chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a mother concerning her 16 year old daughter (17 years old now) who in October 2009, was vaccinated with the first dose of GARDASIL (lot # not reported). There was no concomitant medication. Subsequently, the patient had no period in November 2009, or after that. In December 2009, the patient was vaccinated with the second dose of GARDASIL (lot # not reported) and her ovaries failed due to auto immune disease. The patient now (in 2010) had fibromyalgia and was taking ELAVIL and estrogen. The patient had reached menopause. The patient did not recover at the time of report. The patient sought unspecified medical attention. Follow up information has been received from the physician who reported that the now 17 year old female patient with trivial mitral valve regurgitation and back pain at the time of vaccination, on 20-OCT-2009 at 3:30 pm was vaccinated intramuscularly with the first dose of GARDASIL (lot # 663558/0819Y). The physician reported that in November 2009 the patient experienced premature ovarian failure, loose stools, abdominal pain and headache. At the time of the report, the patient had not recovered. The physician considered premature ovarian failure, loose stools, abdominal pain and headache to be another important medical event. Routine laboratory test were performed which showed result within the normal ranges. Additional information has been requested.
Left upper and lower eyelid slightly swollen with itching. Also, 3 red spots that itch, (1) (R) forearm, (R) abdominal, (L) chest upper.
Patient has not had any adverse event currently as of today. Patient recieved a 3 rd dose of shingrix by accident.
I developed a cough that is lingering since I received the first shot on April 19th. When I received my 2nd shot may 17th the cough is persistent.  When I talking cough, when I inhale I get a tickle in the back of my throat that makes me cough
On 01/25/2022 patient walked in while we were having the COVID clinic and stated  that he had his Pfizer booster on 1/19/2022 at about noon and by 3 O'clock that  after noon his left hand had swelled up and warm to the touch.  Patient stated  that he got his vaccine in the left deltoid.  No other symptoms noted.  He just  wanted us to know.
No adverse event; accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019C22A) for COVID-19 prophylaxis.     Patient had no known conditions.  Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 05-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.).    No concomitant medications was reported. No AEs were reported. No treatment medications was reported.
Suspected vaccination failure; Shingles; first dose on 07/18/2018, second dose on 10/12/2019; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 2nd dose of Shingrix. On 18th July 2018, the patient received the 1st dose of Shingrix. On 12th October 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In February 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received 2nd dose of Shingrix late than the recommended schedule, which led to lengthening of vaccination schedule. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The reporter consented to follow up and provided phone number for healthcare professional (HCP) reference. For another occurrence of shingles in 2021 refer linked case US2021213520, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213520:same reporter
FLUBLOK being administered to pediatric patients with no reported AE; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402396(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER), 2022SA402707(CLUSTER), 2022SA402704(CLUSTER), 2022SA402662(CLUSTER), 2022SA402619(CLUSTER), 2022SA402525(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 7 months old female patient who experienced flublok being administered to pediatric patients with no reported ae while receiving vaccine influenza quadrivalent recombinant vaccine [flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a) for Prophylactic vaccination.  On 12-Sep-2022, the patient received a  dose of suspect influenza quadrivalent recombinant vaccine lot UJ887AA via intramuscular route in the left vastus lateralis being administered to pediatric patients with no reported ae (product administered to patient of inappropriate age)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event flublok being administered to pediatric patients with no reported ae.     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.; Sender's Comments: influenza quadrivalent recombinant vaccine [flublok].
Body aches, chills, and nausea starting at approximately 09:00 PM. Took 2 extra strength Tylenol and symptoms mostly resolved by the following morning (01/21/2021).
Coughing; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and DYSPNOEA (Short of breath) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced COUGH (Coughing) and DYSPNOEA (Short of breath). At the time of the report, COUGH (Coughing) and DYSPNOEA (Short of breath) outcome was unknown.            Patient received second shot of vaccination and experienced coughing and shortness of breath.  No relevant concomitant medications were reported.  No treatment details were reported.
Shivers; Sweat; Cold; Redness on both upper arms that were "fist-sized" that were red, hot and itchy; "Knocked out" (slept from 10pm to 3pm the rest day). Treatment: 2 ADVIL twice a day for 4 days.
This spontaneous report as received from an unspecified reporter (other type) via an other company refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot # reported as H011047, Exp date: September 2012, dose/frequency, route unspecified) on an unknown date. Subsequently on an unknown date the patient experienced an unspecified adverse reaction. No treatment information was reported. The outcome was unknown. Additional information is not expected.
