chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 11:29, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist via company representative refers to an approximately 61-year-old (reported as over 60 years) female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number expiry date, dose and route was not reported). No concomitant medications were reported. On an unknown date, the patient complained of headache 1 hour after administration of ZOSTAVAX. The patient was treated with ibuprofen and the headache on an unknown date. Additional information is not expected.
p/vax, redness, pain, & swelling from lt shoulder to lt elbow mostly on extensor side of the arm;tx w/ice, elevation, motrin;
A report has been received from VAERS concerning an 8 years old male patient. The patient had a history of asthma and upper respiratory infections. Other medication was not provided. On 15-Oct-2009, the patient received nasal FLUMIST (lot number: 500693P) for unknown indication. On 20-Oct-2009, the patient experienced leg pain and lab result showed rhabdomyolysis. The patient recovered from the event of rhabdomyolysis on an unspecified date. The company physician assessed the event rhabdomyolysis to be serious due to important medical event. Follow-up of up information received AstraZeneca/MedImmune on 02-Aug-2012 from VAERS upgraded this case to expeditable. According to the company physician the event rhabdomyolysis was upgraded as serious event due to important medical event criterion. Vaccine was purchased with public funds.
pt recv vax 23SEP96 & the same day pt devel raised, indurated, painful, warm 8 to 9 cm area of erythema radiating from the inj site on the lt arm;
Patient received undiluted Pfizer Peds 5-11 vaccine -Patient contacted to inform - Denies any s/s of Adverse reactions
08/12/2004 Mom noticed red raised spots on child's belly size-1/2 of eraser head. Next day 08/13/04 6-7 on Belly 6-7 on back arms and legs. Denies itching or puss filled spots. Dr visit made. Dr not sure if chicken pox or vaccine related. No treatment rendered. PC to manufacturer reported info.
Vomiting and diarrhea, general ill feeling, fatique, dizziness, platelets abnormally low /weight loss (over 18 pounds since above referenced date)
1. all these symptoms lasted 48 hours: extreme blinding headache; extreme intolerance to any kind of light; aches and pains in every body joint; nausea;  inability to intake medicines or food; extreme tiredness; extreme thirst. 2. after the first 48 hours passed, it took me another two days to feel strong enough to drive and engage in normal activities. Appetite returned quickly.
The injection site was sore immediately following the injection and for the next 7 or 8 hours.  Then the pain at the injection site became worse so that it was painful to lay on that side in bed.   I took 400 mg. ibuprofen around 9 am the following morning, and again at around 1:00, and the pain subsided.  The injection site remained sore and tired, but the really bad pain was gone.
IM  given in left arm 3rd dose. (Booster).  Moderna Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/21 at 11:45 am.  Given on 11/5/21, out of time range.  Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday  letting them know that Moderna was looking into this and would be getting back to us. Also let them  know I would be following up with them once we heard back from them. Called patient today 11/17/21 and let him know that Moderan let us know the  vaccine was viable, no  additional booster vaccine is required.
Pt had a Covid shot on 02-08-2021.She went  home and the next Morning she got out  of bed and ended up passing out and hitting hev head on a coat rack. she came into the Dr on 02-09-2021. She has a Left frontal 1cm Laceration, abrasion at right scalp, bridge of Nose with a shallow 4mm laceration .  Black eyeon the right side
On 7/19/11 pt seen 3cm firm tender erythemic hot nodule (R) upper arm surrounded by 15 x 8 1/2 cm tender erythemic area - no axillary LA, no clavicular LA, oral temp 98.2.
