chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) at a pharmacy (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
feeling unwell; This is a spontaneous report from a contactable consumer. An adult (18- 64years old) female non-pregnant patient (at unknown age) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 17 Mar2021 as a second single dose for COVID-19 immunisation. The patient's past medical history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) as a first single dose on 23Feb2021 for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine 4 weeks prior to vaccination. On 18March2021 the patient was not feeling well and she missed work the next day of vaccination. No therapeutic measures were taken for the event. The clinical outcome of the event not feeling well was resolving.  Information about lot/batch number cannot be obtained. No further information is expected.
I was diagnosed with Morphea in September 2022. I began having the symptoms in June 2021 but didn't go to a doctor until September.
Information has been received from a registered nurse concerning a 16-month-old male, with no pertinent medical history or allergies, who on19-MAR-2008 was vaccinated subcutaneous with 0.5 ml dose ATTENUVAX Vaccine (Enders-Edmonston) (lot# 659617/0187X0. There was no concomitant medications. On approximately 29-MAR-2008, 7-10 days post vaccination, the patient "developed an all over body rash and fever." The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report the patient's status was recovering. It was also reported the patient's twin sibling had an adverse experience WAES#0804USA4868. The records of testing prior to release of lot 659617/0187X have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. This is one of several reports from the same source. Additional information has been requested.
The patient c/o not feeling well, shivering/shakes, and feels like she has the flu.
1/25/12 spots started on abdomen. 1/26/12 patient woke up in the a.m. & had spots on his face, back & back of legs. The spots did not crust or drain. Mom took patient to walk-in clinic & was told he had chickenpox. The spots itched & then lightened in appearance & lasted 4-5 days per mom.
Local redness, swelling, and tenderness to R deltoid after injection on 10/29/07. Has become less red and painful since then.
Chills began 11 hours after shot and continued for 4 hours. Mild fever ( 99.5) began 11 hours after shot and continued on and off until 60 hours after the shot.  All over body aches and skin sensitivity began 11 hours after the shot and continued for  36 hours and then resolved.  Swollen lymph node at left armpit began 11 hours after the shot and was/is uncomfortable and at times painful. Initially the swelling was very pronounced and interfered with arm movement. The swelling has diminished a bit now (75 hours after the shot), but there is still some swelling and occasional pain.
STORAGE IN REFRIGERATOR (2 GRADE C - 8 GRADE C) UP TO 30 DAYS.  (VACCINE USED AFTER 10-16-2021)
Bilateral leg swelling starting 9/16/21. Right leg swelling resolved the next day but left leg/foot.
hospitalized and diagnosed with Guillian Barre Syndrome; This spontaneous report was received from a consumer and refers to a 15-month-old female patient.  The patient's medical history was not reported. Concomitant therapies were not reported.  On 20-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR), administered for immunisation (dose, strength, formulation, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL), administered for immunisation (dose, strength, formulation, lot #, expiry date, and route of administration were not provided).  The patient was hospitalized and diagnosed with Guillian Barre Syndrome on 20-JAN-2023 after receiving vaccines.   This event was assessed as medically significant, and patient was hospitalized due to this event. The patient sought medical attention. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and suspect vaccines was not provided.  Upon internal review, the event Guillian Barre Syndrome was determined to be medically significant. This event was assessed as medically significant, and patient was hospitalized due to this event.
Approx 8-12 hours post shot I had a blinding, pounding headache, muscle and joint pain, joint swelling, numbness and tingling. The left arm of injection was red, swollen and hot in a circle surrounding the injection site. The muscle pain and headache subsided a day or two later. The injection site issues also subsided after a few days.  The joint pain and swelling, as well as numbness and tingling, got increasingly worse for the coming weeks and didn't start to subside until 6 months or so post injection. Those symptoms persist, but at a more tolerable daily level. There are occasional flares. I have also had one or two occasions of the left arm redness, swelling and heat returning as if I just got the injection. That lasts a few hours.
pt recv vax 8/6/97 & pt became preg LMP 9/6/97;expected date of delivery 6//13/98;during preg pt exp gestational  HTN;pt responded well to bed rest; Ultrasound at 8 and 18 gestational weeks indicated an area of placental schogenicity. 29 weeks indicated area was larger.  and at 35 weeks indicated this conditlion had resolved.  on 16-jun-1998, the patient gave birth to a normal healthy seven pounds, nine ounces male infant.  this report is part of the pregnancy registry.
fever 100-103.4 x 4 days. Prolonged irritability: blood and urine tested. Repeat exams. Over after fever resolved. Irritability persisted.
