chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue Narrative:  No further details given
Fever 103.3; chills; aches, stiffness; pain and swelling at injection site.
Admitted to hospital on 4/10 with 2 day history of mydriasis, diplopia with blurry vision, dizziness and balance difficulty. Found to have enhancement of 6th and 3rd CNs on MRI. Patient continued to have blurry and double vision during her stay and mild gait instability. She developed mild frontal headache managed with Tylenol. Her exam was remarkable for mydriasis, mild lateral gaze limitation R>L, mild dysmetria, dizziness and unsteady gait without notable ataxia. No papilledema. Her reflexes were 2+ in her BL UE and LEs.  Pediatric Neurology and ophthalmology consulted and followed patient. Eye exam remarkable for bilateral cranial nerve 6 palsy but no other element of CN3 palsy and bilateral dilated but unreactive pupils. Patient treated with IVIG 1mg/kg/day x2 days for likely miller fisher syndrome variant of Guillain-Barre.
shingles; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 61-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration (at the age of 61-years), administered in arm left on 20Apr2021 at 14:30 as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in arm left on 30Mar2021 at 14:45 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The patient had no known allergies. The vaccine facility type was reported as other. No other medications were received within two weeks. On 23Apr2021, the patient experienced shingles. It was reported that symptoms were started 2 or 3 days after the vaccine on 20Apr21 and prescribed valacyclovir on 27Apr2021. The treatment was received for the adverse event with valacyclovir 1gm 3 for 7 days. The adverse events resulted in physician office visit. The patient underwent lab tests and procedures which included investigation: shingles on 27Apr2021. The clinical outcome of the event was reported as recovering.
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. On or about 31-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of his painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
She received her 2nd Series of the HPV shot March of 2017, a few days later she began to complain about pain in her arm and the tenderness it started to turn red I contacted the Doctors office and they advised her to apply a hot suppressant to her arm to move the medicine around after the 2nd visit, the injection site began to get worse we contacted the doctor and they began to treat it with antibiotics until the exhausted the antibiotics they then referred her to a surgeon. On Nov 06 2017 she woke up in severe pain and her arm locked up on her. I rushed her to hospital and after the MRI Dr diagnosed her with a abscess he removed the abscess after the surgery she began to have problems again and ins currently in treatment for what she is now diagnosed as a tumor.
REDNESS, TENDERNESS, AND BRUISING FROM LOWER UPPER ARM TO MID FOREARM.
Information has been received from a investigator concerning a 71 year old male with an enlarged prostate (April 2005) and an allergy to Sulfonamide who entered a study. On 29 Nov 2006, the patient was vaccinated SC in the deltoid with a 0.65 ml dose of varicella Zoster vaccine. Concomitant vaccination on 15 Nov 2006 included a dose of influenza virus vaccine (unspecified). On 29 Nov 2006, prior to vaccination with study therapy, the patient arose early and went exercising without having breakfast. The patient was then screened and vaccainted with Varicella Zoster vaccine. He was observed for 30 minutes and was released feeling well. The patient went home and had breakfast that consisted of eggs and cinnamon bread. Two hours post vaccination, the patient suddenly felt dizzy and nauseated followed by episodes of vomiting. The patient also experienced the sensation of numbness affection his arms, legs and neck. The patient felt clammy and looked pale to his wife who called the study site and spoke with the investigator and his primary care physician. The patient was taken by ambulance to the emergency room on 29 Nov 2006 for nausea, vomiting and vertigo. he was hospitalized for 24 hours in the emergency room and was discharged on 30 Nov 2006. The discharge diagnosis was rule out myocardial infarction with the additional diagnoses of benign paroxym\smal vertigo, dehydration, possible allergic reaction to varicella zoster vaccine. On 01 Dec 2006, the patient was called post release from the emergency department and he felt well. Again, he skipped breakfast and went to exercise. He arrived home to feel lightheaded and fatigues. He took a nap and felt better. On 04 Dec 2006, the patient was called again for an update. He rested over the weekend without further nausea or vomiting. He stated that he felt about 90 percent. Again, he exercised without breakfast and felt lightheaded. He stated the he has continued to have intermittent feelings of dizziness. The patient considered recovered on 30 Nov 2006. The patient's nausea, vomiting and vertigo was considered to be other important medical events (OMIC). The reporter felt that the patients nausea, vomiting and vertigo was possibly related to vaccination with varicella Zoster vaccine. Additional information has been requested.
Information has been received from a bachelor of science in nursing concerning a 17 year old male patient with no pertinent medical history and no drug reactions or allergies, who "a couple of weeks ago" was vaccinated with a first dose of GARDASIL (Lot # not reported). There was no concomitant medication. The nurse reported that "a couple of weeks ago" the patient experienced dizziness and became diaphoretic. There was no lab diagnosis/performed. The patient was treated with cool compresses and observation in office for 15 minutes. The patient had fully recovered later the same day. Additional information has been requested.
