chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 76 yo male with PMH of OSA, AAA, DM, HTN, and HLP presented to the emergency department department with a week of fever fatigue, exertional dyspnea dyspnea, and diarrhea. He was also concerned about his blood pressures being elevated. In the emergency department he was found to be Covid positive despite having been previously vaccinated. Chest x-ray showed a left basilar pneumonia, however procalcitonin was negative, there is no leukocytosis, and patient did not have a fever. Patient was initially given antibiotics however given unremarkable lab findings was felt that this was likely pneumonia secondary to COVID-19 and not bacterial infection. Antibiotics were discontinued. Pt was admitted for monitoring and discharged the next day.
Per reporter and Regulatory Authority proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and DHA instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
05/2021 I had served muscle inflammation in my both arms, both  wrist and both back of thighs. This lasted just till recently as of today 08/26/2021. Dr prescribed the prednisone 05/2021 and started me on 15mg and gradually went down two mg every two weeks.
Breakthrough case admission after 4 vaccines Moderna 3/3/21 Lot# 010A21A;  Moderna 3/31/21 Lot# 025B21A;  Moderna 1/16/22 Lot# 041J21A;  Moderna 8/27/22 Lot# 011B22A
4MAY pt recvd vax @ 9AM & 1130AM started trembling of arms progressed to entire body intermittent approx 4-7 times over 1 1/2 hrs;afebrile 9PM;t99.8-101.2 ax during nite APAP given;MD noted pink ear drums & red throat;no more pertussis;
High fever or Signs of a severe allergic reaction. Difficulty breathing, hoarseness, paleness, weakness, a fast heart beat.
Pt got very first flu shot on 09/26/2017 at 13:35. Pt says 2 hours later she had redness, itchiness at the site. The next day it had swollen to a quarter size. Pt used cold pack as treatment.
I had intense flu like symptoms the night of taking the vaccine. Uncontrollably shivering, intense body aches,  going from being very hot and very cold.   The morning of I woke up with a bad headache and body aches.
No shots or vaccinations besides teh Pfizer vaccinations received this year.  Initially I was sleepy and tired the first two days. On day two, my joints were achy and a little stiff.  On day three my joints were so achy and painful I could not hold a cup of water without two hands.  I didn't think a lot about it as this also happenend to me at my first vaccine on 08/25/21 and I was told my second vaccine symptoms would be worse my second shot.  On day three through five, I had wheezing, a dry cough and tight chest. I though I might be getting a chest cold, so did not think much about it and nothing became of the symptoms in the form of a cold. I began to take ibuprofen by day three - 600mg three times a day. At end of first week, I contacted my doctor who told me to continue to take Ibuprofen/ Tylenol as I was and nothing else. A couple days later I called the Hospital's Advice Line to get some assistance with determining how much longer this would last. By mid-week if of 9/27/2021 the pains and aches began to lessen. Now, I can walk with slight aching in my feet and my hand joints continue with some discomfort when making a fist. During this whole ordeal, my joints constantly popped, and the popping was sometimes painful all over in my joints.
M.D states child had 2 seizures at home on 01/31/2003. Tx. States also had some breathing problems at hospital.
Pt devel elevated temp greater than 104; Seen in ER by MD rx'd w/APAP & fluids w/good results;
This spontaneous report as received from a office coordinator refers to a 60 year old female patient. No pertinent medical history and drug reactions/allergies reported. The patient's concomitant therapies included albuterol (manufacturer unknown) and estradiol. The reported stated that after a patient received ZOSTAVAX (lot # J008432, 0.65 ml, once, subcutaneous site of administration was not reported), on 16-DEC-2013, she developed a red, raised area at the injection site that was sore to the touch. The reporter stated there was no blisters, pustules or rash present. The patient called into the office today on 18-DEC-2013 and reported adverse reaction. The patient stated the reaction onset date was 17-DEC-2013 (reported as "a day after" receiving the ZOSTAVAX. No laboratory test were performed. The patient sought unspecified medical attention. The physician, instructed the patient to take BENADRYL for the reaction. The reported stated this was the second adverse event associated with Lot # J008432. The reporter requested a lot check for this received ZOSTAVAX on behalf of physician. The outcome of red raised area at the injection site and injection site that was sore to the touch was reported as not recovered/not resolved. Additional information has been requested.
