chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported./unknown  The outcome of event(s), sore arm was unknown.
UNKNOWN: RECEIVED CALL FROM MEDICAL EXAMINER OF BABYS DEATH TODAY. 3/22/07 Received Autopsy Report which reveals COD as undetermined & manner of death undetermined.  Autopsy findings: single conjoined kidney; diffuse mild cerebral white matter gliosis; neg tox, micro & metabolic testing; focal glomerulosclerosis of unknown significance.
BIRTHDATE PROVIDED ON VACCINE CONSENT FORM IS 3/11/2009. WE WERE NOTIFIED BY IMMUNIZATION REGISTRY THAT BIRTHDATE FOR PATIENT IN THEIR RECORDS IS 3/11/2010. UNABLE TO CONFIRM BIRTHDATE WITH PARENT
Instantly severe headache x 2 days; extremely tired. Slept for 2 days
6 days severe headache and vertigo.  Brain fog - couldn't think straight.  Ibuprofen for headache with no effect.
I was pale and had a headache then about 7PM became Nauseous.  Vomited at 3:30AM 1/29/2021 At 4:25AM and also 5:45AM  had dry heaves at 8AM  severe stomach pain.  Friday the day after vaccine I could not get out of bed slept a lot when would get up was dizzy and Nauseous that day only ate 1/4 piece an 2 soda crackers.  Saturday I was able to be up for a couple of hours then would have to lie down and rest.  That day still had stomach pain gas and bloated feeling.  was able to eat chicken nooodle soup .  Sunday up most of day had to nap twice symptoms better but still unable to eat much. Tired easily. Today Monday I am much better some stomach pain still can't eat much.  I am able to stay up.
Patient had a red swollen area at the site of the injection that was tender to the touch. Patient thought it was more than just a typical injection site reaction. Had a similar reaction with the first shot that went away after a week or so. I followed up with the patient on 12/10/2018 at 11:20 AM and verified that the reaction had cleared up and was not causing any additional concerns.
continual abdominal discomfort from bottom of sternum to bowls easily bruised and abnormal looking bruises that heal very slowly rash under right arm that does not heal
This spontaneous report was received from a physician and refers to a 65 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 21-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX23, in the right deltoid (dose, route, lot number and expiration date were not reported). The patient's concomitant therapies included FLONASE and IMITREX. On 22-SEP-2015, the patient sought medical attention by visiting the physician's office because she developed a "lump" (induration) and an "area of redness" on the axillary area of the right arm (erythema). On 23-SEP-2015, an unspecified ultrasound was performed., the result was not reported. It was unspecified if a treatment was given to the patient.  At the time of the report, the outcome of developed a "lump" and an "area of redness" on the axillary area of the right arm was reported as not recovered. The relatedness between the events and therapy with PNEUMOVAX23 was not reported. Additional information has been requested.
Swollen (L) arm, jittery, dizzy started about hour and a half after shot. Client received shingles vaccine on her left arm. Developed large reddened induration 3 x 3 (24 hours after vaccination). Client advised to call her MD/PCP.
This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored M-M-R II (dose, route of administration, injection site, lot# and expiration date were not reported). Administered dose of M-M-R II underwent temperature excursions at 47 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received AVA #2 and primary SPV 8/11/2010. Day 7 with site check c/o site "smelled bad" with site being white and had red circle, axillary pain and lymphadenopathy, and body aches to hips/legs (was working out) which resolved 3 days later. Approximately 8/26/2010 (Thurs night) c/o several small pruritic red bumps to bilateral forearms, legs then calves. Bumps later looked like small pimples with white heads (does shave arms so thought folliculitis). Had lesions on lips and in mouth and went to medical, transferred and admitted. Also has "red dots" to palms of hands and soles of feet not like arms/legs.
