chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting on the day of the vaccine, my arm felt sore (nothing abnormal).  I had a little bit of joint pain and felt tired.  The joint soreness slowly went away but the vaccine site (right arm) felt very sore and did not go away.  About a month afterwards, I started to notice weakness and could not lift anything heavy with my right arm.  About a month later, I went to my PCP and he recommended a nerve conduction test, which I was able to schedule for  April 2021.  I was sent for blood work and X-ray in March, which all came back normal.  In 5/2021 I also tore my ACL when getting up from the sofa and had a MRI to  confirm (6/2021).   Not sure if related but I still want to report.  I am are still recovering. I still am suffering from  right arm weakness.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about, 01-MAR-2013, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) 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. On or about 19-OCT-2015, the patient was treated by a physician for a vesicular rash, which was diagnosed as severe herpes zoster, or shingles. 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.
10 yr old previously healthy, presents for neck swelling x 1 day. No fevers, cough, congestion or other symptoms. Patient had received influenza vaccine on 11/12/21 and COVID Pfizer vaccine on 11/6/21. Neck swelling was suspected to be salivary gland - specifically submandibular gland swelling.
Still having a fever after a week  , which has been as high as 101 Degrees, also having some chills ,also feeling very tired and not able to do much. I also still have a place showing where the vaccine was given in right arm.
Redness, swelling, and itchiness surrounding area of the vaccination shot roughly an hour or so after injection (continuing as of the present time, 11:41 PM 6/22/2021)
Shot given 2:15 PM, left office about 3:45 PM. Pt and wife were at travel agency when ears started itching, became red, hives, felt like throat was closing up-went to ER-given oxygen and antihistamines per wife. Discharged at 5:15 PM with Prednisone and Benadryl. 7/17/03-TC-talked with wife-states pt doing fine-has appointment with PMD 1:20 PM.
24hrs p/vax pt started hives on trunk & arms, gen itching;no wheezing, facial or airway tightness or swelling;
went to the doctor / received the shingles diagnosis; blister broke; very painful and increases in pain every day; no appetite; is nauseated; malaise all over her body; blister came back with a circular red area around; flu like symptoms; Valacyclovir made her sick to her stomach; developed a pimple near the blister; blister on the arm / fluid filled blister on her left forearm /blister came back with a circular red area around; This case was reported by a consumer via call center representative and described the occurrence of blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ325, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) unknown for shingles.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir at an unknown dose and frequency. On 26th September 2020, 1 days after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced blister. On 1st October 2020, the patient experienced pimples. On an unknown date, the patient experienced shingles, blister rupture, pain, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach. The patient was treated with topical antibiotic (nos) (Antibiotic Cream (Nos)). Valacyclovir was discontinued. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema, influenza-like symptoms and upset stomach were unknown.   It was unknown if the reporter considered the blister, shingles, blister rupture, pain, pimples, appetite absent, nausea, general malaise, erythema and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the upset stomach to be related to Valacyclovir.  Additional details were provided as follows: The patient received Shingrix in her upper left arm and had blister on the arm, went to the doctor and received the shingles diagnosis. The patient developed a fluid filled blister on her left forearm. The blister broke and the blister came back with a circular red area around the blister.  The patient still had the blister and it was very painful and increases in pain every day.  The patient was seen by her MD who stated that it was possibly Shingles and prescribed Valacyclovir and an antibiotic cream.  The patient developed a pimple near the blister, but it has not developed into a blister.  The patient also had no appetite, nauseated, and was experiencing malaise all over her body and flu like symptoms.  The patient received Valacyclovir made her sick to her stomach, so she stopped taking it. The reporter did not consent to follow up. The reporter reported FAQ regarding side effects, referred caller to physician and to provide MI contact physician.
Breakthrough covid infection on 3/30/2022 at pre-op appointment for cholecystectomy. Asymptomatic. Patient received Pfizer doses on 8/17/21 and 9/7/21.
Pt experienced mild swelling to injection site 4 days after injection given. No fever. Also experienced redness and skin warmth.
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea.  Everything resolved on 1/20 and 1/21.  01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea.  In the evening hives started on hands/back/legs.  01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
About 10 min after receiving the vaccination, the patient described feeling of throat closing, coughing. Patient given IM epi with initial improvement in symptoms. No rash. On arrival to ED, no stridor, no oropharyngeal swelling, speaking normally in full sentences, clear lungs. Subsequently, patient complained of nausea, but resolved after Benadryl. Patient had recurrent "funny feeling" in throat about 3 hours into observation and had difficulty swallowing liquids, but had normal speaking voice normal oropharynx. Currently pending ENT evaluation.
