chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mistakenly gave (2) injections with no reported adverse event; Initial information received on 06-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69-year-old female patient who mistakenly taken (2) injections with no reported adverse event while receiving vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and SHINGLES VACCINE for Prophylactic vaccination.   On 06-Sep-2023, the patient received a dose and strength of 0.7 ml (Frequency = once) suspect Influenza Quadrival A-B High Dose HV vaccine injection (lot: UT8079AA, Expiry date: 30-Jun-2024) via intramuscular route in the left deltoid for Immunization and patient had mistakenly (2) injections with no reported adverse event (extra dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  Additional information was received on 06-Sep-2023 from a physician. Concomitant medication (SHINGRIX) added, CO updated, however no significant information received, text amended accordingly.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 05-OCT-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration date 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 56, 34 and R. The storage criteria was refrigerator (R). This is one of several report received from the same source. Additional information has been requested.
Two days after injection patient developed tenderness and erythema at the site of injection, and there was a slight edema at the area, He was sent to clinic for a physician visit.
Presented to ED w/CP, diarrhea, fever; tested positive for COVID-19; admitted for COVID-19 pna & UTI; tx w/ abx, steroids, remdesivir, mag, zinc, O2 therapy; dc'd to home with HHC and O2.
Uncontrolled spasms and shaking for 3 hours (9 hours after administration) Extreme fatigue for 36 hours.   Day 2 - sunburn type rash throughout torso and forearms and thighs
Information has been received from a nurse practitioner concerning a "late 60's" year old female who "16-18 months ago", approximately in September 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). The nurse practitioner reported that "recently" the patient developed a severe case of shingles with Post Herpetic Neuralgia (PHN) after vaccination with ZOSTAVAX (Merck). The patient was given unspecified treatment. It was unspecified if the patient sought medical attention. Upon the time of report, the patient present status was unknown. Additional information was received from medical records regarding a 75 year old obese female (65.5 inches, 180 pounds), non-smoker, non-drinker, with lupus, thyroid disorder, hypertension, back pain, osteoarthrosis (prim lower leg), chronic lymphedema of both legs, varicose veins, keratosis/acquired keratoderma, alopecia/telogen effluvium, "kidney and ureter disorders unspec," palpitations, degenerative joint disease, venous (peripheral) insufficiency, diverticulosis, polyarthritis/osteoarthritis with left knee injections of HYALGAN, and with a history of chicken pox (childhood), hypogastric pain, hysterectomy who on 10AUG09 received a dose of ZOSTAVAX 0.65 mL subcutaneously in the right arm. On 22JAN11, she developed a rash on dermatome T5-6 with numerous lesions to cover from mid back to left breast. Pain was a 9-10 out of 10. There was no recent exposure of chicken pox or herpes zoster. The patient reported that on the evening of 21JAN11, she had pain on her left lateral ribs and left back pain radiating around to the front underneath her breasts. She took some aspirin for it. Subsequently the patient was taken to the ER via ambulance because she thought she was having a myocardial infarction. She reported no high fevers, no chills, no difficulty breathing although it hurt to take a deep breath. Upon examination, the patient did have a red erythematous rash in the dermatomal pattern. It started in the midline of the left back in the T5-6 region which radiates around underneath the left breast typical of a herpes zoster. The patient's pain was limited to this dermatome. Concurrent medications were SYNTHROID, sulindac, MAXIDE, VICODIN, LIDODERM, NEURONTIN, prednisone, and PLAQUENIL. Patient was diagnosed with herpes zoster. Treatment included VICODIN and FAMVIR. Patient instructed to follow-up with her physician if worse. On 02FEB11, rash had begun to dry out but was still painful. There was peeling off of herpes zoster with scarring. On 03MAR11, patient had pain at the site which was significant especially anteriorly and she was wondering if her lupus could be making her pain worse. Patient complained of sleep has been poor because of the pain. BENADRYL apply to affected area for itching. Information received included the following events: abnormal EKG (22JAN11); bilateral ear wax, lost 13 pounds since 28OCT10 (02FEB11). Additional information has been requested. All available medical records will be provided upon request.
Patient says she experienced tingling in her lips immediately after receiving vaccination.  Her lips became slightly swollen and dry.  She developed "fever blisters" that were painful and remained for approximately 7 days.  She discussed the reaction with her general practitioner who advised her to go ahead with the second dose.
