chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for Covid-19 using an antigen self test at home; Saturday evening I did not feel well; This non-serious case was reported by a consumer and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-AUG-2023, the patient received the 2nd dose of Shingrix. On 19-AUG-2023, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Saturday evening I did not feel well). On 21-AUG-2023, the patient experienced covid-19 (Verbatim: I tested positive for Covid-19 using an antigen self test at home).The outcome of the feeling unwell was not reported and the outcome of the covid-19 was not resolved.   It was unknown if the reporter considered the feeling unwell and covid-19 to be related to Shingrix.   It was unknown if the company considered the feeling unwell and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-AUG-2023 The patient received a Shingrix vaccine more than two months after the first.  The patient felt completely normal during the test and for the 9 hours.  On Saturday evening, he/she did not feel well and symptoms worsened.  At the time of reporting, the patient tested positive for Covid-19 using an antigen self-test at home.  The reporter wanted to know if there was any chance the Shingrix vaccine caused a false positive on the Covid-19 antigen self-test.  The reporter also wanted to know if he/she was truly positive for Covid-19, this invalidated his/her Shingrix vaccination or he/she should schedule a third one.
A 5 year old female was vaccinated with a 1st dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. In approximately 1989 the patient experienced leg paralysis. No further info was available. The patient subsequently experienced nausea, fatigue, chills, fever, myalgia, chest constriction,   headache and diaphoresis while on therapy with hepatitis b vaccine recombinant. Upon internal review leg paralysis was considered to be other important medical event. F/U information was received from a physician indicating that the pt still has a problem with leg paralysis. She had an ANA blood test done and the results were 1:8. The physician reported that the pt is being referred to a rheumatologist because he thinks that the pt may have some type of rheumatoid problem. Additional information has been requested. At age 17, pt had dyspnea after receiving her 3rd Recombivax HB. Follow up information has been received from a medical assistant indicating that the physician who prescribed the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) for her sister is deceased and that all of his inactive files, including the patient's records from 1989, has been destroyed. Upon internal review leg paralysis was considered an other important medical event. No further information is expected.
Received COVID vaccine on 3/11/2021 and 2/18/2021.  On 4/1/201 developed cough, diarrhea, headache, nasal congestion, and shortness of breath.  Tested positive for COVID.
DEHYDRATION; FEEL NAUSEOUS; VERY LOW ENERGY AND CANT STAND FOR LONG; STRUGGLING TO SLEEP; RESTLESS NIGHT WITH TOSSING AND TURNING; CHILLS; FEVER; FEELING SHAKY; BODY ACHE / PAIN; LIGHT HEADED; LIGHT AND SOUND SENSITIVITY/HEADACHE; ARM STIFFNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included strong reaction to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 05-APR-2021, the subject experienced arm stiffness. On 05-APR-2021 19:00, the subject experienced body ache / pain. On 05-APR-2021 19:00, the subject experienced light headed. On 05-APR-2021 19:00, the subject experienced light and sound sensitivity/headache. On 05-APR-2021 20:40, the subject experienced feeling shaky. On 05-APR-2021 20:40, the subject experienced fever. On 05-APR-2021 23:00, the subject experienced chills. On 06-APR-2021, the subject experienced restless night with tossing and turning. On 06-APR-2021 00:40, the subject experienced struggling to sleep. On 06-APR-2021 09:30, the subject experienced very low energy and cant stand for long. On 06-APR-2021 13:00, the subject experienced feel nauseous. On 06-APR-2021 17:40, the subject experienced dehydration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from light and sound sensitivity/headache, and dehydration, had not recovered from arm stiffness, and feel nauseous, and the outcome of body ache / pain, feeling shaky, light headed, chills, struggling to sleep, restless night with tossing and turning and very low energy and cant stand for long was not reported. This report was non-serious.
