chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In 10/2013 she said I don't fell well, I have something in my head. She have CT scan, but in 11/25/2013 she awoke with nausea, dizzy she get another CT scan. But on January 13, 2014 I bring her E.R. in Hospital and they Dx with Pontine Glioma Tumor Brain.
~16 days after immunization pt. developed bilateral [[name]] pain and refusal to weight bear, extreme irritability and fussiness.  Waking from sleep at night.  ~25 days after vaccine continued irritability and ED visit with pain with neck flexion as well as hip flexion.  No fevers.  Given Tylenol/Motrin throughout course.  Admitted to hospital, underwent LP with high protein, no other abnormalities.  Had EMG which demonstrated conduction velocities of acquired peripheral nerve disease and diagnosed with Guillan [[name]] Syndrome. 12/21/06 Received medical records from hospital which reveal patient admitted 11/4/06-11/13/06 after having severe cervical & back rigidity & pain with significant irritability for approx 9 days.  Patient had been seen at multiple outpatient facilities prior to admit & dx w/viral syndrome.  Admitted with meningismus & irritability.  Tx w/IVIG.  Responded slowly but was able to again walk at time of d/c.  Was to f/u w/neuro & have PT/OT at home. Final Dx: Guillain [[name]] Syndrome with additional dx of sensory neuropathy, encephalopathy and plexopathy changes.
Vaccines given 5/22/15. Pt developed fever/rash initially thought to be enterovirus. Rash came in crops and crusted. All sx resolved until 6/23/15. Pt brought in for lymphadenopathy. Dx with  vaccine type varicella and secondary lymphadenitis.
Information has been received from a business partner via a consumer regarding a 55-year-old female with a history of rheumatoid arthritis who had been receiving injections of Enbrel (etanercept) since 01/01/2000. Concomitant medications included: methotrexate, folic acid, calcium, nabumetone, estradiol, medroxyprogesterone acetate, and hydrocodone. In Sept 2002, the pt developed an unspecified intervertebral disc disorder requiring epidural treatment. In Dec 2002 the pt developed bronchitis which resolved. One week later she developed urticaria on her abdomen and lower extremities following the receipt of an influenza vaccine (manufacturer unknown). The urticaria resolved within 6 days. See related case, HQWYE606224FEB03.
Information has been received from a registered nurse concerning a 20 year old female who on 2/12/99 was vaccinated with the 1st dose of Hep-B vaccine recombinant. Two hours, post vax, the pt experienced arm pain and numbness, dyspnea and chest discomfort. The pt was taken to the ER. She was given diphenhydramine HC1 (Benadryl) and was released. The pt recovered on 2/13/99. No further information is available.
Expired Vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that on 18-Nov-2021, Punctured vial left in refrigerator overnight outside the recommended 12 hour vial puncture range and was given as COVID-19 Vaccine booster dose from vial that was expired by a couple of hours on 19-Nov-2021.
awakened @ 1AM this morning crying w/pain lt arm & wouldn't let anyone touch arm;fever 101-L tricep red, swollen, & hot to touch;
My symptoms started with a bad sore throat. Fever 102.4 , chills, bad cough, congestion and runny nose. Other than taking Advil cold and sinus and Tylenol, that was it for medications. I went back to urgent care since today is day 5. The fever is better. Congestion, sore throat is still here.
This case involves a fatal event was considered medically important for the events of vomiting and fever. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting and died due to an overwhelming sepsis from Group A Streptococcus pyogenes. The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and the second dose of ROTATEQ (Merck & Co Inc). On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room. On an unspecified date in May-2010, a culture (reported as "a very early culture of unspecified origin) was performed that revealed Streptococcus pneumoniae, however a blood culture on 18-May-2010 revealed Group A Streptococcus pyogenes. On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes. The cause of death was reported as streptococcal sepsis. The autopsy cause of death was undetermined. No additional information was available at the time of this report.
