chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse reported no other adverse events; Patient received first and second dose of Gardasil 9 on 12-SEP-2018 and 24-FEB-2020 respectively. On 24-SEP-2021, the patient was scheduled to received third dose; Patient received first and second dose of Gardasil 9 on 12-SEP-2018 and 24-FEB-2020 respectively. On 24-SEP-2021, the patient was scheduled to received third dose; This spontaneous report was received from a registered nurse and refers to a 23-year-old female patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.     On 12-SEP-2018 and on 24-FEB-2020, the patient was vaccinated respectively with  a first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for prophylaxis (inappropriate schedule of product administration). Registered nurse also reported, that there were no other adverse events and no product quality complain.   On 24-SEP-2021 (also reported as today),the patient was scheduled to receive third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date and route were not reported) for prophylaxis.
c/o nausea, stomach cramps, rash on lower legs starting 6AUG92 vomiting & diarrhea started this morning; states leg rash is almost gone today; pt seen later in day 7AUG92 in ER & c/o fever, cont nausea, diarrhea, body aches;
1 1/2min p/vax were given pt was noted to be dizzy;c/o lt earache, some tightness in the throat & blurry vision, appeared pale, brady cardic & was cold & clammy;2min later pulse was nl;ordered 02 & pei;
Syncope episode after leaving clinic. Patient was taken to ER by parents, Negative CT, Urine culture with >100,000 colonies, treated with antibiotics with instructions to follow up with PCP.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history included allergic rhinitis, iatrogenic hypothyroidism and fibromyalgia. The patient had no drug reactions/allergies. On 14-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, lot # was reported as K004148, expiration date and dose was not reported) intramuscularly. Concomitant medications included desipramine, levothyroxine sodium (manufacture unknown), RHINOCORT AQUA, MEDROL PREDNISONE, BENADRYL, SINGULAIR, VIIBRYD, ORTHTRICYCLEN. The patient experienced an anaphylactic reaction after receiving PNEUMOVAX 23 on 14-AUG-2014. The patient had sought for medical attention by office visit on an unspecified date. Treatment given for the anaphylactic reaction included EPINEPHRINE. MEDROL PREDNISONE and BENADRYL. The patient recovered on 14-AUG-2014. The reporter considered the anaphylactic reaction as life threatening and needing intervention to prevent serious criteria. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on right buttock once monthly) and genital herpes. Previously administered products included valacyclovir and SHINGRIX (1st dose received on 29th December 2018 on left arm). On 1st February 2019, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in right upper arm. The patient had event occur after her 2nd SHINGRIX shot. The patient needs to see a new dermatologist, as her previous one left and she also needs a new prescription for the valacyclovir. The patient was not relating the events to SHINGRIX but did not it occurred after the shots, so this report being filed. The patient noted history of shingles had been monthly every month for 4 years now. This case has been linked to the US2019023101, reported for the dose 1 of the same patient.
p/vax pt cried for approx 8hr & was fussy for approx 24hr;
adverse reaction to vaccine product Patient with history of multiple severe antibiotic allergies (she refered to as anaphylaxis) reported onset of similar symptoms less than 15 minutes after vaccine administration today. Reported itching and swelling of ear canals. Some swelling seen on examination. Patient given epipen and 50 mg diphenhydramine IM. EMS called. Patient reported neck tightness, stiff muscles and hives. Given dexamethasone 4 mg IM. Patient reported confusion and racing heart. Denies chest pain and SOB. Vitals monitored closely throughout with good 02 sats. Consistent BP of 140-160/80's and fluctuating tachycardia. EMS arrived and transported patient to ER for further eval.  I suspect patient was having a severe allergic reaction, but also presented as having acute panic attack.  Advised against getting second Moderna vaccine. Patient should follow up with her PCP.  Start dexAMETHasone sodium phosphate 4 mg/mL injection solution 1 mL every day Start EpiPen 0.3 mg/0.3 mL injection, auto-injector 1 auto Start diphenhydrAMINE 50 mg/mL injection syringe 1 mL
