chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So intense I couldn't walk; I began having pain in both my knees. It gradually got worse; I began having pain in both my knees; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (So intense I couldn't walk), CONDITION AGGRAVATED (I began having pain in both my knees. It gradually got worse) and ARTHRALGIA (I began having pain in both my knees) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced GAIT INABILITY (So intense I couldn't walk), CONDITION AGGRAVATED (I began having pain in both my knees. It gradually got worse) and ARTHRALGIA (I began having pain in both my knees). At the time of the report, GAIT INABILITY (So intense I couldn't walk), CONDITION AGGRAVATED (I began having pain in both my knees. It gradually got worse) and ARTHRALGIA (I began having pain in both my knees) outcome was unknown.            No concomitant medications was reported. Treatment medications was not provided.
Patient given second dose of ZOSTAVAX. Initially vaccinated on 5/14/2012. Patient had requested PREVNAR at the time. No adverse reaction reported.
Severe local reaction over deltoid extending 10x25cm with warmth and erythema.  Pt. instructed by Dr. to take Aleve 2 tablets 3 times per day until symptoms subside.  Telephone follow up scheduled for Monday, July 12, 2010.
unable to stand; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (unable to stand) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. COMD19 and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis. Concurrent medical conditions included Hypertension and Food allergy (Allergic to iodine). Concomitant products included METOPROLOL and LISINOPRIL for Hypertension, PYRIDOSTIGMINE BROMIDE (MESTINON) and PREDNISONE for Myasthenia gravis, AMLODIPINE, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) and LORAZEPAM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DYSSTASIA (unable to stand). On 12-Feb-2021, DYSSTASIA (unable to stand) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up received 20JUL 2021and concomitant medication were updated, patient demographics and medical history updated.
c/o lymphadenopathy left subclavian and axilla started 1 week after injection, lasted 2 weeks
I have rashes just formed today underneath the armpit and next the groin area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Lot number: FF2587) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety; "Depression" (unspecified if ongoing), notes: Verbatim: Depression. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 04Oct2021, outcome "unknown", described as "I have rashes just formed today underneath the armpit and next the groin area".  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
stroke; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported an employee of (institute name) suffered a stroke within a week of taking the Pfizer Covid Vaccine on an unknown date. Dr. (Name) told the physician that he didn't think it was related. The event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Very limited information is currently available.  As the reported stroke occurred within a week of taking the Covid Vaccine, BNT162B2, the Company cannot completely exclude the possible causality between the reported event and the administration of the suspect.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Pt was administered HPV9 in arm lt. About 5 mins after vaccine given pt was moved to a chair in the hallway..two minutes later pt tensed up and seemed to loose consciousness for about 30 seconds. Pt then opened eyes and appeared pale. Pt started vomiting. Pt vitals taken BP 90/52 HR 68 Spo2 100%. Pt moved to rm 14. Pt laid down & given water. Pt continued to vomit. BP taken about 10 mins later
pt recv vax; papular area on face then feet; mild pruritis;c/o myalgias, bilaterally b/w elbow & shoulder; T approx 100 w/ apap; d started, n & cont to break out;
Pt describes symptoms as occurring after 3rd Gardasil injection.  Also received meningococcal vaccine on same day. Symptoms include headache, dizziness, URI symptoms, goggy feeling, malaise for 7 days.  Improved for 3 days then symptoms reoccurred.  Vaccines administered on July 2, 2008.  Outpatient clinic visit on 15 July.
Thursday day of vaccine no problems.  Friday around 8 pm she was having itching at the vaccine site and noticed the arm was swollen "about softball" size.  Now, on Monday (22nd) she states her right arm from her elbow to her shoulder is swollen, red, and has some heat.
Immediately after receiving the vaccine, she was seated in the pharmacy, where myself and another person witnessed her eyes roll back, body slump forward, then legs at the knee flew up into the air twice.  Then upper body stiffened at shoulders, entire upper body made several flailing movememts to the right.  Upon standing over her calling her name she then began to respond. She was then brought an ice pack, a granola or protien bar, a chocolate bar and some water.  She was asked questions by the Pharmacist and was a little confused with some of the questions but began to improve.  She was followed up at the Emergency Room.
