chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning we took patient to Clinic, he was a happy, healthy toddler who spoke in 5-word sentences and was learning to read. He knew his alphabet, as well as all of his shapes and colors. He could count to 20 and he knew all of his animals and their sounds. Family members described him as 'brilliant'. After receiving his flu vaccine, patient became very tired, so he went to bed early that evening. The morning after receiving his flu vaccine, patient was extremely tired and weak, unable to stand or speak. We believed that the flu vaccine had given patient flu-like symptoms, which I have experienced myself, so we let patient rest. It was my understanding that the flu symptoms can last for up to two weeks. As the days and weeks went by, patient was still not speaking. He began walking very slowly with a pigeon-toed, shuffling gait, as if he was in pain. He also refused to eat or even hold a spoon. Family members were convinced that he was "going through a phase" and that it would pass. As time went by, it became clear that it was not just a phase. We had patient evaluated by a pediatric neurologist who performed an MRI and EEG. We have seen several specialists who performed genetic and nutritional assessments. We have also consulted speech and occupational therapists. Being eligible for Pre-K, the school district evaluated for special needs services. The therapist that evaluated patient wrote his condition as "catatonic." When patient finally said his first word several months after the flu vaccine, the cadence of his voice was noticeably different ? flat and toneless. It has now been nearly two years since the vaccine. Patient is still in intensive ABA therapy for 8 hours a day, four days a week, as well as two days a week of special education. Instead of playing with toys like he did prior to the flu shot, patient exhibits extreme stimming behaviors. These include constant hopping, clapping, drumming, hitting his chest, or running in circles. Every aspect of patient's life has been affected. Before the vaccine, he enjoyed a variety of foods and would feed himself with utensils. After the vaccine, he refuses to eat all but a few foods, and must be spoon-fed. At the age of 5, patient is still not potty trained, and wears diapers full time. Patient is unable to verbalize any of his needs or feelings. Patient went from being a healthy, neurotypical child, to exhibiting extreme, life-altering behaviors the morning after receiving his flu vaccine. We firmly believe this is a case of vaccine injury.
Nerve pain; Joint swelling; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0164) in the left arm on 15Apr2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removal, gluten allergy, dairy allergy and allergy to most antibiotic medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included birth control and cetirizine hydrochloride (ZYRTEC); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021, at 15:30 the patient experienced nerve pain and joint swelling. Since the vaccination the patient not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events nerve pain and joint swelling was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
mom described pt was feeling ill begining 4PM on 5OCT92; emesis w/fever of 101.4 on 5OCT92 limp 7 pale AM 6OCT92; seen by MD on 6OCT92; felt it was not an adverse reaction to DTP; dx w/sinus infection & tx w/Augmentin, t102.4;
This case was reported by a pharmacist and described the occurrence of nausea in a 51-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline). Concurrent medications included Vitamin B-5 and Omeprazole. On 14 January 2014 at 09:30 the subject received 1st dose of ENGERIX B (10 mcg, unknown route, right arm) and experienced underdose. The subject received less antigen than was indicated for her age. On the night of 14 January 2014, within hours of vaccination with ENGERIX B, the subject experienced nausea, headache, and fatigue. Per the pharmacist, the immunization series was not delayed or discontinued. At the time of reporting the events were resolved.
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 18-OCT-2017 and 19-OCT-2017, were administered for prophylaxis improperly stored doses of VARIVAX with lot number N009768 and expiration date on 24-MAR-2019, M-M-R II with lot number M044350 and expiration date on 04-NOV-2018, and PROQUAD with lot number N009774 and expiration date on 20-SEP-2018. The vaccines were reconstituted with properly stored sterile diluent (MERCK) with lot number M046371 and expiration date on 06-JUL-2019. The reporter also stated that one dose of VARIVAX and M-M-R II were administered concomitantly while one dose of PROQUAD was separately administered. Information regarding dose, dose number and route of administration of the vaccines were not provided. It was reported that on unspecified dates, the vaccines were exposed to a temperature of 16 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA007662.
07/09/21- 9:35am- Itching in throat approximately 5 minutes, resolved with no treatment 07/09/21 2:30pm- Left knee swollen on inside heat and redness, told it was thrombophlebitis 7/09/21 4pm- Primary Care visit for knee, use heat and elevate 07/09/21- most of day nausea and headache. bruising-BRUSISING NOT RESOLVED 07/09/21 pm- arm pain at injection site 7/10/21- 8am- Body and bone pain severe, continuing swelling of knee also right knee now swollen NOT RESOLVED YET 7/10/21 9am- Blew nose and had bloody nose NOT RESOLVED NOW INTERMITTENT 7/10/21- all day- extreme fatigue NOT RESOLVED 7/14/2021- Cardiologist visit and he said diagnosis of knees was inflammation due to vaccine INCREASED INFLAMMATION NOW 4 PLACES ON LOWER LEGS also increased PAC's 7/15/21- Dr. visit- regarding vaccine side effects and pain 7/26/21- Dr. visit Primary care- swelling and inflammation continued suggested I wear compression stockings full time 8/23/21- Still experiencing swelling and now areas are dimpling in the swollen areas, severe pain, bloody noses, ,increased PAC's, bruising, as well as severe fatigue, My life functioning has severely decreased as a result of the vaccine.
