chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 17 year old daughter with no medical history or drugs allergies, who in May 2009, was vaccinated with her first dose of GARDASIL. The patient received her third dose of GARDASIL on 27-OCT-2009. There was no concomitant medication. On 28-OCT-2009 the patient had a seizure and was hospitalized; the physician at the hospital stated that GARDASIL caused the seizure. No laboratories studies were performed to the patient. At the time of this report the patient was recovering. Additional information has been requested. 11/20/09 Hosp. records received for dates 10/28/09. DX: syncope. Presenting sx: pt. states passed out and hit head at school. Pt received immunizations 1 day ago. Pt. had a seizure that lasted approx. 10 mins. Was taken to hospital by ambulance. Was given "2 shots" per mth. and being referred to a neurologist. Reported by mth. today (11/9/09).
Swelling, tenderness, redness to injection site. Area felt warm to touch for several days with these symptoms.
Lost sense of smell; Lost sense of taste; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sense of smell/anosmia and taste/ ageusia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 025I20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient lost sense of smell and taste. The patient did not receive any treatment to alleviate the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events lost sense of smell and taste was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
No adverse Event; patients information that got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients information that got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients information that got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients information that got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients information that got vaccinated after BUD).    No concomitant medications were reported.  No treatment medications were reported.
I came into work on 11/30/2020 and had a message to call patient. I called her when time permitted about 4pm. She reported to me that she started having a great deal of pain in her arm and shoulder within a few days of getting her flu shot. Now after 6 weeks it is getting worse instead of better. She explained that she had looked on-line and a flu shot given in the wrong way can cause this problem. she also told me she remembered me standing to giver her shot. I told her that i have been in the habit of kneeling to give vaccines in order to be careful not to give it in the wrong place. then she said oh maybe you were kneeling. I explained while that is true that a flu shout could result in
fever; shivers - hot and cold and has thrown-up; thrown up last night and this morning; This is a spontaneous report received from a contactable consumer (patient, self reported). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 05May2021, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date in May2021, the patient had high fever, shivering hot and cold, thrown up last night and this morning and mentioned she is in the military and was told by her instructor to call Pfizer. The patient wanted to know on what she should do about the side effects if she would be good to carry on and response included. Response: Spoke from attached documents and as per the Pfizer-BioNTech COVID-19 EUA PI (6 Overall Safety Summary and 6.1 Clinical Trials Experience) LAB-1457-7.0, Revised: 06 April 2021. Gave disclaimer that Pfizer was unable to make any treatment recommendations for individual patients and referred to HCP for further guidance. There were medical questions addressed by this program forwarded/referred to medical information. Outcome of the events were unknown.  No follow up attempts are needed. Information on lot/batch number cannot be obtained.
Pt received Prevnar on 9/4/01 (2nd dose). As per mom, the pt woke up on 9/5/01 with erythematous rash around right eye, neck and arm and also had pruritus.
feels awful; chills; flu-like symptoms; skin hurts; This case was reported by a consumer via sales rep and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 2nd December 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 3rd December 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced feels awful, chills, influenza-like symptoms and skin pain. On an unknown date, the outcome of the feels awful, chills, influenza-like symptoms and skin pain were unknown.   It was unknown if the reporter considered the feels awful, chills, influenza-like symptoms and skin pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the GlaxoSmithKline employee. The patient received a dose Shingrix shot along with the flu shot, the day before reporting at her primary care physician's office and at the time of reporting, she feels awful, has chills, flu-like symptoms, (no fever) and her skin hurts.
PATIENT WAS GIVEN PFIZER FOR 5-11 YEARS OLD,   INSTEAD OF   PFIZER 12 AND OLDER , PATIENT ARE 15 YEARS OLD, PATIENT DECLINE ANY SYMPTOMS OR ANY ALLERGIC REACTION .
