chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 41 year old female pharmacist of unknown age and who was reporting on herself. The patient was not pregnant and did not have any drug reactions or allergies nor concomitant medications. The patient had a history of being immunocompromised due to an unspecified reason. The pharmacist reported that she administered ZOSTAVAX (multiple unspecified lots and expiration dates) to multiple unspecified patients in an occupational contact setting on multiple dates (exact dates were not reported). On an unspecified dates in 2015 (reported as this past year on unspecified dates), the patient had two active cases of shingles that were diagnosed by her primary care physician. The patient was advised by her rheumatologist "not to have occupational contact with ZOSTAVAX" and she has been "administering ZOSTAVAX to multiple unspecified patients over the past year". There was no lab diagnostics and studies performed. The outcome of the shingles was recovered/resolved (on an unspecified date). The pharmacist felt that it might be a possibility that she may have had shingles due to the occupational contact with ZOSTAVAX. Additional information has been requested.
Left arm raised rash, hot, itching, continued to spread. Lymph node swollen like grapefruit size.
her arm tingles and feel heavy; her arm tingles and feel heavy; Left arm pain at injection site/it really hurt like something was in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 12:00 (Lot number: EW0176) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "her arm tingles and feel heavy"; VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Left arm pain at injection site/it really hurt like something was in her arm".  Additional Information: She stated she was a Dietary Aide before. No Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine(s). She went in and got shot and a day after, it really hurt like something was in her arm.  Ever since then, her arm tingles and feel heavy.  Left arm pain at injection site was reported as worsened. She has previous health problems and she got it to prevent herself from getting sick. Left arm pain at injection site - she woke up first thing in the morning with really bad pain in that arm.  No follow-up attempts are possible. No further information is expected.
Following administration, patient reported lightheadedness (within 5-10 min post-IMZ) , and a few minutes later reported nausea. (within 15 min post-IMZ). Patient denied headaches, chest pain, lip/tongue/mouth swelling, trouble breathing, hives, or itching throughout provision of supportive care. She denied emergency care and emergency transport. She accepted our offers for water, glucose tablets, and a packaged snack bar to help her lightheadedness and nausea (which we believe largely to be from the ibuprofen on an empty stomach).
Redness, slight swelling, induration on right upper arm at site of injection with warmth to touch.
I had very, very mild symptoms, runny nose for one day and a little tired. I thought it was allergies, I tested because I was exposed to COVID-19. I used my home COVID-19 test that came back positive, called my doctor who prescribed PAXLOVID, after five days I am feeling much better.
could be allergic reaction to polyethylene glycol (PEG) can cause anaphylactic reaction; anaphylactic reaction; large red rash left arm; presistent rash all over; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 20Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 04Mar2021 09:30 (Lot Number: EM 9810) as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AE. The patient's concomitant medications were none.  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm left at 11Feb2021, 09:30 (Lot number: EL9269) for covid-19 immunisation. The patient experienced presistent rash all over on 14Apr2021, seriousness Criteria was Life-threatening; Hospitalization.; Persistent / Significant disability / Incapacity; Important medical event, hospitalized from 14Apr2021 to 15Apr2021 required visit to emergency room and physician office, received treatment with Solumedrol: (resulted in) SOB (short of breath), Prednisone: (resulted in) Rash, Pepcid: (resulted in) anaphylaxis shock; large, red rash left arm on 09May2021, seriousness criteria was hospitalized from 09May2021, required visit to emergency room and physician office, received treatment with Solumedrol: (resulted in) SOB, Prednisone: (resulted in) Rash, Pepcid: IV, pertinent details indicated could be allergic reaction to polyethylene glycol (PEG) can cause anaphylactic reaction saw allergist, primary dermatalogist, ER physicians, immunologist, cause unknown, could be viral or allergy- do not know. The patient also experienced unspecified ongoing adverse event since 04Aug2021 and required visit to Emergency Room, Physician Office, received treatment with Solumedrol: (resulted in) SOB, Prednisone: (resulted in) Rash, Pepcid: IV. The patient underwent lab tests and procedures which included Antibody test to platelet factor IV: unknown results on unknown date, Covid Test: negative on 14Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Pt approximately 8 weeks gestation. Approximately 15 min following injection, pt started vomiting violently with no previous history fo vomiting during pregnancy. BP elevated to 147/82.  RN monitored patient for approx 20 min and vital signs normalized and vomiting decreased. Pt returned to baseline and was allowed to leave vaccine clinic.
