chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine to a 16 year old/ Vaccine administered to a patient who is under 16 years old based on the date of birth provided/ Pharmacist confirmed the date of birth and agreed that patient did not turn 16 yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 16 year old/ Vaccine administered to a patient who is under 16 years old based on the date of birth provided/ Pharmacist confirmed the date of birth and agreed that patient did not turn 16 yet) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 16 year old/ Vaccine administered to a patient who is under 16 years old based on the date of birth provided/ Pharmacist confirmed the date of birth and agreed that patient did not turn 16 yet). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered vaccine to a 16 year old/ Vaccine administered to a patient who is under 16 years old based on the date of birth provided/ Pharmacist confirmed the date of birth and agreed that patient did not turn 16 yet) 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.    Warm Transferred case number 00166244  A pharmacist called in on 18May2021 to report that the first dose of Moderna COVID-19 vaccine was administered to a 16 year old on 17May2021 (Lot number: 033C21A, Expiration date: 27Oct2021) in the left arm. Caller denies knowledge of any adverse reactions experienced by the patient or any treatments used.  On 18May2021 at 1:05 PM EST the agent reached out to the healthcare provider to verify the patient's age. Pharmacist confirmed the date of birth and agreed that patient did not turn 16 yet.  Consent to contact the pharmacist granted. Preferred method: telephone or email.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Email received
Mom states child had a fever of 103-no other problems. Fever began around 03:00 on 9/13/02. Was seen in the ER later that day-no medical problem was found. Treated with Motrin/Tylenol. OK on 9/14/02. OK now.
Narrative: Patient completed COVID 19 vaccine (Moderna) series in April 2021. Patient reported to ER on 7/21/2021 complaining of chest congestion, productive cough, headache, sore throat, fever, body aches, fatigue, malaise times approximately 3 weeks and a loss of taste and smell starting on 7/21/2021. Patient tested positive for COVID 19 on 7/21/2021.
Itching rash on fourth day after injection administered. Rash still continues. It is dark pink in color and warm to touch. It is 7in. in length and 4in. in diameter at the widest point.
Received Gardasil 9/16/08 at gyn office.  Reports sensation of obstruction in throat 1/2 hour after vaccine given.  Seen in this office 9/18.  By history, breathing and eating fine.  Exam negative.
Lightheadedness; dizziness; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's husband) from medical information team. A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 13:15 (Lot number: EN6202) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single,, LOT:EM9809 , Anatomical location: Left Arm.), administration date: 04Feb2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "dizziness"; VERTIGO (non-serious) with onset 25Feb2021, outcome "unknown", described as "vertigo"; DIZZINESS (non-serious) with onset 25Feb2021 13:15, outcome "not recovered", described as "Lightheadedness".  Additional information: The reporter stated that he was transferred. He reported that his wife received her second dose of the Pfizer Covid vaccine on 25Feb2021. She had experienced dizziness/vertigo since receiving the vaccine. He wants to know if anyone else has reported this and how long it could last. Patient, had been experiencing lightheadedness on and off for a week. Reporter states he was trying to find online and couldn't find anything about it. Reporter states patient felt the lightheadedness right after she got the second dose that day. Reporter states patient attributed it to being nerved up that day about the shot, but now it has been going on, on and off, for a week. Reporter states that they wanted to call and see if it is a reported side effect. No other Product were received and no other history and no investigation Assessment. No additional Vaccines Administered on Same Date of the Pfizer Suspect and AE(s) did not require to visit to Emergency Room or Physician Office. No prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. No family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Calcium deposit in left shoulder-extreme pain/little to no mobility.   Went to orthopedic-received cortisone shot-resolved ~1 week later.  Not sure if due to COVID shot or strange coincidence.
very red; hot to the touch; swollen; itchy; angry looking, infection like; rash came back; developed rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy) and INFECTION (angry looking, infection like) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE (FLOVENT) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (developed rash at injection site). On 15-Jan-2021, the patient experienced ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy), INFECTION (angry looking, infection like) and RASH (rash came back). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE RASH (developed rash at injection site) had resolved. At the time of the report, ERYTHEMA (very red), INJECTION SITE WARMTH (hot to the touch), SWELLING (swollen), PRURITUS (itchy), INFECTION (angry looking, infection like) and RASH (rash came back) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with all 3 doses of GARDASIL (lot number unknown) on unknown dates. No other co-suspects were reported. No concomitant medications were reported. After each dose, the patient experienced stomach pain, bloating and stomach cramps. It was unspecified if the patient had sought medical attention. The outcome was reported as unknown. Follow-up information has been received from a healthcare professional concerning a 13-years-old patient with inflammatory bowel disease and no illness at time of vaccination, who on 19-AUG-2011 at 12:00, 02-NOV-2011 at 15:15 and 02-JUL-2012 at 15:15 was vaccinated with the dose 1, 2, and 3 GARDASIL respectively, IM, left arm (dose not reported, lot numbers: dose 1: 670048/0963AA, exp. 09-NOV-2013, dose 2: 668262/0841AA, exp. 08-APR-2013, dose 3: 673256/0629AE). It was reported that after dose 2 of GARDASIL the patient experienced emesis and nausea. On 03-JUL-2012 at 12:00, after dose 3 of GARDASIL, the patient experienced emesis, abdominal pain and nausea. The patient did not seek medical attention. The patient recovered on 05-JUL-2012. This is one of several reports received from the same reporter. Additional information is not expected.
