chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL (lot # not reported). After receiving the second dose of the vaccine the patient developed painful menstrual periods. The patient will receive the third dose of vaccine. At the time of the report, the patient had not recovered. Follow-up information was received from the registered nurse which reported that there was no adverse reaction and the symptoms were unrelated to GARDASIL. Additional information has been requested.
Patient stated at night, arm was swollen and red and warm to touch.  She said could not sleep on that side of bed last night and continued this morning so called her allergist.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient with high cholesterol and hypertension. No drug reactions or allergies were reported. On 01-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K006438 and expiration date 05-AUG-2015, dose 0.65 ml, subcutaneous because he had shingles years ago and his physician told him that it would be a good idea to get vaccine. Concomitant therapies included an unspecified blood pressure medication and unspecified cholesterol medication. On 02-OCT-2014, patient experienced that the back of his right arm became quite red with a red mark down quite a bit of arm and one area about the size of a quarter that looked bubbled and scabby fairly close to the ZOSTAVAX injection site. No treatment was given for the adverse events. At the time of the report the outcome of the events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Pt came in to office complaining of redness and swelling in right arm noted on 2/14/17 after receiving vaccine on 2/13/17. Pt stated in office visit 2/15/17 that the redness/swelling was better today but wanted it be checked. Dr. advised local reaction take BENADRYL, ice.
he got felling hot; Chills; his skin is on fire; got hives or something; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dosebnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On 15Aug2021 the patient experienced he got felling hot, chills, his skin is on fire, got hives or something. The outcome of the events feeling hot, chills, skin burning sensation, urticaria was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a non licensed healthcare worker refers to a 4 years and 11 months (59 months) old patient of unknown gender. The patient's pertinent medical history was not reported. On 17-APR-2015, the four years and eleven months old patient was inadvertently administered with GARDASIL (lot #, expiration date, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Pt reported to ER on 6/6. Reports experiencing Fatigue, SOB. Worsened w/ exertion.  Denies cp. fever, cough, runny nose.
sore arm; made a mistake giving the first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and WRONG PRODUCT ADMINISTERED (made a mistake giving the first vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and WRONG PRODUCT ADMINISTERED (made a mistake giving the first vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) and WRONG PRODUCT ADMINISTERED (made a mistake giving the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter said patient received Moderna first dose by mistake instead of Pfizer, and want to find out if it's ok to take second dose Pfizer vaccine instead of Moderna. No concomitant medications provided.
-injection site rash/redness  -injection site pain  -fever -muscle aches  -headache  -fatigue
2 weeks after started administering H1N1 mist severe exacerbation of RA. Extreme redness, swelling, pain in hands. PREDNISONE increased to 15 mg QD, naproxyn sodium added. Joints calmed down 11/12/09.  12/08/09 Rheumatology consult notes for DOS 11/09/09. Pt c/o flare up of arthritis in hands with swelling, redness and pain. Physician's impression: mixed connective tissue disease with Raynaud's phenomenon (joint flare probably related to live vaccine intranasal), acute arthropathy of hands nondeforming. Tx: steroids, which may be discontinued, NSAID and pain medications.
Localized reaction.  Pt with noted edema, erythema, and induration to injection site 24hrs after injection.  Pt was instructed to apply ice Q15mins, take Benadryl and/or other OTC allergy medication.  Pt instructed not to rub or scratch site.
git the vaccine and after i had the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and after had the shingles. The physician told him/her sometimes he/she could not get sick. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Heaviness in injection arm one hour after vaccine followed by cough, swelling and itching eyes, eye redness and discharge, fever, fatigue, head pressure.
Pain in left arm, radiating to neck and head. Progressed to generalized, widespread pain or upper torso. Nighttimes shaking, sweating began approx. 2 weeks later and has persisted to date. All muscles continue to be sore.
Facial swelling - Swollen eyes Hives Rash Pruritis From initial information received on 10/29/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 51 year old female patient received a dose of FLUZONE SV '2003-'2004 at 10:40 AM. 19 hours later, the patient developed facial swelling, swollen eyes and a hive around her chin, neck and nose. The patient had no respiratory problems. She developed a rash on her chin after the hives resolved and also experienced itching. She took Benadryl and used hydrocortisone cream to treat the symptoms. The patient's physician prescribed Zyrtec. On 10/28/2003 the patient still had some facial swelling, but this symptom was resolving. The reporter of this case is the same reporter of case U1998-00297.
