chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 16JUL98 AM & seen @ clinic 23JUL98 645PM for c/o dizziness & vomiting x3 episodes;exam by MD concluded nl results;no tx given;
Patient may have inadvertently been given 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notifed. State notified.
tingles on the left eye; dizziness; tired for a couple of days; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired for a couple of days), HEADACHE (headache), CHILLS (chills), PARAESTHESIA (tingles on the left eye) and DIZZINESS (dizziness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (tired for a couple of days), HEADACHE (headache) and CHILLS (chills). On 11-Apr-2021, the patient experienced PARAESTHESIA (tingles on the left eye) and DIZZINESS (dizziness). At the time of the report, FATIGUE (tired for a couple of days), HEADACHE (headache), CHILLS (chills), PARAESTHESIA (tingles on the left eye) and DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took acetaminophen on 10-Apr-21 for treatment of headache.
needle of the syringe was not secured and some of the vaccine leaked; needle of the syringe was not secured and some of the vaccine leaked; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked), DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked), DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked), DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked) and DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked).    No concomitant medications were reported.  Reporter confirmed that vaccine was not related to Moderna Clinical Trial.  No treatment medications were reported.
Patient came in today and said that she is still experiencing a sore arm from her vaccine on 10/23/23. Pain started the same day as immunized. Patient had annual appointment with her doctor 11/3/23 and mentioned still having a sore arm.
Client presented for first ever flu shot.  VIS and possible side affects including possibility of allergic reaction reviewed. Client was self reported as very anxious prior to vaccination.  Vaccinated without incident and declined staying near nurse after vaccination for 15 minutes. Returned about 10-15 minutes later complaining of tightness in throat but could breathe okay.  Also had cold sweats and complaint of weakness/heaviness in both arms. BP 138/80; P 80 and R 20 and regular. No shortness of breath. Lungs clear bilaterally with no wheeze present.  Client denied itching, rash, hives or redness on skin. No tongue or lip swelling..  Skin was cool and damp to touch. Denied dizziness. Client talked with nurse about psychological fright versus anaphylaxis and she agreed that her symptoms were from being so anxious.  By the time she left the area, she did not have any complaint of tightness in throat.  Nurse recommended she seek medical attention if symptoms returned.
pain in my arms; pain in my body; itchy throat and nasal mucus; itchy throat and nasal mucus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in my arms"; PAIN (non-serious), outcome "unknown", described as "pain in my body"; THROAT IRRITATION (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "itchy throat and nasal mucus".  Additional Information: Caller asked: "I got the first dose of the Pfizer COVID vaccine in (State). The problem is since Tuesday I'm experiencing symptoms. should I be tested for COVID? My question is should I get a COVID test if I feel all these symptoms; first I started having pain in my arms, pain in my body. Now I'm feeling an itchy throat and nasal mucus."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
So I was having a very heavy feeling on the left side of my chest. It feel like stabbing in my chest. It happens really quick and once it's over, my chest hurt for a few days. I am a very healthy person. I have been healthy. This pain started after the vaccine. I keep records of when this happen. I went to the doctor and she told me to keep a record and she said to do a FU with her but I had been out. I had to miss the appointment due to my present job.  I did a sick call and they ran test and one of my test came back positive and it was a muscle enzymes. It was something like a heart attack, to me. When they repeat the test after a while, my enzymes wasn't as high.
About 30 hours after receiving the 2nd does of the Pfizer vaccine (6pm, June 24), my daughter started experiencing severe neck pain concentrated around the base of her head and eventually extending down her neck and shoulders. Her neck was very stiff and she had a constant severe ache. We treated it with moist heat (wet hot towels) and when that failed to work, gave her Advil even though we usually avoid it given her single kidney. The Advil provided temporary relief. The pain subsided on its own after about 3 days. My daughter also got her period off cycle two days after receiving the second Pfizer dose (June 25.) She is on a BCP for acne and was taking the active pills at that time so did not expect her period. It lasted nearly 2 1/2 weeks even though she was on the active BCPs the entire time. The flow was never as heavy as a typical period but it was more than spotting.
