chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received her first dose of the Pfizer Covid-19 Vaccine (lot # EW0185 exp. 08/2021) at 11:28 AM. The client was brought to the EMT station by lead RN stating that the client was feeling "dizzy? at 11:46 AM. The client was a 12-year-old female alert and tracking with her eyes and appeared anxious. The client had a chief complaint of lightheadedness. The client stated that she ?began to feel lightheaded? after her initial 15-minute observation had completed. This was the client's first dose of the Pfizer Vaccine and she stated reluctance to receive her first dose. The client denied any allergies and her parents stated that the client had a history of unspecified behavioral disturbances that require her to see a therapist. The assessment revealed no hives, swelling, discoloration, shortness of breath, or other signs and symptoms of anaphylaxis. The client denied a headache or wanting to throw up. The client refused to have her vitals taken by EMTbut agreed at 1150 to remain lying down until she felt better. The client was encouraged to drink water while she waited. After 15 minutes and drinking a bottle of water, the client stated "I feel all better" but "I think I'm overthinking this" and stated that she was now experiencing a ?headache?. RN asked the client?s parents? permission to speak to the client. RN came over to reassess the client and that client finally agreed to have her vitals taken at 1208: 148/84 blood pressure, Pulse 94, 100% O2 on room air, Respirations 16, alert and oriented to person, place, date, and event. The client revealed to RN that she was experiencing anxiety from her vaccination but became much calmer after discussing her concerns further. Client also revealed that she engages in acts of self-harm but has no intent to end her life. The client's last set of vitals at 1216 were 128/76 BP, HR 96, O2 100%, Resp. 16. The client then stated that she was ?ready to go? after her last set of vitals. Lead RN asked to speak to client?s mother in private. Lead RN provided mother with crisis hotline. Mother informed lead RN that client was in therapy and already seeking help. The client's parents were instructed to seek emergency care if a significant allergic reaction occurred later in the evening and were provided with all relevant vaccine-related information by RN. The client departed at 1220 in a positive disposition with her parents.
On 1/2/01, mom reports small 2" diameter of blister-like rash around injection area on both thighs. Just noticed this AM.
Headache ongoing since day of injection. Pulsatile Tinnitus, right ear. Arm pain first 3 days after vaccine. Rash at injection site appearing 1 week after injection.
vomiting, turned gray, unresponsive, eyes rolled to back of head, couldn't focus; No tx @ ER; Pt recovered soon p/arrival @ ER;
About 12 hours afterward the initial injection (0330) I began feeling very cold, started shivering violently to the point where I seemed to feel like I was a Parkinson's patient and nearly froze my jaw with severe muscle aches. Was able to calm the symptoms after standing by a hot oven.  Only reason I'm fairly certain this was some kind of reaction as I had a similar event happen when when I last got a tetanus shot 14 years ago where I was in the ER overnight, staff at the vaccine clinic even held me for a longer period (30 minutes)  then other due to that issue and were given full disclosure of prior events before receiving the injection .  I was diagnosed with Covid 19 on 12/10/20 (They discussed giving the injection with a health dept worker before giving it to me and declared it ok)  and troughout the entirety of my quarantine I have never experienced something like that.
Soreness in arm, difficulty lifting in arm. MD gave pt. Tramadol for pain and Meloxicam for inflammation.
