chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative referring to a 13 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 1st dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. The patient's concomitant medications were not reported. It was reported by the physician, that on an unknown date, 8 months after receiving the first dose, the patient was vaccinated with the 2nd dose of GARDASIL 9 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). Furthermore, it was reported that, no adverse effects were developed and that no product quality issue was involved. Additional information has been requested.
Unconsolable crying for 48 hours after administration.  Exam was normal.  Partial septic work up was done to rule out other causes.
Generalized erythema, rashes, papules, fever, headache with lymphadenopathy, L arm pit 9 days post-vaccination.
On February 4th, I noticed a slight discoloration of the injection site. It appeared to have a light red ring around the injection site. On Sunday Feb 7th, the discoloration started getting darker around the injection site. On Tuesday, Feb 9th the discoloration moved down my arm and looked like a blotchy redness. Today, Feb 10th, the color became darker and got bigger. There is no pain. There is "pins and needles" feeling, and some very minor numbness on my right forearm.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in July 2018, the patient's arm developed a hard knot bump and was very tender to the touch. The patient sought medical attention. The outcome of the events and the causal relationship between the events and GARDASIL 9 were not provided.
UNILATERAL SUPRAPUBIC VESICULAR RASH, ITCHY. ITCHY ABDOMEN AND HEAD, SENSATION OF COLDSORE ERUPTING AND PHOTOSENSITIVE, 48 HOURS AFTER FIRST VACCINE.
Information has been received from a mother concerning her 8 year old daughter, who is asthmatic and on albuterol, who was vaccianted with a dose of varicella virus vaccine live. It was reported that the patient sat next to a child in her class who was not vaccianted and apparently came to school for 2 days with active chickenpox. At the end of May 2005, the patient experienced itching and broke out with approximately 30 to 40 spots that resembled little mosquito bites. The patient was seen by a physician who diagnosed the chickenpox. The rash went away within 48 hours and was described as mild. Additional information has been requested.
4cm x 6cm, red hot area on left upper deltoid; Zyrtec 10 mg qd, NSAIDS
stopped my Shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "stopped my Shingles". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped my Shingles".  Additional information: The patient shared that all COVID 19 shorts and the two booster also stopped the shingles.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200068023 same patient/drug/event, different dose;
Rash on arms, wrists, legs, ankles, feet. Diagnosed as Lichen Planus, Auto Immune Deficiency. Started shortly after my vaccinations while at work. PLAQUENIL prescribed for treatment.
Sore throat and fever 2 days after vaccination according to mother.  Mother says patient is now OK.
Patient hospitalized 10 days later with covid like symptoms, with negative covid test results; This is a spontaneous report received from a contactable consumer (patient's daughter). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot/Batch number: Unknown) on an unknown date via an unspecified route of administration at single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccine in four weeks, other medications in two weeks. In Feb2021, the patient hospitalized 10 days later with COVID-19 like symptoms, with negative COVID-19 test results. It was unknown if the patient received treatment for the event. It was unknown if the patient had COVID-19 prior to vaccination and post vaccination. The seriousness of the event was reported as hospitalization. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
pt recv vax 20FEB97 & on 4MAR97 pt devel less than 50 lesions described as red spots on face & abd;not fluid filled;
Swelling and redness of arm.  Pain, limited mobility, weakness, headache, upset stomach, vertigo.
About 10PM, she had a fever of 102 and I did not provide medication and checked it throughout the night and it self-resolved without intervention by 6AM. She did have diarrhea in her sleep, but that could be related to on going issues she already has. 12/25 she had another temp of 101 at 8PM and resolved in the morning without intervention.
Last night my daughter complained of an upset stomach that she felt "queasy" she felt hot, I took her temperature and it was 101.6 Tylenol was given. When she woke up this morning I took temp and it was normal at 6:00am 98.6 but when we started to get dressed I noticed a rash on her shoulders, back and under her arms. Temp rose to a low grade today of 99.3.
I was not aware that I gave an adult a pediatric dose of Hep A until the billing specialist notified me on 12/5/18. Patient was unaware of the medication error until notified on 12/6/18.
she called in saying she got pain and redness at injection site . pain is going away but redness was spreading around was the concern . she has not reported other symptoms.
Fever of 103-104 degrees, nausea, HA, chills, and slight soreness at injection site.
I went for a hike and felt extremely fatigued. That evening (9/18) through the following day I experienced fever (peak was 101.5), difficulty breathing, and elevated HR. HR was in 80's and 90's at rest, which is 20+ bpm higher than usual (I monitor my fitbit closely).
