chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received from health care professional on 09 June 2014. A 5-year-old patient (gender not reported) had received a dose of ADACEL instead of fifth dose DTaP vaccine series on an unspecified date. No adverse event was reported. List of documents held by sender: None.
Developed chest pain and had elevated troponin values without any echocardiographic abnormalities.
p/vax pt was evaluated for speech & language development & dx w/autistic spectrum disorder;upon medical review it was determined that pt exp was disabling;
Right upper arm has palm-sized swelling, warm to the touch with itching.  Temperature - 99.3 - by mouth.
1453: complained of tingling to tongue; Dr. examined, ordered Benadryl 25 mg IM, temp: 98.1, BP 135/61, HR: 59 1456: Benadryl given 1508: reports tongue feels better, examined by MD, MD released to home after 30 more mins of observation  Assessment: lungs clear, no SOB, VS stable, no rash, resolving after 15 mins post benadryl
6 Doses administered beyond the expiration date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MENINGOCOCCAL Lot number: ABXB58AA ROA: Intramuscular Body site: Right arm).    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Vial taken out of freezer on the same day doses were administered and no side effects had been experienced by the patient.   This case was linked to MOD-2021-381144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Reporter's Demographics and Narrative were updated. On 12-Nov-2021: Significant follow up Route of administration, historical vaccine has been updated.
1 day post vax pt devel fever (unk how high), diffuse arthralgia, 1 episode of vomiting & diarrhea;sx resolved p/1 day;
Serve headache, chills, temperature of 99.2, night sweats & tiredness
High pitched crying, unconsolable >3 hours. Right leg 2.5x2.5cm purple bruise.
Erythema and induration on both upper arms, in the shape of the deltoid muscle. The right side has a small amount of fluctuance. Skin reaction to the MENVEO immunization reviewed supportive care and reasons for to call back.
Left arm is red swollen and warm to touch. Parent states area has become red and warm within the last 24 hours.
I have never had a history of hearing loss or ringing in my ears. Within 1 week of receiving my first dose of the COVID vaccine, I began experiencing horrible tinnitus, dizziness and nausea.
I went in for my routine wellness exam, my doctor noticed I had a very promote heart murmur. At that time, I did not have any symptoms.  Since that time, I have developed fatigue, headaches, shortness of breath. My doctor has ordered multiple test, to find out what could be causing the symptoms.  The echocardiogram I had in November confirmed I have mitral valve prolapse. In December I had a TEE were it was discovered I had a congenital heart birth defect, and a heart catheterization that did come back negative. In January I had Angioplasty that show my valves are enlarged from working harder. I am now awaiting heart surgery to replace my valves.
Fever up to 105 after injection of DTAP (INFANRIX) cried from 1:00 AM - 6:00 AM. Brought to office following am. Child was given TYLENOL/MOTRIN during the night.
Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Male received his second vaccine on February 28, 2021 and had been following the vaccine. Symptoms included nausea, vomiting, hypotension, and bradycardia. He was admitted to the hospital on March 1st. Medical history included Coronary Artery Disease, A-Fib, and a previous CABG procedure.
The excursion expiration date of 7 days thawed in refrigerator was followed because of the Pfizer email approving the 7 day. The pharmacy policy was to follow the expiration of 5 days.
Influenza vaccine in (L) arm 24 hrs ago redness began that evening, worsened today - warm as well moderate erythema over (L) arm shoulder to distal humerus area.
4/1/06 noticed breakout (vesicles) on face/head/neck and arms and upper chest. 4/1/06 that night started running fever 100.4. 4/3/06 saw Dr, given meds.
Increased pain, redness and swelling at injection site.  Headache,  nausea, chills.  Diagnosed with cellulitis.  Antibiotic was prescribed.
Within 2.5 hrs of receiving shot, I had a harsh migraine headache, body aches, with my hands, feet and areas of known arthritis throbbing. I couldn?t think and operate coherently as my thoughts were scattered. I was home from work the rest of the week and weekend. The bigger deal is that I have since experienced shortness of breath, loss of stamina, tire easily and I have loss of mental focus and concentration.  I also can?t remember what what tasks or things that I?ve done short term.  I have regular headaches now (which I never had before) My body constantly aches, especially arthritis zones. I experience sharp ?phantom? pains in my body that have no explanation. Basically, I feel that my body is failing me, whereas I was in very good shape prior.
