chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt c/o numbness w/in 1/2 hrs of inject in the arm of inject site; progressed down arm; also c/o achiness all wk & through the weekend; numbness lasted to a degree for several days; states had sx p/1st inject to a less degreee;
Mild rash developed on injection arm and face. 24 hours later, rash worsened and spread over face, chest, stomach, arms, forearms, thighs, and legs, causing severe itchiness. Symptoms persist at 48 hours with no sign of improving.
When I was going to bed I started to get chills, hard time falling asleep, would wake up throughout the night with chills and severe aches that were in all my joints especially my hips joints. The next day was even more of the same if not worse. Stayed in bed and even with multiple blankets was still shivering, but sweating like crazy. Towards the evening there was a slight break in the cold and aching. Woke up and there were still aches and cold chills, but way less painful. Third day was just  dull aches that went away in the evening. No more noticeable effects since then.
A spontaneous report has been received from consumer concerning a 6 years old, female patient. The relevant history, concurrent diseases and concomitant medications were not reported. From unknown date the patient had been receiving nasal FLUMIST for unknown indication. During Dec 2012 the patient had experienced tough bout of flu. The action taken with FLUMIST was unknown. The outcome of the event of tough bout of flu was unknown. The event of tough bout of flu was considered to be non-serious by reporter.
72-year-old male with past medical history of basal cell carcinoma, colon cancer, hyperlipidemia, hypertension, insomnia presents to the emergency department with shortness of breath.  Diagnosed with COVID-19 on August 8, 2021.  Has tolerated outpatient therapy until now.  Prompting emergency department visit.  Shortness of breath has improved in the emergency department.  Complaining of cough productive with clear sputum.  Admits to subjective fevers and chills.  Denies nausea vomiting or diarrhea.  8/11/2021 tested positive
Breakthrough case admission after 2 vaccines Moderna 8/23/21 lot# 007B21A;  Moderna 9/28/21 lot# 045C21A
pt recv vax & exp inj site rxn characterized by severe swelling & inflammation;This is 1 of 3 patients from this site who exp the above sx
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Other medical history: Anxiety; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, augmenten, erythramycen. Concomitant medication(s) included: ESCITALOPRAM, start date: 31May2022, stop date: 29Jun2022 was also other medication in 2 weeks. Past drug history included: Augmentin, reaction(s): "Known allergies: augmentin", notes: Known allergies: Sulfa, augmenten, erythramycen; Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Known allergies: Sulfa, augmenten, erythramycen. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of symptoms after a negative test after completing full course of paxlovid; Unknown results, notes: Rebound of symptoms after a negative test after completing full course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: Other medication in 2weeks product was Plan B emergency contraceptive; start date: 09Jun2022; stop date: 09Jun2022. Rebound of symptoms after a negative test after completing full course of paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afraid she was going to die; head and hands felt heavy; extremely tired, could barely lift a glass; Blood pressure went way up; felt groggy; back pain; back spasms alternating with throbbing in her back that was quite significant; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced   back pain, back spasms alternating with throbbing in her back that was quite significant, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired, very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 10:12 am 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left upper arm for prophylaxis for COVID-19 infection.  On 6/Feb/2021, The patient experienced back pain, back spasms alternating with throbbing in her back that was quite significant. On 7/Feb/2021,The patient experienced, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired. On 8/Feb/2021,The patient experienced very motionless all night, thought she was in a coma,  pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. Treated with Baclofen, IV with morphine, Tylenol, Motrin, back patch with lidocaine.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events were  unknown.; Reporter's Comments: This case concerns a 67-year-old female who had a serious unexpected event of Heart rate decreased with NS unexpected blood pressure increased, pallor, miosis, dysarthria, back pain, muscle spasms, discomfort, somnolence, fear of death and NS expected fatigue. Event onset 1 day after first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient initially reported feeling tired and achy the next day, as well as having a migraine. She then developed diarrhea, as well as a rash on her trunk and neck, which spread to her arms and legs. She said she became "puffy", and the injection site became swollen and hot. These symptoms persisted for about 7 - 10 days, after which they resolved.
Fussiness, irritability, didn't want to eat. Fever x2 days.
A week after the vaccination, my upper chest broke out with a rash and small bumps, which also appeared on my arms, and everything itched.  My right ear also has felt slightly blocked since my rash/bumps appeared.  Otherwise, I feel ok.
shingles in her right eye; shingles the right side of her head; pain; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (25 years before reporting).   In October 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 weeks after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and eye pain. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the shingles and eye pain were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles and eye pain to be related to Shingrix.  Additional information was provided as follows: The patient received the first dose of the Shingrix vaccine around last week of October 2020 in her left arm and about two weeks later she started to have shingles on the right side of her head and shingles in her right eye. The patient's physician instructed for her to be seen at the hospital.  At the hospital she was given some treatment. She was not admitted. The patient continued to have shingles and especially the shingles in the right eye was very painful. The patient had shingles about 25 years before reporting and then this was the second time she was having shingles which had not resolved. The reporter consented to follow up.
