chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a currently 24 year old, non pregnant female patient. No medical history or drug reactions/allergies were reported. On unspecified date the patient was vaccinated with first dose of 0.5 ml GARDASIL, intramuscularly. Subsequently, in May 2010 the patient received second dose of GARDASIL 0.5 ml, IM. In August 2010 the patient was vaccinated with GARDASIL dose 3, .65 ml, intramuscular. Concomitant therapies included TRI-SPRINTEC. The patient had CO2 laser on an unspecified date in September 2010 for vulva condyloma which developed on an unspecified date. On 26-JAN-2015 (reported as "today") the patient was in the office and underwent colposcopy due to having an abnormal pap smear (performed on 20-NOV-2014). The colposcopy showed that the patient was positive for an unspecified high risk HPV type. Patient sought medical attention. The outcome of the event (positive for an unspecified high risk HPV type and abnormal pap smear) was unknown. The outcome of vulva condyloma was resolved in September 2010. The relatedness between events and vaccination with GARDASIL was not reported. Additional information has been requested.
Breakthrough COVID-19 case. Asymptomatic. case was sent to the hospital on 06/14 and admitted to ICU because of suspected renal failure. Hospitalized for unknown duration
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. No medical history, drug reactions or allergies were reported. On 01-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous, (lot # reported as K009769 expiration date 09-OCT-2015) (dose not reported). There was no concomitant medication. ON 01-OCT-2014, since receipt of the vaccine, the patient experienced that the area in which she received the vaccine was red, raised and a little warm and it was about 1.5 inches in diameter. The patient sought medical attention she visited pharmacy. No lab diagnostic studies were performed. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
1st dose 29th Oct 2020, 2nd dose 6th May 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 29th October 2020).   On 6th May 2022, the patient received the 2nd dose of Shingrix. On 6th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The health care professional reported that a patient received 2nd dose later than recommended interval. No other details were available of vaccine. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccine schedule.
I got shingles on my right side neck, Sholder, chest, back. Doctoor give me a 7 day pill program. I dont remember the pill name.. After 2 1/2 weeks I am getting better.
Patient is a 47 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 020321A on 4/8/2021. The patient experienced the following reaction(s) during the immediate of observation: 8:50am Patient vaccinated. 9:03am Patient c/o nausea during observation period. Patient was treated/managed as follows: 9:04am Patient taken to treatment area. Water and ice pack provided and applied. Patient c/o dizziness. 9:09am VS BP 140/70, HR 83, RR 20, O2 sat 99% on room air. Patient reports symptoms improving. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 9:19 VS BP 116/72, HR 62, RR 18, O2 sat 100% on room air. Patient reports symptoms improving. 9:25pm Patient escorted to car accompanied by significant other and RN.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Severe, Systemic: Confusion-Medium, Systemic: Fever-Medium
symptoms presented 03/02/2021(day after first dose) and subsequently every three weeks since: extreme difficulty in breathing with burning sensation in chest and throat, numbness/tingling in extremities, discombobulation, extreme lethargy, dizziness, fainting, inability to get up and walk across room without losing breath and fainting.  These episodes last from 3-6 days. I had to quit my job and am unable to lead a productive life due to the severity of these symptoms
muscle soreness, fatigue, shivering, fever, nausea, vomiting.
Large circular area (around 2 inches in diameter) of redness with swelling on the right arm, about 2 inches below injection site. This was noted 2 days after vaccination. It feels hard/swollen and warm to the touch. Also associated with some minor pain upon touch, as well as when trying to move the arm. Minimal itching.
PATIENT WOKE UP LAST NIGHT, 08/11/2009, TEMP OF 104.0 C/O HEAD, NECK AND MUSCLE PAIN
Patient admitted to Hospital. Tested positive for COVID on admission despite full vaccination status in Feb 2021
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Infant patient who broke out in a rash and hives, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious broke out in a rash (rash) and hives (urticaria) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data reported.) Final diagnosis was hives and broke out in a rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for broke out in a rash and as Unknown for hives.
Breakthrough case admission after 2 vaccines Moderna 10/26/21 Lot# no lot #; 11/26/21 Moderna Lot# 065F21A  NO LOT # AVAILABLE FOR THE 10/26/21 VACCINE IN THE DATABASE
Pt noted metallic taste at 1 minute. Lasted a couple minutes. Noted rash on forearms at about 30 minutes. Fine papular, erythematous. Lasted until now which is 4 days. Still present. Pruritic. No hives, SOB, Fever, Chills, myalgias. No relief with Benadryl. History is from the patient. Pt not seen until today.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had no adverse effect after vaccination.  No temperature excursion issue was noted.  On 21-OCT-2021 Vaccine was placed in refrigerator.  No treatment medications were reported.
