chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced feverish, and I woke up in the middle of the night with severe chills/shaking, fever, nausea, vomited throughout the night, fatigue. The next morning, I could not catch my breath, I was coughing while gasping for breath, used my rescue inhaler but it did not work to alleviate my symptoms. If I got up and moved around at all I was out of breath and coughing excessively which continued for 10 days before I went to see my PCP. My PCP prescribed prednisone 40mg, which also did not alleviate my symptoms. After over 20 days I was able to see a Pulmonologist, and I was not able to do any normal activities, I was very non-functional. When I saw the Pulmonologist, I had a CT scan that showed scarring in my lungs from interstitial lung disease which most closely resembled Hypersensitivity Pneumonitis. I was sent for heart scope where they found 3 blockages, was diagnosed with coronary artery disease, and received 3 stints. A few weeks later I suffered a cluster of pulmonary emboli, and was treated with IV blood thinners, then later with oral blood thinners when released from the hospital. I was also diagnosed with Gastroesophageal reflux disease. The doctors believe that the vaccine caused a mass cell activation response with exacerbated/uncovered the symptoms of the underlying diseases and conditions I was not aware of at the time of vaccination.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 2 years old child patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Five days after vaccine felt terrible, got rash on chin, scar on chin. Two weeks of sore muscles and tiredness.
At risk pt came in at 39 weeks and 1 day pregnant for H1N1 immunization 10/28/09. On 10/29/09 pt called c/o no fetal movement. Pt brought into office to be monitored and no cardiac movement was noted on sonogram. Pt had a normal biophysical profile 10-27-09 with normal cardiac movement on 10/27/09. Fetal demise vaginal delivery 10-31-09.   11/04/09 Medical records and discharge summary received for DOS 07/28/2006-10/31/09. Discharge DX: 39 week fetal demise, Rh negative, Abnormal first trimester screen, Advanced maternal age, Tight nuchal chord, Evidence of fetal maternal hemorrhage based on KB stain, Questionable placental abruption. AMA patient with h/o past ectopic pregnancy. Current pregnancy with abnormal first trimester screen. Followed closely. Refused amnio.  Normal fetal growth through out. All exams and BPP WNL. Last prenatal visit + fetal movement. Next day fetal movement decreased but then movement resumed. Next day no fetal movement felt. No fetal heart tones detected in office. Sonogram confirmed fetal demise at 39 3/7wks gestation. Labor induced same day. Non viable male infant 7lbs 12 oz delivered vaginally.  Very tight nuchal cord. Unable to reduce until fully delivered.  No blood in cord. >50% of placenta very pale.  Placental path abnormal. Stable. Discharged to home.
Patient seen in ED for generalized weakness which patient attributes to J&J COVID vaccine.  MD notes indicate that the vaccine may be at least partly responsible.  Examination & diagnostics (labs,  did not indicate other likely cause.  Patient given script for meclizine which was filled & patient took 1 dose by time clinic staff called and expressed improvement in symptoms compared to previous day.
Rash within 12 hours very urticarial waxed and waved. Also had other rash erythematous papules and some areas on LE of ecchymosis. Resolved after several days with Benadryl and Prednisone. Notes pt was 1st to get a dose from vial of Varivax, 6 others had dose from MMR prior to use.
Pt recvd 1 dose of Engerix-B & exp nausea, vomiting, dizziness, fever, h/a & diarrhea 2-6 hrs p/recvd vax;
very bad migraine; This case was reported by a consumer via patient support programs and described the occurrence of migraine in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included belimumab (Benlysta) solution for injection in pre-filled pen for product used for unknown indication and belimumab autoinjector device (Benlysta Autoinjector Device) administration system for product used for unknown indication.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Benlysta 200 mg at an unknown frequency and Benlysta Autoinjector Device. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, Benlysta and Benlysta Autoinjector Device, the patient experienced migraine. The action taken with Benlysta was unknown. On an unknown date, the outcome of the migraine was unknown.   The reporter considered the migraine to be possibly related to Influenza vaccine Quadrivalent unspecified season. The reporter considered the migraine to be unrelated to Benlysta and Benlysta Autoinjector Device.  Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received Benlysta. After receiving Influenza vaccine Quadrivalent unspecified season, Benlysta and Benlysta Autoinjector Device, the patient had very bad migraine.
REDNESS AT VACCINE SITE HOT TO TOUCH PAIN/TENDERNESS  4x5 CM
Post vax, the pt became extremely weak and muscles were stiff. She struggled for a two week time frame dealing with this problem. Myalgia - Complained of soreness in left arm, shoulder pain, soreness in groin and hips, low grade fever. She was hospitalized and started on prednisone with dramatic improvement.
