chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of bradycardia in a 53-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced bradycardia (serious criteria GSK medically significant), cardiac arrhythmia (serious criteria GSK medically significant), fever, injection site erythema, pain in arm, hypotension and palpitation. On an unknown date, the outcome of the bradycardia and hypotension were not recovered/not resolved and the outcome of the cardiac arrhythmia and palpitation were recovering/resolving and the outcome of the fever, injection site erythema and pain in arm were recovered/resolved. The reporter considered the bradycardia, cardiac arrhythmia, hypotension and palpitation to be unlikely related to SHINGRIX. The reporter considered the fever, injection site erythema and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received the SHINGRIX first injection of a two vaccine series, and experienced the common side effects of redness at injection site, sore arm, and low grade fever which had all resolved. The pharmacist reported that the patient said she was a very healthy person prior to receiving the SHINGRIX vaccine, and since that time, the patient developed hypotension, bradycardia, arrhythmias, and palpitations 3 to 4 week after receiving the SHINGRIX vaccine and at the time of reporting, the patient was seeing a cardiologist. The pharmacist was unable to obtain physician's name and phone number and permission to contact physician since reporter was pharmacist.
difficulty breathing/ huffing and puffing; pain; Distress; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced difficulty breathing and pain. On an unknown date, the outcome of the difficulty breathing and pain were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing and pain to be related to Shingrix.  Additional information was provided as follows: The patient was in pain and having difficulty breathing.  She was huffing and puffing on the phone asking what should she do. She was informed to call 911, her doctor, or go to the emergency department.  Demographic information about the patient was not collected.   The caller needed emergency assistance immediately. The patient was in such distress, it was reporter's opinion that she call 911 immediately. The reporter did not consent to follow up.
Severe erythema at injection site. Decreased ROM and edema of entire leg (injection was LLE).
Pt. states that after receiving the 2nd dose Phizer 09/17/2021, started experiencing symptoms 09/24/2021 of raised redness at the injection site, soreness, fatigued, and dull headaches. Primary appt. planned for 09/28/2021. Still experiencing symptoms.
Hives, angioedema. Pt sent to ED for monitoring. Vaccine 1st dose at 12:30 pm. Hives began 7 pm.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant product information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-015763 (Patient Link).
nose is running; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and RHINORRHOEA (nose is running) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 11-Feb-2021, the patient experienced RHINORRHOEA (nose is running). At the time of the report, PAIN IN EXTREMITY (sore arm) and RHINORRHOEA (nose is running) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medication for diabetes. Treatment details included none.
immediate symptoms - bowel movements are very different and continue to this day. Like babies poop. Specific date of occurrence 3/24/2021 - 2 pm: was standing in my home office feeling just fine and then my heart started racing and I was immediately nauseous to the point I had to lay on the floor on my back and tell myself to breathe.  I felt like my heart was going to jump out of my chest, so I got up and grabbed my wrist blood pressure monitor and went and lay back on the floor telling myself to breathe. I took the first reading and it said 200/52/57  so I too it again 199 / 50 / 58.  I started to panic and remembered I had bought some cans of oxygen for my father and had one in the bathroom. I went and breathed on that for about 2 minutes. My reading then went back down to a more normal range. Since that time my head doesn't feel the same and it scared me enough to tell my husband and mom, yet they both told me not to stress about it. I have only experienced ongoing bowel movements and the weird head feeling since that time but did contact my Dr. for an appointment. I want be certain I didn't have a stroke or something peculiar.   I had noticed my heart rate increasing but wasn't sure if I was imagining it, so I restarted taking my blood pressure numbers on 3/22. My blood pressure that morning at 6 am was 113/59/72.
The following side effects/symptoms began after my 2nd Moderna Covid Vaccine: - Fatigue. Began a few hours after vaccination - Chills. Began a few hours after vaccination. Lasted about 2.5 days - Cold sweats - Began approx 10-12 hrs after vaccination. Last approximately 2.5 days - Fever - Fever began approx 10-12 hours after vaccination and temperature was 102.6 the first time it was checked. Fever lasted for 3 days and temperature ranged from 100-102, with highest being 102.6 on 10.3.21 (when temperature was 1st taken). Tylenol was taken to reduce fever. - Body aches - Headache - Arm soreness at site of injection - Eye pain. Eye sockets began to hurt. Whenever I moved my eyes either left, right, up, or down, they were sore. Still present as of 10.6.21 - Random sharp shooting pain in right lower abdomen. Lasted about 2 days - Loss of appetite and nausea
Nausea; Sore arm; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea) and VOMITING (Vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.  Concomitant products included LABETALOL, LISINOPRIL, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE and SIMVASTATIN for an unknown indication.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Symptomatic treatment, at an unspecified dose and frequency. On 13-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 18-Mar-2021, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Used for Warts on her fingers; No adverse effects; This spontaneous report as received from a pharmacist refers to a female patient of unknown age with skin papilloma.    On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for skin papilloma.       On an unknown date the patient experienced product use in unapproved indication and no adverse event.    The outcome of product use in unapproved indication and no adverse event is unknown.
