chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Legs shaky; Weakness; Felt really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Legs shaky), ASTHENIA (Weakness) and FATIGUE (Felt really fatigued) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced RESTLESS LEGS SYNDROME (Legs shaky), ASTHENIA (Weakness) and FATIGUE (Felt really fatigued). At the time of the report, RESTLESS LEGS SYNDROME (Legs shaky), ASTHENIA (Weakness) and FATIGUE (Felt really fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
PATIENT REPORTS THAT APPROXIMATELY 4 HOURS AFTER RECEIVING THE PFIZER COVID-19 VACCINE, HE STARTED TO EXPERIENCE SOME SYMPTOMS INCLUDING: HEADACHE, CHILLS, SWEATS. THIS CONTINUED FOR ABOUT 8  HOURS.
18DEC91 tc from parent, pt screaming continuously w/no stopping; parents notified MD; Md advised pt should not have any more pertussis & to give APAP;
PT STATES THAT ON 03/06/2021 AT AROUND 1600 SHE NOTICE A SMALL ITCHY RED BUMP.  SHE STATES THAT OVER TIME BUMP(WINGWORM LIKE) INCREASED IN SIZE TO ABOUT 2.5 INCHES.  PT STATES THAT SHE STILL HAS SMALL RED ITCHY RASH.
Injection site sharp pain (left arm)that came and went over a period of a few days. Almost felt like an itch. No skin difference. Eventually sharp neck and upper arm pain along nerve on left. I have arthritis in my cervical spine so thought it was just a bad neck but it is not responding well to precsribed pain controls (Vicodin and Skelantin). Sharp pain. Itchy pain continues at injection site along with pain up into neck. Reported pain to GP on 03/09/10 and asked if there was a possibility of a connection. GP assumed it is coming from arthritis in the cervical spine (per MRI). Due to continued discomfort at injection site and timing of neck pain, I decided I should report it.
burning; blisters; itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Feb2021 (Batch/Lot number: unknown) at the age of 79 years as dose 2, single for covid-19 immunization.  Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: was scheduled to get radiation for breast cancer; "Radiation", start date: 15Feb2021, stop date: 19Feb2021, notes: Reason for Use: Breast cancer. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EL9263; Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 03Feb2021, for Covid-19 immunization.  The following information was reported: BURNING SENSATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "burning"; BLISTER (non-serious) with onset 25Feb2021, outcome "not recovered", described as "blisters"; PRURITUS (non-serious) with onset 25Feb2021, outcome "not recovered", described as "itching". Therapeutic measures were taken as a result of burning sensation, blister, pruritus.  Additional information: The next day of vaccination, caller broke out with blisters, itching, and burning where she got the radiation which reportedly scared the doctor and he gave her silvadine. The caller was set up to get the booster of vaccine but was worried. She stated that it was caused by radiation and it just made the reaction worse. The prior vaccinations within four weeks prior to the first administration date of the suspect vaccine were reported as none. She had radiation for 5 days 15Feb2021 to 19Feb2021  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
she got the covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she got the covid) in a female patient of an unknown age 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) (unknown route) 1 dosage form. In October 2021, the patient experienced COVID-19 (she got the covid). At the time of the report, COVID-19 (she got the covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  It was reported that the patient participated in the pediatric COVID 19 vaccine trial. Upon unblinding, it was confirmed that she got the vaccine, not placebo.  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse events of special interest COVID-19. The event occurred an unknown time after the most recent dose of mRNA-1273. Information regarding medical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse events of special interest COVID-19. The event occurred an unknown time after the most recent dose of mRNA-1273. Information regarding medical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Tested positive COVID-19; Detached retina; A spontaneous report was received from a consumer concerning a 66-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Detached retina (Retinal detachment) and Tested positive COVID-19 (SARS-CoV-2 test positive).  The patient's medical history was not reported. The patient's concomitant product was not reported.    On 14 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient's retina got detached. The event detached retina was assessed as medically significant.  On 24 Jan 2021, the patient tested positive for COVID-19. Treatment details included eye vitamins and surgery.   The action taken with mRNA-1273 in response to the events detached retina and tested positive COVID-19 was unknown.  The outcome of the events, detached retina and tested positive COVID-19 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a consumer, as part of a marketing research program, refers to a 22 year old, female patient. Patient's medical history and current conditions were not provided. On an unkonwn date the patient was vaccinated with a dose of pneumococcal vaccine, (manufacturer unknown) (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. On an unknown date the patient experienced the event of pneumococcal infection (unspecified) (described as "I got those diseases after being vaccinated"). The outcome of adverse event was unknown. The related between adverse event and pneumococcal vaccine, (manufacturer unkonwn) was not reported. Additional information has been requested.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/11/2022 Discharge Date:  6/13/2022  PRESENTING PROBLEM: Choledocholithiasis [K80.50] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 73-year-old male with no significant past medical history who presented with right upper quadrant pain.  