positive for COVID virus after receiving the first dose of Pfizer-BioNTech COVID-19 Vaccine. She had symptoms the first 2-3 days after getting the vaccine and assumed it was a normal immune response, but after that she continued to have the symptoms. They went to see the provider and tested positive for COVID virus. They were asking how to handle their second doses. Outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the short duration of less than 5 days since the vaccine first dose is given.,Linked Report(s) : US-PFIZER INC-2020516628 same reporter, same drug, same event, different patient.
Has redness and swelling at injection site - (L) deltoid area. Induration approx 10 cm in diameter with redness about 2 cm beyond induration. Also has itching, is able to move arm without prob.
Severe muscle aches and pain beginning in the large leg muscles and migrating to hips, shoulders, arms, neck and back
Patient had pain and stiffness in the arm of the injection site on the first day after the vaccine and then on the 2nd day her upper left arm was red with swelling and the patient felt nodules on her underarm.  No red streaks noted by pharmacists when she visited pharmacy on 10/8/21 to report adverse effects.  Patient  stated that the symptoms had improved.  The patient was advised to continue observing and to notify pharmacy if the redness and swelling became worse instead of continuing to improve.
Seen by another provider in our office 6/24/08 without herpes zoster (10 crusted papules in a linear cluster r side of abdomen) per provider documention
About a week later I started having shingles like pain, no rash.  I went to the doctor and he told me I had a hypersensitive skin reaction.  That my body did not have shingles but I was reacting as if I did.  He prescribed me  ValACYclovir 1 GM .  I took all of it but the last days worrth, because pain had gone and I had then  come down with the flu and started taking Tamiflu.  A few days the shingles pain started up worse than ever, but it was worse now on my side.  This has been going on for a month now with no end in sight.
Hypotonic-Hyporesponsive Episode, onset was about 2 hours after receiving DTaP vaccine, lasted approximately 4 hours
Pain in her right eye. Unable to close the eye. Seen in ER on 12/13/09. Pt states that the right side of her face feels funny. Obvious Bells Palsy per PCP.
About four months after receiving my fourth dose (second booster) of Pfizer, I contracted COVID-19. I was experiencing congestion, tightness in my chest and a low-grade fever. When I went to my local clinic, I waited in the parking lot where they came out and tested me. The doctor gave me Paxlovid. My symptoms never got worse, and they went away within a few days. I did have the persistent cough for a few weeks, but it went away after a little while.
Mother reports today that child became ill after vaccine was given on 10-18-12. She states her fever went to 102. She reports nausea and mild redness at injection site. Mother did call primary Dr and was told to use TYLENOL. Child was well on 10-22-12 and went to school.
Reported that he was under dosed. Noted injector did not give full dose. Reported had slight stiff neck over L side of neck x 1 minute within 15 minutes and subsided. Overnight had L side of neck tenderness and subsided the day after.
Pt recvd vax 19APR91 & on 20APR91 devel swelling & redness @ the inject site, dec ROM, & an enlarged lymph node under lt arm; 22APR91 devel stiff neck on the lt side;
Anthrax shot #1 red, itchy knot in the area the shot was administered. Anthrax shot #2 same reaction as the first.  Anthrax shot #3 same reaction as first two; along with severe respiratory and allergen problems in Jul 1999.  Was only given nebulizer treatments and albuterol. I had also developed severe muscle aches and pain in my upper and lower back, hips, knees, feet, and ankles.  I had to go to physical therapy once a week.  Anthrax shot #4 same reaction and treatments as the first three. Anthrax #5 same reaction as first four. Was given an allergy skin test in Oct 2000.  This is when I first found out why I was developing breathing problems after being exposed to any type of nature environment.  I am severely allergic to all trees, grasses, weeds, cats, dogs, dust, dust mites, salt water, peanuts, and soy.  I was treated as a patient with asthma, and was given two prednisone treatments in Oct 2000 (10mg of prednisone) and Dec 2000 (20mg of prednisne).  I had also started receiving allergy shots in early 2001, where I would receive 3 shots twice a week. I had experienced a anaphalaxis attack after receiving my shots in Dec 2001.  I was given 40mg of prednisone, Benadryl, and albuterol to help reverse the reaction.  I was also placed on Singulair, Flovent, Serevent, and Zyrtec in Oct 2000.  I later developed liver problems in May 2003.  I was hospitalized May 9 - 11, 2003. 12/31/09 Respiratory infection and allergies has gotten worse. Muscle and joint pain was worsen and joint pain had developed into Osteoarthritis. The muscles pain is Fibromyalgia. There are no changes in the migraines.
