chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms Hot and Cold), FEELING OF BODY TEMPERATURE CHANGE (Hot and Cold) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms Hot and Cold), FEELING OF BODY TEMPERATURE CHANGE (Hot and Cold) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms Hot and Cold) and FEELING OF BODY TEMPERATURE CHANGE (Hot and Cold) had resolved and HEADACHE (Headache) had not resolved.No concomitant medications were reported.The patient was doing better. She still have headache other then she was doing ok. Patient did not had any problems with the first two shots.Most recent FOLLOW-UP information incorporated above includes:On 17-Nov-2021: Follow-up was received on 17-NOV-2021 and Added new event  headache. Added event details in narrative.
POOR QUALITY VACCINE ADMINISTERED; TEMPERATURE EXCURSION (INCORRECT STORAGE OF DRUG); This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced poor quality vaccine administered. On 07-JUN-2021, the subject experienced temperature excursion (incorrect storage of drug). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and temperature excursion (incorrect storage of drug) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210616693 and 20210617020.
1st dose 15Feb2023, 2nd not yet; 19 YO received adult dose; 19 YO received adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   On 15-FEB-2023, the patient received the 1st dose of Engerix B adult. On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On 15-FEB-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 19 YO received adult dose) and adult product administered to child (Verbatim: 19 YO received adult dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 15Feb2023, 2nd not yet). The outcome of the overdose, adult product administered to child and incomplete course of vaccination were unknown.   Additional Information: GSK receipt date: 28-Apr-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The pediatric patient received an adult dose of Engerix-B (first dose), which led to overdose and adult product administered to child. Till the time of reporting the patient did not receive second dose of Engerix-B, which led to incomplete course of vaccination.
Patient tested positive for COVID 19 on 10/12/21.  No vaccine lot information available on database.
Dose number=3; Pain at site of injection; Chills; Achiness; Tiredness; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Lot number: FF8839) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot number: EN6203 Route of administration: Unspecified.), for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot number: EL3247 Route of administration: Unspecified.), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Pain at site of injection"; CHILLS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Achiness"; FATIGUE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, chills, pain and fatigue.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures taken as a result of the events and included treatment with TYLENOL.
Information has been received from a nurse concerning a "13-15 year old" female who "last week" (on approximately 18-APR-2008) was vaccinated with a first dose of GARDASIL (Lot # not reported).  Concomitant therapy included MENACTRA and Tdap.  It was reported that the patient received GARDASIL and fainted.  Subsequently, the patient recovered from fainting (date unspecified).  The patient sought unspecified medical attention.  Additional information has been requested.
pt recv vax;3-4 hr later,became very irritable & cried unconsolably for several hr then began to have sz activity;to er then adm to hosp; tx w/ meds & eval of sz;
Myalgia, CoughWheeze, 4/13/21 He developed loss of smell, cough,throat irritation, bod yaches. Narrative:
NUMBNESS & TINGLING OF RIGHT ARM AND HAND WITH RADIATION TO RIGHT LEG AND RIGHT FOOT/GREAT TOE
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA HYPOXIA
Chills Extreme fatigue  Lower back pain Pain in left shouder blade  Painful/burning urination Fever Headache
Shaking chills, Fever (102.2), nausea, vomiting, mlalaise, head pressure, hard red rash at injection site, swollen nodes at injection site arm axilla
Pain in area of injection site at onset. Felt like a throbbing tooth ache and progressively got worse. Then starting getting lots of pain in the shoulder, with stiffness and limited movement.
101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection site.
Experienced headache, soreness in left arm, fatigue, muscle aches, nausea, sore throat. Slept 13 hours night of March 25-26.  On morning of 26th, all symptoms but sore throat subsided and that subsided during the afternoon. Felt great the next day.
Vaccine 1/14, 2/4. Admit 4/8. treated w/ steroids, zinc, antibiotics. Many comorbidities, acute encephalopathy possibly d/t COVID-19. DCd home.
Patient had begun the primary series using the Moderna 6 mo-5 year vaccine but on 9/9/22 received the Pfizer 5-11 y vaccine.  No other adverse events.