This spontaneous report as received from a physician refers to a 90 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX23 on 20-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The physician stated that evening on 20-DEC-2012 the patient arm was really, really sore and she had difficulty moving it. The outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
h/a & neck, general body ache for 17 hr (bruise 1" x 1");
seizure; eyes rolled back; Initial information received on 13-Jan-2020 regarding an unsolicited valid serious case received from a nurse.  This case involves a 2 months old male patient who experienced seizure (seizure) and eyes rolled back (eye movement disorder), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE (HEPATITIS B VACCIN) second dose and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) first dose.  On 10-Jan-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Daptacel and IPOL lot U6629AA Expiry date 02-May-2021), (ActHIB  lot number UJ208AB Expiry date 02-May-2021) via intramuscular route in the right thigh.  On 10-Jan-2020, the patient developed a serious seizure and eyes rolled back (eye movement disorder) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  No lab data was reported.  Final diagnosis was seizure.   It was not reported if the patient received a corrective treatment.  On 10-Jan-2020, the event outcome is reported as Recovered for seizure and eyes rolled back.; Sender's Comments: This case involves a 2 months old male patient who experienced seizure, while he received vaccine PENTACEL. The time to onset is compatible with the role of vaccine. However, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of suspect vaccine cannot be assessed separately from the concomitant vaccines.
Pt. did not eat or drink, feels numbness in face and tongue.  Body felt heavy (only had a protein milkshake this morning) BP: 130/26; HR: 65
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. Since 03-JUN-2015, (specific dates unknown), the patients were administered doses of ZOSTAVAX subcutaneous (dose, lot number and expiration date were not provided) which underwent a temperature excursion. Concomitant therapy was not reported. No adverse effects were reported. This is one of several cases from the same source. Additional information has been requested.
Vaccination 1/29/21 - Slightly tired 24hrs after injection; nausea and diarrhea 36hrs after injection until Tuesday afternoon, February 2nd; slight nausea and some diarrhea through the date/time of this report; UTI diagnosed evening February 3rd
Contracted COVID-19. Flu-like symptoms; headaches , body aches, chills, fever, pneumonia
13 hrs after injection woke with chills, body aches and fever of 100.9. Felt like severe flu. Also fatigue so bad could not get out of bed for 1 day.  Fever lasted for 12 hrs. Body aches  and headache lasted 2 days.  Felt slightly better on 04/23/21.  Today is 04/24/21 still have fatigue, weakness and sweating. feeling better but not back to normal.
DOSE OF VACCINE GIVEN TO PATIENT GREATER THAN 20 HOURS, VIAL PUNCTURED ON 26/MAY/2021 AT 9:13; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced dose of vaccine given to subject greater than 20 hours, vial punctured on 26/may/2021 at 9:13. The action taken with covid-19 vaccine  was not applicable. The outcome of dose of vaccine given to patient greater than 20 hours, vial punctured on 26/may/2021 at 9:13 was not reported. This report was non-serious.
Information has been received from a physician concerning a 3 year old male with no past medical history or drug reactions or allergies, who was vaccinated subcutaneously with only one dose of Varivax (0.5 ml) on 17-JUN-2004 (Lot # 646140/0539N). There was no concomitant medication. On 07-JUN-2006 the patient was diagnosed with a case of breakthrough chickenpox. It was reported that the patient had no known contact with chickenpox and there were greater than 50 poxes. The patient experienced itching, however, had no other problems to date. Unspecified medical attention was sought, and the patient was to be followed by his physician. At the time of this report, the patient was recovering. Additional information has been requested.
Intussusception, attempted air contrast enema without resolution. Taken to surgery for repair. Was reduced in surgery; no bowel was resected/remained. 06/13/07-records requested from facility and from pcp for vac rec. krk 6/20/07-vac rec received, supports submitted documentation on VAERS form. No changes. krk 06/20/07-records received from facility for DOS-6/6-6/7/07- DC DX: Intussusception, Status Post exploratory laparotomy and appendectomy. On 6/5/07 at 7 a.m. began to vomit after feeding. Refusing bottles. No bowel movements since 7 a.m.PE: abdomen soft, slightly distended, positive bowel sounds. Non tender.
full body rash; pox on her legs/Chicken pox; some minor scarring present.; This spontaneous report has been received from a nurse practitioner via field-based employee (FBE) referring to her daughter, an 18-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On approximately 10-MAY-2023 (reported as "in May 2023" and "it has been approximately 4 weeks since administration of varicella virus vaccine live (oka/merck) (VARIVAX)"), the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered for prophylaxis via injection (strength, lot #, and expiry date were not provided).  On an unknown date in May 2023 (reported as approximately 1 month ago), the patient experienced a full body rash (rash), and approximately 7 days later, developed pox on her legs (also reported as chicken pox) (varicella). At the reporting time, the patient was still healing with some minor scarring present (scar). The reporter also had questions regarding administration of subsequent doses of varicella virus vaccine live (oka/merck) (VARIVAX), specifically, if her daughter should still be given the second dose. The patient had sought for medical attention. Treatment was given for the adverse events. It was unknown if any lab/diagnostic tests were performed. The outcome of events rash and varicella was recovering, and outcome of event scar was unknown.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX) and events was related (reported as the patient had a reaction to the first dose of varicella virus vaccine live (oka/merck) (VARIVAX)).
