chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED AN HPV AND MENINGOCOCCUS AS FIRST TIME DOSES TO 21 YEAR OLD FEMALE. ADVISED CLIENT THAT IF SHE DID NOT EAT LUNCH SHE MAY FAINT AS IT IS A SIDE EFFECT OF BOTH VACCINES. SHE STATED SHE DID NOT EAT LUNCH. ADVISED CLIENT TO WAIT 15 MINUTES IN CASE SHE DID FEEL FAINT. AFTER RECEIVING THE IMMUNIZATIONS THE CLIENT STAYED IN THE CHAIR AND DID NOT GET UP. AFTER 5 MINUTES TELLS NURSE SHE IS FEELING BAD. I TELL HER IF SHE IS FEELING BAD TO STAY IN THE CHAIR. A FEW SECONDS AFTER STATING THIS SHE STARTS TO MOVE AND BECAME STRAIGHT AS A BOARD AND STARTED TO TURN FACE DOWN TOWARD THE CHAIR THEN FELL OFF THE CHAIR TO THE FLOOR LANDING ON HER LEFT SIDE OF HER BODY. SHE MADE A GROWLING SOUND AS SHE WAS MOVING. ON THE FLOOR SHE DID NOT MOVE AND I WENT TO SHAKE HER TO SEE IF SHE WAS BREATHING. I TOLD THE CLERK TO CALL 911 AND WAS CALLING HER NAME AND SHE STARTED TO MOVE AND TOLD ME "I AM ALL RIGHT". I ASKED HER AGAIN TO BE SURE AND SHE STARTED TO SIT UP AND SAID AGAIN "I AM ALL RIGHT". I TOOK HER PULSE AND IT WAS SLOW AND SLIGHTLY IRREGULAR. I ASKED HER IF SHE EVER HAD HER HEART CHECKED AND SHE SAID SHE DID WHEN SHE WAS YOUNGER BUT THEY DID NOT FIND ANYTHING. I ASKED HER IF SHE EVER HAD THIS HAPPEN BEFORE AND SHE TOLD ME WHEN SHE WAS LITTLE IT HAPPENED BUT THE LAST TWO TIMES SHE WAS IMMUNIZED NOTHING HAPPENED. SHE TOLD ME THEY USUALLY GAVE HER IMMUNIZATIONS WHEN SHE WAS LYING DOWN. SHE TOLD ME RECENTLY SHE WAS HAVING BLOOD DRAWN AND SHE PASSED OUT. I ASKED HER IF SHE SAW LIGHTS OR ANYTHING AND SHE TOLD ME SHE SAW A CARTOON LIKE THE ONE SHE WAS WATCHING IN THE WAITING ROOM BEFORE SHE WAS IMMUNIZED THEN EVERYTHING WENT BLACK THEN SHE SAW MY FACE. SHE SAID SHE DID NOT REMEMBER WHAT HAD HAPPENED. SHE SAID THAT HER LEFT UPPER FOREHEAD HURT BUT THAT WAS ALL. NOTHING ELSE HURT. SHE WAS ABLE TO SIT UP ON HER OWN AND FINALLY WAS ABLE TO STAND AND GET INTO THE CHAIR. THE CLIENT WAS VERY LARGE AND IT WAS NOT POSSIBLE TO KEEP HER FROM FALLING OUT OF THE CHAIR TO THE FLOOR BECAUSE OF HER SIZE. I GAVE HER A WET TOWEL AND SHE RUBBED IT ON HER FACE AND NECK AND STARTED SHE FELT BETTER. I TOLD HER WE CAN CALL THE AMBULANCE BUT SHE REFUSED ANY MEDICAL CARE. I ADVISED HER IF SHE FELT WORSE TO SEE HER DOCTOR. SHE GOT UP AND WALKED INTO THE WAITING ROOM WITHOUT PROBLEMS. SHE SAT IN THE WAITING ROOM FOR 15 MORE MINUTES AND I CHECKED ON HER PERIODICALLY AND SHE WAS TALKING ON HER CELL PHONE THE WHOLE TIME. I CHECKED ON HER THE 4TH TIME AND SHE WAS NOT THERE. SHE LEFT WITHOUT PROBLEMS.
