chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered only the liquid CWY component; administered only the liquid CWY component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA604A, expiry date 30th September 2022) for prophylaxis.   On 2nd March 2022, the patient received Menveo. On 2nd March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse stated that only the liquid CWY component of the Menveo vaccine was administered to the patient in the left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown).  Subsequently, the patient developed a rash after the first dose.  On an unspecified date the patient was vaccinated with a second dose of Gardasil injection and developed a rash.  Medical attention was sought.  The location of the rash and the dates were unspecified.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested.
A 47 year old female received an injection of Flu Shield '00-'01 on 10/30/00. On 10/31/00, she reportedly developed swelling at the injection site.
Patient tested positive for covid next day of receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for covid next day of receiving 1st dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B2A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Apr-2021, the patient experienced COVID-19 (Patient tested positive for covid next day of receiving 1st dose). At the time of the report, COVID-19 (Patient tested positive for covid next day of receiving 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was taken by patient.
Client fainted, lips became pale. Per mom also became swollen. Client slow to respond. Epinephrine 0.15mg given IM. EMT responded and client taken to ER. Later it was determined at the hospital that the child only had a syncope episode and not an anaphylactic reaction. The child has received subsequent vaccines (Hep B, DTaP) without any reported adverse effects.
incredible headache; This is a spontaneous report from a contactable consumer (reported for himself). A 43-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 21Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headaches. It was reported that the patient experienced headaches a day after receiving the vaccine. The event was described as incredible, really painful and almost blinding pain. The patient was treated with Tylenol and Ibuprofen. The outcome of the event was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Diagnosed at urgent care 10-23-08 with Henoch-Schoenlein Purpura.  Seen by Dr. 10/24/08
Patient received Moderna COVID 19 vaccine for 1st dose in series on 07/19/2021.  He was mistakenly given a Pfizer shot for the second dose on 08/14/2021.  He did not report any adverse events or adverse reactions as of 08/16/2021.
Reddened nodule at injection site.  Has grown to size of a large orange.  Developing rash that is spreading over body.
fever (3 days), chills (3 days), dizziness (3 hours), nausea (2 hours)
Breakthrough case of COVID-19: I tested positive on 11/19/2022, I was tired and unmotivated, I could not do my normal workout, I had a change in my appetite, I had some congestion and stuffiness which you could hear in my voice, I had aches in my hips, I was waking up all night, my throat was sore and some post nasal drip and I could feel I was getting a fever, along with an ear ache, my initial fever was 100, and by mid-day it was 101. It never went up before that. I started coughing a bit much. After the third day of the PAXLOVID, I started to get gas really bad, and I had heartburn and acid reflux, and I did a bit of workout during the night and it went away. I also had Plantar Fasciitis in my left heel, when I would try to walk it was very painful and a tremendous amounts of pressure. I spent most of my COVID-19 symptoms resting and not doing too much moving around. I did talk to my Dr. during my symptoms and he prescribed the PAXLOVID, and I finished that within five days, after the rebound COVID I had inner ear pain and the Dr. prescribed an antibiotic, and I would have a low grade fever for those last 8 days, and of about 99 or so. Now I am at the third day other than the congestion, I am feeling much better with no fever for the last few days. The gas pain issue was very bad for me which was about 4 days as I was taking the PAXLOVID. The exercise helped throughout the night. I also could not concentrate throughout that time, I could not really read or write to much because I could not focus that well. I just rested and ate well. My sleep has been altered with me going to the rest room constantly throughout the night.