Red, swollen, tender to touch.  Right deltoid swollen 3 1/2 x 2 1/2 length width.  Treatment: Benadryl/Tylenol.
child received 1 dose of quadracel not recommended for his age.   Child is having no adverse effects.  Spoke with guardian child is acting fine .
Patient developed a high fever and possible seizure approximately 2-3 hours after injection. Patient was brought back to our office and temp was 103.7. Patient was given ibuprofen and labs were ordered. We also completed a chest xray and gave a dose of rocephin.  Patient was also brought back in on 4/9/19 for re check and second rocephin dose. Later that day she developed high fever and seizure like activity at home and was advised to go to ER.
47YO was admiistered Pediarix; Pediarix administered instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 26th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-September-2022 Reporter's comment: Reporter stated that patient was inadvertently administered a dose of Pediarix instead of Boostrix. At the time of reporting, patient had not been redosed. The vaccine administration facility is the same as primary reporter. Reporter consent to follow up. Additional supportive information: A 47 year old patient was inadvertently administered a dose of Pediarix instead of Boostrix, which led to inappropriate age at vaccination administered and wrong vaccine administered.
Patient reported black and blue about 2 inch in diameter at site on injection. Patient reported incident to RPh on 10-6-17.
about 20 hours after injection, starting feeling mildly achy all over.  Symptoms lasted throughout the day.  After sleeping 11 hours, woke and symptoms were no longer present.  However, Friday morning, two days after injection, experienced redness and swelling at the injection side.  Swelling and redness was about the size of my hand on my right bicep.
Nausea; Body aches; Severe muscle/body ache in left arm; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 at 14:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart failure and spinal stenosis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other concomitant medications within two weeks of the vaccination which are unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 10Feb2021 at 13:30 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021 at 03:00, the patient experienced nausea, body aches and severe muscle/body ache in left arm. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, body aches and severe muscle/body ache in left arm was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received the Spikevax 50mcg/0.5ml inj  and  noticed red, itchy , and slightly swollen site of injection the day after she received her Covid vaccine. She said symptom is better now, but wanted  to know if she is allergic to a component in the Moderna vaccine.  In the past, she has only received the Pfizer formulation  vaccine
local injection site reaction. Redness, painful, swelling. started approx. 30 hours post vaccination. States had some chills as well.
This spontaneous report was received from a Licensed Practical Nurse regarding a 5 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 20-APR-2016, 5 year old patient was inadvertently administered a dose of ZOSTAVAX (lot # L036823, expiration date: 24-DEC-2016, instead of (Oka/Merck) VARIVAX) (wrong drug administered and inappropriate schedule of drug administration). No adverse effect was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
24APR fever, 25APR rash, vomiting, diarrhea, ear problems;
Tinnitus; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN5318) via intramuscular route of administration in the right arm on 02Feb2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) on an unknown date for unknown indication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248) via intramuscular route of administration in the right arm on 07Jan2021 (at the age of 51-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 an unknown date in Mar2020, the patient experienced tinnitus. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. On 02Apr2021, the patient underwent lab test and procedure which included COVID-19 test and the result was found to be negative. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information rec'd from LPN states pt's hepatitis b antibody test was elevated at 8.5.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cronic osteo arthritis" (unspecified if ongoing), notes: that was under control with medication, until after this vaccination; "sulfa based drugs" (unspecified if ongoing), notes: known allergies: sulfa based drugs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3), for Covid-19 Immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 05May2022 at 02:00, outcome "recovering", described as "A extreme increase in my osteo arthritis"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 05May2022 at 02:00, outcome "recovering" and all described as "increased pain in my arms and back". The events "increased pain in my arms and back" and "a extreme increase in my osteo arthritis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain, osteoarthritis, pain in extremity. Additional information: The patient did not receive any other vaccine in four weeks. The reporter reported extreme increase in my osteo arthritis, that was still elevated as of this date (at the time of this report). It was very debilitating for about four weeks and was slowly diminishing as time passes. My knees are better but recovery was slow. The patient was treated with increase in doses of pain medications. The patient not had COVID prior vaccination. The patient was tested post vaccination.
Started on 2/28/04- 4/6/04: Irritable, High Pitched cry, Inconsolable, Face puffy, pale for 2 days, no fever.
