chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; The last 3 weeks it had gotten progressively worse/ progressed to not pleasant; Had minor muscle pain.; The injection site was sore; joint pain throughout his body, especially in his hands and wrists, and that they almost feel arthritic; This is a spontaneous report from a contactable consumer. A 58-years-old male consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182) via an unspecified route of administration on 18May2021 in right arm as dose 2, single for COVID-19 immunization. The patient medical history (including any illness at time of vaccination), prior vaccinations received within 4 weeks, adverse events following prior vaccinations, family medical history relevant to adverse events, additional vaccines administered on same date of the Pfizer suspect and concomitant medications were reported as none. This report was not related to a study or programme. Investigation assessment was not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number: ER8735; expiry date and NDC number was unknown) on 27Apr2021 in afternoon around 13:30 or 14:00 in right arm for COVID-19 immunization and experienced myalgia, joint noise, loss of personal independence in daily activities, joint swelling, hand deformity, pain in extremity and peripheral swelling. The patient reported that within a week after the second dose injection site was sore, and he had aches. It progressed worse over the next 2 to 3 weeks. He also had minor muscle pain five weeks ago and had progressed to not pleasant. He experienced joint pain throughout his body, especially in his hands and wrists, it was almost arthritic feeling. He did not require emergency room and physician office visit. He wanted to know how long the effects had lasted with others that reported similar effects. He asked if it's common, and if it was, he might wait a little longer to see his HCP. He stated that he had not gone to the doctor or ER as it would be a waste of time because if there was a .0001 percent chance of a reaction, he doesn't want unneeded tests and procedures. He thought the events would go away. He stated that if events went on for 6 to 8 weeks, he would probably get into his doctor. He did not like running to the doctor. He said that if he cut off his leg, he would probably not go for 3 days, he did not like the process. He had been negligent, and his symptoms were not getting any better, they were getting worse. He reported that all of his family had been vaccinated with no issues at all. Relevant tests were reported as none. The outcome of all the events was not resolved.   Information on Lot/Batch number was available. Additional information has been requested.
I was asked by RN to confirm patient expected death following recent intubation earlier today. He was noted to be a no CPR in the event his heart did stop.    Patient's wife, sister and two sons were present during death pronouncement assessment.    Patient identify confirmed by wrist band. Patient in bed, eyes closed with no signs of life. Unresponsive to verbal and noxious stimuli. Pupils are fixed and dilated. No heart sounds were auscultated. No carotid pulse palpated. No spontaneous respirations are noted or breath sounds auscultated. Asystolic on telemetry.    Pronounced deceased at 1047
Information has been received on 26-MAY-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 15-DEC-2014 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient has been prescribed valacyclovir (VALTREX) and  methylprednisolone acetate (DEPO-MEDROL) injections for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Pt recv vax on 8/17/98; on 8/27/98 pt exp 7 mins seizure.  Pt hosp for 1 night.  Tests taken.  Pt tx=Dilantin(50 mg a day) for a while.  Pt doing well as of 8/31/98.  Pt will f/u with Dr.
Fibromyalgia; Hair Broke was ruined; fingernails ruined; Joint pain in shoulders Knees; First shot. Jan- second Feb; This case was reported by a consumer via interactive digital media and described the occurrence of fibromyalgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   In February 2022, the patient received the 2nd dose of Shingles vaccine. In February 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On 15th March 2022, the patient experienced hair breakage, nail disorder and arthralgia multiple. On an unknown date, the patient experienced fibromyalgia. On an unknown date, the outcome of the fibromyalgia, hair breakage, nail disorder, arthralgia multiple and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fibromyalgia, hair breakage, nail disorder and arthralgia multiple to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR091436   Additional Information: GSK Receipt Date: 08-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that he/she took the shots but had bad side effects from it. The reporter stated that by March 15 his/her hair broke was ruined, fingernails was ruined, had joint pain in shoulders and knees. The reporters said he/she also had fibromyalgia, would never take the shots again. The reporter said it appeared to affect all of those who got Covid or just taking the injections. On 15th March 2022, less than 2 months after receiving Shingles vaccine, the patient experienced hair breakage, nail disorder and arthralgia multiple. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced fibromyalgia. Additional supportive information: The patient received 2nd dose of Shingles vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR091436:same report, 1st dose
Pfizer-BioNTech COVID-10 Vaccine EUA.  After receiving her 1st dose of Pfizer vaccine, patient experienced an intermittent headache, nausea, fatigue, and a "weird sensation." Her VS included BP 132/92, P 77, O2 99%. Patient stated she in is remission from sarcoid. Certirizine 10mg PO and Famotidine 20mg PO administered at 1304. Patient denied SOB, trouble breathing or swallowing, and symptoms of anaphylaxis. At 1316, patient reported feeling better but had a localized left breast pain rated at a 6/10.  Patient felt comfortable with no additional or worsening symptoms upon leaving clinic.
