chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Before vaccination, father identified patient with name and DOB. NKDA. father agreed to covid vaccine #1 and  received pfizer pamphlet. pt received imm w/out incidence. father asked to wait 15 mins due to first time dosing of pfizer.   As I was inputting patient's covid vaccine lot # into pt's EHR, i noticed that I gave Pfizer toddler dose (3mcg) instead of children's Pfizer dose (10mcg).   I informed Dr. and another person of incident around 1000 on 8/9/22. She looked up CDC policy for interventions for medication error (underdosing of covid vaccine) and stated that we could give the correct dose (child's pfizer vaccine 10mcg) as soon as possible with no minimum interval required.   At the 15 min check: looked for father and patient in waiting room to check for adverse reaction(s) and to notify about medication error, but they were nowhere in sight.   I called father at @ 1024 and father stated that they were already almost out of town and could not make it back today (8/9/22) to received correct dosage. Father was aware that patient was given lower covid dosage. Father agreed to  schedule appt on 8/12/22 @ 1430 for reimmunization of correct Pfizer vaccine #1.
10 minutes post vax the pt had an allergic reaction consisting of shortness of breath and chest tightness. She was sent to the ER for further evaluation per EMS. the latest information received reports the condition of the pt is unknown.
Vaccine on 10/12 at 1:32 (L) arm. She woke up and noticed red, hot, itchy rash on face/cheek/(R) ear. No SOB, CP or resp. distress. No fevers, emesis. No angioedema. She use CLARITIN-D every night for seasonal allergies. I treated her with MEDROL pack. She will FU on 10-16-17.
Left tricep inflammation to elbow. Not raised but hot to the touch. Infant/child not in any acute distress. Watch for expectancy.
Information has been received from a nurse practitioner concerning a male senior in high school who on unspecified date in July 2010, was vaccinated with the first dose of GARDASIL (lot # not reported). Approximately two months after the vaccination (in approximately September 2010), the patient experienced a rash over his entire body. The nurse practitioner reported that the patient was treated for the rash by a dermatologist, who might have prescribed an unspecified steroid cream. At the time of reporting, the patient's rash over his entire body persisted. Follow-up information has been received from the nurse practitioner concerning the 16 year old male senior in high school with a family history of psoriasis and no illness at time of vaccination or pre-existing allergies, who on 15-JUN-2010 p.m., was vaccinated with the first dose of GARDASIL into his left arm. Approximately on 15-AUG-2010, 2 months after receiving GARDASIL, the patient got a severe red rash from head to toe. The patient went to urgent care to see 5 different doctors, it was reported that the patient "now see dermatology". The patient was diagnosed with psoriasis. The patient's mother felt the vaccine weakened the patient's immune system. No labs/diagnostics studies were performed. At the time of reporting, the patient's rash over his entire body persisted. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (all the flu symptoms), DIARRHOEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced INFLUENZA (all the flu symptoms), DIARRHEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, INFLUENZA (all the flu symptoms), DIARRHEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication as reported , No treatment medication was reported. Reporter did not allow further contact.
Extreme Fatigue, Muscle Weakness, Aches, Fever, Chills, Nausea, Leg (calf) pain, headaches.
Information has been received from a physician concerning a 75 year old male with hypertension, hypothyroidism, high cholesterol, no known allergies and a history of atrial fibrillation, who on 30-NOV-2005 was vaccinated intramuscularly into the right arm with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#651329/1047P).  The patient's list of concomitant medications was not available.  On 02-DEC-2005 the patient experienced rash at the injection site and on the legs and trunk.  The doctor prescribed him with methylprednisone (MEDROL) Dosepak, cetirizine hydrochloride 9ZYRTEC) 10 mg daily,a nd famotidine (MSD) 20 MG twice a day.  It was noted that the patient has not been back to the office for follow up yet.  No diagnostic laboratory studies were performed.  It was noted that the patient was improving but the outcome was unknown.  It was also noted that the patient received his first dose of pneumococcal 23v polysaccharide vaccine in 1998.  No product quality complaint was involved.  Additional information has been requested.
General Flu like symptoms.  Chills, Tremor, Malaise lasting 24 hours.  Patient recovered without outside assistance.  No current complaints.
Patient came in for J&J vaccine 05/14/2021.  She selected "no" on her questionnaire to the question "have you received the first dose of a COVID-19 vaccine and want to schedule a second dose".  We administered the vaccine and when inputting her information in we noticed she had received a J&J vaccine #3205 on 3/11/2021
patient had  headache and pain at injection site , went to PCP and ER checked up  they did ultra sound and cat scan on her head .  The result is no head trauma.  Instead patient report has Urinary tract infection
Starting from my cycle in May, my cycle length increased from 28 - 30 days to 40 - 70 days.  Between April - May: 41 Days.  May - July : 67 Days. July - Present: Still haven't started my cycle.    When I did get my period, my flow was heavier.  I do have an IUD, Paraguard, but have had the IUD in place since 2016, and have had fairly stable period cycle lengths leading up to May of 2021.