Swollen under arm; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 10Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin, seasonal allergies and apple. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced swollen under arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen under arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Ever since I have taken this vaccine my health has plummeted. I have no immunity to colds/flu. I have gotten covid twice. My menstrual cycle is screwed up. I am back on asthma medicine I haven't needed since I was a child. This vaccine has changed my entire body chemistry for the worse
Swelling, erythema, redness, pruritis at local area of injection. SOB (Left upper arm)
I feel up normal heart beats with kind of PVC events; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENb202), via an unspecified route of administration, administered in arm left on 01Mar2021 at 12:00 PM as dose 1, single for COVID-19 immunization. Medical history included congenital heart disease- ASD, hypertension, acid reflux history. The patient concomitant medication included Vitamin D2 at a dose of 50,000 IU ERGO capsule RX from Walgreens (patient receive medication in two weeks) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 01Mar2021 at 04:00 PM, the patient experienced I feel up normal heart beats with kind of PVC events with some dizziness. The patient did not receive treatment for the events. Outcome of the events was not recovered
nauseated; head spinning; This is a spontaneous report from a contactable other healthcare professional (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Jan2021 07:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 18Jan2021, the patient was nauseated and had head spinning after receiving the vaccine. Outcome of events was unknown.  Information about lot/batch number has been requested.
This prospective pregnancy case was reported by a consumer (mother of subject) and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception for the current pregnancy. There was no evidence of a defect from prenatal testing. There was no maternal or paternal history which may have an impact on the current pregnancy. On 11 September 2013 the subject received a dose of FLUARIX Quadrivalent (intramuscular, unknown details) and experienced vaccine exposure during the 1st trimester of pregnancy. The gestational age was calculated to be 8 weeks. The date of last menstrual period was reported as 17 July 2013 and the estimated date of delivery was reported as 10 May 2014. There was no evidence of a defect from prenatal testing. At the time of reporting, there were no adverse events reported and the pregnancy was ongoing. On 11 September 2013, on the same day as vaccination with FLUARIX Quadrivalent (described as "on Wednesday"), the subject experienced injection site pain. The subject's mother reported that the subject experienced arm pain "where she received the vaccine on Wednesday". The outcome of the injection site pain was resolved. At the time of reporting, the mother of the subject reported that the "pain is gone".
DEATH DUE TO THE VACCINE; This spontaneous report received from a consumer concerned a 32 year old of unspecified sex. 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 patient died due to the Johnson and Johnson vaccine. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210914084-Covid-19 vaccine ad26.cov2.s-Death due to the  vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I had two small 'valves' on my arm, why they were two at the injection site; it just keep more swollen; Nausea; Diarrhea; I was having chills; My heart was pounding so bad; I said the 'valves' is spreading, the swelling and like the blending together; the area is getting more red and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "I had two small 'valves' on my arm, why they were two at the injection site; it just keep more swollen"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; CHILLS (non-serious), outcome "unknown", described as "I was having chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I just had some soreness"; PALPITATIONS (non-serious), outcome "unknown", described as "My heart was pounding so bad"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "I said the 'valves' is spreading, the swelling and like the blending together; the area is getting more red and swollen".  Additional information: Patient had soreness, nausea, diarrhea, last night, was having chills but no fever according to the thermometer but my heart was pounding so bad like patient had already taken Tylenol. Patient was just afraid and don't want to take any like it bothers my liver but also suffered from allergies on a regular basis. So, was little concerned, it hasn't spread all over body. The 'valves' was spreading, the swelling and like the blending together, the area was getting more red and swollen so patient didn't know anything to do other than putting cold pack on it because that was not doing anything, like patient just don't want to put cortisone or something. Patient do have to take Claritin-D Daily and do have to take Benadryl sometimes at night, don't know if shampoo was going to make it worse, don't know if soaps.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9-18-08/1500, redness, swelling - whole circumference left arm, elbow to shoulder.  Took to Urgent Care at 1800 - told to give Benadryl and ice.  Somewhat improved today though still very red and warm to touch.  Patient complained of itchiness but denies pain.  Mother brings her in for evaluation.  9-19-08/1040 - discussed with mother at hospital - said give Tylenol or Motrin - should see improvement.  Right arm circumference 7.5 and left arm circumference 8 5/8.
