chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported fever and lingering fatigue 3 days following vaccine. Pt stated arm is a little hotter and tender to touch and is localized. Pt reported pain is not too bothersome, given home care and monitoring parameters for worsening fever and pain.
low platelet count; bruising; nose bleeds; bloody discharge from his penis; Thin skin; Immune thrombocytopenic purpura/ purpura lower extremity; This case was reported by a physician via call center representative and described the occurrence of platelet count low in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 28th July 2019, between 3 and 4 months after receiving Shingrix, the patient experienced contusion (serious criteria hospitalization), epistaxis (serious criteria hospitalization), penile hemorrhage (serious criteria hospitalization and GSK medically significant), skin thinness (serious criteria hospitalization) and immune thrombocytopenic purpura (serious criteria hospitalization and GSK medically significant). On 31st July 2019, the patient experienced platelet count low (serious criteria hospitalization). On an unknown date, the outcome of the platelet count low was not recovered/not resolved and the outcome of the contusion, epistaxis, penile hemorrhage, skin thinness and immune thrombocytopenic purpura were unknown.   The reporter considered the platelet count low, contusion, epistaxis, penile hemorrhage, skin thinness and immune thrombocytopenic purpura to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, however the patient could be 86 or 87 years old. The physician reported that a family member was admitted to the hospital yesterday after having seen a physician for 3 days history of unexplained bruising, nose bleeds and bloody discharge from his penis. The patient was diagnosed with Thin skin after having been seen by several physicians.  This physician reported that he noted lower extremity purpura and demanded a CBC. The results returned yesterday with a critical platelet value of 3000, so the patient received a phone call and was told to go straight to the Emergency room.  The reporter was trying to manage this all by phone with pictures, but states the family member was told by a physician at the hospital that these issues were caused by the Shingrix he received 4 months ago. The physician did not believed these issues to be related to the Shingrix and he was not aware if that was the first or second dose he had or any lot and expiration date information. The physician wanted to know if GSK was aware of any reports of ITP (idiopathic thrombocytopenic purpura) with Shingrix. The reporter consented to follow up.
Client received Flu vaccine on 10/18/12 and developed diminished taste and smell by early evening on 10/19/12. She is still experiencing symptoms as of 10/26/12.
p/vax was a small knot on arm;it swelled up to a 7xm x 5cm area;area is warm & itchy;
Pt had routine MD appt re: chronic kidney disease, office found low electrolytes/eFGR, sent to hospital, admit to ICU, given IV potassium and treated with remdesivir/mAbs, due to (+) COVID test. Reports case did not present w/COVID related symptoms.
Information has been received from a woman concerning her daughter who at the age of 15 months, developed seizure following vaccination with 1st dose of MMR. Afterward, the pt experienced another seizure. Lab test conducted showed that she is "highly allergic to something" in the vaccine. Upon medical review, the pt's condition was considered "important medical event". The reporter believed there to be an association between the pt's symptoms and the vaccine. The pt sought unspecified medical attention. No further information is available.
tingling - issues in both legs; stress; anxiety; Leg weakness; Pain, shooting pain; numbness, Leg numbness; This non-serious case was reported by a consumer and described the occurrence of pain in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28-FEB-2023) for prophylaxis.   Additional patient notes included the patient was a completely healthy individual, no health issues, no injuries, no falls and active soccer player.   On 28-JUL-2022, the patient received Menveo 1 ml. On 31-JUL-2022, 3 days after receiving Menveo, the patient experienced pain (Verbatim: Pain, shooting pain), numbness (Verbatim: numbness, Leg numbness) and lower extremities weakness of (Verbatim: Leg weakness). On an unknown date, the patient experienced tingling (Verbatim: tingling - issues in both legs), stress (Verbatim: stress) and anxiety (Verbatim: anxiety). The outcome of the pain, numbness and lower extremities weakness of were not recovered/not resolved and the outcome of the tingling, stress and anxiety were not reported.   It was unknown if the reporter considered the pain, numbness, tingling, lower extremities weakness of, stress and anxiety to be related to Menveo.     It was unknown if the company considered the pain, numbness, tingling, lower extremities weakness of, stress and anxiety to be related to Menveo.   Additional Information: GSK receipt date: 23-Mar-2023 This report was submitted via the online direct entry reporting system. The patient received a dose of Shingrix and had leg numbness, pain, shooting pain, weakness and tingling issues in both legs.  The reporter reported that when they contacted the physician office on 8th January 2023 inquiring if symptoms could be a side effect from one of the vaccinations received, physician said it was not and most likely stress or anxiety etc.  7 months later, test after test, and had seen several physicians, no one can figure out what was going on. The reporter was patient's mother and was tracking back to see if this vaccination could be the cause, when she searched side effects of Menveo online, the patient's symptoms align with information listed.  The reporter stated that please help them to find a resolution to resolve her pain. The reporter denied to follow-up.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-APR-2015, the patient was treated for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of the 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. Additional information has been requested.
