chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dissociation for 30 minutes on first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 09:30 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRYSELLE. Past drug history included: Hep b vaccine, reaction(s): "known_allergies", notes: known allergies: Hep B vaccine. The following information was reported: DISSOCIATION (non-serious), outcome "recovered", described as "Dissociation for 30 minutes on first dose". Therapeutic measures were not taken as a result of dissociation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
3-24-08 - SPOKE WITH CHILD'S FATHER PER PHONE. FATHER REPORTS THAT CHILD RECEIVED SHOTS 3-21-08 AND THAT ON 3-23-08 - CHILD C/O ITCHING WITH RED RASH OVER ENTIRE BODY. FATHER DENIES FEVER OR OTHER PROBLEMS AT THIS TIME, ADVISED FATHER TO TAKE CHILD TO MO TO MD TODAY.
tinnitus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had tinnitus, after first shot it increased gave her two sounds and first sound is pretty loud, one of the sounds are going away. due for the second shot soon and is wondering if she should even take it. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Patient had terrible side effects, he has aches and pains (like the flu); Patient had terrible side effects, he has aches and pains (like the flu); He did not take the second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient had terrible side effects, he has aches and pains (like the flu)), PAIN (Patient had terrible side effects, he has aches and pains (like the flu)) and PRODUCT DOSE OMISSION ISSUE (He did not take the second dose of Moderna) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Patient had terrible side effects, he has aches and pains (like the flu)), PAIN (Patient had terrible side effects, he has aches and pains (like the flu)) and PRODUCT DOSE OMISSION ISSUE (He did not take the second dose of Moderna). At the time of the report, INFLUENZA LIKE ILLNESS (Patient had terrible side effects, he has aches and pains (like the flu)), PAIN (Patient had terrible side effects, he has aches and pains (like the flu)) and PRODUCT DOSE OMISSION ISSUE (He did not take the second dose of Moderna) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication information was not provided.  On 09-Dec-2022, it was reported that a patient started treatment on an unspecified date in 2020 with Moderna Covid-19 vaccine. It was reported the patient had terrible side effects, he had aches and pains (like the flu), and was calling out for his deceased father in his sleep, and he did not take the second dose of Moderna.  Treatment information was not provided.
Heart palpitations for 7 days after vaccine. Right arm pain in shoulder and bicep. Going on 20 days and no sign of getting better. Still have nausea.
INSIDE OF MOUTH RAW TONGUE SWOLLEN BUMPS ON TONGUE RECOMMENDED TAKING BENADRYL
Dr. self disclosed that he administered 0.1 ml IM of Moderna vaccine .  Patient was notified via telephone and instructed to return to the site were she received a full dose (0.50 ml) of the Moderna vaccine as instructed by MDH. No side effects reported by patient after administration or during resting period of 15 minutes. Supervisor notified and all vaccinators reminded that 0.5ml is the recommended dose for the Moderna vaccine.
Pt had febrile sz at time vaccines administered on 12/16/09. Temp 101 degrees prior to sz & had gone up to 102 degrees immediately after sz. O2 via FM at 6C & TYLENOL PM. Sz at 2025, awake & in MOC's lap at 2100. Had febrile sz in office when seen for f/u 12/17/09 at 1820. Pt had had high temperature 102 when mom brought to office & she had not medicated. Child had O2 via FM & had has MORTRIN po prior to sz.
Patient reports headache, fatigue/weakness, diarrhea, sore stomach, unable to eat solid food beginning 1/29/2021 and a fever of 100.9 beginning 1/31/2021. Patient is scheduled for series 2 of COVID Vaccine on 2/25/2021. Patient evaluated by Primary Care physician on 2/2/2021- Patient's symptoms continue, fever reduced to 99 with Tylenol on 2/2/2021. Patient advised to continue Tylenol & increase fluid intake (Gatorade).
