chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9265), in right arm, on 26Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 26Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ALLERGAN; LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Vaccine received. Start date of treatment COVID-19 was 13Jun2022.
Patient developed pericarditis with chest pain and pericardial effusion.  This did subsequently resolve
an expired dose of IPOL was given/no AE; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demography who received vaccine IPV (VERO) [IPOL] and reported that an expired dose of Ipol was given/no AE (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 04-Dec-2019, the patient received a dose of suspect 0.5 ml IPV (VERO) lot N1K921M and expiry date: 14-Nov-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was not reported whether the patient had any adverse effect.  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.
Immediate pain in the left shoulder. Since then 7 weeks of pain and decreased range of motion. No visible nerve damage. Suspect bursitis. Given physical therapy exercise, otc nsaids. will consider cortisone shot in 2 weeks.
pt recv vax 3APR98 & 7 days later devel ecchymosis on arms & legs;JUL platelet count was 2000;dx immune thrombocytopenia type picture & indicated that pt had been hosp;
Patient was administered SHINGRIX as subcutaneous injection inadvertently. The injection should have been intramuscular according to manufacturer information. Did not revaccinate due to CDC recommendation that if this were to occur the dose is still considered valid.
pt recv vax & devel a gen rash that has cont to get worse since onset;pt sought unspecified medical attention;
after completion of post vaccine observation (15 mins), began feeling light headed/dizzy in her car, felt like she was "going to pass out".  Used a wheelchair to wheel herself back to clinic for further observation and discharged home after 2-3 hours after being provided with water and pretzels.
Skin rashes in arms and hands after 2 weeks from second vaccine shot. No treatment. They went away after 2 weeks
A nurse reported the occurrence of an injection site reaction in a 16 month old male who received Infanrix. The vaccinee had no relevant medical history or concurrent mediations. On 4/22/02, the vaccinee received his fourth injection of Infanrix. On the same date, he received an injection site reaction characterized by redness and bruising. He was treated at the physician's office with Benadryl. As of 4/26/02, the symptoms have resolved.
Woke up the next morning with Dizziness never experienced before.  Has persisted.   I went to a doctor on 4/7 and he said I have Vertogo.  I have never had vertigo in  59  years until I got this shot.
10 days after second dose, developed illness which has included cough, shortness of breath, and chest pain, followed by polyarthritis (knees, elbow) and polyarthralgias (multiple joints).
lighthead; diarrhea; Nauseous; cold sore; just not feeling good; Itching at injection site; chills; Fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (lighthead), ORAL HERPES (cold sore), FEELING ABNORMAL (just not feeling good) and INJECTION SITE PRURITUS (Itching at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251921A and 0251921A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Stomach surgery) in 2017. Concurrent medical conditions included Sulfonamide allergy and Drug allergy. Concomitant products included ESCITALOPRAM from 09-Jan-2020 to 13-Apr-2021 for Depression, VITAMIN D [VITAMIN D NOS] for Vitamin D low.   On 12-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 13-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 23-Apr-2021, the patient experienced ORAL HERPES (cold sore), FEELING ABNORMAL (just not feeling good) and INJECTION SITE PRURITUS (Itching at injection site). On 24-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (Nauseous). On an unknown date, the patient experienced DIZZINESS (lighthead). The patient was treated with ONDANSETRON ongoing since an unknown date for Vomiting, at a dose of 1 mg 1 dose. On 15-Apr-2021, CHILLS (chills), HEADACHE (headache) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (Nauseous) had resolved and DIZZINESS (lighthead), ORAL HERPES (cold sore), FEELING ABNORMAL (just not feeling good) and INJECTION SITE PRURITUS (Itching at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-057793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31MAY2021, contains Non significant information.
Pt presents with left upper arm pain and swelling, 1 day after the pneumoccal vaccination
Left arm nerve pain on top of fore arm and down to the knuckles of left hand. Relatively mild, nuisance level, pain that sometimes goes away but is there most of the time. Now two and a half months after the shot, I wonder if this is a permanent condition.  FYI - I had my second Shingles shot on February 4th, 2021 and had one day of fever, chills, head ache, and nerve pain which went away after 48 hours or so.