Local erythema and induration, 60 X 75 mm (R) deltoid.
her blood pressure today is so high; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, she was scheduled for the second shot today (22Mar2021). However, her blood pressure was so high that she felt it was not safe to drive. She was wondering, if she could reschedule her second dose of the vaccine for tomorrow (unspecified date) even though it was past the 21-day interval. The patient underwent lab tests and procedures which included blood pressure measurement: high on 22Mar2021. The outcome of the event high blood pressure was unknown.  No follow-up attempts are needed. Information about lot/Batch number is requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: PT GOT VACCINE NO ISSUES AT THE TIME.  STOOD UP TO WALK DOWN AISEL, FELT  LIGHT HEADED AND DIZZY.  SAT BACK AND FELL TO KNEES, DIDNT HIT HEAD.  SAT PT UP SLOWLY, GAVE WATER AND GATORADE AND COOL TOWEL,.  OT REMAINED IN PHARMACY FOR 15 MIN. FELT OK TO GET UP.. PARENTS TOOK PT TO MD TO CHECK. HAD VERY LOW BP AND WAS STARTING TO FEEL BETTER.. SPOKE WITH MOM, SHE WAS DUE TO FOLLOW UP WITH MD.
Patient got extremely fatigued about 12 hours after the vaccine. She was at another doctor's appointment and they were very concerned for her getting home. She arrived home but her neighbor found her sleeping in her running car. Luckily she was not injured but she slept for the rest of the afternoon and evening. She felt better after sleeping for 12 hours.
This is an initial spontaneous report from a contactable nurse.  The nurse called for her 3-year-old son who received one shot of PREVNAR 13 on 12Jan2011 at an unknown dose to prevent illness.  The consumer did not have any relevant medical history.  The consumer was not taking any relevant concomitant medications.  It was reported that her son was given PREVNAR 13 vaccine and after that he was diagnosed with walking pneumonia on 18Jan2011.  The consumer was diagnosed with pneumonia on 22Jan2011 and was hospitalized on the same day.  The relevant laboratory work included blood test and chest X-ray however the results were unknown.  The consumer had taken the vaccine for only one time.  Therapeutic measures taken included IV antibiotic fluids and OMNICEF (dose, frequency unknown).  The consumer was recovering at the time of report.
A couple of hours after receiving the shot, I became dizzy, sick to my stomach and nauseous. For the next few hours, I suffered from diarrhea, bad stomach pains, vomiting and was very chilled. I felt like I was going to pass out numerous times. Once the above subsided, I slept on and off. The symptoms never were that bad again. By morning I was feeling better, just weak and chilled. That feeling has stayed for the past two days.
