chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful sores around her waistband; shingles; This case was reported by a consumer via call center representative and described the occurrence of wrist pain in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pneumonia. Concurrent medical conditions included asthma (hospitalization for asthma). Concomitant products included budesonide, formoterol fumarate (Symbicort).   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 wrist pain and shingles. On an unknown date, the outcome of the wrist pain and shingles were unknown.   It was unknown if the reporter considered the wrist pain and shingles to be related to Shingles vaccine.  Additional details provided as follow: The patient reported case for herself. The patient stated that some time in the past (could not remember exact date), she developed painful sores around her waistband that she believed was shingles. The shingles vaccine manufacturer was unknown. The patient got the 2nd dose of the vaccine some time later. All of this occurred prior to the patient starting on Nucala. For the tolerance of Nucala, refer case US2020AMR115171.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR115171:same patient, Nucala case
Patient brought to Hospital via EMS on 02/17/2022 for SOB.  CT of thorax showed large right effusion, lung metastasis, bone metastasis, supraclavicular and left axillary lymphadenopathy.  Patient had a known hx of Prostate cancer, Parkinson's, dementia, and Peg Tube.  Chest tube was placed in ED and drained 1 L of bloody fluid.  Arterial blood gas showed PO2 88 and sats 98% on RA.  Patient was also COVID positive.  Patient had leukocytosis with left shift, tachypneic in the 30s.  Patient was started on Zosyn and Vancomycin.  Patient was tachycardia in the 100s.  Patient expired on 02/23/2022.
Aproximately 40 minutes after receiving the vaccine, patient felt "itchy all over." Her throat was hoarse and she eventually had difficulty speaking. Diphenhydramine 25mg IM and had no effect. Patient was taken to the ER where she received Solu-medrol. Patient recovered.
Mumps uncomplicated on 2013-11-15. Clinician comment: Had mumps 2 weeks after getting the MMR vaccine.
15 minutes after vaccine administration, patient developed weakness, diaphoresis, light headedness, paralysis of all extremities, no blinking, aphasic.  Corneal and pupil reflexes remained intact.  Proximal weakness remained for several hours after recovery.  Treated with Benadryl 50 mg IVP and Solumedrol 125 mg IVP.
developed a fever; left arm pain became worse; whole body ached; felt like she had acid reflux; couldn't finish eating; headache; sore left arm; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left arm), LETHARGY (lethargy), HEADACHE (headache), PYREXIA (developed a fever) and PAIN IN EXTREMITY (left arm pain became worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Sinusitis, Headache, Hormone replacement therapy and Dry eyes. Concomitant products included PROGESTERONE (PROGESTERONE ABBOTT) for Hormone replacement therapy, FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D 12 HOUR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AZELASTINE HYDROCHLORIDE (AZELASTINE [AZELASTINE HYDROCHLORIDE]) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (sore left arm) and LETHARGY (lethargy). On 24-Feb-2021, the patient experienced HEADACHE (headache). On 25-Feb-2021, the patient experienced PYREXIA (developed a fever), PAIN IN EXTREMITY (left arm pain became worse), PAIN (whole body ached), GASTROOESOPHAGEAL REFLUX DISEASE (felt like she had acid reflux) and DECREASED APPETITE (couldn't finish eating). At the time of the report, MYALGIA (sore left arm), LETHARGY (lethargy), HEADACHE (headache), PYREXIA (developed a fever), PAIN IN EXTREMITY (left arm pain became worse), PAIN (whole body ached), GASTROOESOPHAGEAL REFLUX DISEASE (felt like she had acid reflux) and DECREASED APPETITE (couldn't finish eating) outcome was unknown. Not Provided          This case was linked to MOD21-039087 (E2B Linked Report).; Sender's Comments:  MOD21-039087: US-MODERNATX, INC.-MOD-2021-026947:1st dose
Approximately 23 hours after administration of Moderna #2 vaccine, subject began loosing muscle strength and control, especially of the legs.  The symptoms became severe enough that he had trouble standing, walking and, ultimately, suffered a fall.  Normally, the subject is able to maintain all functions of independent daily living, exercises regularly and is able to walk more than 5 miles.  These symptoms were also present in similar severity, within a similar time frame after receiving Moderna #1 vaccination. The subject had received a positive test for Covid 19 in late November, 2020 and was largely asymptomatic.
