chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles after the shot/ Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital 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 provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles after Shingles shot. The physician said many people do so. This case was linked with the case US2021AMR224139, reported by same reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224139:Same reporter
This spontaneous report was received from a licensed practitioner nurse and refers to a unspecified number of patient of unspecified demographics. On an unknown date the patients were vaccinated with GARDASIL dose 2. Nurse stated that a client was vaccinated with a second dose of GARDASIL 6 months after the first dose. Nurse stated that they were a large practice and they have clients that occasionally come in late for the GARDASIL vaccination. No adverse effects were reported. On an unknown date the patient experienced a client was vaccinated with a second dose of GARDASIL 6 months after the first dose and no adverse effects reported. Additional information is not expected. No new follow-up information was received. The case will not be voided because there are another unspecified patients mentioned, who received delayed doses of GARDASIL.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/9/2021 and 3/30/2021. Presented to ED on 11/12/2021 with complaints of difficulty breathing, fever, and chills. Reported previous tx'd at home with decron 6mg POD x7 days, tessalon and azithromycin without relief.  Admitted 11/12/2021 for acute respiratory failure with hypoxia, Covid-19 pneumonia and sepsis of undetermined organism. Reports testing positive for COVID on 11/5/2021.  Inpatient treated with remdesivir, dexamethasone, and antibiotics. On 11/15/2021 patient's Airvo demand rapidly worsened to 93 FIO2/60L with sats of 92%. Transitioned to comfort care and expired on 11/20/2021.
Local erythema, tenderness over the injection site about 3 x 3cm. Rash, lesions or vesicles.
It became slightly difficult to breathe a minute or two after the injection and became lightheaded. Breathing problems only lasted a few minutes and the light-headedness maybe 20 minutes. Joint pain in my fingers the next day. (Strangely, my reaction was similar to what I get when I ingest sulfites; which I haven't consumed in a long time.)  My arm was incredibly sore after the shot and became slightly swollen. The sore arm lasted 10 days. Prior to this, the longest I've ever had a sore arm from a vaccine is 3 days. Was also from a meningococcal shot, MCV40.
Patient became extremely pale, lightheaded, experienced "bloody" taste in mouth immediately after having MCV4 administered. Patient was monitored for approximately 20 minutes, was given water to drink, had normal skin color return and left clinic with parent after symptoms resolved. Was advised to seek medical attention if symptoms return or call if has any questions.
Pt. reports mild fever approximately 8 hrs after vaccine. Self-limiting, resolved = 24 hrs.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses ROTATEQ (lot # L048854, Expiration date 31-AUG-2017; batch L035637, Expiration date 09-JUN-2017; lot # M019708, Expiration date 25-OCT-2017) (dosing details not know). The administered doses experienced a temperature excursion of 49.7 degree Fahrenheit for 8 hours. The call was because of a data logger. There was no previous temperature excursions. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
One minute after receiving the GARDASIL vaccine, the patient developed dizziness, nausea and abdominal cramps. T 98 BP decreased/cannot be determined - patient subsequently vomited. After 10 mins BP improved, 103/76.
Have had the shingles 7 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient had one shot and had the shingles 7 times.
The pt developed a 6 x 9cm are of erythema and induration around the area of DTaP administration.
Patient had hallucination, unusual behavior, felt that bugs were buzzing around her head, was seeing strange things, was also not making sense while talking.
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. In 2015, the patient was inoculated with the ZOSTAVAX vaccine, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, and on an unknown date, the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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. The outcome of the events was considered to be not recovered. Additional information has been requested.
Chills, shaking, headache, achy joints, nausea - lasted about 6 hours
A report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Nov-2012. The patient experienced gave 16 month old FLUMIST which started on 27-Nov-2012. The outcome of the event of gave 16 month old FLUMIST is unknown. The report was considered to be non-serious.
