chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & approx 3 hrs later exp, itchy,watery eyes; a cough w/ chest congestion & wheezing, & difficulty breathing;felt chilled but did not take t; sxs lasted approx 4 hrs; pt did not seek medical tx; took DPH;
This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 06-OCT-2017, the patient was vaccinated with ZOSTAVAX (exact dose and route of administration were not reported; lot # N020939 with the expiration date of 26-OCT-2018) reconstituted with sterile diluent (lot # N020611 with the expiration date of 04-NOV-2019) for prophylaxis. During the administration, an unspecified part of the ZOSTAVAX dose was not administered due to leakage on the patient's arm. No adverse effects were reported.
Burning bi-laterally; Severe headache; This is a spontaneous report from a contactable pharmacist. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via intramuscular route of administration in the left arm on 05Aug2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MOTRIN) over the counter (OTC), taken for an unknown indication from an unknown date and unknown if ongoing. On 05Aug2021 at 12:00, the patient experienced burning bi-laterally and severe headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events burning bi-laterally and severe headache was not resolved at the time of this report.
This spontaneous report as received from a Healthcare worker refers to a 15 years old female patient. On 10-AUG-2012, the patient was vaccinated intramuscularly with lot # (0459AE) GARDASIL exp date: 13-DEC-2014. The primary reporter stated that on 10-AUG-2012, the patient received GARDASIL, then 1.5 minutes later, she became pale, clammy, and had ringing in the ears, she had to lay down also. The patient experienced after 10 minutes. Additional information has been requested.
Approx. 4 hours after receiving MMR and Chickenpox vaccine child developed a rash all over chest, back, arms, diaper area and face.  Was given Benadryl which didn't help.  Taken back to doctor the next day (rash had worsened) and was given an anti-allergy medication and steroids. Has had consistent diaper rash since receiving the shots as well as a welp at the injection site (chickenpox) that has turned into a reddish, bruised area.
symptoms; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (symptoms) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MORPHINE SULFATE and Oxycodone 60mg for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms). The patient was treated with LIDOCAINE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
urinary symptoms, needs to go regularly to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (urinary symptoms, needs to go regularly to the bathroom) 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 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 URINARY INCONTINENCE (urinary symptoms, needs to go regularly to the bathroom). At the time of the report, URINARY INCONTINENCE (urinary symptoms, needs to go regularly to the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-073419 (Patient Link).
Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HOT FLUSH (Hot flashes). At the time of the report, HOT FLUSH (Hot flashes) had not resolved. Not Provided      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 treatment information provided. No concomitant medications reported. Patient reported to get hot flushes about 15 min after vaccine and started to fade away and came back again.
little pain in the arm; very tired and falling in and out of sleep; very tired and falling in and out of sleep; lymph nodes near the tonsils on her left side were protruding out; she gets sore throats a lot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 10:40 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included heart attack, two blood clots and anxiety. Concomitant medication was not reported. Patient previously took first dose of BNT162B2 for covid-19 immunization. On an unspecified date in 2021, the patient experienced little pain in the arm, very tired, falling in and out of sleep and lymph nodes near the tonsils on her left side were protruding out. Patient got 2nd Pfizer covid vaccine 10Feb2021, yesterday, tired, falling in and out of sleep, she read paper and knows tiredness is a reaction, she put her hand on her left side of neck which is also the injection side, Patient was notorious for sore throats, but, she had no sore throat. her lymph node felt like it was protruding out on unspecified date in 2021. She had some hot soup and it went away. She woke up this morning and it was there again. She had a couple of cups of hot tea, it was gone down. No pain to touch, it was really protruding, a good size. When I have hot stuff, it kind of shrunk it. I saw my health care provider on 11Feb2021, the day after her shot, she did lab work, but she didn't this when she saw her. She got this on Valentines Day. She took Coumadin and there are vegetables she cannot have, she like to had vegetable soup for the warmth. Once she had that the lump goes away. If she tells me to go to the hospital, she was going to go over the bridge. Caller was asked what she meant by that statement, Caller states, That was a figure of speech. She was too afraid to do that. Her throat was not red, she had looked. she had read the documentation, front and back, she was a worrier, since 27 years old, she can turn something into nothing. That was how her anxiety gets. She had a heart attack at age 49, and two blood clots years after. She hasn't been anywhere in over two years. She has done everything. She hasn't seen her family and grandkids. She goes to the market gloved up and masked up. No one has been in her house. She has been tested for COVID because she gets sore throats a lot. The COVID test have been negative. Nothing has ever shown. Caller states she is not going to the hospital. She has a new doctor. She doesn't know what to do. She wants to know if that is a side effect. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. Outcome of the event lymph nodes near the tonsils on her left side were protruding out was recovered on unspecified date in 2021. Outcome of the other events was unknown.  Information about lot/batch number has been requested.