Dizziness and vertigo. Became more extreme on the Saturday 1 week following the vaccine. Vomiting also on Saturday. Extreme vertigo and nausea lasted for another day. Today, Monday, still have dizziness but able to function.
developed shingles; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed shingles on an unspecified date. The reporter was asking if has anyone else reported getting shingles after receiving the Pfizer COVID vaccine. He stated that he had a patient who came in to get the Pfizer COVID vaccine and developed shingles a week later and is due to receive the second dose of the vaccine. The reporter was asking if it is okay for the patient to be prescribed an antiviral prior to getting the second dose of the vaccine and said that he has already reported the adverse event. The reporter was asking if why prescribing antiviral considered off label. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, swelling, itching at injection sight.  Began a week after dosage and is continuing.
The patient has not had any adverse effects/events.  We are reporting an adverse event due to administering a Moderna COVID-19 vaccine to a patient under the age of 18 years old (17 y/o at the time of the visit).
This was my second booster shot. I had a headache that ladted 6 hours where I could not lift my head and the only relief the whole time was moist heat. I think drinking tea for caffeine also helped.  I did not have any tea that morning before the headache stared. I have never had a migraine before, I'm  not sure this was, but clearly the worst pain of my life. The second pifer shot and first maderna booster also caused headaches, however not nearly this bad. My doctor suggested I report this.
The morning following receiving immunization, the patient became weak fell to the ground and is believed to have had a seizure.
Patient did not have an adverse event but she did experience a med error. She came to us to get a Tdap shot and we had done so many flu shots we made an assumption she was her to get a flu shot. The error was discovered after administration when patient said she had a grandchild on the way. I apologized for the mix up and gave her a Tdap in her other arm. Patient had not yet received a flu shot for this season. Patient has not reported any adverse reactions to either vaccination.
Chills, fever up to 102 degrees, fatigue, body aches, nausea.
This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included iritis, macular edema and visual disorder. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). This case was reported via medical records forwarded by a lawyer and described the occurrence of unspecified adverse event(s) in an adult male subject who was vaccinated with LYMERIX (GlaxoSmithKline). On an unspecified date the subject received unspeciifed dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced unspecified adverse event (s). At the time of reporting the outcome of the event (s) was unspecified. Follow up information was received on 13 November 2008 via a statement of injuries. At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, vision loss, hearing loss, eye pain, headache, fatigue, possibly memory loss, and decreased activities of daily life impaired. He also experienced rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX, including but not limited to those set forth above. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Go to continuation Page          Pt. had NO prior vaccines until 09/09/2019. He received a MMRII Live, containing cell W1-38 aborted Fetal tissue.          The vaccine was administered at clinic. I. Serious Adverse Reaction       A. Epistaxis - Nose bleeds            1. Unprovoked Nose bleeds while sleeping                  -10/20/19 -11/08/19 -12/11/2019 -12/14/2019 & 06/23/20 Last time       B. Febrile Seizure            1. Elevated body temp @ 11:20 12/31/19                 a) 100.6-102 FUO            2. First Seizure @ 11:23 PM Temp 102 12/31/19                Sign: left arm jerking --> then straight out rigid                        body arched & stiffened rigid                         blank stare                         seizure lasted 10-15 seconds            3. 2nd Seizure @ 11:50 PM 12/31/19                Sign: body twitching                         eyes rolling up into head                         Lasted 10 seconds            4. Called Dr. 11:52 PM                Recommendations: -if seizures persist take to ER                                            -give tylenol -1/2/20 Dr Visit                                            -Monitor -seizures stopped 1/2/20                                                         -Fever Stopped 1/3/20 II. Adverse Reactions         A. FUO              1. No symptoms                  No -ear infection                       -sore throat                       -Nasal congestion                       - Cough wet or dry                       - Asthma or environmental or food allergies              2. Record of Temps. FUO                  2019 9/17-18 @ nite 100.6-102.2                          11/12-14 @ nite 100.4-101.2                  2020 10/3- @ nite 100.3                           5/17- @ nite 100                            7/30-31 @ nite 103.9, 101.4                           8/1 @ nite 104.7                           8/3 @ nite 102.5                    3. Pediatrician was contacted every time                    a. Recommendations                         1. Monitor                         2. tylneol                         3. ER if seizures             4. I am a Registered nurse - 13 yrs Experience                     a. Fevers were of unknown Origin                     b. fevers voids of symptoms common to colds or Flu             B. My concerns is the Pattern of Health anomalies that occurred After vaccination. ie FUO, epistaxis, & seizures             C. I am exempt from Flu vaccines due to severe adverse Reaction - I still get migraines             D. I believe my son may have similar disposition sensitivities - I need a medical Exemption for my Son                                                                                                                   Thank you.