I got the shot during the day, later that night I felt as if I was getting the flu, just sort of  icky feeling. By the next morning , after I was up and moving for a while, my chest felt heavy . By about 24 hours after I got the tdap it was becoming difficult to breathe. I didn?t have an appetite for about 5 days. It became more difficult to breath doing normal daily things. I never had a problem going up our stairs, now I have to stop. Before this shot I had been walking our new dog 5-7 days per week, we would do fast speed walking for a half mile, then walk another half mile. I was never out of breath or winded, only my heart would beat faster, as to be expected. Now walking short distances I get out of breath. If I talk in conversation about 30 minutes I am short of breath .If I do too much talking, and or walking I add to the heavy feeling in my chest/lungs and a burning feeling .It reminds me of having pneumonia. I have had PFT, stress treadmill test, CT scan, and heart angiogram, all tests have shown nothing. All of this started after the tdap shot. I am told by Dr. to build my endurance, I HAD endurance built up until I had the tdap shot. I am tired, feel like I?m going to get the flu, have more and more headaches daily. I  use to play WITH my grandchildren, now I sit and watch them play, after trying to play with them. I keep trying to build endurance back, it?s Not getting better. My chest hurts, it?s hard to breath. An inhaler didn?t help.
Cellulitis right thigh since day after immunization, full recovery on amoxicillin.
Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In November 2021, the patient experienced BRONCHITIS (Bronchitis). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. In 2021, BRONCHITIS (Bronchitis) had resolved.            No concomitant medication was reported. The patient went to the emergency room and got a special cough syrup, cough pills, expectorant syrup, Amoxicillin, Prednisone. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
9:48 am Np called into room when pt c/o feeling dizzy & sweaty after Hep B #1, Tdap, and Gardasil #1 given. Appeared pale, BP 104/60, pulse 64, pulse ox 98%, pt moved to exam table and had lie flat. 9:51 am pt talking  Bp 106/62, pulse 52, still lying down, feels alittle better. 10:02 am pt sat up on table BP 100/72 pulse 56.  10:10 am pt moved to chair, states feels OK, Bp 94/60, pulse 46, alert & oriented x3; gave apple to eat (no breakfast); 10:20 am BP 104/70, pulse 60, A & Ox3, steady on feet and ambulating. Verbaliezed feeling back to normal.
Vaccine was administered more than 12 hours after the puncture; Patient received Moderna Covid-19 vaccine after the manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered more than 12 hours after the puncture) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered more than 12 hours after the puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered more than 12 hours after the puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The date of the vial initially stored in refrigerator was unknown. It was reported that the provider was not aware that a punctured vial was only good for 12 hours and expired vaccine was administered to the patient. It was reported that vial did not undergo any temperature excursions. No adverse reactions or side effects were reported. No treatment drug was reported.   This case was linked to MOD-2022-577155 (Patient Link).   Reporter did not allow further contact
She developed local reaction at the injection site. Right arm with pain, swelling and erythema (Pnuemovax site)
PLAQUE PSORIASIS FLARE UP; STRESS FLARE UPS; SICK; PAIN IN ARM; MUSCLE PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE UP), STRESS (STRESS FLARE UPS), ILLNESS (SICK), PAIN IN EXTREMITY (PAIN IN ARM) and MYALGIA (MUSCLE PAIN) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE UP), STRESS (STRESS FLARE UPS), ILLNESS (SICK), PAIN IN EXTREMITY (PAIN IN ARM) and MYALGIA (MUSCLE PAIN). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE UP) had not resolved, STRESS (STRESS FLARE UPS) was resolving, ILLNESS (SICK) outcome was unknown and PAIN IN EXTREMITY (PAIN IN ARM) and MYALGIA (MUSCLE PAIN) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant product reported by reporter. No treatment medication reported by reporter.
2 weeks after shot complaining of vision issues that worsened over the following months. Eventually called Posterior Cortical Atrophy that spread throughout the brain, leading to full incapacity and death.
