chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ERECTING; BLADDER ISSUES; TROUBLE WALKING; BOTH LEGS ARE WEAK; NUMBNESS IN FEET AND ANKLES; HAVING PROBLEM GETTING OUT OF BED; WEAKNESS IN RIGHT LEG; PAIN SHOOTING DOWN RIGHT LEG/ SHOOTING PAIN FROM HIP DOWN THE RIGHT LEG/ PAIN IN CALF; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, latex allergy, and swallowing problems, and other pre-existing medical conditions included: Patient does not take flu vaccines. Patient was allergic to leviditin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUN-2021, the patient experienced weakness in right leg. On 10-JUN-2021, the patient experienced pain shooting down right leg/ shooting pain from hip down the right leg/ pain in calf. On 07-JUL-2021, the patient experienced having problem getting out of bed. On 21-JUL-2021, the patient experienced bladder issues. On 21-JUL-2021, the patient experienced trouble walking. On 21-JUL-2021, the patient experienced both legs are weak. On 21-JUL-2021, the patient experienced numbness in feet and ankles. On 06-AUG-2021, the patient experienced erecting. Treatment medications (dates unspecified) included: gabapentin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness in right leg, having problem getting out of bed, both legs are weak, numbness in feet and ankles, bladder issues, pain shooting down right leg/ shooting pain from hip down the right leg/ pain in calf, trouble walking, and erecting. This report was non-serious.
R arm pain; decreased range of motion swelling. Chills. Inability to sleep secondary to pain.
Initial information received from a consumer on 27 December 2013. A female patient of unspecified age, whose medical history and concomitant medications were not reported, had received a dose of Flu vaccine from unknown manufacturer (Route, dose number, lot number and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed a big red bump from flu shot. Laboratory investigations and corrective treatment was not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
The patient was admitted for recurrent syncope that began on Friday evening 2/19. He fell twice and struck his head, knocking 2 teeth loose. He continued to feel lightheaded the next day and came to the ED and was admitted for syncope workup. His workup was negative. On discharge, patient recalled that he received his 1st Covid vaccine.  His symptoms resolved after admission. This event was likely related to his vaccination.
Pain; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) 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 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Patient called to report that his arm had swollen, he also experienced back pain, and vomiting the morning following the vaccination. He went to the nurse at his workplace, she advised him to take benadryl and tylenol, which has helped.
Pain in the arm w/vaccine; chills; lightheaded; severe cough with lots of phlegm; lowgrade fever; sluggish; very tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1283, Expiration date was not reported), via an unspecified route of administration, on 25Jan2021 10:00 right arm as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any other medications within 2 weeks of vaccination. Allergies to medications, food, or other products reported as no. Prior to vaccination, the patient diagnosed with COVID-19 reported as unknown. Since the vaccination, patient has not been tested for COVID-19. Patient experienced Pain in the arm w/vaccine, chills and lightheaded on 25Jan2021 12:00. Next few days had a severe cough with lots of phlegm low-grade fever, sluggish, very tired on an unspecified date in 2021. My wife called our Primary and he gave me prescribed cough medicine and antibiotics which I am drinking now. Ironically my wife did not get the vaccine but tested positive for covid on 03Feb. She got very ill on 31Jan. As per the reporter seriousness criteria for the events reported as non-serious. The outcome of the events was unknown.
My son got 6 month vaccine 7/27/18 around 0930 am. Dtap-HBV-POL, HIB PRP-T, PREVNAR 13 on Rt and Lt thigh and start fever on  7/29/18. 7/29 and 7/30 was 102-103 F average and Tylenol given. 7/30 @2030 pm he was 103.8 and Tylenol given again after that it went down and 7/31 @ 0300 am, I found he was exteamly hot and found Tem 106.9 F. I'm a L&d nurse and checked with 2 different thermometer in rectal and it was correct. I gave Tylenol and motrin PO and tub bath given and within hour temp went down to 100 to 99. He was vomiting and has rash on checks, tachypnea. I took him to Dr's office at 7/31 in the morning and Ped did UA and UA culture but it was contaminated.
Information has been received from a health professional concerning a 78 year old female with diabetes, high blood pressure, gastroesophageal reflux disease, arthritis and codeine and sulfonamide allergies who on 18-JUL-2006 was vaccinated with a dose of varicella-zoster virus vaccine.  It was reported that the patient was vaccinated because she had "shingles 3 times a day".  Concomitant therapy included valacyclovir HCL (VALTREX), amlodipine besylate (+) benazepril hydrochloride (LOTREL), amlodipine besylate (NORVASC), nitroglycerin, donepezil hydrochloride (ARICEPT), risperidone (RISPERDAL), fluconazole (DIFLUCAN), tramadol HCL, LANSOPRAZOLE (PREVACID), hydrocodone bitartrate and furosemide (LASIX).  On approximately 21-JUL-2006, "three to four days" after vaccination, the patient experienced nausea and vomiting.  She also felt very weak and her heart rate had been fluctuating.  She was treated with promethazine hydrochloride (PHENERGAN) for nausea and ordered to stay in bed.  On 11-AUG-2006 the patient was seen by the physician, GERD was noted.  Her heart rate was 81 and regular.  She was also given a new prescription of glimepiride (AMARYL) for her diabetes.  The patient thought her stomach problems were related to vaccination, however she stopped her donepezil hydrochloride (ARICEPT) and felt much better.  Subsequently the patient recovered.  Additional information has been requested.
