chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/18/00 and 8/18/00, the pt received her 1st and 2nd doses of Havrix, respectively. The pt had no adverse event after the 1st injection. Two days after the 2nd dose of Havrix, on 8/20/00, the vaccinee experienced a rash without fever. The rash began on her back and was very itchy. She was treated with Medrol Dose-Pak on 8/21/00 and 8/29/00. She was also treated with Elocon creme on 8/29/00. As of 9/1/00, there was no improvement in the rash. She was still breaking out. As of 9/1/00, the outcome of the event in unresolved.
Patient received PREVNAR 13 injection on 5/16/14. When patient presented for follow-up appointment on 6/11/14, she reported injection site reaction (erythema, mild edema, and pain) that followed the administration of the vaccine. No systemic symptoms were reported. Skin rash, rash and erythema Multiform.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 67 year old male pt who received Lyme disease vaccine recombinant Ospa (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 5/5/99 and 6/2/99 with the understanding that the third and final vaccination would be required at twelve months "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "joint pain, fatigue, rashes, tingling, vision problems, nightmares, night sweats, neck and shoulder pain, balance problems, memory loss, and ear ringing." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of an infectious disease specialist and received anti-inflammatory, antibiotic, and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcomed information, is being pursued through the litigation process and will be reported if obtained.
Rash at injection sites. Pt took 1 Benadryl at 2300 and 1 at 2330. Pt had trouble swallowing, chest pain, and itching. Was taken to the ER at Medical Center.
Experienced atrial fibrillation beginning in March 19 for approximately 4 days. Symptoms included lightheadedness and mild chest pain. General practitioner confirmed atrial fibrillation on March 22. Symptoms resolved on March 23 without treatment, before visiting a cardiologist.
pt recv vax 4/7/98 & 4/10/98 pt devel hives & a rash on legs, arms, chest, & back & a fever of 101;pt was irritable, blotchy & red;pt was treated w/oral DPH & pred;When prelone was finished hives returned;
Intense sharp pain down left arm, sweating, nausea, felt like fainting or passing out, shivering after.
Sore swelling arm from shoulder to fingertips with swollen red finger/joints lasting 1 week. Still bruised at site of injection.
Mother states has red spots with a white center on left shoulder, left side of back of neck, on her lower scalp and 3 spots under her left armpit.  Parent states approximately 30 total spots.  States itching, no fever, denies loss of appetite and has had regular level of activity.  States child was also walking around in woods over weekend with family and friends. Parent had called MD 7-6-09 to speak with MD about "bumps", was to schedule appt for AM of 7-7-09 and then parent states remembered child getting vaccines and potential for reaction.  Called health dept to report this AM and has chosen to take to MD to diagnose.   Mother reports has treated her with Equate allergy relief 1 tsp=15mg diphenhydramine HCl (orally) X 1 and topical benadryl creme/ gel 2% for itching per instructions on package.
38 year-old patient received fluzone HD instead of fluzone quadrivalent with no AE; 38 year-old patient received fluzone HD with no AE; 38 year-old patient received fluzone HD with no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 38 years old patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot: UJ221AB, expiry date: 01-Apr-2020), via Intramuscular route in the right deltoid instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 28-Oct-2019.  The patient past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose.   At the time of reporting, the patient had no adverse event.  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.
We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.; Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The vial was initially stored in the refrigerator was on 31 March 2022. The vial did not undergo any temperature excursion. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Non Significant Follow-up appended on 31-Mar-22, included No new information.
Approx 1wk post vax, pt devel flu-like illness, felt run down, h/a; Seen by MD felt sinus h/a; 11DEC88 admitted to Hosp; sx included muscle weakness, gait disturbances, facial weakness, rt shoulder pain, neck stiffness, sensory  loss, GBS;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not reported. The pharmacist reported via online chat. The reporter said that a patient developed shingles after the 1st dose. The reporter asked was it still recommended for the patient to received the 2nd dose. As the reporter had a patient currently in this situation. The reporter did not consent to follow up. The reporter stated, This was a question that the reporter received from a provider. The reporter did not know the background information about the patient.
Said she woke up with burning and aching of every muscle and joint in her body.  States this continued through Saturday 9/21, but had lessened by then.  Denies had any fever.  States all of pain was gone by Saturday night.  States she took Tramadol Wednesday night and Ibuprofen on Wednesday morning.  States she didn't take anything on Thursday, Friday or Saturday.  Did not go to physician either.
