chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWEATING; ORAL INTAKE REDUCED; DIZZINESS; EYE NUMBNESS; INFECTION; COUGHING; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to DEC-2021 for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating, oral intake reduced, dizziness, eye numbness, infection, coughing, weakness, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with upadacitinib was withdrawn on DEC-2021. The patient recovered from eye numbness, had not recovered from weakness, dizziness, and infection, and the outcome of sweating, oral intake reduced, tiredness and coughing was not reported. This report was non-serious.
Covid + on 10/09/2021. Received Pfizer vaccine with 1st does on 04/08/2021 and 2nd dose on 04/29/2021.  Per ED Note: History of Present Illness   Patient is a 74-year-old female with past medical history of bronchitis, diabetes mellitus, hypertension and hypothyroidism presenting to the emergency department with chief complaint of cough and shortness of breath.  Patient states that she has been experiencing cough, dizziness and difficulty breathing for approximately 1 week.  She went to her PCP and was prescribed cough medicine with codeine and an unknown antibiotic but has not experienced any significant relief of her symptoms.  She states that the shortness of breath is worse with exertion and alleviated by rest.  She states that the cough is productive of clear sputum.  Patient states that she is received both of her COVID-19 vaccines and denies any known sick contacts.  Patient denies headache, blurry vision, fever, chills, nausea, vomiting, diarrhea, chest pain, abdominal pain, numbness, weakness or tingling her extremities. ED Course/Medical Decision Making:     The evaluation, management, services and procedures as well as the key components of the patient's care described here in were performed in the presence of the attending physician.  Old E-care/clinical records were reviewed.   Pulse oximetry interpreted by me: 89 % room air - normal    Initial vital signs are stable.    ED Course/Reevaluation:   Labs -COVID-19 rapid test is positive. Creatinine 1.3 mg/dL.   Imaging -  Bilateral peripheral predominant airspace disease suspicious for viral pneumonia.  Congestive heart failure changes with diffuse interstitial edema.   EKG -ventricular rate 91 bpm, PR interval 170, QRS 74, QT/QTc 340/418, normal sinus rhythm.   ED Course -patient presents with complaint of shortness of breath for 1 week.  Physical exam significant for a tired appearing patient, clear lungs bilaterally, otherwise unremarkable. Upon arrival patient was hypoxic at 89% and required supplemental oxygen to bring her SPO2 to 93%.  Patient also received an albuterol/Atrovent breathing treatment with some improvement in her shortness of breath.  Basic labs obtained are significant for positive COVID-19 rapid test, acute kidney injury (creatinine 1.3 mg/dL).  CXR demonstrates bilateral peripheral predominant airspace disease suspicious for viral pneumonia and congestive heart failure changes with diffuse interstitial edema.  EKG is normal.  Patient was treated with Lasix 10 mg.  This patient symptoms are most likely related to COVID-19.  I recommended to the patient that she be admitted for her acute hypoxia requiring supplemental oxygen and she agrees.  I contacted this patient's PCP and the on-call physician, and she accepted the admission with request that the patient be evaluated by infectious disease as an inpatient. Patient demonstrates understanding and agrees with the diagnosis and plan. Patient is well appearing with stable vital signs.  Admitted to inpatient. Final Impression:
Information has been received from a secretary of a physician's office concerning a 19 year old female who on 15-MAY-2008 was vaccinated (route unknown) with a first dose of GARDASIL (Lot # 660393/0067X).  On the same day the patient was vaccinated with a dose of tuberculin purified protein derivative (PPD, unspecified).  On 15-MAY-2008 the patient passed out 10 to 20 seconds after vaccination and hit her face.  The physician attended to the patient and the rescue squad was contacted.  She was brought to the emergency room where blood work, x-rays and EKG were performed.  All tests results were normal.  The patient was not admitted to the hospital and released from the emergency room that same evening.  It was also mentioned that this patient is "not apprehensive".  Subsequently on 15-MAY-2008 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Patient experienced chest pain and tightness approximately 15 mins after administration of a Moderna booster dose. Patient experienced numbness down through his hands and still feels the same way nearly 2 weeks later.
11:26am mild dizziness and confusion. Roof of mouth itching   11:35am moderate to severe dizziness and confusion. Roof of mouth itching and mild tongue swelling. Saw nurse at observation site and was taken to paramedics. They took vitals and blood glucose which were normal. They gave me two shots of 25 mg of Benadryl, which helped tongue swelling but nothing helped dizziness and confusion. Agreed to go to the hospital by ambulance. By the time I was seen in the ER, symptoms resolved other than fatigue from benadryl. Discharged around 2:30pm
On 5/3/12 10-11cm circular dull redness in (L) upper arm midline redness 5-6cm posteriorly within - bright red the site of ZOSTAVAX vaccine. That was given 2 days ago. Treatment. Heat to site 15min x3d continue ibuprofen 200mg f/u if increased pain or swelling.