DTAP given IM in L/thigh on 12/13/99.  On 12/15/99, presented to MD with increase in size, redness, induration at injection site.  Instructions given, warm cloths to area, tylenol by mouth.  Call MD if condition worsens.
I got a gnarly rash - it developed on my arm to my shoulder and then to back; neck and face. I looked like I had chicken pox - red, bumpy and really inflamed. Highly uncomfortable.  Also, had fatigue; whole body pain - like an RA flare up. Fatigue and body pain lasted five days. I went to Dr through Tele-Health on the 3rd day - they told me to take Benadryl. It didn't help. When things didn't change after two days of taking Benadryl I asked a physician friend - it took 8 or 9 days to go away.  Used Oatmeal baths and applied raw aloe vera and that helped.
face swelling and a butterfly rash; face swelling and a butterfly rash; anti-histone antibody test was positive; This spontaneous report was received from a nurse practitioner via a company representative and refers to a 14-year-old female patient. The patient had family history of unspecified autoimmune disease. The patient did not have any concomitant medications, drug reactions or allergies. Additionally, the reporter informed that on an unknown dates (reported as in the past), the patient received unspecified flu vaccines without any issues.  On 18-JAN-2020, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) first dose in the series, intramuscularly (exact dose, anatomical location, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). On the same date, during the same office visit the patient also received one dose of an unspecified influenza virus vaccine (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported).  On 20-JAN-2020, the patient developed face swelling and butterfly rash and was sent home form school. The patient sought medical attention and on an unknown date in 2020, she was seen in the office by an unknown physician. As a treatment, the patient received diphenhydramine hydrochloride (BENADRYL) and lab tests were ordered. On an unknown date in 2020, the anti-histone antibody test was positive and the autoimmune workup (details not provided) was negative. The outcome of the event was reported as not recovered (also reported as condition improving, details not provided).  The causality assessment between the event and the suspect therapies was not provided.
2/9/06 Injected at about 1300 for routine, preventative measures.  I felt fine all day.   2/10/06 @ 6:30 A.M. when I woke I had pain, swelling, tenderness, bruning, and heat to touch.  I was unable to reach sholder level and unable to grasp whith my arm at different positions.  A week later I was told by the office that the ice I was applying and tylenol/advil that I was taking was appropriate and I should continue.  On the second week doctor examined my arm and started me on antibiotic for concern that I may have gotten an infection in that arm.  My arm, although the swelling has improved greatly, and there is no more heat to touch, still has some tenderness and some weaknesses.
Brain foggy; joint pain; swelling on the face; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0151), via an unspecified route of administration in left arm on 19Jan2021 at 10:00 (at the age of 41-year-old) as dose 2, single for COVID-19 immunisation at nursing home/senior living facility. Medical history included neuropathy peripheral from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing, food allergy (peanut butter) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took metoclopramide and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on an unknown date (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Jan2021 at 08:00, the patient experienced brain foggy, joint pain, swelling on the face. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. X-rays, blood work was done, and pain medication was received as treatment for all the events. The outcome of events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
1 dose ERYTHEMA  at injection site location. Skin was red and hot to touch and itchy for four days.
A Phase II Study in Healty Adult and Elderly Populations to assess the Safety and Immunogenicity of a Sonofi Pasteur H1N1 Influenza Vaccine administered at different dose levels given with and without GlaxcoSmithKline AS03 adjuvant. Subject: 70EHC050. Initial report received on 01 November 2009 from the investigator. This report was received from a phase II trial with investigational product H1N1. The following information was received by email: SAE Terms: Weakness in Legs, Muscle aches, Joint Pain, Fatigue. Onset Date: 17 October 2009. Causality not reported / unknown. Seriousness Criteria: not reported. The subject received a first dose of study vaccine on 08 October 2009. Nine days post-vaccination, on 17 October 2009, she experienced weakness in legs, muscle aches, joint pain, and fatigue. She also reported mild myalgia, chills, arthralgia, and mild to moderate malaise on her memory aid. No local reactions were reported. Medical history included an ear infection, pneumonia, kidney stones, hypothyroidism, degenerative back arthritis, right breast cancer, and a vaginal yeast infection. Concomitant medications included SYNTHROID, ACTONEL, ARIMIDEX, NAPROXEN, calcium, vitamin D, multivitamin, MUCINEX, echinachea, and AMIBIEN. Investigator assessment of causality had not been provided at the time of the report.
