chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of pruritus in a 23-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Co-suspect product included TB skin test (Sanofi-Pasteur) placed 23 October 2012. Concurrent medications included IMURAN, Levothyroxine, T3, SEASONALE and ADDERALL. On 23 October 2012 at 10:40 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 23 October 2012, 45 minutes after vaccination with FLUARIX, the subject experienced pruritus of forearms, hives/rash on forearms, pruritus of lower extremities, pruritus of buttock, itching of stomach. Later in the afternoon on 23 October 2012, hours later, the subject experienced itching neck, itching upper arms, and a low grade fever of 99.6 degrees Fahrenheit. Medical attention was required at the emergency room and employee health. At the time of reporting the outcome of all itching events and hives/rash had improved but were still present. The outcome of the low grade fever was unresolved. Follow-up information was received on 27 November 2012 via healthcare professional. Concurrent medical conditions included asthma, attention deficit hyperactivity disorder, hypothyroidism and psoriatic arthritis. The reporter clarified the subject received FLUARIX via intramuscular injection. It was clarified that the subject made an appointment at employee health for evaluation; medical attention was not required at the emergency room. The subject has discharged from the employee health clinic in stable condition. The subject did not go to the emergency room. The reporting healthcare professional considered the events may have been associated with medical history/concurrent illness of psoriatic arthritis; unclear if associated with her symptoms. At the time of reporting the events were resolved.
Pt was administered Monovalent vaccine as a booster instead of Bivalent vaccine.
The Patient suffered a red, irritated, and itching eye and was diagnosed with herpetic involvement and keratitis of the right eye; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In or around 23-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for prevention of shingles.         On an unknown date (reported as "shortly after vaccination"), the patient experienced a red, irritated, and itching eye and was diagnosed with herpetic involvement and keratitis of the right eye (ophthalmic herpes zoster).  The outcome of ophthalmic herpes zoster was not recovered.     As a result of the vaccination, the patient had severe and permanent personal injuries, for that reason, the event was considered as a disabling event.   The reporter considered ophthalmic herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, the event of ophthalmic herpes zoster was considered as medically significant.
Patient reports that her upper left arm became swollen, warm to the touch, and developed a red rash 8 days following her vaccination. It was on the left arm, the upper arm only, where she had received her vaccine. Patient reports that it lasted four days, then went away on its own. She said that she Googled "Covid Arm" and believes her experience fit that collection of symptoms. Patient reports no other symptoms.
After patient received Flublok Quad and Pneumovax23, patient experienced dizziness, then few minutes later patient complained chest pain.  We called 911, paramedics came and assessed patient.  Patient rested in consultation room for 15 to 20 minutes and felt better.  Patient contacted her cardiologist, and also called her friend to come and pick her up.  Patient's friend took patient home.
shrill persistent crying throughout noc & following morning w/in 24hrs of inj;t102.2 during noc & 101 following AM;
Patient RTC on 12/31/08- c/o .5cm red area with 3 small bumps that appeared 2 days after Immunization.
Moderne COVID-19 vaccine EUA  Sore and swollen throat Achy Fatigue , weak  Light headache
c/o pain lt arm & shoulder upon receiving flu vax;limited movement in arm & cannot sleep on arm;has seen chiropractor, MD & now having physical therapy;
Pt recvd vax & exp a red, swollen arm; No further details were provided;
HA, Fever, Chills, Dizzy, itching ears and arms, blurry vision, feeling like throat is closing. Treatment Benadryl and steroids. Symptoms improving.
Fever to 102 night of immunization for 2 days.  Large 5 x 5 cm area of induration and redness to right arm at site of injection.
This spontaneous report as received from nurse refers to three unspecified patients of unknown age. On 28-APR-2014, three unspecified patients were vaccinated with ZOSTAVAX, expiry date 10-APR-2014, 0.65 ml (milliliter), subcutaneously. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. This report is linked to 1405USA001640 by the same reporter link. Additional information has been requested.
fever 101 chills aches , diarrhea, fatigue all symptoms progressive at time of eval.
I went to the MD for a blood pressure check on 5/5/99 and received Lymerix vaccine, Lot LY12069. The 2nd one was given on 6/16/99, lot LY120A9. I was in bed the rest of the day with flu-like symptoms. I am starting therapy again at the hospital on 11/28/00, 2nd time. I lost the use of my hands and strength in arms. All my joints hurt. Have had 2 years of MD visits. 60 day follow up states patient experienced fatigue.
The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 18-Apr-2023.).    No concomitant medications were reported. Patient was not breast feeding. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported. This case contains information for the 5th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:
Starting 05/22/2022, I developed fatigue and body aches and possibly a very minor fever. That evening my breathing started to be compromised and my SpO2 rate was declining. I tested myself at home that evening and it was positive. I went to the doctor that morning and they prescribed me Paxlovid and Medrol Dose Pack. I developed some sinus congestion within a day or so after developing symptoms and I had a slight productive cough. I continued with breathing difficulties for a few weeks like with going upstairs. Now, its much better and I have very minimal issues if at all. I still am experiencing a lot of sleeping issues (not sleeping through the night) and I wake up early in the morning (3-4am) and unable to fall back asleep until late am or afternoon. When I do nap, I wake up feeling very groggy. I'm also having very vivid dreams but that is starting to subside.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 61 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 001B21A), on 16Apr2021 as dose 2, single (Lot number: 020B21A) and on 09Jun2022 as dose 4 (booster), single (Lot number: 056A22A) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 18Jul2020; PEPCID AC, start date: 18Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has received Paxlovid from 14Sep2022 to 19Sep2022 for the treatment of COVID-19.
