chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported). 1 sot, route reported as injection. The pharmacist reported that 6 months ago (in approximately February 2014), she saw the patient who asked her about ZOSTAVAX reaction described as a red line that looked like it originated from injection site, going across her neck (onset date of reaction was unknown). The pharmacist told the patient to go to the hospital, but did not know if the patient actually did visit the hospital. The reporting pharmacist did not administer ZOSTAVAX. Laboratory tests were not performed. The patient sought medical attention - went to pharmacy. The outcome of a red line that looked like it originated from injection site, going across her neck was unknown. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On an unknown date, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (Lot No. R013570, expiration date 18-MAR-2021) and ROTATEQ (Lot no. R007988, exp. data 16-OCT-2019) following a temperature excursion. Call made because of "data logger". No adverse event was reported. Temperature: 48F. Time frame: 1 hour 3 minutes. Previous temperature excursion: No.
About 8 days after my vaccine I developed an erythematous, indurated, itchy patch about 2-3 cm below my injection site. It started as 3 x 2cm and grew to 8 x 3cm. It resolved within 3 days with no treatment.  I had no other symptoms besides the skin reaction. I am a nurse so I've had many vaccines and have never had a reaction to any of them.
just had a little fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "just had a little fatigue".  Additional: Other HCP himself was patient and he queried if there was allergic reaction, was there a maximum amount of time before it would show up. "When he got vaccination, he had to wait 15 to 30 minutes."He was totally fine, just had a little fatigue."    No follow-up attempts are possible. No further information is expected.
Myalgia after vaccine Then rash under (L) arm Appears like Zoster with lesion on back and underarm. TXT with Acyclovir (Herpes Zoster)
Individual received the vaccine at 3:57 pm and at 4:15 pm pt report she was hot, her heart was racing, she felt flushed. She was given Pepcid 20mg by mouth and Benadryl 25 mg by mouth and monitored at the hospital vaccination site. Vital signs remained stable throughout. By 4:54 pm patient's flushing had resolved and pt reported feeling back to base line.
PATIENT RECEIVED IMMUNIZATION AT 0907 AND PROCEEDED TO THE LABORATORY TO HAVE HIS BLOOD DRAWN. WHILE WAITING TO HAVE HIS BLOOD DRAWN PATIENT STATED HE FELT NAUSEOUS, VOMITED X 1, AND DEVELOPED A HEAD ACHE. PT DID NOT REPORT FEELING THIS WAY AT THIS TIME. PT WENT AND HAD BLOOD DRAWN ANYWAY AND THEN REPORTED TO LAB TECHNICIAN THAT HE DID NOT FEEL WELL AND PATIENT WAS BROUGHT TO DOCTOR TO BE ASSESSED. DR ASSESSED PT AND BP WAS 150/100, HR 80, HEART RRR, NSR ON TELE. LS CTAB, HYPERACTIVE BS NOTED TO ABDOMEN. RESCUE WAS CALLED AND DR RECOMMENED IV FLUIDS ANTIEMETICS, MONITORING. THIS ASSESSMENT WAS PER DR. REPORT. PT LEFT BY RESCUE. WILL F/U.
No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    No concomitant medications were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Follow up received wherein patient's DOB, gender, initials and age added.
Initial case received from a healthcare professional (the patient's responsible physician) on 01-Oct-2014. A 43-year-old male patient, with no reported medical history and no illness at the time of vaccination, had received her intramuscular dose of FLUZONE QIV, (batch number UI172AA) in the left deltoid on 15-Sept-2014. On 20-Sept-2014, 5 days post-vaccination, the patient had a possible Guillain-Barre syndrome diagnosed. The patient was admitted to the hospital on 30 September 2014. No other symptoms were reported. The responsible physician was notified by an infectious disease doctor. The outcome was unknown. No further details were provided. Documents held by sender: none.
