chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received telephone call from patient at 9:00 a.m. He states he had a flu and pneumonia shot 11/6/08 at 10:30 a.m. in his left arm.  He states he had a sever reaction to his shot per ER.  He is ok this morning.  He is a little sore and red.  Thursday a little after lunch his left arm became swollen, stiff and sore.  Later he developed weakness and was not feeling well, "feeling fluish".  Had headache, sick, dull, arm swollen and red from the shoulder down.  Started chilling late in the afternoon and evening.  States very uncomfortable, and lackadaisical.  Did not want to eat.  Took Advil and went to bed.  When he got up in the night he was unstable on his feet.  Friday the redness extended down his arm to his armpit and was light pink and swollen and very sore.  Stayed in bed till 10 a.m. with a headache.  Did not eat breakfast.  Ate very little lunch just did not feel like eating.  Arm still bright pink.  Called CDC hot line at 6 p.m.  It said if you have a reaction that last past 24 hours you need to see the MD.  He said it was too late to see anyone that night.  Saturday morining arm is still inflamed.  Called clinic and they told him to call the Nurse hot line.  They refered him to an MD.  So midmorning he went to the ER.  This is 48 hours after immunizations.  They said no infection.  Allergic reaction.  Since he had taken the flu shot in the past with out reaction it was probably the pneumonia vaccine.  Gave him a steroid shot in the hip.  Told him not to take the penumonia vaccine again or it could kill him.  Gave him Rx for steroids to get filled on Sunday if not improved.  Sunday morning he was a little better.  Arm still pink but better.  Monday (today) his arm is norm color and he is feeling much better.  Just wanted to let us know he had a severe reaction to the pneumonia shot.  I told him I would report it to VAERS.
Vaccine breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    Concomitant, treatment medication information were not reported.  This is a literature-non-study case  concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious event of Vaccine breakthrough infection. The event occurred on an unknown day after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The reporter assessed the events as related to the product. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-491471, MOD-2022-491379, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491481 (Patient Link).; Sender's Comments: This is a literature-non-study case  concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious event of Vaccine breakthrough infection. The event occurred on an unknown day after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The reporter assessed the events as related to the product. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female student, with no pertinent medical history, who on 10-APR-2007 at 16:00, was vaccinated IM in the left arm with a first dose of GARDASIL (lot # 657621/0387U). On 22-APR-2007 at 17:00, the patient experienced significant malaise, sore throat, headache, chest pain, weight loss and nausea. The patient sought unspecified medical attention. Lab tests included complete blood cell count, serum antinuclear antibodies test, serum rheumatoid factor test, erythrocyte sedimentation rate, serum C-reactive protein test, total serum thyroxins test, serum thyroid-stimulating hormone test, stool culture test, serum serotonin, stool for ova and parasites, and urine culture (results not reported). At the time of the report, the symptoms were still present despite appropriate therapy- labs. Additional information is not expected.
Patient with onset of tickle in throat, cough, sweats, hoarse voice, and headache s/p 2nd dose COVID vaccine Brought to observation area for assessment, water bottle given Consulted with Dr - MD evaluated pt's throat, visualized with otoscope, and no swelling seen Able to talk with scratchy voice, feels better sipping water Episode of dry heaves with no emesis Cetirizine 10 mg PO given, pt able to tolerate after dry heaves resolved Monitored for 30 minutes post admin of Cetirizine with improvement of symptoms, pt reports tickle in throat and cough resolved, overall feeling better, no further dry heaves. Advised to go to ED if any symptoms return or any new symptoms, pt verbalized understanding
1by 2 dozen blisters on my large toes; This case was reported by a consumer and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (1st dose received on unknown date. Please refer the case US2020AMR106507).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blister. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. Since getting the 1st of Shingrix the patient experienced about 1 by 2 dozen blisters on patient's large toes for no explainable reason. The patient asked was that a possible side effect.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106507:1st dose
SLEEPY; TIRED; This spontaneous report received from a patient concerned a 94 year old female. The patient's weight was 137 pounds, and height was not reported. The patient's concurrent conditions included atrial fibrillation, oral cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergies but can not remember which allergies patient had. patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included diltiazem for atrial fibrillation, acetylsalicylic acid, biotin, calcium carbonate/magnesium hydroxide/zinc, colecalciferol, glucosamine hydrochloride, glucosamine sulfate, magnesium, and nutrients nos. On 29-MAY-2021, the subject experienced sleepy. On 29-MAY-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepy, and tired. This report was non-serious.
