chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General malaise; Local itchy rash; Local swelling; Local heat; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2019 (Batch number; AS9CM, expiry date 25-APR-2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication.  The patient received dose one of Shingrix on May 8, 2018 and has not yet received dose 2, which led to incomplete course of vaccination. The reporter was consented to follow up.   Follow up information was received from the pharmacist on 18th February2020: The patient's demographic details were updated. The patient's past medical history included chemotherapy and non-hodgkin's lymphoma (remission).  The reporter stated that the patient received chemotherapy prior to 2nd dose of vaccine. Previously administered products included Rituximab, Acetaminophen, Dexamethasone, Diphenhydramine, Palonosetron, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone (given on day 2 to 5 after each treatment) and Pegfilgrastim (given 2 day after each treatment).  The patient took the chemotherapy treatment on 30th July 2018, 20th August 2018, 10th September 2108, 8th October 2018, 29th October 2018 and on 19th November 2018. Concurrent medical conditions included cancer.  On 26th November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 26th November 2019, 2 hrs after receiving Shingrix, the patient experienced pain.  On 27th November 2019, the patient experienced local swelling and skin warm. On 28th November 2019, the patient experienced itchy rash. On 29th November 2019, the patient experienced general malaise.  On 1st December 2019, the outcome of the pain, local swelling and skin warm were resolved.  On 3rd December 2019, the outcome of the itchy rash was resolved.  On 10th December 2019, the outcome of the general malaise was resolved.  The reporter considered the pain, local swelling, skin warm, itchy rash and general malaise to be related to Shingrix. The VAERS details were updated.
Patient states approximately one hour after the the vaccination, rash and itching began at area and began to spread to body.  Felt nauseous.  States fever of 103F.  Had breathing difficulty.  Had Epi-Pen at home for another use and used for this this reaction.  Afterward, used diphenhydramine.  Patient states that after this, felt better and did not seek medical attention.
Shingles on face near mouth, on the right side.; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021, at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar I disorder, type 2 diabetes mellitus, generalised anxiety disorder (GAD) and chronic bronchitis. The patient had history of allergy to penicillin. Concomitant medications included aripiprazole (ABILIFY), quetiapine (SEROQUEL), clonazepam (KLONOPIN) and lamotrigine (LAMICTAL), all for unknown indications from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, at 09:00, the patient had shingles on her face near mouth in the right side. Therapeutic measures were taken as a result of shingles included valacyclovir (VALTREX). Adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Approximately at 2am on 5/2/21, I began feeling nauseous and extremely hot.  Within 30 minutes, I was vomiting and went from being hot to shivering from chills. I didn?t  have a temperature reader, but I was fairly certain I was suffering from a fever. I continued to vomit and shake from chills until approximately 10am after taking Tylenol. From 10am to 11pm, I suffered from fatigue and body aches. I woke up at 11am 5/3/21 feeling no longer suffering from side effects. In addition to side effects after the vaccine, I was also suffering from head cold symptoms (sore throat, coughing, congestion). I had these symptoms start 4/30/21, so I tested for COVID-19 that day and my results came back negative.
No ADR, timing ERROR 2nd dose given 45 days after 1st Narrative:  No ADR, timing ERROR, 2nd dose given 45 days after 1st one
Had the shot still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Experienced strong all-day headache.    A number of days later I experienced strong abdominal pain on at least two separate occasions. There is no history of pregnancy.
This spontaneous report was received from a vaccine coordinator and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients received doses of improperly stored VARIVAX, lot # M035688 with expiration date 10-AUG-2018, lot # M042496 with expiration date 19-OCT-2018 and lot # M049127 with expiration date 15-DEC-2018 (doses and route of administration were not reported). Administered doses of VARIVAX experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 570 minutes and an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 300 minutes. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. Administered doses of VARIVAX were reconstituted with STERILE DILUENT, also reported as "sterile water diluent" (lot # and expiration date were unknown). The STERILE DILUENT was properly stored. No adverse effects were reported. Additional information has been requested.