Muscle pain that does not go away; This spontaneous case was reported by an other and describes the occurrence of MYALGIA (Muscle pain that does not go away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Muscle pain that does not go away). At the time of the report, MYALGIA (Muscle pain that does not go away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever chills and injection site pain Narrative:  symptoms lasted 24 hours  Other Relevant History:
Patient under the age of 18 was inadvertently administered  1st dose of Modena at  pharmacy; per patient and CDC card.  2nd dose of Moderna was given toda as off-label use.
feeling funny; if a person got vaccinated with the first dose of PFIZER BIONTECH COVID19 Vaccine and got COVID symptoms and tested positive for COVID after 3 days; This is a spontaneous report from a contactable consumer (the patient's mother). A male patient of an unspecified age received the first dose of BNT162B2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via an unspecified route of administration on 18Mar2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history concomitant medications were not reported. The patient started feeling funny on 22Mar2021. The patient was tested positive for COVID virus on 27Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 27March2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
1 week after had menstrual cycle out of cycle; 7 days of heavy menstrual cycle; severe mood swings from crying to anger, very uncharacteristic; Lathergic and need to take several naps throughout day to function.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 right arm on 07May2021 at 13:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included gliclazide (CLARITIN), rubus idaeus leaf, sambucus nigra flower, sambucus nigra fruit (ELDERBERRY), mometasone furoate (ASMANEX), ketoprofen (TOP), cyanocobalamin, pyridoxine hydrochloride, thiamine hydrochloride (SUPER B) and fish oil (OMEGA 3); all for unspecified indication from unknown date. Prior to the vaccination, the patient was not 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 vaccination. The patient had no known allergies to medications, food or other products. On 13May2021, the patient experienced 1 week after had menstrual cycle out of cycle, heavy cycle when normally it was light. Normal cycle lasted only 3-4 days, but (cycle started on 13May2021) was approaching 7 days of constant bleeding. The patient also experienced out of normal severe mood swings from crying to anger, very uncharacteristic and also felt lethargic and needed to take several naps throughout day to function. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event 1 week after had menstrual cycle out of cycle, heavy cycle when normally it was light, normal cycle lasted only 3-4 days, but (cycle started on 13May2021) was approaching 7 days of constant bleeding, out of normal severe mood swings from crying to anger, very uncharacteristic and lethargic and needed to take several naps throughout day to function was not recovered at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information was received.
Rash on front back sides of torso started 3/5 or 3/6. Did not notice until they became painful. Red blotches that increase in number. Take  Allegra to relieve them. No effect. Each day more rashes appear. Discussed with Dr. who recommended I generate a report.  Early am of the 3/5 I had a very fast heart beat that woke me up. It was fast but not pounding. From the moment I work up it lasted around 10 seconds then stopped. Did not repeat. Dr  did not think it was related to the vaccine. A fast heartbeat like this has never happened before.
The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 02-Feb-2021 this case now contains all required information to be considered valid.   This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, in 2012, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2012, the patient was hospitalized with high temperature and swollen arm. She stayed in the hospital for 3 days. Clinical outcome of the events was unknown at time of this report.   Information about lot/batch number has been requested.
LMP, 04/12/2021 Miscarriage / bleeding / cramping, 06/2021
Constant diarrhea, fever, rash. Shortly thereafter, he became lethargic, loss of speech, flapping arms, total regression within 2 months after vaccination with continued diarrhea and eczema. 11/3/2008 PCP records received. Normal growth and development noted at 9,12, 15 &18 month exams. Seen 10/23/06 for rash. At 2 yrs noted to be immature. Sent for audiology consult 1/17/08 but unable to complete, pt unco-operative. By 3 yr check, dx of autism-non-verbal.
Small red area next to the right arm injection site with a golf size lump in the upper pole of the right breast leading into the right armpit area which started on 01/05/2021.
This is a non serious case from a consumer in the USA involving nasal congestion (labeled,USA). The reporter causality is not provided. An adult female received FluMist on 01/22/2005 and began to experience runny nose on 01/23/2005. On 01/24/2005, she experienced nasal congestion, sneezing and felt tired and irritable. It is unknown if the patient recovered from the reported symptoms. Information from missing data report states: several attempt to contact the reporter has failed and no further information is available.
A nurse reported that a female pt received an injection of Typhoid Vaccine, USP, Heat Phenol Inactivated, on 6/21/99 and immediately, felt lightheaded. The pt also developed an injection site reaction characterized by swelling and "3 by 5" area of redness as well as fatigue. As of 6/24/99, the light-headedness and fatigue had resolved, but the injection site symptoms persisted.