complain of feeling numbness on left 4th and 5th fingers on same side as injection. No associated symptoms. symptoms resolved prior to release
4/14/07 - Presented with "coffee ground emesis" and bloody stools. Mom took him to ER, dx'd with adenovirus and intussusception. Unable to reduce with barium enema reduced with surgery. S/P Appendectomy. 6/1/07 Received vax record from PCP which indicates RO Lot # is as reported & was 2nd dose.  VAERS database updated w/same. 6/5/07 Received hospital medical records which reveal patient experienced diarrhea x 7 days, bloody mucous x 1 day & abdominal pain.  Also w/rhinorrhea, cough & sneeze.  Admitted 4/14-4/17/07 for bacterial gastroenteritis.  On initial hospital day had coffee ground emesis.    Taken to OR for laproscopic reduction of IS & appendectomy.  Stable post op FINAL DX: Ileocolic intussusception, surgically reduced; adenovirus.
COUGH, SHOB, RUNNY NOSE, CONGESTION, CHILLS, FATIGUE, BODY ACHES, HEADACHE
pt recvd vax 30SEP88 & was hospitalized 30OCT92 w/strep pneumonia; required hospitalization for 18 days; pt recovered;
Fever, cough. Diffuse bilateral pneumonia. Staph aureus MRSA.  5/12/09 Autopsy report states COD as organizing diffuse alveolar damage w/bronchiectasis; multiple bronchopleural fistulas secondary to influenza B & MRSA infection; extensive pleural adhesions.  Autopsy limited to lung only.    4/15/09 Received hospital medical records of 2/16-3/21/2009. FINAL DX: death; influenza B pneumonia w/secondary MRSA pneunonia; ARDS; leukopenia; thrombocytopenia; hyponatremia; coagulopathy; hypotension requiring pressors; high frequency oscillatory ventilation; bilateral pneumothorax; bilateral bronchopulmonary fistulas. Records reveal patient experienced sorethroat, fever, cough, post-tussive emesis x 4-5 days & hemoptysis x 1 day prior to admit w/increased work of breathing.   Admitted PICU for severe respiratory distress secondary to bilat pneumonia & leukopenia.  Pulm, ID, heme consults done.  Patient had long & complicated PICU course while continuously vented, feeding tube, bilateral chest tubes, tracheostomy, multiple blood product transfusions, IV antibiotics & steroids, Tamiflu, IVIG.  Progressively declined, extubated per family request & expired shortly therafter.
Pt seen in ER 36 hrs p/immun given; Mom states pt had inc fever, broke out in rash all over body, swelling in hands, face, & feet; Given DPH for allergic rxn; Condition worsened throughout the night & was taken to MD in AM-given Pediapred;
ABOUT 5 MINUTES AFTER ADMINISTRATION: PATIENT REPORTED FEELING HOT AND SWEATY.  SHE REMAINED IN POST VACCINTATION AREA AND WE GAVE HER AN ICE PACK AND GLASS OF WATER.  SHE LAYED DOWN ON 2 CHAIRS.  AFTER ABOUT 30 MINUTES SHE REPORTED FEELING BETTER AND SHE LEFT ACCOMPANIED BY HER FATHER.
Darkening of the skin (circular around site around 2 inches in diameter), roughening or drying or skin, itching, "heaviness" feeling.  These symptoms have lasted (and are still there) for 2 weeks so far.
6 year old was given Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number H242K, expiry date 09-JUN-2025) for prophylaxis.   On 21-APR-2023, the patient received Boostrix. On 21-APR-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 year old was given Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 Clinical supervisor reported that a 6 year old was given a Boostrix.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. via phone.  No address was provided. The six year old patient was given Boostrix which led to Inappropriate age at vaccine administration.
