chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine triggered immune system causing destruction and suppressed production of red blood cells resulting in hospitalization due to significant drop in hemoglobin (4.6); necessitating and extreme number of tests and multiple and ongoing blood transfusions and treatments.
nearly 10 weeks after 1st dose; nearly 10 weeks after 1st dose; mild headache; mild fever 99.5F; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received second dose (redo of the second dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Intramuscular on 8Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 dose 1, on 31Jan2021 for covid-19 immunisation. The patient had 2 doses of vaccine, the 2nd dose was unfortunately given in the back of her arm into subcutaneous fat on 21Feb2021. It has taken quite some time to get an appointment to have what she thought was a total redo of both doses. Yesterday was 68 days after the 1st original dose and she had an appointment. They said it was a redo of the second dose only. This was nearly 10 weeks after 1st dose.  The patient experienced mild headache, mild fever 99.5F. The outcome was unknown.  No follow up attempts are needed. information about lot/batch number cannot be obtained.
This is a spontaneous report from a non-contactable consumer. A 7-month-old female patient of unspecified ethnicity received the first dose of PREVNAR, via an unspecified route of administration on 07Aug2012 at a single dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On 07Aug2012, after the first dose of PREVNAR, the patient broke out in hives. Relevant laboratory data was unknown. Therapeutic measures taken in response to the event, broke out in hives, were unknown. The clinical outcome of the event, broke out in hives, was unknown at the time of report. No follow-up attempts possible. No further information expected.
fever; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and NAUSEA (nausea). At the time of the report, PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            Med Info. AE submitted.  patient has second moderna vaccine and is suffering from fever and nausea Concomitant product use was not provided. Treatment information was not provided.
11-15-05 Arm with large reddened area at injection site; 11-17-05 Total body urticaria and swelling, temp 102.  Given Benadryl, cold compresses; 11-23-05 Mom took to Dr. and he said give Benadryl.; 11-30-05 Saw Dr at Head Start.  Continue Benadryl and decrease baths; 12-14-05 Dr at Head Start gave Cortisone Topical and lotion.
10/07/23: Mother reports patient noted with redness on left thigh after vaccines.  Patient received Pentacel yesterday, site noted with redness and swelling,  no difficulty breathing, warmth, hives or severe swelling noted. Patient able to bear weight on left lower extremity. Explained to parent common vaccine SE usually lasting from 24-72 hrs, advised to apply cold compress, may give Ibuprofen if necessary and scheduled appointment on Monday 10/09/23. 10/09/23: Per provider's note, redness around site has increased and has some bluish discoloration noted to left thigh,  able to ambulate. Return to clinic in 2 days,  appointment scheduled on 10/11/23 for f/u.
Dose administered past expiration/beyond-use date. Per Moderna lot administered maintained activity necessary to protect against SARS-CoV-2 (COVID-19) virus at time of administration. No need to repeat dose per CDC interim recommendation for vaccine administration errors and deviation.
got injections, waited my 15 minutes, left, headed back to work was on the interstate, suddenly got real hot, pulled jacket off, turned the air conditioner on, look in mirror, face and neck was blood red had rash head to toe, somewhat short of breath,  called the health department back spoke w/nurse, she advised to either come back there and get some benadryl and take 50 mg.  I stopped went into store bought benadryl, took the 50 mg was not far from work, went in, shortness of breath was worse so they told me to go home.  Went home, that day laid on couch covered with quilt.  Around 9 p.m. that night, had another spell got hot again.  I did  not think to check blood pressure or heart rate or oxygen that day,   The next day I did, by blood pressure was low  I have lost the logs but on blood pressure machine  106-65 hr 109, bp 85-60 hr 91, bp 115-81 hr 90 this remained for next 2 weeks, then went back to normal. kept the rash for a week, then went away, had the sore arm, pain radiated down arm into hand, felt fatigue and tired.  I called back spoke she advised not to take the second shot, I was orginally scheduled to take it on 2-5-21 @1:20 but canceled after all the trouble I had from the first one.  I did not go to the dr for myself, as I don't have very good insurance since my husband is on disability and we have insurance which does not pay very well. My husband has many dr's appt. and I could not afford to go.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL concerning a female who in December 2007, was vaccinated with the second dose of GARDASIL (dose, route, lot# not reported). The patient learned that she was pregnant in April 2008 and delivered the baby in October 2008. She had a "C-section", but she delivered a healthy baby. The patient had not yet received the third dose of GARDASIL. No further information was available. Obstetrical complication was considered as an other important medical events. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), TREMOR (shaking uncontrollably during the night), NECK PAIN (pain in the neck) and BURNING SENSATION (burning sensation in the legs.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. Patient had no medical history. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (pain) and TREMOR (shaking uncontrollably during the night). On an unknown date, the patient experienced NECK PAIN (pain in the neck) and BURNING SENSATION (burning sensation in the legs.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain), TREMOR (shaking uncontrollably during the night), NECK PAIN (pain in the neck) and BURNING SENSATION (burning sensation in the legs.) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The action taken with mRNA-1273 in response to the event was not applicable.
