chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On 22-MAR-2017, the patient was vaccinated with improperly stored vaccine VARIVAX (lot number: M030138, with an expiration date: 15-JUN-2018; dose regimen details were not provided) as prophylaxis. The nurse could not provide the lot and expiration for the properly stored sterile water diluent used to reconstitute the dose of VARIVAX. No adverse effects were reported. Temperature/Time : 15°F to 46°F (28.4F) for 75 hours Previous temperature excursion? NO Was call because of a "data logger"? NO Additional information has been requested.
hard to walk; pain in his right hip/ knee; Injection site tender to touch/ njection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-AUG-2023, the patient received Arexvy (intramuscular). On 20-AUG-2023, less than a day after receiving Arexvy, the patient experienced injection site tenderness (Verbatim: Injection site tender to touch/ njection site pain) and pain in hip (Verbatim: pain in his right hip/ knee ). On 21-AUG-2023, the patient experienced walking difficulty (Verbatim: hard to walk).  The outcome of the injection site tenderness and walking difficulty were not resolved and the outcome of the pain in hip was resolved.   It was unknown if the reporter considered the injection site tenderness, walking difficulty and pain in hip to be related to Arexvy.     It was unknown if the company considered the injection site tenderness, walking difficulty and pain in hip to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that the patient received Arexvy vaccine. On same day evening patient experienced injection site pain and pain in his right hip and knee. On Monday 21st August 2023 it was hard for him to walk.   He massaged his leg Monday night, which helped the pain to subside some.   On Tuesday 22nd August 2023 his leg did not work right something was not firing in there.  Patient had an appointment with his healthcare professional tomorrow. The reporter consented to follow up.
Skin discoloration in the thumb / hand; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Skin discoloration in the thumb / hand) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin discoloration in the thumb / hand). At the time of the report, SKIN DISCOLOURATION (Skin discoloration in the thumb / hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I though I had allergies. I started getting symptoms of itchy throat and runny nose. I felt like I had a cold. I had a dentist appointment the next day so I did an at home COVID-19 test which was positive. I took another one as well which was positive. My husband and child tested positive as well. Then my symptoms progressed cough, sore throat, congestion with chest pressure, and headache. I called my doctor and was prescribed PAXLOVID on 5/16/2022. The PAXLOVID did help and I did have some improvement. I finally feel better today but with a mild cough and runny nose.
pt recv vax 22APR97 & 1MAY97 exp malaise, fatigue, nasal congestion & a sore throat;tx w/amoxicillin which was replaced by Augmentin;5MAY failed to respond to amoxicillin;9MAY pt not well found to have elevated LFT's (transaminases);
Patient vaccinated on 12/2/05 and complained of vomiting, headache and 103 fever for 2 days approximately 27 hours status post vaccination.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient received the first two doses of GARDASIL (lot # not reported) in 2009 (dates of the first two doses were unspecified). The patient was in the office on 13-AUG-2012 to receive the third dose of GARDASIL (lot # not reported). No adverse event reported. Additional information is not expected.
lightheadedness,dizziness,nauseated & vomited;better in 24hrs;taking some type of steroid for upcoming knee surgery in 1mo;may advise to postpone series until a later date;
Information has been received from a pharmacist concerning a patient with asthma who on 26-OCT-2010 was vaccinated with a single injection of PNEUMOVAX 23 (lot# 667418/0978Z). Subsequently the patient experienced fever, rash, headache, nausea and vomiting. The patient experienced these side effects for 3 to 4 days after the initial injection. This is one of several reports received from the same source. Additional information has been requested.
Pt got pfizer covid vaccine on 1/3 (approx 48 hrs PTA) where she a CNA. She got the vaccine in the afternoon. Pt felt well on the day of the vaccine, but yesterday (1/4, one day after vaccine), pt syncoped at work in the evening. She had eaten normal meals that day. After syncopal episode, her blood sugar was normal. Her blood pressure was 76 / 56. Pt felt very lightheaded prior to syncope. No chest pain, dyspnea, no palpitations. Pt was unconscious just briefly. Pt states she did have some tingling in her R arm, R foot, and entire tongue. Pt is still having a HA. No other sxs. Has not taken anything for these sxs. When pt syncoped, she landed on soft bed, did not hit head on anything hard. Pt syncoped once previously at age 9. Pt has soreness at injection site, but no swelling or erythema.
Approximately 48 hours after I was administered influenza vaccine, I experienced frequent bowel movements, frequent bloody stools, frequent abdominal pains, etc.
ELEVEN DAYS AFTER VACCINE MY HUSBAND BEGAN AN ALTERED MENTAL STATE & ELEVATED BLOOD PRESSURE.   ALTERED MENTAL STATE & DELUSIONS WORSENED DURING HOSPITALIZATION.   HE ENDED UP HAVING TWO PSYCH EVALUATIONS.  MANY TESTS WERE PERFORMED AND HE ENDED UP ON A VENTILATOR IN ICU FOR 12 DAYS.   BOTH HIS NEUROLOGIST AND HIS PRIMARY CARE PHYSICIAN ADVISED HIM NOT TO HAVE THE SECOND COVID VACCINE.  HE IS BACK HOME FOLLOWING A BRIEF REHAB PERIOD.   HE APPEARS TO BE IN HIS NORMAL MENTAL STATE AT THIS TIME BUT CONTINUES TO HAVE AN ASSORTMENT OF MEDICAL ISSUES  THAT NEED TO BE RESOLVED INCLUDING ELEVATED BLOOD PRESSURE WHICH WAS NEVER A CONCERN BEFORE.
