chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had resolved.       Concomitant medication not reported. No treatment information provided. Thinks it is the delta variant given as event.
Large hive-angioedema of upper arm by injection site.  Became extremely "itchy" and when looked in mirror was reddened, about 3 inches by 3 inches.  Also, hardened.  Given Benadryl and the again next day. 10/13/2015 swelling down but soreness remained.  10/15/2015 no further problem. Never had problem with Pneumovax (received # 23 lot # 012042).
Induration, edema, local allergic reaction measuring 7.5cm x 7.5 cm at time of visit per pt. Child was kicking and screaming at time of injection. No fevers, stridor, wheezing, shortness of breath.
Information has been received from a 38 year old female pt who on 8/22/06 was vaccainted IM with a dose of HPV vaccine. The reporter stated that on 8/22/06 I had pain for two months after the injection. Medical attention was sought. The pt was recovering. A product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a physician concerning the 24 year old patient (previously reported as 38). The patient was complaining of pain, right hip: was seen by the nurse and the doctor; however there was no clinical indication of any problem. The patient was recovered.
pt had been seen in ED earlier in wk and diagnosed with COVID but she left hospital; back to hosp again with increasing SOB; admitted; COVID pneumonia; O2 supplementation; given remdesivir, Vitamin C, zinc, ABX; developed AHRF and ARDS; DNR/DNI; pt's condition deteriorated and she was transitioned to comfort measures; she passed away in the hospital
Patient explained about 24 hours after receiving 2nd dose of shingrix she experienced sharp pain/joint pain in knee area- site looked swelled. Patient stated she did not injur it during the day so is unsure why the pain appeared. I contacted patient on 5/6/18 and she explained she was still experiencing pain at the knee site. I explained I would contact her primary care doctor 5/7/18 and discuss symptoms with them to see if they would like to further evaluate her.
Swelling in left leg. Neuropathy. Severe cramping symptoms in legs thoracic, abdominal area, feet and hands.
spine is really brothering me like anytime I turn my neck side to side or up and down like forward or backward when I shift my body from one side to the other; Tiredness; Headache; Chills; Muscle ache; Joint pain; have this pain/I wanted to tell what's going on with my spine after I received the Pfizer vaccine; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 23Jan2021 at single dose for covid-19 immunisation in hospital. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EH9899) on 04Jan2021 at single dose for covid-19 immunisation and experienced arm pain. patient got her second dose on 23rd and she had a typical stuff she talked about injection site, tiredness, headache. she had chills, muscle ache and she had lots of symptoms (not clarified) (Jan2021). that they mentioned and one that is of particularly continuing is joint pain, asked if it was going to be issue for some people, because for she her spine is. If she was going too fast. her biggest concern is her spine was really brothering her like anytime she turned her neck side to side or up and down like forward or backward when she shifts her body from one side to the other. she just wanted to make sure if this part is normal on part of the joint pain and that she was not missing anything. Patient further reported have this pain, she wanted to tell what's going on with her spine after she received the Pfizer vaccine. No Lab works. no treatment. Outcome of the events was unknown. Causality was yes.
Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp of 99.3; sweats then a temp of 99.3; I had to crawl in order to move from place to place; This is a spontaneous reporter from a contactable consumer (patient). This 83-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in right arm via unknown route of administration on 17Feb2021 at 10:30 am as single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Medical history of patient was reported as osteoarthritis, rheumatoid arthritis, penicillin allergy, allergies from components of Epinephrine Solution and AVALOX. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin B1 nos, vitamin B12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), ascorbic acid, retinol, tocopherol (OCCUVITE), cholecalciferol (D3) and aspirin. No covid prior vaccination. No covid tested post vaccination. No vaccine in four weeks. On 18Feb2021 at 07:30 AM, 20 hours after the injection the patient experienced severely dizzy and weak unable to stand. She had to crawl in order to move from place to place. This lasted about 15-20 minutes. She vomited and developed severe chills and sweats then a temperature of 99.3. No treatment was given. The outcome of events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
couldn't sleep / Can Not Sleep after Second dose; ump on her left shoulder Injection Site (Tennis ball size) after Second dose; Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose; Itchy all over back after Second dose; Pain in shoulder / Can Not Work after Second dose; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (couldn't sleep / Can Not Sleep after Second dose), VACCINATION SITE MASS (ump on her left shoulder Injection Site (Tennis ball size) after Second dose), DERMATITIS (Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose), PRURITUS (Itchy all over back after Second dose) and ARTHRALGIA (Pain in shoulder / Can Not Work after Second dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K2OA) for COVID-19 vaccination.     The patient's past medical history included Broken wrist and Wrist surgery (Surgery on Dec 2-2020 on a broken wrist.) on 02-Dec-2020. Concurrent medical conditions included Inflammation (Wrist inflammation.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced SLEEP DISORDER (couldn't sleep / Can Not Sleep after Second dose), VACCINATION SITE MASS (ump on her left shoulder Injection Site (Tennis ball size) after Second dose), DERMATITIS (Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose), PRURITUS (Itchy all over back after Second dose) and ARTHRALGIA (Pain in shoulder / Can Not Work after Second dose). At the time of the report, SLEEP DISORDER (couldn't sleep / Can Not Sleep after Second dose), VACCINATION SITE MASS (ump on her left shoulder Injection Site (Tennis ball size) after Second dose), DERMATITIS (Inflammation on skin all over back after Second dose / Diagnosed as Allergy via biopsy after Second dose), PRURITUS (Itchy all over back after Second dose) and ARTHRALGIA (Pain in shoulder / Can Not Work after Second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details included as Ice Pack.   This case was linked to MOD-2021-246758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Significant follow up appended
Within a minute of vaccination the patient ran to the bathroom vomiting. She came back into the pharmacy waiting area and complained of a rash on her chest and arms and difficulty breathing. We contacted EMS and administered her own Epinephrine 0.3mg/0.3mL pen. The patient said within a few minutes that she was having an easier time breathing and was feeling slightly better. EMS arrived and continued monitoring her and brought her to the local hospital for further observation and treatment.