Fever within 16.5 hours of vaccine administration followed by progressive hypoxemic respiratory failure and death on 12/10/2021 at 014o
TOOK TWO UNREFRIGERATED DOSES OF VIVOTIF; This spontaneous case report (PVX2019-2103) was received from a caregiver on 14-Aug-2019. It described a female consumer who "took two unrefrigerated doses of Vivotif" (PT: Product storage error), while being on Vivotif for travelling.  Case report: The consumer took two unrefrigerated doses of Vivotif, which were placed at 75 to 80 degree Fahrenheit for approximately 28 hours. She stated that may be, she took the doses on 10-Aug-2019 and 12-Aug-2019. She will be arriving on 31-Aug-2019.  Concomitant medication included Hepatitis A vaccine.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses of Vivotif" was considered as not applicable.
Headache, dizziness, foggy brain, depression, anxiety, nausea, diarrhea, loss of appetite Took Tylenol Fluids Lasted 6 full days.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021, contains no new information.
Injection site swelling, edema, and warmth. Initial Tx with benadryl and icing with good relief. Then subjective complaints of intermittent muscle spasming and warmth at injection site without obvious physical exam findings X 1 week.
Rash all over body with a particular concentration in stomach, legs, and arms. Symptoms started mild after two days of vaccine and are still persistent in increased intensity after two months of vaccine injection. This type of rash had never occurred before and it can only be attributed to the vaccine since my exercise and eating habits, which are healthy and regular, have remained the same.
Severe right arm pain with chest pain on right side. Nausea and sweating. Large knot on right arm at injection site. Right arm swelling at ER. *Given TORADOL.
*Rash ,whelps  and swelling on bilateral arms from the shoulder area to hands.  *Rash ,whelps  and swelling on bilateral legs from upper thighs down to feet *Severe Itching  Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm.  Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.
First of 3 doses of Engerix-B on 9-10JUL90 developed a raised rash (legs, arms, back, trunk & neck that caused itching. Also developed fatigue & headache (described as poss. rxn to Hep-B vax). Tx Benadryl.
After J&J vaccination developed rash over entire body on 3/17/2021 and visited an emergency room and was prescribed medication for the rash.
Patient was 17 and received first Moderna vaccine, which was not approved for <18yo at the time of administration.  No adverse effects noted.
A report has been received from a Health Professional concerning a 1 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient experienced patient under 2 received FLUMIST QUADRIVALENT which started on 04-Nov-2014. The outcome of the event of patient under 2 received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
50 yo male presented with a spreading rash after his second Covid vaccination. Rcvd vaccine day before and the next morning presented with red, itchy, burning rash on feet,. Rash traveled up both legs and arms. Denied any fever, throat tightness or itchiness, SOB, or breathing difficulty. Did not have reaction with the first vaccination. Denies any new foods, meds, soaps or lotions.
Back of left arm red (about the size of hand), there is also a small lump in the area, but not as large as the redness.  Area feels "hot to touch".  Denies any generalized fever.  No other s/s of illness or distress.
Infection; fever; weakness in legs; fell down; could not get up; This case was reported by a consumer via call center representative and described the occurrence of infection in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 12 hrs after receiving Shingrix, the patient experienced infection (serious criteria hospitalization), fever (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization), fall (serious criteria hospitalization) and mobility decreased (serious criteria hospitalization). The patient was treated with antibiotics nos. On an unknown date, the outcome of the infection, fever, lower extremities weakness of, fall and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the infection, fever, lower extremities weakness of, fall and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. It was reported that about 12 hours after receiving Shingrix the patient had to use the bathroom and fell down due to weakness in his legs.  He could not get up and paramedics were contacted.  The patient was taken to the hospital and was diagnosed with fever and possibly an infection. The patient was placed on antibiotics and admitted to the hospital and patient had spent four nights in the hospital. An infectious disease specialist was consulted during his visit.  The patient informed the specialist that he had received a dose of Shingrix. The specialist then told the patient that, it would be the reason for the fever and then he was discharged from the hospital.  The reporter consented to follow up.
1. irregular heartbeat every few minutes with breath difficulties 2. muscle pain 3. Joint pain 4. Fever
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5,l) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) were 216, 34 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Nausea Vomiting, CHILLS Narrative:
Chills; light headed; body aches; headache; fatigue; injection site pain; This is a spontaneous report from a contactable other-HCP.   A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899), via an unspecified route of administration on 29Dec2020 11:15 at single dose for covid-19 immunisation.  Medical history was none.  Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC).  The patient experienced Chills, light headed, body aches, headache, fatigue, injection site pain on 30Dec2020 02:00. All events were non serious. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved.
Given at  hospital in a city. Then on 4/5/21,  6 days after his 2nd Pfizer dose, had Shingles rash appear, clinically confirmed at office visit 4/7/21. Some post herpetic neuralgia as of 5/20/21, improving.
Headache, dizziness, tinnitus, arm tingling, hot and cold flashes (pre-syncope sxs)
Severe itching day of injection (and again today, 5 days after vaccine).  Swelling day(s) after swelling (to date - 5 days after vaccine).