Left upper arm swollen, red and warm to touch. Mom rotated Motrin/Tylenol. Took child to ER for evaluation. No further recommendations from MD.
Upon second medical examination of the case during internal review on 01-Feb-2019, a significant correction was performed on 11-Feb-2019 to correct report type from unsolicited literature to unsolicited non literature. Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a patient (age and gender was not reported) who was administered the diluent for the PENTACEL vaccine which was not mixed with the ACTHIB diluent, lot number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient experienced any adverse events following the vaccination. 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 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. Documents held by sender: none. Addendum on 11 Feb 2019: a significant correction was performed on 11-Feb-2019 to correct report type from unsolicited literature to unsolicited non literature.
WAS SORE DAY OF VACCINE. NEXT DAY ERYTHEMA AND EDEMA DISTAL TO SITE. IMPROVE BUT STILL WITH MILD ERYTHEMA & EDEMA ON DAY 4. ADVISED CONTINUED ICE, ELEVATION AND PO BENADRYL.
I am off birth control now for 2 weeks and no period  Chonte to think of it I haven't had one since the vaccine
Difficulty breathing; tight chest; hives on face. Required epinephrine at ED. Vaccinated at 10:30 am reaction at 6 pm given BENADRYL; steroids-po for 1 week. 12/24/09 ED Medical records received for DOS  11/16/09.   Pt. presented with sudden onset dyspnea and sensation of throat closing off 6 hours post vaccination. Treated with benadryl and solumedrol. Discharged, improved. DX: allergic reaction 01/05/10 PCP records for DOS 11/18/09. Followup ED visit. Pt. reports symptoms improved.
PC fr pt's wife stating had devel a cellulitis of lt arm; also stated had a shunt in place & recv IV ATB;
vaccinated /with an expired Shingrix vaccine.; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number N72HC, expiry date 9th June 2021) for prophylaxis.   On 21st July 2021, the patient received Shingrix. On 21st July 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The physician reported that the patient was vaccinated with Shingrix which was already expired on 9th June 2021, which led to expired vaccine used. The reporter consent to follow up.
230PM 12JAN96 pt recvd vax 530-6PM diarrhea, nausea, t101.3, vomiting;cont 13JAN96 & seen 14JAN96;15JAN96 nausea & achy;16JAN96 feeling much better;
Pt was red and itchy on neck and forehead. Pt was also pale and complained of dizziness.
Case number PHEH2016US032437, is an initial spontaneous report received from a pharmacist on 08 Dec 2016. This report refers to a 30 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165801 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 08 Dec 2016 when she was 30 years old. It was reported that, vaccine was administered to patient under the age of 65 years old on 08 Dec 2016. No adverse event reported following this medication error (drug administered to patient of inappropriate age). The case was assessed as non serious by the pharmacist.
pt recvd vax & an unspecified time later exp severe arthralgias; was unable to open a door; sx were treated w/NSAIDS & are still present; pt discontinued the vax series;
Per father, she developed redness, swelling in arm where 2 injections were given - swelling existed from site (deltoid) down to wrist. Redness outside and extending down arm. Was seen at hospital approximately 36 hours after injection (continues).
Patient wife called clinic today at 12:00pm to report husband is having constant chest pain and no other symptoms. Advised her to call 911 since his Chest pain is getting worse and to follow up with his PCP after being seen at ER. Patient wife verbalized understanding.
Decreased muscle tone, poorly responsive, altered breathing (sounded like "hiccups") and pale. Admitted to Hospital where by that time GCS of 15. Had bradycardia, hypotension and altered breathing but all self-resolved by evening.  No further fevers.
Within 30" of receiving vaccines, pt felt dizzy, faint, nervous. Symptoms continued intermittently "in waves" over next 48 hrs. Episodes only lasting a few seconds. Seen by his doctor who thought symptoms wee related to immunization. On 6/19/03, started having loose, watery, foul smelling stools-3-4 day; one loose stool this am and now improved. No problems at injection site.
I started having itchy skin, and then just a full body rash all over from head to toe. I received steroid shots, and a round of steroid pills, which cleared up the rash. I was also given an ointment to use on my skin as well. Triamcinolone cream is what I used, and I used one whole tube to cover my whole body.
1 expired dose was mistakenly given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes on 09-Nov-2021 the follow up information received on 09-Nov-2021 contains No New Information.
Information has been received from a licensed practical nurse concerning a 7 year old female who on 06-OCT-1999 was vaccinated with Varivax (lot #631071/1002J). Concomitant therapy included MMR II. On 08-MAR-2007 the patient developed 30 chickenpox lesions with no other symptoms. NO medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Flu symtoms, high fever (103F), aches and pains, brain fog for 2-3 weeks.
Pregnant 1 week after she received the 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant 1 week after she received the 1st dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concomitant products included PROGESTERONE for Pregnancy.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 13-Oct-2021. On 19-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant 1 week after she received the 1st dose). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant 1 week after she received the 1st dose) had resolved.            Concomitant medication include allergy medications and supplements. No treatment medication details was reported.
Developed an itching rash, soreness shoulder Rt. rash looked vesicular - like zoster.
Pt had anaphylactic response to the hep B vaccination. Pt was transported to ER by ambulance for tx and eval.
Beginning overnight after being vaccinated patient reports a bothersome redness and swelling at the site of vaccination that made moving her arm to certain positions uncomfortable and difficult. Patient took acetaminophen for the pain with marginal benefit. Patent reported to the pharmacy the night of 4/18/23 to report the reaction and says that today the swelling and soreness appears to be improving.
Patient admitted with SOB and change in Chest Xray.  Tested positive  for COVID
devel typical varicella disease-fever, vesicular rash;25 lesions face 7 head;25 back, 16 abd, 8 elsewhere had fever x 48hr @ beginning;
This spontaneous report was received from a Nurse refers to a patient of unknown demography. The nurse reported that the patient was vaccinated a dose of GARDASIL, 0.5 ml, intramuscular on 14-JUL-2009, 21-SEP-2009, 26-JUL-2011, 18-OCT-2013 and on 21-FEB-2014. No adverse events were reported. Additional information has been requested.
Red, hard, warm, elevated/swelling, pain, some itching at injected site.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No symptoms reported; HCP called to report an expired dose of VARIVAX was administered to Multiple patients.; Date of excursion: 3/2/2023; This spontaneous report was received from a pharmacist referring to 1-year-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 13-JUN-2023, the patient was vaccinated with improperly stored and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL, lot #W0252273 was established as not valid, expiration date was reported as 02-JUN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used, Improper storage of product in use).  On 02-MAR-2023, the suspect vaccine experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes. No symptoms reported (No adverse event). No further adverse event (AE) details. No product quality complaint (PQC).  This is one of multiple reports from the same reporter.
On 08/25/20, mother noticed some redness and swelling at injection site and patient was complaining that it was itchy. The redness and swelling continued to progress and covered majority of the upper half of right thigh. Mother took patient to Urgent Care and was diagnosed with cellulitis and prescribed antibiotics. Patient was seen here in our office on 08/31/20 and the redness and swelling seemed to be resolving.
DRY MOUTH; NO ENERGY; SEVERE PAIN IN RIGHT LEG; HEADACHE; FEELING LIKE BODY TORN APART; WHOLE BODY NUMB/NUMBNESS TO RIGHT LEG, FACE, RIGHT ARM/HAND/EAR; WHOLE BODY PAIN; COUGH; HOLDING  FLUID; BUTTOCKS BURNING HEAVY; LOSS OF SENSATION; LACK OF SALIVA; LIPS DRY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included mucous in chest, and cough, and concurrent conditions included hyperlipidemia, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling like body torn apart. On APR-2021, the subject experienced whole body numb/numbness to right leg, face, right arm/hand/ear. On APR-2021, the subject experienced whole body pain. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced holding fluid. On APR-2021, the subject experienced buttocks burning heavy. On APR-2021, the subject experienced loss of sensation. On APR-2021, the subject experienced lack of saliva. On APR-2021, the subject experienced lips dry. On APR-2021, the subject experienced severe pain in right leg. On APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced dry mouth. On 11-APR-2021, the subject experienced no energy. On 13-APR-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: furosemide/potassium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no energy, dry mouth, and whole body numb/numbness to right leg, face, right arm/hand/ear, and the outcome of feeling like body torn apart, whole body pain, cough, holding fluid, severe pain in right leg, buttocks burning heavy, loss of sensation, headache, lack of saliva and lips dry was not reported. This report was non-serious.
On April 19th 2021, I started having severe pain on the left side of my face.  A stabbing pain in my left ear. My scalp was very sensitive to the touch. I went to the Dr. and he diagnosed me with Ramsay Hunt syndrome.  I am finishing a course of antiviral medication and have been on ibuprofen for pain which is over the counter.  Doing much better at the moment but I have breakthrough pain when the ibuprofen wears off.
Possible sz assoc w/fever; 2 hrs p/inject pt had shrill cry, glassy & a stiffened back; Lasted 30-45sec; Temp 100; hx of sz; Pt not hospitalized;