chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid Arthritis; has received the vaccinations has joint pain; This is a spontaneous report from a Pfizer sponsored Regulatory Authority support. A consumer (patient's father) reported for a female patient (reporter's oldest daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller reported that, his oldest daughter, one who has received the vaccinations has joint pain, however he was uncertain if this joint pain was before or after receiving the injections. He was trying to call her during the INT but was not successful and stated he will call back to provide more clarity. He stated that she was having a lot of joint pain and they have diagnosed her with Rheumatoid Arthritis and the caller was unsure if it may had been vaccine related. The outcome of the event has received the vaccinations has joint pain was not resolved. The outcome of the event rheumatoid arthritis was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt had high pitched screaming 3-4 hrs the afternoon p/receiving vax;
Couldn't do anything and it was really weird; Vaccine had "knocked him out; Couldn't stand up and couldn't get out of his chair; Sore spot; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Couldn't stand up and couldn't get out of his chair), FEELING ABNORMAL (Couldn't do anything and it was really weird), VACCINATION SITE DISCOMFORT (Vaccine had "knocked him out) and VACCINATION SITE PAIN (Sore spot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.   Previously administered products included for Product used for unknown indication: Flu, Pneumonia and Shingles. Concurrent medical conditions included Multiple sclerosis (He had a lift chair to help him get up. He went in every 6 weeks for an infusion for his multiple sclerosis.), Blood pressure high and High cholesterol.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore spot). On 14-Mar-2021, the patient experienced DYSSTASIA (Couldn't stand up and couldn't get out of his chair). On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Couldn't do anything and it was really weird) and VACCINATION SITE DISCOMFORT (Vaccine had "knocked him out). On 15-Mar-2021, DYSSTASIA (Couldn't stand up and couldn't get out of his chair) had resolved. On 16-Mar-2021, FEELING ABNORMAL (Couldn't do anything and it was really weird), VACCINATION SITE DISCOMFORT (Vaccine had "knocked him out) and VACCINATION SITE PAIN (Sore spot) had resolved.   Relevant concomitant medications included medications for multiple sclerosis, high blood pressure and high cholesterol. The patient went in every 6 weeks for an infusion for his Multiple Sclerosis.  No treatment information was provided.   This case was linked to MOD-2021-219961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information contain information regarding start and stop date of event could not stand up and could not get out of his chair.
Patient had vaccine administered at 6PM. Noticed a red circle and slight swelling at 10AM the following morning. Red circle was quarter-sized when first noticed and has since grown to 4.5 inches wide and is warm and mildly itchy and sore 2 days later (48 hours).
While conducting a mobile vaccination clinic for workers , patient came to the clinic for her 1st dose of the Moderna Vaccine. She received the vaccine at 15:10 hours and proceeded to the 15 minute waiting area where she was observed with no complaints and or reactions at that time. The patient then proceeded back to work in the cold storage area of the packing shed. at about 16:15 we received a call that there was female who was not feeling well. she was brought back to the vaccination area, where she stated that she had a severe headache, numbness to both arms and had emesis one time. patient vital signs were BP 124/78, pulse normal sinus rhythm at 73 beat per minute, oxygen saturation 99% at room air, glucometer reading of 101, respirations 16 non labored. Patient states that the headache is an 8 on a scale form 1-10 and denies having felt bad at all in the last week. patient was transport to ER.
disseminated herpes zoster started on Nov 24th and progressed to ear dermatome.  was hospitalized and received IV acyclovir
PT RECVD 1 INJECT OF ENGERIX-B AND EXPERIENCED ACHING ALL OVER, GENERAL MALAISE, NAUSEA, LOW GRADE TEMP AND HEADACHE ON 2-22-90. EVENTS CLEARED ON 2-24-90. SYMPTOMS STOPPED ON OWN.
