chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RASH DEVELOPED ON BACK OF RIGHT KNEE ABOUT 10/11/2021 AND SPREAD OVER MUCH OF BODY. CLIENT SAYS IT'S VERY PAINFUL AND FEELS LIKE HER NERVES ARE ON FIRE. PAIN WORST ON HER BACK. PT WENT TO hospital 10/19/2021 AND WAS GIVEN LORATADINE 10 MG TABLETS AND TRIAMCINOLONE ACETONIDE 0.1% CREAM. HER RASH STARTED TO CLEAR UP BUT PAIN PERSISTED. PT WENT TO  ER ON 11/07/2021 AND WAS PRESCRIBED CYCLOBENZAPRINE 10 MG TABLETS AND DICLOFENAC 50 MG TABLETS. PAIN HAS NEVER SUBSIDED AND RASH HAS RETURNED TO ORIGINAL STARTING PLACE ON BACK OF RIGHT KNEE.
Woke up on Sunday May 9th with Bell's Palsey; classic symptoms of drooping on LEFT side of face.  Has seen 2 doctors; one says vaccine is to blame other Dr says stress is to blame.  She was under extreme stress the 2 days before symptoms began.  Symptoms still persist on Tuesday, May 11, 2021
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at the Pharmacy for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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, including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life, increased risk of premature death, aggravation of pre-existing conditions and activation of latent conditions; lost wages; loss of earnings capacity, and other losses and damages and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
rash on her mid legs and around her knees; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0202) via an unknown route of administration (at the age of 27 years old) on 23May2021 at 15:30pm as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced rash on her mid legs and around her knees. The patient stated that she received the second dose of her Pfizer COVID 19 vaccine at around 3:30 pm. Since then patient has been experiencing a rash on her mid legs and around her knees. It was 2-3 inches in length and on the front and back of her legs. Patient found information on injection site reactions but was not sure if other had experienced rashes on parts of their body not related to the injection site. The outcome of the event was reported as unknown.  Consumer was not willing to complete the report. Hence, limited information available.
started 2APR98 w/3 red areas today covered w/50 or more red raised spot some water filled w/itching;
Was informed child was on Zithromax day immunization given. Deferred kindergarden shots but gave HIB. Thought  4th Hib needed as only 3 doses  on our record.  Today Mother called stated she had dose 05/04/2006. Also reported 8/20/09 child was hoarse, C/O of scratchy throat and broke out in hives that were itchy on entire body.  Was taken to ER and doctor put on Benadryl.  Thought was due to combination of zithromax and immunization.
Developed Melanoma of skin at site of previous Anthrax vaccine injections. I received the vaccine seven times in the right upper arm from 2004-2012. A flat pale tan 1.5 cm skin discoloration was noted at the site in Jan 2011. It was located in a site that I do not ordinarily see, but I had no history of birthmark at the site. The margins were regular at first. In May 2014, the skin mark appeared to be changing. The margins appeared speculated. An excisional biopsy was performed on 10/27/2014. The diagnosis of melanoma-in-situ was made. Re-excision occurred on 11/10/2014 for a positive margin. I am a physician as well and suspect a possible link to vaccine. I have received multiple vaccines over the years but the only one that I can recall in the lower aspect of the right upper arm was anthrax. Untreated melanoma is fatal. Fortunately, I have been treated and have no recurrence thus far.
She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg; She had all common symptoms like headache on same day 4 hours after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg) and HEADACHE (She had all common symptoms like headache on same day 4 hours after receiving 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced MUSCLE TWITCHING (She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg). 12-Jul-2021, the patient experienced HEADACHE (She had all common symptoms like headache on same day 4 hours after receiving 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 6 mg. At the time of the report, MUSCLE TWITCHING (She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg) had not resolved and HEADACHE (She had all common symptoms like headache on same day 4 hours after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fleeting chest pains followed by a chest ache  Started approximately 2 hours after the injection. Consulted Nurse Line and was told to monitor it & go to er if it worsens.
Symptoms started next day when I woke  up for work at 5:00AM. I had body aches and nausea.  Later that day I had a bad headache which started shortly after vaccine on 12/28/2020.  I had body aches, chills , headache , and fever of 100.8
approx 15mins p/vax devel fine, raised rash on inner arms (elbow-hands); denied itching c/o weak legs; no difficulty breathing on 1MAR95 c/o joint pain; ? low grade temp, rash remains but lighter per description of mom; rash never spred
SWOLLEN TONGUE; A spontaneous report has been received from the regulatory authority in (RA) concerning a female patient of Unknown ethnic origin (age 15 years).    No medical history was reported. No concomitant products were reported.    On 27-SEP-2021, the patient received via nasal route, Fluenz Tetra (influenza vaccine live reassort 4v) (batch number Nf3594),for acute allergic reaction.     No malfunction has been reported for FLUENZ TETRA.    On an unknown date, the patient experienced Swollen tongue  (preferred term: Swollen tongue).Reaction not severe this time but could be worse if dose given again. Advised not to have flu nasal spray again.    Action taken with the suspect drug was not applicable.    The patient recovered from the event(s) on an unspecified date.     Reporter assessed the event swollen tongueas serious due to seriousness criterion important medical event.                   Device Information:     Combination Product Report: Yes    Product As Reported: FLUENZ TETRA  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Swollen tongue is not listed in the company core data sheet of Quadrivalent/live attenuated influenza vaccine (Q/LAIV). Due to limited information on relevant medical history, concurrent diseases, concomitant medications, exact start date of suspect drug, exact start date and circumstances leading to the event, complete etiologic and diagnostic workup (Complete Blood count, Imaging studies) evaluation did not find evidence to suggest a causal relationship between Event and Q/LAIV.