Positive covid 19 test. Sick with headache, sinus, no smell,no taste, fatigue.
Slight swelling directly under injection site.  Approximately 1 1/2".  Next day, it was 3", and the next it was covering half my arm horizontally and about 5" vertically.  Swelling, hot, minor pain, some itching, and sporadic having a crawling sensation under the skin.  Today is Day 6.  It is still a little red, still large area, but closer to normal skin color.  No itching, pain or crawling feeling. All of that was still occurring on Day 5.
An MA reported that a 60 year old male received an injection of Pnu-Imune 23 vaccine on 10/29/01. He subsequently developed an injection site reaction characterized by heat and redness. He was seen in the ER on 10/30/01; dx'd with cellulitis and treated with 1gm of Rocephin daily. Additional information received from the vaccine provider on 11/20/01, stated that a dx of allergic reaction to pneumococcal vaccine was made and subsequent treatment included antihistamine drugs which cleared the pt's erythema.
Completed vaccine series 2/8/2021, then tested positive on 3/26/21 after developing symptoms on 3/24/21. Had known household exposure (spouse).
Large red area on right arm where vaccine was administered.  The area remained red and itchy for 11 days after the Moderna vaccine, and then continued to be red and warm to the touch for another 7 days.
Information has been received from a physician concerning a female patient with a history of passing out during immunization who on 05-AUG-2010, was intramuscularly vaccinated with a dose of VAQTA (Lot# 667859/0569Z). On 05-AUG-2010, while the patient was coming out of the patient's room she got syncope. It was noted that this was not the first time the patient passed out during immunization. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Syncope was considered as an other important medical event by the reporting physician. Additional information has been requested.
On 01/25/2001 the patient developed a fever of 101.8 to 101.9F. As of 01/26/2001 the patient's fever continued. Unspecified medical attention was sought. In follow-up, the physician reported that he would not consider the patient's temperature of 101.8 to 101.9F as a significant reaction or adverse event. No further information is expected.
On February 23, 2019, I woke up with a rash that started on top of my right thigh and left thigh. More red bumps on my right thigh. Went to see dr on Feb. 27, 2019, and she prescribed Medrol dose pak with atarax. The rash did not improve and in fact within 2 days was spreading to other parts of body, to the back of both arms, got worse on my right thigh, started itching terribly, could not relieve the itch with meds. Had to use ice to the rash on thigh and elsewhere to try and keep from scratching. I finished the Medrol dose pak on March 4, 2019.  The rash continued to increase in size on right thigh with whelps, and a vesicle showing on one of the bumps, spread more to both lower legs, back of arms, to my belly, to my hips, and increasing with itching and could not sleep because of itching and atarax did not relieve it. Went back to Dr on Friday, March 8, 2019. She did not know what is causing the rash. She thought in the beginning as I did that it might some kind of allergic reaction to maybe detergent or soap. I changed my detergent and soap and lotion to everything unscented without preservatives. Rash did not improve and got worse. Dr referred me to my dermatologist Dr. I saw Dr  on March 11, 2019. He said he did not think that the rash was shingles but he did think that since other things had been ruled out that the rash was a reaction to the SHINGRIX and stated that it was showing that the vaccine was working in my body and my immune system was fighting the vaccine by the allergic reaction to it. He prescribed prednisone 30 mg for 5 days; Prednisone 20 mg for 5 days. Atarax for itching. Also TMC cream to put on rash. I did not run a fever. Today is March 12, 2019, the rash is still present so far after one dose of Prednisone. I am to call Dr tomorrow if rash not improving. The rash is very itchy still and especially at night it is worse and keeps me awake.