Per Web report received to Health Department. Patient noted to be positive for COVID-19. Pfizer: (1) 3/16/2021 EN6207 (2) 4/12/2021 EW0150 (3) 11/5/2021 FG3527 Patient was admitted to Hospital 10/5/2022 with concerns for night sweats, mental fog, and abdominal pain. Patient found to have Epstein Barr viremia (EBV) with additional concern for recurrence of lymphoma which was subsequently treated with rituximab on 10/10/2022. Patient underwent tumor lysis syndrome resulting in acute on chronic renal failure, transferred to the ICU for initiation of CVVH (continuous venovenous hemodialysis). At the same time, he was experiencing acute hepatic failure. A diagnostic liver biopsy showed EBV reactivation within lymphoma cells in the liver. Upon arrival to the ICU on 10/13/2022 the patient appeared in significant respiratory distress secondary to increased metabolic demands and fluid overload. Patient was also noted to be in atrial fibrillation with RVR. The patient was intubation. CVVH was started however patient became hypotensive requiring the placement of a central line. In addition, the patient was on the maximum of three different pressors. The patient?s acidosis and multiorgan failure continued to worsen. His family made the decision to transition to comfort cares. Patient was terminally extubated 10/14/20 AM and shortly thereafter passed. Patient was surrounded by his family. Complications in the hospital: Acute renal failure, shock, death. Health department has no further information on this patient.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 9-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 17 in the literature article. On an unknown date, several minutes after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant and cough. The subject was treated with epinephrine, antihistamine, steroid (unspecified), bronchodilator and ice pack (Nos). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved) and cough (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema and cough may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 9-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). No information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, less than 30 minutes after the vaccination, the patient developed eyelid angioedema and cough. This was classified as anaphylaxis by the emergency department doctor and the paediatrician. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine, oral steroids, bronchodilators and icepack. At the time of reporting the outcome of the events was recovered.  The patient was referred to a paediatrician. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Chills, joint pain, 4 inch diameter raised, red, left arm area where injection given. Sore lymph node under arm.
Area around vaccine site swollen the size of a golf ball and warm to the touch this morning when she woke up the day after the vaccine was given. Benadryl was given as treatment. Patient was told to monitor reaction for further symptoms and to do benadryl for the next two days .
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. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-DEC-2015, a healthcare provider at the office of a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 03-JAN-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is considered to be not recovered. Additional information has been requested.
Patient Complaints of sore arm and limited range of motion. Patient using ice and ibuprofen 600mg every 4 to 5 hours. Patient will begin to use heat as well.
Information has been received from a registered nurse concerning a patient who on 15-OCT-1996 was vaccinated with a dose of Varivax. Subsequently, 14-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Pt complained of hypersensitivity-like reactions (rash, hives, urticaria, pruritus) and injection site reaction (pain, inflammation at site).
Patient stated after taking the 1st vaccine she experienced really bad chest tightness and feels like her lungs is filled with bricks. She stated that it's starting to taper down some after 6 days was still having a hard time moving around.
patient describes covid arm. She stated after 5 days she had a grapefruit sized lump that was hot, itchy, and hard for 3 days. She stated that she did NOT take anything and did not seek medical help
10:45AM 12/2/22 Patient was administered an expired Pediarix (DTaP-Hep B-IPV) vaccine. Expire date 11/28/22
PT STATES FEVER, BODY ACHES, SOB, LOCALIZED RASH 3 HOURS AFTER RECEIVING VACCINES--SEEN IN ED
Two weeks after vaccination had tingling in hands/fingers, numbness/tingling in feet/toes. Increased to point where she could not walk. Admitted to hospital with Dx of GBS by Neurologist. She is receiving IgG Rx.   05/11/05 Received Discharge summary of 1/3-1/11/2005. FINAL DX: GBS  Patient experienced LE paresthesias & unsteady gait. Neuro & Cardio consults & LP done.  Abnormal gait & areflexia.  Treated with IVIG, improved slowly, and d/c to inpatient rehab.       Follow up 03/24/05: Patient's recovery status unknown. Lost to follow up outside of hospitalization.
Patient said on the night of the injection she developed a large "blister" over the injection site. Her arm itched the next day. On 12/29 she presented to the pharmacy to show her reaction. Her entire upper arm from shoulder to elbow was dark red, warm to the touch, slightly swollen and tender. She wanted to point out that she has a flu shot every year, except the prior year and that this was the first time she had received the FLUZONE HIGH DOSE injection.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a red, itchy rash on her palms. At first there were four or five marks and eventually at least twenty developed.
10/16/18 evening, he felt strong pain in left arm where vaccines were given earlier that day at his PCP visit, and he began to feel generally unwell. 10/17/18 he woke up feeling worse, went to work anyway, and vomited around noon. Then came to our urgent care this afternoon where this reporter learned he has fever (101.1 in clinic), chills, headache, body aches (all over), a little stomach pain, vomiting, nausea, and reduced appetite. Of note, he does NOT have any cough, runny nose, or sore throat.
Extreme  pain in shoulder after vaccination that lasted 3 days. Injection was given at the top of my shoulder. I did not have the rash or redness at the injection site. I could not move my arm without felling pain and could not sleep well because of it.