On March 11, 2019 at 3:15 pm, I had an appointment to have the first in a series of two MMR vaccines administered.  I waited a while, so I'm estimating the time of the injection to have been 3:45 pm that day.  A gentleman took me to a room and injected the MMR in my left arm since I'm right-handed.  I was given no paperwork as to side effects or any other information regarding to take home.  On April 7th, I was rubbing the sight of the injection and found a quarter-sized lump under my skin.  I emailed Dr., my primary care physician.  She had employee from that location message me with the details of the immunizations as follows:  MMR Vaccine  Expiration: 10/2/2020 Lot:R028225 Manufacturer: Merck Sharp & Dohme NDC: 0006-4681-01   Diluent (which is used to reconstitute the MMR)  Lot: R033667  Expiration: 6/14/2021 NDC: 0006-4309-01
Dizziness, Headache, Syncope, Tachycardia, "in and of unconsciousness" felt very dizzy and lightheaded Narrative:  Called EMS and taken to local emergency room. Given IV fluids, medications, lab test, CT of head and EKG. Discharged with a dramamine patch behind ear  Other Relevant History:
GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired  Normal activities affected
Information has been received from a licensed practical nurse concerning two patients who on 16-FEB-2009 was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (Lot # 661994/1390X). The nurse reported that after vaccination the patients developed injection site reactions. The patients sought medical attention went to the office. At the time of reporting the patients were recovering. This is one of two cases received from the same source. Additional information has been requested.
BODY IS IN PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body is in pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body is in pain was not reported. This report was non-serious.
Acute pericarditis--presented with pleuritic back/chest pain 1 week after her Moderna booster, found to have a pericardial friction rub on exam along with characteristic ECG changes (PR elevation in aVR w/ diffuse PR depressions elsewhere) and elevated inflammatory markers. She is being treated with high dose ibuprofen and colchicine.
Rash x4 day ago/ H1N1 given 8 days ago. Temp. 97.9, rash on trunk and extremities. BENADRYL x1 wk.
pt recv vax 4APR97 & 23APR97 pt devel swelling of the inguinal node on the lt side, proximal to the inj site;it was noted maximum size 2.7cm;
Just after receiving vaccine, subject fainted for approximately 30-40 seconds.  Describes feeling light headed with tunnel vision.  Eye open entire time, rolled back.
The day of the 9th, I started having chills and body aches in the evening and that went through the weekend. I slept a lot and had fatigue. I didn't have any other symptoms. Monday morning, the 12th, I woke up at 04:00 am with rigors. I knew something was wrong. Shaking chills so bad that your teeth are going. I went ER - a friend took me. My fever went up to 102.9 after I got to ER.  I had a bag and 1/2 of fluids with antibiotic - Rocephin. After I went home, the next day, a doctor from Kaiser called me to be admitted to hospital because my blood cultures showed bacteria - so I went back to the same ER Hospital within 24 hours. The second time, the RN asked me why I was there because I looked good. They worked me up again with tests and they did blood cultures again and started me on the IV again. The doctor came in and said that I didn't get need to come in again because the new doctor had made a mistake. He said there wasn't enough bacteria in there to be re-admitted since I had already had the Rocephin. They gave me another dose though of it and IV fluids - and I was out again after that. I didn't have any problems after that. I had a follow doctor appt a week later - on the April 21st, 2021 and that was an in office visit and then I talked to her on the phone on the 29th.
Mild symptoms of left arm soreness, body aches and headache began Friday, October 22nd , 2021 in the morning. These symptoms continued until Tuesday, October 26th , 2021 at 7pm when  a fever, chills, headache (not migrainous), PE symptoms including shallow, painful breathing and stabbing pain in right chest radiating to back, began. This was followed by a trip to the Emergency Department on Wednesday, October 27th, 2021 at 8:30am which led to hospitalization, Heparin injections, and Xarelto treatments following release from hospital on Friday, October 29th, 2021 at noon.
Tingling towards extremity (distal) left arm. BPs 149/86 (pulse 96), 147/88 (pulse 89). O2 sat 99%-100%.
Localized reaction at injection site on left arm extending 3 to 4 inches from site.  The reaction began that night and continued into the next day.  It was treated with benadryl and the symptoms resolved.
Info has been received from a physician concerning a 3 to 4 year old pt who was vaccinated with a dose of varicella virus vaccine live. On 2/15/05, the pt experienced breakthrough varicella of about 10 or 12 lesions. Subsequently, the pt recovered. The report indicates no treatment. Unspecified medical treatment was sought. No product quality complaint was involved. Additional info has been requested.