(5/11) after eating beef jerky & salmon jerky :throat swelling, tightness in chest, indigestion, tongue burning, dizziness, lightheaded, high bloodpressure ?. (5/12) after eating pistachios, lettuce:  throat swelling, tightness in chest, tongue burning, pain in mouth went to urgent care.. did ekg, heart ok , vitals ok initial high reading of blood pressure returned to normal and released (5/14) pain in chest, tightness same as above with throat swelling , went to ER ?. ekg, chest xray, high blood pressure ..nitro glycerine tablets given TWICE ...tightness in chest feeling gone, bp returned to normal .. follow up with primary care and cardiologist was recommended. (5/15) after eating baked potato, same allergic reactions returned in mouth, patient went to urgent care.. was seen and diagnosis food allergy given epi pen, Pepcid, bentyl  (5/16) after taking medications : Bentyl and Pepcid was having allergic reaction, discontinue use of those 2 meds
Patient initially tested positive for COVID-19 on 7/31/2022. Her symptoms were fevers, chills, fatigue, weakness, headache, nasal congestion, and shortness of breath; All her symptoms resolved except for the weakness, fatigue, and shortness of breath.  FIRST HOSPITALIZATION:  On 9/6/2022, patient presented to the emergency department for evaluation of acute and chronic shortness of breath. She was given a COVID-19 NAA test in the ED which resulted positive; Her chest x-ray showed a new right mid alveolar infiltrate. Patient's oxygen saturation was 87% on room air; She was started on supplemental oxygen. Patient was diagnosed with acute hypoxemic respiratory failure, and pneumonia of right lung due to infectious organism. She was admitted to the hospital for further evaluation and treatment.  Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital.  SECOND HOSPITALIZATION:  On 12/5/2022, patient presented to the emergency department for evaluation of dyspnea that increased over the past week, hypoxia, and sore throat. She had a respiratory viral panel done and it was positive for COVID, suggesting recurrent COVID; Her chest x-ray showed patchy bibasilar parenchymal opacities likely related to the patient's known COVID infection. Patient's oxygen saturation was 82% with exertion on room air and 88% at rest on room air; She was started on supplemental oxygen which brought her oxygen saturation up to the mid 90s. Patient was diagnosed with dyspnea, COVID-19, hypoxia, and thrush. She was admitted to the hospital for further evaluation and treatment. Patient died on 12/28/2022 while an inpatient at the hospital. Her death abstract listed immediate cause of death as acute hypoxemic respiratory failure, interstitial lung disease exacerbation, COVID-19 pneumonia; with other significant conditions listed to be cardiac arrest, stroke, obstructive sleep apnea, diabetes mellitus type 2, pulmonary embolism, acute kidney injury, heart failure with preserved ejection fraction, and pseudomonas bacteremia.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
My dad had shingles and it wasn't very pleasant for him either; wasn't very pleasant for him either; First shot / for free / $175 for the next one / more than I could come up; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, feeling abnormal and incomplete course of vaccination. On an unknown date, the outcome of the shingles, feeling abnormal and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for himself/herself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient received first dose of Shingles vaccine and had shingles and it wasn't very pleasant. The patient got first shot in his/her working place and it was offered for free. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The patient was waiting the time out for the next dose, but he/she had to switch jobs and found that the next one was a little more expensive than he/she could come up with.  The patient did want to get it though.  The patient state that his/her father had shingles and it was not very pleasant for him either. The follow-up would not possible as no contact details were available.  Note: As the follow-up would not be possible the event shingles with 1st dose of Shingles vaccine was conservative captured.
I administered the Pfizer COVID vaccine to the patient at about 2pm. I completed the vaccine, put the used syringe into the sharps container, grabbed the bandage, and turned back toward the patient. As I did this, he started slumping over in the chair, and his eyes rolled back into his head. I immediately put my arms around him so he wouldn't fall out of the chair. The patient's father was in the room as well and knelt down in from of him. The patient's body spasmed for a few seconds, then he came to but was breathing heavily and starting to sweat. I called to technician in the pharmacy and asked him to call 911 at 2:03pm.  I brought the patient a cool cloth and asked a technician to bring some water. The patient's breathing started to slow, but he was nauseous and dizzy. He dry-heaved once, and I put the garbage can in front of him. He slumped over the garbage can for a few minutes. Then he asked to lie on the floor. He seemed to do better lying on the floor. When the EMTs arrived, they attempted to have him sit in the chair again, but his dizziness returned, and he complained of being cold. The EMTs moved the patient to the gurney and transported him to the Hospital for further medical attention.
Had shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Had shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient got vaccinated and within 2 weeks he/she had shingles go figure. Follow-up would not possible as no contact details were available.
Patient was administered  the Moderna Bivalent booster on 9/13/23 after the FDA had pulled the Authorization on 9/11/23
I was dizzy leaving the hospital (4/21/2021), I woke up the next day (4/22/2021) with a rash all over my neck and it?s still itchy, red and hot (4/23/2021) I have a persistent headache and fluctuate between feeling hot and cold, Nausea on and off
Mother of pt noted small rash about 2 weeks before first Covid-19 injection (about 1 week after Influenza vaccine). Similar rash with severe flare on day of the first Pfizer Covid-19 vaccine. Worsening of same rash right after second Pfizer vaccine. Rash resolved with oral steroids. Approx 1 month after rash began, patient was admitted for facial swelling and neck venous distention. CXR showed thymic mass. Biopsy proven Hodgkin Lymphoma stage IV
Pt had injections on 06/18/02. Returned 06/19/02 c c/o vomiting fever (none at this time) and red and swollen left deltoid. Feels warm to touch and is tender.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication provided. No treatment information mentioned.  On an unknown date patient experienced COVID.   Reporters causality of events with Skyrizi was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 27-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first and second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 27-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first and second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
TINGLING; DIARRHEA; ACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included contrast dye allergy, and novocaine allergy, and other pre-existing medical conditions included patient is allergic to novocaine and contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180898L expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced tingling. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling, diarrhea, and aches. This report was non-serious.