AMS   Source of Information:  Available medical record, Daughter   History of Present Illness:  This is a 87y.o. male with a past medical history of hypertension and dementia on Aricept and Namenda who presented to ED via EMS for concern of AMS.  Patient is a poor historian and minimally responsive on presentation, history gathered from daughter.  She states that 2 days ago while on video call, the patient appeared to have slurred speech and then became "checked out" staring blankly which lasted about 2 minutes before he returned to his baseline (alert and oriented to himself and surroundings).  The group home he lives at reports that a similar event occurred earlier that day lasting about 90 seconds.  The following day, another event like this lasted approximately 1 hour.  His physician was called who recommended he go to the ED for evaluation.  Daughter states that the work-up was negative and his symptoms were attributed to any UTI.  Prior to this admission, individuals from the group home reported that patient had a clenched jaw and his SPO2 was 89% prompting them to give supplemental oxygen which was available and EMS was called.  Patient's daughter states that at his baseline patient is conversational with those around him and is aware of himself and surroundings.  She also reports that patient tested positive for Covid 3 weeks ago and has previously received the COVID vaccine, but not the booster.   In the ED: BP 152/80, HR 102, RR 18, SPO2 97%, T 97.6F.  Labs remarkable for lactic acid 7.5, sodium 132, bicarbonate 17, creatinine 1.89, glucose 176, albumin 2.9, Procalcitonin 0.28, WBC 17.9, Hgb 9.2.  COVID-19 detected on nasal swab.  Troponin 0 0.18,  1.15, 1.73.  D-dimer >10,000.  ECG shows sinus rhythm with HR 89, incomplete right bundle branch block, no acute ST segment changes or T wave inversions.  Chest x-ray shows patchy bilateral airspace disease concerning for atypical/viral pneumonia.  CT head shows no acute intracranial process with nonspecific white matter changes likely related to chronic microangiopathy.  Lower extremity Doppler shows no evidence of DVT.  Urinalysis shows >50 WBC, 3+ LE, 4+ bacteria, 11-20 RBC.  Patient is admitted to internal medicine with consult to neurology and cardiology for further management.
Two weeks after the MMR immunization was received, the child complained of severe neck pain. She developed a papular rash on her face that spread to her neck, chest, arms, then over her whole body.  She experienced joint pains, and the mother reports she had pus on her right tonsil.  She also had swelling of sub lingual lymph glands.  She had a low grade fever, malaise and sweats.  She felt sick for 5 days, but the rash didn't clear for 14 days.  She still has a slightly swollen lymph node behind her ear, but otherwise feels fine.
Mother described onset of 104 degrees F fever within 24 hrs. of vaccination. Fever persisted for 4 days, decreasing to below 101 degrees F on day 4. Pt taken to pediatrician where source of fever was not identified. Neg. strep, neg ear infection.
Patient woke up at about 3 AM the day after the Shingrix vaccine with chills, fever and nausea. She felt very tired and continued to feel weak, tired and ill for the next 3 days following.  She also had a mild rash about 2 inches surrounding the injection site and mild arm pain.
Adverse event of clotting after COVID-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Adverse event of clotting after COVID-19 vaccination) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Adverse event of clotting after COVID-19 vaccination) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Adverse event of clotting after COVID-19 vaccination) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported. Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of thrombosis which occurred in the context of SPIKEVAX 2023-2024 dose administration, which was unidentifiable dose in COVID-19 vaccination schedule. Latency cannot be calculated due to event date and vaccination date unknown. No further clinical information or details on clinical course, concurrent diseases, concomitant medications, any accompanying circumstances or risk factors, etiologic and diagnostic work up with treatment were provided for medical review. Thrombosis outcome was unknown at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-746627.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746627:same reporter
Some type of skin rash (big red/purple lesions all over neck and chest); This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 42 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 16Dec2021 20:30 (Lot number: FL3197) at the age of 41 years as dose 1, single and administered in arm left, administration date 21Jan2022 08:30 (Lot number: FJ6369) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Antiphopholipid Syndrome" (unspecified if ongoing). Concomitant medications  included: WARFARIN; SERTRALINE.  The following information was reported: RASH (non-serious) with onset 26Dec2021 07:00, outcome "not recovered", described as "Some type of skin rash (big red/purple lesions all over neck and chest)". The event "some type of skin rash (big red/purple lesions all over neck and chest)" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: some type of skin rash (big red/purple lesions all over neck and chest) appeared 10 days after 1st dose and also again 10 days after 2nd dose. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, has not been tested for COVID-19. The were no known allergies.  No follow-up attempts are possible. No further information is expected.
Left lateral aspect upper left arm 5x5cm swelling, warmth, left arm pain, no AROM in this arm, sent to ER ASAP.
pt was given vax & p/waiting 20min went to car where began having SOB, chest pain, & hip pain;pt had 02 applied BP 160/82,P78, ambulance was summoned & 2:00 transported to ER: pt was discharged to home @ 230PM;
Visit to ER on Jan 30, 2004 with cough and fever. Nasopharyngeal culture positive for B. Pertussis by PCR. Amoxicillin prescription for 10 days also Albuterol MDI 3-4 times a day. Diagnosis: RSV/Pertussis/ Bilateral otitis media.
