chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-APR-2016, the patient was vaccinated with a dose of improperly stored GARDASIL or GARDASIL 9, lot number K010215 with expiration date 05-MAY-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 544 hours and at the lowest recorded temperature of 32 (0 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Pain, swelling, lump in left armpit lymph node.  Muscle pain and discomfort in body. Pain in left arm at vaccine location.
Hair loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) 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, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Information has been received from a medical assistant concerning a 19 year old female patient with no pertinent medical history and a history of an allergic reaction to Amoxil (reaction unspecified), who on 13-JUN-2008 was vaccinated with her first dose of GARDASIL (Lot: 659962/1740U). On 13-AUG-2008 received the second dose of GARDASIL (Lot: 660393/0067X) and 19-DEC-2008 received the third dose of GARDASIL (Lot: 660393/0067X). On 27-NOV-2008 the patient developed swollen lymph nodes on her neck. The patient sought medical attention with her primary physician. MRI and CT scan were negative. As of 29-DEC-2008 the patient's symptoms persisted. Additional information has been requested.  2/5/09 Received GYN vaccine & medical records of 6/13-12/29/2008. FINAL DX: lymphadenopathy Records reveal patient experienced good health on 6/13 1st HPV.  Received call form parent 12/29 about painful neck lymphadenopathy since week of Thanksgiving.  Had seen PCP & tx w/antibiotics.  Improved initially but then recurred.  Had been referred to ENT who had CT/MRI done which revealed benign lymph nodes.
This spontaneous report as received from a physician refers to a patient of unknown age and gender who on 14-JUL-2014, was inadvertently vaccinated with a single dose of ZOSATAVAX (lot # J000436) subcutaneously that was expired 01-APR-2014. No adverse effects were reported. Additional information is not expected.
5 minutes after administration of vaccine, patient states he does not feel well.  He was sitting and passed out.
ON day 9 after vax, PT noted erythema on left lower leg. On day 10, PT developed pustules in center of erythema. On exam, 7 pustules noted on LLE, 1 on RLE and 2 on back. PT denies pruritus but does not mild discomfort from clothing rubbing. No F/C/N/U/ Wt loss/ sweats.
Second morning after vaccination I had an 8 cm round, red, warm,  rash at the injection site on my right arm with pain which slowly resolved over a period of days.  I also had fatigue and chills without fever for approximately 24 hours.  Now, two months later, I have significant atrophy of the soft tissues/muscle of my arm at the injection site directly beneath the area of the red rash.  I have not seen this atrophy in any discussion of delayed reactions.  No other symptoms.  I have photos of the arm from January 7 and March 11, 2021.
Pfizer/BioNTech/Treatment of COVID-19; Pfizer/BioNTech/Treatment of COVID-19; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 09Oct2020 at 13:30 as DOSE 1, SINGLE (lot number: P220395-0053L), in the left arm; on 30Oct2020 at 12:30 as DOSE 2, SINGLE (lot number: P220395-0024L), in the left arm and on 22Oct2021 at 13:00 as DOSE 3 (BOOSTER), SINGLE (lot number: P220395-0090L), in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication included: OLMESARTAN/HYDROCHLOROTHIAZIDE, start date: 01Feb2017, stop date: 09Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Pfizer/BioNTech/Treatment of COVID-19." Therapeutic measures were taken as a result of Vaccination failure, Covid-19.
a dose of QUADRACEL was inadvertently administered to an 11 year old with no adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was given a dose of quadracel was inadvertently with no adverse event , after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL) for Immunisation.  On 30-Aug-2022, the patient received a  total dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE l(Lot U7526AA  and expiration date: 07-Sep-2024) at a dose of 0,.5ml via intramuscular route in the left deltoid for immunization.  On 30-Aug-2022(latency: same day ) the patient developed a non-serious event of a dose of quadracel was inadvertently administered to an 11 year old with no adverse event (product administered to patient of inappropriate age) following the administration.   Action taken :as not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 08/21/01, this child got her shots at 9 AM and at 5 PM she got a fever of 99.9. The next morning 08/22/01, she had irregular breathing and it was very labored and she was hoarse and said her body hurt. At 10 AM on 08/22/01, her fever was 100.8, and she had a barking cough along with everything else. On 10/23/01, she got worse, with her breathing and cough. Taken to the doctor on 10/23/01, his diagnosis was bronchospasms that she never had prior to the shot.