Adverse events experienced and are they still occurring now:   -double vision (MRI done last week and everything seemed normal) What happened as a result of the adverse event? went to her pcp and did various check ups and everything was normal, doctor still recommended her to get her vision done also went to the eye doctor and they told her she doesnt have anything abnormal
Breakthrough of COVID-19 virus after bring fully vaccinated. I received the antibodies infusion.
pt recv vax 20OCT95 & devel skin hypersensitivity to the point where clothes irritate skin;pt states it feels like a bad sunburn;also exp muscle weakness & cannot pick up anything;
A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year old male.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the vaccine program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670;  MEDI-0006671;  MEDI-0006672;  MEDI-0006673;  MEDI-0006674;  MEDI-0006675;  MEDI-0006676;  MEDI-0006659;  MEDI-0006678;  MEDI-0006679;  MEDI-0006680;  MEDI-0006681;  MEDI-0006682;  MEDI-0006683;  MEDI-0006684.
Vaccine administered at 4pm. Patient sat in waiting area for about 20 minutes and didn't express any issues when I was checking on her and her other family members that were vaccinated. At about 4:20pm she and the other family members headed towards the front of our store. She was accompanied by her daughter. At about 4:30-4:40pm a customer yelled into the pharmacy to dial 911, because a woman was starting to lose consciousness. When EMS arrived 4-5 mins. later, they left, because the patient's daughter said she didn't want her transported to the hospital. After about 10-15 minutes, I was informed that patient was regressing and patient's daughter called 911 this time. When EMS came 2nd time, patient was transported to local hospital for follow-up. I followed up with patient's daughter next day via phone (07/31/2022). She informed me that her mom arrived at the ER and was vomiting so they were suspecting gall bladder issues our colitis. They did not think the vaccine caused her reactions, because she was feeling tired/dizzy all week before and her heart rate was extremely low despite having a pacemaker.
During observation period at the clinic, patient developed rash and a hoarse voice. Rash spread out through her arms and back. No tongue or lips edema.  No slurred speech. Pt speaking in full sentences, provided her mother's full name and phone number. BP stable in 128/72, HR 80. She was given 2 tablets of Benadryl 25mg PO. Pt walked towards ambulance on site. Placed in supine position, vitals remained stable, BP now in 120/76. Pt developed dry cough and was feeling anxious. Nasal cannula  and Solumedrol were started by paramedics. Was also placed on Atrovent respiratory therapy. Pt was then taken to the ER. Pt was contacted 3 days after event, she refers to be feeling better. Reports
developed itching; rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing has had for the longest time, at least 10 years. The concomitant medications were not reported. On 30Jul2021 the patient developed itching and rash. Caller received her first dose of the Pfizer COVID-19 vaccine on 26July2021 and on Friday developed itching and a rash. Caller states she wants to know how to get rid of the itching, she is putting on lotion and it goes away for a little bit but comes back, it's in her hair, arms, legs, face. She scratches gets read, takes a shower with cold water and it goes away but comes back. Patient did not received any vaccine within 4 weeks. She went and got her first vaccine last Monday. She got a lot of itching and rash that started Friday. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Arm hurts with any type of movement.
Patient reported itching at the ears, palms of hand and hairline. No rash, just itching. Onset Saturday, 4/1/2023. Also had Flu-like symptoms, headache, fatigue
Immediately after receipt patient fainted. She was on a couch, so assisted to lie down in recovery position. Faint lasted about 10 seconds. Patient roused after ammonia capsule, vomited into trash bin. BP 126/82, pulse 84. Rested and had sips of water under RN supervision until recovered. After 20 minutes stated she felt recovered, walked unassisted to lobby where she waited another 15 minutes for a friend to come pick her up. States she had fainted before after venipuncture and implant device but never with vaccination.
A patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a Licensed Practical Nurse referring to a 3 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of  hepatitis a vaccine, inactivated(VAQTA) (strength, dose, frequency, and anatomical location were unknown) with lot # S032358, and expiration date 11-JAN-2021, intramuscular for prophylaxis.    The administered dose of hepatitis a vaccine, inactivated(VAQTA) experienced the temperature excursion above of  47 °F degrees Fahrenheit  / 9°C (8.9 °C) Celsius degrees for 33 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  manufactureraddress:  manufacturercity:  manufacturerstate: ; manufacturercountry: ; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt developed raised red whelps on bilateral arms, bilateral legs, buttocks, face. 1-2hrs after receiving the injection.
The injection site is red, warm, raised, and tender to the touch. Hurts to raise her arm.. Patient has been taking ibuprofen, APAP and will add an ice pack.