More distress, crying, scratching leg.  Awoke on 3/14 in distress, crying, leg injection site red, 4 pox at injection site.
ARMS SORENESS, ACHY IN THE BODY ESPECIALLY THE JOINTS, FEVER, TIREDNESS.
mom states noticed a quarter-sized red, warm area approx 17-18 hr p/inj site;states redness & warmth cont to get bigger;inj site upon presentation to clinic was hard, red, warm & raised an area of 9cm by 3 1/2cm w/t99.4;
All at the injection site: 1. Pain 2. Redness  3. Swelling 4. Itching Other adverse affects... 1. loss of equilibrium 2. Nausea/ Vomiting  3. Exhaustion
Ever since receiving the flu mist patient has had sinus congestion and drainage. On December 17, 2010 he was seen at the Doctors office and put on medication for a sinus infection.  It has not cleared up and needs to go in again.  He has not ever had a sinus infection before and things have not been right since receiving the flu mist.
It wasn't anything serious but I wanted to report it. 8 hours after shot-very  tired, body aches, felt very weak like the flu, low grade fever, chills, headache. Had shot at 3 pm , felt sick all night. It really came on fast at around 10 or 11pm for 5 or 6 hours. Then finally fell asleep. Woke up still exhausted , weak. most of the day. took Tylenol. It seemed to help the next morning but not that night.
Painful urination; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Painful urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included LOVASTATIN, GABAPENTIN, DULOXETINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSURIA (Painful urination). At the time of the report, DYSURIA (Painful urination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. it was reported patient had painful urination few minutes earlier.   This case was linked to MOD-2021-316173 (Patient Link).
Information has been received from a registered nurse concerning a 44 month old female who on 04-DEC-2003 was vaccinated subcutaneously in the right arm (also reported as the left outer arm) with a 0.5 ml first dose of Varivax (lot # 646138/0475N). On 05-JUN-2006 the patient developed a mild case of breakthrough chicken pox. The patient had less than 50 lesions. At the time of examination the patient had 12 lesions on her face only. There was no treatment or other symptoms noted. There was no product quality complaint involved. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Lot number: 33036BD), in right arm 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: "Migraine headaches" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies. The patient has experienced Awful taste in mouth Severe lower abdominal pain (start date: 28Jun2021) and was not recovered. The patient has taken Paxlovid for the treatment of covid-19 (treatment start date=25Jun2022, Treatment stop date=29Jun2022, Lot number=GC6416).
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case involves two patients who was vaccinated with a dose FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients' medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. Temperature excursion (fridge went down to 29 F for 75 minutes) that was reported on FLUZONE QUADRIVALENT for 6 to 35 months. HCP states that 3 patients received vaccines that were involved in excursion, 2 FLUZONE and 1 PENTACEL. It was unknown whether patients experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Tiredness  that night and the next morning i felt like i had not slept and continued over 5 days. i was so sleepy. legs were very shaky and i was very nervous inside. I had shortness of breath and i still have it. I road a bike 4 to 6 miles every day and now i cant.  i had chills and body pain, i feel like i had the flu. dizziness, just just random spouts of sleepiness and it would last for about an 1 hr and half.  My muscle in my chest just tightens and is hard as a rock. and then it goes away.