Patient fully vaccinated.  COVID + on 11/28/2021.  ED visit on 11/28/2021. 52-year-old male presents complaining of cough, congestion, and body aches that began approximately 4 days ago. The patient's wife is having similar symptoms. He denies any fevers or chills. Denies any nausea or vomiting.He denies any shortness of breath. Patient has a history of tachycardia at baseline, evaluated by cardio. BP 149/80  | Pulse 108  | Temp 98.4 °F (36.9 °C) (Oral)  | Resp 22  | Ht 182.9 cm (6')  | Wt 113 kg (250 lb)  | SpO2 99%  | BMI 33.91 kg/m²  EKG Final interpretation: sinus tachycardia, no signs of ischemia and no infarction. d-dimer the patient but it was elevated (507). CTA ordered. No evidence of PE. Patient does have right-sided consolidation.He was given steroids. He'll be referred to Dr clinic for infusion. Discharged.
Donor became dizzy and nauseated. Placed donor in supine position, elevated lower extremities bilaterally, applied cold compress. Donor stated he only had bowel of cereal and had smoked a cigarette immediately before vaccination.
Information has been received from a RN concerning an 18 month old biracial female who on 08Jan04 was vaccinated with a dose of varicella virus vaccine live (lot 646361/0572N). Subsequently, the pt developed a rash that a pediatrician diagnosed as zoster with about 5 blisters on the backside of the pt's waist on the left side. The entire area was the size of a dime. The mother noted that there was no apparent rash or chickenpox following the administration of the vaccine. The physician believed the zoster rash was a result of the vaccine. The pt was prescribed antiviral medication but did not yet get the prescription filled because they were just seen in the office. A product quality complaint was not involved. Follow up information was received from a physician who indicated that the pt allegedly had the varicella virus vaccine live at one year of age. On 21Jun04, the pt was seen with classic shingles on the trunk and back. No further information is expected.
Eight days after the vaccination I broke out in hives that covered my hands and arms. The itching was almost unbearable. The hives spread to my back and legs. Now seventeen days after the vaccination I still have very itching hives over most of my body. Benadryl helps some, but it is always very difficult to concentrate on my work which requires me to research and write.  I feel like I have been dropped into a nightmarish alternate universe, where all I can do is try to fend off the itching and the pain.
Pt came in for 2nd HPV on 10/3/11. Mentioned to nurse she broke out with hives 1-2hr later on arm with first HPV. Dr. spoke with mother on 10/11/11 who stated that within 1hr of geting HPV developed raised red welts on arm with HPV only. (HepA in alternate arm). Gave 50mg Benadryl. Hives resolved by next morning. No ongoing changes in arm. Dr. advised not to get 2nd HPV and discussed with CHP ID.
This spontaneous report as received from a 73 years old female consumer reporting on herself with diabetes, 3 pacemakers and drug hypersensitivity to codein, cortisone and phenobarbital. The patient's medical history included stroke. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 11-JUL-2012. No other co-suspects were reported. Concomitant medications included CORDARONE, metformin and SYNTHROID. About 3 days after getting the vaccine (approximately on 14-JUL-2012, she experienced severe itching and burning of her genital area. She had a yeast infection and a fungal infection of the area and had now been diagnosed with lichen sclerosus. She also had shrinkage of her genitals. Her health care professional put her on clobetasol and niacin. No lab diagnostic tests were performed. The patient saw the doctor 3 times. The adverse event did not improve and the outcome of lichen sclerosus was reported as not recovered. The relatedness for lichen sclerosus was not provided for ZOSTAVAX. Additional information has been requested.
ringing in the ears after receiving the COVID-19 vaccine booster. It started up a day or so after receiving the shot. It is now  two weeks later and it is still ringing loudly. I am planning on going to the doctor because it is persisting.
After receiving the vaccine, I had a sore arm for a day. On 10/28/2022, I went on a trip with some friends. On 10/30/2022, I began to feel sick. My cough was just not getting any better, so I went to my doctor, and I tested positive for COVID-19 on 11/14/2022. I did not receive a prescription, but it was recommended that I isolate for five more days.
Patient admitted 2/6-2/13 for coronary bypass surgery. On 2/10 patient received pneumovax vaccine. On 2/11 the patient developed fevers of unknown origin. Fevers treaded downward and patient discharged 2/13. Patient re-hospitalzied 2/15 for fevers of unknown origin up to 102. Infectious disease consult obtained and it was felt that most probable cause of fevers was pneumovax - no other suspected source. All cultures negative. Fever resolved and patient discharge home on 2/17/06.
Pt began having multiple staring/seizure like episodes on 9/19/00. Pt was taken to ER for this and was hospitalized overnight for observation and neurology consult. Pt had no previous such episodes. Of note: pt received 12 month shots; both MMR and Varivax on 9/13/00.