Redness; quite a bit of puffiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness). At the time of the report, ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
9/29/05 left arm pain, progressed to generalized aches 9/30 with possible fever. On 10/1/05 left arm 2" above elbow to shoulder neck area red, swollen; slight crepitus at neck 10/3/05. Area warm and painful to touch. Referred to PCP.
Redness, swelling, tenderness. Symptoms worsened on 12/13/14 prompting urgent care visit. Rx: ADVIL, DURICEF 250mg/5mL, 9 mL BID for 7 days.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High Cholesterol" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: COVID 19 Treatment Paxlovid from 05Aug2022 to 11Aug2022,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP/MMR experienced screaming for 2 days, adm. acetaminophen as directed - symptoms relieved "some what" mother states child would "grab head". Ears checked by MD 10NOV90. no sign of infection.
24 y/o male received Janssen vaccine @ 3:45 pm, while in the post recovery area, @ 3:50, Patient began to become diaphoretic, c/op lightheadedness, nausea and feeling faint, was assisted by the recovery Nurse from the chair to sitting on the floor w/knees drawn toward his chest, initial vitals: 113/83, HR 53, sats 98% on RA, skin clammy to touch, respirations/deep breathing. AAox4, verbalizing freely, able to answer questions clearly. Repeat vitals @ 4:00pm: 113/83, HR 63, stats 99% on RA, continued to monitor, 4:05pm stated feeling was passing, no longer diaphoretic, stated feeling much better. Ongoing monitoring by the recovery Nurse. 4:18 repeat vitals: 110/70, 73  no longer in distress, stable, stated no further issues, ready for release, dc from recovery to self care.
A growth of bone appeared visible to the naked eye (it was noticed by my girlfriend) on the top of my left shoulder above the injection site. Palpation confirmed its existence as bone. I googled the side-effect and it said bone growths were often a side effect of vaccines, and since there were not adverse effects and  I didn't have a doctor, I didn't report it. I just went to urgent care yesterday and mentioned it to the doctor who told me to report it to the CDC. The lasting effects have been a small decrease in mobility, stiffness and slight soreness in that shoulder.
After I had the shot, I did get the chills, fever and achiness.  However, it kickstarted a really bad bout of IBS/Diverticulitis that has continued on through today.  The doctor has prescribed medication to help, but this is one of the worst bouts I've had.
Pt had suffered significant medical expenses, and pain and suffering, and damages until her death; Chronic pain; Pt was treated for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-DEC-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) in a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 10-FEB-2014, pt was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. Patient was prescribed with valacyclovir (VALTREX), lidocaine, gabapentin and hydrocodone (+) acetaminophen (VICODIN) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, patient had suffered significant medical expenses, and pain and suffering, and other damages until her death. The cause of death and if an autopsy was performed was unknown. The outcome of herpes zoster and chronic pain was unknown. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: Unknown cause of death
For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 7/6/21 and the second dose of Pfizer COVID-19 Vaccine on 7/21/21 which is earlier than 21 days and outside of the 4-day grace period. There were no adverse events associated with the administration. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Pt received influenza vaccination previous day and passed away from believed to be heart attack the following morning. An autopsy is being performed.
Monovalent vaccine was given on the day it was removed from the market. No adverse reaction or consequence was reported.
10 x 8 cm of erythema, calor and induration at site of IZ.
Temperature stability evaluation of vaccines and reported that pediatric patients received PROQUAD vaccine since excursion date on 14-JUL-2022.; This spontaneous report has been received from a medical assistant referring to a 1-year-old female patient. The patient pertinent medical history, historical drugs, previous drugs reactions or allergies, and concomitant medications were not reported.    On an unspecified date in 2022, the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) at dose of 1.5 milliliter (ml) for prophylaxis (lot number W002781 had been verified to be a valid number; expiration date  24-JUL-2023; strength, route of administration and antomical location was not reported). It was reported the temperature stability of vaccines was summited on an evaluation after excursion date on 14-JUL-2022 (product storage error).; Sender's Comments:  US-009507513-2208USA004135:
administering the half dose booster shot of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering the half dose booster shot of Moderna COVID-19 vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering the half dose booster shot of Moderna COVID-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering the half dose booster shot of Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. nurse assumed that this patient received the second dose in May 2021   This case was linked to MOD-2021-377687 (Patient Link).
Received DPTa and Hep A on 5/10/07. Low grade fever on 5/10/07. High fever to 105.9 on 5/13/07 - 5/16/07.