chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Head to toe joint pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMOVAX. On 9th September 2021, 2 days after receiving Shingrix, the patient experienced joint pain and fatigue. On an unknown date, the outcome of the joint pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient had fatigue and head to toe joint pain. The reporter gave medical disclaimer and referred to health care professional, spoke per product indication and content and offered product indication.  The reporter provided phone number for health care professional reference. The reporter consented to follow up. This case was linked to case US2021193294 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193294:Same reporter
pain to injection site arm; sore arm; This is a Spontaneous report from a Pfizer sponsored program. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Left arm on 15Jun2021 at 16:00 (at the age of 68-year-old) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient concomitant medications were not reported.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EW0178), via an unspecified route of administration on 24May2021 administered in upper left arm as single dose for COVID-19 immunisation. The patient experience pain to injection site arm. The caller is asking if the Ibuprofen she took will interfere with the Pfizer Covid Vaccine. The CDC Committee has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine). These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate. The caller states the sore arm began 2 hours after the caller received the second dose Pfizer Covid Vaccine on 15Jun2021.The caller states she still has the sore arm. Therapeutic measures were taken with ibuprofen (Product strength and count size dispensed :200mg each tablet, count size 500, Lot: O8E2445A, Expiration: May2022, UPC: 9661962159). The outcome of event was not recovered.
10cm x 6cm area of induration, warmth, erythema at the (R) deltoid area, Non-tender to touch. Treatment prescribed: ATARAX 10mg tid x 4 days Orapred 30 mg once a day for 3 days.
4/10/17 - vaccine administered on 1/25/17 (TDaP) to (L) Deltoid. Today, 4/10/17, patient reports ongoing pain to (L) upper arm. Initial reaction on 1/25/17 - Redness, swelling at site. No redness or swelling noted. Small marble size, firmness to area on palpation noted.
Information has been received from a physician concerning a 17 year old female who on an unspecified date was vaccinated with a dose of GARDASIL. The physician reported that "a couple of months ago", the patient experienced injection site reaction. The patient sought unspecified medical attention. Additional information has been requested.
Symptoms were; fever, cough, congestion, fatigue, headache, muscle aches, nausea, vomiting and left ear ache. Treated in hospital with Remdesivir and increased prednisone dosage.
4 days post injection fever Left arm soreness 3 days post 5 days post injection began left armpit pain related to swollen lymph nodes for approximately 7 days. Ongoing cough and chest tightness post injection around day 2. Increased slowly over time to uncomfortable chest pain and shortness of breath. Chest xray 3-22-22 shows partial lung collapse. Start of azithromyacin 3-22-22
edema & swelling of entire lt arm @ least 2x size to point pt could not bend arm @ elbow;
HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/7/2021  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Scratchy throat, SOB, cough, itchy tongue, redness/flushing
DTP recv lt thigh on 31JAN92 on 1FEB92 lt thigh began to swell had rubor calor swelling lt thigh to knee 1FEB92 to 3FEB92;
I don't know if this is related or not, but felt I should report it now in retrospect.  I had injured my shoulder in January and initially thought the symptoms I started experiencing in March were were related.  I was considering surgery on my shoulder and reported the twitching and tremors in my arm to my orthopedic surgeon.  That's when I found out  the tremors could not be related.  Instead of subsiding, the tremors moved into my left arm.  And now they've moved into my right leg.  I have an appt with neurology in 1 week to further assess what's happening.  It occurred to me that the twitches and tremors started in March, after my first vaccination.
on 10/7/21, pt developed developed spontaneous DVT left leg.  no PE.  no other obvious cause.
PATIENT HAD A VACCINE AND FALL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unknown) dose, start therapy date were not reported 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, the subject experienced subject had a vaccine and fall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had a vaccine and fall was not reported. This report was non-serious.
HEART RATE OF 120; FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 26-MAR-2021 08:40 at right deltoid for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced heart rate of 120.  On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2, and Heart rate (NR: not provided) 120. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and heart rate of 120. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Received Moderna Covid vaccine booster dose at 09:24 am, left clinic after his dose and went to work. Called and left message at clinic. Patient reported that at 0200 am he was feverish and had injection site pain, called EMS who visited and informed patient that fever and injection site pain were common and not emergent, took Tylenol po and still feels slightly feverish and fatigued today. Has appointment with doctor today at 2:15 pm.