7 days after my vaccine my left  upper arm became red,swollen,painful and itchy. It continued to spread over the next 3-4 days until it ran from my shoulder to almost my elbow.  Now 7 days after the reaction started it is almost all gone.
Temp of 105 degrees 12 hours after Prevnar and Comvax, continues to have elevated temp of 103-105 with muscle twitching. Was seen in office.
Information has been received from a health professional concerning an unknown number of patients, who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 that had been exposed to temperatures between 22 32 degrees F, for about 5 months (doses, routes and lot numbers not reported). No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information will be provided if available. Follow up information has been received from the health professional who indicated that patient identifiers could not be provided because no one experienced any adverse event. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status, healthcare provider name and contact information. Additional information is not expected.
p/vax dizziness & nausea; pain in muscles of arm; pain limiting internal & external rotation at shoulder; pain w/ bruising hair; shoulder bursitis & rotator cuff tendonitis; tx naproxen
PATIENT HAS DEVELOPMENT AN ACTIVE CASE OF SHINGLES, IS BEING PLACED ON AN ANTIVIRAL, UNKNOWN EXACT DATE OF TIME OF CONVERSION TO ACTIVE CASE, WAS DIAGNOSED TODAY BY DR.
Paralysis of arm injected, erythema and edema surrounding injection site. Mottled skin, headache, extreme fatigue,  abdominal cramping, diarrhea. Onset 3 hours post injection. Over the counter meds, Tylenol extra strength , ibuprofen, Benadryl. 72 hours mostly resolved symptoms
puffy/hard large lump under skin that can see through shirt. red/hot. Started monday, has been icing and gotten better
This spontaneous report as received from a consumer via Clinic refers to a currently 11 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-APR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # M005733, Expiry date: 01-OCT-2017), subsequently on 23-JUN-2017 and 18-AUG-2017, the patient was vaccinated with second and third doses of improperly stored ROTATEQ (lot # M005733, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Extremely severe, sharp, deep pain in arm around injection site; deltoid pain continues to spread around injection site over two weeks later.
This case was reported by a consumer via call center representative and described the occurrence of induration in a 37-year-old female patient who received DTaP vaccine for prophylaxis. Previously administered products included Dtap with an associated reaction of induration (1st dose received at 3 month of age, other events were skin warm and erythema. Refer case US2018228793.). On an unknown date, the patient received the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced induration, mass, skin warm and redness of legs. Rechallenge with DTaP vaccine was positive. On an unknown date, the outcome of the induration, mass, skin warm and redness of legs were recovered/resolved. It was unknown if the reporter considered the induration, mass, skin warm and redness of legs to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. On unknown date, the same three reactions presented with the second shot but the knot was bigger. The size of half a baseball. The reporter could not provide dimensions. The events were resolved after a week. The reporter reached out through the whooping cough website and was instructed to call the agency. The reason for reporter call was to advocate for vaccines not to report an adverse event (AE). The reporter had 3 kids and at the advice of the physician, she did not vaccinate the other two because of the reactions her first child experienced but now she wishes she had vaccinated them as well because the other 2 kids had bad cases of whooping cough but the first child (the patient in this report) never had it. For tolerance to further doses, refer cases US2018GSK232634 (3th dose).
Initially a red, warm area around the injection site. Increased itching and pain in the upper arm over the next 3 days. General muscle aches.
