chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the flu vaccination at the respective location, on the date and hour listed above. I was with my roommate, friend, and fellow pharmacy student. I had the typical side effects from the vaccine including sore arm, mild fatigue in the couple of following days. Roughly 5-7 days after the vaccination, I began feeling slightly short of breath which would progress to moderate shortness of breath until date of hospitalization. I also, began to have palpitations and heart racing which would not go away. These symptoms went on for roughly 1 week before I sought urgent care which then referred me to the hospital. After a series of tests, imaging, etc. I was found to have multiple, small blood clots (pulmonary embolism) in my right lung. My hypercoagulable workup was negative, as well as US doppler for any evidence of simultaneous DVT. I was treated with LMWH therapy (lovenox) while in the hospital where I was eventually transitioned to apixaban. I was released a few days later. I was on no other medications and had no other concurrent illnesses at time of hospitalization. I was physically active and working on pharmacy rotations until that time. This is the first of two pulmonary embolisms I would be hospitalized for in two consecutive years. With the second occurring almost one year later in October 2018, also coincidentally after receiving the same manufacturer FluArix vaccine in the same two week (following administration) time frame as this first thromboembolic event. This will be in a separate reported entry on VAERS. During the second event, I was anticoagulated on Apixaban 2.5mg daily.
w/in few days of vax pt devel vertigo, n/v;no other sx;+ mild end gage nystagmus rt gaze;pt reports similar rxn last time recv flu shot;
Redness at injection site that extended down arm to elbow. Swelling at injection site. Patient went to urgent care the day after injection and was given prednisone and pepcid. The day after treatment was initiated the patient states the redness has gone down slightly.
Follow up information has been received on 18-APR-2017 as a part of media monitoring and as a literature article. During July 2015 to May 2016, a mumps outbreak occurred at the University diagnosed among students. To characterize the outbreak, an investigation was conducted through telephone interviews, medical chart abstractions, and review of immunization records. Among 287 (95%) students with mumps for whom clinical information was available, 20 (7%) patients with complications were identified (16 self-reported and four clinician diagnosed). The 20 cases included 15 (5%) cases of orchitis, three (1%) of transient hearing loss, two of mastitis, and one of meningitis (one patient had both orchitis and transient hearing loss). All 20 patients had documentation of receipt of at least 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). Because data were limited regarding the presentation and clinical course of mumps complications in persons who have received 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) three illustrative cases of complications (orchitis, transient hearing loss, and meningitis) in students with mumps were presented. This case pertains to a 21 year old male patient. On unspecified dates, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (route and site of administration, lot # and expiry date were not reported). On 02-NOV-2015, he developed left facial pain and swelling and tested positive for mumps by polymerase chain reaction (PCR) on a buccal swab specimen. In approximately November 2015, twenty-two days after onset of symptoms, he was treated at an emergency department for neck stiffness, fever, and tachycardia. A lumbar puncture was performed, and he was empirically treated for meningitis with acyclovir and ceftriaxone. Volume of cerebrospinal fluid was inadequate for performing PCR testing for mumps, but Gram stain and bacterial culture were negative, and analysis was consistent with viral meningitis (40 lymphocytes/mm3, 60 mg/dl of protein, and 67 mg/dl of glucose). Because the onset of mumps-related meningitis was described as ranging from 4 days before the onset of parotitis until 3 weeks after, the patient's viral meningitis diagnosis was attributed to mumps. He was discharged with recommendations for symptomatic care, and meningeal symptoms resolved within 1 week in approximately 2015. The case studies underscored that complications occurred even within vaccinated populations and could present at varying times throughout the course of illness and even when parotitis ended.This case is linked with the same literature article (MARRS# 1704USA013976 and 1608USA004560). Additional information has been requested. Sender's Comments:  US-009507513-1704USA013976: US-009507513-1608USA004560.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
This is a 14 month old female who was in a state of good health until approx. 4 days ago. A week prior, the child had an MMR shot and had been started on Amoxicillin, at the time, for presumed otitis media. The pt had been on Amoxicillin when she developed a fever, 4 days ago. The pt was treated with Tylenol and she has had persistent fever off and on since then. This morning, mom noticed that she had a red rash over her face and subsequently, noted a rash on the rest of the body as well. The pt was taker to ER, where she was noted to be febrile and had a maculopapular generalized rash. There was no neck stiffness and the pt was hemo-dynamically stable. Oxygen sats were 92% in 1 liter nasal cannula O2. Temperature was 104.2F. The pt was given a dose of Cefotaxime IV and transferred to another hospital for further management. The child has been listless all day. HR-144; Resp-26. On exam, throat appears slightly congested. Chest has occasional respiratory rhonchi. The dx is most consistent with a viral exanthem. Will observe closely in the ICU, IV Cefotaxime (pending culture results), symptomatic management of bronchospasm and coughing and if the child remains listless over the next several hours, will consider doing a lumbar puncture.