The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non HCP (a manager) and from a contactable Physician. This Physician reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at single dose at right deltoid on 13Jan2017 11:00 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced erythematous rash, which progressed to a tender, edematous plaque with fever, all treated for a cellulitis episode. The outcome of the events was apparently recovering. The AEs required an emergency room or physician visit. The patient was apparently recovering. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017070804 same reporter/drug/AE, different pt; US-PFIZER INC-2017070703 same reporter/vaccine/ event, different patient.
Information has been received regarding a case in litigation concerning a 25 month old male who on 12/29/00 at approximately one year of age was vaccinated with MMR, diphtheria toxoid (+) pertussis acellular 4-component vaccine (+) tetanus toxoid, and poliovirus vaccine inactivated. On 1/10/00 the patient was vaccinated with hepatitis B immune globulin. On 2/11/00 the patient received diphtheria toxoid (+) Hib conj vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid and poliovirus vaccine inactivated. On 4/17/00 the patient was vaccinated with poliovirus vaccine inactivated and poliovirus vaccine inactivated. On 1/14/00 the patient was vaccinated with HIB conj vaccine, diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid; hepatitis B virus vaccine; poliovirus vaccine inactivated. On 12/29/01 the patient was vaccinated with HIB conj vaccine. On 2/4/02 at 25 months of age, the patient was diagnosed with delayed receptive and expressive language skills, with an auditory comprehension age of 15 months, an expressive communication age of 16 months, and a total language equivalent of 16 months. On 1/3/02 at the age of 29 months, the patient was tested on the Peabody Developmental Motor Scales and was evaluated at a gross motor age of 18 to 25 months and a fine motor age of 20 months. On 8/22/02 at the age of 33 months, the patient was administered the Childhood Autism Rating Scale test and was diagnosed with Autism Spectrum Disorder. The patient's autism and delayed receptive and expressive language skills were considered important medical events (OMIC). Additional information is not expected.
Information has been received from a physician concerning a 8 year old male who in 1999 and again in 2002 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 13-JUN-2006 the patient presented to the doctor's office with swelling. The physician was doing tests to determine if it could be mumps. There was no product quality complaint involved. Additional information has been requested.
I caught Covid after having the booster. I had increased sinus problems, infection. My mucus was greenish. I had a lot of congestion in the upper lungs. The problem is I'm also going through radiation with prostate cancer which is hard to distinguish between the two. I am feeling increased fatigue due to the cancer and Covid. I would say it was a general reaction. I am still experiencing some nasal congestion and cough which is definitely from the Covid.
Pt describes receiving the shot and "feeling the liquid going down into her arm". She then almost immediately reported severe arm soreness and inability to raise her arm above her head. This persisted for at least a month and only improved by seeing a chiropractor. The chiropractor helped, but patient still experiences some discomfort.
weakness, cannot walk, swelling of extremities, could not swallow, gallbladder enlarged and removed, hospitalized for 14 days. Gullian barre syndrome.
Sudden shortness of breath, hoarseness, constricting of throat, wheezing, increased heart rate.  A few hours later, around 2:00 am on 9/24/14, I experienced a severe headache and severe muscle pain.  I was alone and could not drive to the hospital so I treated it my reaction as I would any allergic reaction, with OTC antihistamines and Albuterol to help with my shortness of breath.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. On an unknown dates, the patients received improperly stored doses of ROTATEQ (batch/lot #, dose, route and site of administration were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker (also reported as employee) regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On an unknown date, an unknown number of patients was vaccinated with GARDASIL (dose, route, product lot and expiry date was not reported) that had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Severe back - pain in shoulder area, awoke w/ it in the middle of night, diagnosed as muscle pain and given muscle relaxation pain prescription. No relief. On 7-18, broke out w/ shingles on the rt back shoulder and breast and under arm. The pain lingers.
