chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nonreactive Serological Test; Initial Report Received 18-Apr-2023  This spontaneous report was received from a nurse regarding 57-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   Medical history included no previous reactions to other vaccines.   Concomitant medications were not reported.   On 31-Jan-2023, dose 1 of HEPLISAV-B (Lot# 941055, expiration 29-Nov-2024, NDC 43528-002-01) was administered in the right deltoid.   On 01-Mar-2023, dose 2 of HEPLISAV-B (Lot# 941055, expiration 29-Nov-2024, NDC 43528-002-01) was administered in the left deltoid.   On 14-Apr-2023, serological testing (not specified) was performed, and the results were reported as nonreactive.  No adverse reactions were reported by the patient.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient did not get the Moderna vaccine at our pharmacy, but came to pick up an antibiotic, cephalexin, to treat an infection she developed after her 2nd dose on 4/10/21. Unknown the exact day when these symptoms started, but she described a hot arm, very sore, and a lump.
This spontaneous report as received from a Licensed Vocational Nurse refers to an 8 week old male patient. The patient's medical history included reflux. No drug reactions or allergies reported. On 21-APR-2015, the patient was vaccinated with the first dose of ROTATEQ (lot#07Jun2016; exp date: 07-JUN-2016) oral suspension 2ml. Concomitant therapy included PREVACID. On 21-APR-2015, the patient was diagnosed with reflux. The nurse was unsure if the patient developed the reflux prior to receiving his first dose of ROTATEQ or after. The nurse stated that the patient was prescribed ranitidine on 21-APR-2015 for the reflux. The nurse also reported that the patient was seen in the office on 22-APR-2015 due to developing diarrhea at an unspecified time after receiving his first dose of ROTATEQ. The patient sought medical attention and the physician ordered the following labs on 12-MAY-2015: stool culture, ecoli, stool occult, and other unspecified labs. The Nurse was unsure if the labs have been drawn on the patient yet. There was no intervention to prevent serious criteria and the events were reported to be not: cancer, significant disability or incapacity, hospitalization or prolongation, life threatening, overdose or PQC. The nurse reported that the patient was currently experiencing diarrhea. The outcome of the events was reported as not recovered. The relationship between the events and ROTATEQ was unknown. Additional information has been requested.
The patient had redness, swelling, itching, and soreness around injection site.  He noticed it starting about 2 days after getting vaccination.
sreness in arm at site of injection, perspiration and fatigue, all  the next day.
Vaccines given on 07/21/2003 in right thigh DTap # 4 RUT and HIB #4 RLT . Thigh red, swollen, warm. Went to ER/UC 07/22/2003. Per note 07/23/2003 Dx's splenomegaly, 2 vaccine- large local reaction  2 1/2 x 5 1/2
Very lethargic,  pain on both sides of lower back seemingly Kidney area, developed pneumonia.
pt recv vax 17JUL95 & 10DEC96 pt exp shingles;
Information has been received from a physician concerning his wife who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, sometime last week on approximately 08-APR-2008 the patient experienced pain, redness and swelling at the injection site after receiving the vaccination. It was unspecified if medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
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 03-SEP-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-FEB-2017, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles with complications. The patient has been prescribed valacyclovir (VALTREX) and acetaminophen and hydrocodone (NORCO) for management of his painful symptoms and chronic pain. 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. The outcome is unknown. Additional information has been requested.
lt.lymphangitis,enlarged lymph node under jaw bone, fever (100-101)X 2 wks. c/o rt. side nose swollen. Seen by MD and prescribed Duracef antibiotic X 1 week and Loracet for sleep  *sorry this is late, I thought it had been reported.
Fever (101 degrees), severe chills, body aches for 3 hours; treated with ibuprofen, 300 mg
Before receiving the first shot my GFR was 53. After receiving the first shot my GFR was 43.
Erythema, 1cm of vesiculation w/5cm of induration; had vero cell vax in school approx 8 yrs ago;
Breakthrough asymptomatic COVID infection. Tested positive 07/25/2022 as part of routine screening prior to admission.
Injection-site discomfort-left deltoid. Backache. Legs ache. Cold sweats. Sx began 48 hours after vax given one day prior to visit.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/22/2022 Discharge Date: Jul 23, 2022  PRESENTING PROBLEM: Shortness of breath DOE (dyspnea on exertion) Hypoxia COVID-19   HOSPITAL COURSE: 32 year old female presented with history of transposition of the great vessels status post fontan procedure as an infant who underwent a laparoscopic gastric sleeve procedure on 5th July. She started having symptoms of covid on Tuesday followed by positive covid test. She was admitted to hospital on Saturday. She had CT angio done which was negative for PE though left pulmonary artery was non diagnostic. She is US venous duplex which was negative. She was evaluated by congenital heart. It was felt her symptoms were unlikely from PE. Her symptoms are felt from covid. She was not hypoxic even with exertion. She was discharged home with close follow up with PCP and congenital heart.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a pt who experienced a (non specific) allergic reaction. The pt received a dose in Jun 2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered in Jun05. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The pt experienced a allergic reaction in Jun 2005. No additional information was available at the time of this report.