Within 10 minutes I felt lightheaded. Went back to the pharmacy and they had me sit down. My eyes were dilated and became pale.  Then within an hour I couldn?t speak or move. Signs much like a stroke. At the hospital I began to speak about 2hrs after entering hospital. Doctors ran all kinds of tests everything came out ok. But my speech and head still are not normal.
Patient received Moderna booster. Same vaccine as previous 2 doses. Administered vaccine around 2:29pm on 11/4/21. Patient called around 7pm stating that she was experiencing lumps in her mouth and that it seemed to be interfering with swallowing and speaking. No trouble with breathing.
Patient recieved Menactra that was expired with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00573158) and transmitted to Sanofi on 22-Apr-2021.  This case involves an 18 years old female patient who received a 0.5 mL expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (once) (lot U6586AA and expiry date: 14-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 22-Apr-2021.  Medical history, past medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know if there was in wiggle room for expiration date of product and would it affect the HPV vaccine that was given concomitantly?  At the time of reporting, the patient experienced no specific adverse event.   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 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.
Narrative:  Patient received Janssen vaccine yesterday 4/12/21 at 9:30am. This morning his mother presented to clinic to report that he experienced muscle rigidity of his upper and lower extremities. He also experience profuse diaphoresis that lasted for a short time. He did not report any other type of neurologic, respiratory or cardiac symptom. The muscle rigidity lasted a few hours and has now resolved. Discussed need for immediate emergency room evaluation with verbal understanding. Mother will take him to medical facility now.
Severe pain in left arm; Excessive weakness or tiredness continuously over 24hr following vaccination; Excessive weakness or tiredness continuously over 24hr following vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus (HIV) undetectable. The patient had no known allergies. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate, bictegravir sodium (BIKTARVY) from unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 17:00, the patient experienced severe pain in left arm and excessive weakness or tiredness continuously over 24 hour following vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, severe pain in left arm excessive weakness or tiredness continuously over 24 hour following vaccination were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
They bit me up a little bit; Achy all over; Felt like a good flu; Tired; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (They bit me up a little bit), PAIN (Achy all over), INFLUENZA (Felt like a good flu) and FATIGUE (Tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma (The patient was a cancer survivor (late stage lymphoma), 24 year remission. ) in 1997. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (They bit me up a little bit), PAIN (Achy all over), INFLUENZA (Felt like a good flu) and FATIGUE (Tired). At the time of the report, VACCINATION COMPLICATION (They bit me up a little bit), PAIN (Achy all over), INFLUENZA (Felt like a good flu) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was nit reported.   This case was linked to MOD-2021-400091 (Patient Link).
I felt very light headed and collapsed; did not lose consciousness and was not injured.  Lightheadedness resolved over the following15 or so minutes.  Left arm remained sore for two days and rash appeared  upper left arm on 9/29/2023  in the morning.
Redness and erythema to left deltoid area, instructed to use otc Benadryl orally and apply cold compresses until redness and pain subsided, if no better than to RTC.
70mmx70mm raised erythema around MCV4 injection site on Right Arm.  Ice applied PRN.  No fever.
Extreme fatigue, swelling at the injection site, chills, fever for a 36 hours.
Noted redness on 8/6/02 of left thigh. Came for office visit on 8/7/02 and had a very large (15cm X 18cm) of erythema, induration and heat; almost the whole circumference of the leg on left thigh surrounding injection site.
5/3/21 Description of incident:  Following administration of COVID-19 vaccine, patient experienced overall dizziness and weakness   Initial Vitals at 1545 Blood pressure:  214/102 Pulse: 84 O2 saturation: 98% RA   Actions taken:  Observe   Re-Check of Vitals at 1549 Blood pressure: 214/103 Pulse:  85 Respirations: 20 - regular    Orders initiated per RN protocol: None, protocol not warranted Provider from  clinic paged.  Dr. attended pt.    Patient outcome:  Continue to observe   Re-Check of Vitals at 1600 Blood pressure:  186/91 Pulse:  79   Re-Check of Vitals at 1606 Blood pressure: 203/96 Pulse: 80 O2 saturation: 99%   Provider recommended pt to go to Urgency Room or ED for further evaluation, blood tests, and monitoring.    Re-Check of Vitals at 1606 Blood pressure: 186/97 Pulse: 79   Patient left vaccine clinic via car with her daughter.  Daughter spoke with Dr. who agreed to take her to Urgency room at this time.    Patient presented to Urgency Room @ 1700
pt recv vax & entire lt thigh swelled & became firm to touch, hot to touch & remained x 3 days, diminishing to nl @ end of day p/vax;pt had temp 101ax;1st day 100 ax 2nd day wasnl temp by end of day 3;cried & stopped only when mom held pt
5 hours post vaccination fever was up to 103 with fussiness and irritability. Fever persisted for 48-60 hours. On 8/6 which was 6 days post vaccination had an episode of decreased alertness, was just staring. Was seen in ER. Pt is currently back to normal state prior to reactions and stable at this time.