The patient was vaccinated on the left thigh secondary to extensive tattoos of the deltoid areas.  The patient reported to the ED 10 days later with a  CC "redness and swelling of the area 4 cm around the site". He also had inguinal lymphadenopathy.  The patient was treated with 2grams of Ancef and kept overnight for observation. Thereafter he was released without/with unknown ABX therapy. The diagnosis was unclear  but seemed to be cellulits vs smallpox reaction.
arm soreness, muscle ache, mouth cold sore Narrative: Employee states: she experienced arm soreness for about 3 days and muscle aches on 1/10/2021 she had a mouth "cold sore" which has since resolved
Child c/o chest pain & tightness in throat 5 min after vaccines given.  No hives, no SOB, VS stable - sent to ED for care.
Patient received booster dose at 3:37pm when should have received first dose in series. We identified and corrected by administering a second booster dose (i.e. qs to full first dose) at 5pm. Patient did not have any adverse events from this.
I have a history of mild to moderate hearing loss. within 2 months of the first two shots I lost almost all hearing in my right ear and no noticeable loss in my left.   I  saw and ENT Dr. , had a hearing test, an MRI which ruled out a nueroma on the 8th cranial nerve.  hearing aids have been ordered.  I am reporting this after seeing a study which investigated reports of "sudden" unilateral hearing loss post covid vaccination.  today I received my third  shot today
PAIN AT INJECTION SITE, MUSCLE ACHES, FATIGUE, METALLIC TASTE, HEADACHE
I experienced the common effects of pain,minimal redness & swelling at injection site, muscle pain, tiredness, chills, slight upset stomach & lastly a herpes fever blister on my lip (which is normal for me if I do not feel well).
Patient came in for a post hospitalization visit with provider and asked to receive his booster dose of the above vaccine. Medical Assistant with provider gave the vaccine and signed off to provider before going to lunch that the vaccine was given. The patient stated to the provider that he did not get the vaccine yet and was waiting. Provider did not ask the MA that was on lunch and asked someone that was covering to please give a booster to this patient. The MA did give the booster to the patient. It turns out when the providers assigned MA returned from lunch  she did report that the patient had already gotten the vaccine. Patient insisted that he did not get it. Patient received two booster doses of Pfizer in the same day. Patient is severely immunocompromised with ESRD and does not have a general good immune.
Menactra, that reached 33.5 C on july 9; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 17 years old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019 .  The patient's medical history not reported. Concomitant medication included HPV vaccine.  It was an actual medication error case due to incorrect product storage. It was reported that Menactra reached 33.5C on 09 July 2019.  It was unknown whether the patient experienced any adverse event post vaccination.  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.
No other AE reported; patient received VAQTA that expired on 07/10/2020; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 23-DEC-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S005724 with expiration date 10-JUL-2020, at a dose of 0.5 milliliter (frequency, route and anatomical location were not provided) for prophylaxis. The reporter stated that if the patient had to repeat the dose or not. No other adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005724; expirationdate: 10-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received 1/2 dose of FLUMIST spray in error (perhaps expired med), following immediately by dose of FLUZONE injection. Also received GARDASIL-9 vaccine same day. Day later, pt experienced nosebleed and hematemesis. Dizziness continued 2 wks later perhaps due to anemia (undiagnosed) or poor sleeping habits.
pt recv vax & exp shaking, tremor, w/semi-loss of consciousness-barely responsive x 15min;pt came out of shaking episode & resumed nl activities;taken to hosp for eval;upper lip mucosa-noted to be bluish;hypotonic/hyporesponsive;?cyanosis;
swelling at injection site; redness at injection site; itchiness at injection site; pain radiated throughout the arm / pain at injection site / could hardly touch it; pain radiated up the shoulder and back of the neck; pain radiated up the shoulder and back of the neck; could hardly touch it; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, pain in arm, shoulder pain, neck pain and tenderness to be related to Shingrix.  Additional information received were as follows: The caller was a pharmacist reporting that patient received Shingrix on left arm and experienced swelling, redness, itchiness and pain at the injection site, additionally the pain radiated throughout the arm.  The caller reported that the issues did resolved after about one week's time after about one week's time. The healthcare professional stated that the pain hurt so much that the patient could hardly touch it. The pain radiated up the shoulder and to the back of the neck.
When I woke up, I was shaking really bad. I was freezing. I had the chills. It was 101. I kept going to the bathroom that night - 7 times. My hands went completely numb - both of them. I felt like I was going to throw up but didn't at that time. I couldn't breathe. My chest was heavy and hurting. I had tons of blankets on but couldn't get warm and was up all night sick. I felt like I couldn't walk - I had  no strength to do anything. I had to hold on to things to get to the bathroom. I did throw up the next couple of days and I couldn't eat the next couple of days. I tried to call my doctor - and they told me take Advil/Tylenol for pain. They told to me to keep drinking even though I was throwing. I was throwing up for four days. My arm was sore for a week at least. My hands are still numb. This hasn't gone away since I've gotten the shot. My bladder - I'm in more pain from it - it's worse pain than my normal - it exacerbated it. I think something from the shot did something to make my immune system not work. I had a migraine for a month - really bad headaches for a month after. I had to keep taking migraine medicine and lay down. It knocked me off my feet. I am still having the bladder issues and the numbness in my hands.  I had called the doctor a second time but they didn't know what to do and only advised ER which I didn't do.