9 days after receiving the vaccine, woke up in the middle of the night with a right arm redness, swelling and itchy.  Running low grade fever 100- body aches
Received Moderna 12/31/ 2020 Received Moderna. 1/28/2021 Received Pfizer.   9/24/2021  -- Day 1: exhaustion , Day 2: redness from shoulder to elbow & burning pain, Day 3: large swollen gland in right armpit and on neck under ear lasted 7 days approx.
This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, stiffness, headache and lupus like symptoms. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of Injuries.
itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Alavert). Concomitant products included LORATADINE (ALAVERT) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) outcome was unknown.
13cm area of induration at site of Pneumovax. Reaction developed. Several hours after the injection/ treated with Clarinex
See first aid (incident report from school-also copy on ER vs(9/17/04) vs with pediatrician 9/20/04 allergy testing was recommended but has not been scheduled. Pt was having a hard time breathing, she looked flushed in her face. I called the office and sent her to the nurse.
Metallic smell; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30(at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and QYSMIA ENGAGE started from an unknown date and for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 07:30, the patient experienced burning metallic smell, very strong metallic smell, as if it was burning metal. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event metallic smell was not resolved at the time of this report.  No follow up attempts are needed; Information about lot/batch number cannot be obtained.
8 hours after shot: Tremors,vertigo,hot flushing, pallor, nausea,headache,lower back pain,fatigue & dehydration.  Pulse and respiration was high, blood pressure high.  Most symptoms resolved within 24 hours except for fatigue and headache.
Pt is complaining for pain at the injection site, sore arm, discolored around injection site, small pin prick dot where needle was injected. Sore to lift arm. Arm is not swollen, not hot to touch.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. On an unspecified date the multiple unspecified patients were administered a dose of PNEUMOVAX23 (lot# unspecified) (dose, route, frequency and location unspecified) that went through an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right arm where varicella vaccine was given became swollen, red, warm about 12 hours after vaccination. Swelling significanty increased in size within 6 hours. Mom recalls similar reaction when child received 1st dose of varicella vaccine at 1yr of age. Area affected was thigh. Treatment required at this time included drainage of affected area and hospitalization.
Fever 07/05-07/06/2003: 100-102.  Rash developed 07/07/2003.
extremely hungry, wherein she was eating every 2 hours; Nauseous; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (extremely hungry, wherein she was eating every 2 hours), NAUSEA (Nauseous) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HUNGER (extremely hungry, wherein she was eating every 2 hours), NAUSEA (Nauseous) and HEADACHE (Headache). At the time of the report, HUNGER (extremely hungry, wherein she was eating every 2 hours), NAUSEA (Nauseous) and HEADACHE (Headache) 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.   Concomitant and treatment medications were not provided.
For the past two months I have been having severe pain, numbness and tingling sensation in left arm that starts at injection site and progresses to fingertips. Cannot move my arm backwards due to severe pain in that position.
pt recvd 1st dose of Engerix-B on 19AUG92 & on 23AUG92 exp inc liver function tests & severe rt upper quad pain which conts; no nausea or vomiting; has seen MD;
UNDERAGED CHILD.  CHILD DOB WRITTEN ON CONSENT BUT DOB IN DATABASE IS DIFFERENT. UNKNOWN IF CHILD RECEIVED SECOND PFIZER DOSE.
Tinnitus, bilateral.  No treatments.  Was present as of 5/3/2021
child ingested at least one full dose of Fluzone High Dose vaccine, No AE; child ingested at least one full dose of Fluzone High Dose vaccine, No AE; Initial information received on 29-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a seven-year-old male patient who ingested at least one dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and expiration date was not reported) via oral route for prophylactic vaccination on 28-Jul-2020.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It is an actual medication error case due to unintentional injestion of product by child. It was reported that the patient ingested at least one dose of Fluzone High Dose and it is possible the patient ingested up to 16 doses of Fluzone High Dose (date of vaccination not reported).  It was also a case of overdose.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  There will be no information available on the batch number for this case.
Vaccine was mislabeled with a frozen storage expiration date of 11/01/2021 and it should have read 10/03/2021. The vaccine was used on 10/29/2021 to vaccinate this employee
Slight swelling around mouth. ( Previously had  juvederm injections June 2020. ) No  medicine taken for swelling and it subsided within a couple of hours.  No issues after that.
64 year with Covid-19 viral infection, has mild symptoms fully vaccinated. He is  maintaining normal saturation on room air and lungs auscultation normal, no x-ray  taken.
Started getting bad headaches that has intensified and have worsened after the second dose. I had to be put on medication.
