chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of itching in a 24-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2012 at 15:15 the subject received 1st dose of FLUARIX (unknown, left arm). On 11 October 2012, within hours of vaccination with FLUARIX, the subject experienced itching, elevated blood pressure and hive. The healthcare professional reported that the subject is a staff member in the office. The subject experienced itching, hives and elevated blood pressure. At the time of the call the subject was still in the office being treated; BENADRYL was given as treatment to prevent hospitalization. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the itching, elevated blood pressure and hive was unspecified. The healthcare professional considered the events were probably related to vaccination with FLUARIX. The healthcare professional reported another case, see also A0997591A.
tachypnea, tachycardia, fever, lethargy lasting approx 12 hours
Swollen, painful lymph nodes in right arm; Pain and tenderness at injection site; Headache; Fever (2 days so far); Splotchy rash on thighs
Patient was administered an undiluted dose of the Pfizer COVID 5-11yr vaccine.
1st shot 12/20/2019; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on 20th December 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. At the time of reporting, the reporter asked should start series over.
I woke I started a hard chronic coughing, 4 hours in time. It didn't go away, and it lasted all night. In the morning I contacted my Dr. ask was this a side effect. The Dr. was unsure, and it was two weeks later. The Dr. asked me to make an appoint at the local urgent care the soonest appoint was 12:55pm April 5. The Dr. at the urgent care clinic gave COVID test which came back negative, and they said it may be allergies and my lungs were clear.
I experienced fever that did not respond to TYLENOL, shivering, muscle aches, fatigue, headache and nausea. All of these symptoms were very severe and kept me in bed through Monday, January 7th. The fever took approximately 36 hours to resolve. I would classify the headache as a migraine. I was unable to eat during most of this and tried to keep water down. I spoke with an on-call physician on Sunday, January 6th, who didn't have a lot to offer except to attempt to stay hydrated and if I could not then proceed to the ER. The headache and fatigue resolved almost a week later on January 10th.
Persistent high fever of 105-106 for 24-48 hrs following immun;
Vaccine was administered around 9:30 pm on Monday, September 9th. At around noon on Tuesday, September 10th, patient woke up with swelling of the lips and cheeks. Patient went to the ED. No treatments were administered. Swelling came down and patients lips and cheeks returned to normal prior to waking up the next day.
Presented to ER on 12/5/21 and admitted. 3 day history of worsening cough, dyspnea primarily with exertion, and orthopnea.  Patient with bilateral pleural effusions and cardiomegaly on CXR.  Also noted to have a positive COVID 19 test.  She is fully vaccinated and has received a booster.  She has a mildly elevated BNP.  She is hyponatremic at 128.  She has significant B/L LE edema.  She was noted to have a Hgb of 7.5 which is stable from previous and denies dark tarry stools or frank blood in her stools.  She is receiving a unit of PRBCs while in the ED.  She is hypertensive while in the ED.  She is on minimal O2 and stable hemodynamically.  She is to be admitted at this time for further evaluation and management. On 1L NC for comfort. placed on azithromycin, ceftriaxone, dexamethasone, and remdesivir. Discharged on 12/13/21
Tdap vaccine expired 4/1/2023, given 4/6/2023 0 adverse reaction to patient known
Runny nose; Fever of 100.1 for a couple of days; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), FATIGUE (felt tired) and PYREXIA (Fever of 100.1 for a couple of days) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (felt tired). On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Fever of 100.1 for a couple of days). At the time of the report, RHINORRHOEA (Runny nose), FATIGUE (felt tired) and PYREXIA (Fever of 100.1 for a couple of days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1f (High) 100.1F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Patient received vaccine after 30 days of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30 days of expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included ETHINYLESTRADIOL for an unknown indication.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30 days of expiry). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Others concomitant medications included Multivitamin  No treatment medication was reported
On May 10, 2001, my son received the following vaccines:  DTaP Hib - HbOC IPV Pneumococcal Conjugate  Approximately 24 hours later, he had a medium (103 degress) fever, which lasted for two days, accompanied by listlessness and mild nausea.  By the third day, he was recovering, but was very agitated, and exhibited a mild rash with numerous tiny red pin-prick sized dots on his thighs.  The rash disappeared in two to three days, but his demeanor remained significantly altered.  Prior to the vaccinations, he was a bright, healthy, happy child with normal levels of activity.  Afterwards, he "went ballistic," exhibiting significant restlessness, agitation, wild behavior, general inattentiveness, and marked aggression.  These symptoms wax and wane between once and three times throughout each day, and have been noticed by several daycares, pediatricians, friends, family, neighbors, and two child behavioral specialists.  He remains very intelligent, with excellent vocabulary and cognitive capabilities, as well as motor skills.  While he requires no special care, and can successfully coexist with other children at daycare, managing his behavior is difficult.  One of the daycares he attended expelled him for biting other children more than five times.  He is slowly, but steadily becoming capable of controlling his own behavior in response to our comments, but it's clear that "the pot is still boiling beneath the lid."  I'm unsure of whether to check "Resulted in permanent disability," as it's uncertain at this time as to how his condition will affect the remainder of his life.