AFTER RECEIVING THE VACCINE, SHE COMPLAINED OF ALLERGIC REACTION SYMPTOMS. ON SITE EMS RESPONDED AND VITALS LISTED BELOW. SHE FELT BETTER AND WAS RELEASED TO HOME
pneumonia; got very sick; Initial information received on 18-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional.  This case was linked to cases 2020SA294125, 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294173, 2020SA294172, 2020SA294151, 2020SA294171, 2020SA294170, 2020SA294149, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294158, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves a patient (with unknown demographics) who got very sick (malaise) and pneumonia, when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (malaise) and pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for events was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns a patient (with unknown demographics) who experienced pneumonia and malaise after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Also, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Moderna 2nd shot = Broke out in hives across my neck, up both ears and side of face. First onset of hives happened 7 days post 2nd shot.  Moderna booster shot = Again broke out in hives across neck, up both ears and side of face.  Also happened 7 days post shot.   The pattern and placement of hives are exactly the same both times.  Have had to take prednisone and benadryl.   Other symptoms for both shots included headache, bodyache, chills and soreness on arm. But those symptoms went away after 24 hours. the hives are extremely severe and uncomfortable and I had to go to urgent care on both occasions.
treated for suspected UTI (though urinalysis was normal) with antibiotic; kidney failure; He passed away on 24Mar2021 due to heart failure; diagnosed with pericarditis; Developing fever; weakness; This is a spontaneous report from a contactable consumer. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) (at age of 81-year-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation, stroke, kidney disease, hyperlipidemia and Known allergies: NKDA. There was no other vaccine in four weeks. Concomitant medications included rivaroxaban (XARELTO); allopurinol; and acetylsalicylic acid (ASPIRIN 81). On 20Feb2021, The patient started developing fever, weakness. Saw family Dr on 26Feb2021, treated for suspected UTI (though urinalysis was normal) with antibiotic. On 01Mar2021 high fever returned with extreme weakness. Admitted to hospital from 01Mar2021 to 18Mar2021 and diagnosed with pericarditis. He was sent home on Hospice. He passed away on 24Mar2021 due to heart failure. Prior to the vaccination, he was having no symptoms of infection, he was active and healthy, and he was seeing a cardiologist regularly.AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Patient died on 24Mar2021. Death cause: heart failure, kidney failure. AE treatment: numerous medications given during hospitalization. No covid prior vaccination.Covid tested post vaccination: was Yes. Covid test type post vaccination: Nasal Swab, Covid test result: Negative. No autopsy performed. The outcome of the events heart failure and kidney failure was fatal, of the rest of events was unknown.   The lot number for BNT162b2, was not provided and will be requested during follow up; Reported Cause(s) of Death: kidney failure; heart failure
Ocular Migraine - Severe Migraine Headache - Nausea/Vomiting - Diarrhea - Vertigo. All continued for approx. 5.5 hours occurring simultaneously or sequentially. Treatment: Sumatriptan (100 mg) 2 times as prescribed, rest, then finally slept for 2.5 hours. Upon awakening the ocular migraine (auras) were gone, the headache continued but it wasn't as severe, the vomiting stopped, the nausea continued but not as severe, no diarrhea, no vertigo.
local reaction to injection. c/o hard, throbbing area at injection site. Brought to administering RN by school nurse with ice applied to site. About 45 min after administration. C/o redness but no redness/ swelling  after ice removed. When asked if throat was scratchy by another nurse, boy stated "feels  a little funny' No difficulty swallowing . Decision made to administer 50 mg Benadryl po,@ 8:00am.  Multiple BP Stings" at injection site.  Sent back to the office and SNT then sent back to class.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (lot number reported as L007531 and expiration date 04-NOV-2016) dose, frequency and route of administration were not provided, which on an unknown date underwent a temperature excursion. No adverse effects were experienced by any of the patients. Additional information has been requested.
Got shingles on left side, on back,shoulder, down left arm and onto hand.  Pain in arm and hand, strong pain in thumb.  Took three and a half months to get over pain.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. The patient was treated with Paxlovid from 05Mar2023 to 09Mar2023.
PT DEVELOPED VOMITING 1.5 DAYS AFTER RECEIVING THE COVID VACCINE ON 12/10/21. , WAS SEEN IN OFFICE ON 12/13/21 AND HOSPITAL ED ON 12/15/21 AND DETERMING :LIKELY A REACTION TO THE VACCINE"
It has been 2 months since becoming fully vaccinated. I have ALWAYS had very regular periods, 28 days apart (+/- 1 day). Since becoming fully vaccinated I have had incredibly irregular cycle lengths and duration. I had a very heavy 7 day period, one light 3 day period and random spotting with one "regular" cycle in between. I am not pregnant. I have never taken hormonal birth control. I have no changes in health status during this time.