Noticed edema of lower legs within 24 hours of administration; This is a spontaneous report from a contactable consumer, the patient. A 55-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 19Feb2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypothyroidism, gerd (gastroesophageal reflux disease), asthma, hypertension, obstructive sleep apnea, arthritis and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID), omeprazole (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and loratadine (CLARITIN), All for an unknown indication from an unknown date and unknown if ongoing. On 20Feb2021 at 16:00, the patient experienced edema of lower legs within 24 hours of administration. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of event edema of lower legs was not recovered at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Arm Soreness; Sharp Pain; Numbness/Tingling in Hand; Shortness of Breath; Restlessness; Lethargic; Loss of Sleep; Increased Body Heat; Fever; Chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath) and RESTLESSNESS (Restlessness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PAIN (Sharp Pain), PARAESTHESIA (Numbness/Tingling in Hand), DYSPNOEA (Shortness of Breath), RESTLESSNESS (Restlessness), LETHARGY (Lethargic), INSOMNIA (Loss of Sleep), BODY TEMPERATURE INCREASED (Increased Body Heat), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        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.   Concomitant medications were not reported. Treatment information in response to events was not provided.
Patient developed hives approximately 8 hours after administration of her 6 month vaccines. Patient was given BENADRYL at 9:57 am the next morning at doctor's office. Mom reports hives resolved overnight 1/14/17-1/15/17.
arm was sore. around 9-10pm all of my joints started burning. the fatigue kicked in and nausea as well. I had night sweats overnight. The pain in my body was significant. hips knees and ankles continue to hurt and have not gone away. it is a burning and throbbing sensation. I went to he ER 03/15/2021 because I needed medication. I got an injection for an anti inflammatory and I was given valtin (anti inflammatory) but it didn't help the pain. on a scale of 1-10 I am a 12 for pain and discomfort.
Pt. reports she woke up the morning(Thursday 5/5/22) after the vaccine in "excruciating pain from my chin to my elbow" on left side.   Denies redness at injection site, reported swelling of L shoulder area.  States she was seen at ED 5/6/22 and given a lidocaine patch.  Reports then went to Urgent Care Friday night (5/6/22) and had an EKG which was normal per patient.  States Saturday, 5/7/22,  she then went to ER again related to pain and had an X-ray and lab work, which was ok per patient, prescribed meloxicam and gabapentin.  She spoke with RN with Employee Health 5/9/22 regarding events above.  This RN called her 5/9/22 afternoon to gather information for Vaers and she stated at that time that her symptoms were improving, but were not resolved.
a rash on entire right upper thigh extending to the knee, patient does not want to walk on it; a rash on entire right upper thigh extending to the knee, patient does not want to walk on it; This spontaneous report was received from a physician via a company representative and refers to a 4-year-old female patient. Her concomitant therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX). The patient's historical vaccinations included measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) and varicella virus vaccine live (Oka/Merck) (VARIVAX) administered one year ago with no adverse reaction. Her concurrent conditions and medical history were not reported.  On 30-APR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA), in right thigh, lot # R015742, expiry date: 02-DEC-2019 (dose and route of administration were not provided) for prophylaxis (reported as cdc schedule).   On 03-MAY-2019, the patient had a rash on the entire right upper thigh extending to the knee and she did not want to walk on it. The mother brought the patient to the physician's office on the same date for examination.  The outcome of the events was reported as recovered on an unknown date in May 2019. The relatedness between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Information has been received from a health professional concerning a 4 year old male with mild pulmonary valve stenosis and a cough (for 3 weeks per pt's mother) who on 05Jun03, at 11:00AM was vaccinated SC in the left arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 06Jun2003 the pt's left upper arm became red with sterile swelling. Subsequently, the pt recovered from the left upper arm redness and sterile swelling. Additional information is not expected.
Fever developed on 11JUN91; t104F to 106F rectal; 12JUN91 unable to bring fever down w/APAP; Rt arm site swollen reddened, lt tender;
Fatigue, loss of appetite, inflammation around injection site extending over 2/3 of upper arm with attendant heat
Patient received a hepatitis B vaccine at aprox 10:30am on 07/21/2008.  There was no adverse reaction at the time of the vaccination.  She also had phlebotomy performed after the injection with no adverse reaction.  However she was awaken during the night with pain in her left arm that increased over the next day. Patient was referred to Occupational Medicine for evaluation.  She reported the physician felt her pain was due to a strain or a sprain and not the injection or phlebotomy.