2-month-old patient was given expired Pentacel vaccine with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient was given expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was given an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (dose, strength and lot number not reported; expiry date: 22-Jul-2022) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1223 notified of occurrence after vaccination time 1219. Recipient of Moderna vaccine to right deltoid. Noted to be diaphoretic, stated had dizziness with nausea which subsequently resulted in vomiting x2. VS: 98%, 58, 102/44. Stated that he had only 2 hours of sleep today, started work at 0230 am. 1232: Stated feeling less nausea, continued to observe. VS 99%, 67, 106/58. 1243: 98%, 69, 16. Stated feeling much better, no longer has dizziness, no nausea, no diaphoresis.  1253: 99%, 63, 108/54, stated continues to feel better, no nausea, no dizziness and would like to leave, left on own recognizance.
This spontaneous report as received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ which had lot # L004456, expiry date: 07-AUG-2017, (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Pfizer vaccine. Side effects: fever, nausea, body aches. These symptoms occurred 36 hours after vaccine was administered. These side effects are still very much present all most 2 weeks later!
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2022 at 1:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 1:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient ethnicity was white. Concomitant medications were not reported by the reporter. Patient received booster dose. Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported by the reporter.
Patient developed Covid Feet on both feet, burning, itching, painful measle like rash. Treated with Cortisone cream. As of today 5-10-21 symptoms have mostly resolved.
Headache; Migraine; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Jun2021, the patient experienced headache. On Jun2021, experienced migraine Therapeutic measures were taken as a result of headache and migraine. She had excedrin and aspirin and ibuprofen. The patient received the first dose of Pfizer's COVID-19 vaccine yesterday, she had a bit of a headache today and wanted to know if she could take Ibuprofen to relieve her symptoms. She received the vaccine at a pharmacy. The patient suffered from migraine. The response was received, Pfizer does not have an specific recommendation as it is still unknow how medications like Ibuprofen could affect the COVID-19 vaccination. According to the CDC, medications like Ibuprofen could be taken to treat side effects of the vaccination if medically appropriate. For additional recommendations refer to her physician. The clinical outcome of the events was reported as unknown.  Information about batch/lot number has been requested.
Received .25 ml FLUZONE 11/11/10. Developed urticarial lesions and low grade fever (100.9) on 11/17/10. Malaise and complaints of body aches/joint pain began on 11/23. Unable to walk 11/25. Urticaria/fever persisted. 11/29 - less complaint of arthralgia but not completely WNL - suspect serum sickness.
Every night since getting the vaccine I have not been able to sleep I am woken up to what feels like my heart racing I have taken my pulse during these moments and have had a pulse over 100 at resting, I have not seeked medical treatment yet due to looking on the internet and finding that this is said to have happened to other people. But if it continues I will be seeking a doctor to see what the recommendation would be.
I experienced COVID-19 after my vaccine. My symptoms began in December 2022. I also had a telehealth call with a nurse practitioner who prescribed PAXLOVID which was very beneficial that minimized my symptoms. I took a COVID test but do not remember the date. I have fully recovered from my symptoms.
Breakthrough case admission after 2 vaccines Pfizer 4/19/21 Lot# ER8731;  Pfizer 5/10/21 Lot# EW0172
Rash few weeks later formed on left elbow where moderna vaccine was injected.  Small red bumps that after few days turned to small red circle.   Bumps now forming on right arm elbow on 3/4/21.   No pain. only itching at location site of bumps. I have pictures if needed email me
a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 043L20A and 017E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hyperthyroidism, LIOTHYRONINE SODIUM (CYTOMEL) for Hypothyroidism, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Lupus-like syndrome.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On an unknown date, the patient experienced PRURITUS (a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.). At the time of the report, PRURITUS (a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.) outcome was unknown.            No treatment information was provided.
She tested positive with Covid-19 after taking the 1st dose; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified gender started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got the first dose of the vaccine on 16Apr2021. She tested positive with Covid-19 after taking the first dose and it's already been 2 weeks. She's scheduled to get the second dose on 07May2021 and she wants to know if she should take the second dose on the scheduled date or if she needs to be tested as negative with Covid-19 first before taking the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10/19/2009 7pm - temp 102.7. 9pm -temp 100.7. 10/20/09 6 am 98.9
Information has been received from a healthcare worker referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with ROTATEQ (lot # M017514, expiration date 07-NOV-2017; L048854, expiration date 31-AUG-2017), which was improperly stored at 50.9 F for 10 hours. No adverse effect reported. No data logger was involved. There was no previous excursion. This is one of several reports received from the same source. Additional information has been requested.