Coughing, wheezing, trouble breathing, temperature, numbness in hands, a lot of swelling and itching at injection site. Lasted about 6-7 hours and then I started to get better and was able to breathe normally & temp went down.
pt recv vax 25JUL96 & 31DEC96 lab eval revealed that the pt was ELISA index thus no antibodies;20JUN97 the ELISA value said the pt had some antibodies @ 0.26;
One day after receiving the 3rd dose of COVID-19 got a fever of 101; Gave tylenol and was seemed better the next day; Two days later had another high fever of over 103 this time;  Planned on seeing Pediatrician first thing on monday, but then he also started to develop a rash on legs and feet and was alternating between fever and chills after taking fever reducers; Used an oximeter to check his oxygen and it was really low;  Went to Urgent Care, given a breathing treatment and was tested for COVID-19 and Strep, both were negative; The Breathing Treatment wasn't helping, was rushed to the hospital by an ambulance; Given a chest X-ray and was diagnosed with Pneumonia; Given more breathing treatments, and was hospitalized for 1 night and was given Amoxicillin through his IV; Released the next day and sent home an Albuterol Inhaler and Amoxicillin;. A few days later he developed a heavy cough; Went back to Urgent Care and was told he had Croup; Went to Pediatrician and was given Dexamethasone. Seems to be doing better now.
headache, fever, chills, body aches, neck pain starting one day following vaccination. Ongoing symptoms at time of re-evaluation 2 days after vaccination however improving, fever resolved.
Appendicitis (perforated). Severe stomach pain began morning of 11/26, approximately 48 hours after booster administered.   Admitted to ER on 11/30/21. CT scan confirmed appendicitis. Underwent surgery, appendectomy, on 11/30/21.
Headache, tachycardia, body aches, malaise, lethargy,
Site: Pain at Injection Site-Severe, Additional Details: per pt, has pain all across deltoid around to biceps on injection arm, unable to lift arm since the vaccine (for a little over 6 months now). visited PCP but only had an xray ordered with no abnormalities and no other remedy was given. pt decided to come into pharmacy to ask for advice.
Patient developed swelling and redness at the site of injection that went all the way down to his wrist.
Numbness in arm, wrist and hand of injection arm after 2nd dose; Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose; Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose; Legs a problem after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in arm, wrist and hand of injection arm after 2nd dose), PAIN IN EXTREMITY (Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose), MOBILITY DECREASED (Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose) and LIMB DISCOMFORT (Legs a problem after the 2nd dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hand injury. Concurrent medical conditions included Leg discomfort.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in arm, wrist and hand of injection arm after 2nd dose), PAIN IN EXTREMITY (Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose), MOBILITY DECREASED (Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose) and LIMB DISCOMFORT (Legs a problem after the 2nd dose). At the time of the report, HYPOAESTHESIA (Numbness in arm, wrist and hand of injection arm after 2nd dose), MOBILITY DECREASED (Can't do anything with hand when first wakes up after 2nd dose/Legs started giving out upon walking after 2nd dose) and LIMB DISCOMFORT (Legs a problem after the 2nd dose) outcome was unknown and PAIN IN EXTREMITY (Hand hurts so bad she can't even make a fist after 2nd dose/Legs hurting after 2nd dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: unknown (Inconclusive) hasn't heard back regarding the results.         No relevant concomitant medications were reported.  No treatment information was provided.
got very ill; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves female patient (unknown age) who got very ill (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got very ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, she stopped taking flu shots and did much better without getting them. No one could ever explain why she got so ill after getting a flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Narrative:  Patient admitted for tachycardia, reports of throat swelling following COVID-19 vaccine.
angioedema; hives; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a physician in the United States.  This case involves patient of unknown demography who experienced angioedema and hives (urticaria), while the patient received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past vaccination(s) included INFLUENZA with no reactions and has no egg allergies. Medical history, concomitant therapy, medical treatment(s) and family history were not provided.  On 01-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 01-Oct-2020, the patient developed non-serious angioedema and hives (urticaria) 6 hours following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Patient was not recovered from both the events at the time of reporting.  There will be no information available on the batch number for this case.
She was given a trivalent influenza vaccine 10/15/14. She reported significant swelling 10/21/14 worse 10/28/14 and improving 10/29/14.