Reaction to Jynneos vaccine; Case reference number US-BN-2022-002230 is a spontaneous case report initially received on 01-Sep-2022 from a consumer via Bavarian Nordic and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, the patients were vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) at an unreported dose, route or anatomical site for unknown indication.   On an unspecified date, the patient experienced a reaction.  The outcome of the event was unknown.  The reporter did not provide seriousness or causality assessment.  At time of this report, no further information was provided.  Additional information received from reporter on 02-Sep-2022 included confirmation of country of occurrence.; Reporter's Comments: A patient of unknown age experienced a reaction, unknown time after vaccination with Jynneos vaccine, at an unreported dose, route or anatomical site for unknown indication. Adverse reaction (unspecified) is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. With limited information provided, causal relationship is conservatively assessed as related at this point. The case is non-serious.; Sender's Comments: A patient of unknown age experienced a reaction, unknown time after vaccination with Jynneos vaccine, at an unreported dose, route or anatomical site for unknown indication. Adverse reaction (unspecified) is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. With limited information provided, causal relationship is conservatively assessed as related at this point. The case is non-serious.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 56 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Spe-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Pt was to receive 0.25ml booster dose but instead, rec'd 0.50ml dose. Denies any adverse reaction
pt recvd vax;t spiked to 104.3,3-4 hrs p/ vax;apap given thru noc;motrin given,brought fever down;listless & dec of appetite; called HD & referred to personal MD;
10 days after receiving vaccination I began having mild congestion and dry scratchy sore throat. Sore throat worsened to a dry cough. Congestion, sore throat, and cough worsened the next day. That evening I began having fever. Fever was 101 also had fatigue and chills. During this time I had to use my rescue inhalers. Called PCP on Friday and had video visit on Saturday. Was prescribed flovent inhaler and paxlovid. Began Paxlovid that afternoon. Symptoms were the worst on Saturday and have slowly been improving.  At telehealth visit on 11/19/2022 also discussed possible drug interaction between Buprenorphine  and Paxlovid. It was decided that the reward outweighs the possible risks.
Patient is a 76 y.o. female patient of MD with a history of COPD, Chronic respiratory failure on 2 L oxygen, Paroxysmal atrial fibrillation, HFpEF, Diverticulitis, Renal cancer s/p partial nephrectomy, Chronic pain, admitted with diverticulitis.Hospital course complicated with respiratory failure    Acute on chronic respiratory failure...resolved Covid-19 Virus Infection COPD exacerbation Possible Fluid overload with history of HFpEF Date of onset of symptoms: 11/13/2022 Symptoms present on admission: Cough, loss of taste/smell, subjective fever/chills, nausea Date of covid positive test: 11/10/2022 Vaccination status: vaccinated Imaging: CXR revealed possible residual airspace disease (hospitalized for pneumonia 9/2022), repeat CXR on 11/17 with Increased reticular opacities in both lungs could represent edema or infection Oxygen requirements on admission: Chronic 2 L Current oxygen requirements: transitioned off of BIPAP, on 2 L NC Medical therapy: decadron,  IV lasix X 2 doses followed by PO lasix, not a candidate for remdesivir Consultants following: Pulmonary Anticipated special isolation end date: 11/21/2022 On 2 L NC currently   Acute diverticulitis CT abdomen/pelvis with IV contrast revealed colonic diverticulosis with pericolonic inflammatory changes involving sigmoid colon, bladder wall thickening (reactive versus cystitis-denies UTI symptoms) On omnicef and flagyl currently Complete total 12-14 days course   Atrial fibrillation with RVR Initial troponin 17 EKG atrial fibrillation with RVR, no acute ST/T changes appreciated TSH Unremarkable,  serial troponin w flat trend IV metoprolol PRN Continue Cardizem and Eliquis HR remains stable     COPD Substitute Symbicort and Spiriva for Trelegy Continue PRN albuterol Continue chronic 2 L oxygen, currently on BIPAP  Chronic HFpEF EF 65% on echocardiogram 4/11/2022 Clinically compensated Continue metoprolol Monitor volume status  Resume PO lasix 20 mg 11/18
Wheezing, red and rash by the injection site, facial swelling , arm swelling right arm,  and tingling down my arm and right side and rash throughout body.
pt put in crib on side @ 0500 alert, awake, afebrile, seemingly in good condition found by family 0900 blue, limp, no resp & no heart rate-resuscitation unsuccessful; (intrathoracic petechia lungs w/interstitial congestion)
BP 141/87 Immediate reaction to injection. Tired, Dizzy H/A.  Breathing clear. Possible anxiety due to previous vaccine reaction. Increased watch time then went home.
Information has been received from a RN concerning a 10 year old male child who on 10/09/95 was vaccinated with a dose of varicella virus vaccine live (Lot # 609285/0430B). Subsequently, between the dates of 10/06/03 to 12/04/03, the child developed a "mild case of chickenpox breakthrough" that was diagnosed by a physician. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that this case was part of 16 cases of chickenpox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live. The reporter also mentioned three other children who experienced similar reactions (WAES # 0312USA00810, 0312USA01002 & 0312USA01003), two of which were siblings, respectively.  Additional information has been requested.