Breakthrough SARS-CoV-2 infection; This literature-non-study case was reported in a literature article and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough SARS-CoV-2 infection) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Tobacco user. Concurrent medical conditions included Squamous cell carcinoma of lung.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough SARS-CoV-2 infection) (seriousness criteria death and hospitalization). The reported cause of death was Breakthrough SARS-CoV-2 infection. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 128.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient received an unspecified chemotherapy for thoracic malignancy of squamous cell carcinoma histology. Patient was not hospitalized during infection. Time from initial vaccine dose to SARS-CoV-2 infection was 130 days and last vaccine dose to SARS-CoV-2 infection was 101 days.  Patient deceased following complications of SARS-CoV-2 infection.  Company comment:  This literature-non-study case report concerns  a 73-year-old patient of an unknown gender, who was former smoker with underlying medical history of Squamous cell carcinoma of lung on Chemotherapy, who experienced serious (due to fatal outcome and hospitalization) unexpected event of Breakthrough COVID-19 infection which occurred nearly 4.5 months after initial dose of the mRNA-1273 vaccine (first dose) and nearly 3.5 months after the last (second) mRNA-1273 vaccine. Reportedly, the patient experienced symptoms of COVID-19 infection and required hospitalization. According to the information provided, the patient deceased following complications of SARS-CoV-2 infection, as stated. No additional details regarding clinical course of the event were disclosed. The patient's underlying malignant disease remains a major confounder for complicated SARS-CoV-2 infection that led to fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-712298 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Follow up received by safety on 24-Feb-2023 has email with full text article and contains significant information. Reporter, literature information, laboratory data, product details, even details, seriousness and narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712298:61-years-old patient (Master case); Reported Cause(s) of Death: Breakthrough SARS-CoV-2 infection
Patient c/o chills, pain in left arm, increase redness and swelling at injection site.
HBP; trouble sleeping; headaches; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): EC-2022-115296 (RA).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), (Batch/Lot number: unknown) at 20 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, unknown manufacturer), for COVID-19 immunization.  The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "HBP"; INSOMNIA (non-serious), outcome "unknown", described as "trouble sleeping"; HEADACHE (non-serious), outcome "unknown", described as "headaches". The action taken for lenvatinib mesilate was unknown.  No follow-up attempts are possible. No further information is expected.
ELASTICITY ON BACK OF HANDS UNRESPONSIVE; TIREDNESS; BACKACHE; NIGHTMARES; DIARRHEA; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported.  The patient's past medical history included herniated disc, and concurrent conditions included penicillin allergy, high blood pressure, smoker, back pain, plantars wart, diabetes, and alcohol user.  The patient experienced drug allergy when treated with Cleocin (clindamycin hydrochloride).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  Concomitant medications included metformin for diabetes, losartan for high blood pressure, salicylic acid for plantars wart, and Wellbutrin (bupropion hydrochloride).  On 08-APR-2021, the subject experienced nightmares. On 08-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced backache. On 10-APR-2021, the subject experienced tiredness. On 16-APR-2021, the subject experienced elasticity on back of hands unresponsive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elasticity on back of hands unresponsive, and the outcome of backache, tiredness, nightmares and diarrhea was not reported. This report was non-serious.
Starting getting what I am to assume are hives on Friday approximately two days after my second dose. Had two that I noticed itching before I went to bed.  Woke up next morning with more.  About twenty welts in all. Majority on my left forearm and thumb.  None at or near site of shot. The remaining were on the buttocks area and two on my right hand. I went by a pharmacy and spoke with a pharmacist which asked if I felt anything in the throat area and the reaction I was having may not have come from the shot.  She stated I should take Benadryl which I started taking Saturday. Welts seamed to peak on Sunday 4-25-2021 with no more coming out. Seems to be subsiding now.  I did speak with my doctor on Monday morning and concluded I was doing okay and taking Benadryl was a good course of action. As of 4-27-2021. The hives seem to be getting better and calming down.
