chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of facial palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed facial palsy. Serious criteria included GSK medically significant. The outcome of facial palsy was unknown. It was unknown if the investigator considered the facial palsy to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic facial nerve palsy in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 1-21 days after vaccination, the patient developed idiopathic facial nerve palsy. The case met the definition of Brighton level 2. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event idiopathic facial nerve palsy and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
At dinner approx. 5 hours after administration of SHINGRIX, pt became lightheaded and experienced severe chills. The next and pt reported flu like symptoms with chills and no fever.
Sudden onset of enlarged, swollen, lymph nodes in underarm and clavical area.
Patient, 5/8 for anemia/iron deficiency readmit 5/9 for stroke symptoms and transferred to Hospital after receiving tPA.  The patient received a J&J COVID vaccine 5/5.  Patient found to have a right MCA stroke and went to IR for thrombectomy with partial recanalization.   Patient with hemorrhagic conversion 5/11 leading to right hemicranectomy for mass effect.  Patient with risk factors for stroke of HTN and obesity.    Cannot confirm or rule out relationship to COVID J&J vaccine. This was not a case of the stroke type that has been associated rarely with the J&J vaccine (cerebral venous sinus thrombosis) but shall report to the FDA VAERS program.
Pt presented 24 hours post vaccination. Pt c/o nodule at vaccine site with erythema 3 cm in diameter. Site was warm to the touch. Pt also c/o shouler arthralgia times 24 hours. Sx resolved completely over 48 hours. Pt denies N/V/D, fever, chills, malaise. Pt is 9 weeks pregnant. No previous hx of adverse reaction to immunizations.
trouble walking several meters without being out of breath; extreme pain on the other leg; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble walking several meters without being out of breath) and PAIN IN EXTREMITY (extreme pain on the other leg) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble walking several meters without being out of breath) and PAIN IN EXTREMITY (extreme pain on the other leg). At the time of the report, DYSPNOEA (trouble walking several meters without being out of breath) had not resolved and PAIN IN EXTREMITY (extreme pain on the other leg) had resolved.            No concomitant medications were reported.   Patient stated that after the first dose he experienced extreme lateralized pain on one side of his body, particularly his leg. Upon second dose patient experienced extreme pain on the other leg and the pain lasted for 2 days. Now, the patient has trouble walking several meters without being out of breath. Treatment information was not provided.   This case was linked to MOD-2022-526516 (Patient Link).
Patient is 15 years of age and received a pfizer booster shot. Eligibility is 16+ right now for pfizer.
Muscle weakness, leg pain from knee up to groin. Symptoms especially worse at night. Patient has had MRI and being treated with steroids/NSAIDs.
After 1st dose I developed a slight ringing in my left ear. After 2and dose, whithin a few hours I have a really really loud piercing ringing in my ear that will not go away. It's like full blown tinnitus. It hurts so bad at night that my fingers twitch and I am miserable every day. Its LOUD and will not stop and I have extreme fatigue ever since the 2nd dose
This case was reported by a physician via another manufacturer and described the occurrence of pellet-like stools in an infant subject of unspecified gender who was vaccinated with ROTARIX. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject produced 4 to 5 tiny pellets in stools. At the time of reporting the outcome of the event was unspecified. No further information was available. Follow-up information received on 27 February 2009 indicated that the subject was a 6 week old male. The infant received ROTARIX orally on 09 January 2009 and one day later, on 10 January 2009, experienced a stool change. There were pellets in his stool and it was chalky in color. Not every stool, but some here and there until resolution 7 days later on 16 January 2009. In the reporter's opinion, the events were possibly related to treatment with ROTARIX.
immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown.  Follow-up attempts are needed. Further information on the lot/batch number has been requested.
Lightheaded and feeling weak for one week total so far. Immediate symptoms were headache, lightheaded, fatigue, some nausea.
Information has been received from a female patient who on 01-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient reported that on 03-JUN-2008, 2 days after receiving the vaccine, she developed a rash 2x4 inches in the area where she received her ZOSTAVAX injection. At the time of the report the patient had not recovered. The patient did not seek medical attention. No further information is available.
two hours post vax, pt experienced flu like symptoms which lasted for 4 hours. As of08/07/2000 the outcome of the event is resolved.