Information has been received from a registered nurse concerning a 34 year old female with no known drug allergies who on 10/28/1997 was vaccinated SC in the left arm with a first dose of varicella vaccine. On 12/08/1997 the pt was vaccinated SC in the left arm with a second dose of varicella vaccine. There was no concomitant medications or illnesses at the time of vaccination. On 06/22/2001, the pt had a serum varicella zoster virus antibody titer drawn which was reported as: negatvie, no antibody detected. Unspecified medical attention was sought. No adverse symptoms were noted. No further info is available.
1/5/21 symptoms began.  She reports swelling, itching, warmth and burning at the injection site and surrounding area.  Patient is still having the same symptoms.
Arm pain in lower left arm; Extreme fatigue; Chills; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 71-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 04Mar2021 at 10:00 (at the age of 71-years old) as a single dose for COVID-19 immunisation. Medical history included asthma, latex allergy and allergic reaction to analgesics (opiates). Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Feb2021, the patient underwent lab tests and procedures which included SARS-CoV-2 (nasal swab) test and the result was negative. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not take any concomitant medications. On 04Mar2021 at 17:00, the patient experienced arm pain in lower left arm, extreme fatigue, chills and was feeling unwell. 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 been tested for COVID-19. The clinical outcome of the events arm pain in lower left arm, extreme fatigue, chills and feeling unwell was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. The vial expired at 4:55 AM this morning. patient received their at least 4 hours past expiration. After each withdrawal the vial was put back in the fridge No treatment details were reported.
Initial information received on 08-Apr-2019 regarding an unsolicited valid serious case received from a Pharmacist. This case involves a male patient (age not reported) who experienced severe anaphylactic shock, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA (expiry date: Oct-2019) via unknown route in unknown administration site. On an unknown date, the patient developed a severe anaphylactic shock couple of weeks ago (Unknown latency) with symptom throat closing up (throat tightness) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These events were assessed as medically significant. Other relevant tests were not reported. Final diagnosis was Severe anaphylactic shock. It was not reported if the patient received a corrective treatment. The outcome was the events was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns a male patient of unknown age who experienced anaphylactic shock with throat closing up after vaccination with MENACTRA. The time to onset is unknown. Further information including patient's medical history of allergies with any product, food, etc, previous vaccination and tolerance, time to onset, allergy testing and laboratory investigations excluding other etiology would be needed to complete assessment of this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Presented  w/ cough X 1 wk and n/v, sore throat w/ abdominal pain and myalgia. Covid+ and pancytopenic w/ elevated LFTs. Tx w/ O2, IV Dexamethasone, Zinc.
One hour after injection client describes breathing difficulty, SOB, Heaviness in chest.  Used rescue inhaler, Albuterol, several times over the next day and an half.  Took Benadryl over same time period.
Muscle pain left arm (Shingrix) within 1 hour;  Malaise and fever developed within 10 hours post-injection (peak fever 100.7; not responsive to acetaminophen); Fever resolved by Thursday morning (24 hours). Malaise persists to present time (3 days post-injection).
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concomitant therapies, pertinent medical history, drug reactions and allergies were not reported. On 16-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N028258 with an expiration date 30-MAY-2019), orally for prophylaxis (dose was not reported). Administered dose of ROTATEQ, was stored in the temperature of 47.8 degrees Fahrenheit for 23 hours and 8 minutes. Previous excursions were not reported. Temperature excursion was detected by digital data logger. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA003002: US-009507513-1812USA003003.
pt recv vax&devel an inj site rxn,characterized by a tennis ball sized welt&swollen leg from hip to ankle;pt was also cranky&feverish;No other info was available as of reporting date
high pitched crying: excessive & inconsolable-bright red cheeks, waking up shaking similar to convuls, disoriented, foggy eyes, wandering, voice change-scowl, less attention span, cough, whites of eyes pink, little eye contact, blisters
I started menstruating again (note, this is only 2 weeks after my previous period)/lasted 7 days - nearly twice my usual period length; It was more than twice my usual flow; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 43 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy to mango from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced normal menstruation on 29Mar. It lasted its usual 3-4 days. A week later, on 07Apr, she had the first dose of the Pfizer vaccine. A week after that, on 13Apr, she started menstruating again, this is only 2 weeks after her previous period. This menstruation was extremely unusual. It started mid-cycle, when she normally is very regular. It was not accompanied by any of the usual PMS symptoms, like sore breasts or fatigue. It was more than twice her usual flow and lasted 7 days which is  nearly twice her usual period length causing menstrual disorder and heavy menstrual bleeding on 13Apr2021 with outcome of unknown. No follow-up attempts are possible; information about Lot/batch number cannot be obtained.