Diffuse maculopapular rash x 2 days. Supportive care.
Sweating to drench his shirt. Achy.  Cough. Dizzy.  Tired. He went to a walk-in clinic. Had chills. They are testing him for COVID.  Has been sick for 2 days.
He began to run a fever of 101.4 and vomited. He then began to get red spots throughout his body. As the evening went on the spots began to itch and swell up, the his face and most especially his mouth became swollen. We then took him to the emergency room at the local hospital. There they administed and epinephren shot, prelone, and benadryl.
ERYTHEMA AND INDURATION OF THE LEFT ARM WHERE DTAP WAS ADMINISTERED.REACTION OCCURED AFTER 24 HRS. TREATMENT CONSISTED OF COLD COMPRESS AND OTC BENADRYL.  MMR AND IPV ALSO ADMINISTERED ON THE RIGHT ARM BUT THERE WAS NO ADVERSE REACTION.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K019933 and expiry date: 20-APR-2016, lot # L007720 and expiry date: 08-JUL-2016). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Trembling, chill-like behavior started 1 1/2 hrs p/vax; crying unconsolable;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "obesity" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: Yes, sulfa; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: Yes, shellfish. There were no concomitant medications. patient had no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had redness and swelling to posterior aspect of L arm radiating down to elbow.  Positive warm to touch.  Readness measures 210mm.  Pt c/o tingling and numbness to 4th and 5th didget l Hand.  Pt seen by Dr 6/15/04.  Redness started Monday and has continued to spread
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In June 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician at a primary care center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-JUL-2016, the patient was treated by a physician at a primary care center for a blistering vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed valacyclovir and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before).    No concomitant medications were reported.  Consultant pharmacist stated that in a facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose. Patient hadn't received any other dose before. Caller stated that the CDC indicates that they should get the monovalent vaccine right away.  No treatment information was provided.
Pt had Redness at injections site size of 50 cent piece.  Also, itchiness, soreness and warm to touch. Doctors office recommended Benadryl and hydrocortisone cream.
Information has been received from a physician and a nurse, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female consumer who in June 2007, was vaccinated with her first dose of GARDASIL, IM. Subsequently, she became pregnant. This was the patient's first pregnancy. She was hospitalized for a caesarean section due to "low transfer". On 03-JUN-2008 the patient delivered a healthy baby. Then on 15-JUL-2008 she received her second dose of GARDASIL (lot # 658560/1062U). On 07-OCT-2008 the patient has an intrauterine device insertion. Additional information has been requested.
Headache, Myalgia, NauseaVomiting, chills Narrative:  Other Relevant History:
Erythema, swelling from biceps to elbow, urticaria starting about six hours post vaccination (#4 of series, first with this lot)
Arm became red and itchy, took BENADRYL went away after 2 days.
Information has been received from a pharmacist concerning a patient who was "recently" vaccinated with a 0.5ml dose of PNEUMOVAX 23 (Lot# 655592/1175F). Subsequently, the patient experienced redness at the injection site and swelling at the injection site. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information is not expected.
Abdominal Pain Narrative: Patient is a 70 year old male who received Janssen COVID-19 Vaccine (Lot# 1802070) on 3/9/21. Vaccine was administered with no complications and patient was advised to remain in facility for 15 minutes following administration. On 3/15/21 patient contacted hospital reporting that he has had diarrhea every day since his vaccination. Reported bowels on 3/15 turning pink and noted blood in stool with most recent BM. Patient also reports occasionally abdominal pain (4/10). States no improvement after taking Imodium. Patient was recommended to visit hospital for evaluation. Patient was admitted to hospital from 3/15 for observation with dx of leukocytosis, diarrhea and orthostatic hypotension. No complications during stay and diarrhea resolved resulting in discharge on 3/17.
Patient had redness, pain, and inflammation at the site of immunization. Stated that the burning/pain began immediately after receiving the shot and the swelling began the following day was seen by MD and given Hydrocortisone 25% cream and cephalexin 500mg. Has been Improving
SX started about 8:00 PM 2-1-17 consisting of redness and slight swelling in the thigh from diaper area to knee and persistent shrieking crying from about 8:00-10:00 PM.  TX w/TYLENOL-crying subsided about 10:00-redness gone by 2-2-17.