09/25/2021 I woke up with a very dry mouth and throat. The next day it was extremely dry.  I went to the clinic on 10/05/2021 and they made me an appointment with a doctor for 10/20/2021-he prescribed Pilocarpine HCL 5mg tab and told me to get Mucinex to help. Those have helped somewhat but only for a short period of time. I still have dry mouth to this day.
It was about a week after vaccination I started to experience headaches when I would eat certain food. I narrowed it down thinking it might have been wheat of gluten. I went to see an allergist in January and ruled out that I don't have allergies to a lot of things. However I continued to have the symptoms and went to a GI doctor and that wasn't much help. The GI doctor did a celiac test which came back negative.
severe headache; chattering teeth and chills; Joint aches in wrist, elbow, knees and ankles; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 17Mar2021 at 02:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient previously received levofloxacin (LEVAQUIN) on an unspecified date for an unspecified indication and experienced drug allergy.  Concomitant medications included calcium citrate, colecalciferol  (CITRACAL MAX) and calcium ascorbate, gelatine hydrolysate (YOUTHEORY COLLAGEN) all for unknown indication, from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 01:00, the patient reported that initially she experienced severe headache within 12hrs, chattering teeth tupe chills no fever and also joint aches in wrist, elbow, knees and ankles. No therapeutic measures were taken as a result of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events headache, teeth chattering, and joint ache were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Patient walked out of room feeling dizzy, then lead to nausea. Medical assistant gave patient water and had him lay down.
From initial information received on 2/18/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a total of seven patients received a dose of DECAVAC, lot number U1206DA, administered IM in the deltoid on an unspecified date. An unspecified amount of time later, five of the patients experienced arm soreness and some pain, resulting in decreased mobility in the arm that the vaccine was given. The patients all recovered from these events.
The vaccine was HepA. I?m not sure if it was (Havrix or Vaqta)  Motor Tics. Eyes squinting really hard, sniffing and straining in the neck. It started happening for an hour and 2-3 hours apart. After a full week it?s now down to only few times a day.
Patient received Fluad vaccine on 9/11/20 and complained of pain down his legs and arms while receiving vaccine. However, we were not notified until 3 days later on Monday 9/14/20. He had trouble walking to his car, When he got home, over the weekend he had trouble walking. Was not able to walk so paramedics were called. Vitals taken and all within normal range except slight evalated heart rate. Was told by paramedics to contact primary care provider. So patient has upcoming PCP appointment coming up on Tuesday for further assessment. Currently patient is being cared for by a family member.
CONGESTION; DIZZY; COUGHING; RUNNY NOSE; VOMITING; TEMPERATURE 101; DIARRHEA; WEAKNESS; NAUSEA; COULD NOT EAT/BARELY EATING; ITCHING LIKE CRAZY; HOT TO TOUCH; CHILLS; INJECTION SITE REDNESS; SORENESS TO SITE; DID NOT FEEL WELL; MUSCLE ACHES; FELT THIRSTY LIKE DEHYDRATED; FELT AWFUL/DID NOT FEEL RIGHT; ITS LIKE HAVING COVID; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included thyroid disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:15 on left arm for prophylactic vaccination. Other concomitant medications were reported. On APR-2021, the subject experienced felt awful/did not feel right. On APR-2021, the subject experienced its like having covid. On APR-2021, the subject experienced felt thirsty like dehydrated. On APR-2021, the subject experienced did not feel well. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced soreness to site. On 01-APR-2021, the subject experienced itching like crazy. On 01-APR-2021, the subject experienced hot to touch. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced injection site redness. On 02-APR-2021, the subject experienced could not eat/barely eating. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced diarrhea. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced coughing. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced temperature 101. On 03-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful/did not feel right, and the outcome of vomiting, chills, could not eat/barely eating, did not feel well, temperature 101, diarrhea, congestion, dizzy, weakness, coughing, runny nose, its like having covid, nausea, muscle aches, injection site redness, itching like crazy, hot to touch, soreness to site and felt thirsty like dehydrated was not reported. This report was non-serious.
21OCT98 neck, chest area started to itch & broke out w/rash in these areas raised reddened fine type;rash still apparent & itching-same site-has not spread;to MD;
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 conditions, or concomitant medication. On or about 31-AUG-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of the events were considered to be not recovered. Additional information has been requested.
Chills and headache one day after vaccine which resolved on day two. Runny nose on day two.
Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Cat).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment was provided.
Janssen-COVID-19-EUA CAMVU-Run # 2021005124  30 y/o female c/o blurred vision s/p vaccination. Pt had episode of dizziness that lasted 5 min. Pt has no other chief complaint. Pt stated she feels normal and signed AMA form.
