chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a Non-health care professional via other company (Merck) on 10 August 2016. This case involves a male (age was reported as unknown) patient who was vaccinated with TETANUS TOXOID ADSORBED (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The medical history and concomitant medications were reported as unknown. On an unknown date, after vaccination patient experienced swelling of the whole body. Lab data and corrective treatment were reported as unknown. The outcome of the event was unknown. List of documents held by sender: none.
Itching of tongue,  face, under arms & groin,  headache, intense chills & shakes,  fever 101.9, stomach pain, diarrhea  Still experiencing fever and diarrhea.
Expired Havrix  administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-DEC-2022 Reporter's Comment: The reporter was health care provider. The reporter called to report that a patient received an expired dose of Havrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email. Additional Supportive Information: The reporter called to report that a patient received an expired dose of Havrix, which led to expired vaccine used.
Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine.  Lightheaded, shortness of breath.  No history of Hypertension (though always on the borderline (averaging 120/80).
The patient had headache, fever, chills that started the day after the immunization. There was a red swollen spot the size of a gold ball around the injection site. The red spot became larger, about the size of a softball so the patient went in to urgent care a couple days later. They determined that there was an infection at the injection site and treated it with Clindamycin three times daily for 10 days. The spot has completely resolved.
Pt experienced a local reaction of redness and swelling the same day of receiving vax. Pt seen by physician three days post vax with redness the size of palm of hand extending downward from the injection site. Redness lasted for 5 days per parent.
Left with nasty scab; Hand was wet from where she had scratched/busted open water blisters on her hand; A rash and hives on that hand/rash unilaterally from the vaccination-side armpit to her breast and collar bone; A rash and hives on that hand; This is a spontaneous report from a contactable other health professional (patient).  A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at 14:00 at single dose for COVID-19 immunization. The patient medical history included breast cancer survivor, radiotherapy, psoriasis, pre-diabetic, hypertension, hypercholesterolemia and chronic obstructive pulmonary disease (COPD), all from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient reported that: " on 23Dec2020 at 6:00, she woke up and her hand was wet from where she had scratched/busted open water blisters on her hand (same arm that she received the vaccine in).  She also reported a rash and hives on that hand, and a rash unilaterally from the vaccination-side armpit to her breast and collar bone but nothing at injection site.  She stated she took BENADRYL, symptoms subsided until BENADRYL wore off, then resurfaced, took more BENADRYL, then symptoms resolved. Symptoms lasted about 24 hours post injection, patient was left with a "nasty scab" on her hand from where she scratched the water blisters". The patient outcome of the events was recovered except for the "nasty scab" whose outcome was not recovered.   Information on the lot/batch number has been requested.
Dizziness reported ~5 minutes after injection. Water and juice provided, LE elevated. Shortness of breath reported ~45 minutes after injection. After 1 hour of observation at Vaccine Clinic, patient transferred to Urgent Care per family request.
Sudden extreme acne on chest and back. Painful and itchy. After showering, hives on shoulders. Menstrual cycle delayed 1 week, was always every 28 days.   Acne started to subside after 3 weeks, then started again Jan 19, 2022.
This spontaneous report as received from a pharmacist refers to a 54 years old female patient. None pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 25-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneously, lot # L011537. expiration date 03-JUL-2016). On 27-AUG-2015, the patient sought medical attention, she came to the pharmacy and reported that she had swelling, slight redness and itching around ZOSTAVAX injection site. The patient also had spots on her lower back that could be chickenpox or shingles. No treatment was given for the adverse events and none lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Pt developed dermatomyositis over the few months following her mass vaccines for international travel (see attached history). Dermatomyositis is a rare, very serious autoimmune inflammatory muscle/skin disease. 1/5/10 Ongoing serious autoimmune conditions-deramatologists is still requiring subatartial daily immunoserppriadats (Celliept and Prednisone) as well as IVIg infurine mortally.  06/04/2007 VAERS report submitted with unsigned HPI attached.  Pt. initially experience low grade temps and fatigue for several days following multiple vax for foriegn travel in May 2005.  Upon returning from travel in 8/2005 pt. again experienced low grade temps and fatigue as well as bilateral shoulder and upper arm muscle aches and soreness as well as weakness. Skin flushing and pruritic nodules noted on wrists and elbows. By 9/2005 muscle symptoms and fatigue had increased as well as cuticle changes.  Txd with steroids, IVIG, Minocycline and topical creams to skin. DX: Dermatomyositis.  07/03/2007 MR received from neurologist for several visits beginning 8/28/2005 to 12/08/2005 for initial c/o profound weakness in the arms which was progressing. Pt also c/o hip pain and tightness as well as some skin irritation around the nail cuticle and skin discoloration of the chest area and knees. PE significant for minimal neck flexion weakness as well as minimal biceps/triceps weakness. Knee reflexes depressed. Skin discoloration noted at the cuticles, eyelids, knees.  DX: Dermatomyositis. Pt admitted to hospital 10/23/2005 for increasing weakness, swallowing difficulty and head/neck weakness r/t the dermatomyositis.  F/U 12/8/2005 doing well.