Oh I noticed around 11 that I had a very itchy spot on my arms near the injection site but also on my neck, shoulder, my left arm, knees, stomach, breasts, and  thighs.  I Then check out areas that are itching and is raised urticaria. They got worse over the next few days. I also had some lip swelling and swelling around my jaw as well as some elevated heart rate. I called my doctors office and they prescribed me prednisone for five days to resolve the overactive immune issue. I have this happen a lot.
On January 16, 2022, Patient woke up at 8:30 am and had an 11:20 am appointment at Pharmacy for the 2nd dose of Pfizer pediatric. After waiting, she ended up getting up around 12:00 pm.   At 5:30 pm, she told me that she felt tired which sounded like a normal side effect of the vaccine. Around 6 pm, she mentioned it again.   At 9:00 pm, I noticed that she was more active than usual.   By 10:30 pm, I was still waiting for the ?common? side effects of the vaccine but instead, she was more active than before. She had a weird excess of energy and was breathing faster (like a person does after a breathing treatment). She also looked like she was ?under drugs? because she was way too happy and funny/silly.  At 10:22 pm, she was very cold, shivering, her teeth were chattering even though her forehead temperature was 97.1.  However, at 12:25 am (Monday, January 17), I switched her pajama because her body felt hotter (97.5).   At 2:43 am, I gave her Tylenol because her body (especially her hands, belly, and back of her neck) felt hotter (98), and she looked tired. However, she was still unable to sleep. Her comment was ?I want to sleep but my body doesn?t let me.? She was moving constantly.  At 3:58 am, she was still completely awake, very hyper, and with a temperature of 98.2.  At 6:18 am, still not sleepy and with a lot of energy. And, at 7:01 am her hands and back of her neck were still a little hot.   At 9:00 am, she went to urgent care. The nurse took her blood pressure and pulse three times because the numbers were high. An EKG was also performed. She was also referred for a second EKG and an echo to make sure her heart wasn?t affected.  At 1:00 pm, after 28 hours with 30 minutes, she was finally able to sleep. She slept for 2 hours. During the afternoon, she still had the energy to play around. She wasn?t hyper as she was before but, she wasn?t acting like someone who have barely slept. She was not sleepy.  9:00 pm - Went to bed and was able to sleep peacefully. At this time, she slept for 13 hours and 33 minutes (until 10:33 am).
I felt fine for the first 5 minutes after my Pfizer shot (my first shot), but then started to have rapid heartbeat, anxiety and felt warm.  The nurse checked my breathing and checked for rashes and said it was not an anaphylactic reaction.  Symptoms subsided after 5 or so minutes and I went home and have not had further side effects. But my question is, should I get my second shot in 3 weeks?
tingling in my feet. numbness. pins and needle feelings. diagnosed with neuropathy at the same time as my Covid 19 Pfitzner vaccines. progressively becoming worse unto today.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-OCT-2014, the patient was inoculated with ZOSTAVAX, administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by the same physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 08-JUL-2016, 26-JUL-2016 and 09-AUG-2016, she sought subsequent treatments from the same physician for new and worsening outbreaks of severe shingles. On or about the dates of 16-FEB-2017 and 29-JUN-2017, the patient was further treated for uncontrolled shingles pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed valacyclovir (VALTREX), gabapentin, hydrocodone, and lidocaine patches for management of her persistent and painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Case number PHEH2013US001846, is an initial spontaneous report received from a consumer on 18 Jan 2013: This report refers to a 66-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: Not reported) intramuscularly on 16 Jan 2013. Thirty minutes after vaccination he experienced uncontrollable shaking and chills followed by high fever and projectile vomiting. He was taken to the emergency room of the physician and was treated for his symptoms. On the next day (17 Jan 2013) he still had high fever and experienced hallucinations not knowing "who she was and where he was". He was again taken to the emergency room of the physician. The outcome, seriousness, and causality of the events were not reported.
inj site is warm, has redness and mild itching that began 1 week after vaccination
Information has been received from a health professional concerning a 5 yr old male who on 07Nov01 was vaccinated with a dose of varicella virus vaccine live (lot634852/0935K). It was reported that the pt developed chickenpox lesions. In June 2005, beginning after his brother experienced chickenpox lesions following vaccination with varicella virus vaccine live (WAES0506USA03092). It was noted that the pt was generally healthy. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. The pt's other brother experienced chickenpox following vaccination with varicella virus vaccine live (WAES0506USA03233). Additional information has been requested.
Parents phoned late on 10/05/01 and stated child had hives and rash. No other adverse effects. Dr talked with parents and instructed to see a physician in ER or see him if symptoms worsened.