chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of malaise in a 35-year-old male patient who received BOOSTRIX (batch number TB2R2, expiry date 18th May 2019). On 16th January 2018, the patient received BOOSTRIX (intramuscular) .5 ml. In January 2018, 2 hrs after receiving BOOSTRIX, the patient experienced malaise (serious criteria other: as per reporter), injection site swelling (serious criteria disability and other: as per reporter), injected limb mobility decreased (serious criteria disability and other: as per reporter), fatigue (serious criteria other: as per reporter), abdominal pain (serious criteria other: as per reporter), headache (serious criteria other: as per reporter), fever (serious criteria other: as per reporter) and chills (serious criteria other: as per reporter). On an unknown date, the outcome of the malaise, injection site swelling, injected limb mobility decreased, fatigue, abdominal pain, headache, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the malaise, injection site swelling, injected limb mobility decreased, fatigue, abdominal pain, headache, fever and chills to be related to BOOSTRIX. Additional details were provided as follows: The patient was not on any medication. The nurse practitioner reported that one of her patients had the BOOSTRIX vaccine on left deltoid. Within a couple of hours the patient experienced high fever, malaise, swelling at injection site, chills, fatigue, abdominal pain, headache and loss of motion on that arm where he received the injection due to the swelling. No other vaccines were given on that same day. At the time of this report, the patient had not recovered from side effects and the nurse was treating him. The reporter said that she was hoping with her treatment that the patient would not have to be admitted to the hospital.
Information has been received from a health professional concerning a 25 year old female who in approximately 1995 or 1996 was vaccinated with two doses of varicella vaccine given 1 month agart. A registered nurse reported that a recent titer, in approximately December 2001, failed to prove seroconversion. Follow-up info indicated that on 05/19/2001, the pt's VZV AB IGG EIA was <0.91. No further info is available.
Lower back pain; High Lymph abs (3.48 k/uL); Sore neck; Vertigo; Weakness/ heaviness in legs; Weakness/ heaviness in chest; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 28Apr2021 at 09:00(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 07Apr2021 at 08:30(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 the patient experienced lower back pain, high lymph abs (3.48 k/ul), sore neck, vertigo, weakness/ heaviness in legs and weakness/ heaviness in chest. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with anti-inflammatory prescribed and chiropractor visit. The clinical outcome of the events lower back pain, high lymph abs (3.48 k/uL), sore neck, vertigo, weakness/ heaviness in legs and weakness/ heaviness in chest was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe
small rash about 1cm noted in site of vax 3 days p/not itchy non painful;when seen 2wk p/rash was about 3-4cm w/no vesiculation;seen later about 6 days & rash cleared;
Right deltoid, redness and swelling. Ibuprofen and cool pack recommended. Reasons to RTC discussed including pain, fever, more rapidly changing color/swelling.
Early ovulation resulted in pregnancy; Shift in menstrual cycle, approximately 8 days early.; The initial case was missing the following minimum criteria: [unspecified AE]. Upon receipt of follow-up information on 26Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This is a maternal report. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via intramuscular, route, administered in left deltoid on 19Mar2021 at 10:15 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via intramuscular, route, administered in left deltoid on 19Feb2021 at 15:15 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. On 10Apr2021, the patient experienced shift in menstrual cycle, approximately 8 days early and mentioned that early ovulation resulted in pregnancy on an unknown date. The patient was trying to get pregnant so she was happy about it but wanted to report the possible issue so that women who do not want to be pregnant can be informed if this was not coincidental. Thank you for your time and attention to this matter. An unspecified therapeutic measure was taken because of shift in menstrual cycle, approximately 8 days early. The outcome was recovering for the reported event.  Follow-up (26Jul2021): Follow-up spontaneous report received from a contactable consumer (patient) includes: events added, case updated as valid.  Information about lot/batch number has been requested.
SHAKY; LOSS OF APPETITE; FELT HORRIBLE; SICK; VOMITED; FATIGUE; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, and thyroid issue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 03-APR-2021, the subject experienced fatigue. On 17-APR-2021, the subject experienced sick. On 17-APR-2021, the subject experienced vomited. On 18-APR-2021, the subject experienced felt horrible. On an unspecified date, the subject experienced shaky, and loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited, and fatigue on 04-APR-2021, and the outcome of sick, shaky and loss of appetite was not reported. This report was non-serious.