Fever on and off; Slight nausea; Very unusual fatigue; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 17:15 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included was not reported. The patient reported that her blood group was B negative and was healthy. The patient was allergic to metal, as stated that her skin could not tolerate anything that has nickel in it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 19Mar2021 at 15:00, the patient experienced fever on and off, very unusual fatigue, some slight nausea and diarrhea. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, fatigue, nausea and diarrhea was not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
On 1/13/22 staff member received the Moderna 1st dose and on 2/10/22 she received Pfizer as a 2nd dose.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L008660, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 920, 34 and R; 168, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
4/21/21- developed cough. 5/12/21 developed shortness of breath and exertional dyspnea. 5/15/21 developed substernal chest discomfort, blurred vision. Went to local ED- no significant findings. 5/19/21 transthoracic echo showed LVEF 52%. 6/7/21 -symptoms resolved except for mild congestion. 6/27/21 cardiac MRI: demonstrated normal biventricular function (LVEF 63%), mild epicardial scar (mid inferolateral and lateral walls), mild patch mesomyocardial scar (mid septum), mildly elevated T1, T2 in the septum.
5 hours after getting IPV, DTap, Comvax, and Prevnar. 2nd set of vaccines. The infant vomited 3 times and became lethargic, 2 hours later he was back to normal. And had ????  on 12/21/2005.
MD reported having multiple pt w/adverse rxn p/flu vax;one pt had been hosp & another who is very sick;
Foaming at the mouth, rigid, unresponsive for 20 minutes. Memory loss after event and headache the following day.
Case number PHEH2013US017646 is an initial spontaneous report received from a pharmacist on 15 AUG 2013. This report refers to a patient whose identifies were not reported. The patient's medical history and concomitant medications were not reported. IT was reported that on 15 AUG 2013, the patient received only an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: not reported) without being reconsituted with MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Patient is an 82-year-old female admitted with subacute GI bleed (hemodynamically stable) who had positive COVID-19 on admission.  She has chronic anemia, hemoglobin 10.4 on 3/25, 8.7 on 9/24, and 7.9 on admission this morning.  She has reported some intermittent melena at home over the past couple weeks.  Stool occult blood was positive, but no overt signs of GI bleeding and patient has been hemodynamically stable.  Reviewed with GI attending, Dr., and primary team,  second Dr. .  Given subacute bleed, hemodynamic stability, and COVID-19 status resulting in high sedation risk, will hold off on endoscopic evaluation at this time.  GI will follow peripherally and complete formal consult in the future if pat
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 7 May 2014, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown). Her last menstrual period was on 22 September 2013 and estimated date of delivery was on 29 June 2014. The subject was exposed to the vaccine during the third trimester. The pregnancy was ongoing. Follow-up received on 04 November 2014: No relevant test performed. At the time of the follow-up report, the pregnancy outcome was unknown.
No additional AE/PQC's reported; excursions vaccine was administered to patients; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-AUG-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # T002847, expiration date23-JAN-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.5 F) for the time frame of 57 minutes, and between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (7.3 F) for  the time frame of 15 minutes. There was no previous temperature excursion. No adverse event was reported.  This is one of two reports from the same source.; Sender's Comments:  US-009507513-2108USA006421:
had a temperature of almost 102 F which is similar to what happened after the other doses; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (had a temperature of almost 102 F. which is similar to what happened after the other doses) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (had a temperature of almost 102 F. which is similar to what happened after the other doses). At the time of the report, PYREXIA (had a temperature of almost 102 F. which is similar to what happened after the other doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 F. (High) 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-372655, MOD-2021-373022 (Patient Link).
This spontaneous report was received from a registered nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided. On 07-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter (lot number T015598, expiration date 02-NOV-2022; route of administration, vaccination scheme and anatomical location of vaccination were not reported) for prophylaxis. The administration of a vaccine that was involved in temperature excursion (product storage error). The measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) underwent a temperature excursion of 23.10 degree Celsius for period of 65 hours and 25 minutes. The previous temperature excursion was unknown. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported. The physician reported that on an unknown date, the patient developed flu-like symptoms after receiving ZOSTAVAX. The outcome of flu-like symptoms was unknown. Additional information is not expected.
Pt c/o "funny feeling in tongue" swelling, feels like her throat is closing. Swollen neck.