Information has been received from a consumer concerning his son who was vaccinated with a dose of MMR II. Subsequently the patient developed spectrum and swelling at the injection site. No medical attention was sought. At the time of this report, 03-NOV-2008, the outcome was unknown. Additional information is not expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided by reporter. Treatment information not provided by reporter.   This case was linked to MOD-2021-294436 (Patient Link).
Pain in hand; Swelling; stiffness in hand; Fatigue; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in hand), SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness in hand), FATIGUE (Fatigue) and CONDITION AGGRAVATED (Condition aggravated) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Rheumatoid arthritis: HUMIRA (HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB).). Past adverse reactions to the above products included No adverse event with HUMIRA.   On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in hand), SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness in hand), FATIGUE (Fatigue) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, PAIN IN EXTREMITY (Pain in hand), MUSCULOSKELETAL STIFFNESS (stiffness in hand) and FATIGUE (Fatigue) had not resolved and SWELLING (Swelling) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            No Concomitant medication reported. Event Onset date reported year 2022. The patient experienced swells up real bad after the Covid Booster. It was unknown if patient was enrolled in covid vaccine trial. No Treatment medication reported.
arm  was really sore; ache in the whole body; shivering; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  was really sore), MYALGIA (ache in the whole body), CHILLS (shivering) and PYREXIA (fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm  was really sore), MYALGIA (ache in the whole body), CHILLS (shivering) and PYREXIA (fever). On 21-Jan-2021, MYALGIA (ache in the whole body) had resolved. On 22-Jan-2021, PAIN IN EXTREMITY (arm  was really sore), CHILLS (shivering) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 101 degree fahrenheit (High) 101 degree Fahrenheit.         No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-022349 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information received contains non-significant information. On 16-Aug-2021: Follow-up information received contains no new Information.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 10:00 (Lot number: EW0177) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Wasp stings" (unspecified if ongoing), notes: known allergies of Wasp stings. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 27May2021 16:00, outcome "recovering", described as "I experienced severe brain fog". The event "i experienced severe brain fog" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal. Additional information: Patient had other vaccine in four weeks. Patient did not have any other medications in two weeks. Patient experienced severe brain fog & disconnectedness within one week of the first dose. It was persistent daily for at least one month. Patient still had frequent sensations of brain fog now 4 months after the last dose, but it was decreasing slowly. Patient did not have covid prior vaccination. Patient was covid tested post vaccination. Patient received Dose 2 of bnt162b2 (BNT162B2) administration date 14Jul2021 10:00 (Lot number: EW0217) as dose 2, single, administration in left arm.
Client presented to drive through flu exercise for influenza vaccination.  Gave history of having had flu shots in past without incident.  No contraindications to vaccinations identified. Client was vaccinated and returned home.  At some time after returning home client went to Hospital emergency room where he coded and expired.   10/23/07 Reviewed hospital medical records which reveal patient experienced weakness & decreased respirations upon arriving home s/p flu shot.  Collapsed in seat of pickup truck.  EMS intubated, started CPR & transported to hospital.  CXR revealed right pneumothorax & chest tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with atherosclerotic cardiovascular disease & CHF as contributing factors.
Mom noted redness and swelling warmth at site of injection.  Redness spread over upper leg 7.5cm in diameter.  Painful to touch Treated with amoxicillin.
Fever, shaking, nausea. Breaking out in sweats, muscle aches, pt could not function properly.
Injection site red, warm to touch and painful.  Also swollen.  Redness and swelling about 1 1/2 in size.  Afebrile.  Patient advised to call PCP for further advice.  Recommended tylenol and cool compresses.
3/31/2022 at 1021 Employee called the Nurse Vaccine Support line to report symptoms post COVID-19 booster vaccine. Vaccine Name - Moderna Vaccine Date - 3/28/2022 Booster Dose - Yes Location - Left Deltoid Date of Symptom Onset - 3/29/2022 (~0300) Symptoms - Body Aches, Fatigue, Nausea, Fever (100.4F - Last Fever on 03/30/22 in the Morning). Last Day of Work and Shift ? Monday, 3/28/22, (7a -3:30p) / Missed work on Tuesday, 3/29/22, & Wednesday, 3/30/22. Home Remedies ? Zinc, Emergen-C, Ibuprofen Any Improvement ? No
Approximately 20 min. after immunizations, infant's left temporal and top of scalp area was observed to be purple, blotchy appearance. No change in vital signs- HR 120's/min, Resp Rate 30's/min; no local reaction at injection site. Over course of few minutes, discoloration faded; infant playful and in no apparent distress. 12/11/09 P.C. to FA, child doing "fine".
Temp 103 w/Tylenol - began 4-5 hrs p/vax was given; Had fever & cried for long periods for 24 hrs.