Information has been received from a nurse concerning a 13 year old female who in approximately June 2007, was vaccinated with Gardasil (0.5 ml).  The patient subsequently experienced pain at the injection site following the vaccination.  At the time of this report, the injection site pain persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Patient had no symptoms or adverse events until the next evening after shot (1/29/21) where daughter reported her having heart palpitations. Family told her to rest and did not seek medical attention. Saturday afternoon (1/30/2021), patient started experiencing labored breathing. Daughter called 911 and before the ambulance arrived, the patient's breathing became more and more shallow. Patient was taken to the local hospital and passed away Saturday evening around 5:30 pm.
I received an H1N1 at 11 weeks pregnancy. All was going well until I took the shot. I had a severe back ache and flu like symptoms the next day. A few days later, I miscarried. I feel like there may be a connection between the shot and the miscarriage.
Fatigue; shortness of breath; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 08Jan2021 at 10:00 AM, at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 50-years-old. Facility type vaccine was public Health Clinic/Veterans Administration facility. No other vaccine was received in four weeks. Medical history included blood pressure high (HBP), Sjogren's syndrome, Raynauds. Concomitant medications included sambucus nigra (ELDERBERRY), fish oil, magnesium, vitamin NOS (MULTIVITAMIN). On 09Jan2011, the patient experienced fatigue and shortness of breath. No treatment was received for the event. Outcome was unknown.
Slightly raised, slightly blotchy, itchy rash around injection site 8 days post-injection.  Itchiness lasted less than 24 hours.  Rash still slightly visible about 24 hours after first noticed.
POST VACCINE, C/O PULSATING LUMP IN THROAT, NUMNESS IN VACCINATED ARM, PAIN IN THROAT 2/10 WITH TIGHTNESS FOLLOWING AFTER, AS WELL AS PRESSURE IN EAR. BILATERAL LS CLEAR, TOLERATING COLD WATER, STARTED TO IMPROVE. SIG OTHER COMING TO DRIVE PATIENT HOME, AND BROUGH HOME MEDS INCLUSING FLONASE, PATIENT USED AND STATED FELT MUCH BETTER. VSS THROUGHOUT. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S IMPROVED, INSTRUCTED TO SEEK FURTHER EVAL/TREATMENT IF S/S RETURN/WOSREN. EXITED 1600. 1503 BP 119/81 HR 67 RR 20 SATS 99% RA 1515 BP 124/81 HR 94 RR 18 SATS 100% RA 1545 STANDING BP 118/84 HR 80 RR 20 SATS 100% RA
Called by Med Exam on 8APR91 child found expired @ home; Likely "SIDS"-autopsy pending @ time;
Pfizer on 1/29 and 2/19. Positive on 9/7 admitted 9/7 to now
1st dose on 27Aug2018, 2nd on 12Apr2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NK3R, expiry date 11th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th August 2018).   On 12th April 2022, the patient received the 2nd dose of Shingrix. On 12th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The pharmacist called to inquire the patient need the second dose again or how did it work. The pharmacist reported the patient did not received the second dose until 12th April 2022.  How to proceed since the patient was over 6 months for the second dose. The healthcare professional confirmed that the patient received both the first and the second doses at other facilities and not theirs.  The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Developed herpes zoster opthalmicus and several herpetiform lesions on posterior chest bilaterally.  5/13/08 Reviewed PCP medical records which consisted of vax record & hospital d/c summary.  Hospitalized from 4/27-4/30/2008. FINAL HOSPITAL DX: left periorbital pain secondary to herpes zoster ophthalmicus. Records reveal patient experienced URI s/s approx 3 wks prior to admit.  S/S persisted & intensified.  Tx w/antibiotics for presumed sinusitis.  Developed left periorbital edema, mild erythema & increased facial pain w/low grade fever.  Tx w/IV antibiotics for presumed orbital cellulitis.  On day of admission, developed chest lesions then developed forehead lesions.  Tx w/antiviral & ophthal consult done.  5/23/08 Reviewed additional hospital records of 4/27-4/30/2008: H&P & labs.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported. No treatment medication was reported.  This case pertains to the 2nd patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