Tested positive on 8/25/22. Contacted CRNP at Network, was prescribed Paxlovid. Symptoms were mild, no fever. Took about seven days to recover.
This spontaneous report as received from a consumer refers to his 76 year old female mother with diabetes, high blood pressure and a history of colon cancer. On approximately 11-AUG-2014 ("about two weeks ago") the patient was vaccinated with PNEUMOVAX 23 (lot # reported as K004282, expiration date 22-MAR-2015), which is an invalid lot# for PNEUMOVAX 23 (dose, route unspecified). Unspecified concomitant medications were taken. On an unspecified date in August 2014, the patient experienced weakness, blurred vision and she fainted one day after receiving the PNEUMOVAX 23 vaccination on approximately 12-AUG-2014. The patient was seen at Hospital Emergency room and then released and returned to her home. About one week after receiving the PNEUMOVAX 23 injection, on approximately 18-AUG-2014, she experienced rectal bleeding and was taken to the hospital on 22-AUG-2014 and admitted and diagnosed with colitis. The patient was prescribed IV antibiotics (details not specified) and was released on 26-AUG-2014. The patient underwent Computerised tomogram (CAT scan) and blood work without results provided. The events outcome was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, pain/swelling at injection site Narrative:
I received my   first  booster shot on 09/29/2022 . My adverse event started on 09/30/2022 I was achy, exhausted, tired, I couldn't  get up the bed for a week. I  stayed in  bed  and got better. I did not take any medications. And I also didn't go to any doctor.  I had my second booster shot and it was fine. No reactions.
Sudden onset dizzyness 5 minutes after immunization.HR Increased 130, decreased to 90 w rest. Transported to medical Clinic for observation
Patient is a 67 y.o. female patient of local CNP with history of asthma, DM-2, HTN, hypercholesterolemia, hyperthyroidism, multinodular goiter, papillary thyroid carcinoma, and paroxysmal atrial fibrillation who presented with shortness of breath and altered mentation and was found to have acute respiratory failure requiring intubation due to Covid/PNA. She failed extubation twice due to thyroid mass, so will be transferred to Hospital for ENT surgery   Acute respiratory failure  Intubated 11/7 due to covid/PNA with underlying asthma Pulm/CC consulted Extubated 11/8 and reintubated shortly after due to stridor IV lasix x1 on 11/9 Extubated 11/10 and reintubated 11/11 with vocal cord edema noted on reintubation  FiO2 (%): 40% S RR: 18br/min S VT: 320ml PEEP/CPAP (cm H2O): 5cmH2O MAP (mmHg):  [71-91] 73 Transfer to Hospital   Covid -19 infection Bacterial pneumonia Severe sepsis Sepsis present on admission CXR with b/l infiltrates Urinary antigens negative Vaccinated Covid positive 11/7 Started on rocephin/azithro, decadron and remdesivir Change decadron to solumedrol due to stridor Back on decadron 11/12 Azithro/remdesivir completed 11/11 Sputum culture MRSA 11/16 Vancomycin started 11/15  Acute metabolic encephalopathy - Resolved Likely due to hypoxia from above HeadCT negative 11/7 and 11/11 Follows commands, alert, oriented, and appropriate Has capacity and communicating by writing   DMT2 A1c 6.8 On lantus 55U and metformin at home Currently on lantus 50U qAM and lantus 30U at bedtime with SSI with ongoing hyperglycemia Change to insulin gtt 11/10 Transition to lantus/SSI on 11/12 On lantus 45U and SSI   Hyperthyroidism Papillary thyroid carcinoma S/p partial thyroidectomy TSH wnl Failed extubation x2 as above CT chest/neck on 11/11 with soft tissue mass from thyroid invading into airway ENT consulted 11/12; discussed patient has extensive involvement of tumor into thyroid cartilage, pharynx/trachea and likely involving the recurrent laryngeal nerve causing vocal cord paralysis. She is unsafe for a trach or extubation at this time and would need an extensive surgery at Hospital for stable airway and tumor resection   Hypernatremia - Resolved Na+ 153 on 11/12; add free water Na+ 148 on 11/13 Na+ 136 - 11/16 Stopped FWF   HTN Home lisinopril and hydrochlorothiazide held on admit Start lopressor and hydralazine prn 11/10   Obese BMI 38
Warm and dry, erythema, swelling and mild tenderness on right deltoid. Given BENADRYL and Ibuprofen.
She know somebody with kidney problems; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced kidney problems. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax the patient's left arm was red and swollen at the injection site , approximately 3cm diameter.