Right thigh w/10x12cm area if erythema/edema, 2x3cm area of deeper erythema no fluctuance.
mild Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (mild Cold symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication and COVID-19 VACCINE for an unknown indication.    No Medical History information was reported.   In 2020, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form. In 2020, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient received fifth dose of COVID-19 VACCINE (unknown route) 1 dosage form. In June 2022, received sixth dose of COVID-19 VACCINE (unknown route) dosage was changed to 1 dosage form. In October 2022, received seventh dose of COVID-19 VACCINE (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (mild Cold symptoms). At the time of the report, NASOPHARYNGITIS (mild Cold symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.         Concomitant medication not reported. Treatment medication not reported.  The patient got quick 24-hour turnaround PCR testing plus two types of rapid testing when he got mild cold symptoms (covid-19 negative).
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of RECOMBIVAX HB (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
swelling, itching and redness of left arm 24 hrs after injection. treated with ice pack and Doxycycline 100 mg bid for 7 days
Patient received expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Soreness in armpit (lymph nodes); This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced soreness in armpit (lymph nodes). 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. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the event soreness in armpit (lymph nodes) was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
It was reported through a clinical trial in the USA that a 15 year old female subject was pregnant. Last menstrual period: 4/25/05, expected delivery date not provided. She has no previous obstetric history. Maternal drug exposure includes OrthoEvra Patch (5/8/05 - 5/30/05), Tylenol (5/6/05), Flonase (Mid March 2005 - present), Diazepam (6/1/05), Tylenol Arthritis(date not provided, Cyclobenzaprine HCl (6/1/05) and Flurbiprofen (5/31/05). The subject received her first dose of the study vaccine on 5/4/05, she did not experience any adverse event. The Adacel IND number 9266, has been added to this case. From additional information received on 7/8/05, it was reported that the subject had an elective abortion performed on 6/12/05. A home urine pregnancy test on 7/2/05 was reported as negative.
About 6 pm on 4/15, chills began. By 9 pm, teeth chattering and shaking with chills. At 5 am, got up with dog and feinted. Lay in floor, then got up, and feinted again, injuring my back. Too weak to get up. Had to lay in floor resting. Slowly scooted down the hall on my backside. Husband came on his walker and helped me up and back to bed. Tried to get up about 8:30 and fell into wall, so back to bed. Became steady in the afternoon. Spent all day in bed on 4/16 through 4/18, having chills, alternating with drenching sweats, and stomach upset. Could not eat on 4/16 and 4/17. Had headache on 4/16. Arm hurt for 3 days. Had terrible fatigue for several days. Vaccine side effects began to clear 4/19. Still pain in back.
Received 2nd dose of the vaccine around 9:15AM and started to notice headaches and malaise in late afternoon/early evening. The symptoms continued overnight and started to improve the next morning.
SkinRash, UrticariaPruritus, Itchiness Narrative: Patient has h/o of allergic reaction to Cipro and therefore was kept for a 30 minute observation period. Twenty minutes following vaccination with her first booster (she received a 3 dose primary series d/t immunocompromise), nurse who administered the vaccine noticed that the employee was scratching her skin around her watch. She asked the employee to remove her sweater. Her arms were red. The redness progressed to her back. She developed hives on her back only. She was given 25 mg of Benadryl. The rash spread to abdomen before starting to respond to the Benadryl. Employee denied difficulty breathing, SOB or swelling of her airway.
Patient reports onset of diffuse rash one week after the first dose that lasted about one week and progressed to hives after prolonged itching. After the second dose, he also developed a diffuse rash 1-2 days after receiving the vaccine which has lasted for 3 weeks.
In mid October I had a 1-2 days with urticaria The first week of December I started to have daily urticaria that lasted until late January when I increased my antihistamine dosage to 40 mg cetirizine daily (had been on 20 mg daily for most of December/January with as needed benadryl/hydroxyzine). I saw allergist late January who diagnosed chronic urticaria and recommended the dose increase.  I took 40 mg cetirizine daily for about 2 months and have since decreased to 20 mg daily without recurrence of urticaria.
Anaphylactic rxn, vomiting, wheezing, IM Epinephrine, IM Benadryl. Discharge summary states edema arround eyes, edema of lips, difficulty breathing, vomit. msv
Headache, Myalgia, Arthralgia, chills, fatigue Narrative:  missed one day of work due to flu like symptoms  Other Relevant History:
This spontaneous report was received from a registered nurse regarding to multiple unspecified patients of unknown age and gender. No concurrent conditions or pertinent medical history were reported. The registered nurse reported that on unspecified dates between 01-AUG-2016 and 23-AUG-2016, multiple unspecified patients received improperly stored doses of PROQUAD lot number M007961, expiration date 15-AUG-2017, lot number M002056, expiration date 11-JUL-2017, lot number M014304, expiration date 22-SEP-2017, lot number L051100, expiration date 17-AUG-2017 and lot number M007965, expiration date 15-AUG-2017, (dose, frequency and route not reported). No adverse effects were reported. The registered nurse confirmed that the excursion temperature was 8F for a time frame of 552 hours. The temperature went back in range and there were no previous excursions. It was unknown if the report was part a data logger, and no product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
trigeminal neuralgia; This is a spontaneous report from a non-contactable consumer (daughter). A 61-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (also reported as a couple months later), the patient got symptoms of the Pfizer COVID vaccine - severe pain, got really worse and the physician diagnosed her with trigeminal neuralgia. It was reported that the symptoms were severe. The events were reported as non-serious. The outcome of the event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
2 mins p/inject, p/walking into waiting room, MOC called "help" carrying pt to nurse pt laid on floor, pale in color, blue around mouth, pupils constricted arms rigid & turned inward, remained sl responsive; gagging;
6hrs after taking the 1st dose her mom experienced hard time in breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. Medical history included ongoing amyotrophic lateral sclerosis. The patient's concomitant medications was not reported. The patient stated 6hrs after taking the 1st dose her mom experienced hard time in breathing on 14Jan2021. Outcome of the event was unknown.   Information of lot/batch number has been requested.
Numbness, pain and tingling in radiating from the injection site to the tips of my fingers (left arm & hand). The pain, numbness & tingling have become unbearable & I will have to seek medical treatment.
Left arm - Pain at the radial notch of the ulna, numbness in fingers 2-4 for approximately a week.  Approximately one week after vaccine, numbness shifted to fingers 1-3.  3rd finger has always been the most affected.  Pain persists at the radial notch.
PATIENT DIED FROM BLOOD CLOT 3/29/2021 - AUTOPSY PERFORMED AND CONFIRMED
received her second  dose of Shingrix 1 month after 1st dose instead of 2 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included the patient was immunocompetent. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: received her second  dose of Shingrix 1 month after 1st dose instead of 2 months).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The patient received her second dose of Shingrix 1 month after 1st dose instead of 2 months, which led to shortening of vaccination schedule. The reporter thought the patient received her doses in February and March of 2023 but not sure since they were not administered at her pharmacy. The reporter did not consent to follow up since she did not have additional details to share given the vaccines were administered at another pharmacy.
Patient received DTaP in right arm as well as varicella. Patient experienced slight swelling around injection area.
After 10 minutes after I received the vaccine a sharp pain shot up the left side of my neck.  Then it felt like bees stinging my left shoulder, upper arm and upper back and a rash developed.  Then I experienced my tongue and throat get very dry with a metallic taste in my mouth.  They brought me to urgent care and gave me a couple of Benadryl and watched me for any other reactions
High temp of 105.1 rectal temp after vaccine was given. Tylenol and Motrin were given to Pt by mom.
pt suffered from fever 101, erythema multiforme, swollen tender palms & soles of feet;resolved w/o tx p/4 days;this occurred 1wk post vax
11hours 30min after vaccine administration, Pt. starts to experience fever 103.1, Chills, body aches, fatigue.  28 hrs. from vaccination Pt still experiencing fever 102.3 with the use of  fever reducing medications. body aches, fatigue
shortly after receiving vaccine patient began to feel itchy.  patient had urticaria to neck and shoulders as well as the injection site.  patient also states she felt like she had a really dry throat.  patient taken to ED for further evaluation and treatment
This case was reported by a other health professional and described the occurrence of expired vaccine used in a patient who received ENGERIX B (batch number AHBVC148AB, expiry date 6th September 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Received flu shot left deltoid on 11/3/08.  No significant increased pain when administered flu shot as compared with other years when got flu shot.  Continues with pain at injection site # 6 at activity; # 0 at rest.  Denies cons dehersitious (L)UE.  Pain does not radiate past injection site.
Pt experienced scattered red and itchy blotches on face, arm and abdomen X 5 during the past 4 days that lasted for a few hours, the resolved. Benadryl taken for relief.
No additional AE; an adult patient was administered PROQUAD; This spontaneous report was received from licensed practical nurse (LPN) and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 mls/once, lot #X004372 (lot # X004372 has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date: 07-AUG-2024 (anatomical location, route of administration, and indication were not provided). It was reported that an adult patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Product administered to patient of inappropriate age). There were no adverse events reported (no adverse event).
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Patient received additional booster dose.  Concomitant medication list was not provided.  It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains significant information: Updated patient demographics and case narrative.
Breakthrough COVID infection in fully vaccinated patient. Positive date 11/04/2021.
Pt. received BEXSERO in error. Gma reported no adverse events as a result,
Approximately 10 min into the post-vaccination waiting period, patient collapsed out of his chair.  Patient stated that he started feeling hot and dizzy and that's all he remembers/
A report was received from a healthcare professional on 12/Oct/2006 concerning a 44 year old female vaccinee. The vaccinee has a history of "allergies" and sees and allergist. Allergy testing was negative for egg allergy. No details of concomitant medication were provided. On 10/Oct/2006 the vaccinee received Fluvirin by intramuscular injection. By the evening she had developed facial swelling and her eyes were swollen shut. She was treated the next day with a steroid injection and antihistamines, and the facial swelling resolved overnight. On 12/Oct/2006 the vaccinee reported bilateral low back pain radiating to her thighs, pain upon rising from a seated position and severe pain in the left wrist. The vaccinee is being treated with oral prednisone. Further information has been requested. Follow-up report was received on 22/May/2007 regarding this 44-year-old female vaccinee. The vaccinee has a history of anxiety for years for which she has been treated intermittently and which was discontinued on 04/Oct/2006 (concomitant drug unknown, illegible). The vaccinee received Fluvirin 0.5mls intramuscularly on 10/Oct/2006. The same day she developed facial and periorbital oedema, and a generalised pruritic rash which was consistent with urticaria, which resolved on 20/Oct/2006. On 12/Oct/2006 the vaccine awoke and was unable to walk. This had resolved on 18/Oct/2006 after treatment with prednisone. The reporter considered the events to be serious and medically significant (possible angioedema/anaphylaxis).  The events periorbital oedema and generalised pruritus were considered to be possibly related to Fluvirin. The causality of the inability to walk was provided as unknown. No further information is expected.
UTI; This is a spontaneous report from a Pfizer sponsored program  support. A contactable consumer (patient) reported that a 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a UTI and was taking antibiotics on an unspecified date. The patient wanted to know if he needs to postpone his second dose because of his antibiotic prescription. The outcome of the event was unknown.No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Additional information 13Nov2012: MMR vaccine Date given 11/01/2012. Lot # 1571AA. Additional information has been requested.
Soreness of left arm/neck for 4 days. Then had a seizure 1 week after vaccination. No prior history of seizures.
After receiving the vaccine in my left arm I had pins and needles in the left side of my face for about 1.5 hours. I was able to move my face and it was symmetrical, but I could feel the pins and needles like the left side of my face was asleep.