Severe Chills, fever to 100.8, vomiting-   vomiting lasted periodically for 4 hours or so (not much output), fever returned on/off throughout the next day.
pt recv vax 5SPE95 & 10OCT95 lab eval revealed varicella antibody 0.87;repeat lab eval on 14NOV95 was negative for varicella antibody;no further details were provided;
Hives, redness, swelling of lymph nodes, swelling of neck on left side, tenderness, redness of face.
11/4/99 - Arm painful, some swelling, warm.  11/5/99 - elevated pain, chest tight.  11/6/99 - fever, chest tight, local inflammation went to ER, on antiobiotic for cellulitis.  11/8/99 - no fever, inflammation decreased, dizzy, headache.
I woke up at 6am the morning after receiving the vaccination. I was awake for about 2 and a half hours when I began feeling exhausted, nauseated, had an intense headache and cold chills. I went back to bed at 8:30am. I covered myself with 2 quilts and my bathrobe due to chills. I had cold sweats, a fever, nausea, diarrhea, body pain, a migraine, lucid dreams, and hallucinations for the next 36 hours. At around 36 hours I still had a migraine, muscle and body pain, the other symptoms had waned. My last three symptoms lasted for about 4 days and slowly lessened over time.
Pt reported difficulty fevers (unrecorded with sweats), difficulty swallowing without sore throat, weakness, nausea without vomiting, anorexia, L neck pain, L chest pain x 4-5 days.  Exam with normal VS, mild shoddy LAD on the L anterior cervical chain on his L with a small mass under his L mandible (boggy) which is slighlty tender, no overlying skin changes/warmth/erythema no stridor, no increased WOB no axillary LAD B, no supraclavicular, no pre/post auricular LAD slight tenderness overlying the angle of Louis, sternoclavicular joint  lateral arms (sites of injection) without tenderness/warmth/erythema; could not see the site of injection B
Vaccine admin approx 0950 1/22/13. Pt. developed chills & body aches (systemic) approx 2230 1/22/13. Early AM 1/23/13 Pt. developed a fever 102.7 that lasted until the afternoon of 1/24/13. She noted a pea sized area of erythema around injection site & a large amt. of swelling in the deltoid.
Joint pain this morning- than itching in different places... some numbness all over my arm.. than at 1pm  sudden onset of tachycardia, lip numbness and tongue numbness with nausea.  I immediately took 10mg Benadryl.  - but bc my tongue was feeling different I had to call 911.  Upon arriving in the ER - they checked vitals and found tachycardia.  They administered Benadryl 25mg.
patient was given moderna bivalent vaccine, patient was outreached and is coming back to clinic on 6/3/23
Initial report received 30 December 2009 from a health care professional. A 75-year-old female patient had received a first dose intramuscular left deltoid of H1N1, lot number UP099AA on 28 December 2009, and one day later, she developed a five inch black and blue area at the injection site. No soreness or pain was present and the patient had no other symptoms. The event did not require a doctor's visit. The patient had been taking baby aspirin, MOBIC, "plaqeunel", ZESTRIL, folic acid, XANAX, ALLEGRA, LIPITOR and an "irregular heart med" concomitantly. She had a history of sulfa allergy, hypertension, RA (rheumatoid arthritis) and high cholesterol. The patient had no illness at the time of vaccination and she had not experienced any adverse events following prior vaccinations. At the time of the report, she had not recovered. Follow up information received on 01 March 2010 from a health care professional. Concomitant therapy also included Acebutolol 200 mg (previously reported as irregular heart medication) and "Plaqeunel". The bruising at the injection site persisted for 7-10 days and then resolved. No other information was provided. Documents held by sender: None.
