chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed rheumatoid arthritis after this dose of the vaccine. I started having joint pain and swelling more than previously. I also had other digestive issues. They ran an autoimmune profile test, and it came out with a positive rheumatoid factor and high levels of inflammation. I went to the doctor, and she did X-rays and additional blood work that confirmed that I had rheumatoid factors and rheumatoid arthritis in the x-rays and blood work. I was prescribed hydroxychloroquine twice a day as well as folic acid and methotrexate. It is the beginning protocols to stop the progression of the disease. I was also given prednisone for the flare. I am seeing improvement, but I am still having joint pain and swelling in my hands, wrist, shoulders and neck.
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients. On unspecified dates the patients were vaccinated with improperly stored ROTATEQ lot # L008053 (expiration date 30-NOV-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
States "about few hours after flu vax noticed she had itching red blotchy areas around neck and shoulder. This lasted several hours went away on own. No resp distress.
Information has been received from a RN concerning a 7 yr old male with no allergies or medical history who on 28Jan00 was vaccinated with a dose of varicella virus vaccine live (lot631769/1016J). There was no concomitant medication. On 01Mar06, the pt developed chickenpox with itchy, crusting, pimple like blisters, and a cough. No diagnostic lab tests were performed. Unspecified medical attention was sought. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
Within 4-5 hours, muscle soreness on shoulder at injection site.  Within 12-13 hours, migraine, fever, chills, body aches, nausea, and vomiting.  Symptoms lasted 36-38 hours from the time of vaccination
Swollen itchy lips; Swollen itchy lips; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 14:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other product. Concomitant medications included probiotic nos (PROBIOTIC), pyridoxine hydrochloride (VITAMIN B6), MULTIVITAMIN for an unknown indication, from an unknown date.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 after 2 days of vaccination the patient experienced swollen itchy lips. No therapeutic measures were taken as  a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen itchy lips was ongoing at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received flu shot 10/29/04. Site was hard and tender Saturday as reddened, hard area 2.5"x2.5". Area around injection site warm and red. By Tuesday when reported, area had decreased in swelling and hard area but still red and round. Very tired and decreased energy Sunday and Monday. Some shortness of breath. Monday with frequent cough. Treatment: Monitor for now.
Had a little sore shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6203) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anemic" (ongoing), notes: was diagnosed with after son was born 31 years ago. Concomitant medication(s) included: VITAMIN B 12 [CYANOCOBALAMIN] taken for anaemia. The following information was reported: ARTHRALGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "Had a little sore shoulder".  Additional information: The patient received first dose Pfizer BioNTech vaccine (expiration date and NDC number was unknown) in the morning between 08:00 and 09:30. Other Conditions reported as Yes. Investigations reported as No. No additional Vaccines administered on same Date of the Pfizer Suspect. Patient had no Vaccinations within four weeks prior to the first administration date of the suspect vaccine. After the first dose Pfizer BioNTech Vaccine the caller wasn't really bothered, had a little sore shoulder. After first dose patient had a little sore shoulder. This began on 16Mar2021 and went away in about a day. Further asked if recovered completely or with lasting effects and the patient clarifies, maybe the next week his arm continued to be sore, and he put ice on arm. AE does not required visit to Emergency Room or Physician Office. Stayed at home. No relevant tests.
Per admission record report developed Varivax induced varicella, remains hospitalized 9/29/06. Admitting DX: acute respiratory failure. Dependent exposure 8/29-9/4/06 (5 days prior to 9/2 the date of isolation.). Progress note 9/4/06-continues to spike temps 102.2, increased vesicular type lesion on chest/neck all blood cultures negative. Note of 9/5/06-remains on ventilator, continues to develop new lesion. Decreased renal function, temp 103. Impression: sepsis syndrome, RDS. RX with Acyclovir.  12/19/06-per facility, no DC summary Per 60 day follow up: dischared from hospital to home, Nov. 6, 2006.