I received a Shingrix  vaccine shot on 14 Aug 19 and on 15 Aug 19  I experienced nausea, headache and a completely out-of-character nervous/ emotional outburst.  My wife of 50 yrs mentioned that she had never seen me react this way at any time.  This was definitely a once-in-a-lifetime event.  My reaction was not against her but, related to a minor situation.  She was puzzled and wondered what could have triggered this response.  I related to her that before the event I was feeling nauseated with a head buzz.  The emotional outburst came a few minutes later and was directed towards a benign question from a coworker.  I do not, and have never taken, non-prescribed drugs; nor, do I drink alcohol.  We were both befuddled until she mentioned that the only difference in my routine was the Shingrix shot the day before.  This was the second dose of the two-dose vaccine.  After the first dose (two months ago), I experienced extreme eye-redness and irritation which last a week.  My son indicated that my eye problem could be  Herpes simplex keratitis and, advised me against getting the second dose.  I felt that I should complete the second dose and that the eye problem was a tolerable situation, if the vaccine prevented shingles.  Obviously, I cannot make a direct cause and effect relationship between my nervous/ emotional response and the vaccine.  My intent here is to relate to you a possible adverse reaction to this vaccine in the event that other individuals have similar experiences.  Below I have listed the pertinent data from the vaccine. NDC: 58160-0819-12   DAW: 0  MFR:  GLAXOSMITHCLINE
About an hour after vaccination, patient experienced tingling sensation at tongue, swelling at throat, and flushing at neck and face. Immediate BENADRYL administration resulted relief of the symptoms.
Noticeable swelling, pain (difficulty moving the arm), and unusually warm skin at injection site. MOTRIN and TYLENOL didn't help. Applied ice. ARNICA topical gel seemed to provide the most relief. I believe this will resolve itself in the next day or two but she has never experienced a reaction to a vaccine such as this before this incident.
Red itchy rash at injection site noticed 3 days after injection. Per patient, site is warm to touch. Patient also described feeling chills. Local rash was about 1 inch long and 3/4 inch wide.
cried for 1 1/2hrs p/vax; slept 30mins then cried & screamed for 3 1/2hrs w/o stopping; t101 but did not respond to APAP; inj site swollen; refused formula-no appetite; seen by MD-no tx;
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment information for the event was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AE's for this 32 year old female. Patient will continue to be contacted for further monitoring of AE's during pregnancy.
swelling/erythema @ site;hives that day on arm/axillae x 4 days;facial swelling on day #5
(L) arm swollen, red, Hot to the touch, sore at the site of injection.
Ischemic Stroke on 4/15/2021; Extensive and closely adjoining foci of acute infarction in left, extending from parietal operculum through insula and external capsule to eat ependymal margin of left lateral ventricle;
Extensive erythema involving LLE. Redness extended from groin to knee within 48 hours. Patient given oral antibiotics. Redness resolved within 36-48 hours.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in aN elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported she just administered SHINGRIX to the patient and the patient got a raised swollen bump at the injection site immediately after getting the vaccine. No further information was provided.
This is a spontaneous report from a contactable consumer. A 68-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 12, 2021, patient experienced a rash and spreading now. They called the hospital, and told her to take Benadryl. The event considered non-serious, with outcome of unknown. Follow-up attempts completed. No further information expected.
Pain in arm at site of injection; Body aches; Chills; Feverish; Stomach pain; Headache; TIRED!
1/9/21 swollen left cervical and supraclavicular lymph nodes 1/12/21 blunt effusion left knee with subsequent development of Baker's cyst, swollen bilateral axillary lymph nodes 1/25/21 worsening of left knee pain, swollen left calf
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # L040459, expiry date: 06-APR-2017 and lot # K010215, expiry date: 05-MAY-2017, (strength, dose and route were not reported), which underwent temperature excursions of 46.5 Fahrenheit degrees for 30 minutes and 30.8 Fahrenheit degrees for 108 hours on unspecified dates. No previous temperature excursions were reported. Data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Family member called 4 days post vaccination that patient experienced shortness of breath/chest pain a couple days post moderna booster vaccine administration (with abnormal EKG). The patient is currently admitted at hospital and is being monitored by the doctor.