Kidney Pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney Pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced RENAL PAIN (Kidney Pain). At the time of the report, RENAL PAIN (Kidney Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Chronic cough  during hospitalization 10/31/21-11/15/21.Tested positive for COVID 11/5/21.  Casirivimab/imdevimab given 11/5/21.
Charlie horses and cramping on left side of my body especially in left thigh. Started 20 min after.; Charlie horses and cramping on left side of my body especially in left thigh. Started 20 min after.; But by 8pm I was tired.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included slight nerve damage and allergic to mangoes. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) 25mg daily for an unknown indication from an unknown date. Prior to vaccination, it was unknown whether 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 vaccination. On 14Apr2021 at 14:30 the patient experienced Charlie horses and cramping on left side of the body especially in left thigh, which started 20 min after. It went away in the evening of the day the patient got the shot, but by 8pm was tired. The patient felt okay the morning of reporting but by evening had intense Charlie horsing on the left side again and even into the arm and back. The patient was told to go to the ER at the onsite vaccine aftercare if she still had cramping continuing later. So, the patient would probably call the doctor then go. The patient was not really sure what to do, as Charlie horses were not normal and it was making her nervous. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the event Charlie horses, cramping on left side of the body especially in left thigh and tired were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Guerre barre syndrome; This spontaneous case was reported by an other health care professional and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guerre barre syndrome) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guerre barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guerre barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient was retired schoolteacher. Company Comment This case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient's parent stated she noticed redness around the patient's face around 0900. Notified technician at 0905. Patient taken in back office for further evaluation. Rash/redness noted on face, lower back, neck and chest. No other signs or symptoms noted. PA evaluated child/listened to breath sounds. Gave instructions for patient to be observed for additional 30 minutes to ensure no progression. Patient's viatls taken and observed by clinic personnel. Patient recovered and released at 1000. No other interventions needed. Patient advised to follow up with doctor if symptoms returned.
Received DTAP #5 left arm (deltoid). Approximately 26 hours later, mom noted left upper arm red, swollen, warm to touch, painful. Seen in office 8/29/02. Dx severe local reaction. Area measures 2.5" across by 2" down. Advised ice, Motrin. Patient afebrile.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L031602, expiry date 20-OCT-2017)(strength, dose and route of administration were not reported). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
sick; Headache.; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced ILLNESS (sick) and HEADACHE (Headache.). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache.) outcome was unknown.            No concomitant medication details were provided. Treatment information included Tylenol.   This case was linked to MOD-2021-060870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: AE updated in TCR form.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I have developed a strong fluttering in my left ear that is progressively getting worse. It comes and goes but the frequency is becoming more.
Hives at injection site and across chest and neck, shortness of breath, minor swelling of face and throat as symptoms progressed.
PT PRESENTED TO ER WITH COMPLAINTS OF CHEST PAIN. REPORTED RECEIVING COVID VACCINE 5 AND 2 EEKS PRIOR. IT WAS NOTED SHE HAD ELEVATED TROPONIN LEVELS, NSTEMI. PT TRANSFERRED TO ANOTHER MEDICAL CENTER FOR HIGHER LEVEL OF CARE/CARDIOLOGY. HEART CHAT PERFORMED. THE DISTAL ONE FOURTH OF THE LAD WAS OCCLUDED AND APPEARED TO BE FROM THROMBUS. OTHER FINDINGS ALSO NOTED . PT DID NOT REPORT PRIOR HISTORY OF CORONAY HEART DISEASE OR MI.
1. fever 2. chills 3. N/V                                       2days 4. vomiting x 5 5. cough
Information has been received from a certified medical assistant concerning a 12 month old male with a chronic lung disorder and no allergies, who on 14 Nov 2006 was vaccinated subcutaneously in the right arm with a 0.5 ml dose of Proquad (lot #655266/0975F). Concomitant vaccinations given on 14 Nov 2006 included: a dose of Prevnar, a dose of Vaqta and a dose of Fluzone. Other concomitant medications included: Pulmicort and Zantac. On 24 Nov 2006 the patient developed an unspecified number of lesions on his abdomen, chest and neck. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Pt recvd vax 14FEB92, 5MAY92, & 3NOV92 & 4th dose on 3DEC92 & on 15Dec92 exp nausea, abdo pain, glandular swelling, vomiting; No further details were provided;
Mom called: Reported that child started with onset of temp of 104, increase heart rate and limited use of legs. Recommended that Pt go to ED for evaluation.
10-30-12 Notices mouth sloughing. Remembered had last year after flu vaccine too. Involves mucous tissue. No other symptoms at this time.