Vaccines given at 9:30 AM - Grandmother removed band aids at 2:00 PM and noticed qtr sized areas of redness. Mom picked up and noticed bruising at sites. Fever started between 6:30-7:00 PM. Treated with Tylenol. Ice to shot sites overnight. Vomited x1 this AM.
I want to know if there was a side effect that I have, I wait I don't want to just speak to you.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I want to know if there was a side effect that I have, I wait I don't want to just speak to you.) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no.) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I want to know if there was a side effect that I have, I wait I don't want to just speak to you.). At the time of the report, IMMUNISATION REACTION (I want to know if there was a side effect that I have, I wait I don't want to just speak to you.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   Reporter did not allow further contact
Patient received both Menveo and Bexero in clinic.  Within 2 to 4 hours after receiving both vaccines the patient developed fever and sore throat.  Mom took the patient to the ED and she reports the provider in the ED told her receiving both vaccines at the same time compromised his immune system causing an illness.
Fever up to 104; mom gave MOTRIN & bath for fever on 6/6 in the evening. Immediately after bath child began "whole body shaking and her eyes rolled back into her head" per ER report. This last 4 1/2 to 5 mins per mom in ER report. Irritable. Treated with TYLENOL; MOTRIN in ER for fevers. 6/8 mom called primary care office and still has fever of 103.
Administered FLUVIRIN five min later pt complained of tongue swelling and SOB. Administered Epi- Pen. Sx resolved called MD next day.
low grade fever/  fever went up to 101°; fatigue; headache; body ache; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included the day before she got the vaccine she ran down a little, thinking she had allergies which she was not sure, like an allergy nasally. Concomitant medications were not provided. The patient received first dose and asked if her side effect was normal, she still experiencing a little bit of a fever, questioning if it was normal, was it okay to take Tylenol. Second dose is scheduled for 27Apr2021, she did not know if she wanna get it though, been feeling symptoms, she would call doctor and see what he recommends. On 06Apr2021, a couple of hours after receiving the shot, patient stated that she started experiencing low grade fever and fatigue. At night on 06Apr2021, she was having a headache, body ache and until the morning on 08Apr2021, she still had a little fever and aches which it had been two days ago. She also mentioned that her temperature of her fever went up to 101°, and in the morning of 08Apr2021, she took two paracetamol (TYLENOL). Wondering if that could have a combination with the vaccine, if having side effects is normal. Patient was still experiencing side effects (fever and fatigue), asked if this was normal. Outcome of the event headache was unknown, while not recovered from other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 days after receiving the vaccine there was a firm, swollen nodule under the injection site. Small red lesion around it. Very itchy. Only painful when pressure is applied.
MILD NEGATIVE EFFECTS; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced mild negative effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild negative effects was not reported. This report was non-serious.
Her heart was racing for 3 hours in the middle of the night.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced her heart was racing for 3 hours in the middle of the night. Patient stated she received the first shot on Thursday, 01Apr2021. Then on 02Apr2021 and 03Apr2021 her heart was racing for 3 hours in the middle of the night. She had this again on Sunday and Wednesday. This was early in the morning at like 5:00 in the morning. She had 2 events Sunday going into Monday. She went to see her GP but he said she needed to see a cardiologist. She had to go to the ER that Wednesday night but it was gone by the time she got there. That was the last event. It has not happened since then. She stated she has to assume it was from the shot. She exercises every morning, has never had any heart problems and has low blood pressure so this is out of character and thinks it is linked to the vaccine. She has a history of a pretty robust immune system. She stated she had a heart monitor and nothing happened. She was supposed to take the second dose on 22Apr2021 but delayed it and would prefer to wait to get more testing done before she gets the second dose. She stated she could probably get it past the 42 days if she needed to. She stated she wanted to take it but does not want to have a heart attack. She stated she knows we are collecting safety data and we have to have some information. She stated she knows she was not the only one reporting cardiac symptoms. She stated there is an article of heart muscle inflammation after the Pfizer Covid vaccine. She asked for more information on these types of symptoms and reports of it. She asked how long would it take until an antibody test would show up positive so she can see if she is protected after one dose? CDC stated that antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. The adverse event resulted in emergency room visit. The outcome of the event was reported as recovered on unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SEVERE ILLNESS NOS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has an unspecified condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced severe illness nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe illness nos was not reported. This report was non-serious.