03/13/13 7 pm: General malaise; 03/14/13 6 am: febrile and body aches; 03/14/13 5 pm: slight axillary lymphadenopathy; 03/15/13 6 pm: axillary edema.
Patient is a 75 y.o. male with medical comorbidities significant for prior CVA, hypertension, hyperlipidemia, type 2 diabetes mellitus c/b diabetic retinopathy, s/p gastric bypass NASH, OSA, CAD, PAD s/p right SFA to peroneal artery bypass, CKD Stage IIIB and recent hospitalization (06/23-07/02) for intestinal perforation requiring ex lap for repair of gastrojejunostomy marginal ulcer. His hospitalization was complicated by acute renal failure requiring iHD which improved prior to discharge, and delirium. He presented to the ED today for evaluation for 3 days of cough and poor oral intake. In the ED he was afebrile and hemodynamically stable. Oxygenating well on room air. Labs were notable for
6 days after 2nd vaccine - onset of vertigo - continues on and off (now on day 4)  Initial illness 24 hour after vaccine - malaise, fever, feeling poorly - lasted 48 hours and then feeling almost back to normal before vertigo started
Went to Emergency room with redness, swelling, fever at site of pneumococcal vaccine.
PATIENT CALLED HEALTH DEPARTMENT 20-30 MIN AFTER RECEIVING INACTIVATED INFLUENZA VACCINE AROUND 1610 ON MONDAY, SEPTEMBER 26, 2011.  CALLED WITH COMPLAINS OF TIGHTENING TO FACE, THICKENING OF TONGUE AND BACK OF THROAT.  STATES HAS HIVES TO FACE AND NECK.  HAS HAD FLU SHOTS FOR 2 YEARS AND NEVER HAD A REACTION LIKE THIS.  IS INTOLERANT TO BENADRYL - BECOMES TACHYCARDIA WITH AND INTOLERANT TO SOME SINUS MEDICATIONS AND PERFUMES.  DOES STATE SHE IS INTOL TO LATEX POWDER BUT ONLY WITH PELVIC EXAMS AND SHE USES CONDOMS FREQUENTLY WITHOUT PROBLEMS.
Approximately eleven hours after vaccination patient reports extreme chills, increased blood pressure, irregular heart rate, and headache.  This reaction prompted a call to EMS.  Emergency responders medically evaluated the patient and confirmed hypertensive status and irregular heartbeat suggesting patient follow up with her cardiologist.  Patient is now recovered.
Received vaccines early afternoon. By late evening, began to  feel nauseous. 6/18-6/20/16 Patient reported nausea, achy, tired. Arm was swollen and red. 6/21/16 DR. looked at it and reported allergic reaction. Patient took Cetirizine then BENADRYL at bedtime. 6/22/16 improving, arm improving.
That day felt "off" and had fever and pain at the site. Next day woke up still febrile with HA and nausea, fever to 102, and local hematoma/ pain at the site. Lasted 48 hours. All of those I realize do not require a VAERS. The VAERs is written because on complete discussion of the event with Mom, there is a concern for true ataxia vs just being unstable and in pain on the L side. Was unable to walk c/o mild pain but reeling to the right that Mom thought was just from pain in the leg; however, patient described the room "swimming" and would throw up / get nauseated with quick movements; she was unstable or falling over SITTING and to the right consistently so they allowed her to stay laying down. For 4 meals she stayed on the ground and ate her meals on the floor so she would "not be swimmy" and not fall.  By 48 hours symptoms markedly improved and just a hematoma at the site. She is 100% back to normal.