Nose bleeds without any direct irritation. Occurred approximately 6 times over the course of 2 weeks, specifically while driving.
Developed red sore spot at injection site. Developed rash and severe itching  on legs and arms on day 6, 4/20/2021. Itching was so bad that it kept me awake itching at night and has left me bruised on my legs from scratching so hard. Itching and rash has begun to subside by day 12, 2/26/2021.
rash appeared on 1/26/2020, swelling and redness and soreness on 1/25/2020, localized to left shoulder 3 inches below injection site.
10/13/08 received varicella in LA.  10/14/08 started itching in area of injection - "reddened size of dime". Felt warm and hard. Firm area around injection site - 25 mm. Surrounded by larger reddened area on 10/15/08.
Hives extensively-face, chest, arms/lip within 1 hr of vaccination. On exam withiin 4 hrs noted  no distress no vomiting.
Pt C/o numbness and tingling radiating down Left arm, where vaccine was injected. Pain went from shoulder to wrist.
Headache; Fever; Cannot get to sleep at night; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A patient of an unspecified age and gender (children) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had headache, fever, and cannot get to sleep at night. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Headache, Fever, Diarrhea, sweats Narrative: Night of vaccine, severe headache, fever, sweats (soaking wet), days after continued with headache, fatigue, diarrhea. All resolving. Taking Advil consistently.
Moderate dizziness/headache post-flu vacc: got vacc. @ approx. 9:45am on 10/23/20: dizzy/headache started abruptly @ approx. 12:20-7:00pm,  then on an off for rest of night with mild nausea; mild diarrhea @ 7:00pm (howevercould have been from recent fatty meals). Next day (10/24/20): arm very slightly sore at site the next morning and still some slight nausea. Mild dizziness as going to bed that night (for about 1 hour - felt like vertigo as falling asleep). Fully recovered by morning of 10/25/20.
Malaise; fever; nausea; vomiting; headache; bodyache, muscle pain; chills; lump at vaccination site; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.  The patient's past medical history included No adverse event. Concomitant products included chemotherapy                                                   for breast cancer for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced MALAISE (Malaise), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache), MYALGIA (bodyache, muscle pain), CHILLS (chills), VACCINATION SITE MASS (lump at vaccination site) and ARTHRALGIA (joint pain). At the time of the report, MALAISE (Malaise), PYREXIA (fever), VOMITING (vomiting), HEADACHE (headache), MYALGIA (bodyache, muscle pain), CHILLS (chills), VACCINATION SITE MASS (lump at vaccination site) and ARTHRALGIA (joint pain) had not resolved and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-091897 (Patient Link).
Had DTaP shot about 10am. Had seizure at 6:30pm called paramedics. Has another seizure 11:30pm, stopped breathing turned blue had to do CPR fever 103.9 at hospital. Had Tylenol every 4 hours since 10am.
This case was reported by a healthcare professional (office manager) and described the occurrence of arm pain at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced arm pain at injection site. Per the office manager, the subject had "experienced 'extended arm pain' for many days following vaccination with FLULAVAL." No further details were available at the time of reporting. At the time of reporting the outcome of the event was unclear from the report and, therefore, unknown.
First Shot of the covid vaccine. Started with a slight headache, chills, and muscle ache approximately 36hrs. after the shot. The symptoms progressively worsened throughout the day followed with an additional symptom of a slight fever (99.5°F) around 48 hrs. after the shot. A dose of Ibuprofen, plenty of fluids, and rest resulted in all of the symptoms running their course with 60 hr. after the shot.
was notified by EMS at 4:10 pm that a client at approximately 3:20 pm had experienced onset of allergic reaction (throat tightness/closing) post vaccination while sitting for observation.  EMS administered 125mg of solumedrol.  Continuous monitoring/observation by EMS until client was stable.  Client alert and oriented prior to departing facility with spouse, EMS release signed.
VERTIGO; GETTING SHORT OF BREATH; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, bad breathing, peanut allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient had an allergy to whatever is in like medication to lower cholesterol and allergy to NSAIDs. The patient stated that she was very healthy, motivated, hands-on, very energetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate for bad breathing, meloxicam for fibromyalgia, tramadol for fibromyalgia, ascorbic acid, cyanocobalamin, magnesium, and paracetamol. On 21-SEP-2021, the patient experienced vertigo. On 21-SEP-2021, the patient experienced getting short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting short of breath, and vertigo. This report was non-serious.
This spontaneous report as received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-AUG-2016, the patient was vaccinated with improperly stored PROQUAD injection (lot # M015695, expiration date 26-SEP-2017 and 0.5 ml/once) subcutaneously. The administered dose experienced a temperature excursion of 56.8 degree Fahrenheit for 22 hours 47 minutes from 15-AUG-2016 to 16-AUG-2016. No adverse effects were reported. It was reported that the safety committee may speak to the registered nurse if there are any questions or concerns. Additional information has been requested.