Pain at injection site starting approximately two hours after injection. This pain increased in severity over the course of the next two hours and remained at that intensity (approximately a 5 out of 10) for about 48 hours and then decreased to non-detectable over the following 48 hours. Pain was well managed with Aleve.
Vaccine administered 8/16/16 approximately 1 pm- that evening pt said she had pain and throbbing in her shoulder that went around neck. She said by next day her joint and hips hurt and she had restriction in movement. On 8/17 she said she took 2 ALEVE  and by 8/18 the joint pain was gone the neck pain was present but much less severed. No complaints of redness or swelling.
Suffered syncope dec 10 th .. assumed post viral work up was done essentially negative. Was slowly improving except for a little brain fog . covid test was neg then . First vaccine dose was on Jan 4 th .. min arm soreness for 24 hrs and no reacion after that  Second dose was on Jan 29 th .. started with tachycardia to 11o that night and developed POTS .. with severe flares the next 2 weeks,,, now im 4 weeks out suffering from hyperadrenergic POTS / severe flares with in appropriate tachycardia( proven by holter)  and inc blood pressure with it .
Got the shingles with the shot/Suspected vaccination failure; Got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The patient self reported the case via interactive digital media. The patient stated that he/she got the shingles with the shingles shot and with having all of the childhood diseases. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising). At the time of the report, CONTUSION (bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
pt w/prolonged, painful swelling & redness @ site of inject assessed as allergic to tetanus vs cellulitis 4" x 5" area;
approx 2yrs p/ vax pt exp 5 lesions, fever 101.2f & several vesicular, itchy, red lesions. f/u info 22sept pt devel fever & was not feeling well. also lesions got an infected appearance 29sept. treated w/bactroban & augmentin
Facial swelling & itching the next day after vaccination. Pt took a generic BENADRYL 25 mg.
reacts to your vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (reacts to your vaccine) 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, the patient experienced VACCINATION COMPLICATION (reacts to your vaccine). At the time of the report, VACCINATION COMPLICATION (reacts to your vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
extrenmely dizzy/light-headed and seeing bright lights.  BP dropped to 105/71, pulse 80 resting
Pt given flu shot and returned about 15 min later covered with hives. No respiratory distress. Gave nebulizer treated with Xopenex 0.63mg, 4mg Decadron IM, 0.1 ml of Epinephrine 1:1000 mg hives resolved after about 30 min.
Patient expired after 5 days hospitalization.  73y Male pm hx ESRD/kidney transplant 2018, CAD, HTN, PHTN, DM-2 -  Presented to BWED 12/27 w/dyspnea - dx'd COVID - HFNC/NRM. Imaging without significant infiltrates c/w COVID - suspect pHTN uncontrolled. Transferred to ICU 12/31 and placed on Veletri. Oxygenation worsened after Veletri increased from 30 to 50 ng - suspected secondary to developing pulmonary edema from increased vasodilation. Patient became encephalopathic - trying to pull off his mask. Code status changed to DNR/DNI. Respiratory status then improved after Veletri decreased back to 30 ng, placed on BiPAP and given a dose of Lasix. Precedex started for agitation. Now having fever - cultures ordered and antibiotics initiated. With his ongoing work of breathing and discomfort the patient's family ultimately transitioned the patient to comfort care "to ease his suffering".  Patient was pronounced dead on 1/1/22 at 18:30 p.m.     Medical Examiner Case Assessment Select Applicable Patient Criteria: Does not meet any of the listed criteria
Pt developed L sided seizures 24 hours after receiving PENTACEL, ROTATEQ and PREVNAR.  EEG is abnormal, so likely not vaccine related.  Pt was afebrile.  4/6/09 Received hospital medical records of 2/6-2/8/2009. FINAL DX: Tuberous sclerosis Records reveal patient experienced seizures of twitching of face, left eye deviation, left arm & leg & staring episodes.   Had been transferred to PICU from outlying ER for seizures & elevated liver enzymes.  Neuro consult done.  Tx w/antiseizure meds but continued to have brief seizure activity.  Tx w/additional antiseizure meds & no further seizures.  D/C to home w/ Neuro, genetics & PCP f/u.  Returned to ER 2/22/09. FINAL DX: partial seizure disorder Records reveal patient experienced multiple seizures of left eye deviation & left sided hypotonia followed by dazed appearance.  Had been seen in another ER recently & antiseizure meds increased due to multiple seizures.  Neuro consult done & meds adjusted.  D/C to home w/neuro outpatient f/u.  The patient has been diagnosed with tuberoses sclerosis and her seizures are continuing. There are unrelated tot he vaccine.
