chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the clinic on 5/16/19 C/O pain, redness and swelling measured about 4 inches x 4.5 inches. Patient's mother reports symptoms began 24 hrs after vaccination. Dr. evaluated patient and prescribed Benadryl 25mg capsule q6h PRN and clindamycin 300mg caps TID x 10 days. Patient will f/u in 1 week on 5/24/18 for cellulitis.
Day of vaccination: fever (100.5 degrees), rash at injection site, swelling. Day after: no fever, minimal swelling, still had a rash & itchy. 2 days after: fever reappeared, itching all over body. 3 days after: hives on left side of body (upper thigh, stomach) injection was administered to Left arm).
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves over 30 patients (age and gender not reported) who were vaccinated with dose of PENTACEL, QUADRACEL, FLUZONE QUADRIVALENT and MENACTRA (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. (patients were given vaccines that were outside of the recommended temp range (below 32F). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 06-Oct-2015 - 06-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, the patient inadvertently administered expired AFLURIA PFS. Reporter comments: The reporter stated that she heard no complaints from  any of the 10 patients. She also confirmed that no patients were pregnant. For relevant test results see appropriate report section.
Info has been received from a health professional concerning a 5 year old white female who on 1/24/01 was vaccinated with a 0.5 ml, SC dose of varicella virus vaccine live. It was reported that the pt was brought into the office on 4/8/05, with a few lesions on the back of her neck and some on her chest that were diagnosed as chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Patient had a moderately severe syncope reaction.  Patient had trouble communicating, reported loss of vision and hearing, light headedness, dizziness, semi consciousness. Patient was seated when the episode began. By the time staff were notified, patient was barely conscious, and could not be safely told to put their head between their legs for fear of falling. Patient came out of the episode within 10 minutes before emergency services could arrive.
Sick for six weeks with joint with all kinds of pain; all kinds of pain; joint with all kinds of pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for six weeks with joint with all kinds of pain), PAIN (all kinds of pain) and ARTHRALGIA (joint with all kinds of pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for six weeks with joint with all kinds of pain), PAIN (all kinds of pain) and ARTHRALGIA (joint with all kinds of pain). At the time of the report, ILLNESS (Sick for six weeks with joint with all kinds of pain), PAIN (all kinds of pain) and ARTHRALGIA (joint with all kinds of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. Patient stated that he had taken Pfizer Biontech COVID -19 vaccine and experienced Adverse events for Pfizer vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR  form received and it contains No New Information
Pt recvd flu vax immed afterward exp redness & itching @ the site of inject;
approx 17 days post vax pt became lethargic; no known cause could be identified; pt was hospitalized over 24 hrs; spinal tap neg, neuro neg, HAO neg CT pending are organic acid levels; pt began acting nl p/24 hrs was d/c; drug screen neg;
PAIN AT THE INJECTION SITE, PAIN TRAVELED FROM INJECTION SITE DOWN THE ENTIRE LEFT ARM, THEN THE ENTIRE LEFT SIDE OF MY BODY WAS IN TERRIBLE PAIN.  BECAME VERY NERVOUS, FATIGUED AND DIZZY.  DEVELOPED HEADACHE, HIGH FEVER, BODY ACHES, CHILLS, SORE JOINTS.  THROAT/TONSIL AREA BECAME IRRITATED AND SWOLLEN.  VERY PAINFUL TO SWALLOW.  COULD NOT SWALLOW SOLIDS - VERY LITTLE LIQUIDS.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 26-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number# and frequency not provided) for "patient request for shingles prevention". Pharmacist used a 5/8 inch needle for subcutaneous injection. Pharmacist described the patient's skin as taut and stated she could barely push the ZOSTAVAX into the patient's skin. Fluid filled under the patient's skin at the injection site of administration. Pharmacist removed the needle from the initial site and administered the ZOSTAVAX remaining in the syringe into at least two more sites in the same activity. The patient ended up with three, small fluid bubbles in the same area also described as a subcutaneous bubble under the patient's skin. Pharmacist additionally stated there was no problem with the syringe used. The action taken and outcome were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Gave varicella vaccine on 8/11/08.  On 8/12/08 patient reported fever, chills, headache.  Sore, red, tender arm.
running fever; Upset stomach; Cold chills; Cold chills; Loss of appetite; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 12:00 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRALAX. The following information was reported: PYREXIA (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "running fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Upset stomach"; NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 21Nov2021 01:15, outcome "not recovered" and all described as "Cold chills"; DECREASED APPETITE (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Loss of appetite"; PAIN (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Body aches". The events "running fever", "upset stomach", "cold chills", "cold chills", "loss of appetite" and "body aches" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal discomfort, nasopharyngitis, chills, decreased appetite, pain.  Additional information: No other vaccine in four weeks. other medications in two weeks: toddler multivitamin. No covid tested post vaccination.  Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
rash on her body located on her neck and back; allergies; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (rash on her body located on her neck and back) and HYPERSENSITIVITY (allergies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, FAMOTIDINE (PEPCID [FAMOTIDINE]), OMEPRAZOLE and HYDROXYZINE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on her body located on her neck and back) and HYPERSENSITIVITY (allergies). At the time of the report, RASH (rash on her body located on her neck and back) and HYPERSENSITIVITY (allergies) outcome was unknown.        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.   Reported the prednisone therapy had been prescribed for a body rash which had started prior to the first dose. The patient has asked the reporter if she can still have her second dose today, as the patient has read online about perhaps not having a dose if a person has allergies or rash. Since receiving the first dose, this rash has been diagnosed by an HCP as a dairy allergy.
