chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parsonage-turner syndrome; pain along inner arm; numbness on his left side of this hand; numbness on thumb and index finger; His wrist dropped in his left hand.; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 12Feb2021 18:30 (78-years-old at the age of vaccination), (Batch/Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, Coronary artery disease, High blood pressure, prostate cancer, a little arthritis from an unknown date and unknown if ongoing. Concomitant medication included metformin taken for diabetes mellitus from an unspecified start date and ongoing; metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken for diabetes mellitus from an unspecified start date and ongoing; amlodipine taken for hypertension from an unspecified start date and ongoing; atorvastatin taken for coronary artery disease from an unspecified start date and ongoing; metoprolol taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN 81) taken for coronary artery disease from an unspecified start date and ongoing. Patient reported that received both doses of the Pfizer covid vaccine. Diagnosed with possible Parsonage-Turner syndrome: Had the test done last week and the report received today mentioned this. His doctor mentioned the high likelihood that it may have a connection to the vaccination. The test was 10 days ago. Has had the symptoms since about 03Feb2021. Had the last dose, the second dose, 12Feb2021. He developed pain in the arm, not at the injection site, but along the inner arm. The next day he developed numbness in the left side of the hand, in the middle and ring finger. A couple of days later he developed the same thing on the thumb and index finger. A few days later, he woke up in the night and had wrist drop in the left hand. He recovered most strength of muscles and was able to lift the fingers. Within the next few days, he recovered his strength in his muscles. The numbness continued to be there but slowly showing some improvement. He still had little patches of it. Had the test done last week, it was a nerve conduction EMG. Was initially shocked that this was all of a sudden happening. He knew it was not life threatening. Of course, we know these days doctors are not like they used to be. It took a long time to get an Appointment. Got an appointment more than a week later with the neurologist. A week later, they got the tests. The patient underwent lab tests and procedures which included electromyogram: possible parsonage-turner syndrome on 25May2021 possible Parsonage-Turner Syndrome. The clinical outcome of the events numbness on thumb and index finger, numbness on his left side of this hand was recovering, remaining all were unknown.  No follow-up attempts are possible. No further information is expected.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Covid vaccine #1 2/5/2021 Lot # N/A  Pt had cardiac arrest at home- died in the emergency room-not a covid related death
This is a spontaneous report from a contactable nurse. This nurse reported similar events for four patients. This is the fourth of four reports. A 4-month-old male patient received the second dose of PREVNAR13 via the intramuscular route on 28MAR2012 at 10:03, the second dose of rotavirus vaccine orally on 28MAR2012 at 10:30, and the second dose of PENTACEL (ACELLULAR)) via the intramuscular route on 28MAR2012. The patient medical history was not reported. The patient's concomitant medications were not reported. On 28MAR2012, the patient experienced low grade fever, fussiness, vomiting, and extra puffiness. Therapeutic measures taken as a result of the events were not specified. The outcome of the events low grade fever, fussiness, and vomiting were recovered on 29MAR2012. The outcome of the event extra puffiness was recovering at the t ime of the report. Follow-up (17APR2012): New information reported by a contactable physician included product lot numbers and expiration dates, route of administration, additional adverse event of fussiness, onset and resolution dates, and outcome information. Follow-up (30APR2012): Follow-up attempts completed. No further information expected. Follow-up (24MAY2012) Follow-up attempts completed. No further information expected.
I started getting symptoms of pains in my body and tiredness. The tiredness continued and I was exhausted. I went to bed early. The next day I was sneezing and had a runny nose. I took an at home COVID-19 test that was positive. I contacted my doctor and did a telehealth visit. I was prescribed Paxlovid. My symptoms did progress to fever, extreme body aches, headaches, and sinus congestion and sinus pain. The last day that I had issues I had very bad low back and hip pain and it was hard to sleep. I feel that the Paxlovid did help with my symptoms.