The vaccines were out of range for 12 hours due to the refrigerator door being left open with a max temperature reached of 72°F with no reported adverse event.; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves no patient and reporter stated the vaccines were out of range for 12 hours due to the refrigerator door being left open with a max temperature reached of 72°f for vaccines HIB (PRP/T) VACCINE [ACT-HIB], IPV (VERO) [IPOL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  On an unknown date,  the reporter stated that the vaccines were out of range for 12 hours due to the refrigerator door being left open with a max temperature reached of 72°f with no reported adverse event. (product storage error). Vaccines have not been administered post excursion.  Action taken: not applicable  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Information has been received from a physician concerning an 18 year old female patient who was vaccinated with the first and second dose of MMR II on 24-AUG-1992 and 13-MAR-1997 respectively.  On 09-JAN-2010 the patient experienced mumps.  Mumps was diagnosed on 11-JAN-2010.  The patient was afebrile and developed right parotitis.  It was unspecified if lab tests were performed.  At the time of the report, the patient's outcome was unknown.  Additional information is not expected.
Received vaccine at 8:45am, at 09:00am began feeling "woozy" then complained of chest tightness.  Vital signs checked, HR & SpO2 . 911 called. EMS transported patient to area emergency room.
I had all the possible side affects at once and lower back pains which started to bother my kidneys and I ended up going to the hospital and they treated me for dehydration because I lost so much fluid because of vomiting and sweat, They gave me tramadol and Zofran
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012614: US-009507513-1904USA012967: US-009507513-1904USA012968: US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012980: US-009507513-1904USA012981:
Felt hot; Burning feeling; Rash on arms, on both legs; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot), BURNING SENSATION (Burning feeling) and RASH (Rash on arms, on both legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING HOT (Felt hot), BURNING SENSATION (Burning feeling) and RASH (Rash on arms, on both legs). At the time of the report, FEELING HOT (Felt hot) and BURNING SENSATION (Burning feeling) outcome was unknown and RASH (Rash on arms, on both legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided Treatment Benadryl
Pt. had Tdap on 1/25/15 at 12 PM. Developed fever, body aches, epigastric pain. Treated at Urgent Care. Possible cold chain failure - "cooler not plugged in as per patient".
Vomitting-started at 10PM on 20FEB; Child has vomitted 5-6x since 10PM on 20FEB; Hasn't been able to keep even liquids down otherwise isn't sick po temp 100.2; lt leg isn't sore;
woke up the next day feeling nauseous, by 12 noon I had a fever 100.4 feeling very tired malaise and headache. This feeling lasted for 24 hours. By Friday afternoon I was feeling better and by Saturday no reactions.      Arm was sore for 24 hours
Cough for 30-40 minutes followed by swelling of tongue, throat, and face.  Within 30 minutes experienced chills and shaking.  Personal MD notified.  Took Benadryl 25 mg.  Symptoms gradually subsided overnight.
On Aug 21 child developed fever in afternoon, decreased appetite, fever developed every day Aug 21-24 in afternoon, temp maxed 103-104 F, Accompanied by decreased appetite and lethargy. No other SX. Developed 4 bumps together on left FA and 2-3 others scattered, never blistered, went away by Aug 27th. No spots/bumps at inj site.
I could not walk and I was then hospitalized with Hypercalcemia. Via biopsy I was diagnosed with systemic sarcoidosis (inflammation through out my body).  I?m could not eat or get out of bed and I am still currently  bed ridden most of the time. There is no cure for my disease. In addition, I have been diagnosed with fibromyalgia.
Facial sinus pain. TMJ pain.  Stiffness and tenderness on the back of neck and head. lightheadedness immediately after administration that continued for about 2 hours.