Left arm is red, hot and swollen about 5 inches in diameter. Patient was at her dermatologist who first noticed it (patient did not have any discomfort). Dermatologist dismissed it. Patient called and was right next to Dr.'s office, I told her to have him take a look at it. I spoke to the nurse who stated Dr. said to use a cold compress and some advil if needed. I asked if I should report it via VAERS and she stated no. Patient came into pharmacy at 2:30 and due to the large area, I feel it needs to be reported.
pt had proquad on Wednesday 12/11. pt woke up Next morning with redness and swollen in the left upper arm the size of silver dollar.
pt recv vax;tested & found to lack antibodies to varicella zoster virus;devel vesicles on rt ear & face;to MD w/ vesicles on rt side of mouth,several small lymph nodes behind ear;ear pain;dx of shingles;no prior hx of chicken pox;tx Zovirax
104° fever, 2nd day following shot. Managed with OTC medication. Developed severe jaw and tooth pain approximately 4-5 days following dose 2 on right lower jaw. I had recently had a tooth that fractured in that area and was crowned as repair. Pain was so intense I could not sleep and radiated along the entire jaw. Ibuprofen treatment, but marginally helped pain. During dental appointment on 6/1, X-rays were taken, and it was confirmed no defects or other issues with tooth. Pain continued for approximately 1 week longer before disappearing. Pain was so intense at times that I could barely function. No other vaccinated persons I know had similar symptoms, but none had recently had dental work. Total duration of the issue was approximately 2-3 weeks from appearance to relief of symptoms.
Approx 15 minutes after receiveing 2nd dose of Moderna, patient reported feeling a "lump"  in his throat. Symptoms progressed to light-headedness. Pt was administered epi and benadryl and transported by EMS to nearest emergency department.
Patient is fully vaccinated. COVID + at admission to hospital. Patient admitted with shortness of breath and cough.   She states that she started feeling fatigued about 2 weeks ago, DX Pneumonia due to COVID-19.  During hospitalization: blood loss anemia, CHF and dyspnea. CXR Correlate for congestion versus atypical pneumonia. Hemoglobic 7. One unit PRBC given. Lasix and metoprolol given for CHF. Cr 2.11 acute kidney injury. Elevated troponins. Remdesivir given. Discharged to home.
Pt recv vax on 4/12/99; on 4/13/99 pt exp staring episode w/ hypotonia
sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy: Erythromycin"; Morphine, reaction(s): "Allergy: Morphine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The reporter stated that she was sick after the first 2 Pfizer BT Covid vaccine doses and no allergic reactions. The reporter stated that she was signing up for the Pfizer BT Covid booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A reaction her son had after receiving the Moderna vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (A reaction her son had after receiving the Moderna vaccine) in a male patient of an unknown age 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, the patient experienced VACCINATION COMPLICATION (A reaction her son had after receiving the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (A reaction her son had after receiving the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
bladder problems resolved; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (bladder problems resolved) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Bladder discomfort.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (bladder problems resolved). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (bladder problems resolved) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   After couple of weeks of vaccination, Patient noticed that her bladder problems had resolved. Patient had overactive bladder, and she can now sleep through the night without urinating frequently.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter's Email address and Street address has been added.
Patient complains of small rash appearing on abdomen approximately 24 hours after vaccination, lasting over the past 2 weeks. No pain or itching associated with rash. Patient complains of bilateral hamstring tingling inside (not on surface of legs). No visual changes to bilateral legs. Patient reports he will speak to his doctor today (12/3/18), wanted to report it as an adverse event for SHINGRIX vaccination. After further discussion, patient reports sometimes during cold weather he will get abdominal rash as he has now, but is unsure if it could be due to vaccination.
Patient passed out, opened ammonia salt within 2 minutes, pt lost responsiveness after 7 minutes, gave Epipen, called EMS.  Patient observed for additional 15 minutes, BP and HR stable per EMS review.
Approximately 15 hours after vaccine onset of rigors, fever, significant joint pain, difficulty walking, generalized fatigue.l for 5-6 hours.  Episode of soapboxes is then felt much better for a few hours.  Then next round of rigors, fever, worsening of joint pain again, fatigue and difficulty moving.  Similar duration follow again by diaphoresis and feeling better.  Same cycle occurred two days after booster.  Third day aching and fatigue but no fever.  Say 4 the same as day 3.  Day 5, I noticed supraclavicular edema and pain in my shoulder and cervical lymph nodes and the same side as the injection.  Went to work, spoke with employee health.  Received paperwork for this report.  Today is day 6.  Edema still present, my PCP believes it to be lymphedema.  I am painful beneath the swelling and have a sore throat.  Otherwise feel OK.  To add perspective.  First dose given on January 1 with just mild localized redness and pain. Typical for a vaccine in my body.  Second dose on January 18.  Mild fever, chills and aching for 25 hours.  Nothing concerning.  Given these two responses I was shocked at how strong my immune response was this time and that I am having ongoing issues with that supraclavicular swelling/edema and discomfort.