Pt received Tdap at 10 AM 8/18/15 and by 4:00 pm had stomach pain. The next day 8/19/15 the pt woke with nausea and vomited accompanied by diarrhea and a temp of 99.8 that rose to 101.3 by midday. Pt still feels ill today 8/20/15 nauseous with stomach pain, afebrile.
This report was received from manufacturer and was assigned manufacturer report number (A0650497A) for INFANRIX. A 4 year old male with a history of extrinsic asthma, respiratory tract infections, and a unspecified reaction to oxybenzoyl described as a rash from baby oil, on 03-MAY-2007, was vaccinated with a second dose in the left arm of Proquad (lot # 656307/1391F). Suspect vaccination on the same day included a 0.5 mL fifth dose in the left arm of INFANRIX (lot # AC14B056BA). Other concomitant therapy included albuterol sulfate and budesonide (PULMICORT) nebulized. On 04-MAY-2007, within 24 hours of receiving the vaccinations, the patient's left arm became swollen and red, and he developed a fever of 104 degrees Fahrenheit. The patient was treated with ibuprofen (MORTIN) and diphenhydramine hydrochloride (BENADRYL) with no improvement in symptoms. On 05-MAY-2007 at 15:43 PM, the patient presented at the physician's office and was diagnosed with cellulitis. The patient's left arm was swollen from the deltoid to th elbow, his skin was taut, warm to the touch, and red. The patient was prescribed amoxicillin trihydrate (+) potassium clavulanate (AUGMENTIN) for 10 days. At the time of reporting, the arm cellulitis, swelling, redness, and warmness to the touch were improved, but the outcome of the fever and skin tautness was not specified. The reporter considered the events were possibly related to vaccination with MMRV and INFANRIX. Per the source document, the reporter was uncertain if cellulitis was due to Proquad or INFANRIX since both vaccines were received on the same day. The patient had no history of adverse events following previous vaccinations. The patient's experience were considered to be other important medical events. This was originally reported by a registered nurse. Additional information has been requested.
On September 19th I was supposed to go away on the 21st but I had a fever for several days and a sore throat. The headache was extreme and had to take medication ever 4 hours, it was really bad. I had nasal, head congestion and into the chest. The headache and fever is gone but I still have congestion. I don't have a sore throat anymore but my throat is still raw from the coughing. I never lost my appetite or diahrea, not intestinal problems at all. Its all been in the throat and chest. I called my Dr and they offered me Paxlovid but I didn't take it. Today I still have the chest heaviness and may go on steroid.
Patient reported vomiting and passing out at home after receiving the SHINGRIX vaccine but states that she was fine the next day.
BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9265), via an unspecified route of administration on 12Feb2021 16:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 05:00 PM at left arm at age of 44 years old with lot number EL1283. Patient is not pregnant at the time of vaccination. The facility type vaccine was Doctor's office/urgent care. The patient medical history was not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included omeprazole, levothyroxine, montelukast sodium (SINGULAIR). The patient experienced BCG vaccine site/mark became red on 14Feb2021 after 2nd dose. No itching as of now. Did not happen after 1st dose. It's been red for few hours now. There was no treatment received for the adverse event. The outcome of event was unknown. The event was reported as non-serious.
