chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to get out of bed; difficulty walking and has been having to use a walker; edema in legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; sever leg pain (muscle and joint pain)/severe pain in her legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; leg swelling/edema in her legs/calf and upper leg are still swollen; This is a spontaneous report received from a contactable consumer (Patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 24Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient's medical history included Diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient had not visited emergency room or physician office due to the event. On 05Apr2021 the patient experienced sever leg pain, Muscle pain, leg swelling, edema in legs while on an unspecified date the patient was unable to get out of bed. On 12Apr2021 the patient experienced difficulty walking and has been having to use a walker. The reporter reported that the patient received both doses at (Redacted). The patient was not provided with any paperwork or information on who to call to report side effects when patient received her vaccine. Patient's husband received the vaccine at the medical center. The patient called the number that was listed on the papers. The reporter reported that patient's left ankle is back to normal in regards to the swelling. Patient's calf and upper leg are still swollen. The patient underwent lab tests and procedures which included Arthritis on an unspecified date. The outcome of the events of Joint pain, Leg pain, Muscle pain, Swelling of legs was recovering while for Movements abnormal was unknown and for Walking difficulty and edema in legs was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient specifically told administering nurse that she was pregnant and needed preservative free, nurse consulted another nurse (not a physician) and told patient it was fine. Spoke w/OBGYN and CDC. Advised to fill out VAERS form. This patient has cystic fibrosis. 11/9/09 Vaccination record received and updated. 12/11/2009 ED records for 11/6/2009, patient 8 weeks PG with c/o's SOB, wheezing, fever, chills, runny nose, myalgias, abdominal cramps and headache. Tx'd with po ABX, DC DX Influenza
one 10/15 the following day in the evening symptoms were swollen arms and legs could barely walk. patient went to the doctor on the 16th he prescribed Predinisone 20 mg
swelling on his face; rash on the left and right sides of his face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on his face) and RASH (rash on the left and right sides of his face) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SWELLING FACE (swelling on his face) and RASH (rash on the left and right sides of his face). At the time of the report, SWELLING FACE (swelling on his face) and RASH (rash on the left and right sides of his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications provided No relevant treatment information provided
No additional adverse effects; One male patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a vaccine coordinator, concerning a 7 months-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 27-FEB-2020, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (product storage error) (lot number 1658255 has been verified to be a valid number; expiration date reported and validated as 07-FEB-2021) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The reporter stated that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius.  On 02-MAR-2020, the temperature was 0.8 degrees Celsius for a time frame of 5 hours and 9 minutes, on 04-MAR-2020, the temperature was 0.9 degrees Celsius for 11 hours; and on 05-MAR-2020, the temperature was minus 1.3 degrees Celsius for 9 hours and 29 minutes as recorded by the data logger .   Other temperature excursions occurred on 25-FEB-2020 and the temperature was above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours and 33 minutes and on 03-MAR-2020, the temperature was below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours and 39 minutes, also recorded by the data logger.   No adverse effects were reported.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA006325: US-009507513- 2003USA006305:
After 2 days (approximately 44-46hr of vaccine) I noticed a triangular red rash below the injection sight.   it is **NOT** a raised rash.  On day 3 the rash became very occasionally itchy;  this is when I reported the reaction.  I take 10mg zyrtec daily, but have added the hydroxyzine (hydroxyzine normally is taken when I have physical itchy reactions to allergies such as pollen or animals).   In the late evening on day 3 of vaccine I applied a small amount of hydrocortisone cream topically onto the rash
This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-APR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
SVT - I woke up with a very rapid heartbeat, over 130.  Waited for it to subside but it didn't.  My husband drove me to Hospital ER, about 20 minutes away, where my heart rate had lowered to 125 while waiting and then to the 90s in the exam room.   I had not been to an emergency room in over 20 years.  After test results came back and several hours of observation I was instructed to set up a follow up appt with a cardiologist, which I did
Deltoid tenderness; This case was reported by a nurse and described the occurrence of tenderness muscle in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 1st June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Bexsero (intramuscular) 1 dosage form(s) and Bexsero Pre-Filled Syringe Device. In October 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tenderness muscle. On an unknown date, the outcome of the tenderness muscle was not recovered/not resolved.   It was unknown if the reporter considered the tenderness muscle to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Bexsero in the right deltoid. After vaccination with Bexsero, the patient still experienced tenderness in his arm. The reporter was the health care professional therefore did not asked for consent from patient.