This spontaneous report as received from a nurse refers to 2 patients of unknown ages. On an unknown date, the patients were vaccinated with 0.5 ml doses of VARIVAX (Merck) (lot # not reported) subcutaneously. The nurse reported that on an unknown date, the patients were given VARIVAX (Merck) and then got chickenpox. There were no Lab diagnosis or studies performed. The outcome of chickenpox was unknown. Additional information has been requested.
shingles; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 09-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered a vesicular rash on the left abdomen with scattered lesions on the lateral surface with pain, itching, and burning, which was diagnosed as Shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Vomiting and Diarrhea x 3 days; Treatment: admitted to hospital for IV fluids. 2/14/08-records received for DOS 1/18-1/20/08-DC DX: Gastroenteritis. Presented to ED with vomiting and diarrhea for 1 1/2 days. Watery diarrhea, non-bilious vomiting. Decreased oral intake and decreased urine output.
1-2 weeks post 3rd dose of vax, in April 2000, the pt experienced upper left arm swelling and pain with movement. The left arm swelling includes the entire circumference of the upper arm. The vaccinee complained of muscle pain with movement in the deltoid area. She was treated with nabumetone. The vaccinee has been seen by a rheumatologist and a neurologist, whose findings have not yet been made known. She was also seen by an orthopedist, who x-rayed her shoulder and swollen arm. He did not know the reason for the cause of the swollen arm, could be arthritis, but was unsure. He injected the vaccinee's shoulder with cortisone and said if that did not help, maybe he would operate. The cortisone injection helped the pain but did not relieve the swelling, reportedly. She still felt weakness, occasionally.
1. On 4/30, on only Day 18 of my menstrual cycle, my period began. It was fast and furious, dumping quickly. (I have never had a cycle less than 21 days; usual cycle is 23-25 days.) 2. My next period followed 27 days later, but rather than being usual, the blood was thick, viscous, and heavy (not a more than usual but chunky and dropped to the bottom of the toilet bowl rather than floating down). 3. I had heard these changes may happen, so I did not report it, but now 5 periods in, I need to report things have not gotten back to normal. The cycles are of normal length, but there is bloating prior (never experienced before), and the flow is still chunky/heavy, as if the uterine wall is getting too thick. My usual vaginal lubrication is excessive as well.  I can only assume my estrogen levels has increased, but my doctor advised that testing wouldn't help as the numbers vary so much person to person and day to day (even hour by hour); I would still be in the "normal" range, as I am still ovulating and having my period monthly.
Some of the vaccine leaked from patient's arm; Patient received Shingrix but part came out of needle / Some of the vaccine leaked from patient's arm; Some of the vaccine leaked from patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of injection site leaking in a female patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 12th February 2021, the patient received the 2nd dose of Shingrix. On 12th February 2021, immediately after receiving Shingrix, the patient experienced injection site leaking, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in an unknown arm but some part came out of needle because the needle was loose. The reporter stated that some of the vaccine leaked from patient's arm immediately after vaccination with Shingrix, which led to injection site leaking, accidental exposure to product and exposure via skin contact. The reporter did not consent to follow up.
1. Side effects started with significant arm pain and soreness around injection site two or three hours after injection. Arm pain lasted about 2 or three days. And inhibited sleep. Treated with Ibuprofen two days after injection.  2. Six hours after injection fever of 100 degrees F and chills started. Lasted about a day. Not treated. 3. Headache and fatigue was noticed on second day and lasted 2 or three days.
Fast heartbeat and moderate to severe dizziness began at 3:30 PM on March 6. Fast heartbeat slowed considerably after 10:30 pm. Dizziness is mild to moderate as of 5:00 pm March 7.   I am reporting this simply because it said we should make you aware of adverse events with the vaccine.
Inflammation in hand; Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in hand) and PAIN (Pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Pain). In December 2021, the patient experienced INFLAMMATION (Inflammation in hand). At the time of the report, INFLAMMATION (Inflammation in hand) and PAIN (Pain) outcome was unknown.            No concomitant medication was reported. In 2021, the patient experienced INFLAMMATION IN HAND and PAIN.   In Dec 2021 patient right hand did not close from inflammation, she was in more pain after vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.   Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of INFLAMMATION IN HAND with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of PAIN was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
At aproximately 15 minutes after patient had the 1st Vaccine she complained of upper and lower lips feeling tingly. A couple of minutes later she said she had some difficulty swallowing saliva and the sensation of her throat feeling tight. She then reported resolve of her lips tingling but reoccurrence of same. She was given water and juice to drink w/o difficulty. She continued complaining of throat swelling sensation becoming worse and denied SOB. Patient stated she does smoke tobacco.                        VS 142/88 P 90 P/Ox 86% on RA   Appears anxious w/o distress                              Heart RRR                              Lungs Some very mild diffuse wheezing      A/P At approximately 45-55 minutes patient monitored with improvement in P/Ox to 91% on RA but continued complaining of sensation of throat closing. 911 called, IV started, paramedics  administered Benadryl and patient was transported to ED without need of O2.
