chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 5 year old, male patient. No relevant medical history and concomitant medications provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal) started during 2014. The patient received two flu vaccines. Nurse stated that the patient received FLUMIST on 24-Oct-2014 and afterwards she found out that he had received another influenza vaccination 19-20 days prior. She did not know what type of vaccines was the first, nasal or injectable. Action taken with suspect was unknown. The outcome of the event of child received two flu vaccines was unknown. The reporter considered the event of child received two flu vaccines to be non-serious.
Call rec'd from pt; she wants to report a reaction to the J & J vaccine which she got this past Saturday 4/10 at 10am; her symptoms began that night at 9pm , primarily nausea and vomiting. she could not keep anything down, finally she remembered a past txment from her childhood, pepto bismol and milk; ( she had IBS as a child); her sxs persisted for about 3 days, finally on Wednesday she felt better and has been tolerating a bland diet; she is better now; pt feels that there is a strong correlation between her diabetes and the vaccine; she is asking that this be reported via the VAERS system;  pt did not experience anaphylaxis nor rashes/urticaria, nor any classic blood clot sxs; rn
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected. Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
patient received full 3rd dose despite no pre-existing conditions; slight upset stomach; I'm feeling kind of blah; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received full 3rd dose despite no pre-existing conditions), PAIN (body aches), FEELING ABNORMAL (I'm feeling kind of blah), ABDOMINAL DISCOMFORT (slight upset stomach) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced PAIN (body aches) and CHILLS (chills). On 21-Oct-2021, the patient experienced FEELING ABNORMAL (I'm feeling kind of blah). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient received full 3rd dose despite no pre-existing conditions) and ABDOMINAL DISCOMFORT (slight upset stomach). On 20-Oct-2021, CHILLS (chills) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (patient received full 3rd dose despite no pre-existing conditions) had resolved, PAIN (body aches) had not resolved and FEELING ABNORMAL (I'm feeling kind of blah) and ABDOMINAL DISCOMFORT (slight upset stomach) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow-up received contains NNI
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 18-Sep-2013. The patient experienced cold symptoms which started on 19-Sep-2013. At the time of reporting, the event of cold symptoms was improving. The report was considered to be non-serious.
Pt recvd a series of 3 Engerix-B vax 4JUN90, 20JUL90, & 3DEC90 did not seroprotect p/3rd dose; Pt recvd a 4th dose on 25JAN91 did not seroprotect p/4th dose; recvd 5th & 6th vax on 8MAY91 & 25JUL91; seroprotected p/6th dose;
Swelling in lymph node at armpit chest side. Started icing and heat on 25th. On the 28th it moved to deltoid and my hand began to feel numb. My Dr suggested Zyrtec. It is improving.
This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with the first shot of GARDASIL. No concomitant medication was reported. The reporter stated that after receiving his first shot of GARDASIL he experienced (unspecified) bleeding. The reporter added that her son still has not yet received the 2nd or 3rd dose of GARDASIL and was not vaccinated with the recalled batch of the vaccine. The outcome of bleeding is unknown. The reporter did not provide a causality statement. No further information was provided. Additional information is not expected.
1 month after receiving GARDASIL pt. would periodically experience tingling & numbness in her lower extremities which lasted for approximately 2 months - no other symptoms. No longer has this problem.
I got an extra - extended - period. I spotted and bleed for almost a month after the shot from April 2nd - April 29th. I also had the regular initial symptoms for 3 days after the shot. But that's not my issue. The issue is the extra - extended - period. I don't normally have this problem, my cycles are regular. It's now May 12 and I haven't got my period since April 29th. Hopefully, this is over and I'll return to my regular cycle.
Restrictions - No shoulder work, no lifting > 10 pounds. Onset on pain left arm 5 days before 10-26-09 with increasing pain tenderness over anterior shoulder along bicepital tendon. Heated puncture wound over deltoid without erythema tenderness and swelling. Not related to flu shot per physician.