12/17/20 10-mintues post injection headache, l numbness in face (15 mins, then resolved),  injection site  l arm  and pain in r upper arm (has not resolved), nausea, loose bowel movements. 12/18/20 severe body muscle pain has not resolved not as severe today 12/22/20,  12/19/20 joint pain in fingers more severe to l hand than the r hand, unable bend from pain today 12/22/20
This non serious case was received on 11 March 2009 from VAERS (reference number 251873) via a search of the QSCAN database. A 30 year old female patient received FLUZONE SV 2005-2006 USP (lot number U1873) intramuscularly on 03 January 2006.  Approximately 3 to 4 hours post vaccination, the patient's eyes became red, otherwise her were asymptomatic. Later that evening she had tightness and difficulty breathing. The patient recovered.
This spontaneous report was received from a consumer referring to a teenage patient of unknown age and demographics. There was no information about the patient's concurrent conditions, medical history concomitant or therapies provided. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (the lot #, expiration date, route, frequency, dose, and strength were not reported). On an unknown date, the patient experienced an unspecified adverse event regarding to the M-M-R II vaccine. Reportedly, the patient was sent to the hospital after receiving the vaccine. It was also reported that the patient was in a diaper as a result of the reaction they had from the MMR II. The outcome of the event was unknown. The reporter considered the event to be related to M-M-R II. Additional information is not expected since the healthcare professional's contact details were not provided.
This spontaneous report as received from a nurse refers to a 19 month old male patient with asthma, irritable bowel syndrome, allergy to latex and drug reaction/ allergy to BIACIN and AUGMENTIN. On 23-JAN-1998, the patient was vaccinated with MMR II (dose, lot number and expiration date were unspecified). Concomitant therapies included SINGULAIR, fluticasone propionate, ADVAR and albuterol sulfate (manufacturer unknown). On 23-JAN-1998, reported as "shortly afterwards", the patient experienced injection site reaction of swelling and redness. Patient recovered in an unspecified time frame. Nurse states that the physician's office was notified of this reaction but no additional medical treatment was provided. No diagnostic tests have been performed. Relatedness between the event and MMR II was not reported. Additional information has been requested.
Pt stated numbness/tingling that started 2 wks after injection. Pain only occurs at night. No issues at work.
Migraines since December 1 starting at 3:30-4 a.m. and continuing until 8, after I?ve had coffee. Mild headache intermittently throughout every day Joint pain in shoulders, knees, fingers, toes.  Chills December 1 only starting at 1 a..m. and subsiding by daybreak. Fever of 100 degrees F.
CHILLS AND SEVERE BODY ACHES THAT LASTED ONLY 5-6 HOURS
After the second dose about 3 or 4 days later my face started feeling sunburned and then peeled off starting in left hand corner near hairline of forehead and progressing through the rest of my face.  I did not report this on the app at the time because I did not link it to the vaccination.  This has happened 3 times since April 2, 2021.  Starting April 12, 2021 I noticed my legs starting swelling during the day.  On April 27, 2021 I noticed a rash on the inside of both legs right above the ankles.  I have also  been very sleepy and tired during the month with bouts of nauseousness. Since my blood pressure was high 141/85 (taken by my school nurse where I work) while on medication on 4/27/2021 and legs swollen, with rash she recommended calling the doctor.  The doctor scheduled an appointment for 4/28/2021.  The doctor said he feels the repetitive face burning/peeling with the swollen legs and rash is a delayed allergic reaction  to the COVID vaccination along with Vasculitis.  He gave me a Methylprednisolone Dose Pack of 4mg.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history who in August 2007, was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  In August 2007, in the office, the patient became "queasy, pale, lightheaded and dizzy".   There was no laboratory or diagnostic tests performed.  In August 200, "after about a half hour" the patient recovered.  Additional information has been requested.
dizziness; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 2 days after receiving Shingrix, the patient experienced dizziness and upset stomach. On an unknown date, the outcome of the dizziness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm.  The patient gave consent to contact the safety physician and provided contact details for the same. There is a discrepancy in the reporting the outcome was reported in the Argus structured field (not recovered) and the outcome reported in the source document (recovering/resolving).