This spontaneous report has been received from a Physician assistant, concerning to 65 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown by reporter. On 07-APR- 2017 (reported as a week ago), the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, frequency, lot # and expiration date were not provided) for prevention of shingles. Approximately in April 2017,  the patient developed a 9 inch circle on the back of her arm that was red, warm and swollen. The patient was treated with an unspecified antihistamine and ice. The outcome of skin lesion, erythema, warm and swollen was unknown. The causal relationship between the therapy with ZOSTAVAX and the events of  skin lesion, erythema, warm and swollen was unknown. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Also tingling comes and goes in arm; I noticed the night of  injection that I had an indention in my arm at shot site.  If any change at all it has becime even more pronounced and deepened.  Also  tingling comes abd goes in arm.; This is a spontaneous report from a contactable other hcp (patient). A 64-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Dec2020 12:30 (Batch/Lot Number: EK5730) as single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination. On 22Dec2020, 18.00, the night of injection, the patient noticed that she had an indention in her arm at shot site. If any change at all it had become even more pronounced and deepened. Also tingling comes and goes in arm. AE resulted in Disability or permanent damage and Doctor or other healthcare professional office/clinic visit. The patient received treatment and had healthcare provider look at. The patient had not tested Covid post vaccination. Outcome of the events was not recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the events and administration of BNT162B2 cannot be excluded. Due to limited information, a complete medical assessment cannot be made. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pain in left arm, swelling and redness in arm outside of injection site. Loss of mobility and increasing pain swelling, inflammation in upper portion of arm outside of injection site reaction.
Pt received Pediatric Pfizer formula even though he was 12 at the time of the administration. No adverse signs or symptoms were exhibited, mother of pt was informed after the administration.
On 01/16/2023, very late at night, I had burning in my chest.  I thought I was getting a cold. I had a 101 fever and I took a COVID-19 test the next day and it was positive. I went to see a PA at the clinic and she talked me out of Paxlovid.  On the 19th, I had no more cough, but I had night sweats. My temperature was 103.3.  On the 20th, I was sneezing and blowing my nose. I went back in the the clinic, I cannot recall which day, and I was given a steroid for the cough and some antibiotics.
pt's sister was vaccinated on 07jun95 & devel chicken pox; 2 wks later pt devel chicken pox which the father felt was contracted from sister;
dec responsiviness & muscle tone for about 48hrs p/vax given;pt was unarousable @ times
Reddened area to right thigh IPV injection site approx 7x4 cm. Rx for Benadryl given by FNP.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009261: US-009507513-1811USA009142.
mother called unit stating the child had rash on face that began 10/22/20 at 5PM gradually spreading to arms, upper torso, mid abdominal area and entire back beginning at hairline and ends at his diaper. Rash described as raised red bumps. Mom reports a few raised bumps on upper legs as well. Mom states he had flu vaccine the first of October but unsure of exact date. Mom reports n o fever and said child is not fussy or acting like he feels bad.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
12/21/21 presents to ED for "lower back and lower extremity pain" "fever". PMHx of "Sickle Cell Anemia, s/p chiari malformation decompression surgery in 2012, h/o recurrent subarachnoid hemorrhage of unclear etiology post neurosurgical decompression, h/o hemachromatosis
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 54-year-old female patient who received MENVEO (batch number M16096, expiry date 31st March 2018). On 23rd May 2017, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 24th May 2017, 1 days after receiving MENVEO, the patient experienced pain, hives, pruritus and swelling. The patient was treated with Steroid Cream. On an unknown date, the outcome of the pain, hives, pruritus and swelling were not recovered/not resolved. It was unknown if the reporter considered the pain, hives, pruritus and swelling to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on right deltoid. The pharmacist reported that the patient returned to physician's office on 25th May 2017 after receiving vaccine. The noted symptoms had worsened requiring a physician visit and a topical steroid cream was being prescribed. The pharmacist noted the patient did take other medications but those were not provided. It was unknown at the time of reporting about continuing with this vaccine in the future.
awakened with  sensation of numbness/tingling in all fingers of both hands on 3/28/2021 after having COVID vaccine in left arm on 3/26/2021.  Sensation has been continuously present until 3/30/2021 at 5 pm when he is seen by me for a family medicine clinic visit.  He had mild tenderness at injection site but otherwise no other effects.  He has no weakness in his hands.  No paresthesias in his feet.  No clumsiness or motor problem of any time.  No fever.
Second dose after 38 days of first vaccine; Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
vomiting & diarrhea 36hrs p/vax; felt generally weak & feverish (did not take temp); ill for approx 48 hrs; took pepto bismol for diarrhea; condition resolved as of 17APR95;
Rash started on head and spread to rest of body over a period of 24 hours. Treated with Benadryl. On 2/9/01, pt's mother stated rash had completely covered child but rash is healed.
Fever between 101-103, Vomiting, Cough, Rash on face and neck. Lasted on and off for a week.
01/02/2002, patient examine by PCP. PCP noted erythematous edematous area on left leg. This area had an induration of 6 cm and erythema of 8 cm.