4/14/21: onset of right leg swelling from the knee down that was painless. Calf circumference of the right leg had increased to 2cm greater than the left. No fever, chest pain, or difficulty breathing.
her first dose of Gardasil 9 approximately three years ago. What is the recommendation for series; No additional AE information reported; This spontaneous report was received from a nurse concerning a currently 26-year-old female patient. No concurrent condition, medical history, or concomitant therapy was reported.    In 2018 (reported as approximately 3 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis. The reporter requested the recommendation for series completion (inappropriate schedule of product administration). No adverse event was reported.
Information has been received from a nurse practitioner concerning a 21 year old female with high risk HPV who within last two years was vaccinated with 0.5mL IM third dose of GARDASIL (lot # not reported). The nurse reported that the patient "had a PAP test done at age of 19" and " it came back high risk HPV". The physician then suggested to the patient to have LEEP procedure done and the patient refused and decided to get GARDASIL. The patient was tested after GARDASIL and came back high risk HPV; however it was worse than previously and will have to have a procedure done (unspecified what kind). The patient sought unspecified medical attention. At the time on the report on 13-MAY-2010 the patient had not recovered from high risk HPV. Additional information has been requested. P
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: Caller states she is 70 years old and tested positive for Covid yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included Patient states she is 70 years old and tested positive for Covid yesterday. Her doctor immediately prescribed Paxlovid for her but she now feels worse than she felt before she began taking the medication. She has Taken 3 doses and is debating the fourth dose. Caller says prior to beginning Paxlovid she had some congestion and weakness. Patient say she weighs 150lbs. and is very healthy. Patient says she plays pickleball 3-5 timer per weak. Patient says she's had all her vaccines and recommended boosters from Pfizer. number and Expiry Date of Pfizer COVID vaccine were not provided. The case was reported as non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives & itching on torso developed on 27AUG; Took an antihistamine which caused the sx to subside for 24 hrs; Then came back again & he took Benadryl;
I had two grand Mal seizures 6 hours after receiving my COVID booster. I was witnessed having 1 grand Mal seizure which lasted 4 minutes. Then I went limp and immediately went into a second grand Mal seizure. I was transported ER by EMS
Back pain required cat scan. Enlarged nodes in back, waited 60 days for another cat scan which showed more normal. Pain in back remains with no known cause. Pain in hips knees and feet have been increasing. Fatigue
PATIENT RECEIVED MORE THAN THE RECOMMENDED DOSES OF COVID-19 VACCINE. THE MODERNA SERIES WAS ADMINISTERED ON 1/20/2021 AND 2/23/2021, THEN THE PFIZER SERIES WAS ADMINISTERED ON 4/30/2021 AND 5/21/2021.
Mom states 10 days after receiving immunization, pt developed rash on L leg. Was treated by pediatrician with Keflex and topical ointments.. Rash continues to spread. Dermatologist unable to determine cause. Peds believe rash is from vaccinations. Rash continues.
Information has been received from a physician concerning a 70 year old female who on 06-JUN-2005 was vaccinated intramuscularly with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  On 07-JUN-2005, the patient's arm was swollen with cellulitis.  The patient was treated with amoxicillin (+) clavolanate potassium (AUGMENTIN).  On 09-JUN-2005, the patient developed a fever and pain in the right hip when walking.  The physician requested an investigation into the lot number.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
This spontaneous report as received from a Nurse Practitioner refers to three patients in their 30's and unknown genders who on unspecified date were vaccinated with GARDASIL (dose, lot # and route not provided). No other co-suspects were reported. No concomitant medications were reported. The Nurse Practitioner stated that on unspecified date, the patients did not experienced any adverse effects. No additional information provided. Additional information has been requested.