Dizziness, Headache, Nausea Vomiting,  FATIGUE Narrative:
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On an unspecified date in September 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route unspecified). On an unspecified date in 2014, after receiving the vaccine, the patient experienced a flare up of her multiple sclerosis. The patient sought medical attention via contacting pharmacist. The outcome of the event "a flare up of her multiple sclerosis" was unknown. Follow up information has been received from reporting pharmacist on 14-NOV-2014. The patient details updated. The pharmacist reported that the patient, received ZOSTAVAX on 07-JUL-2014 (previously reported as unspecified date of September 2014). She stated that a few days after that the patient called the pharmacy reporting a "big rash" at the injection site. The pharmacist reported that the patient does have multiple sclerosis, but that she was not taking any immunosuppressant around the time of administration of ZOSTAVAX. The pharmacist stated that at some point after administration of the ZOSTAVAX, on an unspecified date, the patient was hospitalized at an unspecified hospital for "a flare up of her multiple sclerosis" (HOSPITALISATION). The pharmacist stated that she did not know what symptoms the patient was experiencing, but that the patient did mention "respiratory problems" to her. It is unspecified how the patient was treated during her hospital stay. She stated that the patient was discharged from the hospital and has recovered at this point. Causality of the reported events was unknown (not provided). No further information provided. The pharmacist stated that she has already filed a Vaccine Adverse Event Reporting System (VAERS) form on the website. Additional information has been requested.
8MAR c/o fever of 103 onset 7MAR: unsure of APAP dosage; Anorexia & general malise; had ear infect;
Headache, Runny nose, Diarrhea, Vomit, dizziness
Hives, feverish, chest heaviness, shortness of breath within 24 hours. Taken to ER - rec'd IV Benadryl, Decadron, Duoneb - admitted for observation.  8/26/08 Reviewed hospital medical records of 10/26-10/27/2007. FINAL DX: allergic reaction to pneumovax Records reveal patient experienced chest tightness & discomfort, SOB, flu-like symptoms of achy, tired, hives in left axilla & scratchy throat.  Admitted for observation & to r/o MI which was r/o.
Patient complained of dizziness, wheezing, cough, and nausea.  BP 180/110, P 72, O2 saturation 99% RA; 3:23PM BP 180-110, P 84, O2 sat 99% RA; 3:35PM BP 210/100 P88, O2 sat 98% -- > called emergency services; 4:25PM BP 140/92.  Paramedics administered 1 dose 25mg  diphenhydramine.
I got my first Pfizer injection on 3/10/2021. I normally get Humira injections every 2 weeks. I received a Humira injection on 3/28/2021, and I had a reaction I hadn't had before. Usually, I don't have reactions to my Humira injections, but on 3/28/2021, I had an injection site reaction that puffed up and became very red and itchy. At first, I thought it was a terrible mosquito bite, but it lasted for about half a week, and subsequent Humira injections produced the same reaction. I didn't get any relief from the OTC cream I normally use for bug bites, but after a few months, I discovered that prescription hydrocortisone cream helped with the itching and inflammation. My rheumatologist said that the reaction sounded like an immunological crossfire reaction between the Humira and Pfizer, because I never had this issue until I took the Pfizer vaccine. I have also noticed changes in my menstrual cycle since getting the Pfizer shot. The periods are now more erratic, with much worse cramping, sometimes heavier bleeding, and sometimes ovulation pain that feels like the coming of another period. In October 2021, I had 2 periods in the same month. In July 2021 and January 2022, I skipped a period. In February 2022, I had to wear a pad and tampon together, because the flow was so heavy.
Patient came in Monday night (1/29/2018) stating that after the vaccine both her arms felt very weak. The right and left arms from her elbows down felt like the muscles were very weak and had a hard time moving them. She said she took TYLENOL this morning and they feel better now.
the vial has expiration date of 10/27/2021. we called department of vaccine allocation and representative confirmed that it is good to use on 10/27/2021. we use the vial to do booster dose for patient . after 30 minutes the same representative called to inform that the vial can not be use on 10/27/2021.
Shingles appeared on my left abdominal area(got shot in my left arm) roughly a week after vaccination.
Local reaction - redness around injection site approx 4 cm x 3 cm. Still red and sore on exam 8-15-05.
pt admit to hospital with covid pna on 11/8/21 s/p 2 doses Moderna (12/31/20 & 1/28/21).
Initial report received from a healthcare professional on 25 April 2013. A 33-year-old female patient had received an intramuscular first dose of ADACEL (Lot number: U4612AA, site of administration was not reported) on 25 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 24 September 2012 and estimated date of delivery was 01 July 2013. As of 25 April 2013, the patient had not experienced any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. Documents held by sender: none.