After an hour lips & tongue tingled and throat felt tight.  Took Benadryl and entire face went numb- it took an additional dose and finally went away after 12 hours. Fever, dry heaving and low bp to the point I passed out and my husband called an ambulance.  My pulse was very weak and my bp was 90/60.  Hospital gave me  units of iv.
WITHIN THE FIRST HOUR PATIENT NOTICED HER ARM WAS HOT  AND RED.  THAT NIGHT ARM HURT ALL THE WAY TO HER FINGERS.  ARM IS STILL RED AND HOT TO TOUCH.  ALSO A QUARTER SIZED THICKNESS AT INJECTION SITE
This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. On 22-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported). On an unknown date in July 2013, the patient developed an injection site reaction described as itchy, red, rash with swelling at the injection site. Patient sought medical attention (unspecified). The outcome of itchy, red, rash with swelling at the injection site was reported as not recovered.  Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: pulse, anxiety-Medium
febrile sz 11 AM; 15JAN93 lasted 3-5min post-ictal for  1hr;
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). The patient's past medical history included shingles. On 16th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced breast tenderness, blister, crust and scratch. On 24th March 2018, the patient experienced shingles (serious criteria other: as per reporter). The patient was treated with FAMVIR. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the breast tenderness, blister, crust and scratch were unknown. The reporter considered the shingles to be unlikely related to SHINGRIX. It was unknown if the reporter considered the breast tenderness, blister, crust and scratch to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right deltoid. The healthcare professional (HCP) stated that, the patient was diagnosed with shingles about 1 month after receiving the SHINGRIX vaccine. The patient reported with sensitivity and small, sparse, blisters started on her right breast and gone towards the back, about 3 to 4 cm in width. The patient had a few blisters that did crust over and were scratched off prior to the week of reporting, so the HCP was unsure of the exact start date of the shingles. The HCP did not think this was due to the vaccine. The HCP stated yes for the question that, the event required an intervention to prevent an outcome because they had to start the patient on FAMVIR 500 mg three times daily. The reported lot number (575LX) for SHINGRIX did not exist and was updated to 5Z5LX, according to sales database.
Immediately following the 1st dose of vaccine I felt extreme lethargy until late night on Wednesday March 24th when I got a fever, body aches and chills. This lasted 36 hours. The evening of Friday March 26th night into Saturday morning I had extreme night sweats.
Within 2 hours of vaccine administration, she developed c/o SOB, facial flushing and lip swelling with headache.
Immediately, post vax, developed vasoactive phenomenom with blanching and mottle and shrill, persistent uncontrolable crying. Vital signs were stable.
States after vaccine, reported tingling/electrical feelings in legs & arms. Four hours after, rhinorrhea reported. States at 48 hours, started having nasal and head congestion. States experienced body aches x 12 hours but have improved at 48 hours. States is feeling better with body aches now. States is also having headaches x 24 hours. States is having them "moderately now." States is also noticing fatigue. States starting noticing fatigue at 12 hours after injection and still present now.
12-29-2009 can still feel where immunization was administered 9/29/09. Painful at site, numbness in L pinkie finger continuous-end of week pain began.
hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; pain went across her face to the left side; pain in the right shoulder to above the neck; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration in the right deltoid on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient informed that the hurting started when she was just talking with someone on 17Jan2021. The patient had taken ibuprofen and tramadol. The patient informed that her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides and wanted to know if there was anything she could do to eliminate that or make it less consuming. The patient informed that she didn't notice any problems for a couple days, then her right shoulder right above on the neck began to ache. This pain went across her face to the left side, it has sort of stayed in this particular area. It has not stopped aching since then. The patient informed that she didn't know what to take. The patient informed that the pain in the right shoulder to above the neck started 3 days after, it went on to the face to left side, it was in the neck mostly, and the top part of the shoulder, it was a dull aching pain, sometimes it shrills, and she really felt like, it was like it really hits her. The neck shoulder pain all started on the same day. The patient informed that it was not quite as bad as before, she took ibuprofen. The patient took Tramadol after the onset of the neck/shoulder pain. The patient informed that the end of the second phase of the vaccine is coming on the 07Feb2021. The outcome of the events pain in arm, facial pain was unknown, while shoulder pain, neck pain was recovering.  Follow-up activities are possible, information on the batch number has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/ allergies of these patients were vaccinated with improperly stored GARDASIL (strength, dose/frequency, lot # unspecified). Concomitant medications were not reported. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
few days out from the recommended six week guidelines; fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (few days out from the recommended six week guidelines) and PYREXIA (fever) 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 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (few days out from the recommended six week guidelines) and PYREXIA (fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (few days out from the recommended six week guidelines) outcome was unknown and PYREXIA (fever) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-132191 (Patient Link).
