chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from other health professional of unknown age who was enrolled in a study as an elderly subject entitled first ZOSTAVAX trial. Patient's previous medical history and previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with first dose of ZOSTAVAX (strength, dose and frequency unknown). No concomitant medications were reported. Approximately in 200, at the end of trial patient was informed that he had received ZOSTAVAX. However in the letter patient was informed that second blister dose might be needed. Approximately in 2003, patient discarded the file containing trial contact information. Patient was now contacting as leader of recent journal article addressing shingles. Approximately in 2013 (over the last year), patient developed tingling-itching feeling at bedtime. Patient's family doctor concluded that this problem was not connected with shingles. Patient would like to contact the original principle investigator located agency about this possible side effect and or responsiveness. Action taken with ZOSTAVAX was not applicable. The outcome of tingling-itching feeling at my beltline was unknown. The causality of tingling-itching feeling at beltline to ZOSTAVAX was not reported. Additional information has been requested.
received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Dec-2021 at 3:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021 at 3:40 PM, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Vaccine was expired on 24 October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non significant Follow up received, updated reporter details.
Information has been received from a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P).  Subsequently, the day after vaccination, the patient developed severe arm soreness, high fever, nausea, vomiting, and weakness.  The patient sought unspecified medical attention. Subsequently, the patient recovered. the physician requested a lot check of lot 651321/1036P. The physician felt that the patient's severe arm soreness, high fever, nausea, vomiting and weakness were disabling. Additional information has been requested.
severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.
Administration error - bivalent booster dose administered 1 month after previous bivalent booster dose
Information has been received from a physician concerning a 12 month old male patient who on 19-MAY-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). The physician reported that, on 28-MAY-2008, the patient developed a rash. The patient's mother called the office to inform them that her child developed chickenpox on the torso. The physician had not seen the patient no product quality complaint was involved. No further information is available.
Dark colored / blood? in urine about 24 hours after injection. Resolved by later in the same day.
Severe headache at 12 hours, moderate muscle spasms in neck and hips at same time with chills. I have existing inflammation in neck and hips. General moderate pain in muscles. Ended by next morning and then significant fatigue 48 hours later. No history of any reaction to previous vaccines.
Right shoulder pain at injection sight; Joint aches; chills; hot; headaches; tired no energy; swollen lymph node under right arm; tired no energy; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EK5730, expiration date was not reported) via an unspecified route of administration, in right arm, on 23Mar2021 08:15 (at the age of 55-years-old), at dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included esomeprazole; adalimumab (HUMIRA); atorvastatin calcium (LIPITOR).  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJ1685, expiration date was not reported) via an unspecified route of administration, in right arm, on 02Mar2021 08:15 (at the age of 55-years-old), at dose 1, single for covid-19 immunization. The patient experienced right shoulder pain at injection sight, joint aches, chills, hot, headaches, tired no energy, swollen lymph node under right arm on 23Mar2021 20:00. The outcome of the events was recovering.    Follow-up #1 (30Mar2021): New information received from the same contactable consumer includes: confirmed the events awareness date on 23Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A 21-year-old female patient with no medical history, had received an intramuscular left deltoid injection of FLUZONE sv 2007-2008, lot number U2505AA on 13 November 2007 and one day later, the injection site became swollen, red, hot and sore.  Swelling was the size of a tennis ball.  The following day, swelling had increased to the size of a softball.  The entire arm was sore, muscular pain down to her fingers.  The patient was evaluated by her physician on 15 November 2007 and prescribed Prednizone.  The patient had not received any vaccines during the four weeks prior to receipt of FLOZONE.  Symptoms were still persistent at the time of the report and the patient had not recovered from the event.  No further information was provided.
Patient felt dizzy and nauseated after immunization administration. BP 100/72. Had patient lie down in clinic, ice pack given to back of neck, gave juice and crackers to eat. Patient recovered fully before discharge from clinic by Dr.
Client developed what appeared to be a single welt or induration at site of injection immediately after vaccination. Client was monitored for 30 minutes by two nurses. No other welts or indurations developed, no respiratory signs/symptoms or angioedema. Pt was smiling and happy during observation. Advised mother of pt to get BENADRYL on way home and to monitor for difficulty breathing, facial swelling, and further cutaneous symptoms; advised to go to ED if such symptoms developed. Mom agreed to this plan. Several attempts to follow up with mom were made by this RN and a supervisor over the next two days; messages were left but were never returned.
Started on 9-12-12, red, swollen area on (R) thigh, approx 1 1/2" circular, 9-13-12 2" x 3" circular, red, swollen area, warm to touch.