Tingling on face and left arm; Headache; Fatigue; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm right on 07Apr2021 at 09:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to latex, penicillin and dairy. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no other vaccines in other two weeks. On 07Apr2021 at 10:00 the patient experienced tingling on face and left arm, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tingling on face and left arm, headache and fatigue was resolving.    No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended: Patient full name added, address added. Reporter was patient, VAERS Primary Reporter Addl Qualification updated to patient. Protect Confidentiality was ticked. Known allergy: dairy was recoded as MILK ALLERGY per MedDRA.
Pt recv vax on 11/5/98; on 11/7/98 pt exp inflammation, red, mass at vax site x 2 wk;  tx=antibiotic, anti-inflammatory, analgesics
Swelling under left arm along the bra line. Excess fluid build up, a little bit tender. No fever no rash and not really warmer to the touch.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster. In April 2018, the patient received the 1st dose of SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster, eruption, pain and pruritus. On an unknown date, the outcome of the vaccination failure, eruption, pain and pruritus were unknown and the outcome of the herpes zoster was recovered/resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster, eruption, pain and pruritus to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose in April 2018 and 2nd dose in August 2018. The patient reported that last year she continued to had zoster outbreaks that last 4-6 days. The patient took pictures of the bubbly eruptions on my backside. The patient took a CE program presented by one of your educators and was very impressed at the safety profile and efficacy of SHINGRIX. The patient would like for someone representing your company to draw blood and find out if there was a immune response or titers in my blood appropriate to 2 injections of the drug. The outbreaks are about the same in duration, pain and itch as they were before the inoculations.
Chills; fatigue; generalized muscle pain; back pain; pain in the arm injected; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient received first dose of  BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot number: EK9321), intramuscular om the right arm, on 04Jan2021 at 16:00, single dose for COVID-19 vaccination. Medical history included allergies to mango and swiss chard. Patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient experienced chills, fatigue, generalized muscle pain, back pain, pain in the arm injected from 05Jan2021 at 01:00. Facility where the most recent COVID-19 vaccine was administered was in a hospital. No treatment was reported for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.   No follow-up attempts are possible. No further information is expected.
Patient received flu shot 9/12/09. She states she has felt nauseated and has flu like symptoms since that time.
pt recvd vax & 1130AM started screaming @ 1PM; screaming lasted 3-4 hrs; treated w/infant APAP drops  q 4 hrs;
BRIEF OVERVIEW: Admission Date: 9/8/2023 Discharge Date: 9/13/2023   DETAILS OF HOSPITAL STAY:   Clinical Narrative: Patient is a 78 y.o. male patient who presents with malaise, weakenss. He has history of alcohol use, COPD on 2L, GERD.   In the ED, he was hemodynamically stable, tested (+) for Covid. CXR with evidence of emphysema but no new infiltrate or effusion. Labs overall unremarkable, with mild hyponatremia 130, normal renal function, mild elevated transaminases <200, lactate normal, no leukocytosis or anemia.    He was hypoxic into 80's with ambulation off oxygen and additionally quite fatigued and weak such that his wife did not feel she could care for him at home.    He was treated for COPD exacerbation due to Covid and empirically covered for community acquired pneumonia.   His course was complicated by 1/2 sets of blood cultures with CONS which is likely a skin contaminate as repeat blood cultures have been negative to date.   Pt with significant functional debility requiring 1-2 person assist with all ADLs, bowel  and bladder incontinence, and severe COPD coupled with acute covid infection. Due to ongoing covid19 infection, a SAR facility could not be facilitated due to the closest facility being a few hours away from patient's home. Family elected to take patient home with home care services ordered. Electric hospital bed recommended on discharge to maintain HOB elevation and assist patient with ADLs.
Menstrual cycle started 2 days after the shot, which was about 5 days early for my usual cycle. Menstrual cycle lasted about 4 or 5 days longer than usual.
Patient was diagnosed with Guillain Barre Syndrome in late May.  Symptoms began in early May.  Lower extremity weakness and paresthesias.  He did not have any other proceeding illness that might be expected to cause GBS.  I do not necessarily believe the COVID vaccination he received in Jan and Feb caused his GBS.  On the other hand I don't have another explanation and thought it should be reported to VAERS
Information has been received from a physician concerning a 20 year old female patient (also reported as "21 year old" by the physician) with unspecified pre-existing dermatological conditions, who on 10-JAN-2011 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # not provided) IM. The physician reported that on 10-JAN-2011 the patient experienced a red spot at the injection site and dermatitis. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sore arm for 5 days starting evening of day of vaccine Flu like symptoms 1.5 days after vaccine date.  Symptoms included;  lethargy, headache, upper body aches radiating from injection site up neck and across upper back and shoulders.
Patient feeling poorly and had hives/swelling of arms/back. Went to ER was given EPIPEN and fluids. Reaction occurred over 24 hrs after dose. Pt made full recovery.
Mother of client called and reported "she had an allergic reaction. Her eyes swelled and her throat was closing up". Reports client took Benadryl, but had to go to clinic for treatment. States "She's ok now".