the patients got covid 2 weeks later; the patients got covid 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team,   A 7-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1 (orange cap), 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 Nov2021, outcome "unknown" and all described as "the patients got covid 2 weeks later".  Clinical information: Product: Comirnaty, Pfizer-BioNTech COVID-19 vaccine [monovalent] and/or bivalent. Dose/dosage form: orange cap, original (monovalent), 5 to 11 years- 10 mcg/dose, dilute before use. Caller was a pediatrician who reported that two patients received the first dose of Pfizer COVID-19 monovalent for ages 5-11 vaccine on 11Nov2021. Caller stated the patients got COVID 2 weeks later and did not come back in for the second dose. On 11Nov2022, another dose of Pfizer COVID-19 for ages 5 to 11 monovalent was given to both patients. Caller stated she saw the patients on 11Nov2022 and gave them Pfizer COVID 19 for ages 5-11 monovalent vaccine. Caller asked is this the second primary dose or should she repeat the dose. Patients were a boy 9 years and a girl 7 years.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events 'drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201300457 Same reporter/product/event, different patient;
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received five Moderna Vaccines. Received on Jan-2021, Aug-2021 and Apr-2022. Booster lot no was mentioned as 04662.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720282:Product Monovalent
p/vax t103 APAP reduced fever to 102-stayed @ 102-103 for next 48 hrs w/APAP; pt remained fussy, soreness in both arms & lt leg; seen by MD 2OCT;
Numbness Rt hand along ulnar nerve distribution. Some numbness Lt hand also. Dorsiflexion of bilateral toes. Increased problem with balance. Sx similar to when he had Guillain Barre as a child. Pt is feeling better sx have lasted longer than 6 months.
COVID-19 Treatment; COVID-19 Treatment; Vaccination brand other: Moderna/Vaccination brand other: Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 07Oct2021 as dose  3 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "not recovered", described as "Vaccination brand other: Moderna/Vaccination brand other: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received her second dose varicella vaccine. Vaccine administered IM instead of deltoid area in left arm  No adverse reaction noted at the time in clinic.
Boil on inner thigh on the same side of injection within 24 hours of vaccination.
approximately 10 minutes after giving  first covid vaccine patient complained of racing heart, feeling shakey, cloudy, light-headed and burning in chest. asked patient if it may be anxiety and she didn't know. asked patient if she wanted us to call 911 which she did. 911 arrived, performed multiple tests-- all results were okay. patient refused ride to hospital in ambulance. patient was visibly upset and shaken, was still deciding if she and husband would go to hospital or home when leaving store after ems had conducted tests.
Pt recvd vax & 2-3 days post vax exp irregular heartbeat (PVCS?) which resolved in 7-10 days;
pt recv vax; lt arm jerking while being held then went into gene sz w/ both arms & legs; body limp; lips shaking; no color change; no T, lasted 15 min;
After having all three HPV shots, my daughter starting having irregular periods, every two - three weeks. This went on for over a year before we decided to put her on birth control pills. She was very regular before this. She was also achy and tired more often after the three rounds of shots. That still has not gone away. Doctor says neither of these symptoms can be linked to shots for sure.
Rash erythematous raised 4x2.5cm lesion at site of injection, no vesicles, no streaking.  Benadryl given as treatment.
Dizziness, NauseaVomiting, Tachycardia, bilateral numbness/tingling to feet Narrative:
Started running a fever around 4 am of previous day of shots given. Fever started at 101 and rised to 102.5 before TYLENEL took contol and helped the fever break.
I had Covid arm (the rash and swollen red lump at the injection site that looked like a huge mosquito bite) about 1.5 weeks after the first injection, my arm was sore and then it got better and then the rash came on out of nowhere. It was hard and very itchy. It lasted for about a week. After the second vaccine I got an outbreak of vulva shingles. I had my first case around 2006, and have had several outbreaks since, which would be easily fixed with Valtrex. This particular shingles outbreak has not gone away for over 2 months and I still have it dispute taking Aciclovir everyday. Finally I got Valtrex and it seems to be helping a bit but it?s still very painful. The worst part is the nerve pain that runs from my low back to my foot (all only on the left side). It?s debilitating. I have no health issues and I am a young (41 year old female). No diabetes, not overweight, no health conditions, no immune issues. It is very clear to me that the vaccine has something to do with this medication-resistant extremely strong shingles outbreak. If this lasts forever I will not be able to deal with it.