Chickenpox-like reaction / chickenpox-like spots occur 5-7 spots at a time/back, thigh, butt, backside of calf, and; small fiery, red marks/described the size of the marks as "bigger than the top of a pen, but smaller than a dime.; Itchiness /  "itch like crazy"; bumps / Tiny bit raised; skin looks like dry skin; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives (as child) and staphylococcal infection (as child).   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 15th December 2020, 34 days after receiving Shingrix, the patient experienced varicella-like rash, erythema, pruritus, papular rash and dry skin. The patient was treated with triamcinolone acetonide (Triamcinolone Ointment). On an unknown date, the outcome of the varicella-like rash, erythema, pruritus and papular rash were not recovered/not resolved and the outcome of the dry skin was unknown.   It was unknown if the reporter considered the varicella-like rash, erythema, pruritus, papular rash and dry skin to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left deltoid. The patient experienced a chickenpox-like reaction, small fiery, red marks, and itchiness. The reaction started roughly six weeks after getting the shot.  The chickenpox-like spots occured 5 to 7 spots at a time throughout his body (e.g. back, thigh, butt, backside of calf, and other random places). The patient described the size of the marks as bigger than the top of a pen, but smaller than a dime and reports there were bumps that were a tiny bit raised when ran finger across them. The skin looks like dry skin, and they itch like crazy around a 3 inch diameter.  The reporter prescribed Triamcinolone ointment to control the itching. The reporter consented to follow up and not all information was available.  The patient gave permission to follow-up with their HCP. The patient was unable to provide HCP's email at the time of report.  Discrepancy: Reported Date and TTO information are discrepant. Vx on 11Nov2020 and narrative states TTO of approx 6 weeks, however the date is captured as 15Dec2020 which is in 5th weeks after vaccinatin.
Initial report received from a non-healthcare profession on 14 October 2014. A patient had received a dose of FLUZONE HD (batch number, dose in series, route and site of vaccination not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient developed serious confusion and behavior changes (severe crying). Laboratory investigations and corrective treatments were not reported. The patient was sent to emergency room and then released. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a non-healthcare professional on 30 December 2014. Patient initial and responsible physician information was updated. A 75-year-old patient has received FLUZONE HD (batch number U5017AA) in left arm on 03 October 2014 and event occurred on same day after vaccination i.e. on 03 October 2014. Documents held by sender: none.
Major rash lower legs; major swelling all of  right foot with pain in right big toe; increased sciatica that had been much improved with pain in lower back
Patient had Moderna Vaccine at unknown location on 1/19/21 and 8 days later reported a red itchy rash on vaccine arm.
No adverse effects reported; one dose of an improperly stored vaccine, VARIVAX, was administered to one patient; Assistant confirmed route of administration was "intramuscular" .; This spontaneous report was received from a medical assistant and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 11-SEP-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, intramuscularly, lot # S002877, expiration date 29-JAN-2021, for prophylaxis. The sterile diluent (lot # S000130, expiration date 23-AUG-2021) used to reconstitute the vaccine was stored in the correct storage temperature range. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 8.1 Fahrenheit degrees for 20 minutes. The digital data logger was involved in recording the temperature excursion details. There were previous excursions of 8.1 Fahrenheit degrees for 17 minutes and 9.5 Fahrenheit degrees for 21 minutes reported.
Pt reported 11/01/02 AM, Pt c/o pain to upper arm and weakness in arm and hand grasp. Pt had soreness in upper arm after injection given but it has increased over the last two weeks. Swelling or redness in upper arm. Right hand grasp weakness than left. pt had take Tylenol and warm compresses to upper arm.
sore arm; rash all over stomach, thighs, one on her chest and one on neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and RASH (rash all over stomach, thighs, one on her chest and one on neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (sore arm) and RASH (rash all over stomach, thighs, one on her chest and one on neck). At the time of the report, MYALGIA (sore arm) and RASH (rash all over stomach, thighs, one on her chest and one on neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Reporter details were updated which is non-significant
Just a sunburn like rash at injection site - oval shaped and approximately 5 inches long and 3 inches wide.  Looks and feels like a sunburn - very warm feeling radiating from area.  No itching.  About 8 days after first Moderna vaccine.
Myalgia, Fever, Chills, Fatigue, Injection Site Soreness Narrative:
suspected vaccination failure; affects the nerves.; shingles; rash; Felt like pins; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant), shingles, rash and pins and needles. On an unknown date, the outcome of the vaccination failure, neuropathy, shingles, rash and pins and needles were unknown.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, rash and pins and needles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and 3 months later got shingles. The patient stated he/she had most god-awful rash ever, felt like stuck with pins and it affected the nerves. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Flu vaccine to left deltoid on 10/9/12. Later that afternoon felt hot to shoulder then neck was stiff for two days.
I have an IUD and have had it for at least 9 years. I rarely have spotting or any type of vaginal bleeding. Last week a had what seemed to be a full on period for 5 full days and spotting for an additional 2. I am very concerned. This is very abnormal for me and especially since I have an IUD.
Constant and prolonged ringing in the ear/tinnitus starting a few days after the vaccine was administered.  I have never experienced this constant and prolonged tinnitus before and it has continued since it first started around January 20th.  I thought it would go away, but it never did.  It appears I may have some hearing loss at this time now as well, which I did not previously have.
14 days, post vax, pt started with maculo-papular rash in 48 hour, rash spread all over body. She had a low-grade fever, itchiness and overly uncomfortable.
This spontaneous report was received from an office manager and refers to an unspecified amount of patients of unknown demographics. The patients' pertinent medical histories and drug reactions or allergies were not reported. From 01-JAN-2017 to 25-SEP-117, the patients received an improperly stored doses of RECOMBIVAX HB (lot # M000442 with expiration date at 31-MAR-2018; dose, route of administration and anatomical location were not reported), for prophylaxis. There were previous temperature excursions (unknown by reporter). The reporter did not know the ranges of temperature excursions and their time frames. Data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012746: US-009507513-1709USA012635: US-009507513-1709USA012747: US-009507513-1709USA012744.