Headaches (persistent after 96 hours); Severe shivering for 36 hours; muscle aches for 72 hours; initial intense fatigue replaced by insomnia after 48 hours; insomnia lessened after 72 hours but still persistent at 96 hours post-vaccine
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation.  The patient had no relevant medical history. Concomitant medication included: ATORVASTATIN, stop date: 07Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID 19 Treatment".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Nov2022) Positive, notes: Home test positive on Day 6; (13Nov2022) Negative, notes: Tested negative on Day 7 & 8; (14Nov2022) Negative, notes: Tested negative on Day 7 & 8; (16Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (17Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (18Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (19Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (20Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (21Nov2022) Positive, notes: Tested positive on Day 10 through Day 15; (22Nov2022) Negative, notes: Tested negative on subsequent days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: treated with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of GARDASIL 9 (lot #, dose and route not reported). Subsequently, on an unspecified date, the patient had a local reaction to the vaccine as she/he was not able to raise his/her arm for 10 to 14 days after injection. The patient followed up with the physician on unknown date and event had resolved. This is one of three reports from the same source. Additional information has been requested.
5 minutes after given vaccines, mom noted 2 3mm urticarial rash on his inner forehead with no respirating distress. pt given 6.2 mg = 2.5 ml BENADRYL po and rash improved.
AFTER FIRST VACCINATION-HIVES, SWELLING, DIARRHEA, OVER PRODUCTION OF IGE,QN AFTER SECOND VACCINATION-UNABLE TO EAT, EXCRUCIATING STOMACH PAIN, DIARRHEA, WEAK FEELING, SWELLING, HIVES
pt presented on 28NOV95 p/episode of facial twitching eyes rolling & limb twitching 11PM;vax recvd 27NOV95 noted to have temp & lethargic p/episode;Eval in ER, T in ER 102.8 (R)
A relative infected with COVID -19 after vaccination with Moderna; Breakthrough COVID-19 infection on 15Dec2021; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (A relative infected with COVID -19 after vaccination with Moderna) and COVID-19 (Breakthrough COVID-19 infection on 15Dec2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced DRUG INEFFECTIVE (A relative infected with COVID -19 after vaccination with Moderna) and COVID-19 (Breakthrough COVID-19 infection on 15Dec2021). At the time of the report, DRUG INEFFECTIVE (A relative infected with COVID -19 after vaccination with Moderna) outcome was unknown and COVID-19 (Breakthrough COVID-19 infection on 15Dec2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a 49-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective. The events occurred almost 2 months after administration of the second dose of the Moderna mRNA-1273 vaccine. No further details about the events were provided. Treatment information was also not provided. However, the event COVID-19 had resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 49-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective. The events occurred almost 2 months after administration of the second dose of the Moderna mRNA-1273 vaccine. No further details about the events were provided. Treatment information was also not provided. However, the event COVID-19 had resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Extreme left leg pain for > 24hours resulting in him not bearing weight for this entire time period. Minimal swelling at site of injection or erythema. Low grade fever for this time period and diarrhea-nonbloody, four times. Very irritable.
At the end of July, I was having intense chest pains and scheduled an appointment with my family doctor to get checked out due to a history of high heart rate. After tests and being examined, the doctor identified the chest pains as acute idiopathic pericarditis.
This spontaneous report was received from an employee and refers to her father, a 72-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or pertinent medical history provided. On an unknown date approximately in 2014 (reported as 2 to 3 years ago), the patient was vaccinated with a dose of zoster vaccine live (also reported as a "shingles vaccine") (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not reported). On approximately 27-AUG-2017 (reported as last week), the patient experienced fatigue and headache. On the night of 01-SEP-2017, the patient experienced rash around his stomach. The patient sought medical attention via a physician's office visit and on 02-SEP-2017, the patient was diagnosed with shingles. The patient was treated with valacyclovir (manufacturer unknown) (also reported as "generic VALTREX") 1 g, 3 times a day, for 10 days. The relatedness between the events and ZOSTAVAX was not reported. The outcome of the events was reported as not recovered/not resolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 12:45 as dose 1, single (Lot number: 00069-2362-10) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Subacute cutaneous Lupus" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 04 Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03 Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02 Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 01 Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 30Oct2023 to 04Nov2023).
4/22/18- extreme sleepiness resulting in only being awake for 4.5 hrs, soreness in both shoulder and left knee joints, slight headache behind eyes, prickly sensations on abdomen. 4/23/18- Woke up with hives on abdomen. During course of working 4 hrs. hives spread to arms, neck, back,  prickly, itchy scalp--huge severe red welts on abdomen, scratchy throat. Went to walk-in clinic.  Dr gave me Steroid shot, and called in a non-drowsy anti-histamine to pharmacy (don't know name of drug--picking up shortly).
04/292005 Increased fussiness, diarrhea started on 04/30/2005. afebrile. Used Clear Liquid diet & BRAT Diet for relief of diarrhea without relief.