Ran a fever for about 6 hours After about 4 hours I experienced un-controllable shaking for about 4 hours, it was difficult to bring food to my mouth I had heart palpitations during the shaking periods I was not treated for these issues they wore off over time, this happened for both first and second injections.
Pt here 1/28/10 for 3y WCC - pt received H1N1, nasal spray & ACTHIB - dad called about 2 hrs after visit - child crying - could not console - no rash, hives, redness - c/o chest hurt (unsure if vaccine or from crying) cough.
Light-headed and tired immediately following vaccination that lasted a few minutes;  mild labored breathing around 30 minutes post-dose but fine after using inhaler (may have been due to wearing multiple masks vs. vaccine; tension, dull headaches starting 1hr post-dose lasting several hrs; high-pitching ringing in ears starting approx 7-8 hrs post-dose and still have as of March 14 at 5:00pm; systemic itching starting 8-9 hrs post-dose and still have as March 14 at 5:00pm and managing with Benadryl/zyrtec.  Alerted Dr. to ringing in ears and following up with Dr tomorrow on ringing in ears and itching.
Clinical pharmacist was not at the pharmacy the date of administration, pharmacy technician used her own clinical judgement to administer a naive patient a pneumonia shot.  Technician chose wrong vaccine for patient as well as administered an expired vaccination.  Technician reached out to clinical pharmacist after administration in which the errors were then found.  Education was provided to technician to not administer any vaccination that you have not checked with a pharmacist that has adequate clinical decision making skills.  It was learned that a vaccine shall not be given and patient shall return once a pharmacist is present.  The patient was contacted, a message was left to have them return the call to explain what happened.
Starting the day after the second Moderna shot, my wife started feeling sick, with fever, chills, aches, and generally feeling like crap. (I got the shot too and besides some arm soreness am fine) Around 10 PM on the third day, Sunday, the fever spiked and then dropped. She felt like the fever had broken. But around 10:45 she went to the bathroom and started to have significant muscle spasms/convulsions. She called to me as she laid back in bed and I watched as the spasms rolled across her muscle groups. In the past she has had similar spasms when she had a high fever. But now her temperature was not that high.   We discussed going to the emergency room but we both hate doctors so we said if it doesn't better in a couple of hours we would go. Somehow she discovered if she hummed a song the spasms would go away. So she hummed all the songs she could think of, show tunes her mom loved, stupid songs, even Baby Shark. Do do do do. Sorry  After about an hour or so she said the spasms diminished, and she fell asleep.   The next morning she had no more spasms and while still not feeling good, she was feeling better. Only this morning Tuesday the 8th is she feeling back to normal, a little tired but almost completely normal.   Thanks
BODY ACHES; HANDS NUMB; CHILLS AND SHAKING/SHIVERING; VERY ACHY JOINTS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F, 102.3 F, 103.3 F. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced hands numb. On 10-APR-2021, the subject experienced chills and shaking/shivering. On 10-APR-2021, the subject experienced very achy joints. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shaking/shivering, and hands numb, and had not recovered from very achy joints, body aches, fever, and headache. This report was non-serious.
pt recv vax & w//in 5min of shot arm very sore;by noc couldn't move it, lift it or touch;had a fever of 100 1/2 on Thursday (the next day) my arm was very sore w/red blotches on it;still had a fever;by evening had a big red line going down
Information has been received from a health professional referring to a 23 year old patient of unknown gender. Information about medical history and concurrent condition was unspecified. On 24-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (lot # L034930, expiration date 03-MAR-2017, dose and route unknown) in error. The person who administered the dose of PROQUAD (Merck) consumed it with M-M-R II. The patient had not reported an adverse effect. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: 320308d) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Lot number: 0294214) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure controlled" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure management: controlled. Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About a month after getting my vaccine, I was having a lot of drainage and coughing; my chest was aching with congestion. My throat was very dry with a very dry cough following. A couple of weeks later, it got worse with spitting up mucus, but the cough got worse and the mucus became phlegm. On 01/13/2023, I went to see my physician because the back of tongue and lymph nodes were hurting and swollen. While at the physician's office, they tested me for COVID-19 and influenza, which both came back negative. They presumed that I possibly had two viruses leading up to my appointment which became a sinus infection. She suggested doing a sinus rinse and prescribed AUGMENTIN. The prescription helped relieve a majority of my symptoms except a slight dry cough daily.