From occupational health note: patient was asked by her supervisor to call.  Received vaccine on 1/14, had dizziness, seeing spots in her eyes, lethargy and was sent to to ED and discharged.  Generalized itching the next day.  All sxs have resolved since yesterday.  Scheduled to work on Friday, 1/22.  From ED note: 50 yo f c/o mild dizziness and light-headedness today, worse with standing up.  No n/v/d/f/c.  Describes sx as typical early flu like sx today but slightly worse that her usual feeling from flu vaccines.  Received the covid vaccine yesterday and friend experienced same symptoms.  Felt "difficulty concentrating at work", which was very busy.  No weakness, pre-syncope, numbness, cp, sob.  No unsteady gait, vision changes.  occ vision spots assoc with standing up.  H/o anemia, h/o gastric bypass 2005.  Often gets routine labs q 6 months but has not had any yet since COVID.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored VAQTA (lot # M003011, expiration date: 15-NOV-2017; dose and route of administration were not provided). The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Presents with cough and shortness of breath since last 3-4 days.  Patient is vaccinated with COVID-19 J&J in April 2021, patient was in her usual health until about last week Friday, started having cough, shortness of breath, sore throat, generalized weakness and fatigue so came to the emergency room for further evaluation.  Patient was tested positive for COVID-19 at outside facility.  Patient is noted to be hypoxic requiring 2 L of oxygen, presently denies having acute chest pain, has been having yellow sputum on coughing
Stomach cramps, vomiting, diahreah, fever, body aches, fatigue and severe stomach and bowels pain.
Pt called complaining of slight fever, red arm and raised bump. Pt came into store following morning and arm was barely red and no swelling. Pt went to MD and  they gave her antibiotics.
fatigue, chills, injection site pain Narrative:  symptoms resolved after 24 hours  Other Relevant History:
Vaccine was administered to Patient about 3:45 PM on 09/15/2016. Patient called Pharmacy Next day with vaccine area very red and inflamed even after taking benadryl and using Ice packs.
Developed intense tinnitus on April 6th, partially debilitating accompanied with headaches, difficulty sleeping, aches in ear and occasional shooting pain.  On April 7th I had a NEGATIVE Covid test to rule out the disease. Ear Nose and Throat exam ruled out causes other than vaccine induced ototoxic impact to the ear nerve.  audiology exam for hearing loss scheduled.  It is now  a month with no improvement and no proven treatment available.
This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 60 year-old female patient. On 02-Oct-2014, the patient received intramuscular AFLURIA, (batch number 09949211A) in the left arm. On 02-Oct-2014, approximately 1 hour after receiving the Influenza vaccination, the patient felt an aching sensation in her left hand below her thumb. The ache was constant and when she lifts things, the ache radiated to her left wrist area. No visible or apparent inflammation upon inspection. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
This spontaneous prospective pregnancy report was received from a 25 year old female patient referring to herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant therapies. On 25-JAN-2018 the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # and expiration date unknown) for HPV prevention. On 29-MAY-2018, she received the second dose (dose, lot# and expiration date unknown) by intramuscular route. On 29-JUN-2018 she found out she was pregnant. The last menstrual period (LMP) was 11-MAY-2018 and estimated date of delivery (EDD) was 15-FEB-2019. The patient said immediately after finding out she was pregnant she tried initially scheduling an appointment with her gynecology clinic, however, the clinic did not have an appointment opening available until November but the patient did not want to wait until November to see a Gynecologist. So the patient's primary care physician instructed her instead to go to the nearest Emergency Room (ER) which she did on 29-JUN-2018 where at the ER visit she had two sonograms performed. One sonogram was vaginal and the second one was for the surface (results not provided). It was confirmed with the patient that she was not admitted to the ER because after she had the two sonograms done and "some other analysis" (unspecified) was performed she was then released from the ER the same day. The pregnancy gestation was 7 weeks and 3 days at the reporting time and the outcome was pending.