severe chest pain like severe heart burn attack/the doctors do not think it is heart burn/radiating pain into the right arm and lymp nodes; blood pressure was through the rood; severe pain; cardiac issues; GI issues/GI malfunction of the pancreas and gallbladder; GI issues/GI malfunction of the pancreas and gallbladder; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities/She is unable to eat and is very weak; can not eat, work, or engage in daily activities; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Mar2021 09:45 (Batch/Lot Number: Unknown reported as either EN6205 or EM6205) as SINGLE DOSE for COVID-19 immunization; azithromycin (ZITHROMAX), via an unspecified route of administration from 26Feb2021 until 02Mar2021, at unspecified dose and frequency for dental care; and corticosteroid (CORTICOSTEROID), via an unspecified route of administration from an unspecified date with last dose shot on 23Mar2021 at unknown dose, once or twice a year for a couple of years for knee pain and joint pain .  Medical history included dental procedure on an unknown date. Concomitant medications were not reported. On 25Mar2021 (9 days later), she developed severe chest pain like severe heart burn attack radiating pain into the right arm and lymph nodes, blood pressure was through the roof and was in severe pain. She was unable to eat, was very weak and also cannot work or engage in daily activities noted in Mar2021. The patient required emergency room and physician office visit due the events (including cardiac issue and GI issues/malfunction of the pancreas and gallbladder). She was hospitalized on 03Apr2021 and was just released on 04Apr2021. During hospitalization, doctors have ruled out cardiac issue and GI issues/malfunction of the pancreas and gallbladder and they cannot find out the cause. The patient received famotidine (PEPCID), omeprazole (PRILOSEC), pantoprazole (PROTONIX), acetaminophen (TYLENOL) as treatment. While in the hospital they gave her dicycloverine (BENTYL) which she thought was for nausea noted in 2021.She stated a week after she got the vaccine she got a corticosteroid shot which she was wondering if it can impact one's immune system and cause an adverse reaction with the vaccine. She also stated that a month prior to vaccine she took an azithromycin. She also was wondering with the combination of all these three things being close together if it may have caused a disruption in her body organic system. The action taken in response with the adverse event for azithromycin was post therapy while unknown for corticosteroid shot. The patient did not recover from chest pain while outcome of the remaining events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021376222 Pfizer
Immediately after injection patient c/o feeling very dizzy. We elevated her legs immediately. within seconds she lost consciousness. Rph safely lowered patient to the floor and tried to wake patient. She was breathing very shallow, and eventually made a huge gasp for air. She was coughing and very confused. Patient began stating she was having trouble breathing and was reaching up for me and holding her neck at the same time. her head was extended all the way back as if she was trying to straighten her airway. Epi 0.3 was administered. Patient began to control her breathing again, but also began having symptoms of panic. Ambulance arrived. Spoke to patient today and she informed me that the ER believes she had an allergic reaction.  Also was experiencing an irregular heartbeat and she has been referred to a cardiologist for further evaluation, Patient was asked to stay overnight in hospital, but she declined.
Patient was administered the Moderna COVID-19 vaccine at 17 years of age, which is below the authorized use of the vaccine which is 18 years and older. No adverse effects were noted. Patient was monitored for longer than usual to ensure they were safe after receiving the vaccine. Patient was notified shortly after receiving the vaccine and provider was consulted and notified. Consultations occurred within 15 minutes of administering the vaccine. Patient seems well and was sent home as with all other patients but instructed to monitor for any side effects and notify us and their provider if any events occur later.
Patient was given vaccine Boostrix in Dr. office (L) deltoid. Patient came back to office 2 days later for a quarter size raised rash at inj site
HCP stated the Flublok was given to 3 kids who are under the age of 3; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is a linked case with 2019SA331939 (same reporter).  This case involves a 9 months old patient who experienced hcp stated the flublok was given to 3 kids who are under the age of 3 (product administered to patient of inappropriate age), while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  It was a case of actual medication error due to product administered to patient of inappropriate age.   It was not reported whether the patient had any adverse effect.  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 and Module VI of the 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.  Information on the batch number of FLUBLOK QIV was requested.
Diffuse pink macular exanthem less than 4 days, with facial edema and itching.  Temperature of 100 degrees for 4 days.  Treated with dexamethazone, right anterior thigh.