Patient arrived at the clinic for an adult booster dose of the Pfizer Covid-19 Vaccine. Patient received pediatric Pfizer Covid-19 vaccine in error.
pt recvd MMR vax  30AUG91 & on 8SEP91 presented to ER w/prodromal viral illness; while in ER exp sz & placed on ventilator; lab eval showed clear CSF fluid w/ 5RBC's, & 48 WBC's all mononuclear;
POSSIBLY BE GUILLIAN-BARRE; BREATHING BECAME DIFFICULT; COUGHING UP BLOOD; DIED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Within 2 weeks of vaccination patient was barely able to make it 20 feet from his bed to the toilet. The initial reaction from doctors and specialists was that patient would somehow hurt himself but test after test proved that theory wrong, all the while his condition was declining. By the end of JUN-2021 patient lost all ability to get himself out of the bed and walking even with assistive devices. It was also around this time that his doctors started to come around to the idea that it could quite possibly be guillian-barre, especially considering the time line. On an unspecified date in NOV-2021, breathing became difficult, patient started coughing up blood and died in the ambulance. On NOV-2021, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of possibly be guillian-barre, breathing became difficult and coughing up blood was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0 20220217632-  covid-19 vaccine ad26.cov2.s- Died, breathing became difficult and coughing up blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220217632- Covid-19 vaccine ad26.cov2.s -possibly be Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The Patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally lot #: L020859, expiration date on 09-JAN-2017 (dose and anatomical location were not reported) which were stored in a temperature of 31F during 60 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 number M036059 with expiration date 03-JUN-2019 and lot number N002720 with expiration date 12-MAY-2019 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 47 F (Fahrenheit) during 72 hours. There was no previous temperature excursion, digital data logger was filled. No adverse effects were reported in any patients. This is one of several reports from the same source. Sender's Comments: US-009507513-1707USA004419: US-009507513-1707USA004449:
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 2 year old male patient who was diagnosed with pervasive developmental disorder. At 12 months of age, the patient received the fourth dose on Oct 9 2003. The patient also received the third dose of Comvax (haemophilus B conjugate vaccine hepatitis B vaccine) and the second dose of Varivax (varicella virus vaccine, live) on Oct 9 2003. Patient reported to be healthy other than PDD diagnosis. Indication for Prevnar was immunisation. Product was administered on Oct 9 2003. Dose regimen was 1 dose intramuscular. Additional suspect medication included Comvax, MMR, Polio vaccine, and Tripedia. Concomitant medication were not reported. The mother of the patient reported that her son, at age 2, was diagnosed with pervasive developmental disorder (autism spectrum disorder) in Oct 2004. No additional information was available at the time of this report.
A non-serious spontaneous report of given expired vaccine was received from a registered nurse concerning a 58-month-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 his first dose of FluMist on 11-Sep-2008. The FluMist had expired on 03-Apr-2008. The reporter stated that FluMist was given by one of the nurses helping out the clinic on 11-Sep-2008 and not by the nurse in-charge of the immunization. the incident regarding the expired FluMist was noted when the immunization record was being updated. As of 24-Sep-2008, there was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the vent is considered resolved. 09/11/2008 Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.
Had DTap, Comvax,VZV, MMR shots 03/18/2003 (15 mos old) 03/27/2003 developed papular rash on his trunk and some on his arms and legs not itchy. No URI. Had fever after the shots.
Severe body aches and pains, slowly progressed to headache, sinus pressure, lungs hurting, sore throat, cough and culminated in bleeding of nose with green/black phlegm from nose and lungs.
Information has been requested from a physician concerning an adult patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live. Subsequently, the patient tested negative for antibodies to varicella virus vaccine live. The patient sought unspecified medical attention. Additional information has been requested.
Few hours after receiving vaccine, started to feel tight (R arm) swollen, warm, red; client took Antihistamines 9-17-09 spoke with Dr - nurse directed to continue antihistamines and apply cold 9-22-09 Dr - spot remained sore with crusty draining blister itching 9-25-2009 itches swelling has decreased still warm remains "bruised" purple, yellow area discoloration. To follow up with PP next week.
Pt recieved dt right deltoid 4/24/06 subsequently c/o muscle aches to RUE to neck, reports fevers. Pt is unaware if she recieved dt in the past. Physical exam is negative and pt is afibrile.
Approximately 15 hours after vaccine administered reported feeling sick-very tired generalized body aches. Left work, took Tylenol by mouth and slept all day 12/19/06 and night. Awoke 12/20/06-felt better feels like she is getting a cold though.
Roughly 10 months after the vaccine I started developing chest pain. I went to the ER where I was diagnosed with multiple pulmonary emboli in my lungs and a blood clot in my right arm. I was prescribed blood thinning medication and discharged same day. I have now been on blood thinning medication since 08/2022. Scheduled for a follow up in December.