He has noted intermittent right upper quadrant pain spontaneously resolved and had been ongoing for over a year.  He has now been having more frequent and intense right upper quadrant pain.  Patient was also experiencing fevers and a mild cough. In the emergency department he was found to be COVID positive and also found to have elevated liver enzymes.  Chest x-ray showed hyperinflation but no infiltrates, edema or significant effusion Right upper quadrant ultrasound showed cholelithiasis with mild gallbladder wall thickening along with mildly dilated CBD. General surgery was contacted by the emergency department and they recommended admission for biliary colic and possible choledocholithiasis. CT abdomen pelvis was done and showed 2 simple benign hepatic cyst along with distension of the gallbladder, few calcified stones and thickening of the wall. Patient did not have any further abdominal pain after admission.  General surgery felt that patient could have choledocholithiasis with passing of stones as his LFTs were improving and he was not having any further abdominal pain.  Gastroenterology was consulted and they felt that there was low suspicion of CBD stone and did not feel there was any role for ERCP at this time.  Gastroenterology stated that patient should follow-up with General surgery for cholecystectomy and IOC.   Patient was started on a diet and tolerated this well without any increasing abdominal pain.   Bilirubin was 3.3 on admission and had improved to 1.3.  Alk-phos, AST and ALT all had decreased since admission. As LFTs were trending down and patient had no further abdominal pain-general surgery felt that he could discharge home and follow-up with them as an outpatient in 2 weeks time to discuss cholecystectomy.     Patient had no other acute issues and was discharged home in stable condition 6/13/2022
Approximately 12-16 hrs after getting my 3rd booster vaccine (Right Shoulder), I noticed dramatic swelling in my right Axilla (arm pit). No redness, but noticeable swelling. Now 48 hrs later, the swelling remains.  I did take a picture showing the swelling.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a physician concerning a 12 year old male who was vaccinated with a dose of GARDASIL. Concomitant medication included 2 other unspecified vaccines. It was reported that on 13-MAY-2010 "the patient had fainted after the vaccination. The patient recovered on 13-MAY-2010 and went home." The patient received unspecified medical attention. Additional information has been requested.
NO ADVERSE REACTION NOTED. WRONG VACCINE ADMINISTERED. Patient given Moderna as 2nd dose @  3 week return ; instead of Pfizer as 1st dose on 3/12/2021 (EN6206), No adverse reactions noted.  Patient assessed by Dr. EC precautions given. Reviewed CDC Interchangeability of Covid 19 vaccine product summary. Informed patient there would be a follow up; if additional feedback or recommendation  received from CDC or vaers.hhs.gov after report entry. Patient verbalized understanding all instructions given. IMMTRAC  # 242903804
VARIVAX administered 8/28/09 to Rt arm. Saturday, Pt woke with baseball size redness to vaccine site. C/o small amount of itching and mild redness. Denies pain or fever. Pt has full ROM of arm. Pt was not seen by physician, no lab work. Ice applied.
This spontaneous report as received from a company representative reporting on a family member refers to a 54 year old male patient with hypertension and no drug reaction/allergies. On 20-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX vial injection on the arm (dose, lot number and expiration date not reported). Concomitant medications included unspecified medications for hypertension. On 20-JUN-2014, the reporter's family member developed a raised, red lump on his arm at the injection site and a rash and swelling that extended down to his fingers on that same arm, after receiving ZOSTAVAX (also reported as 21-JUN-2014. On 21-JUN-2014, the day after receiving ZOSTAVAX, the family member cut his finger (on the opposite arm of the ZOSTAVAX injection) and saw his physician and received a Tetanus injection in the same arm that ZOSTAVAX had been administered in. The physician evaluated the ZOSTAVAX injection site reaction at that time. No other information is available. The patient did not received treatment for red lump on his arm at the injection site and a rash and swelling. At the time of the report, outcome of red lump on his arm at the injection site and a rash and swelling and cut finger were unknown. No lab diagnostics were performed. Additional information has been requested.
Patient was administered an extra dose of the Pfizer 5-11 monovalent COVID-19 vaccine instead of the intended Pfizer 5-11 Bivalent Booster COVID-19 vaccine on 12/4/22 at 12:33pm.   I called and informed patient's mother, on 12/5/22 and she reported that patient is doing well except for some mild expected post-vaccination symptoms.
PATIENT IS GETTING HER 2ND SHOT AT THE PHARMACY. 1ST SHOT GIVEN ELSEWHERE AND UNKNOWN LOT NUMBER OR VACCINE SITE. SHE REPORTED AFTER HER 1ST SHOT THAT SHE GOT AN ITCHY RASH THAT MADE HER ECZEMA WORSE. HER RASH ALSO SPREAD TO HER STOMACH/ABDOMEN AREA WHICH WAS UNUSUAL FOR HER. IT LASTED ABOUT 1 WEEK
Subject BIT010035, a 30 year old male with no previous medical conditions, received the 3rd dose of Anthrax vaccine (lot FAV031) on 02/08/2000. No other vaccines were given on this date. Concomitant medications at the time of the event are unknown. The pt did not report any illness at the time of the vaccination, nor did he report any reactions to previous vaccinations. Beginning 05/15/2000, the pt experienced daily swelling of the feet and a recurrent rash, with occasional pruritus, that was localized to the hands and feet. The pt was treated with histamine blockers with relief of symptoms. At the time of this report, the pt's symptoms have not resolved.