4 days after 2 dose. Forceful pounding heart.  Heart palpitations. Chest pains.  Shortness of breath. Fatigue. Burning sensation around heart.  Heart rate 40-50 bpm.  No treatment available.
No adverse event; Caller reported expired dose of MMR II was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a certified medical assistant,  and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U006486, administered subcutaneously in the left tight, for prophylaxis (strength was not provided).  The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) expired on 26-FEB-2023.  No adverse events were reported.
Shingles outbreak T4 distribution ~10 days after injection in otherwise healthy 13 year old.  Treated with Valtrex.  Rash is itchy but not painful.
I have Ankylosing  spondylitis and I?m not on any Biologics. I received my first shot back in December and very shortly after I had a pretty serious flare. The flare lasted more than two weeks and this is some thing that I think you should know about
Almost killed me. Was down for about 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient stated that he/she received first dose of Shigles vaccine and almost fainted when he/she was told 200 dollars and plus the so called no side effects almost killed him/her. The patient was down for about 4 days. The follow-up would not possible as no contact details were available.
p/vax pt devel rash on face; tummy; lips; ears (feet hot); swollen glands; fever on/off 1wk; rash persisted; seen 6/7 no fever; body covered w/harsh red rash; taken ER Dx: allergic to vax; tx: DPH;
After administerigng the vaccine, the patient sat in the waiting area. After about 5 minutes, the patient passed out on the floor. The pharmacist went to assist the patient. The patient felt like they were hot and light headed. The pharmacist checked the temperature of the patient and it was fine. The pharmacist asked for assistance from a technician and checked the patient's blood pressure. The patient was asked to move to the floor to prevent further falls, but did not want to. The patient's blood pressure was checked every 3 minutes for approximately 45 minutes. The patient was feeling better at that point and said they wanted to leave.
vasovagal syncope - Fainted 16 hours after receiving vaccination. Felt lightheaded when woke up. Received care from EMTs and was admitted into ER.
Information has been received from nurse concerning a female who was vaccinated with her second vaccination, 0.5 ml, of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced a red big bump on the site of the reaction. It was unknown if there was any reaction to the patient's first vaccination with varicella virus vaccine live (Oka/Merck). No further information was available. unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Body aches and joint pain increased over the day. Had a fever and no appetite. Shortness of breath.
This spontaneous report was received from a pharmacist via company representative and refers to an unspecified female patient of unknown age. No medical history and concurrent conditions of the patient were reported. On 26-NOV-2014, the patient was vaccinated with ZOSTAVAX (lot number, dose, site and route of administration was not reported) at the pharmacy. No concomitant medications were reported. On an unknown date, the patient experienced "goose-egg-size" hematoma at the vaccine injection site. The outcome of "goose-egg-size" hematoma was unknown. The causality of "goose-egg-size" hematoma with ZOSTAVAX was not reported. No further information was provided. This is one of the two reports of the same reporter. Additional information has been requested.
Patient had a flu shot and a PNEUMOVAX 23 shot at the same time, her (L) arm where the PNEUMOVAX was administered became red, puffy, hot to touch with rash spreading even after 2 days of taking BENADRYL. C/O fever, night sweats, chills first 2 nights.
Pt. left tent 13 at 8:20 am.  At observation site at 8:30 am, pt. was complaining of tingling lips and feeling like blood pressure was high.  Paramedics assessed vitals 160/90.  Pt. was monitored until symptoms subsised.  Paramedics released to leave at 8:55 am.
On 2/27/01, was given varivax/SC (R0 LTR about noon. Mother noticed redness and swelling about 15:00 and was getting larger today (02/28/01) and painful. Wt 60 1/2 lbs; T-101F. Redness and swelling 6cm in diameter, center swelling and discolor 2cm, feels warm to touch. Advised children's Motrin for fever; cold compress and Benadryl elixir 25mg every 4-6 hours. Recheck tomorrow but if worsens go to ER. On 3/12/01, swelling and redness were resolved.
Fever started 5/6/04, reached 105 degrees, no local reaction supportive care recommended.
Patient had convulsion 5 hours after receiving immunization - seen in ER - was fine.  Seen in doctors office on 11/04/2004 - exam normal.
Large bump at injection site, warm to touch, and itchy. Applying cold compresses is helping. Other than soreness there is no stinging or sharp pain.
Information has been received from a talk radio show, concerning a female patient, who on unknown date was vaccinated with the dose of GARDASIL (dose, route and lot# not reported). It was reported that on unknown date the patient went into coma's after receiving therapy on GARDASIL. The patient's outcome was unknown at the time of report. It was unknown if the patient sought medical attention. Upon internal review, coma was determined to be an other important medical event. Attempts are being made to verify the existence of an identifiable patient and reporter. This is one of several report received from the same source. Additional information has been requested.
Localized erythema in the left deltoid following vaccination.  Edema and tenderness.
EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue. This report was non-serious.
medical records mention COVID infection in 09/2021; per death certificate, pt died in a hospice facility of Recent COVID pneumonia, prostate CA with metastases and dementia