Received First Dose of Heplisav-B, and 2nd Does of Twinrix; IInitial report received on 14-Aug-2023  A registered nurse reported that a 25-year-old patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first injection and Twinrix (hepatitis A and hepatitis B vaccine) as the second injection.  No relevant medical history, concomitant medications, or allergies at the time of vaccination were reported.  On 30-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot # 942761, expiration date 31 Aug-2025, NDC # not available) intramuscularly in the left deltoid.  On 14-Aug-2023, 46 days after having been vaccinated with HEPLISAV-B, the patient received Twinrix (no details were provided) as the second injection.     No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 temperature, fatigue, and had the shakes.  This was from Wednesday night through Thursday. Felt better on Friday.
Employee developed some anxiety, heart racing and tingling in her lips.  this resolved on its own after 10 minutes.
Anaphylactic Reaction /ER Visit Required; red hive's spots; shortness of breath /could not breathe / could not talk; could not swallow; could not talk; This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) (batch number XN54L, expiry date unknown) for prophylaxis.   On 3rd October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On 3rd October 2017, 10 min after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), erythema urticarial, shortness of breath, unable to swallow and speech disorder. The patient was treated with ambiguous medication nos (Epipen (Nos)), benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved and the outcome of the erythema urticarial, shortness of breath, unable to swallow and speech disorder were unknown.   It was unknown if the reporter considered the anaphylactic reaction, erythema urticarial, shortness of breath, unable to swallow and speech disorder to be related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional details were provided as follows: The reporter was the patient. The patient received Flu vaccine without preservatives in left deltoid. She did not know the name of the vaccine, but known that it was manufactured by GSK. The patient had an anaphylactic reaction and had to be sent to the emergency room. The patient stated that in 10 minutes, she had red hives spots and after 20 minutes she had shortness of breath, where she could not breathe, could not swallow and could not talk. The patient was given an EpiPen, Benadryl and Steroids. The patient was provided with the date 27th July 2015. The reporter consented to follow up with health care professional.
It was reported that a pt allergic to yeast received hepatitis b vaccine recombinant (yeast), subsequently the pt had a reaction to the vaccine given a long time ago.
8PM pt devel tachypnea & followed w/apnea for about 1 min & recovered; had 7-8 episodes; completely recovered in the morning;
Initial misuse report received from a healthcare professional 27 June 2013. A 13-month-old patient had received a dose of ADACEL vaccine instead of DTaP vaccine. No adverse event was reported. List of documents held by sender: none.
The pt's son reported that the pt, a 67 year old man, received a Fluzone vaccination, lot U0673FA, on 10/30/01. On 10/31/01, the pt experienced some form of seizure activity that resulted in hospitalization in the ICU on ventilation support. The physician is conducting further testing to establish the cause. Etiology to be determined.
Pt. came back and had some slight mild/moderate red bumps (scattered) on both forearms and reported itching. Advised pt. to take some diphenhydramine (Benadryl) to help with symptoms and seek emergent medical care if symptoms of possible allergy become more moderate to severe. Pt. acknowledged and will reconsider administering 2nd dose 2-6 months from now.
Severe diarrhea after second shot. Ongoing. Severe diarrhea after first shot as well. Diarrhea after first shot lasted 4 days. Went to doctor.
postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On 27-MAY-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and postherpetic neuralgia was not recovered. The causality assessment was considered as related by the lawyer.  The events herpes zoster and postherpetic neuralgia were considered to be disabling by the lawyer.
chills & fever 6hr p/vax;very large local painful rxn (5x8in);
Patient presents a week after the administration of the vaccine a left side facial paralysis and 2 days before the paralysis had a pressure on the left side posterior.
Information has been received from a nurse concerning a 17 year old female with idiopathic thrombocytopenia purpura, eczema, penicillin allergy and a drug hypersensitivity to nitrofurantoin (macrobid) (shortness of breath, systemic reaction) who on 27-JUN-2007 was vaccinated IM with 0.5 mL first dose of Gardasil (Lot#657737/0522U). Concomitant therapy included eythinyl estradiol/norgestimate (ORTHO TRI CYCLEN) and ranitidine HCl (ZANTAC). 7-10 days post vaccination on approximately 04-JUL-2007 the patient experienced an injection site reaction. The symptoms were described as a raised injection site, abouth the size of a half dollar. The patient reported that a day and a half later (date not specified) the reaction resolved. The patient reported the event to the nurse following the appointment. Additional information has been requested.