Rash/non-urticarial not specified; Initial information received on 16-Jun-2023 regarding an unsolicited valid non-serious Courtesy case received from Pfizer via other health professional.  This case involves Adult and unknown gender patient who experienced rash/non-urticarial not specified while receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection in Pre-filled syringe (route,  administration site, lot number, strength, expiry date, dose not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious rash/non-urticarial not specified (rash) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Within 3 hr of vaccine pt began to develop hives & itching. Hives worsen & spread to trunk & all extremities with intense itch.
Information has been received from a pharmacist, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included an sterile diluent (manufacturer unknown). On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N012615 with expiration date on 16-MAR-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines had a temperature excursion of 35 Fahrenheit (F) during a time frame of 30 hours. It was also reported that previous temperature excursions occurred of 22 F during 22 hours and a digital data logger was involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008138: US-009507513-1709USA008138.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-NOV-2013 the patient was vaccinated with PROQUAD, (lot number H015791) (dosing regimen and frequency unknown) injection subcutaneously which had expired on 12-NOV-2013. No adverse events were reported. Additional information has been requested.
Chills, headache, body aches and very tired for about 24 hours.  Took Tylenol every 6 hours.  Redness and raised area where shot was administered and is still that way.
With in 15 minutes, he developed ringing in the ears. As of Oct 26, 1999, the tinnitis has been almost constant and has not improved.
(Privacy) stated that her son had been complaining of the following symptoms since he received the second dose in September 2021: 1. Tingling in both feet daily 2.  Both heels hurting daily 3. Around beginning of October 2021 hands and fingers started going numb and he started having difficulty grasping and holding onto objects.  4. Blood in his sperm and urine past couple of weeks (Not sexually active) 5. Sinus pressure, sinus drip, Diagnosed with Acute maxillary sinusitis on 10/13/2021 6. Severe cough 7. Past week developed sensitivity to light.  Wanted to remain in the dark as any light source was causing him severe pain to his eyes. 8. 10/27/2021-Started coughing up blood prior to going unresponsive and went into cardiac arrest at home. The patient presented to the ER on October 12, 2021 with multiple complaints, sinus congestion and sore throat, and a cough.  There was a reported lump on the left side of his neck for the past two weeks.  The patient reported that for the past two weeks he noted blood in his sperm.  The patient denied STD's, no testicle pain, no penis pain or lesions (Reportedly not sexually active). The patient denied any recent fevers, chills, chest pain, or shortness of breath, nausea or vomiting, abdominal pain, dysuria or hematuria, diarrhea, melena, hematochezia, rashes or wounds, or new leg pain or swelling. The patient stated there was no recent travel or trauma.   XR Chest 2 Views PA and Lateral (Standard) were said to be completed.  The report stated that lungs were clear without findings of a focal consolidation, pneumothorax, or pleural effusion.  The cardio mediastinal silhouette is within normal limits for age.   The patient returned to the ER on October 19, 2021 for concern his cough is getting worse and his health has not improved after a week of antibiotic (Augmentin). The patient was previously diagnosed with sinusitis. The patient vomited while coughing last night, October 18, 2021. The patient denied recent fever, chills chest pain, shortness of breath, nausea, abdominal pain, dysuria, diarrhea, melena, hematochezia, rashes or wounds, or new leg pain or swelling.   XR 2 View PA and Lateral (Standard)  Two view chest comparison studies.  No definite evidence of an acute infiltrate or pneumothorax.  No significant pleural effusion.  Heart size is within normal limits with no evidence of cardiac failure.  No acute osseous abnormalities are seen. There were no definite acute cardiopulmonary findings seen radiographically.   The patient died on October 27, 2021 at the Hospital, in the Emergency Room.  Postmortem autopsy  completed at (Privacy) Hospital, on October 28, 2021 by (Privacy), MD/Pathologist.  Autopsy Results: (Privacy), Pathologist-MD reported that based on consideration of the autopsy examination, review of available records, and toxicologic analysis, the death of the patient to a reasonable degree of medical certainty, is ascribed to COVID-19 vaccine-related myocarditis.  The death is ruled natural.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 5:27 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 22-Sep-2022 at 5:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    Patient received vaccine in deltoid. No concomitant product reported by the reporter. The patient received first three doses of MODERNA COVID-19 VACCINE,  Intramuscular and deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19. No treatment medication reported by the reporter.