My right leg was completely paralyzed; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (My right leg was completely paralyzed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Primary progressive multiple sclerosis, Walking difficulty (Drop foot), Weakness in extremity (weak leg) and Foot drop. Concomitant products included OCRELIZUMAB (OCREVUS), DALFAMPRIDINE, GABAPENTIN (NEURONTIN) and CLOZAPINE for an unknown indication.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced MONOPLEGIA (My right leg was completely paralyzed) (seriousness criterion medically significant). At the time of the report, MONOPLEGIA (My right leg was completely paralyzed) had resolved.            In MAR-2021, patient started therapy with Moderna COVID-19 vaccine for unknown indication. In MAR-2021, after second COVID-19 vaccination patient's right leg was completely paralyzed.  No treatment information was provided.  Company comment: This spontaneous case concerns a 69 year old female patient with concurrent Primary progressive multiple sclerosis with drop foot, who experienced the unexpected serious (medically significant) event of Monoplegia, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient stated that her right leg was completely paralyzed after the vaccine. No information on detailed clinical course, relevant investigations, treatment of the event and details pertaining to the first dose was available in the report. The event resolved. Underlying Primary progressive multiple sclerosis with drop foot could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female patient with concurrent Primary progressive multiple sclerosis with drop foot, who experienced the unexpected serious (medically significant) event of Monoplegia, unknown days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient stated that her right leg was completely paralyzed after the vaccine. No information on detailed clinical course, relevant investigations, treatment of the event and details pertaining to the first dose was available in the report. The event resolved. Underlying Primary progressive multiple sclerosis with drop foot could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a registered nurse and an administering healthcare professional concerning a 13 year old male patient with a history of meningitis, group B Streptococci, wet lung and seizures who on 21-DEC-2011 at 14:19 was vaccinated with the second dose of GARDASIL (lot number 670050/1229AA), I.M., right deltoid (dose not reported) at private doctor's office/hospital. The immunization with GARDASIL was reported due to out of temperature range, fridge temperature fell below 32 degrees F (it was also reported as 30 degrees F) over 16 day period. It was reported that no adverse reaction occurred. On 11-FEB-2012, the patient was revaccinated with GARDASIL (dose, route and lot number not reported). Follow up information has been received from a registered nurse concerning a 13 year old male patient, who received his first dose of GARDASIL on 20-OCT-2011, second dose on 21-DEC-2011, and this dose was exposed to altered temperatures, third dose on 11-FEB-2012 and fourth dose on 23-APR-2012. There were no adverse event reported. This is one of several reports received from the same source. Follow up information has been received from an other health professional refers to the 13 years old male patient. The patient's medical history included spinal meningitis, streptococcus, group b, wet lung and seizures (resolved). The reporter stated that no adverse event, immunization being reported due to out of temperature range. Fridge temperature fell below 32 degrees F. Patient was re-vaccinated for 0.5 ml GARDASIL (lot # 670050/1229AA) on 11-FEB-2012 at 14:19, IM right deltoid. No relevant diagnostic test and laboratory data performed. No prior vaccination adverse events. Additional information is not expected.
April 10th ( 3 days after shot) developed irritability, cold drenching sweats, chills,  headache, fatigue that lasted 4 days continuously.  For the next month it came and went with no rhyme or reason. For the months of May, June, July. I have experienced the same symptoms (hot sweats, chills at least 2/3 days a week.  When not actively having the cold chills and hot sweats I am experiencing fatique , headaches and irritability..
Information has been received from a pharmacist referring to a 53 year old female patient with asplenia. The patient was allergic to unspecified cephalosporins and unspecified corticosteroids. Concomitant therapies included morphine (manufacturer unknown). On 03-OCT-2016, the patient received a dose of PNEUMOVAX 23 (lot # was reported as M035104, expiration date 06-MAY-2018; 0.5 ml, once; intramuscular) (reported as "she was indicated for it"). On 04-OCT-2016, the patient developed a 2 by 3 inch patch of redness,  that was itchy, which had moved down her arm from the injection site at the deltoid toward the bicep. It was a red patch of irritation with a little lump at the injection site. The patient was seen by the pharmacist on 05-OCT-2016 in regards to the reaction. No treatment was given for the events and no lab diagnostics studies were performed. At the reporting time, the patient did not recover from the events. The causality was not reported. Additional information has been requested.