Red, erythemic skin rash on left deltoid. Roughly 2 inches in diameter. The rash appeared one week after injection at the injection site. Rash was hot to the touch, itchy, and tender. No other symptoms were present.
Soreness in the injection site, nothing else. Pfizer-BioNTech COVID-19 Vaccine EUA.
Pt delivered 29DEC89 & recvd dose of Rubella vax @ Hosp prior to discharge; approx 30DEC89
Since February, I feel nauseous all day (I do not throw up), I can eat very little, many times a day and lost weight. My weight before the vaccine was 116 lbs, now it is 110 lbs. I am of a small frame, 5 ft. At the time, I was unable to contact my physician to report the problems before I receive the second dose that was scheduled on March 10, 2021, due to death in his family. I wrote to the Physicians who were communicating with me about my appointment and reported the above symptoms. An Administrative Assistant responded that these symptoms are not known to be associated with the vaccine.On March 16, 2021 I was able to get an appointment and on that date he did a series of blood tests. The blood tests
evening of 23MAY96 lt upper arm to elbow swollen, red, hard, & hot;no tx given;s/s subsided-saw MD @ urgent care 25MAY;no tx ordered;MD concerned about potential allerg rxn;on date of report 29MAy, no sx remain;
Swelling and redness on left side of face in distribution of ophthalmic branch of trigeminal nerve.
sore arm; arm swelling; redness at injection site; itching at injection site; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm, swelling arm, injection site erythema and injection site itching. On an unknown date, the outcome of the pain in arm, swelling arm, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, injection site erythema and injection site itching to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced sore arm when he/she moved it ,arm swelling, redness and itching at injection site. The patient reported that his/her second shot in 3 months. The follow-up would not possible as no contact details were available.
FACE STARTED FLAKING; RASH ON ONE SIDE OF NECK; HAIR LOSS (FALL OUT IN CLUMPS); FELT SICK; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hospitalization, and pneumonia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 13:30 for prophylactic vaccination. Non-company suspect drugs included: salicylic acid (cream, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative for 3 times. On 30-MAR-2021, the patient experienced felt sick. On 06-APR-2021, the patient experienced hair loss (fall out in clumps). On an unspecified date, the patient experienced face started flaking, and rash on one side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with salicylic acid was not reported. The patient recovered from felt sick on 31-MAR-2021, was recovering from hair loss (fall out in clumps), and the outcome of rash on one side of neck and face started flaking was not reported. This report was non-serious.
CHILLS; SORE ARM; SLIGHT HEADACHE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, sore arm and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and slight headache. This report was non-serious.
Post vax, pt developed seizure in February, followed by leg swelling, hand swelling, paranoia, hallucinations, thought disorder. Some paranoia occurred prior to seizure. Still takes anti-psychotic medications. Doc 178795 received on 12/07/2000 states the following: Please contact Health Department for missing infos.
No adverse symptoms; the patient stated that he is "50 year old" and received "the first dose GARDASIL 9 today."; This spontaneous report was received from a 50 year old male patient refers to himself. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 09-JAN-2020, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, lot#, expiry date, dose, route of administration and anatomical location were not reported) (product administered to patient of inappropriate age). No adverse symptoms were reported. The outcome of product administered to patient of inappropriate age was unknown. No product quality complaint (PQC) was involved with this report.
Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.
flu like symptoms; body ache; nausea; fatigue; head ache; high fever of 103 to 104 Degrees Farenheight; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache) and HEADACHE (head ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache), HEADACHE (head ache) and PYREXIA (high fever of 103 to 104 Degrees Farenheight). On 20-Mar-2021, NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache), HEADACHE (head ache) and PYREXIA (high fever of 103 to 104 Degrees Farenheight) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Constitutional symptoms with fatigue, anorexia, weight loss, fever. Mesenteric Panniculitis. Polyradiculopathy.
PCR, covid test result - Positive, date 12Oct2021; PCR, covid test result - Positive, date 12Oct2021; Patient received 1st dose and 2nd dose on same day (09Apr2021); This is a spontaneous report from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ep6955) via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 09:00 (Age at vaccination was 47-years-old) DOSE 2, SINGLE and DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. On 09Apr2021, patient received 1st dose and 2nd dose on same day (09apr2021) (inappropriate schedule of product administration). on 08Oct2021, the patient experianced loss of smell and taste and eye irritation. on 12oct2021, the patient experienced pcr, covid test result - positive (drug ineffective) and Covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: result was positive on 12Oct2021 (Nasal Swab). Patient did not received any treatment. The outcome of loss of smell and taste and eye irritation was recovering and for remaining events unknown.
Patient endorsed throat tightness after vaccine administered. At  time of evaluation, she states it resolved after drinking some water and getting some fresh air. Pt observed for 30 mins and discharged home
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 11-FEB-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 24 hours with a lowest temperature recorded as -1 degree C; other for a sum of 48 hours with a lowest temperature recorded as 1 degree C and the last one for a sum of 72 hours with a highest temperature recorded as 9 degree C. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Seriousness Criteria other medically significant (OMIC). Initial case received from a health care professional on 10/31/2005. A fifteen year old female patient with no pre existing medical conditions received an intramuscular left deltoid injection of Menactra, lot number U1808AA on Sept 27 2005.Twenty four days later, she experienced confusion, memory loss and was very tired. Per the reporter, the patient had been an A student and was not failing test and could not remember the number of days in a year. The patient was examined by a physician and found to have no weakness and her neurologic exam was within normal limits. A CT scan was also normal. She was scheduled for an EEG and an MRI. At the time of this report, the recovery status was not reported. Follow up information received on 12/19/2005 from the responsible physician. Based upon the new information provided, this case is being upgraded to serious. It was reported that the patient was diagnosed with meningoencephalitis. A spinal tap and MRI was completed, but no results were provided. At the time of this report the patient had not recovered from the events.
Information has been received from a health professional concerning a 22 year old white female student who on 30-JUL-2007 at 3:30 pm, was vaccinated IM, in the left deltoid with a second dose of Gardasil (lot # 657868/0523U). On 30-JUL-2007 the patient "appeared to have a seizure." Unspecified medical attention was sought. On 30-JUL-2007, the patient recovered from seizure. Upon internal review, a seizure was considered to be an other important medical event. Additional information is not expected.
Immediate thumb print above injection sight, increasing redness over first 24 hours 6x7cm.
Information has been received from a medical assistant concerning an 18 year old female with allergies and pertinent medical history reported as none, who on 18-MAR-2008 was vaccinated with the first dose of GARDASIL (lot # 659055/1522U), 0.5ml, IM to the left arm and no reaction developed. Concomitant therapy included YAZ. On 13-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (lot # 659182/1957U, 0.5ml, IM to the left arm). Following vaccination, the patient was observed for 15 minutes and no reaction was experienced. Per the patient's mother who is a nurse, a rash developed three hours afterwards. The rash started at the injection site, spread to the right arm, the patient's stomach and face, the patient took BENADRYL. The next morning, 14-MAY-2008, the patient's rash resolved and the patient's mother telephoned the doctor's office to report the event. No product quality complaint was involved. Additional information has been requested.
Local erythema and inflammation over the inject site and induration approx 5 x 5 cm. Increased tenderness. Negative pruritus.