Begin 4 days after first vaccine on  3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning;  decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great
Started with chills, next day fever, chills, headache, muscle ache, large red patch at shot injection site. 3rd day same, 4th day, fever, chills, headache went away.  Shot site redness larger and extremly sore to touch. Applied cold cloths, massage area.  Week later, shot site still sore, redness slowly going away.
Initial report received from a consumer on 25 October 2013. A 40-year-old female patient had received an intradermal dose of FLUZONE ID (lot number: UT4722AA, dose number was not reported) in the left deltoid on 17 October 2013. The patient denied for the illness at the time of vaccination, allergy, birth defect and medical history. On 21 October 2013, 4 days post vaccination; the patient experienced a burning sensation in chest, tingling and heaviness in hands and legs, generalized joint pain and headache. On 22 October 2013 at 2:00 hours, the patient went to hospital ER and was administered MSO4 for pain and a GI cocktail and discharged. That same day patient went to another hospital ER and was administered MSO4 for pain, lab work and an ultrasound and was admitted for 24 hrs. On 23 October 2013, the patient was discharged from hospital. Patient was not provided a diagnosis. At the time of this report, the outcome was unknown. Documents held by sender: None.
Fever x 2 days highest 106 - 11/30 12/1 warm tender leg where immunization was given. 2 x 4 cm erythema left leg.
LOST BOTH LEGS FROM CLOTTING; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient was a marine veteran. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient lost his both legs from clotting. Reporter stated that, " My friend lost both legs from clotting from your product. He's a marine veteran.... I'd gladly put you in touch with him so maybe you can do the right thing and HELP HIM". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost both legs from clotting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221211865-lost both legs from clotting. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Vaccine - 11 AM - Fri. 9/7/18 arthroplasty. Temp. 99 - hot - aching (L) knee. 4 PM Fri - aching - heat - red over knee - increased 9 PM. (2) ES - Acetaminophen 500 mg - 10 PM and 6 AM Sat. 9/8. 9/9 - Sun. - 8 AM - all symptoms resolved. Nothing happened on (R) knee arthroplasty, minimal soreness at injection site (L) arm. I do not have a computer. All (3) medical providers said "Not a known reaction". But complete VAERS form from CDC. My question remains why did the left knee replacement side become red, hot, and painful within hours of vaccine and (R) knee replacement side did not?? Can I get the vaccine next year?
Client vaccinated with first dose of Moderna without incident at 10:20 am.  Had history of severe allergic reaction to bee sting as  child.  Instructed to stay for observation for 30 minutes.  At 10:40 am reported itchy neck and feeling of "a ball in my throat".  Monitored every 5 minutes for 90 minutes.  Incident occurred at County Jail so jail staff gave him 50 mg Benadryl.  O2 was 99%.  At 11:35 client stated everything feels normal.  Released back to POD at 12 noon.
Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored RECOMBIVAX HB (lot # L004754 with expire date 10-NOV-2016, dosage and route not provided). The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient inadvertently received Adacel, while was supposed to receive Tubersol, no AE; Initial information received on 14-Aug-2020 regarding an unsolicited valid non-serious case from other health professional. This case involves a 22 years old female patient who inadvertently received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number 5723N and expiration date 19-Nov-2022), via intradermal route in the forearm as prophylactic vaccination instead of getting tested with TUBERCULIN TEST [TUBERSOL] (lot number and expiration date were not reported) on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication were not given to the patient.  It was unknown that if she was pregnant.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Fussy, low grade temp, slept a lot, symptoms x 2 day, decreased appetite, woke up on day 3 and was fine.
Febrile seizure - focal for 20 minutes. Tx'd with Ativan, Dilantin 8/23/07-records received for DOS 7/5-7/8/07-DC DX:Epilepsia partialis continua. Febrile convulsions. admitted in status epilepticus. Developed fever to 38.5 on day of vaccine. Twitching on right side persisted for 2 hours.
arm pain was really bad/pain was extreme; sweats; I couldn't raise my arm; I didn't feel like myself; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain was really bad/pain was extreme), HYPERHIDROSIS (sweats), LIMB DISCOMFORT (I couldn't raise my arm) and DEPRESSED MOOD (I didn't feel like myself) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain was really bad/pain was extreme), HYPERHIDROSIS (sweats), LIMB DISCOMFORT (I couldn't raise my arm) and DEPRESSED MOOD (I didn't feel like myself). On 13-Apr-2021, DEPRESSED MOOD (I didn't feel like myself) had resolved. On 14-Apr-2021, PAIN IN EXTREMITY (arm pain was really bad/pain was extreme) and LIMB DISCOMFORT (I couldn't raise my arm) had resolved. On 15-Apr-2021, HYPERHIDROSIS (sweats) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109895 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109895:Husband case