VACCINE EXPIRED PER SITE VISIT 8/12/22. SHIPPING LABEL HAS DATE OF 12/31/2069 NO ADVERSE REACTION NOTED
not have received the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that pediatric patient did not receive the full dose of Havrix due to patient was moving, which led to incomplete dose administered. No additional information provided.  The reporter did not consent to follow-up.
pt. recvd vax & developed measles rash,cough,coryza,conjunctivitis,& Koplik spots.
Injection site: pain, swelling and lymph nodes swelling, extremely fatigue Moderna COVID-19 Vaccine EUA
Severe Inflammation in the inner left ear, hearing loss. Undergoing treatment with oral steroid and steroid shot in ear. As of this reporting dat not yet under complete control though made some progress.
Varicella - Information has been received from a company representative concerning several patients who approximately 1 to 2 years ago were vaccinated with one dose of varicella virus vaccine live (site unknown).  On 20 Apr 2000.  the patient have developed > 100 varicella lesions and a fever.  It was noted that three of these patients are siblings. An unspecified number of patients sought unspecified medical attention.  additional information has been requested.
The day after flu and Tdap, started to have some soreness at the shoulder and over the course of a week or two, was not able to raise the left arm and could not sleep due to pain.  Now 2/19/16 and still with pain and trouble sleeping.
The Pfizer bottle had already been diluted, drawn up and administered to other patients. No vaccines left in Pfizer bottle. RN inadvertently re-diluted empty Pfizer bottle and vaccinated patient with only diluent. Not realizing that the patient did not receive correct vaccination, patient was observed for 15 minutes, no adverse effects seen during that time. This error was not discovered until the end of the day when staff was confirming the number of vials and wasted vaccinations matched up with the number of patients seen.
rash on her both arms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced rash on her both arms (non-serious) on an unspecified date with outcome of unknown.  Information on lot/batch number has been requested.
she had allergic reaction; Rash under her breast is, all over chest, back, and sides and it has moved up into her hairline; fever; achiness; body aches; sore arm; Massive headache; loss of appetite; extremely tired; Chills; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: EL9269) via an unspecified route of administration on 06Feb2021 at 12:30 (at the age of 50-year-old) as a 1st dose, single dose in left arm for COVID-19 immunisation in School/Student Health Clinic. The patient's medical history included allergic to sulfa products taken for bad kidney, bladder infections 30 years ago; flu shots every year in the Fall around September or October and experienced soreness in arms, achiness and never had any other reactions and had COVID virus infection back during the end of the year. Concomitant medications were not reported. On 06Feb2021 Saturday night, the patient experienced sore arm and it was hard to lift like when she had flu shots in past. On 07Feb2021 Sunday, the patient experienced fever, achiness, body aches. The patient felt fine on 08Feb2021 Monday. Later on 08Feb2021, she experienced rash under her breast is, all over chest, back, and sides and it has moved up into her hairline. It does not itched, but irritating under her breast. On 09Feb2021, the patient went to urgent care, visited doctor in physician office and told she had allergic reaction and to not get the second dose, it could turn into anaphylaxis. On an unspecified date in Feb2021, the patient experienced massive headache, chills, loss of appetite, and was extremely tired. Patient enquired whether sulfa products is present in the Pfizer Biontech vaccine, as Sulfa is the only medicine she has been allergic to. The patient underwent lab tests and procedures included SARS-CoV-2 antibody test: unknown result on an unknown date. The clinical outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sudden onset high blood pressure with elevated heart rate (40 to 100% higher heart rate); with elevated heart rate (40 to 100% higher heart rate); This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Lot number: ER2613), via an unspecified route in the left arm on 26Mar2021 at 13:00 (age at vaccination: 55-year-old), as a single dose for covid-19 immunization. Medical history included known allergies with duck egg, dairy, doxycycline, indomethacin and tinactin. Other medical history included Reiter's Syndrome- chronic, depression, damage to spinal column -neck and low back. Concomitant medications included trazodone and venlafaxine. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 05Mar2021 at 13:00 (age at vaccination: 55-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 15Apr2021 at 06:30, patient experienced sudden onset high blood pressure with elevated heart rate (40 to 100% higher heart rate). Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included lisinopril, having limited affect. The patient underwent lab test and procedure which included blood pressure with elevated heart rate (40 to 100% higher heart rate) on 15Apr2021. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
AFTER LEAVING PHARMACY, PATIENT EXPERIENCED REDNESS AND SWELLING IN RIGHT ARM. PATIENT THEN BEGAN TO COUGH AND CLEAR  THROAT FREQUENTLY.  STATED TO PARENT THAT THROAT FELT "ITCHY" AND "WEIRD". PARENT NOTICED FACE FLUSHING. PARENT GAVE DIPHENHYDRAMINE. PATIENT HAD DIFFICULTY BREATHING AND WAS BROUGHT TO HOSPITAL.