0910 PATIENT FEELS LIKE HER HEART IS POUNDING DUE TO SIMPLE PARTIAL SEIZURES. PATIENT IS AWAKE, ALERT, AND ORIENTED X3 0930 PATIENT FEELING BETTER. "CALMING DOWN". PATIENT STATES NEUROLOGIST AND RHEUMATOLOGIST HAD CLEARED HER FOR COVID VACCINE. PATIENT ATE BREAKFAST, TOOK ALL SCHEDULED MEDS PRIOR TO VACCINE. PATIENT STATES SHE IS NOT SURE IF IT WAS VACCINE OR JUST ANXIETY. "ANXIEY CAN BE A BREAKTHROUGH FOR SEIZURE" PER PATENT 0945 PATIENT STATES SHE FEELS GOOD TO GO HOME. DENIES INCREASED HEARTRATE.
arm soreness at the injection site; weakness; flu like symptoms; from her shoulder down to her hand, armpit, and shoulder blade.; upset stomach; This is a spontaneous report from a Non-contactable Consumer.   A 69 years female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 03Feb2021 as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. It was reported that patient received her first Pfizer Covid-19 vaccine on 03Feb2021 and her second dose was due 25Feb2021. Caller stated after her first vaccination patient had experienced left arm soreness at the injection site, from her shoulder down to her hand, armpit and shoulder blade and the caller also stated she did not even pick up a piece of paper, weakness for a day or two and soreness that lasted until the next morning and she had flu like symptoms and an upset stomach. Her first Pfizer Covid-19 vaccine was given in her left arm and the caller wanted to know if she should switch getting the second vaccination to her right arm instated. At the time of reporting, the outcome of the events were unknown.  No Follow-up attempts are possible. No information is expected further.
Leg weakness; This is a spontaneous report from a contactable physician (patient).   An 84-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) intramuscularly, at single dose, on 13Apr2021, at 12:15, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. The patient previously, on 23Mar2021, at 12:15, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) intramuscularly, at single dose, for COVID-19 immunization. After the first dose, on 23Mar2021 at night she could not move her legs. She was not able to stand up on her own and could not navigate her legs. She rushed to the emergency room. It was reported that the patient experienced leg weakness on 23Mar2021 at 01:00. The patient recovered from leg weakness on 23Mar2021. On 13Apr2021, after the second dose, the patient experienced leg weakness. The adverse event was assessed as serious (hospitalization and disability). It was unknown if treatment was received. Clinical outcome of the adverse event (after second dose) was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.; Sender's Comments: Based on the close temporal relationship, the association between the event leg weakness with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt recv vax on 10/19/98; on 10/22/98 pt exp sore LA, swollen, fatigue
On the right forearm, just distal from the elbow on the  prone side there is a purple-brown discoloration that is approx 4 cm by 15 cm.   The area does not blanch when touched and is not swollen or painful.     This is not a typical bruising or discoloration pattern for her.       At the right deltoid injection site there is a 3 cm round induration which is slightly red, warm and painful to touch.   There is swelling around the red spot which is approx 8 cm in diameter.     We are treating the injection site with Tylenol and cold compress.    The discoloration on the lower arm we are watching.    We will pre medicate with Benadryl and Tylenol prior to next dose.
Constant sharp jolting pain X 4 days in back of left arm after Meningococcal with no radiation.  Denies fever, chills, rash or radiation of pain in arm. No bruising.
Patient reported allergy to Pfizer COVID-19 vaccine on 10/19/21 to Pharmacy when reviewing allergy info with the pharmacist (reporter of this VAERS is the pharmacist). Patient stated she got the Pfizer COVID-19 vaccine (dose 1) in her primary care doctor's office around August 10th and had itching, tongue swelling, and throat swelling resulting in an ER visit where they gave her epinephrine, steroids, and Benadryl. Patient did not report who her PCP was or the exact location of the doctor's office.
9 x 8cm area erythema/induration after immunizations. Warm to touch right deltoid area. Pt placed on Augmentin 400/5 1 tsp BID for 7 days. Pt to follow up with MD as needed.
hard shivering, chills, vomiting, some diarrhea, unable to keep anything on stomach, low blood pressure, dehydration, treated at Missouri Delta Hospital emergency Room with 2 bags of IV Fluids and sent home, 1 week later admitted to Southeast Hospital in Cape Girardeau, MO. for sever dehydration, kidney failure due to dehydration, and elevated blood sugar just to name a few of the problems that i had due to this shot. also severe knee pain and inability to ambulate without pain.
Patient states flu-like symptoms, difficulty breathing, and burning in chest began approximately 3 days following administration of vaccine.
pt had devel rash of chickenpox on 24SEp97 w/low grade fever, itchy rash;the vaccine was given 14mo earlier;
Friday night-fatigue, body chills, ache. Saturday-fatigue, ache, congestion. Monday-dry cough Tuesday-productive cough