Chest tightness; small difficulty breathing; Nausea; Muscle aches; Brain fog; Tingling in lips, mouth, tongue; Mouth felt like numb; all her arm felt cold, like a funny sensation.; tingling's in mouth and tongue which also appeared and reappeared; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Brain fog), PARAESTHESIA (Tingling in lips, mouth, tongue), HYPOAESTHESIA ORAL (Mouth felt like numb), PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced NAUSEA (Nausea). On 24-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (small difficulty breathing). On 22-Jan-2021, FEELING ABNORMAL (Brain fog) and PERIPHERAL COLDNESS (all her arm felt cold, like a funny sensation.) had resolved. On 23-Jan-2021, NAUSEA (Nausea) had resolved. On 24-Jan-2021, CHEST DISCOMFORT (Chest tightness), SYMPTOM RECURRENCE (tingling's in mouth and tongue which also appeared and reappeared), DYSPNOEA (small difficulty breathing) and MYALGIA (Muscle aches) had resolved. At the time of the report, PARAESTHESIA (Tingling in lips, mouth, tongue) and HYPOAESTHESIA ORAL (Mouth felt like numb) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medication includes inhaler for shortness of breath
This spontaneous report as received from a licensed practical nurse refers to an unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date, the patients were vaccinated with a doses of an improperly stored LIQUID PEDVAXHIB lot # K019701, expiration date 17-JUL-2017 (doses and routes were not provided). Secondary suspects and concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
stiff neck, headache, shortness of breath, runny nose, weak, no appetite, weakness, trouble wallking
Vaccine #1  on Augusta 26, 2020-Extreme headache,  severe vomiting, severe  pain x 24 hours, right arm site redness and swelling to size of baseball  Vaccine #2 on  February 24, 2021- left arm swelling to size of baseball, dizziness x 2 weeks with onset 4 hours after the vaccine
Began noticing rash/red bumps, hands and bottoms of the feet began to swell. Hives and swelling still apparent.
This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th May 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm and fever. On 6th May 2018, the patient experienced rash and shingles. In May 2018, the patient experienced shoulder pain. On 6th May 2018, the outcome of the pain in arm and fever were recovered/resolved. On an unknown date, the outcome of the rash and shingles were recovering/resolving and the outcome of the shoulder pain was unknown. The reporter considered the pain in arm, fever and rash to be related to SHINGRIX. It was unknown if the reporter considered the shoulder pain and shingles to be related to SHINGRIX. Additional information was received as follows: At 9:00, the patient received SHINGRIX, in the right deltoid. The patient experienced normal side effects such as sore arm and low grade fever which lasted 24 hours. Less than week after receiving SHINGRIX, the patient's soreness in arm went into the shoulder. Three days after receiving SHINGRIX, the patient experienced the rash that was widespread on his face and resembled shingles. The patient did not experience any of the other symptoms which go with shingles. The reporter confirmed proper preparation of the vaccine which appeared to have no abnormalities when reconstituted. The vaccine was placed in the refrigerator for 30 minutes prior to administration. The physician had pictures available. The physician was transferred to Medical Information (MI) for additional assistance. The physician did not have the lot number and expiry date available at the time of the call.
Temp, weakness, nausea, fluid filled rash to neckline around ears, body aches rash systemic.
Information has been received from a registered nurse concerning a 30 year old female who on 12/22/2003 and 1/26/2004 was vaccinated with a 0.5ml first dose of varicella virus vaccine live. On 5/17/2005, and ELISA titer was low at 0.2. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
pt recvd vax & w/in 24 hrs of vax pt devel inject site react of swelling, erythema & warmth @ inject site; approx 10cm in diameter; also exp low grade fever x 24 hrs; seen by MD treated w/cool compresses & APAP; pt recovered;
diffuse rigidity in her stomach area; This spontaneous report was received from a nurse practitioner, via a company representative, concerning an elderly female patient (age reported as at least 65 year old). Information on concomitant medications, pertinent medical history and drug reactions/allergies was not reported.   On approximately November 2019 (reported as between November and December 2019), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.   On an unspecified day in November 2019 (also reported as the next day), the patient was seen by a physician in the practice the next day for diffuse rigidity in her stomach area and was referred to an unspecified emergency room, but she did not receive treatment for the adverse event. The outcome of the event was unknown.  The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Patient reported having night sweats since having the vaccinations.  This prompted him to visit the ER. He also reported having light flu and body aches the next day after the vaccines.  He also experienced mild headaches and queasy.
Redness and discomfort on arm where shot was given, c/o nausea for about 24 hours. Symptoms had subsided wihtin 48 hrs.  At one week, only slight soreness at site, no redness.
Undiluted, a whole vial of Covid vaccine (Pfizer) was given to a patient.  No adverse drug reaction. Absence of death or significant disability.
Came to ER on 5.4.21 w/ abdominal pain. -- > L-sided abdominal pain, dull aching up to 4/10 pain scale non-radiating not associated with nausea, vomiting, diarrhea, constipation  or fever.  WBC was 1.6 with ANC 1.1, low and absolute lymphocyte count of 0.4, low Hb was 9.9 g/dl Plt count was 85 5.4.21 CT abd/pelvis w/IV and po contrast revealed splenomegaly 12.8 x 29.8 x 25.1 cm with retroperitoneal lymphadenopathy.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored adult dose of VAQTA (lot # reported as L027735, expiration date: 12-JAN-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
While during morning school classes began to feel tired, sleepy, weak. Headache, nausea, muscle/body aches soreness, fever, chills persisted through out school day and at home.