No complaints of SOB or facial edema. Rash to Right Upper arm and chest treated wit diphenhydramine 25 mg as directed mg PRN
pt stated she woke up with low body temp of 94.  She was  freezing, shivering, hallucinating, body was hurting, lost the feeling in her fingers and toes.  It hurt for the blanket to touch her skin and she was unable to move.  Her eyeballs hurt. She slept more than ever.  Her body temp would vary from 94 to 100.  She has a headache and joint pain, especially in her neck and back. She was finally about to eat but still feels extremely weak.  She still has joint pain in her neck, fingers and toes and is now having hot flashes. She says it was a very bizarre episode and has never been so sick.  She is going to try to back to work tomorrow.
REDNESS, PUFFINESS, TERRIBLE PAIN, TRIP TO EMERGENCY ROOM.  POSSIBLE MRSA ACCORDING TO PATIENT.
Temp excursion/beyond use date excursion; Temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total 15 patient were involved. No concomitant product were reported. Treatment information was not reported
I woke up and my left arm was seized up. My arm was sore, hot and feverish. I had a slight fever and was very lethargic. On day two, I called my urgent care and went to get looked at. My blood pressure was also affected. My fever was around 101 for two or three days. I took TYLENOL and occasionally ibuprofen to make it more bearable. I also take naproxen for the pain. I'm still experiencing the pain and muscle tightness at the vaccination site.
Head ache, tiredness, fever, shortness of breath, elevated heart rate, pain at injection site
Unknown the exact time or date of onset.  Date and time was when patient was seen in the clinic.  Erythema from AC to superior to left elbow.  11.5 inches by 4.5 inches.  Patient reports pain and swelling in arm.  Redness not localized to injection site.
PRESENTING PROBLEM: Pulmonary aspergillosis Anemia, unspecified type Chronic pulmonary aspergillosis COVID-19   HOSPITAL COURSE: 58 y.o. female with past medical history significant for severe chronic obstructive pulmonary disease, history of recurrent pneumothorax, history of pulmonary embolism, hypertension, chronic pulmonary aspergillosis, recent MRSA pneumonia, anemia who presented emergency department complaints of worsening shortness of breath and cough.     Upon arrival to emergency department, patient was tachypneic other vitals were stable.  Baseline blood work was obtained and independently reviewed.  Blood work was remarkable for sodium 131, stable chronic thrombocytosis and chronic anemia.  Troponin WNL.  Viral PCR was positive for COVID-19.  UA was negative for acute infection.  EKG was obtained showing normal sinus rhythm with sinus arrhythmia and incomplete RBBB.  CXR showing extensive chronic findings which are not substantially changes from 11/20. No new focal consolidations.  Patient was given a dose of her antifungal and a dose of Zofran for nausea. Patient was then admitted for further evaluation and management.   Patient stayed in hospital for approximately 3 days.   During stay patient has been monitored and had remained to be in room air throughout stay.  Infectious Disease consulted and evaluated patient during the 1st 24 hours of stay.  Her voriconazole resumed with course to be determined.  A prescription has been sent to her pharmacy.  She is to follow-up with them in 3-4 weeks.  Plan to have a repeat voriconazole level in 1 week.  Patient was also given medication for her herpes labialis with valacyclovir.   Also patient has been evaluated by LMSW for initially made suicidal comments on admission.  Patient better main to be not at risk for suicide and that she was given resources for support in the community.   Patient was discharged home stable on 12/19/2022 when medications are ensured available at her pharmacy.
Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae.  Follow attempts are needed. Further information is expected.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001852 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (third out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked to cases no. US-BN-2022-001839, US-BN-2022-001851, US-BN-2022-001853, US-BN-2022-001854, US-BN-2022-001855, US-BN-2022-001856, US-BN-2022-001857 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
10 day p/vax acted like getting sick, temp not elevated; skin felt warm when put to bed about 945-10PM; Returned 20 min later, was having sz (1015PM); pt had APAP; no rash to ER via ambulance;
Pt received dose on 10/02/2022 lot expired 09/30/2022 then updated to 10/19/2022
Arm pain - could not reach Back with that arm to attach Bra. She can reach up but not Back. No reddness noted.
pt recvd vax & exp 2 sz; dx: strep/om; 29sep to 30sep hosp;