Menstrual cycle has been shortened from a very regular 30 -31 day cycle to as short as 20 days. I have been managing PCOS with inositol and magnesium, and lifestyle measures, and have had regular menses and ovulation for years. Since the vaccine, my cycle is days shorter and I am not sure if I am ovulating - which is highly unusual for me. After consulting with my HCP,  there does not seem to be a treatment, so we are continuing to monitor.
Patient presented to mobile vaccination clinic on 7/10/21 for a  dose of Pfizer vaccine.  However, patient did not divulge to clinic employees (including the vaccinator) that he had already previously completed a Pfizer COVID-19 vaccine series.    In fact, the patient lied on his completed paperwork (The 'Prevaccination Checklist for COVID-19 Vaccines') and checked 'No' on item #2 of the checklist; stating he had not previously received any COVID-19 vaccine.  Vaccinator, after reviewing paperwork and health history with the patient as per procedure, proceeded to administer an appropriate dose of Pfizer COVID-19 vaccine.  Immediately following vaccine administration, the patient told the vaccinator that 'this is my 3rd shot' and that he was doing his 'own experiment'.  Patient was released from clinic after his 15 minute observation period, per protocol.  Vaccinator reported the event to a supervisor (myself) who later looked up patient in registry,  and found record of two prior Pfizer vaccine doses:  Pfizer #1 was administered on 12/17/20, Pfizer #2 was administered on 1/9/21. Both doses in the series were administered at a facility (hospital) outside of our facility but in same city.
Child developed redness surrounding injection sites 3" L thigh, 1" R thigh, vomiting and diarrhea began 24 hours after immunizations.
Information has been received from a registered nurse concerning an 18 year old female who on 21-MAR-2007 at 3:30 pm was vaccinated with 0.5 ml of the first dose of Gardasil (Lot #653736/0014U) in right deltoid. Concomitant therapy on 21-MAR-2007 at 3:30 pm included MENACTRA (lot # U2228AA) in right deltoid, and BOOSTRIX (lot # C2638AA) in left deltoid. On 21-MAR-2007, at 3:30 pm (previously reported as 10 to 15 minutes after vaccination) the patient experienced fainting. On 21-MAR-2007, the patient recovered from fainting. Additional information is not expected. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a registered nurse concerning an 18 year old female who on 21-MAR-2007 at 3:30 pm was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot #653736/0014U) in right deltoid. Concomitant therapy on 21-MAR-2007 at 3:31 pm included MENACTRA (lot # U2228AA) in right deltoid, and at 3:32 pm included BOOSTRIX (lot # C2638AA) in left deltoid. After the injections were administered, the patient voiced no difficulties, denied discomfort, and no abnormalities in appearance were observed. The patient walked 10 yards to the front reception desk. She visited as paperwork was being completed while she stood at the counter. On 21-MAR-2007, at 3:37 pm (previously reported as 10 to 15 minutes after vaccination) the patient slid onto the floor with syncope. On 21-MAR-2007, the patient recovered from fainting. After syncope went to doctor's office for previously scheduled appointment with no problems upon exam. A telephone call was made later to the patient later that evening with no residual effects. The patient's mother has telephoned to schedule the patient's second GARDASIL injection. Additional information is not expected.
A painful and very tender knot at the vaccination site, woke me up when I rolled onto it on my arm.  Also became very itchy.  Site was red and hot to touch thru 1/24/2012 where today it is finally not so hot and tneder, but knot is still there, still itchy and still painful to touch.
Approximately 3:00am I woke up with severe chills & severe headache.  After not being able to fall back to sleep due to headache I decided to take medication for headache.  Walked to kitchen for water and before I could take medication I passed out and fell to the floor hitting head on cupboard door.  After realizing I passed out and fell I got up to take meds and passed out again.  I woke up on the floor some time later and was able to get to the couch.
About 1-4 minutes following vaccine administration patient stated he was becoming lightheaded. He became increasingly sweaty and pale over the next few minutes. His eyes closed and he appeared to be having seizure activity. EMT's arrived within 10 minutes when the patient exhibited similar seizure activity. He was started on IV fluids as EMT's stated he seemed dehydrated. He was then transported to the ER for further eval and treatment.