Received immunizations 6/29/2009 AM. On morning of 6/30/2009 noted red hard spot on Right thigh 7/1/09 Exam 11 x 20 mm area of erythema induration lateral to injection site. Presumed cellulitis, treated with KEFLEX.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: redness on arm by injection site and on front chest, mild-Mild, Systemic: Shakiness-Mild, Additional Details: patient appeared anxious and was scratching arm, redness, mild
Patient is a 54 y.o. female patient of CNP with history of asthma and anxiety presented to a local Hospital with shortness of breath.   Acute hypoxemic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: 3/20 Symptoms present on admission: soa Date of covid positive test: 3/27 Vaccination status: vaccinated Imaging: CXR no active disease, pulmonary hyperexpansion Oxygen requirements on admission: no oxygen at home  Current oxygen requirements: 2L upon DC on RA Medical therapy: remdesivir and steroids Consultants following: consulted ID  Anticipated special isolation end date: 4/6   Doing very well on room air  chest sounds clear Continuee above treatment and follow with ID  Discussed with ID , ok to discharge after 3rd dose of remdesivir    Asthma in acute exacerbation resolved  In the setting of COVID 19 infection Solumedol Albuterol QID Duo-nebs prn Muinex   Anxiety PRN hydroxyzine zoloft
Vomiting, fatigue, headache, dizziness, chills, low grade temp, loss of taste, difficulty breathing, rapid heart beat. The vomiting stopped yesterday. Rapid heartbeat and dizziness started within 10 mins of having the vaccine.
Pain and numbness in the neck and back the day after the vaccination on the third day spread to the shoulders
administered 4 times after the excursion with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old female patient who was administered Ipol (poliomyelitis vaccine (inactivated)) 4 times after the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); rotavirus vaccine live reassort oral 5v (Rotateq) and HIB vaccine conj (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 07-Oct-2022, the patient received a  dose of suspect poliomyelitis vaccine (inactivated), Suspension for injection lot V1B901M via intramuscular route in unknown administration site for immunization (expiry date-02 Jun-2024).  On 07-Oct-2022 the patient was administered 4 times after the excursion with no reported adverse event (poor quality product administered) (latency same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event administered 4 times after the excursion with no reported adverse event.  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 the guidelines. 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.
FLUZONE QIV NP PFS, reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves child patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.  It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  Action taken: not applicable.  Outcome:  Unknown for both the reported events   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 the guidelines. 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
As I was driving home from injection, the left side of my face began to tingle. Behind my left eye feels tight, and the left side of my tongue, throat, and next feel funny. This is day 8. Symptoms are still there.
24 hours later: severe chills, aches, no fever. Severe pain throughout body but most severe in kidney area and at injection site. Numbness in left arm.  After the chills went away after about 6 hrs., started burning up but again, no fever, still in pain. Insomnia.  Treated with 2 Advil liquidgels and 1 benadryl.
rapid heartbeat-6hrs;12midnight 12/12/99 to 6AM 12/13/99;
Pt developed redness, swelling, heat, stiffness and pain X 5 days in left arm.
With 1st does, I had a very painful period 2  months later (normally not having regular periods) in which tissue and clots were expelled. I also had severe abdominal pain for months after. Two days after 2nd shot, had rash on upper torso, face, scalp, and upper arms with eye itching.
Information has been received from a physician who refers to a 19 year old female patient. The patient's medical history and/or concurrent conditions were unknown. On 01-JUL-2016, the patient was vaccinated with the first dose of GARDASIL. Other suspect therapies included GARDASIL 9. The physician reported that he did not know if the patient was given GARDASIL or GARDASIL 9. Concomitant medications were unknown. The physician reported, an anonymous patient experienced headaches, felt light headed and felt like she was going to faint on 15-JUL-2016. The patient called her doctor but it was unknown if treatment was given for the adverse events. It was unknown if lab diagnostic studies were performed. The physician did not know the patient's present status. The outcome of the events were unknown. No further information was provided. Additional information has been requested.