No adverse reactions at this time  Adult pt received undiluted Pfizer Pediatric 0.3ml dose
Patient called 2 days after vaccination reporting an injection site reaction of swelling, redness, and pain at site. Described as a sizeable knot under the skin around the injection site. States she also had mild fever and some nausea but denies other symptoms/reactions.
arm soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness at injection site ) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Antidepressant therapy.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at injection site ). At the time of the report, VACCINATION SITE PAIN (arm soreness at injection site ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   This case was linked to MOD-2021-092565 (Patient Link).
temperature excursion involving GARDASIL 9 / a dose of GARDASIL was accidentally administered to a female patient; a dose of GARDASIL was accidentally administered to a female patient who is age 46 years old; The patient is not having any adverse effects from the immunization; This spontaneous report was received from a physician, referring to a 46-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was accidentally administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, frequency, vaccination scheme, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prophylaxis, that experienced a temperature excursion (product administered to patient of inappropriate age and product storage error). The patient was not having any adverse effects from the immunization.
Redness and hotness to face.  Given 25mg Benadryl PO at site, given additional 25mg Benadryl PO to take if issues persisted.
2 episodes of syncope on the evening of the day after receipt of vaccine. Child otherwise had been well. Seen in ED, + Orthostatic changes on vitals. EKG WNL Given PO fluids and discharged home
Severe sore arm. Then it went away after about 24 hours then came back 7 days later.
1.)  12/09/2009; My left arm was a bit sore after the shot like a bruise feeling.  It was anticipated. 2.)  12/09/2009 thru 12/13/2009; My arem was still very sore and I thought the feeling was lasting longer than anticipated. 3.)  12/14/2009 thru current 12/18/2009; I have extreme pain with the arm; moving it in every direction is extremely painful (to the point of crying).  I am very weak in the arm and can not lift things.  I went to see the doctor today, (09/18/2009), and since the exam the problem has gotten a bit worse.  Worse in a sence that my upper left shoulder and lower left back are sore.  Along with a paralysis type feeling.  The arm is not numb, but my arm is having trouble responding to brain commands. (???) The doctor thought there was no nerve damage and that my reflexes were good.  She thought I should inform my physician and there isn't anything that anyone can really do for it but monitor it.  She told me to continue the Motrin and/or Advil.
Began to feel short of breath while at rest, later experienced throat tightness.  Was more frequent while at work and occurred on and off for over a month.  I suspect it's a change in how my allergy to mold presents.  Previously it was a just congestion.  Work had a likely mold outbreak due to issues with the HVAC system.
Severe body aches, headache, chills 24 hours, treated with tylenol every 6 hours
fever (101.5), chills with extreme shaking, muscle ache, nausea, elevated heart rate (110 bpm) - onset 8 hours after vaccination. Treated with Tylenol.  Symptoms lasted approx. 12 hours after onset. Tyenol relieved symptoms except elevated heart rate.