Within ~12 hours of receipt of 3rd dose of vaccine on 9/3/21, patietn( who has advanced multiple sclerosis) was noted to be moaning in sleep.  Throughout 9/4/21, she was lethargic, somnolent, unresponsive, not verbalizing.  On 9/5/21, these symptoms persisting, she was noted to be encephalopathic and to have right hemiparesis and was taken to medical center where she was febrile, experiencing SVT and having electrical status epilepticus (per VEEG).  A CT scan of the brain w/wo contrast did not reveal evidence of a CVA.   Serum lactate=12.  LP (? traumatic) was performed.  Empiric broad-spectrum antibiotics (including acyclovir) initiated.  Hospitalized in Medical Step-Down Unit. Developed not-specific  sparce macular-papular rash on 9/6/21.   Seizures treated with Keppra and resolved.  Sensorium and right hemiparesis improved/improving; remains hospitalized as of date of this report (9/9/21).  Awaiting MRI of the brain (to assess status of MS and acute encephalopathy).
Received Flu vaccine at Wellness fair around 1330. Noticed lip tingling and swelling at around 8PM. Took Benadryl 50mg tablet to relieve symptoms.
administered Fluzone High-Dose to a breastfeeding mother, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA263295 (mother case).  This case involves infant patient who was exposed to 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ238AB Expiry date 14-Apr-2020) at the time of lactation, via transmammary route, on 19-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to vaccine exposure via breast milk.   At a 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 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.  List of documents held by sender: none.
30' after jab patient developed "heart burn" and chest discomfort. No SOB/palpitations. He has had same sx's previously after eating spicy foods (did not ate spicy foods prior to jab). sx's lasted for 20' and resolved on its own. sx's re-occurred throughout the day and went to ER 9/23/21 at 700 pm. was evaluated (no labs done) and tx with GI Cocktail and sx's resolved and discharge home. Sx's lasted off/on for a week and resolved. seen at our clinic 10/12/21 and asymptomatic and normal physical exam.
PARENTS REPORT IRRITABILITY, FEVER AND PROLONGED STARING SPELL WHILE PATIENT WAS SITTING UP.  HER NECK HAD ABNORMAL MOVEMENTS - DESCRIBED AS SMALL AND INVOLUNTARY AND JERKING BY HER PARENTS.  VOMITED THE MORNING ON 10/16/2014.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-APR-2010, the patient was inoculated with ZOSTAVAX at a Medical Center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles, and permanent nerve damage and residual pain. On or about 23-MAY-2015, the patient was treated by a physician at the office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. On or about 03-JUL-2015, he received subsequent treatment from a physician at a hospital for worsening symptoms of shingles, which had broken out continuously since his initial diagnosis of shingles. At this encounter, the patient reported issues of neurological interference, persistent burning sensation on his head, and migraine headaches, which were collectively diagnosed as post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. He was prescribed NORCO, oxycodone-acetaminophen, "famicyclovir", hydrocodone-acetaminophen, and increasing doses of gabapentin for management of his painful persistent symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The lawyer considered post-herpetic neuralgia to be disabling. Additional information has been requested.
Per pt report, heart rate increased significantly after vaccine administration.  Pt was taken to the local ER for observation.  Was able to return home same day.
I had confusion with servire mental terror attacks that lasted two days. They lasted a few seconds each.
Administered FLUMIST with expiration date 2/3/09 on 2/12/09. No apparent adverse event.
After receiving vaccination, during 15 minute waiting period, patient felt weak and lightheaded. Father gave her a banana to eat and the pharmacy supplied her with water to drink. About 15 minutes after completion she felt much better and they headed home.
This patient has received 3 doses of COVID vaccine. Her first dose was J&J on 3/5/21. Her second dose of vaccine on 9/20/2021 (should have been a booster dose) was documented on the patient's CDC COVID vaccine card as a Moderna dose (volume not specified on card) with lot # 037F21A, however in database it is documented as a purple cap pfizer dose (0.3mL). Her third dose of vaccine was administered on 10/25/21 and was documented as a 0.5mL dose of Moderna. This third dose should have been a booster dose volume of 0.25mL. This second booster was also administered only 35 days after the first booster dose was given which is under the recommended interval length.