Woke up the morning after receiving the shot & felt fine, so I went to work. As the day went on, I got muscle aches and pains all through my body (especially in my left arm - the injection site - of course) and fatigue. It continually worsened throughout the afternoon and evening, despite bedrest and proper hydration, and I could barely sleep.  However, the next morning I woke up just as I did the day before - no problems, feeling fine.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # N031493 with expiration date on 03-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA007590: US-009507513-1803USA013072: US-009507513-1803USA013074.
left side of body tingling, started in left fingers and grew into whole left side of body.  not pins/needles.  no pain.  1-2 minutes.  I laid down and put my feet up.  It stopped in 2 minutes.   Second time:  another day, probably closer to when I called doctor (4/19/21) both arms and legs so I lied down also,     I was alerted especially because my friend shared with me the day before the same exact symptoms but his was much worse and is continuing still in all limbs.  This is documented in a note to my doctor in EPIC system.
I developed a huge blister on my right inner thigh toward the end of May of 2022. I went to my primary doctor's office on 05/30/2022. The woman I saw stated that she knew what I had but did not know how to treat me. She explained that it was Bullous Pemphigoid and referred me to a dermatologist for further treatment. He performed a biopsy on the area which confirmed the diagnosis. Shortly after that, I started developing a horribly itchy rash, mostly on my torso. On top of the rash, I also get blisters. Still to this day, I get blisters on my stomach, torso, and back. I also get some on my hands, feet, and scalp and there is intense itching as well. I have been taking Doxycycline since receiving this diagnosis and there has been little improvement. On 10/25/2022, I began taking Prednisone which messes with my Diabetes, so I require a prescription of Metformin to counteract the effects of the Prednisone. As of yesterday, 11/01/2022, I have had to increase my dosage of Prednisone because there has been very little improvement. Aside from all of these dermatological issues, on 09/03/2022, I experienced and episode of dizziness, confusion, headache, pain, and sweating. My husband called 911 and I was taken to the emergency room by ambulance. They performed x-rays and discovered that I had two fractured ribs. They also did a CT scan because of the headache I was experiencing but they found nothing there. They advised that I just treat my pain with over-the-counter medication and released me that same day.
Red rash forming on bilateral distal forearms approx. 2 inches in diameter, small raised area on each arm  in addition. Redness is resolving at this time approx 1 hour after it began. Recipient denies pain, itching, or discomfort.
Developed SOB and racing HR during PT, Symptom: Tachycardia Start: 07/2006, Symptom: Dyspnea (shortness of breath) start: 07/2006.  05/24/2007 Lengthy medical record received for OVs from 10/2005 to March 2007, as well as prior hospital records from DX of Guillain-Barre from 8/2004.  Pt. reported no problems 2' to GBS in 2004 until March/April 2006 when pt. c/o increasing dypsnea with exertion and palpitations with exercise per narritive Summary.  1st noted in MR on OV of 6/28/2006 for SOB where HR=181 and PO2 was 93%.  Seen in F/U 7/6/06 to r/o autonomic dysfunction. DX of functional murmur, Palpitations, Paroxysmal Supraventricular Tachycardia Paresthesias in hands and feet noted at 11/29/2006 eval. DX with Sick sinus Syndrome 1/3/07.  Final DX:  Supraventricular arrhythmia: supraventricular tachycardia with more than 4 episode/yr documented by ECG or Holter monitor.
The needle popped off in the middle of the injection and some of the vaccine leaked out.  I repeated the dose.
reported swelling redness and itch at injection site for 3 days occurred 1 week after vaccination
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Swollen Lymph Nodes in neck, lasting two to three weeks. Subsided with advil.
hurting area; warm area; chills; nausea; pink area; puffy area; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix .5 ml. On 19th June 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 20th June 2019, the patient experienced injection site pain, injection site warmth, chills and nausea. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were unknown and the outcome of the injection site pain, chills and nausea were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix the right deltoid region of the arm.  The patient notice a 2 by 3 inch area which was pink and puffy.  On 20th June 2019, 2 days after receiving Shingrix, the patient had stated the area got worser which was pinker, warm and hurting with chills and nausea.  On 20th June 2019, the patient did contact her physician and the physician had advised her to take Tyelnol (dose unspecified) and the patient stated the pain, chills and nausea did resolve.  On 22nd June 2019, the reporter tried to follow up but was unable to reach the patient. The reporter consented to follow up.
Left Axillary pain and mild swelling starting approximately 4 days after vaccination. The pain proceeded to worsen over the next week and moderate lymphadenopathy was also been noted. These lymph nodes are tender to palpation. Additionally some Parasthesias were felt down the left forearm into the hand possibly due to brachial neuritis or nerve pressure due to lymphadenopathy.   The parasthesias lasted approximately 2 days.  Lymphadenopathy is now present in the right axilla along with more severe adenopathy in the left axilla.  - PA-S2