Patient presented as a walk-in to our COVID 19 vaccine clinic.  He requested Moderna after receiving his primary series of Pfizer.  None of our staff recognized his age as a limiting factor to his request.  He received Moderna booster dose (0.25 ml) at age 15 years.
Initial report was received from a consumer who is also the patient on 27 September 2010. A 50 year-old female patient with no illness at the time of vaccination, had received an intramuscular left deltoid injection of FLUZONE SV, lot number UH181AA (needle length not reported) and an intramuscular right deltoid injection of B12 (manufacturer and lot number not reported) on 11 September 2010 and eight hours later she reported she felt like "tons of bricks on brain and bones in back were breaking". She also reported sleeping over 24 hours, being disoriented, unsteady on her feet and her vision was "gone" for one week. On 18 September 2010 she developed nausea that persisted until 27 September 2010. She reported being evaluated by a physician in the emergency department on 12 September 2010 and two other individuals on 24 September 2010. Diagnostic findings included: Complete blood count (CBC), within normal limits (WNL); vertigo testing, negative; CT scan, within normal limits (WNL); chest x-ray (CXR), within normal limits (WNL); and a MRI, within normal limits (WNL) to rule out (R/O) MS. No further information was available at the time of this report. The patient's outcome was not recovered. Documents held by sender: none.
Clinical signs noticed upon waking the day following vaccination #2. Flu-like symptoms: cold chills, joint and muscle aches, headache, general malaise, tenderness in left axillary region, loose stool
1/3/2021 Vaccination 1/4/2021 @ 3pm spiked temp to 100.6. Lasted 4 hours. Contacted clinic.  Tele med.  'If do not feel better, to see PCP'. I felt better after 4 hours and following day.
Minimal erythema macular lesion to cheeks bilateral with 5-10 min of Influenza vaccine administration treated with Diphenhydramine.
Vaccine administered 11/12/21.  Call from patient on 11/15/21 stating her eyes are swollen and wondered if it was related to her second dose of Moderna.  The screening questionnaire completed by the patient was negative for allergies to medications or any adverse reactions to the first dose in the series. Patient has been in contact with her dermatologist and ophthalmologist regarding this reaction and will follow up with them.
7 days after first moderna dose I developed a warm, itchy sensation in my left deltoid - this was in the middle of the night and I kept waking up uncomfortable. When I woke up Saturday morning my deltoid was red and swollen, the muscle was still hot and now starting to ache instead of itch. Throughout Saturday the aching intensified to about a 6/10. Then it radiated into my left armpit and feeling of pain like a hard small ball in my armpit. I went to urgent care, the doctor was not sure if it was delayed allergic reaction or cellulitis so he started me on Bactrim. I have now taken one day of Bactrim - seems to be improving but still have sensation in my armpit/lymphnode.
This spontaneous report as received from a consumer via company representative regarding a male patient in his 70's (years old). The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date in 2015, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dosing details and lot# unknown). Other suspect therapies included PREVNAR 13 (dosing details unknown). On an unknown date in 2015 reported as following the administration of the shot, the patient experienced fever and tenderness. The outcome of fever and tenderness was unknown. Causality assessment was not reported. This case was cross referenced with LRN W2016256280. Additional information has been requested.
SICKEST I EVER GOT WAS AFTER THE NASAL FLU MIST IN THE ARMY.; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine (live, attenuated)), via nasal route, on an unknown date.     On an unknown date, the patient experienced sickest i ever got was after the nasal flu mist in the army. (preferred term: Malaise).     The outcome of the event was unknown.    The event was considered non-serious.