Itching; Swelling, 3 inch area of swelling; Redness; Tenderness; Sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling, 3 inch area of swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and MYALGIA (Sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma, DORZOLAMIDE, BETAXOLOL, LATANOPROSTENE BUNOD (VYZULTA) and LEVOTHYROXINE for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swelling, 3 inch area of swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and MYALGIA (Sore). On 04-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itching). At the time of the report, INJECTION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling, 3 inch area of swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
C/o Lt upper arm itching. Area red, warm to touch. No signs of respiratory distress.  Ice pack to reduce edema, Benadryl 50 mg po.  Client returned to School nurse office 10 minutes after receiving Benadryl with c/o of neck and chest redness with chest tightness.  After 15 minutes, client states no further discomfort.
pt recv vax13JAN97 & 15JAN97 pt returned to clinic w/ c/o swollen lymph glands, water eyes, sore throat, temp 100.4, photophobia, adm to hosp w/addtl c/o frontal h/a, fever/chills, neck & back stiffness;hosp 2 days;dx flu like synd viral
Hypothyroidism NOS on 2013-03-01, clinician comment: The patient had long standing hypothyroidism before the vaccinations were given. This is not a reaction to a vaccine.
Severe fatigue, malaise, nausea, migraine headache all began the same afternoon as injection, approximately four hours post-injection.  Symptoms lasted (and increased in intensity) for approximately 72 hours.
Information has been received from a 72 year old female with no allergies who in the "end of February 2009" (approximately 28-FEB-2009), was vaccinated with VARIVAX (Merck) 0.5mL (lot # not reported) instead of ZOSTAVAX (Merck).  Concomitant therapy included SYNTHROID and LIPITOR.  On 07-MAR-2009 the patient developed rash on her arms and face.  Subsequently, the patient recovered from rash on her arms and face.  No lab diagnostic studies were performed.  Unspecified medical attention was sought.  No further information is available.
pain at the injections site; fatigue; dizziness; headache; second dose greater than six months since first; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 4th April 2022, the patient received the 2nd dose of Shingrix. On 4th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 5th April 2022, the patient experienced injection site pain, fatigue, dizziness and headache. On an unknown date, the outcome of the injection site pain, fatigue, dizziness and headache were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fatigue, dizziness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The patient received 2nd dose of Shingrix that it had been greater than six months since his first dose, which led to lengthening of the recommended interval between vaccine doses The reporter did not consent to follow-up.
dizziness, fainting, depression, chronic fatigue, gastrointestinal issues....Dr prescribed Grapefruit seed extract, supplements, stated NO MORE VACCINES for pt
A severe headache, overall muscle pain, and weakness, nausea, slight fever, warmth and redness in the area of injection, tired. It was much better 2 days later.
tested positive for COVID; stuffy nose; mild tightness in chest; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose), CHEST DISCOMFORT (mild tightness in chest) and MYALGIA (muscle ache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Tremor and Hypercholesteremia (high cholesterol). Concurrent medical conditions included Allergy (pine straw), Drug allergy (sulfa drugs) and Low blood pressure.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose), CHEST DISCOMFORT (mild tightness in chest) and MYALGIA (muscle ache). At the time of the report, COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose), CHEST DISCOMFORT (mild tightness in chest) and MYALGIA (muscle ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
12/03/2021 presents to EC ED for "sinus congestion, anosmia, dysgeusia, intermittent diarrhea and progressive fatigue". PMHx of "DM, htn"
Myalgia, NauseaVomiting, FATIGUE/TENDERNESS AT INJECTION SITE Narrative:
Pt developed RUE erythema and edema. RUE US demonstrated clot in 1 of 3 brachial veins in mid-portion of RUE. Pt prescribed Eliquis x  6 weeks ( 5 mg PO BID once. 10 mg PO BID x 7 days. Then 5 mg PO BID x 5 weeks) followed by repeat RUE US.
This non-serious initial spontaneous case, was received from other health professional on 28-Sep-2017, concerning a 62-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered last year's expired FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286 (as reported), expiry date: Apr-2017, route of administration, anatomical location: not reported). The reporter assessed the report as non-serious.