DEATH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, 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 patient died due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210600235 -COVID-19 VACCINE AD26.COV2.S- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Narrative:  a 85 yo M with recently diagnosed SCC receiving VP-16 and carboplatin, admitted 09/10/2021 (TO PRESENT) with acute resp failure secondary to covid pneumonia. PATIENT remains on continuous bipap - sats 100%. Much more alert today, actually stated that he felt much better. Alert to person, place, year CV: RRR with systolic murmur Lungs: crackles throughout Abd: soft, mildly distended, nttp, pos BS Ext: 1+ BLE pitting edema A/P 1. Acute hypercarbic and hypoxic respiraty failure/COVID 19 pneumonia - secondary to covid-19, however, complicated by lung masses and L pleural effusion (malignant) - have requested trial of high flow - can d/c bipap - to allow patient to eat, sats remain 100% on bipap - continue remdesivir and IV solumedrol - not a candidate for IL or immunomodulators given SCC s/p chemo - overall prognosis still very poor - completed 5 days IV zosyn for possible superimposed bacterial pneumonia - heparin drip changed to treatment dose lovenox as patient with poor IV access and needs IV line for PPN, may need central line vs PICC if unable to wean from bipap and tolerate diet soon - monitor inflammatory markers - IV lasix changed to 80 mg bid for CHF (BNP 700s, monitor)- improved - will reduce to daily dosing given metabollic alkalosis 2. Small cell lung ca stage IIIa - followed by oncology, s/p chemo 09/08/2021 as above - very poor overall prognosis in setting underlying fibrosis/possible ILD and acute infection 3. FEN - D5 1/2 NS to be replaced by PPN today - hopeful that can start oral diet if able to change from bipap to high flow 4. Chronic medical conditions Hypertension - Continue metoprolol 6.25mg PO BID Diabetes Mellitus - aspart tid, adding lantus 10 units daily Diabetic neuropathy and nephropathy - Continue gabapentin. Hyperlipidemia - Continue Simvistatin RLS - ropinirole Overall prognosis very poor given chronic medical conditions, lung cancer, asbestosis
As initial soreness subsided I developed aches in shoulder and neck area, especially after not moving it for a while. I also had similar discomfort in my other shoulder and left hip for a short time. I still have pain in left shoulder that is slowly improving. Rest after exercise seem to bring it on.
abdominal pain N93.9 - Abnormal uterine and vaginal bleeding, unspecified
pt recvd vax & tested barely pos for HBSAG 14SEP92; testing was repeated & was more strongly pos for HSBAG;
I had some swelling mainly in the arm. The injection site was really swollen, red, and hot to the touch. My arm was very very sore that I could barely lift it. I had fatigue really bad, and I couldn't keep my eyes open for a few days. I did a telehealth visit and was told to take OTC Tylenol, Advil, and Naproxen. The majority of my symptoms lasted for about 4 or 5 days. Some of the symptoms eased up at that time and lasted a little longer.
OVER 42 DAYS BETWEEN 1ST DOSE AND 2ND DOSE.
8-10 hours after injection experienced extreme fatigue, broad-based joint pain. confusion. severe headache, burning and sharp stomach pain.  Symptoms lasted till 3 a.m. and then decreased gradually till 10 a.m. following day
Redness, hardness, warm, pain, induration 4.5 x 4.5 cm right deltoid subcutaneous area.
Regularly has low platelet count due to Immune Thrombocytopenia Platelet disorder and keeps monitors of it. Before COVID-19 Bivalent vaccine, platelet count was at 66; after vaccine it lowered to 28. Saw Hematologists for bloodwork and was prescribed Prednisone.
Bone/muscle/body aches, nausea approximately 24hrs duration then full recovery.