Excessive number of PVCs after 4th dose. Vomiting and high temperature after 4th dose. I had this with the first booster as well.
pt recv vax & there was a lack of seroconversion; No further details were provided;
Moderna COVID-19 Vaccine EUA. After receiving the vaccine on 01/08/2021, started to experience pain in left arm which increased in intensity as the day progressed.  Took 800mg Motrin with minimal relief.  Took an additional 800 mg of Motrin again at bedtime.  Woke up on 01/09/2021 with headache, muscle and joint pain, pain in left arm and shoulder, and fatigue.  Took Tylenol and Motrin through out the day.  Woke up on 01/10/2021 with red swollen eyes and face, and a rash (hives) on neck, stomach, back, and antecubital spaces.  Experienced nausea during day.  Took Benadryl and Tylenol through out the day.   Hives and swelling decreased with second dose of Benadryl.  Today, still some fatigue and pain in left arm.
Sore, Redness, Swelling, Heat, Raised Growth, Tired, Hard area of injection site. First noticed 01/07/21 around 6 am. Ptn went to PA and received Keflex for a diagnosed cellulitis.
p/vax pt devel a flat & patchy rash on face & trunk that looked like rubeola, as well as otitis;pt sought unspecified medical attention & tx w/amoxicillin;
A 17-year-old female who was brought to the emergency room because of progressively worsening right-sided abdominal pain since the day before her admission. She developed some nausea and had emesis in the emergency room. No previous history of abdominal pain. Additionally, she had received an injection of Gardasil three to four days prior to onset of these symptoms. She has no fever and no chills, No chest pain. Nausea and vomiting, as stated. No diarrhea. She did have a normal bowel movement yesterday. Her periods had been regular until she was started on Depo-Provera. No fever. No chills. No significant weight changes. No history of diabetes. Mental health problems as stated earlier. 05/16/07-records received for DOS 3/22-3/30/07;DC DX:Abdominal pain, question etiology. Possible GE reflux disease. Gastritis. post traumatic stress disorder. Question biliary colic. Dilated common bile duct, possibly normal variant. Admitted from ED with worsening right sided abdominal pain. Nausea and emesis.  No fevers,
Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on left side of head and neck; General malaise; Lingering headaches; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney stone and liver issues. The patient did not had allergies to any medications, food, or other products. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced dead arm pain at injection site (for 3 days), low grade fever with chills and body aches, migraine with pain on left side of head and neck (for 3 days), general malaise. The patient experienced lingering headaches. The patient was definitely not looking forward to another shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, low grade fever, chills, general body pain, migraine, general malaise and headache were resolved with sequelae (recovered with lasting effects) on an unknown date of Mar2021.  No follow up attempts are needed. No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 15-year-old male patient received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: EW0177), in left arm, on 05Jun2021 as dose 2, single (Lot number: EW0180), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 14 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Selective IgA immunodeficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: We re-tested him for COVID using two at home test kits and he tested positive again for both; (unspecified date) Positive, notes: We re-tested him for COVID using two at home test kits and he tested positive again for both; (17Jul2022) Negative, notes: negative for COVID one day after completing his last Paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2 weeks was reported as No. The patient received anti-viral COVID 19 Treatment (lot number= GA3595) via oral route, on 10Jul2022 and stopped on 15Jul2022. The patient tested negative for COVID one day after completing his last Paxlovid dose. All of his COVID symptoms resolved by day 4 of Paxlovid, but he had remained in quarantine until he tested negative using an at home test kit. Six days after his last Paxlovid dose, his COVID symptoms returned, including headache, runny nose, sneezing, and cough. It was reported that they have re-tested him for COVID using two at home test kits and he tested positive again for both and was re-isolating.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Fever, Diarrhea, Chills and redness at the injection site. Narrative:
The patient had a fever of 102.4, swollen (the size of an orange), hard, hot, painful injection site. The patient also had achiness and feeling "wiped out." On 12/7/00 the fever was 99.6 this morning "feeling better". On 12/11/00 the patient recovered.
Swelling injection site, Left upper arm erythema and edema surrounding and below immunization injection site (13.5/10cm)
Full blown flu - fever, chills, body aches, fatigue, etc. for 5 - 7 days. Required doctor visit in order to avoid patients - so I was off work.
Day after first dose- paresthesia in hands and feet; moderate to severe headache; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 03Mar2021 10:00, outcome "not recovered", described as "Day after first dose- paresthesia in hands and feet"; HEADACHE (non-serious) with onset 03Mar2021 10:00, outcome "not recovered", described as "moderate to severe headache". The events "day after first dose- paresthesia in hands and feet" and "moderate to severe headache" were evaluated at the physician office visit.  Additional information: On 03Mar2021 at 10:00 (a day after vaccination), the patient experienced paraesthesia in hands and feet and moderate to severe headache which were persistent 3 weeks after first dose. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products and was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021351480 same patient, different drug/AE