no adverse reaction; vaccination dates: 25-OCT-2017; 06-MAR-2020; This spontaneous report has been received from a lawyer and a 72-year-old male patient via a Plaintiff Fact Sheet. On 25-OCT-2017, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacture unknown) (strength, dose, route, lot #, expiration date were unknown) for prophylaxis. Then the patient also received the hepatitis a vaccine, inactivated (manufacture unknown) vaccine on 06-MAR-2020 with unknown dose, route and lot# (inappropriate schedule of product administration). There were no adverse reactions or side effects for the patient.   This is one of several reports split from a case in litigation (MARRS# 2010USA001766).; Sender's Comments:  US-009507513-2010USA001766: US-009507513-2101USA012802: US-009507513-2101USA012804:
Dx: Varicella/cellulitis. Note: Unimmunized child! Given Augmentin 600/5, Tylenol with codeine.  Follow up on 12/02/2003: "BACK OF THIS REC. THIS CHILD HAS NEVER BEEN VACCINATED!"
I am an internal medicine resident at medical center.  2 weeks ago I received the Flumist.  I developed some upper resp. symptoms and malaise. Within a week I developed a macular rash that I self diagnosed as pityriasis rosacea.  Rash was limited to torso in a centripetal pattern. Not itchy.  Rash is now resolving.
This initial spontaneous report was received on 20-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 03-APR-2014 the patient was inoculated by an unspecified healthcare worker at a medical center with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-DEC-2016, he was treated by a physician at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The male patient has been prescribed gabapentin for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Swelling and erythemia approximately 3" in diameter at injection site.  Swelling extends to axilla and top of shoulder and extends anterior from shoulder to arm pit. Nausea.
This 58 year old white male hospice patient received the Covid shot on 3/22/21 and died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Chest pains, achy arm and tingly fingers.... will be seeing a cardiologist May 17th
Infant was given Rotateq at 15 wks. of age. Next visit due Jan. 08. There has been no contact with or from family.
began feeling ill on 8/9/21 with cold like symptoms, sore throat, body aches, fatigue
pt recvd vax 24MAR92 & 20JUL93 measles titer was drawn & was neg; No further details were provided;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with either PNEUMOVAX 23 or flu vaccine (manufacturer unspecified)(Lot #, dose/frequency and route unspecified) on an unknown date. No concomitant medications were reported. The pharmacist reported that she had heard that the patient had developed necrosis at the injection site after getting vaccinated with either PNEUMOVAX 23 or flu vaccine (manufacturer unspecified). It was unknown which vaccine of these vaccines the patient had been given. It was unspecified whether the patient had sought medical attention. No treatment information was reported. The outcome was unknown at reporting. Upon internal review, necrosis at the injection site was determined to be medically significant. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 4-year-old male subject who was vaccinated with Infanrix and ProQuad for prophylaxis. The subject's medical history included extrinsic asthma, respiratory infections and an unspecified reaction to oxybenzoyl described as a rash from baby oil. Concurrent medications included Albuterol and Pulmicort Nebulised. On 3 May 2007 the subject received 5th dose of Infanrix (.5 ml, unknown, left arm), and the 2nd dose of ProQuad (unknown, left arm). On 4 May 2007, within 24 hours of receiving the vaccinations, the subject's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The subject was treated with ibuprofen (Motrin) and Benadryl with no improvement in symptoms. On 5 May 2007 at 3:43 p.m., the subject presented at the physician's office and was diagnosed with cellulitis. The subject's left arm was swollen from the deltoid to the elbow, his skin was taut, warm to the touch, and red. This case was assessed as medically serious by manufacturer. The subject was prescribed Augmentin for 10 days. At the time of reporting the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The healthcare professional considered the events were possibly related to vaccination with Infanrix and ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad. Per the source document, the healthcare professional in uncertain if cellulitis was due to Infanrix or ProQuad since both vaccines were received on the same day.
?Moderna COVID-19 Vaccine EUA? Redness in arm began on 12/25 post injection on 12/23 and progressively worsened over the next few days with itching, swelling, and hot to the touch at the injection site in L Upper Arm. On 12/29 the area of redness increased in size and symptoms became worse with intense itching overnight. I went for treatment at an Urgent Care and was seen. Treatment included at the time of visit a steroid injection and a benadryl injection for the localized allergic reaction. Sent home with a prescription for Prednisone, benadryl, and famotidine. At this time (12/31) the redness is beginning to subside although at this time it is 3"x4" in size, with minimal itching but still some heat to touch at the site of redness. No fever, headache, or chills. Outcome to be determined over the next few days.
I experienced minor breathing difficulties received oxygen, resulting in kidney failure; received 3 days of dialysis.