This spontaneous report as received from a health care worker refers to a patient (unknown age and gender). On an unknown date the patient was vaccinated with (Merck) VARIVAX (Lot # not reported (dose, route and frequency not reported). No other co suspects were reported. No concomitant therapy was reported. The health care reported stated that on an unknown date an unspecified patient was accidentally vaccinated with (Merck) VARIVAX who should have received ZOSTAVAX. Additional information is not expected.
R arm swelling and redness with some pain after receiving Imm. Later that night, no fever or decreased ROM. Pt given RX for Artrax 8mg PRN. Taking Amoxicillin for OM
NAUSEA. HEADACHE, LIGHT HEADINESS RASH/ HIVES AND SCRATCHY THROAT  AREA NOT FEELING WELL AFTER SHOT FOR 2 DAYS FELT SOME  SLIGHT BODY  SWOLLEN THURSDAY AND  FRIDAY THRU WEEKEND FEEL BETTER NOW I REPORTED TO  DR CAI, (MY DOCTOR)  TODAY 4-08-2021 AT 12:00 PM  ABOUT THE SHOT SIDE EFFECTS SINCE I HAD A PHONE APPT SCHEDULE. I AM CONCERN ABOUT HAVING SECOND SHOT. I WAS ADVISE NOT TO HAVE SECOND SHOT FROM V-SAFE CONSULTANT AT 12;52 pm today 04-08-2021 I WILL NOT HAVE IT.
Pt received vaccination 2 days prior to arrival at ER in full cardiac arrest. Autopsy shows cause of death as sudden infant death syndrome
Vaccine give at noon.  During routine vitals at 12:37pm patient's oxygen was at 87%  HR 54.  The facility called 911.  Paramedics arrived at approx. 1pm. By 1:15pm pt oxygen was back to 97%  BP 156/66  HR 52.  He was alter and able to communicate.  Patient agreend to be transported to  hospital to be checked.
On 8/18/99, the pt experienced pain on both of her legs and numbness below her knees. She also experienced numbness in her fingers bilaterally.
Parent walked back into clinic with child. She states she received her Hep A #2 approx. 5-10 mins prior. Child has rash on torso and legs - small and lightly erythematous macular lesions. Not particularly itchy. Lesions on the legs appear like they have slight degree of halo around the lesions. Child's cheeks are brightly erythematous and this does appear to be diminishing in the time we are talking with the child. Child was otherwise playful and alert. Temp checked temporally and 98.8F. Mother states child attends daycare and has had rhinorrhea and congestion off and on throughout the last 1-2 months. No Hx of immunization associated rashes in the past. Suspect a cutaneous reaction to hepatitis A vaccine vs viral exanthema. Child was very well appearing. I administered a dose of ZYRTEC 2.5 mg and observe. After 10 minutes, parent stated that she felt comfortable leaving, requested this to be added to the medical record. Precautions given. Given child does not require any further Hep A doses, this does not affect her immunization status and add to her allergy record.
Approximately 3 days after receiving vaccine, developed severe migraine (aura, sharp headache and nausea) that lasted about 4 hours followed by 24 hours of fatigue and weakness.
Dizziness; Not feeling well; Heart started to pound; anxiety; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Not feeling well), HEART RATE INCREASED (Heart started to pound) and ANXIETY (anxiety) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Not feeling well), HEART RATE INCREASED (Heart started to pound) and ANXIETY (anxiety). At the time of the report, DIZZINESS (Dizziness), MALAISE (Not feeling well), HEART RATE INCREASED (Heart started to pound) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
I received my Covid -19 vaccine on 10/5/2022. On the morning of 01/01/2023 I woke up with a dry cough and tired. I became very congested and contacted my doctor. I was prescribed Paxlovid. Symptoms are still ongoing. I am due 04/01/2023.
Onset of scalp itching approx. 1 hr. later. About 16 hours after injection patient had onset of pruritic papular rash widespread on body. Also headache and fatigue.
Terrible pain in right shoulder, and legs didn't work. Had to call 9-1-1 to come and get him. ER gave BENADRYL and sent him home, also told him to take TYLENOL. ER said reaction to flu shot.
15:25 to clinic nurse - BP 144/82, HR 92, T 98.8. C/o nausea, vomiting x2, HA, (R) arm heaviness. Received H1N1 vaccine @ 11:15. C/o problems 15:25 -vomited x 2 earlier but has not happen again. No progression, called mom(15:40) to go home. 15:45 mom arrived, BP 127/84, HR 85, return home in parent care.