A day after shingrix vaccine, pt states he broke out in shingles rashes and blisters in multiple patches around his body. Too painful to wear a shirt. Went in to be evaluated by his MD and MD confirms a case of shingles after shingrix vaccine. MD states this is her 2nd patient case where shingles occurred after getting a shingrix vaccine.
Pain upper arm and numbness of hand lasting 2 days. No swelling or redness at site, arm or hand.  T:97.9 +/= radial pulses and capillary refill 9:30pm Headache, dry mouth, cold sweats.
Patient described burning sensation on skin and lips. She reported that it felt like a bad sunburn on her skin and her lips felt very chapped.
Anthrax #3, fever, flu-like symptoms, severe erythema, edema, pain of right UE, unable to use arm secondary to symptoms. Sun in ER x2, no treatment/medications prescribed.
After vaccination, I worked and drove home one hour. That night I began a 12-hour stretch of inability to function. I was crawling on the floor to go to the bathroom only when it was urgent to finally go. I couldn't fix myself food or get myself water. I could not go to work. I could barely use the energy to speak. Many other healthcare providers I know had this same horrendous illness but did not report it. It occurred to me that I should have reported it, so I'm doing so today.
This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering. On an unknown date, the outcome of the generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering were recovered/resolved. It was unknown if the reporter considered the generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 53 or 54 years. The patient experienced muscle ache all over the body. The events resolved within 2 days. The patient gave permission to contact her health care provider. No further details were provided. The patient experienced similar reaction after 2nd dose, see case US2018156086.
This is a spontaneous report  obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist reported the same adverse event for three patients. This is the third of three reports. A male patient of an unspecified age, race and ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain and soreness of the arm where the vaccine was injected. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017505508 Same reporter/drug/event, different patients;US-PFIZER INC-2017505472 Same reporter/drug/event, different patients.
6-8 hrs p/immun, pt cried excessively; t101.4 for several hrs; moaned thru out the entire noc; could not stand legs touched; on subequent well pt ck; MD advised advil p/next immun/ped DT;
about 8.5 hours after getting the shot, I started an all over not well feeling.  Within an hour I had a fever and was shivering.  That lasted all night.  During the night I got a horrible headache which is still affecting me at the time of this writing.  I have been very fatigued and slept for 3 hours in the afternoon.  When I woke up I felt somewhat better but now a few hours later the headache, body aches and shivering has returned.
Rash starting on trunk 5/20/15. Papular no vesicles, no scabbing. Fever 5/16 and 5/17/15.
Information has been received from a physician concerning a 19 year old female who in June 2007, was vaccinated on the left arm with a first dose of Gardasil.  In June 2007 the patient developed a rash that went all the way down the patient's left arm, down her upper back and down the right arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the rash.  Additional information has been requested.
Pulse rate upon awakening appeared to me to be very slow. I went to my PCP and had an EKG which showed that I was having bigeminy premature ventricular contractions (PVC). I was sent to the ER where I was evaluated and admitted for a 23 hour observations. I had a chemical stress test and echo cardiogram which did not show a cause. PVCs continue to return intermittently and varying intervals, sometimes bigeminy and trigeminy. I have never had this issue prior to receiving the COVID19 vaccine booster on 11/2/21.
Began with pink raised lesion on trunk yesterday which progressed to fluid filled lesion and today is scabbed. Patient has >25 lesions on exam today which range from pink macules to fluid filled lesions. No other symptoms except pruritis.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004535: US-009507513-2005USA004536:
Caller stated that she received her first vaccine on 4/11/2021 and her head started spinning on 4/13/2021 member's head still spinning. She denies any other symptoms at this time. Member set up for 24hr AE follow up appointment.
COVID Arm; injection site lump; injection site pain/ injection site achy; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID Arm), INJECTION SITE MASS (injection site lump), INJECTION SITE PAIN (injection site pain/ injection site achy) and INJECTION SITE RASH (injection site rash) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID Arm), INJECTION SITE MASS (injection site lump), INJECTION SITE PAIN (injection site pain/ injection site achy) and INJECTION SITE RASH (injection site rash). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (COVID Arm), INJECTION SITE MASS (injection site lump), INJECTION SITE PAIN (injection site pain/ injection site achy) and INJECTION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.