No additional AE; Multiple Patients were administered Improperly Stored; This spontaneous report has been received from a registered nurse to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On unknown date in October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 10-OCT-2022, 11-OCT-2022, 12-OCT-2022, and 13-OCT-2022) the patient was vaccinated with improperly storage dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: W010874, expiration date on 12-OCT-2024, lot number: W006721, expiration date on 12-OCT-2024). All of the vaccines were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   The administered doses of the vaccines were stored on 25-JUL-2022, at a temperature of -47.5 degrees Fahrenheit (F), during a time frame of 5 minutes. (Product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.  This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
Confusion, didn't feel good; extremely tired; and extremely high blood pressure. I took him to ER. Admitted to hospital because they said he had a stroke. He was there for 3 or 4 days and then he went to REhab for a month and then went to Rehab. Then he went to a second rehab - then he moved to Care Center here.  Now he's on Hospice at the Care Center- he's been on Hospice since July 6th.  He recovered somewhat but he was extremely confused.
Severe muscle pain, tightness, and spasms in muscles throughout body since the shot. Woke up from severe pain in right shoulder and had irregular heart beat with chest pain and tightness 8/20/21. Have had days of irregular heart beats since the shot. I have ongoing tightness in my chest daily, and a feeling of heaviness in my chest. It feels like my heart is having spasms during irregular heart beat.
Patient received routine vaccines MMR and DTaP in right deltoid 5/10. Presented with fever (tmax 103F) and right arm swelling since 5/11. Pt went to ED 5/12 and sent home on keflex, motrin, and benadryl without relief. Brought to Facility for worsening of symptoms 5/13 and unable to see PCP.  Diagnoses with extreme limb swelling of RUE secondary to immunizations. Edema reduced morning of 5/14 and patient discharged home with epi pen.
The day after the injections, patient is feeling warmth and pain at injection site along with cold chills. Counseled patient to continue taking acetaminophen for the fever, chills and pain.  Can use warm or cold compresses as needed. Counseled that if allergic reaction occurs to contact 911 (difficulty breathing) and md if itchy rash develops.
under eyes swollen and puffy; under eyes swollen and puffy; This is a spontaneous report from a contactable consumer (Patient).  A 68-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EM9890), via an unspecified route of administration, on 12Feb2021 (at the age of 68 years old) as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient medical history was not reported. The concomitant medication of the patient included Simvastatin (SIMVASTATIN) from unspecified start and stop date. No further details provided about Simvastatin, details documented as provided. It was reported that it was not a new medication but her dose was upped for her Simvastatin, it was 10 and now it is 20, but they doesn't think that has anything to do with it. The patient reported that they were calling about the Pfizer COVID-19 vaccine, they received the vaccine on 12Feb2021 and it was weird, the next day (13Feb2021) her eyes were swollen, under her eyes they were puffy when patient woke up. Patient told her husband that the puffy made her look like a little pig and in two days that was gone. Patient took Benadryl, she was little tired and went cross county skiing that day and it was cold outside, she could have stuck her face in the snow it might have helped, her eyes didn't itch or anything, it was just puffy and weird like her sinus under and over her eyes and across her nose. She says that the puffiness was better now. Patient wanted to know if anyone else has reported this or if she should get the second dose of the vaccine. She says she was supposed to get her second dose on March 5th. Patient reported that they have not had any other recent vaccinations or started any new medications. Outcome of event was recovered on unspecified date in 2021. Follow-up attempts are completed. No further information is expected.
As reported by patient's daughter.... Approximately 16 hours after injection. patient woke up feeling like heart was racing and pounding. HR around 120 and regular. Patient was able to complete ADLs during episode. Reports looking pale. Unable to determine how long episode lasted. Office visit in primary care scheduled for evaluation.
Two hours after vaccines patient began crying inconsolably and refused to breastfeed. This episode lasted from 10:30 to 7:00 am the following day.
Her shoulder is sore but not swollen during palpation and she didn?t lose her strength and/or sensibility.
8PM 17JAN93 sudden onset of nausea & dizziness w/ataxic gait; 9-10PM vomited 5x's then to bed; 18JAN93 mild nausea in AM & by noon felt 100% better;
I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in; have not taken shot since 4/22/2021; and they said I had the Flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu). At the time of the report, FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Reported by EMS on site.  client had syncope following vaccine and was transported to a local hospital.  no  phone number given to this writer after the event.  EMS called at 11 am and arrived at 11.01.  blood pressure 101/68 pulse 71.  second reading was 108/76 and pulse 69.