Local injection site reaction. Redness, swelling, warm to touch.  About 3" in diameter.  Full body rash developed 12 hours after injection and spread over entire body.
Patient came for Covid19 vaccination, in observation area she started feeling dizzy. She had to lay down, room was spinning. Vitals were stable, there was no throat closure, no SOB or wheezing. She requested to get her albuterol inhaler refilled. Several attempts to get her to sit up and walk failed due to continue dizziness. She was transferred to room in blue side, there she used her inhaler, was given water, and laid down. She was observed for 3 hours. Eventually she contacted friend who came to pick her up. She was told not to drive until she felt better. Transported to friend's car with wheelchair. Friend was going to be with her for some time.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed clinical varicella with more than 50 papulovesicular lesions and high fever. The pt sought unspecified medical attention. The physician expressed concern with the vaccine lot. Follow up information indicated that some of the pts lesions persisted for 2-3 weeks. The same day the pt was seen by a dermatologist and was diagnosed with possible atopic dermatitis.  Pt was advised to treat with dry skin care; Aclovate cream and follow up visit in 3 weeks. At the time of this report the pt was still recovering. No further details were provided.
Client injured her left leg, bruising it as she hit it against a hard surface on 10/1/2021. Injury caused a large bruise. On 10/4/21 client noticed a hard area in her left leg, "felt like a straw under my skin". Was seen on 10/6/2021 by her medical provider and diagnosed as having a superficial blood clot in her left leg.
Slight fever; didn't feel real good; man-flu/flu-like symptoms (didn't feel good, had a fever); a rash consisting of 5-6 "fired-up red spots" on his right arm but not at the injection site, closer to his elbow/super rash; itchy; kind of hard; This case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 6th February 2022, less than a day after receiving Shingrix, the patient experienced red spotty rash, itchy rash and induration. On 7th February 2022, the patient experienced fever, feeling bad and influenza-like symptoms. In February 2022, the outcome of the fever, feeling bad and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the red spotty rash, itchy rash and induration were not recovered/not resolved.   The reporter considered the red spotty rash, itchy rash, induration, fever, feeling bad and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received a dose of Shingrix in right deltoid intramuscularly on Sunday around 03:00 pm in the afternoon. On same day of vaccination, in night around 7:00 or 7:30 pm, the patient had a rash consisting of 5 to 6 fired-up red spots on his right arm but not at the injection site, closer to his elbow.  These spots were not blistery but were super-red, itchy and kind of hard and they were not resolved. 1 day after receiving vaccination, the patient had a slight fever and did not felt real good.  The reporter joked that he had the man-flu and was resolved. The patient received the shot at a pharmacy. The pharmacy paperwork did not have the lot number or expiration date listed but the reporter provide the pharmacy's name and phone number since the pharmacy should had the lot number on file. The reporter consented to follow-up.
Blood sugar has continued to stay lower than 90 even when I eat. I'm typically always 120 or higher, and when I eat I can go up to 180.
The following day I started to feel very weak and a lot of pain to my left arm and a fever, chills, muscle aches, lost of appetite. I have a lot of weakness, numbness to my hands and feet. I was also very emotional. I went to see the Doctor on the 31st because the pain was unbearable, Tylenol and Motrin were not helping.  They said it was expected but gave me a Steroid shot to help with pain.  The tested me for Covid and Flu, they were both negative.  I'm doing ok until I got the second dose.
pt recvd flu vax/pneumococcal vax & a wk later devel neurologic sxs including sensation deficit & partial paralysis; pt was adm to hosp to r/o GBS;
It was determined there was a preparation error at Facility on 1/19/23. Between 4-5 individuals received Moderna 6 month to 5 years monovalent formulation. Preppers unintentionally prepared 1 vial of the 6 months to 5-year monovalent formulation (with volume of 0.5 ml per dose) and labeled it as a Moderna 12+ years bivalent formulation. There was a total of 14 patients scheduled to receive the Moderna 12+ years bivalent on 1/19/23. Clinic is unable to determine if patient received the correct bivalent dose versus the Moderna 6 month-5 years monovalent formulation.   Information about other Moderna formulation: Moderna 6 months to 5 years monovalent dose, Lot AS1414B, manuf. exp 2/13/23.  Patient has been notified of vaccine error that may have potentially impacted her. No reported signs/symptoms of adverse reaction.
Very delayed systemic side effects; 6 days after vaccination: fever of 100.9 F on June 16 at night and June 17 in the morning. Additional side effects are chills, body aches, debilitating fatigue, and moderate persistent headache. High temperature  subsided on Saturday at 98.3 F.  Headache and chills only lasted 2 days (June 16 and 17). Fatigue and body aches were still present on the third day, albeit less severe.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.