Area on right anterior mid thigh indurated & erythematous, 1 - 1 1/2 inches in diameter with 2 papules.
COVID PCR on 3/12 negative. COVID PCR on 3/17 positive. Symptoms 3/16 onset: runny nose, headache and sore throat. Source: international travel from 2/26-3/15.
Syncope lasting 45 seconds with accompanying nausea and dizziness that occurred 1 and 1/2 hours post vaccine. Required ambulance from restaurant to hospital. Discharged after 2 hours. Mild nausea and dizziness remain 24 hours post vaccination.
Patient received three vaccines Wednesday night. Per patient they experienced muscle weakness and fatigue to the point patient felt the need to be hospitalized.
The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023; No Adverse Event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 5th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:master case
Pt called on 01/13/2021 to report a reaction from the Moderna COVID-19 vaccine. Pt states she received the vaccine on 12/28/20, but that the reaction did not happen until 01/07/2021. Pt reports redness around injections site, with slight swelling, itching and a rash. Pt was evaluated by PCP, and was prescribed oral, and topical benadryl. Pt states PCP has advised her not to get 2nd dose of Moderna due to rash spreading 1inch below injection site and reaction did not appear until 10 days post injection. Pt report that the TDAP vaccine caused the same reaction in the past,but s/s started the next day with the TDAP vaccine.
Pt. states that after receiving the 1st dose of Phizer 09/29/2021, started experiencing symptoms within 10hrs of pain across the abdomen, shortness of breath, and constipation. No noted Primary visit, symptoms have subsided other than Constipation.
Hives, Swelling of lips, Urticaria, Swelling of throat.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history. On 20-JUN-2017, the patient was vaccinated with an expired dose of VAQTA (route and dose were not provided) lot # M022556 , expiration date 26-MAY-2017, for prophylaxis. Patient's concomitant medications were not provided. No adverse effects were reported. No PQC was involved. Additional information has been requested.
improperly stored temperature excursion; This spontaneous report as received from a physician 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 06-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHA, lot # S020160, expiration date 30-JUN-2021 (dose and route of administration were not reported) for prophylaxis and wit improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S038175, expiration date 26-NOV-2021 (dose and route of administration were not reported) for prophylaxis. The administered doses of vaccines experienced temperature excursion of 50 degrees Fahrenheit (F), 6 F to 14 F (10 F) for 1 hour and 15 min, 15 F to 46 F (44.8 F) for 1 hour and 30 min, 47 F to 77 F (50 F) for 2 hours and 30 min. There was no previous temperature excursion reported. Digital data logger was involved.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who had DAPTACEL that was given to an adult, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 20-Sep-2018, the patient received a booster dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5148AA and expiry date: 09-Feb-2019) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. List of documents held by sender: none.
BROKEN DOWN HEAVILY; CAN NOT EVEN WALK A SHORT DISTANCE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced broken down heavily, and can not even walk a short distance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not even walk a short distance, and broken down heavily. This report was non-serious.
Epi pen refill on day of first COVID shot. Hospital admission to behavioral health for major depressive disorder. Visits were within 6 weeks of receiving the COVD vaccine
Shingles: zoster right leg. 11/18/2004 Follow up 1/19/05: Name of Manufacturers and Lot numbers not available.
Throat swelling, difficult to breathe, shakes, cold from waist down. Upper body felt hot, uncontrollable leg movements. Thirsty, vomiting, diarrhea. Onset 5 hrs after shot - duration - 12 hrs.
Information has been received from a nurse (consumer) indicating that on an unspecified date she was vaccinated with the third dose of Gardasil (Lot number not provided).  Six weeks after receiving the third dose of Gardasil she tested HPV positive.  She was retested 4 weeks later and was HPV positive.  The physician felt that the first test was a false positive due to the administration of Gardasil.  Unknown medical attention was sought in the office.  Patient outcome was unknown.  No product quality complaint was involved.  No further information is available.
C/O Lt arm very sore-Lg red area (6" diameter). Both legs and arms hurt, achy, 24 hrs later sx's worsened-felt very weak. Ended up (post being seen in our office 11/6 and 11/7) in ER 11/7/02 evening.