arm pain; like balls (injection site); bruising on her arm at the injection site; redness; body aches/ very bad, the pain is unbearable; unbearable headache; fever over 100°F; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE ABSCESS (like balls (injection site)), VACCINATION SITE BRUISING (bruising on her arm at the injection site), VACCINATION SITE ERYTHEMA (redness) and MYALGIA (body aches/ very bad, the pain is unbearable) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE ABSCESS (like balls (injection site)), VACCINATION SITE BRUISING (bruising on her arm at the injection site), VACCINATION SITE ERYTHEMA (redness), MYALGIA (body aches/ very bad, the pain is unbearable), HEADACHE (unbearable headache), PYREXIA (fever over 100°F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE ABSCESS (like balls (injection site)), VACCINATION SITE BRUISING (bruising on her arm at the injection site), VACCINATION SITE ERYTHEMA (redness), MYALGIA (body aches/ very bad, the pain is unbearable), HEADACHE (unbearable headache), PYREXIA (fever over 100°F) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 100 (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Unable to walk, weakness in legs, high fevers 104 on going for 3 days, sweating, cold shaking chills, neck pain, jaw pain, intense headaches, ear pain went to pcp, said would be better in a couple days, next day was worst, went to ER. treated with Soidum Cloride 0.9 1000mL IV ketorlac 15mg IV push sodium phosphate 1000 mg by mouth was dehydated from sweating HIGH  FEAVER for so many days,  this day 6/26/2017 and is still dealing with this health issue don"t know were to go for help with my condition. DR. and hospital havven't really helped.
On 7th day after receiving MMR had prolonged seizure lasting 45 min. Admitted to PICU diagnosed as Complex Febrile seizure.
One day after vaccination the area became swollen and red then resolved within 48 hours completely then returned again 7 days post vaccination with larger, red, hot , itchy area
Foggy eyesight; Sore throat; Swollen throat; Dry Mouth; Swollen face; Fever; Extreme joint pain; 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 right upper arm on 01May2021 at 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 14:00, the patient experienced foggy eyesight, fever, dry mouth, extreme joint pain, sore throat, swollen face and throat. The clinical outcomes of the events foggy eyesight, fever, dry mouth, extreme joint pain, swollen face and throat, and sore throat were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
little Sore Arm; A little Temperature (After the First Shot); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little Sore Arm) and BODY TEMPERATURE INCREASED (A little Temperature (After the First Shot)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (A little Temperature (After the First Shot)). On an unknown date, the patient experienced PAIN IN EXTREMITY (little Sore Arm). On 17-Mar-2021, BODY TEMPERATURE INCREASED (A little Temperature (After the First Shot)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-086570 (Patient Link).
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pneumovax L deltoid 11/5/02. 11/6/02 afternoon injection site hot, swollen-myalgia, cold, headache-continued spread redness swelling warmth L upper arm. Exam 11/8/02 6" area L upper arm.
Patient stated that: her arms were red the day of the injections and she did not feel well. On 4/23/2018 the patient stated that she experienced slurred speech and could not hold onto things (she said she dropped two coffee cups). She called her doctor and told them who thought she was having a stroke and told her to go to the hospital. There she had low BP, but no other signs of stroke. Her arms were more red and swollen at this time. The doctor informed her she was having an allergic reaction.
Pain very unbearable/pain wont go away ever since Day 1; Severe muscle ache left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain very unbearable/pain wont go away ever since Day 1) and MYALGIA (Severe muscle ache left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 010M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Severe muscle ache left arm). On an unknown date, the patient experienced PAIN (Pain very unbearable/pain wont go away ever since Day 1). At the time of the report, PAIN (Pain very unbearable/pain wont go away ever since Day 1) outcome was unknown and MYALGIA (Severe muscle ache left arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product information was not provided. Treatment information was not provided. Patient had hold his arm close to chest just to relieve the pain.