She is sweating; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included gastro problems, heart attack, stomach issues.     The patient's concomitant medications were not reported.  The patient is sweating on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 days after vaccination, 4cmx7cm red macular area at vaccination site. Tylenol, cool compresses.
pt exp seizure for 1 min. duration 5/1by time got to er fine. sent home brother devel gastroenteritis, & pt, on 5/3 back to er workup showed poss 2nd seizure.
Baby was given 0.5ml IM Left thigh proQuad #0303A (MMR varicella). Immediately baby had transient red rash (blotches) on trunk 3x2 on beyond arms. Baby was taken to exam room a approx 15 feet away-laid on table and the blotches were gone. Mom seen by our PAC and given Benadryl 12.5mg/cc. 1.5cc every 4 -6 hours for 12 doses. Still stable.
FEELING SICK; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch number. No concomitant medications were reported.  On 10-APR-2021, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sick. This report was non-serious.
Information has been received from a LPN concerning a 79 year old white female with a medical history of an allergy to PCN, benign thyroid neoplasm, atrial fibrillation, hypertension NOS and chronic obstructive airway disease (also reported as illnesses at the time of vaccination) who on 10/01/03 in the PM was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot # 643784/0676M).  Concomitant therapy included Procardia, Lanoxin, Coumadin, Advair and albuterol (therapy unspecified). The pt was seen in the office on 10/03/03 in the AM with left arm red at injection site, swollen at injection, and painful. She was treated with Xenalog ointment and Zyrtec. It was unknown if the condition had resolved. Medical attention was sought. There was no product quality complaint involved.  Follow up information indicated that the pt recovered from the redness and swelling at the injection site on 10/07/03.  The reporter also mentioned other pt's who received pneumococcal 23v polysaccharide vaccine every 5 years for 3 to 4 doses (WAES # 0310USA01515).  No further information is expected.
t102.8 noc following vax; cont to have fever 25AUG92 seen by MD dx immunization reaction; pt cont to have fever 8SEP92; t012; c/o head & neck pain; dx strep 8SEP92;
severe headache, fever up to 102, joint stiffness and pain, aches all over, confusion, disorientation, fatigue, nausea most severe lasted up to 2-3 weeks, still having joint pain, fatigue
Pt developed red circular rash at ZOSTAVAX injection site. Pt stated rash onset day after vaccine. Rash small on that date. Dime sized. Rash evolved to silver dollar sized. 2 days after vaccine. Rash appeared red, circular and not raised. No complaints apart from red rash, minor itching.
Stated had temp of 100 F Fri nite, Sat. 6/7 developed a migraine and (L) upper arm warm, 1/2" blotch. Fever continued thru Sun. Sunday arm "slightly worse". Monday "low grade" fever and upper arm increased redness and swelling. Instructed to notify MD.
SWOLLEN LYMPH NODES AT BASE OF NECK IN THE BACK AND AT THE BACK OF THE NECK AT BASE OF HEAD.
Day one and two had fatigue and dull headache...nothing severe Day three felt significantly better  Day four started a running more and irritated throat Day five very irritated throat, running nose, headache, cough
Pruritic, maculopapular rash, covering torso, arms, extremities and face. Rx with Benadryl if needed
pt devel aseptic meningitis 1 wk p/MMR vax; this was felt to be viral meningitis unrelated to vax;
Fever, weakness/exhaustion, hallucinations (playing game that didn't exist), chills, feeling unwell, decreased appetite, loose bm,
Client c/o flush feeling 3 minutes after receiving vaccine.  Client is seen and assessed by EMS and VS are B/P 128/86, HR-90, O2 98.  Client denies any other symptoms and verbalizes that she no longer was having symptoms and velar by EMS.
Patient recieved the first dose of the Moderna COVID-19 mRNA vaccine on 3/25/2021 at another facility.  He was 17 years, 10 months old, according to the EUA of the Moderna vaccine, he was underage at the time.  After consultaiton with our Medical Director Dr., the second dose of Moderna was administered without incident at the facility (5/3/2021).  Parental consent was obtained from his mother prior to his second dose.
Patient presented to pharmacy 12/6/2016 1 PM to pick up rx.  She ask me to look at the injection site of PREVNAR 13 given on 11/2//2016. Area appeared to be red and slightly swollen, bit painful.  Instructed patient to use ice or  Tylenol if needed.  I sxplained to patient redness was expected with this type of vaccine.
Information has been received regarding a case in litigation from a lawyer, spouse and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around October 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered a subacute infarct along the right occipital lobe. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be  not recovered. Upon internal review, subacute infarct along the right occipital lobe was determined to be medically significant. Subacute infarct along the right occipital lobe was considered to be disabling. Additional information has been requested.