Patient admitted to hospital via ED  with left lower extremity DVT and saddle PE.  Patient had no prior health issues.  CT reports bilateral pulmonary infarction.
fainted & had nausea & severe hives the next day;29JAN94 f/u recovered;
She had a skin infection on her eyelid. On 02/20/2023 she was diagnosed, It was called Staph Aureus. Her eye was very itchy, red and swollen. We called the doctor and found out it was a infection. The doctor gave her a skin swap and found the diagnosis. He gave her two different skin ointments to use. It was better around February and March. Now it has gotten worse. It's red and itchy all over again. She has a new appointment with the doctor soon.
pt recv vax & mom reported several hr p/vax pt devel fever of 100 to 100.7;pt also devel redness & swelling the size of a quarter @ the site;tx w/APAP & the fever resolved w/in 1wk;9JUL small area of swelling & discoloration like bruise;
COVID Arm - rash, hives, itchy patch on left arm where vaccine was administered. Symptoms began 1 week after vaccine administered.
Patient received an undiluted 0.3ml dose of the pediatric orange cap pfizer instead of the correct 0.3ml dose of the gray cap pfizer
2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
Pt received his 1st dose of Prevnar on 4/9/01. He began having copious watery diarrhea without vomiting or fever, within 24 hours. He had started to recover when seen on 4/16/01 but had a 3 1/2 pound weight loss.
Fever, chills, fatigue, feeling like I had been beat up, diarrhea,  loss of appetite,  slept for nearly 48 hours,  nausea, severe headache, arm was very sore. This lasted 48 hours after 5 p.m. on the date of the vaccine on March 27. 4 days after the vaccine, I received a COVID test AND flu test because of a cough, low fever, sinus congestion, and headache.
Information has been received from a registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 17-JAN-2013 (lot number H011350, expiration date 21-FEB-2015) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Severe Chills. Arthralgia. Severe muscle aches - all extremities and lumbar and cervical. 6/3 ( about 10days post injection)  Awoke with very severe vertigo and dizziness.  Severe nausea and vomiting and retching and migraine and chills and severe fatigue.- Lasting 12 hours.   Treated with compazine and zofran po and imetrex.    Left arm ache for 3 days post injection and couple days with severe fatigue, headaches.  Remain intermittent itching of extremities with cracked dry skin hands.
Couple of times a week arm just starts hurting for no reason at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 08:45 (Lot number: EW0173) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adhesive tape allergy" (unspecified if ongoing), notes: Known allergies: Bandaid glue; "Connective tissue disorder" (unspecified if ongoing), notes: Connective tissue disease; "Hypoglycemia" (unspecified if ongoing), notes: Hypoglycemic; "Polyarthritis" (unspecified if ongoing); "CREST syndrome" (unspecified if ongoing), notes: CREST; "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos; "Raynauds" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Nauseous", notes: Known allergies: codeine makes nauseous; Codeine, reaction(s): "drug allergy", notes: Known allergies: codeine makes nauseous. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26May2021, outcome "not recovered", described as "Couple of times a week arm just starts hurting for no reason at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The clinical outcome of the event couple of times a week arm just starts hurting for no reason at the injection site was not recovered at the time of this report. Patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 15Jun2021 at 08:45 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning her daughter, a 24 year old female with a history of ectopic pregnancy one year ago who approximately on 13-NOV-2008 was vaccinated with the first 0.5ml dose of GARDASIL intramuscularly. On 13- MAY-2009, the patient was vaccinated with the third 0.5ml dose of GARDASIL while pregnant. There were no concomitant medication, drug reactions and allergies. The home pregnancy test resulted positive on 14-MAY-2009. The patient's LMP was not reported. The patient had sought unspecified medical attention. Follow-up information has been received from the registered nurse, concerning her daughter, a female patient who smoked but stopped smoking at 6 weeks gestation. It was reported that the date of last menstrual period was 02-APR-2009 and the estimated delivery date was 07-JAN-2010. On 17-MAY-2009, pelvic and abdominal ultrasound was performed. On 17-JUN-2009, pelvic and abdominal ultrasound was performed which showed fetal death. Subsequently, the patient experienced a spontaneous abortion. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
Received vaccine about 12:30pm 3/10/21.  When I woke up next morning, besides arm being sore, there were hard welts about 1 inch from injection site.  They were itchy and red.  Over the past few days itching stopped, but the separate welts turned into one long 2 inch raised hard area.  Still there 3/15/21