Patient was fine after vaccine, walked to front of store then fell. Said she felt dizzy, but never lost consciousness. Called ambulance since she hit her knee on boxes.
On 12/23/2021, I received my Pfizer booster. Almost 24 hours later on 12/24/2021, I started having persistent cardiac arrhythmias. I felt nauseous and fatigued. I checked my O2 saturation, which was normal. However, my blood pressure was high and my heart rate fast. I wasn't able to do anything without feeling faint. At about 4 PM, I blacked out while walking through my house and fell. My adult son came over to have Christmas dinner, and he expressed concern, because I didn't look well. I would move from one room to another and immediately have to sit down, because I would get dizzy. My blood pressure was up, and I kept checking it; it was 170/120 with no exertion. My elevated blood pressure and dizziness lasted for about 10 days. The blood pressured dropped to about 140/95 after about 5 days. I was hesitant to call my doctor, because I was sure I would be told to go to the ER. I was terrified to go to the ER, because I knew they were swamped, plus I was afraid I would contract COVID. Instead, I ate healthy food, drank plenty of water, and I got up to walk through the house about once every hour. I slowly got better, but at the time of this writing, I still have occasional episodes of rapid heart rate without exertion and a feeling of faintness. Whenever I climb the stairs, my heart intermittently starts pounding; this never happened until I got the booster.
Pt complained of chest pressure and no other symptoms. Pt stated she had same symptom the day befor. Vital signs taken and were within normal limits. 127/79, p 78, SaO2 100%, conferred with Anesthesia, Pt to ED for evaluation.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 at 16:00 as dose 3 (booster), single (Lot number: FJ1618) at the age of 61 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "PE", start date: 2013 (unspecified if ongoing), notes: PE in 2013; "Low oxygen levels" (unspecified if ongoing), notes: Low oxygen levels (avg. 87); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: XARELTO. Vaccination history included: Pfizer (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Leg Right, Vaccine Administration Time: 03:00 AM), administration date: 04Mar2021, when the patient was 60-year-old, for COVID-19 immunization; Pfizer (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 25Apr2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2022, outcome "not recovered", described as "Can't walk for long periods of time"; DYSPNOEA (non-serious) with onset 2022, outcome "not recovered", described as "Hard to get breath on occasion"; HEART RATE INCREASED (non-serious) with onset 2022, outcome "not recovered", described as "Heart beating faster avg. 103 resting"; CHEST DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "Righting feeling around chest sometimes"; ASTHENIA (non-serious) with onset 2022, outcome "not recovered", described as "Very low energy". The events "heart beating faster avg. 103 resting", "righting feeling around chest sometimes", "hard to get breath on occasion", "can't walk for long periods of time" and "very low energy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chest discomfort, dyspnea, gait disturbance, asthenia. Additional information: patient had heart beat faster than average 103 resting and righting feeling around chest sometimes and was hard to get breath on occasion. patient can't walk for long periods of time and had very low energy.
I experienced a fever a few hours after the vaccine, which only lasted a few hours. I also experienced some injection site pain. Approximately 1 week after the vaccine I developed a large red itchy rash that covered most of my upper left arm by the injection site that lasted about a week.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, patients were vaccinated with (Oka/Merck) VARIVAX, 05. ml, once, subcutaneous (lot number was not reported). Concomitant medications were not reported. Nurse stated that an unspecified number of patients may had received (Oka/Merck) VARIVAX (dose in series unspecified) that was stored improperly at 6.5F for 30 minutes cumulatively (10 minutes each excursion). Nurse stated vaccines were administered on 30-JUN-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
red hives approx 4cm in size @ inject site; no s/s of itching
redness; itchy; warm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd May 2019, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. In May 2019, the outcome of the injection site erythema, injection site itching and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced a red arm at the injection site immediately which the patient described as the size of a hot dog bun.  Less than a day after vaccination, the area was not inflamed but it was red, itchy and a little warm. The symptoms resolved after a week. The reporter had consented to follow up.