Hard red area very painful and warm Thursday.  Friday was severe pain in arm, headache,nausea,extremely fatigued.  Red area on arm still hard and warm and increasing in size.  Saturday was extreme fatigue and unable to perform and task.  Extreme nausea to the point of not movie and unable to eat.  size on arm doubled in size.    It was very red, hard and painful.  Sunday size increased in redness but hardness was much improved.  Still very warm and sore.
Pt complained of throat-closing, itchy, red eyes, and coughing 5 hours after flu shot admnistered. Took Benadryl and all symptoms went away.
Heart is hurting me,squeezing pain; She can't breathe, it is difficult to breathe, painful breathing sometimes; painful breathing sometimes; Whole left side is painful and hurting; Can't move the arm,can't put her hand up; Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart is hurting me,squeezing pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Heart is hurting me,squeezing pain) (seriousness criterion medically significant), DYSPNOEA (She can't breathe, it is difficult to breathe, painful breathing sometimes), PAINFUL RESPIRATION (painful breathing sometimes), PAIN (Whole left side is painful and hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm,can't put her hand up) and VACCINATION SITE PAIN (Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp). At the time of the report, ANGINA PECTORIS (Heart is hurting me,squeezing pain), DYSPNOEA (She can't breathe, it is difficult to breathe, painful breathing sometimes), PAINFUL RESPIRATION (painful breathing sometimes), PAIN (Whole left side is painful and hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm,can't put her hand up) and VACCINATION SITE PAIN (Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not want to answer any more questions regarding cardiac related signs and symptoms specifically for the myocarditis and pericarditis. The patient stated that she started noticing it 4 days ago on 22Oct2021. No additional information was obtained.  Company Comment: This case concerns a 29 year-old female patient with no reported medical history, who experienced the unexpected serious event of Angina pectoris. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 29 year-old female patient with no reported medical history, who experienced the unexpected serious event of Angina pectoris. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
chills; nausea; fever; headache; itchiness; rash; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and RASH (rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     ethnicity: Not Hispanic or Latino.  The patient's past medical history included Type 2 diabetes mellitus in August 2006. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure high, SIMVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 02-Nov-2011, the patient experienced RASH (rash). On 02-Nov-2020, the patient experienced PRURITUS (itchiness). On 03-Mar-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache). On 18-Feb-2021, RASH (rash) and PRURITUS (itchiness) had resolved. On 05-Mar-2021, CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant list is provided. No treatment is given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No information is provided in the attached document of the additional information. On 29-Apr-2021: Additional info-2 On 03-May-2021: No specific follow-up information recorded.
flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who got flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 18-Jul-2016, the patient was vaccinated with improperly stored dose of VARIVAX lot # L011082, expiration date reported as 01-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 7 degrees Fahrenheit for 5 hours 48 minutes. Data logger was involved. There were no previous excursion reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received the Shingrix followed immediately by the Pneumovax23 and remained seated for a few minutes after the shot while waiting for her husband to receive the same injections. After about 5 minutes she looked red in the face stated that she felt hot with a weird taste in her mouth and that she felt really bad and nauseous and dizzy. She also complained of severe backpain. EMS was called in to assist and evaluate the patient.
indication treatment of COVID-19; indication treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK9231), on 13Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 01Oct2021 as dose 3 (booster) single (Lot number: FE3592) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "prolactinoma" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: CABERGOLINE oral, start date: 01Feb2022; XYZAL oral, start date: 01Jan2017; COMBIGAN ophthalmic, start date: 01Jan2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "indication treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) positive again, notes: 10 days after finishing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient had no known allergies. COVID 19 was treated with PAXLOVID (Lot no: FY5657) oral, on 24Apr2022 and treatment was stopped on 28Apr2022. Other medication in 2weeks were CABERGOLINE, XYZAL and COMBIGAN. Patient experienced mild sore throat and tested positive again for COVID-19 on 08May2022 for which no treatment was provided (10 days after finishing PAXLOVID treatment).  No follow-up attempts are required: No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
5/27/05 0930 vaccine received. 1000 Increased SOB and tight chest. 1030 ER and medicated.
About 2 weeks afterwards I started having abdominal and chest pain. It got to where I couldn't walk, so I went to the doctor. I was diagnosed on March 30th with a pulmonary embolism.  I was given blood thinners. I have been on blood thinners since then. I will know after 6 months if I need to continue taking them. They checked my back to make sure there weren't any back problems because of my back pain but they didn't find anything.