patient left vaccination site 15 minutes post-vaccination and noticed vision "was different" while driving, then returned to vaccination site. Upon return to vaccination site, reported chest "felt heavy" and left arm felt cold
no adverse effects reported; vaccinated with improperly stored Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-JAN-2019 the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin) (PROQUAD) injection, lot # R020678 expiration date: 15-JAN-2020, (dose, frequency and route of administration were not reported).  The suspect vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # N035970, expiration date 30-APR-2020). No adverse effects was reported. The vaccine was stored in 16.5 Fahrenheit degrees for 1 hour and 44 minutes. There was no previous temperature excursion.. Digital data logger was involved. This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003435: US-009507513-1904USA003436: US-009507513-1904USA002106:
Body pain,aches,prickly pain with any movement,nausea, weakness,chills,legs feel heavy,this is day two and still no better
Information has been received from the authors in a literature article concerning a 22 year old female patient who was vaccinated with PCV23 (manufacturer unknown) and had received PCV13 vaccine 4 months earlier. No concomitant vaccines were reported. The 22 year old female with sickle cell disease type hemoglobin SS SCD presented to the emergency department with painful swelling of the right arm 1 day after administration of PPSV23 (manufacturer unknown). She was afebrile, with a WBC (white blood cell) count of 13.6 x 1000/mm3 that showed leucocytosis (6.5 x 1000/mm3 before immunization). Patient also experienced oedema (unspecified). She received hydromorphone and hydration, and was discharged home from the emergency department. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013114 and 1506USA013113). Additional information has been requested.
Fever of 102 all night, taken with forehead scanner. Highest fever 103.  Headache and rapid heartbeat all night. Next day headache. Arm soreness started Two days after the shot and continues, very painful in the muscle and skin is itchy over the injection site.
Patient reported feeling suddenly flushed and tachycardic - she reports having a history of SVT. She was immediately moved from chair to cot with feet elevated. She reported feeling better. Shortly after, her HR was 112, checked again 96, BP 124/90. Pt was alert and oriented, reported feeling better, took a few sips of juice. After attempting to sit up, she needed to lay back down, HR up to 120, c/o hands feeling numb. She reported a "heavy" feeling in her chest.  911 was called. Pt still alert, very calm, HR 112, starting to have have "chills" teeth chattering, knees shaking, skin warm and dry. Denies any difficulty breathing, tongue and lips not swollen, lips not cyanotic. Within 15 minutes HR down to 108. Reports her "heart rate feels better" but does still c/o hands tingling.  Pt reports that she has never had any issues with getting vaccines before. Has not had an episode of SVT "in about 10 years" Patient transported to medical center for observation.
From ED Physician's Note 4/16/2021:  45 yr female presents to ER complaining of left arm and leg feeling heavy since yesterday (4/15/2021) morning.  Patient states she got the Pfizer first vaccine on Wednesday (4/14/2021) morning, felt fine throughout the day, went to bed without any problems or symptoms.  Patient states she awoke yesterday morning feeling as if she was" drunk".  Patient states she feels like her left arm and leg are heavy and at times is having slurred speech.  Patient states she feels like her walking is off and that she is dragging her left leg.  Patient denies any numbness and tingling in the upper or lower extremities.  Patient denies any headache or dizziness, vision changes, fever, chills, body ache, infectious respiratory symptoms, chest pain or shortness of breath.
28JAN body aches; 31JAn blisters on feet, saw dermatologist tx w/ointment unsure what;
vaccine was given to patient but it had undergone a shipping temperature excursion, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 58 years old female patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (frequency once) lot UT6686KA via intramuscular route in the right deltoid on 22-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to incorrect product storage. It was reported that Fluzone Quadrivalent underwent shipping temperature excursion and vaccine was given to patient.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 1/25/13, patient felt decreased fetal movement. By ~1/27 she was no longer feeling the baby move. Seen in clinic with IUFD on 1/30. Pathology showed trisomy 12 consistent with dysmorphic fetus at the time of delivery. Pt continued to believe it was related to TDaP and asked that the event be reported.
About 40 minutes after vaccination, started a tingling  in the right side of my face tongue and cheek, throat closing, swollen lips and face on right side. Swollen in areas of the right side of my face.  I called urgent care who said start Benadryl every for hours. Found I was allergic to polysorbate 80.
Patient received vaccine in the left arm around 5:30 pm. About 2 minutes later, patient complained of feeling hot and lightheaded and was sweating. We gave the patient some water to drink and continued to monitor his symptoms. After about 2-3 minutes, the patient said he was feeling much better, though he had a "tingling sensation" in his hands. We continued to monitor for another 15 minutes, after which the patient stated he was feeling much better.