LOSS OF APPETITE; PERIOD DELAYED A WEEK; WORSE CRAMPS THAN USUAL; CHILLS; NAUSEA; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old female. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, period delayed a week, worse cramps than usual, chills, nausea, fever, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, period delayed a week, worse cramps than usual, chills, nausea, fever, fatigue, and headaches. This report was non-serious.
PATIENT DEVELOPED GENERALZIED RASH, WAS ADMINISTERED STEROID INJECTION BY ORDERING PROVIDER.
Patient experienced vasovagal episode approximately 5 minutes post influenza vaccine. Episode lasted about 5 seconds vitals were monitored, patient rested and was observed 30 min. Discharged when stable per provider. F/up call in AM to pt - pt. reported to be fine.
After the first dose of the vaccine (provided on 4/28/2021) I had a bit of moderate inflammation in my right hip joint (front of the hip, groin) that caused light-moderate pain throughout the day, mostly afternoons and evenings but I assumed it would go away.  After the second dose (listed), I had horrific headaches that lasted 1-3 days for about 3 weeks following the vaccination.  I also lost my menstrual cycle completely.   My hip pain has never ceased and has become chronic and at times (however brief) severe.  I have had trouble when getting up from a seated position after long periods of time and have trouble getting up quickly from a crouching position.  Though I exercise almost every day (whether it's light walking, hiking, or training) and have never had something like this occur for this long, with no injury.    The pain is in my joint -- it's inflammation and is moderate and has not been removed or relieved since getting the vaccine.  My period has returned and my headaches are no longer an issue
No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a registered nurse and refers to a 12-month-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 27-JUN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U030162, expiration date: 28-SEP-2023, administered subcutaneously in the right arm for prophylaxis (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA009203: US-009507513-2209USA003332: US-009507513-2209USA003333:
Patient says tongue was burning .  I offered benadryl . She took 10mls ( 25mg) . I made pt wait additional 15 minutes. After 30 mins total , pt said she felt fine. She said she had benadryl in purse if needed . Husband drove pt home. Pt called after she got home and said that she was fine
Pt got a localized reaction from Hep A shot. A red raised rash approx 8cm occurred around the shot area the day following the injection.
Swelling injection site, chest pain,  difficulty breathing,  stomach pain,  extreme fatigue,  excessive thirst,  fever,  chills,  dizziness,  back pain, shoulder blade pain,  elevated troponin, elevated blood sugar,  hospitalization, CAD, pneumonia, antibiotics,  fluids / hospital stay 5/24 - 5/26/21
COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test Positive, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000263135.
Macular rash 4 x 4 cm surrounding injection site. Myalgias B/L posterior neck pain, ache 7/10, non radiating. HA developed 12 hrs post injection, resolved within 72 hrs of injection.
Reported no harm to patient. Advised me to fill out this form. Mom was made aware. No adverse signs/symptoms at this time. Education done in office to person who administered the wrong vaccine.
Pins and needles in face started 12/29 ER visit, physical exam. Intermittent  pins and needles continue
inappropriate age at vaccine administration; the patient developed a bad rash on her scalp, forearms, and upper thighs; This spontaneous report was received from a pharmacist referring to an adult female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 27-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # S005251, expiration date 20-FEB-2021 subcutaneously for immunisation (strength and dose were not reported) and with influenza virus split virion 3v vaccine inactivated (FLUARIX) lot # 7J7T3, expiration date 30-JUN-2021, subcutaneously for immunisation  (strength and dose were not reported).   The reporter stated that "the patient developed a bad rash on her scalp, forearms, and upper thighs." She developed this reaction 1-2 days after receiving the injections. Patient denied difficulty breathing. The patient took diphenhydramine (BENADRYL) for the itching/hives. The outcome of rash was reported as resolving.  The reporter was asking if the patient should receive the second dose of the vaccine.   The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha)  (M-M-R II) and influenza virus split virion 3v vaccine inactivated (FLUARIX) and rash was unknown.
I was having palpitations; the feeling was in upper part of stomach; I had difficulty breathing; The initial case was missing the following minimum criteria: No Adverse effect. Upon receipt of follow-up information on 12Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Consumer (patient)  A 84-years-old female patient (weight reported as '140' only) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (at the age of 84) as single dose for covid-19 immunisation; denosumab (PROLIA), via an unspecified route of administration from 2019 and ongoing, cyclic, twice a year for osteoporosis. Medical history included osteoporosis. The patient's concomitant medications were not reported. The patient experienced palpitations, the feeling was in upper part of stomach (not in heart), difficulty breathing, all on 07Feb2021 at 20:00. No treatment received or hospital admission required. By bedtime she was able to fall asleep and awoke in the morning on 08Feb2021 and was fine. The events outcome was recovered on 08Feb2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
I just had prism vision somewhere after my first shot. I cannot tell you when but I did see my eye doctor who adjusted my prescription.