Moderna vaccine was administered outside of our facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------ I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/29/2021 HX OF GASTRIC ULCER I95.9 HYPOTENSION 7/28/2021 HX OF GASTRIC ULCER I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/29/2021 INTRACTABLE NAUSEA AND VOMITING I95.9 HYPOTENSION 7/28/2021 INTRACTABLE NAUSEA AND VOMITING I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/29/2021 STOMACH CANCER, UNSPECIFIED SITE I95.9 HYPOTENSION 7/28/2021 STOMACH CANCER, UNSPECIFIED SITE I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/29/2021 STOMACH CANCER, UNSPECIFIED SITE I95.9 HYPOTENSION 7/28/2021 STOMACH CANCER, UNSPECIFIED SITE
awakened 4AM 16NOV96 w/pain up spine, tingling feeling, chills, lt arm swollen;stayed in bed 16NOV96 because of ill feeling;no swelling on diff w/rt arm;swollen tongue;to MD 18NOV96 & given DPH;21NOV96 swelling under arm;
Information has been received from a nurse (also reported as "pharmacist") referring to multiple unspecified patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reactions/allergies. Since 22-SEP-2016, the patients were vaccinated with improperly stored VARIVAX (lot # M024683 with expiration date 18-MAY-2018; lot # M028553 with expiration date 07-JUN-2018; lot # M027885 with expiration date 03-JUN-2018; dose and route were not reported). The temperature excursion on an unspecified date was 6.4 Celsius (C) for 3 hours and 10 minutes. Previous temperature excursion was on 22-SEP-2016 of 4 C for 14 hours and 45 minutes. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
At 10:40, pt had a localized reaction at the varicella injection site. Pt complained of 4cm papule/hive and redness with itching, no other reaction observed. Ice was applied and 2 tsp of Diphenhydramine HCL/Benadryl PO was given. Child was observed for 45 minutes. Papule decreased from 2cm to lest than 1/2cm with no apparent reactions or distress.
He has had numbness and pain radiating from his left shouler down to his thumb and fingers.  The pain is constant.  He occasionally complains of "stinging" and "burning" sensations throughout his arm.  He thumb is continously numb. He has significant weakness in this extremity.  He is unable to perform many of the daily tasks that he was once able to do.  These problems began within hours of receiving the vaccination.
Body aches, headache, Injection pain sore, fever, nausea, vomiting
Immediately light headed, within 2 hours redness/swelling at injection site.  Extreme fatigue at 4 hours followed by nausea/diarrhea. Woke up the following morning with increased swelling/redness (large red circle) around injection site and hives/rash with intense itching from the waist up.  Went to clinic at work sent to allergist.  Started on 2 (24hr Allegra tabs) in am and 2 (24hr Xyzal tabs) in the pm.  High dose antihistamines continued for 1 week then weaned.  Upon weaning the dose the red/raised swollen circle got worse and spread to new tissue.  Presented back to allergist - EPI and Steroids administered and topical antihistamines applied.  Continuing to take AM/PM antihistamines the circle on my arm now is not as raised but continues to spread out from the injection site to new tissues.  Larger and larger with each passing day.  Now on day 13+
November 29 on the day I tested positive for COVID-19 along with my wife. I was feeling bad and having runny nose and I had no smell or taste. We isolated until the pain started. December 3 lower abdominal pain. I went to the ER, and they discovered a kidney stone. I was given medication then sent home. I took extra strength TYLENOL and that helped eliminate the pain.
Hoarseness, trouble swollowing.  Sudden hypertension about 35 minutes after vaccine. Immediate metal taste at time of vaccine.
I got a scratchy throat and a little congestion. I was exposed to my sick grandson. Couple of days later after his visit. We tested with COVID-19 rapid home test. I had a cough for a couple of days. I took PAXLOVID, I was not feeling awful, if I had not been exposed, I would have not thought a lot about it. After 3 days of taking the medicine, my symptoms were gone, and I was fine.
Patient became pale, diaphoretic, weak. Patient never lost consciousness and was able to verbalize not feeling well. Symptoms came on after given vaccine within  4-6min and passed after approx 4-6min. *Patient had nothing to eat prior to injections
According to the patient's parent, he received Pfizer dose 2 on Sunday afternoon 6/6/21 around 12-12:30pm and woke up Monday morning 6/7/21 w/ redness, hives, facial swelling, hand swelling, and then the patient became pale and fainted. No vomiting or diarrhea. He was taken by ambulance to the Emergency room where he received epinephrine x1 and Benadryl PO after which he improved.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of ROTATEQ orally, lot # K022990, expiration date 26-JUN-2016 (dose was not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pregnancy (Live full term birth on 5 May 2017). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FOLIC ACID for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in June 2020 and the estimated date of delivery was 29-Mar-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh month of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported positive pregnancy test  JUL2021 and due date is  29 Mar2021 There is discrepancies  between positive pregnancy test  & due date. Patient reported live full-term child birth on 05MAY2017. Concomitant medications prenatal vitamins, folic acid. Treatment medications were not provided This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy