chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After administering HPV vaccine patient fainted while sitting in chair. No harm was caused to the patient. Two other nurses came and assisted. Patient was carried to the exam table and legs were lifted up. Patient was given water and orange juice. Patient stated was feeling better and was dismissed after 30 minutes.
12/24/2021 Diagnosed with kidney stones. Passed one on my left and had to have lithotripsy to pass the one on the other side.
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored  M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
PATIENT WAS ADMINISTERED PEDIATRIC DOSE INSTEAD OF DOSE FOR 12 AND OLDER. NO ADVERSE EFFECTS OCCURRED. CDC WAS CONTACTED FOR ADVISEMENT. ADVICE GIVEN WAS NOT TO GIVE AN ADDITIONAL DOSE. INFORMATION IS TO BE PASSED TO THE MINOR'S GUARDIAN
experiencing numbness in her hands; tingling; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "experiencing numbness in her hands"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe headache, fever 101.4, shakes, nausea, body aches, diarrhea
Inconsolable crying x 6 hours after shots on day immunization, afebrile, finally fell asleep - slept 11 hrs.
Persistent inconsolable shrill crying for more than 4 hours, starting 54 hours, post vax. Treated with Benadryl in ER. Improved over the next hour and discharged home in 2 hours, after feeding. No focal neuro. deficit. AF was level, afebrile.
Pt received 12+ Bivalent instead of 5-11 Bivalent. No adverse reactions
orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 65 years old female patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown) dose 1, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient was to receive second dose on 19Mar2021. Patient had orthostatic hypotension, on an unspecified date. She had been prescribed Fludrocortisone for orthostatic hypotension. Outcome of the event was unknown. Therapeutic measures were taken Fludrocortisone as a result of orthostatic hypotension (orthostatic hypotension).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & 5x4 cm erythema-warm to touch;
raw throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program from a Pfizer Corporate (Pfizer) Media Platforms. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "tiredness" felt was a little tiredness an hour after the first shot took a nap everything was good.  The following information was reported: THROAT IRRITATION (non-serious), outcome "recovered", described as "raw throat". Additional information: after the second shot had a little bit of a raw throat but nothing too bad everything is good now.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling around mouth with swelling spreading over both cheeks over period of several days. Applied steroid cream which helped -> course last 5 days until gone. Negative -> SOB. Negative wheezing. Positive vague HA x 24 hr.
two children less than 18 years old received the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two children less than 18 years old received the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two children less than 18 years old received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two children less than 18 years old received the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided. Clinical Pharmacist (caller) states he is not sure howold the children are, but they are just under the age of 18, he thinks they are 16 and 17 years of age were administered the moderna covid-19 vaccine instead of the Pfizer vaccine.
Redness, swelling and itchiness at and surrounding the injection site. Warm to touch.
In post-vaccine observation, patient was noted to be looking uncomfortable and was clutching at his chest. This RN approached and inquired about how he was feeling. He stated, "Not good." I feel like I'm going to throw up." Patient was noted to be pale and diaphoretic. Denies chest pain or pressure. Pulse check was 54 BPM on initial assessment, BP 110/70, RR 18, oxygen saturation 97% on room air. No respiratory distress or tachypnea noted. Driver seat of patient's seat reclined. Ice packs applied to patient's forehead and neck. Pt. encouraged to breathe slow and deep, in through his nose and out through his mouth. Pt's wife stated he did not want the vaccine, but it was required for work, and that he was extremely anxious about getting the shot, and the ingredients contained in the shot. Patient agreed with this statement. Patient provided with water, protein-containing snack, 1:1 monitoring, rest in shade.  Pt without emesis. Patient's diaphoresis subsided, vitals after rest as follows: 117/64, HR 84 BPM, O2 saturation 97% on RA, RR 14. Patient declined EMS call at this time; rested for a few more minutes and stated, "I feel better now." Patient was driven home by his wife and both were instructed to call EMS if symptoms worsened or recurred.
On 7/22 pt reported pain, itching, swelling, and slight redness and heat at injection site. 7/23, pt had extreme swelling and red from shoulder to elbow, pain.
hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 75 years, on 21Jan2021 10:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient said he had red hives develop on Saturday, 23Jan2021. He went to an Urgent Care for treatment. He said the doctor at the Urgent Care looked at his hives, and told him the hives were likely related to the COVID-19 Vaccine, but the doctor was not positive of that. The patient said he hadn't had any recent changes in his health, or issues before he received the COVID-19 Vaccine, so that was why the doctor thought the hives were from the COVID-19 Vaccine. He clarified he has hives from his knee to his chest, and from his chest to his arm and to his neck area. He clarified the hives have been moving around his body. He said the hives had little red bumps, saying the hives were itchy. Therapeutic measures (Zyrtec and Hydrocortisone Cream) were taken as a result of hives from his knee to his chest, and from his chest to his arm and to his neck area, hives had little red bumps and were itchy (urticaria). The outcome of the event was recovering.
This spontaneous report as received from a physician (also reported as consumer) refers to a 57 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX for prophylaxis subsequent to his mother having shingles. On an unknown date in 2012, 12 hours after vaccination the patient developed T4-T6 dermatomal pain and the duration of pain was unknown, but it was being described as Sine Herpete. The outcome and causality of the event was not reported. Additional information is not expected as the contact details were not reported.
8/23/02 3.8 x 3cm redness at injection site (applied 8/22/02. No warmth or tenderness.
severe pain in legs, feet, hands, arms;swelling-ankles, hands;redness-hands, feet, ankles;h/a, extremely tired, diff to walk;began subsiding last NOV & DEC;now free of sxs;
extended vaccination schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (extended vaccination schedule) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (extended vaccination schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (extended vaccination schedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
3NOV93 pt recvd vax & 6NOV93 started w/a rash rt arm 1st then lt; rash both arms & back only; itching, red;
This spontaneous report was received from a Registered Nurse and refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that doses of GARDASIL 9 (lot # M041990 , expiry date: 28-JUN-2019) were improperly stored at temperature 47 Fahrenheit degrees to 77 F degrees, for 46 hours. The digital data logger was involved. This improperly stored doses of GARDASIL 9 were administered to unspecified number of patients: one dose on 10-MAY-2017, and another dose on 12-MAY-2017 (dose, route of administration not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011163:
Painful abdominal cramping  and headaches starting on Saturday after vaccine. Left arm pain for whole arm and armpit tenderness on Tuesday following vaccine
19 yr female overweight, received SARS - Pfizer vaccine on 3/10 and 3/31. Presenting headaches and visual disturbace the first week of April. Seen by ophthalmology DX papilledema.  Referred to IFH on 4/16, DX pseudotumor cerebri and abnormal thyroid test.
Patient complaint of nausea/vomiting for 2 days since the vaccine was administered. Pt is not able to keep anything down including ice chips
About a week after receiving my second dose I started to experience intermittent heart palpitations. At week 4 I passed out for unknown reasons. Since passing out I have had sharp chest pains that came intermittently. They have increased in severity and duration. I went in to the emergency room since now the pain is radiating my left arm and neck. They weren?t able to see anything causing the pain. I went to the cardiologist and he said I am young and healthy and it shouldn?t be my heart, but I continue to get chest pains and have since receiving my second dose of moderna.
At approximately 2:43 pm, patient notified to pharmacy staff that he felt the room was spinning.  Patient was able to lay down and blood pressure, pulse, and oxygen levels were checked.  Patient spinning symptoms resolved at 3:08 pm and patient was able to leave home.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 Batch/Lot No: FL8095; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 24Mar2021 as dose 2, single (Lot number: FP6955), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145417), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: FL8095) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; CITRACAL + D3; BIOTIN; PROBIOTIC 10; LEVOTHYROXINE; VALACYCLOVIR HCL; TRAZODONE; ONE-A-DAY ACTIVE. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 21Apr2022, outcome "unknown", described as "Dose Number: 4 Batch/Lot No: FL8095"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Adverse event- After sixth dose of medication -Profuse sweating, nausea, vomiting, increased blood pressure, reduced heart rate - 60 BPM. Allergies with Codeine.Other medical history- Hyperthyroidism, depression, obesity, insomnia.
Patient did not have an adverse reaction, The vaccine dose was expired. It expired 01/17/2023 and was given 01/28/2023.
This spontaneous report as received from a nurse (patient's mother) refers to a patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in 2014 and 2015 the patient was vaccinated with first and second dose of GARDASIL 9 respectively, (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date in 2018 the patient finished the series with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
1 1/2- 2hr p/inj swelled up like a rock;24hr later 10cm circumferential erythematous indurated, edematous, tender area sub deltoid;dec ROM secondary to pain;better 24hr later;
Syncope while sitting in chair post vaccination.  HR 70.  Verbally responsive to questions.  Anxious.
Dyspnea, hypoxia tested positive for COVID 19 on 4/27.
after vaccination patient had classic anaphylactix reaction, fainting, dizziness, hypotention 90/60,sweating , feelinf hot, wide spread redness
Patient didn't feel the vaccine going in/wondered about the size of the needle and whether or not the vaccinated administered the vaccine correctly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient didn't feel the vaccine going in/wondered about the size of the needle and whether or not the vaccinated administered the vaccine correctly ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Hepatitis B (Last month she took a Hepatitis B shot.). Past adverse reactions to the above products included No adverse event with Hepatitis B. Concurrent medical conditions included Platelet disorder and Immunocompromised.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient didn't feel the vaccine going in/wondered about the size of the needle and whether or not the vaccinated administered the vaccine correctly ). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient didn't feel the vaccine going in/wondered about the size of the needle and whether or not the vaccinated administered the vaccine correctly ) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Acute pericarditis, left pleural effusion.severe  typical pericarditis and pleuritic Chest pain started 1/13 , got worse , went to Er on 1/15/2021 , was admitted to cardiology service and discharged 1/17/2021 and now on colchicine since admission.
A 32 years old was administered Typhim vaccine that was expired on 31-May-2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00650245) and transmitted to Sanofi on 21-Jun-2021.  This case involves a 32 years old male patient was administered 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot R2A301M, expiry date: 31-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 21-Jun-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications  It was a case of an actual medication error due to Expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  Medical Assistant stated that an expired Typhim was given to a patient and wanted to find out about the next steps.  At the time of report, the outcome of event was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Very painful rash believed to be herpes or shingles by various doctors. The bumpy painful rash appeared on my cheek in a perfect triangle that resembled a shingles rash. I also had very itchy painful bumps on my forehead, chin, ears, neck, in between fingers, and all over my privates. Was tested for both shingles and herpes and both came back negative. Was put on steroids by doctor and rash has gotten  better but has yet to disappear. I am still sick from when I got the shot and am dealing with a feeling that feels like my whole body is bruised and painful to the touch. Rash and bumps are unknown by doctors and the one on my fingers appears to be spreading on my fingers.
Patient experienced unusual skin reaction. Referred her to pcp. He diagnosed cellulitis. Prescribed antibiotic.
Patient developed rash 24-36 hours after vaccination received to L deltoid, started on arms and has spread over body. 48 hours after vaccination patient reported painful swallowing due to swollen lymph nodes. Patient has been monitored at home by daughter, given tylenol as needed for discomfort, denies worsening symptoms at time of reporting to this clinic 1/25/21 10:00 am. Daughter denies need for evaluation at ED or office visit at this time, continuing to monitor. Discussed reporting any new or worsening s/s and seeking emergency medical treatment.
Patient feels like passing out and not being able to hear out of right ear.  She was unresponsive at one point and she was given an epipen.  After a couple of minutes she was feeling better and talking again.  911 was called and assessment was done.  She sat for 30 more minutes and had water with skinny popcorn.  Her coworker drove her home.
pt recvd 3 doses of Engerix-B & 14JUL92 (1 mo p/3rd dose) pt was tested for Hep B antibody & tested neg;
patient who received the Shingrix first dose at 2019; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The medical assistant informed that, the patient received 1st dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter asked for information about how to proceed. The reporter consented to follow-up.
Started with body aches and mainly testicular pain at 10:00 pm on 10/30/2016.  Went to ER next day.  Was discharged same day with no clear results.  That night and next day, pain started spreading throughout muscles in body.
Left arm erythema and pain started approx 4-5 days following administration of TD booster. Follow-up: Sorry, we can't locate the name. Can you give us more information ep. DOB SS# (or sent a copy of the report).
Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL.  Subsequently, the patient developed headache and fever.  Her outcome was not reported.  Additional information has been requested.  Follow up information has been received concerning the patient with no medical history who on 27-SEP-2006 at 2:00 p.m. received her first dose of GARDASIL, lot #653735/0688F, in the right arm.  On 28-SEP-2006 at 8:00 a.m. the patient developed headache and fever (approximeately 100 oral temperature).  The patient complained of headache pain behind eyes that was relieved by ADVIL.  It was reported that on 29-SEP-2006 she recovered.  Additional information is not expected. This is a consolidation of two reports concerning the same patient. WAES # 0610USA01350 was previously submitted on 13-OCT-2006.