Dizziness, Fever, INJECTION SITE SWELLING; LYMPH NODE SWELLING; FATIGUE; JOINT PAIN Narrative: EMPLOYEE STATES 10/28: VACCINE 10/29-10/30 VERTIGO, SWELLING AT INJECTION SITE EXTENDING TO NECK WITH SIGNIFICANT HEAT; FEVER 100.8; JOINT PAIN; FATIGUE 10/31 SWELLING DECREASED BUT DISCOVERED LYMPH NODE SWELLING IN NECK LOW GRADE FEVER; DIZZINESS; FATIGUE 11/1 PAIN AT INJECTI90N SITE RED/SWOLLEN; STILL SWOLLEN LYMPH NODES IN NECK AND SHOULDER PAIN, FATIGUE
Pfizer 1st dose administered at COVID-19 Clinic. Client reported being diagnosed with COVID-19 during the last week of September 2020. Reviewed with client what to expect with side effects after receiving 1st dose. No questions or concerns voiced. Gave vaccine at 1505. Mother then stated after vaccine administered that client has history of syncopal episodes after vaccines. Provided water to client and recommended for client to be moved to a supine position. Client declined lying down. About 1506, client lost consciousness for 4 seconds. Client returned to consciousness without intervention and was alert and oriented x 4. Client had 10mL emesis after returning to consciousness. Recommended for client to lie down, client declined. Provided graham crackers and cycling floor fan. Client able to tolerate water and graham crackers. After 5 minutes, client stated feeling better. Mother elaborated that about 1 year ago had first vagal response to needles when having wisdom teeth removed. Happened again during IV initiation for tonsillectomy surgery and during flu vaccination 2020. Monitored client in clinic room for 20 minutes, no further reaction. Advised for client to state needing to lie down when returns for 2nd dose. Client and mother verbalize understanding. Mother escorted client from clinic to private vehicle.
Pt recv vax on 1/8/99; on 1/9/99 pt exp red knot on rt leg w/ white center, fever; tx=Benadryl & topical Benadryl cream; pt im 1/10/99
Feeling very hot; Sharp pain to lower back; Panic attack; Full blown effect on their mental health condition; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling very hot), BACK PAIN (Sharp pain to lower back), PANIC ATTACK (Panic attack) and EMOTIONAL DISTRESS (Full blown effect on their mental health condition) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Anxiety, DICLOFENAC POTASSIUM (VOLTAREN ACTI) and METHOCARBAMOL (ROBAXIN) for Arthritis, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, Adapex                                                         Weight loss and METFORMIN for Weight loss.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FEELING HOT (Feeling very hot), BACK PAIN (Sharp pain to lower back), PANIC ATTACK (Panic attack) and EMOTIONAL DISTRESS (Full blown effect on their mental health condition). At the time of the report, FEELING HOT (Feeling very hot), BACK PAIN (Sharp pain to lower back), PANIC ATTACK (Panic attack) and EMOTIONAL DISTRESS (Full blown effect on their mental health condition) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt received Varicella #2 on 3/14/13. Pt developed redness & significant swelling & warmth on (L) arm from mid deltoid to elbow. Pt was evaluated in clinic on 3/16/13.
Pounding headache, fever, shakiness, dizziness, muscles and joints hurt to the point there was no position I could find comfort in.   Lasted about 20 hours. Tylenol and IB only dulled the pain. I did not go to the Dr for it, I just rode it out. I have never felt that bad in my life
Case number PHEH2014US019169 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 61 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2013/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with an improperly store dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA011216: US-009507513-1710USA011218: US-009507513-1710USA011215.
i went to unspecified clinic and recieved my J&J covid 19 shot on 4-2-21 in my arm. On 4-4-21 i woke up with pain under my left breast and around to my back. at first it was just pain then i got a rash looking spot under my left breast as time progressed more rash looking spots appeared and what seemed like blisters. .  i called the unspecified clinic and  they told me to come in and see the doc.  he informed me that i had the shingles. Postherpetic neuralgia secondary shingles.. today i was given more meds and i am to see him in another week
suffered an allergic reaction almost immediately; everything was blurry; Throat tightness; Told to sit down but couldn't move; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (suffered an allergic reaction almost immediately), VISION BLURRED (everything was blurry), THROAT TIGHTNESS (Throat tightness) and HYPOKINESIA (Told to sit down but couldn't move) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic reaction to sulfas).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (suffered an allergic reaction almost immediately), VISION BLURRED (everything was blurry), THROAT TIGHTNESS (Throat tightness) and HYPOKINESIA (Told to sit down but couldn't move). At the time of the report, HYPERSENSITIVITY (suffered an allergic reaction almost immediately), VISION BLURRED (everything was blurry), THROAT TIGHTNESS (Throat tightness) and HYPOKINESIA (Told to sit down but couldn't move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment drug include Epi Pen.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: FU- events added On 28-Apr-2021: Email address provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning a 3 year  old male who on approximately 12/06/1998 was vaccinated with varicella vaccine. On approximately 04/26/2001 the pt was diagnosed with shingles. the pt was seen for follow-up on 05/03/2001 and all sores had cursted over and the pt was better. No further details were provided. Additional info has been requested.
11/7/12 Pharmacist admin. Started itching 3 hrs got worse, left arm had a hand size red patch, swollen, hard knot underneath site - saw MD 11/12 "almost anaphylactic shock" prednisone #20 SIG 4 qd x5d.
Onset 2/18/21 evening (after receiving vaccination during the afternoon).  Started with "tingling" in face, progressed to Right-side Facial drooping, increase salivation. Lose of sensation to left side of tongue and nostril (numbness). Decreased muscle tone to left eye (can't close completely). Blurry vision bilaterally. Possible Bell's Palsy ???  Facial drooping still mildly present as of 3/2/21.