Rash 2-10-07 at 3:00-over entire body by 2-12-07. Fever 2-11-07 afternoon 2" reddened area at injection site, warm to touch
Autism. Several years ago I requested these forms, but was told the vaccine did not cause the autism. I still believe it did cause it and now thousands of families are in court to prove it when we tried to sue through a class action suit the act stopped it. Now I just want to make sure my child is registered with VAERS and included in any compensation to help her get through life. Patient is a 4year 10month old female who has been diagnosed with Pervasive Developmental Disorder. At present her mother has requested that patient receive no more immunizations due to the literature suggesting linkage between immunizations and PDD/autism. Attached you will find patient immunization record to present and her rubeola titer which shows that she is immune. Patient's history suggests that she was born normally and began developmental changes after reactions she had following immunizations. These unexplained reactions included high fevers, and excessive diarrhea. After her immunizations given at one year, patient stopped using whatever words had been learned to that point, "skated" between furniture, became a fussy eater, irritable and "zoned out". Her developmental delays became more noticeable. She finally began walking at age 20 months. Patient is allergic to gluten. At present she is on a gluten free diet (no wheat) and a dairy free diet and is doing very well. I have been unable to ascertain if any vaccines are gluten free. I am trying to check through the manufacturing companies, as the pharmacist is unable to tell all the ingredients. Due to patient's neurologically impaired and developmental delayed condition, and her allergy to gluten, I would advise at this time that she receive no more vaccines and stay on her gluten free and dairy free diet.   6/20/2007 VAERS report received with records attached.  Records acknowledge child with DX of Pervasive Developmental Disorder/ Austistic Spectrum Disorder.  PMH:  Gluten allergy.  Infant had unexplained high fevers and diarrhea following vax. Child stopped speaking words after 1 year vax, and became a fussy eater, irritable, and appeared to zone out. Neuro eval describes hand flapping and rocking in place behaviors.  PE revealed a wide-based gait and mild global hypotonia.  Child demonstrates delays is both receptive and expressive language skills. Follow-up: Autism. 1/11/2010 Permanently "Autistic".
This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 12-JAN-2017, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, with lot # L044694 and expiration date on 04-FEB-2018 (anatomical route of vaccination was not provided) for prophylaxis. The reported stated, that RECOMBIVAX HB, was exposed to a temperature of > 46 °F but < 77 °F, for 7 hours and 39 minutes. Data logger was reported. Furthermore, it was reported that, on an unknown date, RECOMBIVAX HB was exposed to a previous temperature excursion of 32 °F and 36 °F for 78 minutes. Additionally, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004201:
Within 12 hours I had swelling, a 3" x 3" perfect circle that was actually slightly below the injection site. The injection area also had slight swelling. It was red, swollen and hot to the touch and itchy. By the 2nd morning, the swelling started to progress toward the inside of my arm eventually another 3" x 3" patch. Lymph node in armpit also painful and skin of swelling painful to touch.    Other milder symptoms were: intermittent chills and hot flashes. Mild heachache, slight metallic taste in mouth within 30 minutes of the injection but gone within 24 hours (much less than dose one) Sore muscles esp. in the back and shoulder.  Left arm on Day one felt weird from injection site to the tip of my middle finger. Fatigue.  The Covid arm did not occur on dose one.
Pt developed maculopapular rashes all over the body, both upper and lower extremities.
No adverse event; A drop of the vaccine fell on patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm).    Patient was taking other medication.  On 04-Nov-2021, the patient had received the 1st booster dose of Moderna COVID-19 vaccine 0.25 mL in left arm intramuscularly (batch number: 051F21A). On 19-Sep-2022, the patient had received the 2nd booster dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)).  No treatment medications were reported.
I got my period forward than the day expected. I have heavy menstrual bleeding.  Lasted longer than normal.
This patient was an 11 year old who received the Pfizer COVID-19 vaccine without incident on 5/16/2021. Due to a screening error. unbeknownst to our clinic team, the patient was less than 12 years old. Based on the EUA criteria, this patient should not have been vaccinated, and will be waiting to receive their second dose in the series until their 12th birthday in August (per CDC guidance). Error discovered at time of scheduled second dose. at which point the patient's mother was notified of the error and rescheduled.
flu like symptoms; side effects; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and adverse drug reaction. On an unknown date, the outcome of the influenza-like symptoms and adverse drug reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The patient after receiving the 1st dose of experienced flu like symptoms and other unspecified events listed in the side effect profile.  The patient had not elaborated beyond the flu like symptoms. the caller did not wish to participate in a safety report and would not elaborated on flu like symptoms, or other side effects. The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR093099, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093099:
Myalgia, Arthralgia, Fever, Rash, UrticariaPruritus, localized numbness bottom lip and chin, facial itching and erythema, sweating, chills Narrative:
felt very tired; Headache; "weird tongue"; sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 38 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt very tired"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as ""weird tongue""; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was taking Ibrance 100 mg oral once a day for the treatment of breast cancer since 05Jan2021 and ongoing.  No follow-up attempts are possible. No further information is expected.