Patient came to pharmacy on 11/3/20. She stated she had developed an infection in her arm from her flu shot. She showed me a round scaled spot with a slightly bleeding center to it. I took her name/dob and looked her up. She had flublok and adacel on that day. She states the flu was in the left arm but our records indicate the adacel was in the left arm. The vaccines were given on 10/17/20. I asked patient if she had seen her provider. She stated no but that she had been trying to. Patient stated that her arm became red a swollen shortly after receiving the vaccine then it developed and pussy /boil type area that popped and drained. I highly advised patient to see a physician. She said she would try to do a walk in appointment today.
Chills, shivers, uncontrollable  shaking, freezing, Fever (102.5), chest pains, high blood pressure, nauseous, aches and pain.  Tylenol, motrin, liquids (tea and water).
This spontaneous report as received from a 58 year old female registered nurse patient reporting on herself via a company representative who on 01-APR-2012 was vaccinated with a dose of PNEUMOVAX23 in the left arm (lot # not provided) (therapy specifications not provided). The nurse stated that on an unspecified the nurse's arm because very painful and swollen. The nurse also noted that she had a reaction after she received vitamin B12 injection (dosage and manufacturer unknown) and experienced redness in her arm 48 hours after receiving the shot. There was not treatment given for the events. There were no labs performed. The outcome of the events was reported as recovered. Additional information has been requested.
Red itchy rash around injection site; Red itchy rash around injection site; Red itchy rash around injection site; This is a spontaneous report from a contactable nurse.  A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular (Arm Left) from 18Dec2020 18:45 at a single dose for COVID-19 immunisation. Medical history included hypothyroidism and pre diabetes. Patient had no known drug allergies (NKDA). Concomitant medication included levothyroxine. On 20Dec2020 23:45, the patient experienced red itchy rash around injection site. The patient underwent lab tests and procedures on 16Dec2020 which included nasal swab with negative result. Outcome of events was recovered. No treatment was required/involved.  Follow-up attempts are completed. Information on the batch/lot number has been obtained.
arm swelled up a little; hot to touch; got red; Itched severly; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up a little), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (got red) and VACCINATION SITE PRURITUS (Itched severly) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up a little), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (got red) and VACCINATION SITE PRURITUS (Itched severly). At the time of the report, PERIPHERAL SWELLING (arm swelled up a little), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE ERYTHEMA (got red) and VACCINATION SITE PRURITUS (Itched severly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  No treatment information was provided.   This case was linked to MOD21-13080, MOD21-13165, MOD-2021-020912 (Patient Link).
I experienced a "break through" period bleed; have been exclusively breastfeeding; have been exclusively breastfeeding; This is a spontaneous report from a non-contactable consumer or other non hcp.     A 32 years old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took thyroid therapy. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced a "breakthrough" period bleed, on have been exclusively breastfeeding on 12Aug2021 with outcome of recovered on unknown date of Aug2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 24-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:  manufacturercity:; manufacturerstate: ; manufacturercountry:; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Pt recv vax on 10/29/98; on 11/6/98 pt exp pruritic rash on face, genital area, buttocks; tx=Benadryl elixir w/ out resolve; tx=Atarax; pt imp 11/17/98
hives, blisters on lips, scleral involvement over 1-2 wk period treated with antihistamines with improvement
a day later after vaccine being administered, patient removed the band aid and notice a rash and swelling. Patient feels tingling and pain in the site. Patient  was advised to take antihistamine and Ibuprofen.
A report was received from a consumer on 10/11/01 and a follow up from a health professional on 12/14/01, concerning a 49 year old male who experienced flu like symptoms and an injection site reaction, approximately 3 weeks after receiving the Fluvirin vaccine on 10/23/00. In November 2000, the patient experienced flu like symptoms and an inability move his arm for a few days, approximately 3 weeks after he received the Fluvirin vaccine on 10/23/00. The patient had recovered at time of the report. There was insufficient information to determine the reporter's causality assessment. A follow up report was received on 12/14/01 which changed the reporter's causality assessment to probable.