Pain in Left arm that began as soon as injected.  Felt med burn when injected. Pain has continued x 18 days.  Has slightly improved.  Middle of upper arm half way down to elbow. No reddness or swelling. At first hurt up back of neck x 4-5 days.  Difficult lifting coffee cup or using arm.  Difficulty sleeping on side. Pt to be seen in clinic as work in client.
disqualibrium; unable to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13May2021 15:30 (Lot number: EWQ182) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic pain", start date: 1992 (ongoing); "COPD", start date: 1992 (ongoing); "High BP", start date: 1992 (ongoing); "Adrenalectomy", start date: 2005, stop date: 2005; "Cholesterol" (ongoing); "Reflux" (ongoing); "Prostate" (ongoing); "Heart" (ongoing). Concomitant medication(s) included: OXYCODONE taken for pain (ongoing); TAMSULOSIN taken for prostate infection (ongoing); LIPITOR taken for blood cholesterol (ongoing); PROSCAR taken for prostate cancer (ongoing); ALBUTEROL [SALBUTAMOL] taken for chronic obstructive pulmonary disease (ongoing); ESOMEPRAZOLE SODIUM taken for gastrooesophageal reflux disease (ongoing); BACLOFEN taken for pain (ongoing); COZAAR taken for cardiac disorder, hypertension (ongoing). Vaccination history included: Shingrix, administration date: 22Sep2020, for Allergic reaction; Shingrix. The following information was reported: BALANCE DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "disqualibrium"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "unable to work".  Additional information: Family medical history relevant to AE: Patient had an allergic reaction following Shingres(2) on 22Sep2020. Treated with Xolair ending, 01Jul2211. Immediately following 1st Pfizer covid vaccine on 13May2021, I had prolonged disequilibrium /proprioception issues for 10-12 weeks. Following the 2nd Pfizer shot I did here initial mild fever and on 31Oct2021 started experiencing urticaria and angioedema again (some as in past) Have Since scheduled follow up 31Oct2021 with Allergist and resumption of Xolair treatment ASAP. Despite current treatment with Prednisone, Symptoms are worsening daily. No relevant tests or Specific Relevant tests were performed. Patient did not report reaction to first shot, but patient should have. Patient disequilibrium was severe and prolonged! Had to be careful to avoid falling and was founcing into walls was fearful to get 2nd shot. Had these issues become more severe, patient would not be able to walk. Not pleased about new allergic event. Resuming Xolair treatment was extremely costly and time consuming. Patient inquired why is not the public informed of the less severe allergic reactions like patient. Have significant discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 66 y.o. female patient    with history of metastatic lung CA, COVID, GI bleed, who presented to  Hospital with SOB.  While in the ER patient found to have COVID 19 infection and is admitted for further management.   COVID-19 pneumonia Patient was initially hospitalized from 11/21-12/4 for COVID-pneumonia Positive for COVID again on 1/1/2023 Given acute decompensation patient has been started on remdesivir and dexamethasone Was on high flow nasal cannula, now doing well on low-flow nasal cannula Encourage incentive spirometry use and out of bed when possible ID consult.  Chest x-ray reviewed with significant bilateral airspace disease. Patient remains on 4 L nasal cannula   Acute hypoxemic respiratory failure Multifocal pneumonia Severe Sepsis and lactic acidosis 2/2 above CT chest reviewed concerning for multifocal pneumonia On 4 L nasal cannula MRSA swab negative.  Vancomycin discontinued Zosyn discontinued per IDFF Follow sputum and blood cultures. ID following.   AKI-improved Hypokalemia Patient's baseline creatinine is around 0.8, creatinine elevated to 1.5 on admission Initially had improved with IV fluids.   Goal to keep net even or slightly negative.   Anxiety and panic attack disorder: Discussed with psychiatrist, will follow up with patient as outpatient as patient is COVID-positive which I agree is reasonable plan.    Chronic anemia: Likely multifactorial due to chemo and recent GI bleed Recent colonoscopy showed multiple tubular adenoma masses Follow up outpatient as previously planned   Stage IV KRAS+ PDL1 low invasive mucinous adenosarcoma of left lung, metastatic to the contralateral lung with mediastinal and bilateral hilar lymphadenopathy: H/o pneumonitis secondary to IO: Transitioned to Sotarasib in Dec 2022 s/p palliative XRT 800 cGy/fraction on 4/13/2022 and 4 cycles of Carbo/pemetrexed and pembrolizumab. She was receiving maintenance Pemetrexed and Pembrolizumab. Clinic oncology consult
approx 4.5 hrs p/vax pt became extremely fussy, yet almost appeared lethargic;pt slept poorly, awake q 1/2-2hr;this pattern cont x 48hrs;temp was not elevated;mom cont to give APAP q 4-6hr;mom did not check w/MD;
had a stroke; I almost died; can´t sleep; can´t even move; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) and NEAR DEATH EXPERIENCE (I almost died) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criteria medically significant and life threatening), NEAR DEATH EXPERIENCE (I almost died) (seriousness criterion medically significant), INSOMNIA (can´t sleep) and MOBILITY DECREASED (can´t even move). At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke), NEAR DEATH EXPERIENCE (I almost died), INSOMNIA (can´t sleep) and MOBILITY DECREASED (can´t even move) outcome was unknown.            Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.  On 27-Oct-2021, patient received the booster dose and last night had a stroke, could not sleep and could not even move. Patient almost died.    Company Comment : This case concerns a  69-year-old, patient of unknown gender with no relevant medical history, who experienced the unexpected events of Cerebrovascular accident, Near death experience, Insomnia, and Mobility decreased. The events occurred approximately 29 days after a dose of mRNA-1273 Vaccine which resulted in a Life threatening situation. The rechallenge was unknown since no information about the events of an earlier dose was disclosed.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  69-year-old, patient of unknown gender with no relevant medical history, who experienced the unexpected events of Cerebrovascular accident, Near death experience, Insomnia, and Mobility decreased. The events occurred approximately 29 days after a dose of mRNA-1273 Vaccine which resulted in a Life threatening situation. The rechallenge was unknown since no information about the events of an earlier dose was disclosed.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Recurrent widespread itching, scattered maculopapular urticaria, and palm sole redness . Symptoms have been recurring since they initially started. They resolve  spontaneously after taking Zyrtec but reoccur 24?36 hours.
Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old). On 12-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by 17 year old/ Inadvertant "off label administration of Moderna vaccine to 17 year old) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant mediactaions were not reported. It was reported that the screening process did not pick up that the patient was under 18 years old.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-053780 (Linked Report). This case was linked to MOD-2021-053780, MOD-2021-053780 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Added patient initials, gender, not pregnant, date and site of administration of first dose with batch number, second dose details and physician information.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: X ) with no associated AEs. US-MODERNATX, INC.-MOD-2021-053780:Crosslinked case
Felt like all of my nerves were reacting when touched; Had shooting pain in injection arm, random pains throughout body; chills; hot flashes; Had shooting pain in injection arm/random pains throughout body; I have had cramping (not on period); This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes), PAIN (Had shooting pain in injection arm/random pains throughout body), ABDOMINAL PAIN (I have had cramping (not on period)), NERVOUS SYSTEM DISORDER (Felt like all of my nerves were reacting when touched) and VACCINATION SITE PAIN (Had shooting pain in injection arm, random pains throughout body) in a 37-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030371) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endometriosis.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 21-Sep-2023, the patient experienced HOT FLUSH (hot flashes), PAIN (Had shooting pain in injection arm/random pains throughout body), ABDOMINAL PAIN (I have had cramping (not on period)), VACCINATION SITE PAIN (Had shooting pain in injection arm, random pains throughout body) and CHILLS (chills). On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Felt like all of my nerves were reacting when touched). At the time of the report, HOT FLUSH (hot flashes) had not resolved, PAIN (Had shooting pain in injection arm/random pains throughout body), ABDOMINAL PAIN (I have had cramping (not on period)), VACCINATION SITE PAIN (Had shooting pain in injection arm, random pains throughout body) and CHILLS (chills) was resolving and NERVOUS SYSTEM DISORDER (Felt like all of my nerves were reacting when touched) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient  hot flashes continued 23-Sep-2023 It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided.
started with achy body and tiredness.  within 3 hours my whole body including joints were sore, had chills.  within another 3 hours (by 2:30pm) I had a fever of 102.4, severe chills but sweating profusely, entire body hurt.  I just rested the entire day (after leaving work early) and today I have no fever, just a bit achy.
C/o nausea and tired, weakness then syncope episode, went to ER given IV fluids.
Initial report received from a consumer on 25 JULY 2013. A 40-year-old female patient had received a first intramuscular dose of ADACEL (batch number unknown) in the left deltoid on 18  JULY 2013. The patient had a medical history of allergy to codeine. Concomitant medications were not reported. The patient had no illness at the time of vaccination. On 18 JULY 2013, i.e. the same day after vaccination, the patient developed quarter sized painful and warm knot at the injection site without redness. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Follow-up information received from a healthcare professional on 09 SEPTEMBER 2013. The patient received ADACEL , batch number: "432TJ" (date of expiration 21 AUGUST 2015). The patient has no illness at the time of vaccination. The patient outcome was not recovered. Documents held by sender: none
9JAN96 crying uncontrollably x 2hrs-slept thru the noc;t102.7;11JAN96 stared;mom reported event only on presentation for dose s eries #2;mom reports child is now fine 26MAR96;
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Patient felt dizzy for 5 minutes after getting the vaccine, she got on her knees, and then passed completely out.  Her body was rigid and was unresponsive for about 30 secs.  The patient woke back up and thought she has urinated.  We took her vitals and her BP came up 141/131 Pulse 88.  The paramedics arrive ad when they took her BP it was 137/82.  She refused transport to the hospital. When she left the store she was feeling normal.
Extreme fatigue and body aches, making walking difficult; fever range of 100.1-101.4 all day, including chills; gross hematuria noticeable by eye throughout Sep 12 and part of Sep 13; dull left flank pain in area where kidney is located.  On Sep 19, noticeable gross hematuria recurred again in the evening, accompanied by dull left flank pain.
Red area around her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Red area around her arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red area around her arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red area around her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Received hepatitis B injection afternoon of 10/21/03. About 1 hour later throat swelled tight; could not breathe. Taken to ER; given Adrenaline, Bendryl and some other injections. Was discharged afternoon of 10/23/03. Sent home on Claritin for 4 days (was unable to take Allegra).
Coughing, trouble breathing, asthma flare ups, fever, bronchitis, bronchicial pnuemonia, very tired, loss of appetite.
Information has been received from a physician concerning a pt who was vaccinated with a dose of hep A virus vaccine inactivated on an unspecified date. It was reported that the pt developed chronic inflammatory demyelinating polyneuropathy. Unspecified medical attention was sought. There was no information regarding this pt's present status. No product quality complaint was involved. Additional information has been requested.