Pain and a hurting sensation present at site of vaccination at 1405. Pt waited 15 minutes in the EMS room with an ice pack and then left vaccination clinic. Pt stated she was feeling better, however,  pt returned with guardian and stated that burning sensation was still present. Pt was provided a second ice pack for site of vaccination. Nurse administered PO 25mg of Benadryl with guardians consent at 1430. Pt states at 1440 that she feels better. Minimal pain and burning sensation present. Pt has a history of needle phobia and anxiety.
Heart issues including irregular heartbeat started March 4, 2021 and prompted an ER visit on March 6, 2021.  Followed up with doctor the next week  and was hooked up to a heart monitor to record irregular heartbeats .  Diagnosed with ventricular ectopy.  The episodes stopped on their own  March 22, 2021
pt came in 28OCT for influenza vax  @ 355PM vas given; pt began arching back, made a loud sound, skipped out of chair to floor & begin convulsing for approx 2-3min;
Case number PHEH2016US023466, is an initial spontaneous report received from a nurse on 12 Sep 2016. This report refers to a 43 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1618401) at a dose of 0.5 ml, intravenous on 12 Sep 2016. It was stated that, patient was administered FLUVIRIN vaccine through intravenously instead of intramuscular. No adverse event was reported following this medication error (incorrect route of drug administration). The case was assessed as non-serious by the nurse.
Subsequent to receiving vax, the pt experienced uncontrollable crying for about 3 hours.
(D:) BP 102/60; P 60  - R-12;- Pt feel lightheaded, skin tone change to pale. Saw spots, alteration in hearing (A:) Pt given Kool Aid to drink Patient lay on back on exam table, syst symptoms resolved, BP 102/60 P. 60  (R:) Symptoms resolved.
8 hrs post vax left shoulder sore; 12 hrs post vax left shoulder stiff - arm wouldn't raise above shoulder height. 24 hrs later shoulder is fine
Red papular rash started 1 week after vaccine 2-3 weeks later significant lesions on head, face and vaginal area saw gynecology and dermatology - no specific diagnosis significant episode in August 2007.
Patient states that today when he was driving his truck, he experienced a sudden, stabbing pain (5/10) in his L upper arm deltoid where the injection was given 2 weeks ago. Patient states that lasted less than a minute or so and now is a very dull, barely noticeable pain (<1/10) in the same location. Patient denies any other problems at this time. Patient has a long sleeve shirt on and has not been able to physically look at his arm to note any changes on the surface of his skin. Patient stated in his VM that he had physically checked his L arm for any signs of skin discoloration, rash, redness and there is no physical sign of a problem. L arm is very slight dull pain in the deltoid. Patient will contact us or office with any further changes or questions.
Patient received vaccine and came and sat down next to his father in the waiting area.  Approximately 5 minutes after sitting down he fainted and fell out of chair.  His father guided his fall.  It took 2-3 minutes for patient to gain conscientiousness.  He was disoriented, pale, groggy.  911 was called and arrived approximately 20 minutes after event.  After the paramedics examined patient, he regained his bearings and color.  The family decided to go home at approximately 10am.  I spoke with mother at 7pm tonight and patient has been fine all day.
This spontaneous report as received from a registered nurse refers to an approximately 18 week old male infant. The patient's concurrent condition and medical history were not reported. On 22-OCT-2015 the patient was vaccinated with the first dose of ROTATEQ (Lot# L004453; Expiry date: 27-MAY-2016) orally when he was 17-18 weeks old. This was outside the label recommendations in the prescribing information. This was the only dose of ROTATEQ that the patient received. No adverse reactions were reported. Additional information has been requested.
Patient received the first dose of SHINGRIX vaccine on Friday, April 27. She had some injection site pain when the vaccine was going in. Patient reports that on Sunday morning, she noticed a rash on her neck and face. She has a history of unexplained neck rash, but said that it has not previously been this bad.. and usually is not on her face. She went to Clinic and was given a steroid shot, steroid pack, and steroid cream. We will follow up with patient to make sure she is okay, and needs no further assistance or treatment. We will also notify the physician who authorized the vaccine to let him know.