Patient experienced pruritis and tenderness to touch in right pectoralis area extending in T4/T5 dermatome pattern. He then developed a  pruritic, vesicular lesion with an erythematous base just to the right of the vertebral column at T4 and T5, 4 cm in diameter. 3 smaller vesicular lesions are noted in the T4/T5 dermatome on the right upper back and right chest. Clinically, this is suggestive of herpes zoster.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:11 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 36.80.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM, 10:00 AM and 11:00 AM respectively and 35 degrees Fahrenheit at 02:00 PM and 03:00 PM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
COVID+ 1/20/23.  Vaccination status - pfizer x4 + Pfizer BIVALENT booster x1 Discharge Summary 1/23/2023  4:52 PM    Attestation signed at 1/23/2023  4:52 PM (Updated)   ATTESTATION: Patient personally seen and interviewed on the date of discharge. Case was discussed in detail with the author of this document. I repeated pertinent portions of the examination and reviewed the relevant imaging and laboratory data. Agree with documentation below with the following additions or corrections:   COVID-19 pneumonia. Improving. On room air. Finished 3 days of remdesivir, complete decadron. 34 minutes for this discharge.    Meets sepsis criteria on admission, fever, tachycardia.      BRIEF OVERVIEW: Discharge Provider: Primary Care Provider: Admission Date: 1/20/2023 Discharge Date: 1/23/2023    Active Hospital Problems   Diagnosis Date Noted POA ? Dysphagia 01/23/2023 Yes ? Pneumonia due to COVID-19 virus 01/21/2023 Yes ? History of seizures     ?  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Transient alteration of awareness Seizure Transient speech disturbance   HOSPITAL COURSE: Patient is a 80 y.o. male with past medical history of seizure on carbamazepine, eosinophilic esophagitis, BPH who presented for altered mental status with concern for stroke versus seizure. Patient's wife reported increasing confusion and EMS found R side weakness and L eye visual field deficits. Neurology was consulted given neurological history and potential stroke etiology. Outside of window for thrombolytics.    Acute CVA workup unrevealing, including negative brain MRI, CTA, and CT. EEG also negative for seizures. Neurology was consulted and, based off MRI and EEG findings, assessed toxic encephalopathy 2/2 COVID as most likely cause. Given the unilateral weakness and confusion upon arrival has gradually improved and since resolved, the time course of recovery also consistent with this etiology. Family was seen at bedside prior to discharge and confirmed patient back to baseline mentation and ambulation. PT/OT initially recommending SNF but, at final assessment on day of discharge, recommended home with no services.   Patient was also treated for acute hypoxic respiratory failure secondary to an acute COVID-19 infection initially requiring 4L oxygen. He was given 3 days of remdesivir, decadron. He was able to be weaned to room air at rest and while ambulating. Patient to be discharged with decadron taper. Two nights prior to discharge, a 10 second run of V Tach was observed on telemetry, which resolved without intervention. Subsequent echo showed somewhat asymmetric septal hypertrophy but normal EF of 63% and no significant valvular abnormalities. Recommended outpatient cardiology f/u for further investigation into potential arrhythmia, communicated this to patient prior to d/c. CONSULTS / RECOMMENDATION: Inpatient consult to neurology - stroke workup negative for acute process, EEG and MRI consistent with covid encephalopathy Inpatient PT/OT/SLP - cleared for discharge home without assistance Outpatient cardiology - recommended outpatient followup on potential arrythmia
Epilepsy; Seizures; ADHD; Allergic to the Pertussis portion; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal epilepsy in a infant patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, less than a year after receiving DTPa vaccine, the patient experienced grand mal epilepsy (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), attention deficit hyperactivity disorder and drug allergy. On an unknown date, the outcome of the grand mal epilepsy, seizure, attention deficit hyperactivity disorder and drug allergy were unknown.   It was unknown if the reporter considered the grand mal epilepsy, seizure, attention deficit hyperactivity disorder and drug allergy to be related to DTPa vaccine.  Additional details were reported as follows:  The age at vaccination was not reported. The patient stated that he/she received vaccine 3 time at 1st year of life. The patient was allergic to the Pertussis portion and still received vaccine which led to documented hypersensitivity to administered product.  The patient experienced epilepsy with grand mal seizure, Attention deficit hyperactivity disorder. The patient stated that he/he heard Tdap was much safer than the DPT shot from old time. The patient still willing to do what he/she must for his/her  children though. For tolerance of 2nd and 3rd dose refer case US2020AMR228496 and US2020AMR228497 respectively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR228496:2nd Dose US-GLAXOSMITHKLINE-US2020AMR228497:3rd dose
Vaccine was administered on 10/06/2022. Batch number FL8095 expiration date was 08/31/2022. Letter from Pfizer and manager confirmed stability data that shows support for the use of the vaccine batch number FL8094 and FL8095 for 18 months from the date of manufacture plus seven days, which is on or before 04/04/23. Pt did not report any adverse effects.