I received my shot Monday evening at 6:15, symptoms such as arm pain did not set it until 10pm. Tuesday, I woke up at 8am with severe arm pain, injection site pain, headache, nausea, a slight fever, body aches (shoulder blades, back, neck) and my skin hurt to the touch. I felt dazed and confused and couldn?t form sentences. These symptoms lasted all day until I went to bed at 10pm. Wednesday morning I woke up at 10am with less injection site pain than the day before but still persistent, pain under my armpit/side of my boob (lymph nodes) and back/shoulder aches.
Covid arm,  red welt at injection site, hot and itchy, hives on face.   all symptoms went away on their own in about  to 2 - 3 days
nauseous; A spontaneous report was received from a consumer concerning a female patient of an unspecified age who received Moderna (mRNA-1273) vaccine and felt nauseous (NAUSEA).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 6 Jan 2021, approximately four days prior to the onset of the symptoms, the patient received their doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.    On 10 Jan 2021, about 4 days after receiving the vaccine, the patient felt nauseous and was still nauseous.No concomitant drugs listed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  On an unknown date, the outcome of the event, felt nauseous was not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Neurological problems, numbness in her toes of both feet, pt states numbness increased after flu shot and has not gotten better. And has not been to Dr. 09-04-2009 Hx of Cushing disease surgery R/T Cushing disease.
At 1500 hours puffy eyes.  Child states, "my throat is itching."  Called EMS - 911 at 1502. At 1502 hours administered diphenhydramine 25mg IM left deltoid.  At 1503 B/P 90/60 pulse 80/min.  Dr satellite check breathing freq of wheezing.  1508 hours B/P 90/60 pulse 80/min. At 1512 O2 at pulse oximeter at 100% sat.  B/P at 1514 hour 90/60.  At 1517 hour EMS at scene and assess client.  At 1525 hour child transport to hospital with grandmother.  Mom at clinic during transport.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Meloicam, reaction(s): "Known allergies: Meloicam".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received Anti-viral Product for COVID 19 Treatment, Lot number: Ga7394. The patient experienced Extreme aftertaste, does not dissipate with gargling or brushing teeth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Information has been received from a physician concerning a male received (age not reported) with no allergies or medical history who received three doses of RECOMBIVAX HB and did not seroconvert. The patient sought unspecified medical attention. The patient's outcome was reported as not recovered. There was no product quality complaint.
Pt receive vaccine 5/11/23 same day PM start itchy Left arm/swelling 5/12/23 Fever chills 5/13 diarrhea 5/14 ED eval.
PATIENT EXPERIENCED EXTREME BODY ACHES ALL OVER THE BODY THAT SHE COULD NOT MOVE
watery diarrhea, onset 15.5 hrs post vaccination.  duration of approximately 24 hrs, resolved after imodium x4.
By swellng at injection site, warm to the touch, dizzy, pain, lethargic all day.
Sore arm - Tylenol temporarily relieved this symptom - continues through 12/19/2020 - milder  Fatigue - Rest relieved this symptom20
noticed an unusual increase in my energy level; noticed an unusual increase in my energy level; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 18Dec2020 as dose 1, single for COVID-19 immunisation. Medical history included chronic fatigue syndrome for 8 years, thought to be caused by Herpetic Seni. Zoster (systemic shingles virus) (both from an unknown date and unknown if ongoing). Concomitant medication(s) included valaciclovir hydrochloride (Valtrex) taken for an unspecified indication, start and stop date were not reported. On 18Dec2020, after first vaccine, patient noticed an unusual increase in his/her energy level. The outcome of both the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient was given a pediatric dose (6-35months) 0.25ml. This adverse event was caught before patient left office and she did receive another dose of 0.25ml per MD order.
I had the shot and still got shingles/Suspect vaccination failure; I had the shot and still got shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.