I started to feel like i had hives and an itchy hand which went up y arm. My heart was racing 149 beats per minutes. I had chills and got tingly. It continued for 3 weeks and my blood pressure started to fluctate from high to normal back to high.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
On 10/2 at 1145 am excruciating lower back pain radiating to R hip, thighs and down to the R knee. No relief by 4pm leading to ER visit at Medical Center. CT scan, steroid injection and pain meds. Sent home with prescriptions for steroid taper and pain medications. Overnight worsening pain. 10/3, visit ER. By 8pm complete bilateral paraplegia from the waist down. To date (10/21) multiple lab tests, MRI, MRA, vascular studies and Spinal angiogram. Treated with high dose steroids and plasmapheresis. Diagnosis remains idiopathic transverse myelitis, with the suspect cause from the Flu Vaccine. 10/21 - Still a paraplegic being discharged to Acute rehab on a steroid taper.
vaccine were exposed to negative 7.7 degree celsius for 30 days/no AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional and consumer or non health care professional via Medical Information (MI) (under reference: 00864731).  This case involves an unknown age and unknown gender patient who was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD], INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE [TENIVAC] (product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE lot number: U6831AA and expiry date: 08-Oct-2022 via an unknown route in an unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site, a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site and a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  It was reported "stated that the vaccines were administered to patients, with an estimate of maybe 50 patients. Want to know what to do".  It was case of an actual medication error due to product storage error temperature too low (latency: same day).  At the time of reporting, no adverse event was reported.   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.
Immediately p/TD/MMR recvd pt stiffened up & fell backwards on to table, pale, BP dec 100/70, p dec to 40, 02 given & NH3 sniffed;
WEAKNESS; This spontaneous report received from a patient concerned a female 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: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included apixaban. On MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weakness was not reported. This report was non-serious.
telephone call from mother approximately 24h after dtap,ipv,hib,pcv-7, and influenza izs. mo stated that 1h after izs given baby began "twitching all over, not actually convulsing, but continuous twitching in all limbs" baby remained alert, fussy with fever to 103 degrees. no prior reaction to previous izs. parents called paramedics, pulse ox, and vital signs all stable. as of 1/18/07 late in afternoon rare twitch, with fever to 101, less fussy.
MAGNET STICKING TO INJECTION SITE; This spontaneous report received from a consumer concerned a 30 year old female. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced magnet sticking to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnet sticking to injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210830342 and 20210830364.
Pt experienced fatigue, pain, itching, rash, and brain fog. This has been present since the vaccine. She also had petechial rashes that have come and gone. She also developed warmth and redness and tenderness over the top of her right foot that lasted for 6 weeks. She continues to struggle with fatigue and brain fog and insomnia.
Moderate swelling, redness and at Td site (right deltoid). Prescribed Clarinex 5mg 1/1 QD for5 days and Augmentin 100 mg 1/1 QD for 4 days. Follow up 02/25/05: Moderate swelling, redness and pain right deltoid, site of DTaP, 01/27/05 in AM, approximately 5 X 8cm, soft puffiness.
Patient complains of sudden onset of numbness/tingling and weakness to "random" extremities of his body for past 3 weeks. Currently his right arm/shoulder is tingling and numb but it tends to disappear and reappear in a different part of his body. Patient also reports he has been having headaches - occipital and temporal -- for the last 2-3 weeks accompanied by nausea. Headaches last for about 45 minutes to an hour and then they disappear. Nausea appears with the headaches. Denies and aura. Patient also complains of "random" blurry vision. All of these symptoms have started acutely about 2-3 weeks ago. Patient denies dizziness, slurred speech, trouble speaking, changes in balance or gait. Patient refused an ambulance at time of visit. Advised patient to go to the Emergency Department.
rib pain/shortness breath/Pulmonary Embolus and viral pneumonia Narrative: Development of symptoms beyond the 48-72 window. Tested at time of ER visit Negative for Covid. Repeated Covid NP swab on 01/05/2021. Was not hospitalized overnight discharge home on oral anticoagulant medications.
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 19-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
first dose with pain in the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: first dose with pain in the injection site). The outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt date: 31-JUL-2023 The reporter was the patient's husband who states his wife had a mild reaction to the first dose with pain in the injection site since administration. The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023104111:Same reporter