pfizer 12+ cov2 tris vaccine ordered.... 5-11yo dose given
Clinical Summary Patient is a 98 y.o. female with a history of COPD and RA presented to hospital11/6/2022 with SOB, Cough, and sputum production. Found to have COVID-19 infection. Improved with steroids. Discharged to SNF 11/9/22.    1. COVID-19 Infection: Vaccinated with Pfizer 1/2021 and 2/2021 without booster. Sx starting 10/28/2022. Mild URI symptoms at that point. On 2L NC on admission. Isolation initiated. Out of window for other therapies. Antitussives prn. Given decadron for 10 day course end date 11/15/22.  2. Acute Hypoxic respiratory failure: Not on O2 at baseline, required 2L NC in ED. Treatment as above. Improved. 3. COPD: Not on O2 at home. Mild cough and URI symptoms since 10/28. Continued home inhaler regimen. 4. AKI: Secondary to poor PO intake in the setting of an infection. Improved with gentle IVF. Baseline Cr 0.9. Cr 1.61 on admission. UA positive without symptoms and Renal US without hydronephrosis. + 10mm renal calculus non obstructive. Cr 0.57 11/9/22. 5. Positive D-Dimer: pt denied h/o thrombosis. No calf pain. Pt elected to defer further imaging/testing to r/o PE.  6. Asymptomatic Pyuria: without symptoms. Urine Cx contaminated. No indication for antibiotic therapy. 7. HTN: started norvasc. Stopped chlorthalidone and losartan 8. Hypernatremia: Na up to 149 and started D5W IVF 11/8/22. Suspect related to poor po intake. Improved. 9. Hypokalemia: Secondary to poor PO intake. Replaced. Mag wnl. Improved. 10. Hyperglycemia: Secondary to stress. No history of DM. Monitored with steroids.  11. Iron Deficiency Anemia: Per history. Baseline Hgb 10. Hgb 10 on admission. Continued home iron replacement.  12. Rheumatoid arthritis: continued home meds 13. Code status: DNR CCA DNI
GI upset, headache, chills, muscle aches, neck pain, back pain, breast pain, arm pain, shoulder pain, myalgias.
2 months later I had two insect bites and the second day I had a severe case of hives (I have never had hives before). This lead to anaphylactic shock resulting in low blood pressure and passing out. EMTs administered saline/epinephrine/steroid.  Currently Doing follow up for allergies.  Stopped taking lisinopril.
Information was received 06-OCT-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX at a pharmacy on or about 08-JUN-2012, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 01-MAY-2016, the plaintiff was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The plaintiff had been prescribed tramadol, lidocaine patches and VALTREX for management of his painful symptoms. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
9:00 pm - very tired, chills and very cold; 2:00 am - extreme headache and neckache; very tired and slept until 6:00 pm Friday.
Large, warm, red area beginning about 2 inches below injection site, and continuing to elbow.
Pt stated she had 5 seizures approximately 2 days after receiving both the flu and RSV vaccine at the same time.
Large raised, red burning area just below vaccination site, followed by nausea, headache, general achiness for about 4 days.
Received a fever 103.5; Tired; This is a spontaneous case reported by other non-health care professional to agency (reference number: SEQ19-06766) and initially received on 18-Nov-2019, concerning a 5-year-old, female patient.  The patient had no medical history and did not take any concomitant medications.  On 16-Nov-2019, the patient was administered Flucelvax Tetra [Influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 263334, dose: 0.5 ml, route of administration: intramuscular, expiration date: 30-Jun-2020 and anatomical location: deltoid] for influenza prophylaxis.  On 17-Nov-2019, the patient was fussy and tired. The patient also developed a fever 103.5. The patient received treatment with Motrin (ibuprofen).  On 18-Nov-2019, fever was 99.7  At the time of initial reporting, the patient was recovering from the event of fever and outcome of the event fatigue was not recovered.  The reporter did not provide causality assessment.  Reporter assessed the events as non-serious.  Company comment: Events were assessed as related to Flucelvax Tetra.; Sender's Comments: Events were assessed as related to Flucelvax Tetra.
Information has been received from a licensed visiting nurse concerning a patient in his/her 30's who at some point in his/her childhood was vaccinated with a dose of MMR II (lot number not reported). It was reported that the patient was an unconfirmed case of mumps in a local correctional facility but they were pretty confident that it was going come back positive after the lab testing. The patient was not hospitalized. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. All telephone call attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Hives to arms and legs starting 2 days after vaccination and persisting despite antihistamine. Non anaphylactic reaction.