Extreme joint pains; muscle aches; chills; headaches; nausea; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (at the age of 24-year-old), as dose 2, single, for COVID-19 immunisation in hospital. Patient was not pregnant at the time of vaccination. Medical history included vasovagal syncope, chronic migraines, hypersomnia, IBS, exercise induced asthma, depression, anxiety, eating disorder. The allergies included shellfish allergy, pollen allergy and allergic to cats. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]); escitalopram oxalate (LEXAPRO); hydroxyzine; ethinylestradiol, etynodiol diacetate (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) and birth control pill. Historical vaccine included flu shot on 15Jan2021 for immunization and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at the age of 24-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Patient was not diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced extreme joint pains, muscle aches, chills, headaches, and nausea on 21Feb2021. Patient received no treatment due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse event as of yet. this is a report due to patient receiving a 5th dose one month after her 4th dose (not eligible, 5th doses not approved)
I was misinformed by a co-worker that a 3 year old is eligible for a booster shot. I was unaware of the resources that I could use to double check that information and took word for it. The child is under the 5 and was given a Moderna booster. Not Bivalent.
Injection site reaction after receiving PREVNAR. Patinet also received FLUVIRIN in the opposit arm.
This spontaneous report as received from a pharmacist refers to a currently 40 year old male patient with no drug reactions or allergies. The patient's concurrent conditions included: diabetes, hyperlipidemia, hemodialysis. The patient's medical history included brain injury. On 06-JAN-2014 the patient was vaccinated with the first dose of RECOMBIVAX HB (strength: 40mcg/ml, dose:40mcg, administered intramuscular in the left deltoid). One month later, in February 2014, a blood draw was negative for the hepatitis B surface antigen. Patient had blood draws taken since October 2013. On an unspecified date in 2014, the patient received the second dose of dialysis formulation of RECOMBIVAX HB (strength: 40mcg/ml, dose:40mcg, administered intramuscular in the left deltoid, lot# J009218, expiration date 22-MAY-2016). Two days post vaccination (2014), the patient had a venous blood draw and was inadvertently tested for a hepatitis B surface antigen. The result was positive for hepatitis B. The pharmacist stated that had created an issue for the facility because they needed to know if the patient was infectious, and whether the hemodialysis patient therapy should have continued. Pharmacist questioned if the hepatitis b vaccine dialysis formulation RECOMBIVAX HB could cause a false positive result. The outcome of the reported event was unknown. The relatedness between the reported event and therapy with RECOMBIVAX HB was not reported. Additional information has been requested.
December 16 until current extreme chronic urticaria, flushing, with dermatographia.  All is full body. Must take steroids, antihistamines daily. Extreme it h and burning has caused days he can not do regular daily activities
Swelling of left armpit, soft and tender; Swelling of left armpit, soft and tender; Muscle soreness all over; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 10May2021 at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included depression. The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL); both for unknown indications and ethinyl estradiol, norgestimate (ORTHO TRI-CYCLEN) for birth control; and all from unknown dates for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 10May2021 at 11:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10May2021, at 19:00 the patient experienced swelling of left armpit, soft and tender, muscle soreness all over, exhaustion. All were still present after 48+ hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event left armpit, soft and tender, muscle soreness all over, exhaustion were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented to the ED on 4/27/2021. Patient presented to the ED and was subsequently hospitalized on 5/4/2021. These visits were for cellulitis/ulcers. These visits are within 6 weeks of receiving COVID vaccination.
High fevers, trembles, pain throughout the body and this happens 1 to 2 times a week lasting 2 days the discomfort since hours of the first dose
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot# M027882, expiry date: 14-APR-2019 (dose and route of administration were not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008154: US-009507513-1705USA000206: US-009507513-1705USA000205.
This spontaneous report was received from a physician via company representative refers to a 70 year (reported as patient in his early 70's) old male patient. Approximately on an unknown date in 2008 (reported as occurred 5 years ago0, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route not reported). No concomitant medications were reported. Approximately on an unknown date in 2008, the patient experienced shingles on his forehead after being vaccinated with ZOSTAVAX. Treatment rendered for the event was antiviral medication. The outcome of the event shingles on his forehead was unknown. The patient sought medical attention. This is one of the two reports received from the same reporter. Additional information is not expected.