Shot site given in Left arm. Started hurting and throbbing. Asked nurse and my doctor and they said it should go away. Almost a yr now, and my arm hurts real bad especially at night. Pain where shot was given a throbbing pain like a tooth ache, hurts every night I have to wrap in a ace bandage and put ice or heat on it. I tried massaging it and nothing works. It keeps me awake at night. What is going on a damaged muscle or nerve. Why does this hurt me so bad. I am afraid to get another flu shot and I have never had any trouble before. Please let me know what is going on, no one seems to know the answers.
bABY FOUND UNRESPONSIBE ABOUT 11 P.M BY FATHER. dAD CALLED THE MOTHER OF CHILD WHO IS AN ICU NURSE. SHE CALLED AN AMBULANCE. DAD BEGAN CPR. THE CHILD WAS TAKEN TO HOSPITAL AND THEN FLOWN TO MC. THE CHILD LIVED ABOUT 12 HOURS OFF LIFE SUPPORT.  12/21/06 Received medical records from initial hospital which reveals patient arrived at ER in full arrest, had been intubated by EMS in the field & CPR was in progress.  Patient had been down approx 20-25 min prior to arrival to ER.  During code in ER given multi doses of atropine & epi with no response.  Developed V tach & was cardioverted multi times.  Finally stabilized after Lido begun & ET tube replacement.  Had to be transported to tertiary hospital via ambulance instead of helicopter due to bad weather in the area.  8/17/07 Received Death Certificate from state epidemiologist office which states COD as necrotizing bacterial pneumonia.  2/11/08 Reviewed autopsy report which states COD as necrotizing bacterial pneumonia.   Brain revealed slightly thickened & mildly inflamed leptomeninges & early signs of hypoxic-ischemic encephalopathy.
vomit; shaking; sleepy; Chills; fever 100 degree; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), SOMNOLENCE (sleepy), CHILLS (Chills), PYREXIA (fever 100 degree) and VOMITING (vomit) in a 79-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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced TREMOR (shaking), SOMNOLENCE (sleepy), CHILLS (Chills) and PYREXIA (fever 100 degree). On 25-Mar-2021, the patient experienced VOMITING (vomit). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), SOMNOLENCE (sleepy), CHILLS (Chills), PYREXIA (fever 100 degree) and VOMITING (vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100f.
Patient experienced redness and swelling approx. 6 inches around injection site. She called MD and was told to the BENADRYL and ice pack.
This spontaneous report as received from a company representative. It was reported from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. It was reported that the patient received an expired dose of PNEUMOVAX 23. No adverse experience reported. No further information was reported. Additional information has been requested.
Had normal menstrual cycle December 11, 2021 -  December 15, 2021. Woke up on December 24, 2021 at 2 AM experiencing extremely heavy bleeding with large clots. Called nurse line and they said I could wait for symptoms to subside but to call them back if I started having to change my tampon every hour. On December 25th, I began needing a tampon every 45/60 minutes so called the nurse line back and they instructed me to visit the ER. I received an ultrasound and bloodwork and they could not determine a cause. I was negative for COVID and for pregnancy and there was nothing on the ultrasound. White blood cell count and iron levels were normal. Heavy bleeding continued into December 27th and subsided overnight into December 28th. Next period began January 14, 2022 and has been normal since.
The patient's mother describes the patient as pale, listless and refusing food. Mother was instructed to take the patient to her M.D.
Pt vaccinated with OPV and was fussy and impossible to calm down; screamed for a few hrs on the 3 following days.  Did not have a fever.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 87 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My son has diabetes type one and when he received the COVID vaccine for a period of time his need for insulin decreased significantly; My son has diabetes type one and when he received the COVID vaccine for a period of time his need for insulin decreased significantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "My son has diabetes type one" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD INSULIN DECREASED (medically significant), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "My son has diabetes type one and when he received the COVID vaccine for a period of time his need for insulin decreased significantly". Clinical information included Patient had diabetes type one and received the COVID vaccine for a period of time and the need for insulin decreased significantly. reporter wondering if there was a way to contact the research department with this information. reporter believed the same biotechnology  used in the COVID vaccine could be applied to this type of diabetes. Blocking the virus that attacks the islets of Langerhans in the pancreas. reporter was describing it as a virus for lack of better choice of words.  The lot number for bnt162b2 was not provided and will be requested during follow up.