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects were reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013268: US-009507513-1904USA013276: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA000187: US-009507513-1904USA013210: US-009507513-1904USA013278:
Attending Physician: (Withheld)   Date of Admission:  4/1/2022   Chief Complaint:  Chest pain    Source of Information:  Patient and available chart review    History of Present Illness:  This is a 58y.o. male with a PMHx of CAD s/p CABG x2 with LIMA to LAD and SVG to OM in 2015 and history of multiple in-stent restenosis and further PCI's following his bypass in 2015 (left main into OM, RCA and LCx which was treated with brachytherapy as well), opiate dependence, essential HTN, hyperlipiemia, anxiety, previous GSW to abdomen, COPD, and OSA who presents to hospital with the complaint of chest pain. The patient states he was at rest today when all of a sudden he started to experience a burning pain in his left chest and substernal region. The patient has a significant cardiac history as above and states this pain feels similar to the past MI's he has had. The patient denies any radiation and states his pain was worsened with exertion but had no change with rest. He took 3 nitros at home without relief. The patients last LHC was in 4/2021 (detailed report in HPI) and patient was started on ASA/Plavix at that time. The patient states he not taken his Plavix in 30 days but has been compliant with his aspirin up until a few days ago. He has not followed up with a cardiologist since April. The patient states the pain was not going away, which prompted him to seek further evaluation at our facility. He denies any other symptoms such as shortness of breath, palpitations, diaphoresis, n/v/d, fever, chills, worsening of chest pain upon inhalation, lightheadedness, dizziness, or abdominal pain. The only complaint he has other than chest pain is a headache. Denies any visual changes.
Client c/o left throat swelling and coughing. Client called her PVT MD and was seen at 3:00 PM.
Site: Itching at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
sore arm; tired muscle; upset stomach; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2020 17:00, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, muscle fatigue, upset stomach and headache. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, muscle fatigue, upset stomach and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle fatigue, upset stomach and headache to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experinced tired muscles, upset stomach, sore arm and headache. The reporter wanted to know how long these likely to last. The patient took Ibuprofen which does seem to help.
45 minutes afer shot (1:45 - 4:30) from wrist down through hands bilaterally were itchy, red; approximately 5:00 PM while in waiting room at urgent care, reported scalp itching and some sign of hives.  Treatment at urgent care between 5:00 - 6:00 PM: reported an IM injection and Benadryl given.  Symptoms resolved with no reoccurence when questions 2 days later.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I would like to comment on the Anthrax vaccination. I am a soldier in the military who has not yet taken the vaccine, but my husband was a soldier until he took the Anthrax vaccine. Up until the vaccine, he was a completely healthy man with less than 10 visits to a doctor in the seven years he spent in the military. When he was seen, it was for injuries to his knees and for acid reflux. He was ordered to take the Anthrax in preparation for deployment. Shortly after his platoon took the vaccination, he developed shortness of breath, and chest pain. He could no longer run with his unit, prior to this he was the physical training instructor and now he was falling out of runs. Eventually, he developed second degree heart block which required him to receive a pacemaker. The odd thing about all of this is he was not the only soldier in his platoon to develop heart block. Another soldier came down with the same symptoms however of a lesser degree which did not require him to get a pacemaker. I, as a soldier, will not take this vaccine, even if it means that I throw away 11 years of service.
About 45 minutes after, my left arm started to feel like there was pins and needles all the way down to my finger tips, and I started to feel very lethargic on and off for 2 days and I also had a few rounds of tachycardia.  As of Monday I have developed severe lower back pain
administered a patient both Kinrix and Pediarix on 16/05/2023; Extra dose administered; Kinrix received as 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number M7HL3) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 3K54FL) for prophylaxis.   Previously administered products included hepatitis B vaccine (the patient received at birth), hepatitis B vaccine (the patient received at 4 months of age), IPV (the patient received at 4 months of age) and DTAP (the patient received at 4 months of age).   On 16-MAY-2023, the patient received the 2nd dose of Pediarix and the 2nd dose of Kinrix. On 16-MAY-2023, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: administered a patient both Kinrix and Pediarix on 16/05/2023), extra dose administered (Verbatim: Extra dose administered) and inappropriate schedule of vaccine administered (Verbatim: Kinrix received as 2nd dose). The outcome of the overdose, extra dose administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2023 The vaccine, patient and event information was provided.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter called and stated that a nurse administered a patient both Kinrix and Pediarix at the time of reporting, which led to overdose and inappropriate schedule of vaccine administered. The patient 2nd dose of Kinrix, which led to extra dose administered.