Starting of new onset depression with suicidal ideation that worsened after 2nd vaccine on 6/23/21
Very sleepy, not making eye contact x 2 days then back to normal. Patient awake only to eat then back to sleep x 48 hrs then normal.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 1:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Mar-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
Warm. Reddened area on back of LA at injection site 13 x 14 in. Seen at clinic. Dx'd with cellulitis. Started on KEFLEX 500mg PO TID. Temp. 99.8 degrees F.
HCP states that PEDVAX HIB and ROTATEQ vaccines that underwent a supported temperature excursion were administered to a patient on 27DEC2022.; No additional AE information provided.; This spontaneous report was received from nurse referring to a patient of unknown age, gender, and ethnicity. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 27-DEC-2022, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1892784 (Lot # has been verified to be a valid lot number), (expiration date: 03-DEC-2023) (strength, dose, and frequency were not provided); and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot #W006596 (Lot # has been verified to be a valid lot number) (expiration date: 11-OCT-2024) (strength, dose, route of administration, and frequency were not provided) for prophylaxis.  On that date, vaccines that underwent a supported temperature excursion (product storage error) for 1 hour and 2 minutes at 8.5 degree Celsius (C). No additional adverse event (AE) information provided. Vaccines had no previous temperature excursion.
Fatigue, injection site pain, fever 99.5-100.5, body aches
Swelling and itching at vaccine administration site x 1 day. Treatment plan of ice and ibuprofen for swelling. Call office if no improvement.
Cutaneous macular and blanchable rash at injection site. Approx. 6 cm diameter.
had rash on left hand after shot in 10 minutes  (same arm having vaccine) then was given one tablet of zyrtac after ~15 to 20 minutes, having swelling tongue   after ~10 to 15 minutes, took one dose of  benadryl  ~1 to 2 hour, all symptoms go away
2 weeks after second COVID vaccine,  immediately after taking polyethylene glycol (Miralax) had severe pruritis of bilateral hands and feet with redness of the skin. Followed shortly by nausea and 1 episode of vomiting, hypotension (70s/50s), and chills. This passed over the subsequent couple hours then about 6 hours later developed sudden onset severe bilateral conjunctivitis which was so painful I couldn't open my eyes or see very well and ended up going to the ED. Seen by ophthalmology there and told it was likely viral conjunctivitis. Over the next couple hours this passed but then started to develop severe diffuse arthralgias  which lasted about 1 day. This then passed and I felt completely fine. About 2 weeks later I tried taking Miralax again and about 6 hours after taking the Miralax developed the same severe diffuse arthralgias as the prior episode, which again passed in about 1 day. I had taken Miralax several times before getting vaccinated without any issue.
hip pain; slightly nauseated; muscle aches; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip pain), NAUSEA (slightly nauseated), MYALGIA (muscle aches), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (hip pain), NAUSEA (slightly nauseated), MYALGIA (muscle aches), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (hip pain), NAUSEA (slightly nauseated), MYALGIA (muscle aches), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
This patient was vaccinated with the flu shot by another nurse/friend.  It was a on a Monday or Tuesday (Oct. 20 or 21) that she was given the shot, and towards the end of the week, she began feeling unusual symptoms such as weakness, back and leg pain, feeling ill, and numbness in arms and legs.  The Sunday after she had the shot, she came home from work and was not feeling like "herself."  That afternoon, she collapsed and was paralyzed.  She was taken to the Hospital to have tests done the following day.  Early the next morning, she was unable to breathe and was then airlifted to the Hospital.  She was then put on a respirator, and was then diagnosed with Guillain Barre Syndrome.  She was taken into another Hospital on October 27, 2003, and is still currently in ICU.  She is still unable to breathe on her own, and also had a tracheostomy done on her.  She can move her head and shoulders somewhat, but is still unable to move anything else. The medical records received on 1/12/04 states respiratory failure. The medical record received on 3/23/04 states basilar atelectasis, decubitus ulcer, anemia, depression and urinary tract infection. She is still paralyzed and cannot fully move on her own. She can move her right arm, but without much control. She was just moved to a long term Rehab Center as of February 2, 2004.
Generalized rash within 24 hours, post vax. Also unable to console. On 12/22/00, pt still has light generalized fine pattern rash and red cheeks.
Severe myalgias and arthralgias as well as chills for 12 hours, then moderate to mild myalgias and arthralgias.
Presented to the Vaccine Clinic complaining of rash all over her chest and itchiness for 2 days  after receiving the COVID vaccine. Complained of mild shortness of breath. Patient was escorted to ED for further evaluation.