Information has been received from a health professional concerning a 33 year old male with no known allergies who on 27-MAR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) SC in the upper right arm towards the back. Concomitant vaccination included Engerix-B in the left deltoid. On 28-MAR-2007, the patient developed a swollen redness at the injection site. It was not warm to the touch and the patient was non febrile. The patient received no treatment. Over the counter Tylenol and Advil was recommended if needed. No product quality complaint involved. Additional information has been requested.
The night following the vaccination I was unable to fall asleep without my thoughts wondering (uncontrollably). This happened for about 2-3 days. A couple of days after the roof of my mouth was very sore and I started to get blisters in that area like it was burned.
Approximately, 45 minutes after immunization child got headache, vomiting, head jerking and leg numbness, went to ER and was given Benedryl was ok after that.
Around 2-3 weeks after receiving the vaccine, I was sitting and noticed my heart was racing really fast. The next morning it did not stop. On 5/1, I went to a doctor who said I was having an anxiety attack and was sent home. On 5/2, I was having palpations around 145/150. I went to the ER and they took my blood, and did a chest X ray. I checked in with my primary care who said I might have PAP. I went to a cardiologist who did a stress test and a 2 week and 24hr Holter monitor. No conclusive results were found so they did a tilt table test with no conclusive results. An echo of my heart was also conducted. I also get fatigued easily, headaches, dizziness, and heat flashes. I was prescribed propranolol which I did poorly on so I was put on cardanol which seems to be helping.
Initial misuse report received from a healthcare professional on 17 JUNE 2013. A patient received 0.1 ml of ADACEL intradermally instead of  TUBERSOL (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
pt recv 5JAN96 & 29FEB96 & there were no adverse rxn;On 27JUN96 pt exp negative seroconversion w/a negative IgG varicella titer;
On day 2 after vaccination. Pain and heaviness in left arm, which lasted 3 days gradually wearing off. Headache which went away with paracetamol. Extreme exhaustion, which has continued since the injection.  On day 6 after vaccination pain started in left arm at the site on injection. It became swollen, red and hot about 2 inches diameter around the injection site and also feels itchy. Extreme exhaustion persists too. On day 10 after vaccination also developing achiness in muscles especially around neck, back and shoulders. All the symptoms that started on day 6 are also ongoing.
Burning pain experienced in thighs on 11/10/2009 followed by bilateral lower extremity weakness on 11/11/2009.  Admitted to hospital on 11/15/2009 where he was treated with IVIG.
During post-vaccination observation period, patient developed hives. The patient was attended to by EMS but refused treatment.
Information has been received from a health professional concerning a 4-month-old female who on 28-JUN-2006 was vaccinated with a first dose of rotavirus G1 G 2G3 G4 P1 reassortant vaccine live (human-bovine).  No adverse symptoms were noted.  No additional information was provided.  Additional information has been requested. This is in follow up to report (s) previously submitted on 9/8/2006.  Information has been received from a registered nurse concerning a 4 month old female who on 28-JUN-2006 was vaccination with a first and second dose of ROTATEQ on 28-JUN-2006 and 28-AUG-2006, respectively.  Concomitant vaccines included a first, second, and third dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown) on 24-APR-2006, 28-JUN-2006, and 28-AUG-2006, respectively, a first and second dose of poliovirus vaccine inactivated (Vero) (IPOL) on 24-APR-2006 and 28-JUN-2006, respectively, a first, second, and third dose of hepatitis B vaccine, recomb (MSD) on 27-FEB-2006, 24-APR-2006, and 28-JUN-2006, respectively, and a first, second, and third dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (MSD) on 24-APR-2006, 28-JUN-2006, and 28-AUG-2006, respectively.  No adverse symptoms were noted.  No additional information was provided.  Additional information is not expected.
Pt presented SOB several days prior to receiving vaccine. His sister reported he had severe COPD and was getting progressively worse. On the day pt was vaccinated, his sister picked him up for the appointment and pt refused a wheelchair. Pt walked into the clinic on his own and recevied his vaccine. Sister reported pt walked to the car after his vaccine and was winded. She dropped him off at his house and called him later to check up on him. Pt stated he was feeling fine but his arm was sore. Pt's sister called the next morning and reported that he sounded terrible. He was strugging to breathe and was SOB. His sister went over to his house to check on him and wanted to take him to the doctor's office or the hospital. Pt refused at that time. Pt agreed to make a doctor appointment for later in the afternoon. Sister left at noon. She stated her brother had made a doctor appointment for 4:00 at Family Practice. Upon arriving, pt started walking towards the entrance and became SOB. His significant other asked the doctor's office for a  wheelchair and was denied. Pt coded in parking lot of Doctor's Office and passed away at 4:31 p.m.
Pt exp a burning sensation over body & skin turned bright red approx 1 hrs p/immun; tx DPH & Pred;
Approxiametly 4 days after receiving the second dose of the Moderna vaccine, I experienced heart palpitations and chest pain. I visited my physician and was diagnosed with a right bundle branch block due to inflammation in my heart.