PATIENT CAME IN FOR A COVID PRIMARY SECOND DOSE MONOVALENT AND RECEIVED BIVALENT VACCINE BY MISTAKE. PATIENT DIDN'T STATE ANY ADVERSE SYMPTOMS AND CAME BACK IN THE NEXT DAY TO FOLLOW UP ON THE INCIDENT AND ALSO DIDN'T STATE ANY ADVERSE SYMPTOMS. WE HAD CALLED PFIZER AND CDC TO VERIFY OUR NEXT STEPS AND THEY RECOMMENDED NOT NEEDING TO BE REVACCINATED AND BIVALENT CAN COUNT AS A FULL 30 MCG DOSE AND TO CONTINUE REGULAR VACCINE SCHEDULE.
cellulitis . day of vasccination normal reaction, patient very red and itchy , white bumps on friday morning. diagnosed by pcp w/ cellulitis on 8/31/20, hot upper arm,patient had no fever however.
Patient received the SHINGRIX vaccine during a routine visit. Patient's wife later reported the patient was "incoherent, lightheaded, blood pressure dropped. He was hospitalized for thirty hours and taken off of his blood pressure pill until his blood pressure came back up." adverse event was the same day as vaccination day.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Rash/Hives, Chest pain, Sweating, shortness of breath, headache and nausea. Patient went to PCP and was given Prednisone, Benadryl and other lab tests performed to evaluate status of patient. Patient is home and was only seen at PCP outpatient clinic
Information has been received from a physician concerning a 12 month old patient who in August 2006 was vaccinated with Varicella Zoster vaccine instead of a dose of MMR/V vaccine. The patient showed no symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information was received on 28 Sep 2006from the nurse at the physician's office who indicated that on 22 Aug 2006, the 12 month old child was inadvertently vaccinated with a dose of Varicella Zoster vaccine instead a dose of Varicella vaccine. The child had not had any reported AE. The nurse was asked if anything in particular caused the product confusion and she reported absolutely, it was the caps on the vaccines as they are both teal colored. The boxes are exactly the same and although the labels have the product names on them, it was very easy to make a mistake primarily because of the color of the caps. She reported that the office has implemented changes in their procedures and all of the same vaccines are kept in large bins and the bins are clearly marked with the correct product name. Additional information has been requested.
Pt received the vaccine at 3:30pm. Reaction started at 3:31pm. Itchiness and burning to top of hands, head. BP 173/101, 99%, pulse 128,  resp 20.
pt recv vax 19JUL97 & approx 25JUL97 lab eval revealed a negative varicella IGG test;
This morning Friday 1/8/21  pt was given injection at 0912. At about 0930 pt C/O diaphoresis, lightheadness. Water was offered. BP taken  manually in 80s. 911 was called. Pt  suffering substernal pain. A/OX4 no fainting.  Paramedics arrived at 0940, assessed pt and EKG performed. Paramedics encouraged for pt to go to her  hospital, Pt declined and exited clinic on her own.
dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided
When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic; once his arm stopped working after; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic) and LIMB DEFORMITY (once his arm stopped working after) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic) and LIMB DEFORMITY (once his arm stopped working after). At the time of the report, IMMUNISATION REACTION (When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic) and LIMB DEFORMITY (once his arm stopped working after) outcome was unknown.      No concomitant drug information was provided.  It was reported that the patient would no longer get the vaccine and made this correlation when patient's arm stopped working.  No treatment medication information was provided.   This case was linked to MOD-2023-695950 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, she was treated for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Overall weakness, headache, upset stomach, itching rash on inside of both arms from wrists to elbows. Worse the next day, then light headedness for about 3 weeks. Still feels weak and unable to resume normal activities. Called doctor on second day after becoming ill. Took Zertec for itching. Went to see doctor 10/03/2016.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756552A, A0756554A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Hepatitis A vaccine given too early. Due on 9/13/18, given on 8/28/18. No negative outcomes known at this time. Patient does not report any problems immediately after administration.
2:15pm Post vaccination reports "left arm hurts" and "feeling anxious";  Medical monitoring x 30 min, rest w/no additional complaints or associated symptoms; "feeling better" Released home.
Rapid-onset severe diarrhea within four hours of second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 07:30 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Major depression" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 Immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 25Mar2021 11:00, outcome "recovering", described as "Rapid-onset severe diarrhea within four hours of second dose". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.