Developed diarrehea, vomiting, loss of appetite immediately.  Continued through December.  Went to Primary care physician Jan. 4, 2022.  He drew blood work.  Came back with elevated liver enzymes.  Took blood work again 2/25/2022 and came back with elevated IGM Lambda monoclonal protein present.  Referred to Hemotologist/Oncologist.  More blood work throughout March, diagnosed with MGUS by Oncologist.   Continuing to be seen by other doctors trying to evaluate random inflammatory outbreaks, knees, foot, mouth sores, continue diarrehea periodically.
pt recv vax @ clinic 10/21/99 & deceased @ home 10/22/99;
pt recv vax 5JUN95 & 1JAN96 pt devel 12 lesions;MD reported that 3-4 of the lesions are open & are very similar to varicella lesions;pt has shown no other sx;
a dose of PENTACEL was administered and only the liquid component was administered, with no reported adverse event; whether the powdered portion consist of only the HIB portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who received a dose of pentacel was administered and only the liquid component was administered, with no reported adverse event and whether the powdered portion consist of only the hib portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 06-Jan-2023, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ684AAA, U7331AA (DILUENT) via unknown route in unknown administration site.  On an unknown date the patient recieved a dose of pentacel was administered and only the liquid component was administered, with no reported adverse event (single component of a two-component product administered) and whether the powdered portion consist of only the hib portion of the vaccine and what diluent it now needs to be reconstituted with, wit no reported adverse event (product preparation error)  (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
This spontaneous report has been received from a pharmacist via a company representative, concerning a 60-year-old (about to turn 61 years old) female patient. The patient's concurrent condition included asthma and chronic obstructive pulmonary disease. Medical history and concomitant medications were not provided. On an unknown date (for many years), the patient had been vaccinated each year with PNEUMOVAX 23 (doses, frequencies, routes, lot numbers, expirations dates and indications were not provided); furthermore, on 18-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (dose, frequency, lot number and expiration date were not provided) for pneumococcal prevention. On 18-OCT-2018, the patient contacted pharmacist with complaints of trouble speaking and trouble breathing. The reporter stated that the patient did not received any treatment. The therapy with PNEUMOVAX 23 was reported as continued. The outcome of trouble speaking, and trouble breathing was reported as not recovered. The causal relationship between the adverse events and the therapy was not assessed.
Patient complaining of stiffness or crick in her neck on the left side.  Denies swelling or severe pain.  She said her left arm was sore for a day after shot, but no pain now.  She said it is getting better, but slowly.  She was going to talk to her primary MD at Clinic.
Seen in office for 1 year exam. Given Hib, PREVNAR, MMR and varicella. Presented to ER in pm w/fever and seizure activity x 30 seconds. Sent home after ER exam.
Pt was given 2nd dose too early, no harm to patient per CDC. Will need to be repeated at age 16-18
Patient was injected with Pfizer-BioNTech "orange top" designated for ages 5-11 years. She was given a 0.2 mL IM dose to right anteriolateral thigh. The MDV was reconstituted correctly for that particular medicine, as well (1.3 mL of 0.9% sodium chloride diluent). The patient was supposed to receive the "maroon top" Pfizer-BioNTech COVID-19 approved for ages 6 months to 4 years; it was to be her second dose in the series as she received her first dose 21 days ago. The patient, naturally, cried immediately after injection but was quickly consoled by parents. No adverse reaction within 20 minutes of administration was observed, and the patient and family left the clinic. The error was not noticed until 30 minutes after that time.
Herpes Zoster, Shingles developed in same leg as Varivax vaccine injection site, two and a half years later.  Diagnosis by urgent care and pediatrician.  Child has never had or been exposed to anyone with chicken pox.
Pouring sweat, hives, light headedness and dizziness and tremors, weakness, burning, itching of all skin, blurred vision
Redness, swelling, discomfort, pruritis, localized urticaria (6 inch diameter surrounding Menactra injection site). No associated respiratory complaints.
This spontaneous case was reported by a consumer and describes the occurrence of CARDIOVASCULAR SYMPTOM (Feeling a heart thing, which she could not explain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOVASCULAR SYMPTOM (Feeling a heart thing, which she could not explain). At the time of the report, CARDIOVASCULAR SYMPTOM (Feeling a heart thing, which she could not explain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.It was reported that the patient felt so sick in December 2020 but had COVID test three times which all turned out to be negative and patient was treated with experimental flu drug.No concomitant medication was reported.No treatment information was reported.This case was linked to MOD-2021-388558, MOD-2021-388559 (Patient Link).