pt recvd vax;3 hrs p/inject coughing,chest pain,swelling of neck glands;SOB; diff swallowing & talking;given epi & steroid;during noc felt like burning up & sweating;no inc t;8nov very tired & sweating;took antihist
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 15-APR-2013 the patient was vaccinated with dose 3 of GARDASIL (lot # was not reported). The reporter reported that the patient received her first 2 doses of GARDASIL (lot # was not reported) "seven years ago". No adverse effect reported. Additional information is not expected.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On 25-JAN-2017, the patients were vaccinated with improperly stored doses of PROQUAD, (lot number M038860 with an expiration date of 13-MAR-2018, lot number M034692 with an expiration date of 24-JAN-2018, lot number M032496 with an expiration date of 02-JAN-2018, and lot number M023931 with an expiration date of 09-NOV-2017; strength, dose, route of administration and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour and 10 minutes at a temperature of -0.5 degrees Celsius on unspecified date. No previous temperature excursion was reported and a data logger issue was involved. No adverse event and no product quality complaint (PQC) were reported. Additional information has been requested. Sender's Comments: US-009507513-1702USA009658.
Tightening in chest, rapid heartbeat, tightening in throat, hives at injection site
General fatigue began at 11:20pm that night.  Severe rounds of chills and fever followed for 24 hours.  Highest fever was 102.6. Nausea, headache, and all over body ache continued through 4/3/2021. Currently it is 7am on 4/4/2021, and my shoulders hurt and the injection site is painful, red, swollen/tight, itchy,  and warm.
Itching in the eyes; Pain in the eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itching in the eyes) and EYE PAIN (Pain in the eyes) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised and Corneal defect. relevant concomitant products usage were not reported by the reporter Treatment included Pataday Eye Drops.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced EYE PRURITUS (Itching in the eyes) and EYE PAIN (Pain in the eyes). At the time of the report, EYE PRURITUS (Itching in the eyes) and EYE PAIN (Pain in the eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Reports shortly after receiving the vaccine, felt pain at first in injection site but after several days felt pain in shoulder interfering with range of motion. She went out of town, still with daily shoulder pain and limited range of motion. Persisted until 11/17 when she came in for evaluation for shoulder pain. By the date of her visit, pain had been improving although still present. Physical exam findings were consistent with subacromial bursitis on the same shoulder I injected 4 weeks ago (although I went into deltoid). We will be trying NSAIDS and will refer for orthopedic evaluation if symptoms persist.
pt had t101 R 4-5hrs p/vax 28APR95; pt remained febrile for next 12 days; episodes of diarrhea & vomiting occurred on 30APR to 11MAY95; temp taken during hosp stay 30APR95 to 3MAY95 was 100.8;
This spontaneous report was received from a 62-year-old male physician who was reporting on himself. There was no information about the patient concurrent conditions and medical history provided. The patient did not have any known drug reactions or allergies.  On approximately 16-MAY-2017, also reported as "3 weeks ago", the patient was vaccinated with ZOSTAVAX, subcutaneously for Herpes Zoster prevention (anatomical location, lot# and expiration date were not reported). On the same day, the the patient had also administered sterile diluent (STERILE DILUENT) subcutaneously for the same indication (dose, anatomical location, lot# and expiration date were not reported). On approximately 17-MAY-2017, also reported as "a day after", the patient had a rash on his whole left arm, which was raised and itchy. The patient did not seek medical attention and and on an unknown date he applied an unspecified strength and dose of hydrocortisone (manufacturer unknown) to treat the rash. At the reporting time, the patient's rash was improved, except for the rash under his arm, which still persisted. The patient declined offer of varicella zoster virus identification program (VZVIP) packet. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
6/11/09 - Vaccine given.  6/12/ - 6/14 - Sore arm.  Itching started 6/13 on arm  6/15 Itchy wrists 6/16 - headache, dry heaves, rash developed on torso & arms - severe itching at night.  6/23 - biopsy of skin taken 6/24 - no viral found.  dermatologist following given meds to put on body until rash disappeared
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 4 month old patient. On 01-JUL-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
For 2 weeks something was crawling on my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (For 2 weeks something was crawling on my arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FORMICATION (For 2 weeks something was crawling on my arm). At the time of the report, FORMICATION (For 2 weeks something was crawling on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment  information was unknown
Lightheadedness occurred approximately 45 minutes after receiving 1st dose. Lasted periodically over a couple days.