Rash is persistent covering the left side of neck and chest; Rash is very Itchy; With in 10 mins heat feet came and went; Mild fever by night; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypothyroidism after total thyroidectomy, asthma and hypertension. The patient previously took flu vaccine (MANUFACTURER UNKNOWN), experienced vaccine allergy; soy (MANUFACTURER UNKNOWN), experienced allergy; shrimp (MANUFACTURER UNKNOWN), experienced seafood allergy; dust allergy, mold allergy and seasonal allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN), ertugliflozin pidolate (STEGLATRO), loratadine (LORATINE), Singular (Unspecified) and Statin (Unspecified) for unknown indication and on unknown date within two weeks of vaccination. 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. On 04Apr2021 within 10 minutes, the patient experienced heat feet which came and went. On 04Apr2021 by night, the patient had mild fever. On 05Apr2021 next day, the patient experienced rash which was persistently covering the left side of neck and chest. The patient was not able to get rid of it, had read that it can last for 7 days and the rash was very itchy. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event heat feet, mild fever by night, rash on left side of neck and chest and itchy rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
vaccination side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination side effects). At the time of the report, VACCINATION COMPLICATION (vaccination side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: NNI- Non-significant follow up appended in which Email address updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SWOLLEN EYES,LEFT ARM SHIVERING, COLD SWEAT SORE THROAT
Parent called and verbalized child c/o headache day of vaccines,body ache,headache, nausea and vomiting three days after vaccines.
no adverse event; an improperly stored ROTATEQ that was administered; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On 25-OCT-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1707460, expiry date 14-MAR-2022, orally for prophylaxis. The dose was stored at 14 Celsius degrees (C) for 3 hours. There was no previous temperature excursions and the patient had no adverse events.
On Jan 2, arm began itching. Got worse and 1 day later heat & redness began than increased until the patient took Benadryl. I advised ice- good results.
Information has been provided from a physician's assistant concerning the daughter of a nurse who was vaccinated with the first doe of GARDASIL vaccine (dose and site not reported). It was reported that the patient developed an allergic reaction to the GARDASIL vaccine. The patient developed shortness of breath and asthmatic type symptoms. The patient did not "come in" for any additional follow-up or any medical treatment. Additional information has been requested.
This is a spontaneous report from a non-contactable consumer that reported for a patient (patient's sister-in-law). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pneumococcal pneumonia on an unspecified date and then died. It was not reported if an autopsy was performed. No follow up attempts possible. No further information expected.
Information has been received from a certified medical assistant (C.M.A.) concerning a 6-year-old male with a history of mild lymphoid hyperplasia and no allergies, who on 25-APR-2001 was vaccinated subcutaneously in the left arm with one dose of Varivax (lot # reported as "1574K") and "1314K"). Concomitant vaccination included a dose of MMR II (lot# 631048/0105K) given subcutaneously in his right arm and the patient also had Tubersol (lot# C0999AA) given intradermally in the right forearm. There was no illness at the time of vaccination. On 27-NOV-2006, after the child was exposed at school, the patient developed chickenpox, characterized by 15-20 eruptions on his face, trunk, arms and legs. Unspecified medical treatment was sought and the patient was treated with diphenhydramine hydrochloride (Benadryl). No laboratory or diagnostic tests were performed. At the time of this report the patient had recovered. No product quality complaint was involved. Additional information is not expected.
Several vesicles at injection site, followed by patch of erythema & induration expanding to 8 X 10 cm by 5/13/09.  Borders slightly raised, mildly tender.  Right deltoid region mildly swollen.
broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. In August 2021, 12 hrs after receiving Shingrix, the patient experienced hives. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. At the end of august this year the patient received the 1st shot of Shingrix and broke out in hives 12 hours later. The event had lasted for 3 days .  The patient was prescribed prednisone which helped minimally. On the 3rd day the patient took Benadryl which turned the tide.
MULTIFOCAL MOTOR NEUROPATHY PATIENT IS BEING GIVEN IV-IG TREATEMENTS THAT WILL CONTINUE OVER THE NEXT 24 MONTHS
Lightheaded and fatigue few days after shot.  Dizziness/vertigo 3 weeks after vaccine. Lasting a week currently. Unable to drive.
from ED notes: presenting with 3 witnessed back-to-back seizures.  Patient does not have a history of seizure disorder. On presentation here in the ER vitals notable for temp of 37.4, heart rate 122, respiratory rate of 25, oxygen saturation 96% on 6 L with a blood pressure of 179/99.  Labs on presentation are notable for white count of 16.2, hemoglobin at 16, platelets at 247, sodium 137, potassium at 3.2, creatinine at 1.15, bicarbonate 18 with anion gap of 18.  EKG done admission, personally reviewed, notable for sinus tachycardia with right bundle branch block (RBBB present on the EKG from 11/17).  Additionally underwent a CT of the head on presentation which was notable for IMPRESSION: 1. No acute intracranial abnormality identified. 2. Minimal low-attenuation changes involving the periventricular white matter suggesting microvascular ischemic disease.
Pt's mother placed phone call to clinic on 4/26/01. States after shots given on 4/24/01, pt would not walk due to discomfort in left leg. States pt would cry. Reports knot on this leg at site.