4 distinct episodes of vomiting, with 3 or 4 separate vomits in each episode. Vomiting lasted over a 6 hour period; Chills; Severe tired; Left arm immobilized by significant pain; Left arm immobilized by significant pain; Weakness; This is spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 10Mar2021 at 09:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 10Mar2021 at 10:15, the patient experienced 4 distinct episodes of vomiting, with 3 or 4 separate vomits in each episode, vomiting lasted over a 6 hours period. The episode of vomiting was stopped about 2 hours after taking a dose of ZOFRAN. The patient had chills for about an hour after initial episode of vomiting and left arm immobilized by significant pain for 2 days. The patient experienced severe tiredness or weakness on the day of the vaccine and could not get out of bed except to vomit.  It was reported that the patient had vaccination on Wednesday, however the patient did not feel back to full strength until 14Mar2021 (Sunday). The patient was very surprised by how sick she felt after the first dose of COVID-19 vaccine. Therapeutic measures were taken for the event treatment included ZOFRAN for severe vomiting. The clinical outcome of events 4 distinct episodes of vomiting and chills was recovered on 10Mar2021, left arm immobilized and significant pain was recovered on 12Mar2021, severe tired and weakness was recovered on 14Mar2021 on an unknown date.   No follow-up attempts are possible. No further information is expected.
today, the foot is swollen; unusual pain on her left foot that has been worsening; This is a spontaneous report from a contactable consumer (patient's daughter). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm, on 22Jan2021, at the age of 95 years, at a single dose for COVID-19 immunization. Medical history included congestive heart failure diagnosed a year and a half ago, reported as "October last year"; blood pressure abnormal (reported as blood pressure), pain and headaches. Patient had no prior vaccinations within 4 weeks. Concomitant medications included metoprolol 50 mg tablet for blood pressure; amlodipine for blood pressure; and tramadol 50 mg tablet for pain and headaches, patient has been on this about a year and a half. It was reported patient gets anxiety from her concomitant medications. The reporter stated that her mother, the patient, received the first dose of the COVID-19 vaccine on the left arm, last Friday, on 22Jan2021. She explained the next day, Saturday (23Jan2021), her mother experienced some unusual pain on her left foot that has been worsening and today, 26Jan2021, the foot was swollen. She asked if her mother's experience was a reported side effect to the vaccine. The reporter added that yesterday, 25Jan2021, the pain was not quite as bad, but today, 26Jan2021, it has worsened and was now swollen. The reporter clarified again it was just her left foot, not her whole leg, and stated it was just odd. The events were reported as non-serious, and did not require a visit to Emergency Room nor the Physician Office. The outcome of the events was not recovered, reported as worsened.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (hypothermia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shingles (chicken pox and shingles in 2001). Concomitant products included ROSUVASTATIN for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced HYPOTHERMIA (hypothermia) (seriousness criteria medically significant) and RASH (Rash on the side of face and around eyes). The patient was treated with VALACYCLOVIR HYDROCHLORIDE (VALTREX) ongoing from January 2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HYPOTHERMIA (hypothermia), HERPES ZOSTER (Shingles) and RASH (Rash on the side of face and around eyes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 95 (Low) 95. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-118918 (E2B Linked Report). This case was linked to MOD-2021-118638 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Updated address and adverse events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approximately 5-6 hours after immunization, mom recalls child being fussy and crying. Left leg appeared red and warm to touch at injection site.  At approximately 4am on the day after immunization mom was awoke with child screaming and crying and a fever of 102.0. Ibuprofen was given and temp went down to 99.0. At 10:00 on same day, mom noticed fever returning and another dose of Ibuprofen was given.
A day after my 2nd vaccine I experienced muscle cramping/pain in neck/shoulder blade area, forearms, calves and hamstring, muscle spams throughout body, palpitations, brain fog, unbalanced, and hypnic jerks. It has been nine days since my 2nd dose and symptoms seem to be worsening.
Started with some itchy dry skin patches a few weeks after shot 1 on 10/24/19.   Within a week of having the second vaccine on 12/27/2019, the rash completely covered my torso then radiated down my limbs and onto my head over the next month.  The itching was unbearable to the point where I couldn't sleep at all. I initially saw my primary care physician on ~12/30 or 12/31, who prescribed oral steroids.  These had no effect on the rash or itching.  I also saw my dermatologist who gave me a steroid shot, and another shot the following week.   He then performed a biopsy. Three months after my second vaccine, the rash is not quite as widespread, but I am still covered with scabs and continue to itch all the time.  It has effected my quality of life significantly.
pt c/o sore throat approx 20 mins p/vax; leaving MD office pt began coughing & hysterical crying about throat hurting; 1 hr later pt given APAP cold liquid & throat became very hard; slept 1 hr upon awaking face was very swollen;
1/28/00, 2:30am, Febrile 101.2, 4:00am, febrile to 103.2 & chills. 1/29/00, red welt (size of grapefruit), raised at site of 2 injections. Rx'd w/Tylenol, Benadryl po & cream to site. Redness fading by 1/31 & temp down & edema, quarter size
Hives/Uticaria.  14 days after the booster shot, I started having itchiness all over my body.  Its very uncomfortable and does not go away. I have no other associated symptoms such as angioedema or SOB, and no changes to diet or environment stimuli.  Went to see a Doctor after 7 days, I'm on my 4th day of Prednisone medication but still no improvement with the itching.
Patient states that she has bits of metal stuck in her arm from the retractable syringe. She states that She got an x-ray which shows bits of metal stuck in her arm. Vanishpoint syringe 3ml 25G
Janssen vaccine was administered outside of facility- reported by patient  HYPOXIA 11/2/2021 COVID-19 PNEUMONIA HYPOXIA 11/2/2021 CHF EXACERBATION, UNSPECIFIED
Injection site swollen, pain radiating down his R flank, swollen lymph notes under R arm