Pt vaccinated with MMR developed local reaction noted at injection site, red rash spreaded to chest & back. Given Epinephrine SQ.
admitted due to fatigue, weakness, right lower ext redness, acute encephalopathy secondary to fever notes document patient states cellulitis flares after any vaccination  Severe sepsis requiring ICU treatment, treated with supportive care and antibiotics for 5 days and discharged on oral antibiotics
Administered first dose of Novavax vaccine before realizing patient had received a dose of Pfizer 11 months prior. No reported injection reactions. Patient has been notified of the mistake.
Similar to the second Pfizer shot I received, with a couple of hours of receiving the injection, my upper left arm was so sore it was too painful to move or touch at all, and 11 hours after the injection, my entire body began intensely aching, and I experienced fever, chills, full body aches, and fatigue for 35 hours before I began to feel better. Subjectively, the symptoms were worse than the second shot, which I also reported to VAERS.
Minor tenderness on chest, about two inches below the left end of the left clavicle. A distinct small lump, tender to the touch, is felt just under the skin.
Nausea, chills, low grade fever, headache, lethargy, right arm soreness. I woke up around 5am and noticed these symptoms.
Patient called me 1 day after her vaccination and stated she had a reaction to the pneumococcal shot she received the day before. C/o of slight chills the night of shot, hardness and pain at injection site and tiredness.
No additional AEs; HCP called to report that MMR II with temp excursion on 22-NOV-2022 was administered on 23-NOV-2022; This spontaneous report was received from a physician and refers to a 12-month-old female patient.  The patient's birth weight was 3.048 kg, she had two siblings, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.   On 23-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at dose 0.5ml, once (lot number W009107 was verified to be a valid number, expiration date reported and established as 04-DEC-2023, administered subcutaneously in the right thigh (vaccination scheme and strength were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (lot number w018836 was verified to be a valid number, expiration date reported and established as 14-JUN-2024), administered subcutaneously in the left thigh (dose, vaccination scheme and strength were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot  number w023937 was verified to be a valid number, expiration date reported and established as 06-DEC-2023), administered intramuscularly in the left thigh (dose, vaccination scheme and strength were not provided); and  influenza vaccine inact split 3v (FLULAVAL) (lot number 5m2h2, expiration date: 30-JUN-2023) administered intramuscularly in the right thigh (dose, vaccination scheme and strength were not provided), all the vaccines were administered for prophylaxis. The vaccines were administered at privade doctor's office/hospital with public funds by a health care professional. On 22-NOV-2022 (reported as night prior), the vaccines underwent a temperature excursion (product storage error). No additional adverse event were reported.
Information has been received from a pharmacist concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent and subsequently, the pt experienced injection site redness, "localized reactions". The pt also experienced a streak down the arm. The pt sought unspecified medical attention.
No additional adverse events; Nurse reports on 15-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reaction, or allergies was not provided.  On 15-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S036635, which have been verified to be valid, expiration date reported and validated as 14-NOV-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).  On an unknown dates, the vaccine was stored in a temperatures of -14 degrees Celsius to -10 degrees C (-11.1 degrees C) for 2 hours; -9 degrees C to 8 degrees C (2.2 degrees C) for 9 hours and 30 minutes; -14 degrees C to -10 degrees C (-9.8 degrees C) for 2 hours and 30 minutes; and -9 degrees C to 8 degrees C (0.4 degrees C) for 3 hours; as recorded by a digital data logger. The previous temperature excursion was of -9 degrees C to 8 degrees C (-6.1 degrees C) for 8 hours. No adverse events were reported.
As doctor inserted needle in the deltoid Right arm and began to give pneumonia vaccine there was a leakage between the needle and hub; therefore client did not get full dose. Spoke with CDC said to repeat dose now.
Swelling of left eyeball. The white of the eye was swollen and almost fluid filled.
Patient felt BP was increasing, and felt very tired. BP 141/72 (pulse 78). Felt better 5 minutes later.
Patient's arm turned red and swollen. Patient got a fever and headache. Stated feeling better the following day.
Hives have been consistently developing over the last two days around his belly and now some are starting  around his armpits
High fever 102.6 documented, 103.3 at home, in office (TM) and non-bilous/non-bloody emesis 5 x within 24 hours.