Information has been received as part of a pregnancy registry from a nurse practitioner concerning a 19 year old female with no prior pregnancies and a history of low grade squamous intraepithelial lesion (LSIL) with a colposcopy and atypical squamous cells of undetermined significance (ASCUS) in May 2007 with her last pap smear who on 28-JUN-2007 was vaccinated with a first dose of GARDASIL (Lot# 657868/0523U). The patient was treated with FLAGYL from 14-JUN-2007 to 21-JUN-2007 for bacterial vaginosis. The nurse reported that the patient was pregnant when she received her first dose of GARDASIL. The patient's last menstrual period (LMP) was 08-MAY-2007 and her estimated date of delivery (EDD) was 12-FEB-2008. No other symptoms were noted. Follow up information has been received from a health professional from the obstetrician's office who reported that on 06-MAR-2008 at 39 weeks estimated gestational age, the patient was induced due to oligohydraminos (amniotic fluid index (AFI) not available). The patient had subsequent non-reassuring fetal heart rate (FHR) tracing which resulted in a primary cesarean section. The patient delivered a healthy and normal male weighing 3065 grams with apgar scores of 8/9. The reporter noted that the patient and the baby were fine at the postpartum visit. Upon internal review, the patient's non-reassuring fetal heart rate resulting in a cesarean section is considered to be an other important medical event. Additional information is not expected.
I received Moderna vaccines previously for vaccines 1 and 2 as well as booster 1. For booster 2, I was offered Pfizer and was told that mixing manufacturers was not a bad thing. For almost all of the COVID-19 injections, I had almost immediately experienced swollen lymph nodes in both armpits and breasts - these conditions resolved after about two weeks or so for every injection except for the last one, the most recent Pfizer booster received in November of 2022. It is now January 2023 and I am still experiencing sporadic lymph node pain in those areas of my body. The swelling never went away like the other vaccines. I made an appointment with my primary healthcare provider to get checked out and she told me not to panic but to report these symptoms to you as it was concerning they were lasting so long.
Woke up at 3:30 AM on 9/2/15 with chills and shaking but no fever. Woke back up at 10:00AM on 9/2/15 with 100.5 degree fever, went to OBGYN because I was 37 weeks pregnant and they admitted me to Medical Center because I still had a fever, my heart rate was 130 bpm and the baby's was around 200 bpm. At hospital received an IV drip for dehydration and stayed for observation. Fevers continued until 4am 9/3/15 and I was released from the hospital at 12:00PM on 9/3/15 after having normal temperature since 6am.
Adverse reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reactions). At the time of the report, ADVERSE REACTION (Adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of the patient who received their Moderna vaccine on 01-Feb-2021 and had very adverse reactions.  No Concomitant product use was reported. No treatment information was provided..   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR Received and contains non-significant information.
Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia
Cellulitis - left arm (deltoid) 2 " x 2.5" swelling with warmth.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 62.83 years. No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 9 AM and 37 degrees Fahrenheit at 10 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a pharmacist concerning a 70 year old male who on 12-APR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). The patient was given a prescription for the "shingles vaccine" and VARIVAX was dispensed and was administered instead of zoster vaccine live (Oka/Merck) (ZOSTAVAX). The pharmacist dispensed the VARIVAX vaccination in error due to both vaccinations containing varicella zoster vaccine. The patient took VARIVAX vaccination to the physician and it was administered. The patient sought unspecified medical attention. It was unclear how or when the error was discovered. No problems reported. No further information is expected.
itching scalp; arms; patient took own benadryl; denies sob; no problems with throat; 17:15 feels better but still itchy; no respiratory issues; no other problems.
Patient came to our clinic on 4/9/09 at 10:05 accompanied by mother. Patient complains of body aces, nausea no vomiting, soreness in bilat. arms and 1cm elevated reddened area noted around injection site.
lightheaded; Headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), HEADACHE (Headache), FATIGUE (fatigue) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EZETIMIBE (ZETIA), LISINOPRIL, METOPROLOL, ATORVASTATIN, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMIN D NOS for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (lightheaded), HEADACHE (Headache), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, DIZZINESS (lightheaded), HEADACHE (Headache), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021, no new information
Fever, severe pain in the arm at and around the injection site. Inability to lift the arm of the injection site. Swelling of the deltoid at the injection site. Headache. Ear ache. Fatigue.  The events lasted approximately 24 hours. Naproxen and Tylenol helped with the fever and the pain.  48 hours later, fever is gone, Swelling is down, the site is still painful, but manageable.
Pt stated she has had muscle pain in the left arm since the vaccination. She states it starts in the back of the arm and radiates down the arm to the wrist/hand. She stated she is having difficulty grasping. She also told me that she had had reaction in the past to statin medication similair to this both occured in both arms.
27-year-old pregnant woman (27 weeks gestation) collapsed and died on 30NOV2009. She was vaccinated on 18NOV2009 with FLUVIRIN and Novartis H1N1 vaccine. The child was delivered by C-section. The autopsy was pending. Attempt to get lot numbers unsuccessful.