Sore injection site; This is a spontaneous report from a contactable pharmacist (patient). A 26-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 08:45 at single dose on right arm for covid-19 immunisation. Medical history included asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No Covid prior vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient experienced sore injection site on 24Dec2020 12:00. Outcome of event was recovered. No treatment received. No covid tested post vaccination.  Information about Lot/batch number has been requested.
Pt receiving post-exposure treatment; start date 8/19/00. On 9/2/00, pt reported stiffness in his neck after shot on 8/26/00 but also went skiing. #4 HDCV given on 9/2/00. On 9/16/00, pt in for last HDCV; stated he had stiffness in his neck and spreading to upper back and shoulders to right deltoid where shot had been given. On 9/16/00, did not give last vaccine. Health officer called CDC.
Kidney stone; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that last weekend (unspecified date), the patient had a kidney stone and he's receiving antibiotic (CEFLIN), 500 mg twice a day for four weeks. The patient would like to know if it's okay to receive the second dose of the vaccine while he is taking the antibiotic. The outcome of the event was unknown.  The information about the batch number has been requested.
The next day pt noticed the injected arm swollen and went down to the arm and there was a blister. Pt came in 9/26 and the swollen already subsided but there was still a bit of blister remaining.
Redness, swelling, redness kept expanding. Treatment: Triamcinolone 0.1% cream, Famotidine 20 mg Prednisone 20 7 day course.
this one hurt more than ever; the whole area is hot to the touch; patient recieved Fluzone High Dose Quadrivalent  instead of Fluzone Quadrivalent; patient recieved Fluzone High Dose Quadrivalent  instead of Fluzone Quadrivalent; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 57 years old female patient who experienced hurt more than ever (vaccination site pain) and the whole area is hot to the touch (vaccination site erythema), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccinations included flu shot every year and used to get allergy shots and it hurts her .  Medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Hepatic cancer 7 years ago. She has experienced two recurrences of the cancer with the last recurrence being 3.5 years ago..   On 02-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE instead of INFLUENZA QUADRIVAL A-B VACCINE (0.5/ 0.7 ml [unclear], lot number not reported via unknown route in the right arm for prophylactic vaccination.  It was also a case of actual medication error due to wrong vaccine administration and  inappropriate age at vaccine administration (PT: Wrong product administered and product administered to patient of inappropriate age) (same day latency).  On an unknown date, the patient developed non-serious events of hurting (vaccination site pain) and the whole area is hot to the touch (vaccination site warmth) (unknown latency)  following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC 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.  There will be no information on the batch number for this case.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUL-2020) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
I tested positive for COVID-19 on 5/31/22. I had congestion, sneezing, watery eyes, it seemed to be like allergies, coughing, diarrhea, slight headache, and some stomach pain. I am still dealing with these symptoms at this time. I mainly have residual coughing and some sneezing. I wouldn't have even tested if I didn't have to meet up with my brother that recently had a kidney transplant. I had to be tested before going around him.
A customer called to report an AE that was reported to her by a nurse yesterday, 20SEP2023. The nurse reported that a boy received his second shot of GARDASIL 9. The nurse was not aware that he had to be monitored for 15 minutes after his second dose and; This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided).         On an unknown date the patient received his second shot of GARDASIL 9. The nurse was not aware that he had to be monitored for 15 minutes after his second dose and the mother was in a hurry, so they let the boy go prior to the 15-minute hold time and the boy passed out (loss of consciousness). The outcome of loss of consciousness was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was not provided.  Upon internal review event loss of consciousness was considered medically significant based on ASTL list.
bright red, hard, hot to touch, sore to touch lasted for 10 days.  after 10 days it has remained red and hard for another 10 days; now just visibly pink and mild hardness Follow up received on 11/03/2009
Raised red rash on cheeks and upper anterior legs and fever 2 days following vaccination and parent report rash getting worse. Advised to go to MD for eval.