Anaphylactic reaction due to vaccination, subs encntr on 2018-02-16.
Minor itchiness by the upper body; Pain going down from the side on my neck; Warm by the rash; Rash on the chest; Soreness at injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Minor itchiness by the upper body), NECK PAIN (Pain going down from the side on my neck), FEELING HOT (Warm by the rash), RASH (Rash on the chest) and VACCINATION SITE PAIN (Soreness at injection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (Minor itchiness by the upper body), NECK PAIN (Pain going down from the side on my neck), FEELING HOT (Warm by the rash), RASH (Rash on the chest) and VACCINATION SITE PAIN (Soreness at injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (Minor itchiness by the upper body), NECK PAIN (Pain going down from the side on my neck), FEELING HOT (Warm by the rash), RASH (Rash on the chest) and VACCINATION SITE PAIN (Soreness at injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
lightning zaps in my head; headache; brain fog; numbness in my hand and arms; fatigue; big sense of being "unwell"; Random shooting pains; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 18Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 05Apr2021 at 10:45 (Batch/Lot Number: EW0151) as dose 1, single, (at the age of 39 years-old) and dose 2 via an unspecified route of administration, administered in the left arm on 26Apr2021 at 10:45 (Batch/Lot Number: ER8736) as dose 2, single (at the age of 39 years-old) for COVID-19 immunisation.  The patient had no relevant medical history.  It was unknown if the patient was pregnant. It was unknown if the patient had COVID prior to the vaccination. It was unknown if the patient had been tested for COVID post vaccination. There were no concomitant medications.  There were no prior vaccinations within 4 weeks. The patient experienced lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains; all on an unknown date. The events required an emergency room visit.  The clinical course is as follows: the patient went to the emergency room after a cascade of scary effects. The patient's head felt like it was bleeding internally. The patient had numbness in her hands and arms for about a month. The patient had a headache for about a month. The patient felt out of her body (brain fog), fatigue and a very big sense of being "unwell". Random shooting pains, lightning zaps in her head. The patient did not undergo any relevant tests. The events did not require the initiation of new medications, other treatment or procedure. The patient recovered from the events lightning zaps in my head, headache, brain fog, numbness in my hand and arms, fatigue, big sense of being "unwell",  and random shooting pains on 06Jun2021.
fever,nausea approx 4-6hrs post inj;mantoux arm neg;REC- observation,recheck @ 24hr,ATB as needed re eval
Adverse effect 1: distorted vision from about 1 hour after vaccine till at least 8 but not more than 24 hours after. Vision clear not blurred, but distorted as if with an incorrect eyeglasses prescription or viewing through a curved lens. Symptoms gone after one day, but increased sensitivity to bright lights noticed from approximately one month after vaccine, through to present submission date and still current.    [Only able to list one vaccine date in this form. With first dose of Pfizer vaccine Lot EW0151 (or EW01S1 -- 5th digit can't be determined from provider's handwriting), distorted vision occurred from 20 minutes after vaccine till about 30 minutes after, lasting about 10 minutes.]  Adverse effect 2: greatly altered menstrual cycle. Typical cycle prior to vaccine has been regular for two decades, on average about 28-30 days in length. After vaccine, cycle shortened to between 16-18 days; condition persisted at this altered length for about 9 months after vaccine; currently has increased to approximately 21-23 days, but still not normal as of current date of submission (nearly 10 months post vaccine). Patient never experienced alterations to menstrual cycle from any other disease, vaccine, or stressful event prior to this time.   No treatment has yet been used; uncertain if treatment exists for these symptoms. It is also uncertain at this date whether this will be permanent damage, long-term damage, or will eventually heal.   All other vaccine aftereffects were what might reasonably be expected from CDC publications, and fairly mild and not lasting more than 24 hours to one week. These included muscle aches, fatigue, and elevated temperature.
Left and right arms sore and achy for 3 days; felt tired and ill the night of the shot and all the next day; general malaise feeling; loss of appetite; headache; slight swelling of sinuses and rash on face.  Took Benadryl the first and second nights, used hydrocortisone cream on rash, took Tylenol. End of day three feeling better, almost normal.