No additional AEs were reported; Medical assistant reported that a patient received an expired RECOMBIVAX.  No additional AEs were reported.  No further information provided.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 14-NOV-2022, the patient was vaccinated with expired dose of hepatitis b vaccine (recombinant) (thiomersal free) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot #T036814, expiration date: 12-NOV-2022 (strength, exact dose, site and route of administration were not provided) for prophylaxis. No additional adverse events were reported.
Patient reported to our onsite registered nurse on 25MAR21 - injection site pain, redness and swelling (left deltoid).
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have a reaction after 18 hours of receiving first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have a reaction after 18 hours of receiving first dose). At the time of the report, VACCINATION COMPLICATION (have a reaction after 18 hours of receiving first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment medications are not provided. Reporter did not allow further contact.
tired, entire body aches, and bad pain in both feet.  persistent numbness in body extremities. The pain in one foot has remained until present which has slowly subsided.  It has caused nerve damage in that foot.
COVID 19 BOOSTER SHOT GIVEN INSTEAD OF COVID 19 PRIMARY SERIES
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
Patient was given a pfizer bivalent vaccine for a primary dose of pfizer age 5-11.
Subsequent to receiving varicella virus vaccine live the pt experienced a rash on his stomach and back and vomited once. The pt was afebrile.
No additional adverse events reported; a limited adverse event on a dose of PROQU AD that was administered improperly stored during a temperature excursion found supported, on 09/14/2021; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T027115 with expiration date on 07-FEB-2022, at a dose of 0.5 mL, for prophylaxis (strength, route of administration and anatomical location were not reported).   The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F(8.5°F) for 0 hours 18 minutes and 0 seconds; and in the range between 6°F to 14°F (11.9°F) for 1 hour 0 minutes and 0 seconds (Cumulative Timeframe: 1 hour and 18 minutes). The vaccine had not had any previous temperature excursions. No additional adverse events reported. No product quality complaint was involved.
4/21/2021 at 20:00, right arm was very sore at injection site.  4/21/2021 at 21:00, fatigue and no appetite. 4/21/2021 at 21:20 all joints ached.  4/21/2021 at 21:40, severe headache.  4/21/2021 at 22:00, chills and nausea. at 22:30, throat dry and sore.  4/22/2021 at 1:05, fever 100.4F.  4/22/2021 at 1:15, lymph nodes swollen and whole body swelling.  4/22/2021 at 3:00, under arm lymph nodes burst and blood drain under skin and feeling of pending danger and unbearable pain over whole body.  4/22/2021 at 4:30, consumed 3 doses of dye-free Benadryl gel tabs.  4/22/2021 at 5:30, swelling subsided and body pain lessened.
PRODUCT ADMINISTERED  2-6 MINUTES BEYOND USE TIME OF 2 HRS; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced product administered 2-6 minutes beyond use time of 2 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product administered 2-6 minutes beyond use time of 2 hrs was not reported. This report was non-serious.
Lip and throat swelling while eating anything cold/frozen. feet and hands tingle in air conditioned room.
Non-stop crying.  Crying worsened when not held.  Crying continued until child fell asleep from exhaustion.  When given a bottle gulped it for 5-6 swallows then pushed it away and screamed.  Ate 4-5 bites of baby food and pushed it away screaming. Stomach sensitive to touch for 48 hours. Diarrhea for 24 hours after shot. Light fever (99.3 F) for 24 hours.
Severe headache; Chills; Fever of 100; Myalgia; Slight Upset Stomach; feeling horrible; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (at the age of 26 years).   On 16th October 2019 14:30, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 13 hrs 30 min after receiving Shingrix, the patient experienced fever, myalgia, upset stomach and feels awful. On 16th October 2019 20:00, the patient experienced headache and chills. On an unknown date, the outcome of the headache, chills, fever, myalgia, upset stomach and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, fever, myalgia, upset stomach and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm On the same day, at around 8 PM at night, 5 hours 30 minutes after receiving Shingrix, the patient developed a slight headache and slight chills. The patient stated, she went to the bed but woke up at approximately 4 AM on 17th October 2019 feeling horrible with violent or severe headache, chills, fever of 100 degree F, myalgia and slight upset stomach. The patient consented to follow up and also provided her physician's details. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the system it was reported as not recovered/ not resolved.
Fever of 105F rectally w/irritability; Note: rxn reported to state a year after event;
48 hrs post injects (R) arm red & swollen with mild tenderness and pain at shot site. SEPTRA D.S. bid x 10 days given.
Patient after receiving her vaccine stated she felt dizzy and lightheaded with nausea immediately.  Patient taken to first aide area for assessment.  Patient is A & O x3, Skin Pink warm and dry and patient appeared in no apparent distress.  Patient states she has a history of migraines.  Patients VS were: B/P 130/66, HR 89, SaO2 of 95% on RA.  Patient stated that she did have a headache with 6/10 pain and states her last migraine was last one week ago with no aura.  Patient discharged home after full 30 minute wait without complications and return to baseline.