Received Inj on 01-14-2021. That evening had chills, fever, muscle aches began.  Took Tylenol and went to bed.  Awoke on 01-15-2021 with severe congestion, dyspnea, fever, chills, diarrhea, muscle aches, back pain, kidney pain, headache, felt exhausted all of which I had when I was Covid positive and to the same severity.  Injection site extremely sore, swollen, warm, unable to lay on the injection site.  Symptoms began to subside on 01-20-2021 and I returned to work on 01-21-2021.  Employee Health representative advised me to complete this form.
Long bone aching pain, involving bilateral humeral bones and left femur.   Pain began on day two and resolved on day five.  I required two doses of ibuprofen to sleep on days three and four.
After receiving 2 vacc (2-8-05) pt reports feet swelling, and pain at injection site with swelling arm. c/o malaise and myalgias (no allergy sxs or rash, no fever).
Started 12 hours after the injection. Sudden swelling and redness a site with pain increasing to surrounding areas with severe itching. Also fevers to 102.
This spontaneous report was received from a registered nurse and refers to a 22-year-old-patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 30-AUG-2016, the patient was vaccinated with a first dose of RECOMBIVAX HB 10/1.0 microgram/ml, intramuscularly, lot # M010682, expiration date: 15-SEP-2017 (dose and anatomical location were not reported). On 13-DEC-2016, the patient was vaccinated with the second dose of RECOMBIVAX HB 10/1.0 microgram/ml, intramuscularly, lot # M039201, expiration date: 04-NOV-2012018 (dose and anatomical location were not reported). The patient has not experienced and adverse effect. Additional information has been requested.
Headache, Myalgia, Arthralgia, Diarrhea & Nausea Vomiting Narrative:
Large local reaction, erythema and induration at site, BENADRYL and prednisone.
Arm got red, swelling, bruising, itchy; Arm got red, swelling, bruising, itchy; Arm got red, swelling, bruising, itchy; Arm got red, swelling, bruising, itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm got red, swelling, bruising, itchy), VACCINATION SITE SWELLING (Arm got red, swelling, bruising, itchy), VACCINATION SITE BRUISING (Arm got red, swelling, bruising, itchy) and VACCINATION SITE PRURITUS (Arm got red, swelling, bruising, itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-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 SITE ERYTHEMA (Arm got red, swelling, bruising, itchy), VACCINATION SITE SWELLING (Arm got red, swelling, bruising, itchy), VACCINATION SITE BRUISING (Arm got red, swelling, bruising, itchy) and VACCINATION SITE PRURITUS (Arm got red, swelling, bruising, itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Arm got red, swelling, bruising, itchy), VACCINATION SITE SWELLING (Arm got red, swelling, bruising, itchy), VACCINATION SITE BRUISING (Arm got red, swelling, bruising, itchy) and VACCINATION SITE PRURITUS (Arm got red, swelling, bruising, itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Generalized body pain; sharp aching joints; Fatigue; Chills; This is a spontaneous report from a contactable nurse (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EM9809, Expiration date was not reported), via an unspecified route of administration (administered on the left deltoid) on 09Feb2021 at 12:00 (at the age of 41-years-old) as dose 1, 0.3 mL single for COVID-19 immunisation. Medical history included known allergies to PCN (penicillin) from an unknown date, asthma and COVID-19 both from Nov2020. The patient has no other concomitant medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 11Feb2021 at 01:30, the patient experienced generalized body pain, sharp aching joints, fatigue, and chills. Therapeutic measures were taken as a result of the events which included home symptom management and time off work. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Patient received vaccine at 3:30pm. Patient was walked to the waiting room to wait 15-20 minutes for observation before leaving the clinic. Around 3:50pm she informed staff she was hot, felt flushed, having heart palpitations and nauseated. RN assessed patient. ** After sitting with the patient about 20 minutes, patient stated she was feeling better. Patient was walked to the restroom and tolerated the walk well. Patient was instructed to wait for another 30 minutes before leaving clinic. Around 4:30pm, patient stated that she was not feeling well. Reported heart palpitations, flushing, and trouble breathing. EMS called at 4:35pm. O2 99-100% consistently. EMS Arrived at 4:43pm. Patient taken to ED/Urgent Care via EMS.