1' needle,  left deltoid area 2-3 cm circle of swelling, tenderness, hot to touch and red. Treated with Keflex 1 tsp po twice a day x 10 days. Improving
Report 20010037851 describes optic neuritis in a 17 year old female who received hepatitis B vaccine (Engerix-B). Concurrent medical conditions included wheezing upon exposure to cold air. The pt has no known drug allergies. There were no concurrent medications. The pt received her first injection of Engerix-B in September 2000. No adverse experience was reported following this injection. She received her second injection of Engerix-B on 10/10/2000. On 12/15/2000, 66 days post-immunization, she fell asleep on the floor at the friend's house. The friend's father accidentally kicked her on the forehead while trying to step over her; there was no brusing or swelling noted on the forehead. About 15:30 that afternoon, she experienced painless loss of vision in her right eye. The neurologist noted that an eye examination in November 2000 was normal. On 12/18/2000, the pt was seen by her eye doctor, who made a diagnosis of optic neuritis. The pt was seen by a neurologist later that day. She reported nausea the morning of 12/18/2000. On examination, the neurologist noted that the disc in the pt's right eye was edematous with blurred margins and there were some hemorrhages medially. The rest of the examination  was normal. The neurologist made a diagnosis of optic neuritis. MRI of the brain and retrobulbar as normal. Erythrocyte sedimentation rate was 72 mm/hr. Antinuclear antibody titer and Lyme antibody titer by ELISA were negative. The pt was treated with high-dose methylprednisolone (SoluMedrol) and then prednisone. The most recent information, received on 03/06/2001, indicated that by 01/08/2001, the pt "had improvement in the vision from her right eye, though it is still not back to normal. She notices a loss of color in the vision, as well as clarity." The papilledema of the right eye had resolved. The neurologist stated, "she can expect further improvement." She was discharged from the neurologist's care on 01/08/2001. Optic neuritis is considered SB medically serious.
chills beginning around 11;00 PM that night and lasting almost 24 hours, slight headache and a localized reaction around and adjacent to the injection site that began almost 48 hours later.  Arm is swollen with red patches  all over that produce heat that is discernable to the touch.
Leg swelling from hip down below knee. Fever in swelling site. Wailing, crying that went on for 5 hours.  3/16/10 adverse reaction to shots.  Fever of 102.  Tylenol was given day before stopped and fever spiked at 11:00 AM on 16th. Ran low grade fever for 12 hrs.
On 5/25/05, patient had episode of emesis, febrile to 102 then had blank stare with tonic clonic activity. Information received from discharge summary states Convulsions.  Information from Medical records states pallor, hypotonia.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications were reported. No treatment medications were reported.  It was reported that Its been 48 hours and patient getting a fever.
Second vaccine dose not given.  Admitted to hospital; given remdesivir, on oxygen,  on dexamethasone
Initial and follow up information has been received through the Merck pregnancy registry from a physician concerning an 18 year old female with asthma, an obstetrical history of a prior pregnancy electively terminated in the first trimester, and a medical history of Chlamydia (2004), vulvar intraepithelial neoplasia (VIN III) (treated October 2006) and Cervical intraepithelial neoplasia (CINI), who on 12-OCT-2006 was vaccinated in the left arm with the first dose of GARDASIL (Lot # 653735/0688F) and on 07-DEC-2006 was vaccinated in the left arm with the second dose of GARDASIL (Lot # 654540/1161F). Concomitant therapy included ADDERALL, CELEXA, CATAPRESS, montelukast sodium (MSD), ZOLOFT, and CALAN. Subsequently, the patient informed her physician that she was pregnant. The date of the LMP was 30-DEC-2006 (previously reported as approximately 26-DEC-2006), with an estimated date of delivery of 02-OCT-2007. The patient sought unspecified  medical attention. In approximately December 2006 the patient experienced depression. On 03-OCT-2007 the patient delivered a healthy, normal male infant, birthweight 3523 grams and 53.3 cm in length. Apgar score of 3/8/9, taken at 1/5/ and 10 minutes. No further information is available.
Nausea. Some vertigo. Headache. Weakness. Diarrhea and queasy stomach. No fever or vomiting.  So far effects have lasted 24 hours.
Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported COVID-19 VACCINE; lot number: EL3246; expiration date: unknown), intramuscular right arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history allergies to seafood, milk and peanuts. The patient was not diagnosed with covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient previously took tetracycline but had allergies. The patient experienced lightheaded, felt like passing out and had intermittent palpitations on 10Jan2021. No treatment was received for the adverse event. The patient did not covid tested post vaccination. The outcome of the events was recovered on Jan2021.
Information has been received from a physician, concerning a 62-63 years old patient, who approximately 07-JUL-2008 (also reported as about 6 weeks ago) was vaccinated with a dose ZOSTAVAX. The patient developed zoster lesions at the injection site. The patient recovered on an unspecified date. The patient sought medical attention on office visit. There was no product quality complaint. Additional information is expected.
Generalized weakness, severe pain in spine, severe headache, cold sweats, fatigue, stiff neck and dizziness. Was unable to hold my infant. Symptoms lasted for about 6 hrs. TYLENOL and MOTRIN provided no relief.