1. After few minutes numbness on right side of body for 2 days. 2. After 3 days erratic blood pressure and rate, now at day 17 and this shortness of breath, dizziness and erratic heart beat and rate continues...my heart rate of 160 is totally out of my norm.
pt recvd vax; devel fever 102.8 despite antipyretics; severe myalgias; crying >3hrs;
had a fever of 99.8 on Saturday evening, and 100.8 Sunday morning, eventually the last time I had a fever was 11pm that evening at 99.6, I have left arm carpal tunnel and everything that I had wrong with me seem to bother me and the arthritis in my right wrist hurt for a couple days.
Ischemic stroke - Left Hemisphere, S/P Thrombectomy, S/P LINQ
RECEIVED FLU AND BIVALENT COVID VACCINE ON 11/23/2022 AND ON SATURDAY 11/26/2022 HE STATES HE STARTED TO ITCH ON HEAD AND ARMS AND OVER TIME GOT WORSE.  THIS MORNING ON 11/30/2022 THE SKIN ON HIS FACE LOOKS PEELED AND EYES ARE SWOLLEN LEFT EYE DID CLOSE UP PATIENT ALSO FEELS DIZZY. PATIENT GIVEN DECADRON 10MG  AND KENALOG 40 SHOT ADMINISTERED DURING THE VISIT.  BENADRYL 25MG BY MOUTH EVERY 6 HOURS FOR THE NEXT 2 DAYS.
Within 15 minutes - hot and flushed, headache. Dizzy.  Fever onset first night. Lowgrade, sub 100.4. General bad feeling. Exhaustion, sore, muscle aches. Felt very hot and flushed even though fever was only 100. These symptoms lasted for 7 days. On day 3, Tuesday, I developed a dull aching pain in both arms. The feeling was like that of a charlie horse in your leg. Dull, painful, like slowly being crushed. Also felt hot pinpoints that itched all over my hands. My hands felt like they were burning, and the itchy pinprick feelings were mostly on my palms and fingers, but would sometimes present up towards my elbows. My hands were somewhat shaky, and still are. Once or twice my hand would flick involuntarily.  The sore hurting arm feeling extends all the way up to my shoulder blades.  On day 7 I went they gave me a steroid shot and a round of antibiotics. They said it was likely a sinus infection.  The symptoms persisted one more day but then the fever resolved Wednesday night, Tylenol took it down and it didn't come back Thursday. The headache, sore back and neck, and arm pain persisted. It is now day 10. I am most concerned about the arm pain, tingling, and shaking. Please advise on whether I should get my second dose. I might go to a hospital for further testing if this doesn't resolve or if it progresses.
Pt received the vaccine in the states during the predeployment process. Arrived 5 days ago. Rash started below breast and has since spread considerably. Presents with severe widespread vaccinia with small pustules covering back chest and right ankle. Referred to dermatologist here in country to confirm. Received the Varicella vaccine on 7/8/2011.
Woke up early morning, 4am on 14 Aug 2020- Fever, 100.9, headache, body aches, fatigue. Fever continued to fluctuate throughout the day and evening, 99.7- 101.  Symptoms lasted 3 days but were milder.
Was administered Hep B vaccination at 3 days old, 4 hours later had a seizure. Immediately after vaccination she became sleepy and slept until she started convulsing which lasted approximately a minute, stiffened all her limbs, jaw was clenched and I had to stick my finger in her mouth because she was not breathing, she turned red then blue and started foaming at the mouth.  I immediately rushed her to the ER and she was admited to the NIC unit where she stayed for 4 days.  All neuralogical and infection test were done, she was administered antibiotics until the results came back which were negative.  The only diagnosis they came up with was acid reflux and she was give prilosec.   I felt they refused to take into consideration that the vaccination had anything to do with her seizure.  They did not test to see if she was allergic to any of the components of the vaccine.  4/20/09 Newborn exam recd dated 1/2/09 with normal exam. 5/12/09 Additional records received from PCP. seen 1/9/09 in f/u to possible seizure episode. W/U was (-). No further episodes. PE WNL, now dx with GERD.  5/14/09 MR received for DOS 1/3-6/2009 with D/C DX:  Term AGA female infant.  Mild GER. R/O Sepsis-never proven.  Neuro staus-R/O seizure. Pt presented after episode of stiffening, shaking, gasping for air, lip-smaking and foaming at mouth. Sleepy upon PE in ER.  W/U result was while episode had the appearance of seizure, more likely a reflux episode with accompnaying apnea and stiffening. D/C on Prilosec and Reglan. ICD9 codes:  779.89 Specified conditions originating in the neonatal period. 530.81 Esophageal reflux.
I started to shake and had a fever.  My right hand started to swell up about 12 hours after the second vaccine. After the second dose I lost my memory, I could barely talk, I was always experiencing falling. I had dizziness and headaches. I have joint pain everywhere. Forearm pain. My hips hurt. I went to a neurologist he prescribed medication to help with my symptoms. The medication I can not take it makes the symptoms worse. He advised that my symptoms would get better, and they have not got better  I am unable to do anything that I could before the vaccines. My shoulders hurt so bad.  I am unable to drive. My vision also declined. I still have extreme fatigue. I also have problems shaking especially my hands.