patient with atypical chest pain on 10/25/2021 & then with ruptured AAA on 10/28/2021.  AAA is inoperable and patient has been admitted to the Palliative Care service. 10/28/2021: Patient is a 67 y.o. male who presents with abdominal pain that started earlier today. It was acute and severe in nature. Has a history of known AAA. He also has a history of COPD/CAD for which is he on home O2. He is received immunotherapy for NSCLC. 10/25/2021: 67-year-old male with past medical history notable for pulmonary hypertension, hyperlipidemia, CAD, atrial fibrillation on anticoagulation, COPD, NSCLC on immunotherapy, CKD 3 who presents with sudden onset of left-sided rib pain. Patient is non-toxic appearing. Hemodynamically stable and all other vital signs within normal limits.  Differential includes rib fracture, intercostal muscle strain/sprain, pleurisy, pneumonia, PE.  Workup is notable for stable anemia, no leukocytosis, normal electrolytes, baseline creatinine, negative COVID/flu/RSV, nonischemic EKG, baseline high sensitivity troponin 49 with stable to or delta troponin of 48, elevated BNP at 2800 similar to baseline.  X-ray of the chest and left ribs did not reveal any focal infiltrate or rib fracture, or other definite etiology of patient's symptoms.  Given this, as well as history of active malignancy with focal pleuritic pain, a D-dimer was obtained which was greater than 9000; a CT PE was then obtained, which showed no evidence of PE, but did unfortunately show interval development of a spiculated mass in the right lung concerning for tumor recurrence.  Given negative workup as detailed above, suspect that patient's pain is related to an intercostal muscle strain/sprain.
fever of 103 on awaking for several days; As of 15JUN93 feels better but lethargic w/weakness;
Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced an adverse event reaction. It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Cold; COVID-19; Anaphylaxis; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499936-00.  A 23-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162439) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Anaphylaxis"; COVID-19 (medically significant) with onset Dec2021, outcome "recovered"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "Cold". The action taken for adalimumab was unknown.  Clinical information: After taking the COVID-19 vaccine in Mar2021, the patient had anaphylaxis. In Dec2021, she had COVID-19. The patient had a cold for two to three days. She did not agreed to have physician contacted. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid-19" and "cold" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "anaphylaxis" related to BNT162b2.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of anaphylaxis after taking COVID-19 vaccine, cold and COVID-19 with Humira (Adalimumab) was no reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of anaphylaxis after taking COVID-19 vaccine and COVID-19 are related to Humira (Adalimumab). Company's opinion is that the event of cold is not assessable.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
About 90 minutes after vaccination, patient returned to  the pharmacy reporting hives.  She reported she had already taken benadryl.  Pharmacist recommended patient immediately seek evaluation at nearby urgent care for further evaluation
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
devel urticaria on 29AUG92 on rt side of chest & abdomen & some on lt side of face; pt was taken to ER on 1SEP92 told poison ivy, infected;
Initial and follow up information has been received from a legal firm regarding a case in litigation concerning a female child who was vaccinated with injections containing the mercury-based preservative Thimerosal. It is alleged that through injections administered during the period from September 1994 through at least May 1994 that the patient was subjected to very high doses of mercury contained in Thimerosal and was poisoned by the cumulative doses. It is also alleged that, as a result of these injections, the patient now suffers and will continue to suffer from the toxic neurological effects of mercury poisoning. Immunization information indicated that the patient was vaccinated two weeks after birth with hepatitis B vaccine recombinant on approximately 9/14/94 (lot # not reported), 2/15/95 (lot # 613383/1066A) in the right leg, and 8/9/95 (lot #613667/1286A) in right leg. Concomitant therapy included diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid (TRIHIBIT) on 2/14/95 (lot # 4J51084), 4/10/95 (lot #4J51140) and 8/9/95 (lot #4A161044); diphtheria toxoid/pertussis vaccine/tetanus and HIB conjugate vaccine (lot # and manufacturer not reported) on 5/31/96; poliovirus vaccine (ORIMUNE) on 2/14/95 (lot # 384939), 4/10/95 (lot # 382926) and 8/9/95 (lot # 392936); and a first dose of MMR on 3/5/97. The patient was administered a TB tine test on 8/9/95; results not reported. Upon internal review, the neurological effects and mercury poisoning were determined to be Other Medical Events (OMIC). No further information is available. A copy of the patient's medical record is available upon request.
Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
Pregnancy- about 27 weeks- estimated delivery= 06/19/2021 On 03/17/2021 around 9pm cst i actually noticed very little to no movement went to labor triage on 03/18/2021 around 9am- baby has demised and on 03/19 /2021 i was induced and 03/20/2021 a 11am cst. baby born stillbirth at 2.05lbs and 14.5 inches long
I was working and around 10 o'clock my back started aching a little bit, and then mild body aches spread all over my body. I started feeling weaker. When I got home I was weak, and I had chills and fever and I was tired. I woke up a few times in the night with night sweats and chills. I was short of breath.
Patient registered complaint with vaccine program coordinator on 12/1/09.  She reported tenderness and soreness in the left arm, but no swelling or redness.  Patient is taking ibuprofen for pain relief.
Shots given afternoon child cried/screamed nonstop from approximately 7pm-11pm and remained extremely difficult to console the rest of the night. On exam 24 hours later he was fine - shot sites showed no abnormalities.