Mother reports that right arm became red right after vaccine was given on 3-14-14. Next morning pt had a temp of 100.6. Arm was sore, red and swollen and hot to the touch. 3-17-14 - Mom reports to health dept and schedule an appointment with her primary care provider.
She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed; low blood pressure; very confused; she slid down the side of of her bed; light headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed), HYPOTENSION (low blood pressure), CONFUSIONAL STATE (very confused), FALL (she slid down the side of of her bed) and DIZZINESS (light headed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke in January 2021.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HYPOKINESIA (She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed), HYPOTENSION (low blood pressure), CONFUSIONAL STATE (very confused), FALL (she slid down the side of of her bed) and DIZZINESS (light headed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (She was very confused and light headed that she slid down the side of her bed. She mentioned that her mother said she was "paralyzed), HYPOTENSION (low blood pressure), CONFUSIONAL STATE (very confused), FALL (she slid down the side of of her bed) and DIZZINESS (light headed) outcome was unknown.            No Concomitant medication was reported.    Treatment information included patient treated with fluids   This case was linked to MOD-2021-403658 (Patient Link).
Rash that had been under arms got worse and spread to chest, back, face and ears; not so much on arms or legs.  Very itchy.  No fever, diarrhea, sores in mouth.  Lasted 3 weeks.
This spontaneous report was received from a registered nurse, via a company representative, referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly, vaccine to prevent human papilloma virus (HPV) (strength, dose, frequency, lot/batch # and expiration date were not reported). On an unknown date, reported as " two weeks after receiving a GARDASIL 9 injection", the patient experienced an injection site reaction. It was reported that her arm was swollen, sore, and tender. It was reported that the patient contacted the nurse, however, not treatment was given, no intervention for preventing serious criteria was performed, no significant disability or incapacity occurred, no hospitalization was needed and no life threatening happened. The patient recovered form peripheral swelling, injection site reaction, tenderness and pain in extremity, on an unknown date. The causality between peripheral swelling, injection site reaction, tenderness and pain in extremity with GARDASIL 9 was not reported. Additional information has been requested.
she is Cranky and it is driving her crazy; arm was red; Itchy; Hard to touch; Headache; Chills; Very sick; Disoriented; Hot; Dizziness; This spontaneous case was reported by a patient and describes the occurrence of IRRITABILITY (she is Cranky and it is driving her crazy), DISORIENTATION (Disoriented), FEELING HOT (Hot), DIZZINESS (Dizziness) and ERYTHEMA (arm was red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included ESTRADIOL, ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BIOTIN, VITAMIN B12 [VITAMIN B12 NOS] and MAGNESIUM CITRATE NONAHYDRATE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 27-Apr-2021, the patient experienced DISORIENTATION (Disoriented), FEELING HOT (Hot), DIZZINESS (Dizziness), MALAISE (Very sick) and CHILLS (Chills). On 28-Apr-2021, the patient experienced IRRITABILITY (she is Cranky and it is driving her crazy), ERYTHEMA (arm was red), PRURITUS (Itchy), INDURATION (Hard to touch) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. At the time of the report, IRRITABILITY (she is Cranky and it is driving her crazy), DISORIENTATION (Disoriented), FEELING HOT (Hot), DIZZINESS (Dizziness), ERYTHEMA (arm was red), PRURITUS (Itchy), INDURATION (Hard to touch), MALAISE (Very sick), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had stated that Benadryl gel did not help and Benadryl 25mg put her to sleep
She started experiencing symptoms on 04/24/2021. Had body aches and cough. No Pneumonia or underlying health conditions. Patient was hospitalized and travelled from 04/21/2021- 04/24/2021. She drove back on 04/24/2021. No info about close contacts.
c/o right deltoid very swollen, red and warm to the touch. dr adv mother to tx with advil and cool compress.
HAD ALLERGY TYPE SYMPTOMS ON  05/15/22 IN AFTERNNOON.  BECAME WLORSE  ON MONDAY.  BECAUSE THERE ARE OTHER AT RISK PEOPLE IN THE HOSEHOLD,  I ADMINISTERED A SELF TEST AND IT CAME BACK POSITIVE.
He had general malaise, nasal congestion, and a low grade fever. He had a lot of body aches and pain. When he went to an urgent car they prescribed him a steroid dose pack and Zithromax. His symptoms lasted about 4 days.
Sudden high fever (105F), backache, profuse sweating, starting on 10/29/00 and is ongoing.
All over achiness, low grade fever (100), swollen lymph nodes right side of neck and above collar bone on right side