Bruise in the vaccination area, nine days after the vaccination inflammation, hot and reddish, under the bruise area, the effected area has continued to grow and is already large to the middle of the forearm
Day after vaccination with both PSV 23 and unknown flu vaccine, pt developed fever, whole body pain, chills, rigors, leukocytosis, along with extreme pain at the injection site.  Site had no bruising.  Patient was admitted to the hospital the next day, blood cultures are negative, pt was started on antibiotics for continued fever and leukocytosis.
Got ringing of the ears or tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Got ringing of the ears or tinnitus) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Thyroid disorder. Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Got ringing of the ears or tinnitus). At the time of the report, TINNITUS (Got ringing of the ears or tinnitus) had not resolved.            Concomitant medications included thyroid medication.  No treatment medications were reported.
-Pt developed the flu for 5 days duration, vomiting, HA, etc. -Pt still has palpable tenderness at injection site (30 + days later)
Flu shot given 11-3-15, called 11/7/15 and said he was sore and his throat was sore and swollen. Took BENADRYL.
Injection site bruising; This case was reported by a pharmacist via sales rep and described the occurrence of injection site bruising in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had bruising effect on the arm at the site of the injection. Still visible 10 weeks following 1st injection.
Experienced "COVID arm" rash 7 days after the vaccine was administered. Rash progressed in size, redness and itchiness over the course of the first two days. The inner part of the rash faded by day 3, leaving a red ring. Faded completely by day 5. Sunlight seemed to irritate the rash.   One week later a similar red, itchy rash developed on the right side of the face; unknown if related, but no prior history of skin conditions.
Several (>4) hours after vaccination patient started feeling fevers and severe body aches - presented to ER where she was found to be borderline hypotensive (systolic BP 80s v. baseline low 100s) - received IV fluids with resolution. Observed inpatient for 24 hours.
10 days after first dose of Moderna vaccine, I developed a very sore arm  starting with sharp pain at injection site and progressively radiating throughout upper arm and shoulder area, severe enough that I could not raise or use my arm.  This lasted about 24 hours and then started to dissipate throughout the next 24 hours.  I thought this was unusual because it was so long after the injection happened, and at the time of vaccination I had experienced very little arm pain.
Patient reports approximately 1 week after receiving Moderna COVID vaccine she started to have tingling in her left arm down to her left hand. The tingling also went back up her arm to her neck causing muscle strain in the area and causing her to crack her neck. Patient's primary care provider told her this tingling is a result of the vaccine being given too low on the arm. Patient also reports she has gone to physical therapy as a result of this adverse event she associates with the Moderna vaccine.
The majority of the vaccine leaked from the syringe (at point where needle and syringe body meet) upon administering.
Day 8 post vaccine, woke up with what seemed like sore neck on right side.  By end of day developed into sensitivity to touch on neck. Felt like a burning rug burn. The next day on right side lower back had a oval size patch of rug burn skin sensitivity. When shirt brushed or laid on that side, uncomfortable. The next morning middle of back had the same sensitivity rug burn irritation. Very uncomfortable sleeping. Neck sensitivity was still present as well. This has lasted 6 days so far. It is getting better, but still present.
After recieving his Moderna vaccine the pt devoloped pallor, complained of being light headed and that his thorat felt "weird". I checked the pt's pulse, it was normal. He complained he was feeling worse, I instructed him to stop drinking water and to lay down and elevate his legs. I had a staff call 911 as the pt was complining he was having trouble breathing. The paramedics showed up before I could check his blood pressure. They checked his vitals then motiored the pt for 15 minutes. They then cleared him to leave when he felt ok.
Within 24 hours my daughter developed headaches. These headaches increased in duration and strength within the next two weeks. She has had almost permanent headaches since then (over 6 years) and is on various medications to be able to function/keep the headaches partially in check.
She got her vaccine, noticed when she got home she had lots of coughing, followed by a scratchy throat.  She had moist, almost watery eyes.  The 2nd day she stayed in bed all day with off and on chills.  It evolved into exhaustion and kind of a sore throat, but more of a scratchy throat.  She was already taking the Tylenol/Ibuprofen for her strange back problems.  She did not call her doctor.    The symptoms have slowly improved, but still has a little bits of the scratchy throat, but not like it was, unique to this.
Noticed itching on  Left upper arm, thinking it was a bug bite, lifted up sleeve and realized it was the site of the vaccination; area was red 2X3 inches long, itches and warm to touch.
59 year old pt reporting to flu clinic given Fluzone HD; VAERS form completed as a precaution since pt is less than 65 years of age. Pt was called 2hrs after vaccination and reports feeling fine with no symptoms from vaccination.
3:30pm Blood pressure/ pulse rate elevated/ low temperature/arm soreness,  4:30pm uncontrollable shivering/ rising temperature/ body aches, 5pm fever 101.4/body aches/took 2 acetaminophen 500mg tablets,  6pm fever reduced, 9pm fever/ took more tylenol, 1am fever/ vomiting/ took more tylenol..... more of the same until fever subsided roughly 28-29 hours after injection