reconstituted Shingrix  with a final volume of 0.3ml; reconstituted Shingrix  with a final volume of 0.3ml; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2022, the patient received the 1st dose of Shingrix .3 ml. On 21st April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-Apr-2022 Reporter's comments: The pharmacist reconstituted a Shingrix with a final volume of 0.3 ml. This incomplete dose was administered to the patient. The reporter did not consent to follow-up. There was no information about lot number or patient´s details at the moment of the call. Additional Supportive Information: The patient received Shingrix which was reconstituted to 0.3 ml which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a nurse and the patient's mother referring to the 15 year old female patient with asthma. The patient had no drug reactions/allergies. On 27-FEB-2013 the patient was vaccinated with her first dose of GARDASIL (lot#, dose not reported) intramuscularly (indication reported as "Had to have it to go to school"). On 10-APR-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose not reported, intramuscular). There was no concomitant medication. The patient's mother reported that on unspecified dates in either April or May of 2013, the patient experienced dizziness, fatigue, weakness, headache, stomach pain, vomiting, joint pain, chest pain, hair loss, appetite loss, insomnia, tremor, shortness of breath, itchy, swelling, rash, aching muscles, pelvis pain and discharge, nerve pain, menstrual cycle pain, fainting, swollen lymph nodes, night sweats, nausea, temporary vision and memory loss, ovarian cyst, cyst in left kidney, and a cyst was in left ear after receiving GARDASIL. The patient was admitted to several different unspecified hospitals on several different unspecified dates. The nurse reported that the patient had been to various unspecified hospitals and had had multiple labs drawn such as: Complete Blood Count (CBC), basic metabolic panel (BMP), amylase and lipase levels (on unspecified date in 2013) since receiving the GARDASIL and experiencing the above noted events. The nurse reported that the patient's laboratory values came back as negative. Unspecified treatment was given for the events. Unspecified lab test and unspecified blood work were performed. It was reported that patient had received her third dose of GARDASIL on 27-AUG-2013 (therapy continued). Outcome of the events was reported as not recovered. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, 7 days after receiving RABAVERT, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to RABAVERT. Additional details were provided as follows: The age at administration was not reported. The reporter stated a veterinary student that received pre-exposure vaccination with RABAVERT. The reporter indicated that she was told the student might have had a reaction to the RABAVERT although she was unsure because what the student was experiencing occurred over a week after the vaccination. The reporter was unable to provide any further details at the time of the call.
L thigh and vaginal area vesicular rash as with fever and back pain. Zoster, Rx-Tylenol
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 06-OCT-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles (onset not reported). On or about 01-DEC-2016, the patient was treated by a physician for persistent and unbearable episodes of pain that has been persistent since she had outbreaks of shingles. The patient was diagnosed with post-herpetic neuralgia, a condition of chronic pain and nerve damage secondary to zoster infections. The patient was prescribed gabapentin and lidocaine hydrochloride for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Case number PHEH2013US006903, is an initial spontaneous report received from a nurse on 22 mar 2013 and a follow up information received from the nurse on 28 May 2013: This case refers to a 12-years-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M11052), intramuscularly without being reconstituted with Men A component on 21 mar 2013. This was her initial application of MENVEO vaccine. No adverse reaction reported following this administration error. Follow up information received from the nurse on 28 may 2013: Updated patient demographic details.
Pt very irritable by bedtime; mom repts t 103.9; pt was lifeless & hardly moved;PMD described as moderate rxn to DTP
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2014, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pharmacist regarding a 43 year old male pt who experienced a runny nose, congestion, red/watery eyes, sneezing, cough, fever (about 100 degrees), feeling achy and dizziness.  The pt received a dose on 12/08/03.  Pt stated that he had no medical history.  He signed a Vaccine Information Statement for Flumist questionnaire provided by the pharmacy flu vaccine program, stating he had no contraindications to receiving Flumist.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/08/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy. On 12/08/03, the pt experienced a runny nose immediately following Flumist administration.  He subsequently developed congestion, red/watery eyes, sneezing, a cough, fever (about 100 degrees), and felt achy and dizzy.  Between 12/11/03 and 12/12/03, his "symptoms peaked" and continued through 12/15/03.  He took Theraflu (caffeine, codeine phosphate, paracetamol, piperylone maleate) for symptom relief.  As of 12/19/03, the pt reported that he was "over it".  No additional information was available at the time of this report.
Pfizer-BioNTech COVID-19 Vaccine EUA - Fever, swollen lymph nodes on left armpit
Breakthrough case admission after 2 vaccines Pfizer 6/23/21 Lot#Ew0172;  Pfizer 8/4/21 Lot# Ew0172
Patient given expired Moderna vaccine from 7/4/2021 at 10am. No adverse reaction reported.