Pt c/o numbness and tingling at injection site with motion beginning next day. Symptoms last 1-2 seconds and at times travels down arm to wrist. Pt advised to take OTC nsaid as directed and apply cold compress 10 min several times a day if possible. Pt to follow with provider at clinic if no improvement or symptoms worsen.
I am a healthy, active male with no previous risk factors.  I had a mild stroke on August 15, 2021.  Admitted to hospital for observation.  Tests revealed small blood clot in the brain.  I believe there is a possible link to my Covid19 vaccination although there still has been no study I am aware of to link the two events.  I encourage you to do more to find out if there is indeed a link between the vaccination and later occurring blood thickening.
Woke up in middle of night extremely dizzy, lightheaded, weak, and shaking. Went to ER. They gave me an aspirin, drew multiple blood samples, performed two EKGs, and a chest x-ray. They could find nothing wrong with me. After about an hour at the hospital the symptoms begin getting better, and I was discharged approximately four hours later.
The morning after the vaccination, patient was unable to stand with or without assistance.  After the first vaccine, she was slightly weak in her legs, but was back to normal on the 3rd day after the vaccine.
JANSSEN COVID-19 VACCINE EUA  I received the vaccine on 3rd April, 2021, at approximately 9:30 am. There were no immediate side effects. Approximately 10 hours later I began to feel EXTREME cold and chills. So much so that I had to put on 3 layers of clothing, socks and cover myself with 3-4 blankets. I also experienced a fever and body soreness. My wife tended to me with two ibuprofen tablets, 200 mg each and continually to put cold presses on my forehead. I drank a lot of water but my fever continued to spike to 102.8. The symptoms continued for another 3 hours. Out of concern we called the emergency room to ask if we should be concerned about the fever. We were advised to take two Tylenol tablets. My wife gave me two Tylenol PM tablets. About 30 mins after taking the Tylenol tablets and continuing to hydrate, my cold and chills began to subside and I began to shed all of my layers. About 30 minutes after that, my fever levelled out to abougt 100.8. Then I passed out. The following morning, I woke up with cold, chills and fever gone. I had a mild headache and took 2 Extra Strength Tylenol tablets. It's been four hours since then and I feel fine, just a little weak.
No adverse effects - reporting vaccine administration error.  Unaware that client received a Moderna vaccine at another facility on 12/31/2020. Additionally, that client ended up getting another Moderna dose at the other facility on 1/28/21.
no additional AE; an expired dose of MMR II was accidently administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent.  On 25-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, at a dose of 0.5 ml, once, lot #T016198, was found to be valid, expiration date: 11-MAY-2022 (strength, route of administration and vaccination site were not reported) for prophylaxis (expired product administered). No additional adverse events were reported.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022 at 4:04 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Feb-2022 at 4:04 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. ethnicity: withheld No relevant concomitant medications were reported.  Vaccine administration time 16:04:41. No treatment information was provided. The patient was administered booster dose that went into 7-8c thaw state on or above 24-Dec -2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.
NauseaVomiting HEADACHE. STATED CAME IN WITH SLIGHT HEADACHE Narrative:  0923 HEADACHE,, 0943 H/A WORSE AND NAUSEATED. V/S 143/88-P-88 02 SAT 100%R-16 STABLE. 0957 FEELS FINE , NOISEY INN OBSERVATION AREA FEELS IT CONTRIBUTED TO H/A. RETURNED TO WORK.  Other Relevant History:
Injection site pain, Injection site swelling, Injection site erythema  This case was reported by a nurse and described the occurrence of injection site pain in a 50-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The nurse reported that, "several other patients" experienced injection site reactions following immunization with Engerix-B, however, a specific number of subjects was not provided.  On an unspecified date in February 2006 the subject received 3rd dose of Engerix-B in the left arm. Approximately 3 to 4 days after vaccination with Engerix-B, on an unspecified date in February 2006, the subject experienced injection site pain, swelling injection site and injection site redness. The subject was seen at a physician's office. The events resolved "the next day."
Developed shingles after vaccine/ took the shingles shot, had tiny dot of it in hairline/suspected Vaccination failure; Developed shingles/ had tiny dot of it in hairline; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received the shingles shot and later patient had tiny dot of it in her hairline. Her doctor was able to give medication and it helped. At least she had not had a full blown case. The reporter considered the events might had been to be related to Shingrix. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.