This spontaneous report was received from a pharmacist and refers to a 70-year-old male patient. The patient was allergic to penicillin and had no other pertinent medical history. On 22-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscularly, lot# M037669, expiry date 09-MAY-2018 (dose was not reported) and with a dose of influenza virus vaccine (unspecified) (formulation, dose and route of administration were not reported). There were no concomitant therapies. It was reported that the patient came into pharmacy on 23-NOV-2016, complaining of an injection site reaction. The pharmacist stated the patient had swelling, redness and induration below the site of injection (onset date unspecified, approximately in November 2016). There were no diagnostic studies performed. The outcome of the events was reported as recovering/resolving. The relatedness between the events and the suspect vaccines was not reported. Additional information has been requested.
I developed flu like symptom approximated 10 hours after receiving the vaccine. Chills, fever, achy. Symptoms much better after 15 hours and gone by 30 hours.
PATIENT CAME IN TO GET FIRST DOSE MODERNA VACCINE AT APPROXIMATELY 1430, IMMEDIATELY AFTER DOSE GIVEN PATIENT SAID SHE HAD A "METALLIC TASTE" IN HER MOUTH BUT FELT FINE. AFTER SITTING FOR HER OBSERVASTION TIME, PATIENT STOOD UP AND BECAME SLIGHTLY DIZZY. BLOOD PRESSURE TAKEN WHICH WAS NORMAL FOR THE PATIENT, IN ADDITION PATIENT SAID SHE FELT FINE THROUGHOUT. PATIENT WAS GIVEN A CUP OF WATER AND WAS ABLE TO STAND AND WALK OUT OF CLINIC WITH NO ISSUE.
Per Safety Officer to this RN: was in post observation after her 1st dose Pfizer. Pt states hx of anxiety attacks and this feels the same. Pt states hx of allergies to oxycodone, cefapime and benedryl. Pt c/o chest pain 3/10, dizznes, and SOB. EMS with patient to assess and released home with boyfriend. Pt boyfriend to drive Pt home and will stop for food along the way.  VS 1257 BP 118/70 HR 73 RR 18 Temp 98.3F temp O2 sat 99% on RA
tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program  A contactable consumer reported for a 17-year-old female patient (daughter). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730), via an unspecified route of administration on left upper arm on 26-MAR-2021 15:00 (Age at Vaccination: 17 years) at single dose for protection, the patient is in volleyball and working. There was no Prior Vaccinations and Adverse events following prior vaccinations. The patient medical history was not reported. Patient's Medical History (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to adverse events was reported as none. The patient Concomitant medications included VITAMIN C ASC ACID and VITAMIN D [COLECALCIFEROL], both taken for immunity and to support immune system since Covid started, for a year now. On 05Apr2021, the patient tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none.The reporter called on behalf of her daughter to ask if she needs to test negative before getting the second dose of the Pfizer Covid-19 vaccine on 16Apr2021. CEP agent states the patient had covid-19 on 3Apr2021. Is there a Product Complaint: Yes. The relevant lab test included test: COVID-19 Test, result: positive on 05Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
little hard ball at the injection site; a bit painful to touch; discomfort at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at the injection site), VACCINATION SITE INDURATION (little hard ball at the injection site) and VACCINATION SITE PAIN (a bit painful to touch) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at the injection site). On 08-Apr-2021, the patient experienced VACCINATION SITE INDURATION (little hard ball at the injection site) and VACCINATION SITE PAIN (a bit painful to touch). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at the injection site), VACCINATION SITE INDURATION (little hard ball at the injection site) and VACCINATION SITE PAIN (a bit painful to touch) 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.   No relevant concomitant medications were reported.   Treatment information was not provided.
For 24 hours after my shot I had a severe headache, body aches, and exhaustion. For the first 12 hours after the shot my entire body itched.  The injection site hurt immediately and still hurts four days later. My entire arm is achy and hurts to move.  I?ve never had my arm hurt like this after a shot and I haven?t been pampering my arm. I?ve been purposely working it in hopes that would lessen the soreness.