Within 1 hr. of HPV inj. pt was at a store laying on floor & body started to jerk with her eyes rolling to back of head, passed out & per mom, she was convulsing for 20-30 sec. Pt was seen at ED & has f/u with PCP.
This is a spontaneous report obtained from a non-contactable consumer. A male patient of unspecified age and ethnicity received TRUMENBA on 05Mar2015. Relevant medical history and concomitant medications were unknown. On 05Mar2015, in the afternoon and all of the night the patient experienced fever, weakness and headache. The patient did not recover from the event at time of this report. No follow up attempts possible. No further information expected.
The patient got sick and tested positive with COVID19 a month after getting the vaccine.  All typical symptoms are present.
Red, swollen (R) upper arm - warm to touch - Pt c/o N/V, generalized weakness & muscle pain. Unsteady gait.
Patient developed an inappropriate sinus tachycardia, marked decline in her functional capacity one day after receiving the vaccine.  We see similar complaints in young patients with long haul covid symptoms
PATIENT REPORTED TO NURSE 15 MINUTES AFTER INJECTION THAT SHE FELT LIGHTHEADED AND HAD AN ITCHY THROAT. SHE SAT DOWN ON THE GROUND AND ATE SOME PEANUT BUTTER CRACKERS AND SOME WATER. SHE REPORTED THAT THE ITCHINESS IN HER THROAT PAST, HOWEVER HER DIZZINESS INCREASED. BP 105/60, O2-100, HR- 108, RR- 12.  SHE WAS ASKED TO LAY FLAT AND SHE REPORTED SHE HAD DIFFICULTY BREATHING WHEN FLAT. SHE SAT UP AND COMPLAINED OF CHEST TIGHTNESS, AND TUNNEL VISION. PATIENT WAS NOT IMPROVING AND 911 WAS CALLED AT 1827. PATIENT AGREED TO 911 BEING CALLED PLACED INTO A WHEELCHAIR. SHE WAS WEAK UPON STANDING.  VITALS BEFORE SHE WAS TRANSPORTED WERE O2- 99-100%, RR- 14, BP 110-62, HR-83. TRANSPORTED VIA AMBULANCE. SHE REPORTED SHE HAS ASTHMA AND DID NOT HAVE HER INHALER. SYMPTOMS WERE "SIMILAR" TO  WHEN SHE HAS AN ASTHMA ATTACK.
pt recvd vax;27aug95 devel gen rash;subsequently devel mild case of chicken pox;
2nd Pfizer COVID vaccine 3/20/21 Hospitalization 11/15/2021
Patient came to get 2nd shot in series as monovalent pfizer vaccine, but was given bivalent in error. No effect shown in patient. patient consulted CDC and will come in 2 months to get monovalent shot.
received on feb 9th their 3rd dose of pediarix/ On 4/20/2021 received/ engerix; On 4/20/2021 received/ DOSE 1( 4TH DOSE OF DTAP AND POLIO) of kinrix.; On 4/20/2021 received/ DOSE 1( 4TH DOSE OF DTAP AND POLIO) of kinrix.; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 9-month-old male patient who received HBV (Engerix B) (batch number YL2L3, expiry date 14th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On 20th April 2021, the patient received the 4th dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 20th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 3rd dose of Pediarix on 9th February 2021. The patient received Engerix B, this becames an extra dose of Hepatitis B. The patient received Kinrix as a 4th dose of Dtap and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reported batch number for Kinrix was YZNZN, which was updated to YZ97N as per sales datasheet. The reporter consented to follow-up.
generalized rash (not just at injection site) without anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced generalized rash (not just at injection site) without anaphylaxis after first covid vacc on an unspecified date. Patient tried to clarify if was safe for her to get second shot. The outcome of the event was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Presented to  clinic with complaints of left upper arm tenderness, redness, and swelling around injection site.  No systemic symptoms such as urticarial, SOB, or swelling of lips, tongue or throat.  5/10 complaint of pain in upper arm.  2" wide x 3" long area of redness with little swelling on lateral/posterior aspect of left upper arm. Upon inspection of needlestick site, it was noted that the IM vaccine was given distally and laterally to the deltoid muscle and more likely into the sub q tissue.  The vaccine was administered as an IM injection otherwise.
Fever, and body aches. Did use acetominaphen rest and fluids. symptoms are gradually subsiding.