Pt recv vax on 11/23/98; on same day pt exp red, edematous, raised area, rash over body, shortness of breath  x 24 hr; vax given SC
Urticaria at site of MMR and Varivax immediately after administration. Given Benadryl in office, urticaria resolved within minutes of administration.
Chronic pain (all muscle and joint pain), chronic and persistent headache, autoimmune disease (Hashimoto's Thyroiditis), ear, nose, and throat issues, Ligamentous Laxity.
side effects from the shot 5 weeks after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the shot 5 weeks after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the shot 5 weeks after the shot). At the time of the report, VACCINATION COMPLICATION (side effects from the shot 5 weeks after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a 74 year old male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On or about 09-MAR-2017, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: herpes zoster. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
(L) arm tenderness and redness. Denies discharge. Improved with ice packs and time.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  ACUTE RESPIRATORY FAILURE 5/5/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/28/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/3/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Presents 12/6/2021 with right arm redness, swelling, itching from right deltoid down to elbow.  Denies SOB, wheezing, throat or facial swelling.  Vitals WNL.
vaccine administered on 04-JAN-2002, 10-APR-2002, 07-JAN-2003; This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (2302USA008667), concerning a 9-month-old female patient. Her historical conditions included pharyngitis, gastroenteritis, viral syndrome, ear infections, allergic rhinitis, upper respiratory infection, abdominal pain and eczema. Family history of mixed hyperlipidemia. family history included: add/adhs (brother), fibromyalgia (maternal aunt), irritable bowel syndrome (mother and maternal grandmother), allergies (mother). Historical vaccines included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), and pneumococcal conjugate vaccine, polio unspecified vaccine.  On 04-JAN-2002 the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep B, unspecified) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis. On the same day, the pt was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) and pneumococcal conjugate vaccine.  On 10-APR-2002 and 07-JAN-2003, the patient was vaccinated with following doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as Hep B, unspecified) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). On 07-JAN-2023, the patient was also vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTaP) and polio unspecified vaccine. Other vaccines included: quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), hepatitis A vaccine, inactivated (VAQTA), measles vaccine, mumps vaccine, rubella vaccine (MMR), meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO), meningococcal vaccine a/c/y/w conj (DIP TOX) (MENACTRA), pneumococcal conjugate vaccine, polio unspecified vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) and varicella virus vaccine live (Oka/Merck) (VARIVAX).  This is one of the three reports received from the same reporter, concerning the same patient.; Sender's Comments:  US-009507513-2305USA007526: US-009507513-2302USA008667:
This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following a shot of the vaccine, the patient experienced a reaction of blood clot. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220408511-Covid-19 vaccine ad26.cov2.s -blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
she inadvertently administered a dose of MMRII which expired on 12/8/2018; Information has been received from a nurse referring to a 29 years old patient of unknown gender. Information of pertinent medical history and drug reactions/allergies was not reported. The patient had a titers test in November 2018, which came back negative for rubella and measles. Concomitant therapies included sterile diluent.  On 18-JUN-2019, the patient was inadvertently vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(lot # M048036, expiration date: 08-DEC-2018, therapy type: rHA, strength, frequency and route were unknown) for prophylaxis (expired vaccine administered). The outcome of the event was unknown.
Information has been received from a healthcare worker concerning a 40 year old white male with no allergies or medical history who in the afternoon of 3/15/05 was vaccinated SC in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 650084/0605P) [originally reported as varicella virus vaccine live ]. There was no concomitant medication. There was no illness at the time of vaccination. It was noted that the patient had blood work done on the same day which was normal. On 3/15/05, the patient experienced chills, redness around injection site, and a swollen arm. The physician prescribed diphenhydramine hydrochloride and ice packs on 3/15/05. On 3/16/05, levofloxacin was prescribed. On 3/17/05, the patient was still experiencing the same symptoms. On 3/18/05, the patient was feeling better. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow up information was received from the healthcare worker who reported that on 3/16/05, the patient's wife called the office to report that her husband had a reaction to the pneumococcal 23v polysaccharide vaccine in the morning of 3/16/05. The patient had a fever of 101 degrees F, a swollen arm, redness, and chills. The patient was advised to use an ice pack, take diphenhydramine hydrochloride, and acetaminophen, and to call if the symptoms worsened. On 3/17/05, the patient called to report body aches, a fever of 102 degrees F, and that the site of vaccination was very red with some pain. The patient was advised to take ibuprofen and levofloxacin. On 3/18/05, there was no change with the vaccine site and the fever went down with continued treatment. On 3/19/05, the patient felt better and continued treatment. It was noted that the patient recovered five days later. The patient's experiences were considered to be other medically important events by the reporter (OMIC). No further information is expected.