This spontaneous report was received from a consumer refers to herself as a 66 year old female patient. On an unknown date in January 2012 (also reported as two years ago), the patient was vaccinated with ZOSTAVAX one injection. Concomitant therapies included prednisone. On 17-JAN-2014, the patient experienced feeling symptoms of shingles across her back. The patient sought medical attention. It was also reported that the patient had shingles 10 years or 5 years ago and then got the vaccine 2 years ago. The outcome of feeling symptoms of shingles across her back was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
I had a 101 fever by 3:00 p.m. that would not go down with fever reducing meds. I had aching joints and lethargy.  I had chills and headache.  My fever broke around 8:00 p.m. and as of this morning I'm better.  It's totally worth it but I was told to report if we have any side effects so that data can be collected
Pt. presented with right deltoid bruised, approx 2" diameter, warm, slight redness, raised area around entire deltoid approx. 8" in diameter. Appeared to look like "giant" hive. No seeping. No open areas, denies chills, no fever.
Pt was given the Pfizer vaccine on 2/4/21 and 2/25/21.  She was admitted to the hospital on 8/29/21 due to a fall and hip pain.  Pt was dx with COVID 19+  a week prior to hospital admit per chart review.   No significant symptoms noted by OT during today's short session, though she was confused.  uncertain if that is due to HOH, language barrier, her baseline cognitive level, vs Impact of COVID.
No adverse effects were reported.; Patient was administered improperly stored PROQUAD; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 13-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) (lot number was S003170, expiration date was 30-JUL-2020) (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (product storage error).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008722: US-009507513-1906USA008789: US-009507513-1906USA008791: 1US-009507513-906USA008903:
Information has been received from a pharmacist referring to a 60 year old female patient with high blood pressure and seasonal allergies. The patient had no drug reactions. Concomitant therapies included olmesartan medoxomil (BENICAR), metoprolol succinate (TOPROL XL TABLETS, reported as TOPROL XL) and olopatadine hydrochloride (PATADAY). On 25-OCT-2016, the patient received a dose of ZOSTAVAX (lot # L029481, expired date November 2016, dose 0.65ml, frequency once) subcutaneous in her left arm for preventing shingles. The pharmacist stated that immediately after receiving the ZOSTAVAX, the patient developed itching and a bump under the skin at the injection site. The pharmacist stated the patient came into the pharmacy on 22-DEC-2016 (also reported as today) in regards to the reaction. When asked present status the pharmacist stated "the itching has resolved but the bump is still there". No treatment was given and no lab diagnostics studies were performed. Additional information has been requested.
She had diarrhea, vomiting, and stomach pain from the 1st dose; She had diarrhea, vomiting, and stomach pain from the 1st dose; She had diarrhea, vomiting, and stomach pain from the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Apr2021 (at 56-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had diarrhea, vomiting, and stomach pain from the 1st dose and went to doctor on 08Apr2021. They were still ongoing. When patient had blood work done, she had positive antibodies for COVID and the office stated she would have to wait until the end of may to get the second dose. Patient was supposed to get her second dose on 29Apr2021. Patient was asking how she can reschedule her second appointment. The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pronounced area of erythema (5"x3.5") and induration, warmth surrounding DTaP injection site. Resulted in ER and clinic visit.
dad called that daugher had developed a 2 inch red, warm slightly raised circle below injection site.
QUADRIVALENT vaccine administered at 10:24 a. Patient came back at 11:20 a c/o generalized itching and scratchy throat. No fever or redness. After 15 min it did not worsen. Pt told may try antihistamine and she agreed. Follow up 10/16. Pt said ok.
Extreme fatigue; Extreme body aches (legs hurt the worst), rested in bed and endured. It calmed down about 4 hours later. It was much like a bad fibromyalgia flare-up;  Fever, tylenol, lasted 2 days; Left arm - redness, hot, raised about 6 inches, itchy. Used cold compress and hydrocortisone. Started feeling better 3 days later, but is still pink, warm, and itchy 4 days later.