hasn't been feeling right; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team.  A 50-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "hasn't been feeling right".  Additional information: The caller was asking for information on behalf of the doctor. She would like to know a few things that could be helpful for their patients. She had a patient that came yesterday on 15Jun2022 after being vaccinated and began experiencing symptoms and side effects. She wanted to know if there are any designated facilities that could help them with their symptoms. It was reported that the caller wanted information on facilities that could help patients that had the Comirnaty vaccine. withheld states the patient started having symptoms yesterday since they got the vaccine, but the caller doesn't know the specific symptoms. Confirmed reporter details and clarified the above information with the caller. Email: Declines, PCP: Caller states the PCP will refer the call to her. Caller clarifies it was not yesterday, the patient has had the vaccine for months now and hasn't been feeling right. Doesn't know when had it done. Clarifies she doesn't know what the patient's symptoms are.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST (INTRANASAL) started on an unknown date. It was reported that 4 doses of FLUMIST were given this morning. They had experienced a temperature excursion which started on 07-Oct-2016. The outcome of the event of 4 doses of FLUMIST were given this morning and medication given after having temperature excursion is unknown. The report was considered to be non-serious.
Given vax approx 1130AM, slept 230-5PM, got up & cried inconsolable x 1 1/2hrs, lethargic t99 (r), fussy all next day; Mom gave APAP;
Patient was in office today for MMR vx.  Vx was given with expiration date of 4/14/2022.  Patient family contacted to update of expiration date.  Vaccine field consultant called to notify of expiration and administration post expiration.  Recommend patient to be re-vaccinated a current schedule with no lapse in time required.
next morning: fever, severe chills, arm couldn?t lift, felt awful missed work (both jobs); 24 hours later: still sweating but cleared and was able to go to work, felt better, worked both jobs
Presented in cardiac arrest with an extensive down time. Labs consistenet with diabetic ketoacidosis. COVID +.Intubated and started on vasoactive medications. Remained hypotensive. DKA resolved within 24 hrs. CT head concerning for anoxic brain injury.  MRI brain/stem confirmed findings consistent with anoxic brain injury.  Physical examination never improved. Neuro evaluation was felt to have poor neurological prognosis. Family decided to extubate with comfort care.
Child received vaccines on Wed mar 23, 2016 in the afternoon. Developed a rash on his back around March 31, 2016. Rash (not blisters) salmon in color. Rash became darker on Saturday 4, 2016 and child developed a low grade fever. Mother tool child to the ER. All family members are current on immunizations. Patient is the youngest child. Mother staying with him for 12 days.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, lot #, dose and route unspecified influenza virus vaccine (manufacturer unknown and AFLURIA could not be ruled out), lot#, dose and route unspecified. The patient had no concomitant medication. On an unknown date, the patient experienced a rash and redness at the injection site "and beyond". The patient sought medical attention via phone call to unspecified physician. The outcome of the patient was reported as recovered/resolved. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 03Sep2021 13:00 (at the age of 50-years-old) at dose 3, booster 0.3ml single for covid-19 immunization. Medical history included High Cholesterol, Over weight, High Heart rate since Covid. Patient had no known allergies. Concomitant medications included aspirin [acetylsalicylic acid], Cholesterol meds, heart meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. Patient was a Covid vent survivor, for first two doses he was already on oxygen support so the dip was not noticed, also he had fever and cold sweats and slept for two days after each dose. As his wife was well versed at this point with his care of just implemented care as needed. After third dose, patient o2 (oxygen saturation) dropped to 85% and required oxygen supplements, had cold sweats, fever of 101.9 on 04Sep2021 04:00. The most recent COVID-19 vaccine was administered at pharmacy or Drug Store. Treatment was given for the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101219421 same patient, different dose and similar event
Pt recvd vax & 5 days later pt devel severe h/a, nausea, vomiting, malaise & blurred vision;
Patient and mom both had the flu shot on 1/17. Mom started with symptoms the night of 1/17 and patient the AM or 1/18. Patient has missed a lot of school. Mom said he was expected to be good enough to attend school yesterday. He didn't feel too good in the morning, but went to school. As the day went on he got worse and worse. Came home and was like a "lump." Has been needing multiple corrections in insulin while ill. Ketones always in range. Multiple kids and his teacher were sick when he was there yesterday.  Mom was diagnosed with shingles in her sinuses, ear and nose. This week she was told by her provider in internal med they believe her and patient had a reaction to the shot since their symptoms began the same time.
Tingling down arm to fingertips, sore arm, very painful. Shot given too high. ASIpuropen is helping.