Rash over whole body, fever, chills, aches.  No information about timing other than Medrol dosepack dispensed on 10/23 (7 days post-vaccine).
About 4 or 5 hours after injections arm became swollen, red and painful. Arm was a little warm. Pt went to see MD 9/23/13 AM. MD said not infected.
Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140962, 2016SA140980, 2016SA140990, 2016SA141097, 2016SA141105 (same literature). The following is verbatim from the article: Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season has been published. Methods: We compared two populations' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines.  Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population (1.32 per 100,000) was more than twice that of the second population. Although fewer first population AEs following MIV were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the second population. This case involves a 40 year old male patient who was vaccinated with H1N1 VACCINE (batch number, dose, route and site of administration was not reported) on an unspecified date. The patient had medical history of Gastroesophageal reflux disease, obstructive sleep apnea, seasonal allergies. Concomitant medications were not reported. On an unspecified date, 36 days following vaccination, patient had ascending weakness, paresthesias in all limbs. Patient was diagnosed with Guillain-Barre syndrome. Lab data included cerebrospinal fluid which showed positive albumin cytologic dissociation. MRI of cervical spine and brain was performed. Corrective treatments included IVIG (Intravenous immunoglobulin). Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre syndrome. Documents held by sender: none. Sender's Comments: Manufacturer of the INFLUENZA VACCINE was not reported. Guillain-Barre syndrome is reported after vaccination with influenza vaccine. More information on past medical history, family history and concomitant medication are required to assess this case further.
Information has been received from a physician referring to an 18 year old patient of unknown gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 12-OCT-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, dose, route and dose number were unspecified) when the patient was 18 years of age. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to an unspecified patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of MMR II, (lot #, expiry date and route of administration not reported). On an unknown date, the patient experienced "redness, rash, a low grade fever for two days, and dots on his face" after administration of MMR II. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was reported. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Pt is 42 year old female who presented to Health Event for moderna vaccine in her left arm. After receiving her vaccination pt became nauseas with lightheadedness. PT developed a rash at posterior neck area with difficulty breathing.  PT was given epinephrine injectable to lateral right thigh. PT continued to have difficulty breathing stating her throat had a swelling sensation. PT was then given 125mg solumedrol and paramedics were then called.. PT was then given Benadryl 25mg. PTs vitals were BP 135/80, HR 100- 102, Spo2 98%. Paramedics arrived and took the pt, pt reported feeling somewhat relived and better than post injection. Pt was taken to hospital.
mistakenly given QUADRACEL in place of the intended DAPTACEL with no adverse event; Inappropriate age at vaccine adminstration; Initial information was received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient to whom mistakenly diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] was given in place of the intended diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose (once, total) of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine (Solution for injection) (lot number, expiry date, strength: unknown) via unknown route in unknown administration site for Immunization (Product administered to patient of inappropriate age) and mistakenly given quadracel in place of the intended daptacel with no adverse event (wrong product administered) (latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
informed them of the erection dysfunction; This case was reported by a nurse via call center representative and described the occurrence of erectile dysfunction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erectile dysfunction (serious criteria GSK medically significant). On an unknown date, the outcome of the erectile dysfunction was unknown.   It was unknown if the reporter considered the erectile dysfunction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced erection dysfunction after first dose, but nurse practitioner unsure if Shingrix caused this. The reporter enquired about any information on any studies showing erectile dysfunction after the first dose of Shingrix. The reporter unable to provide vaccine or patient details. The reporter did not consent to follow-up.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016248113) on 13-Feb-2017. This case involves a female patient (age not reported), who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, route and site of administration: not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, after the vaccination patient had allergy to the vaccine. Laboratory investigations and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none
19 y/o female near syncope, rate tachy, P 30 min, rest.
I have felt brain fog, feeling confused at times and my short term memory is suffering. I will forget what I am doing moments after I have thought of it. I do eventually remember but this is very unusual. I am also still very tired. I didn't experience a head ache, I had body aches for a few days but this is the only symptom that is concerning me. I feel like I'm in a daze for some moments.