chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We received on 14 NOV 2007 via from a healthcare professional the following information: A 64-year-old male patient born on 11 MAY 1943, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 17 OCT 2007. The patient experienced on 05 NOV 2007 confusion and delirium. In the emergency room they have found a high ammonia level. The patient was discharged after a brief hospitalisation. The outcome is unknown. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data There is no timely relationship (19 days p.v.) and no plausible pathomechanism to assume a relatedness. Expectedness assessment according to health authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. :NA07-006414  2/19/08 Reviewed hospital medical records which reveal patient experienced delirium & hyperammonemia.  Admitted 11/5-11/7/2007.  Improved w/med changes.  D/c to home & pcp f/u. FINAL DX: delirium due to hyperammonemia, resolved; acute prerenal azotemia; fatty liver; dementia; morbid obesity (BMI 42); Type 2 DM; carotid stenosis; dyslipidemia.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult male patient who received for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, he experienced sore arm and limit in mobility of the arm. The reporter was agree to follow up from GlaxoSmithKline.
vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.; No adverse event; received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.).    Concomitant product use was not provided by the reporter.  Expiry date of the suspect vaccine was reported as 06-Sep-2023. Dose was administered after 30-day use by date. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information about patient 2nd out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733290 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733290:Same Report Patient 2
7 April 2021, 0945, left arm (injection site) is sore and a bit pink. Was making breakfast started to feel nauseous and cold sweats went to the bathroom. Became dizzy leaned over the sink to support myself while it passed. Lost consciousness fell to the floor hit my left hip, forehead & nose. I was out for less than a minute, my husband came and assisted me to bed.  Contacted the triage nurse and soon received call from doctors nurse.  Using ice pack on left hip, left arm and forehead to relieve pain. Also took a Tylenol for pain from fall. Not dizzy or nauseas at this time so did not go to the hospital at this time.
The teen had a history of autoimmune disorder, alopecia areata for the past 2 years. When received the first dose of pfizer COVID vaccine, she started losing hair rapidly after about 6 to 7 days.  She was started on large dose of prednisone 100mg per day after 2 weeks to slow down alopecia. However, in the span of 4 days she lost most of her hair.  We are wondering if the vaccine could have exacerbated the autoimmune disorder.
Headache, Myalgia, Fever, Shaking, body aches, headache, fever, nausea Narrative:
bullous pemhigoid rash; preceded by fourneir's gangrene; still has rash
Approximately 2 hours after Flu shot her RD area began to hurt & swell with "arthritis-like" symptoms in Rt wrist and Rt hand following.  She treated with Tylenol and ibuprofen.  Pt thinks it might be preservative reaction.
I wasn't feeling anything other than the extreme fatigue.  I did a blood test at my primary doctor office and my iron was low. After that visit, My doctor diagnosed me with atrial fibrillation due to checking my heart rate during another visit. My primary doctor referred me to a cardiologist.  they treated me with cardio version to jumpstart my heart rate but that didn't work.  They are still doing tests to see what exactly is wrong and what caused the A-fib.
Started with a mild facial rash & a little throat swelling.  Over next two days my arm swelled at injection sight, then increased to swelling of the neck, back and most of the upper arm with redness, heat and extreme pain.
Patient broke out with hive like rash about 2-3 hours after receiving immunization. no temp no wheezing. Saw primary care physician this am 08/26/04 dx-multiform erythema-told from mmr.
Anxious, dizzy, hypertensive, lightheaded for 30 min-- monitored throughout -- resolved without intervention -- discharged home
I developed sores on my feet that the doctors said looked like chilblains.  He prescribed antibiotics and it has reduced, but not completely gone away.
had shingles...got the vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and ended up had shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Vaccine Tuesday 2/9, flu like symptoms 2/10, abdominal pain 2/11, pain worsens, nausea,  admitted to hospital 2/11. On saline drip until Monday 2/15.  Pancreas pain and partial bowel obstruction, low contrast test on 2/14, blockage moved and was expelled.  Seeing GI specialist 2/19.  Pancreas duct dialated
possible administration of invalid dose to patient; never reached an acceptable range and was always warm by at least 2 degrees C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.
Arm ache, stiffness, can't lift or move arm, swollen hand, shoulders ache, knees ache, back of legs ache, groin area hurts, can't dress self or drive anymore, can hardly move, in constant extreme pain
She has symptoms of bilateral adhesive capsulitis. She is using NSAIDs, intraarticular shoulder injections, and physical therapy.
Patient suffers from mercury poisoning; mercury induced autism. Follow up 4/12/04: Patient continues to suffer from mercury induced autism. It is probable that she will suffer from the mercury poisoning for the rest of her life to some degree. She has benefitted from mercury chelation. Follow up medical record on 05/14/04 states: completed.  Per annual report- Pt. suffers from thimerosal induced autism and continues to need daily medical and therapatic care.  Pt. suffers from mercury induced autism and probably will do so for the rest of her life.
1535: Received vaccine around 0850, Denies any sign and symptoms at that time.  Around 1500 suddenly felt faint, flush and saw black.  Patient denies Nausea/vomiting, SOB.  Patient was dizzy but was not clammy.  Sat down, felt better after sitting and patient given water. Got back up after 10-15 minutes felt fine until around 1530; again felt faint, flushed and blurry vision and dizziness.  Denies every losing consciousness. 1538: VS B/P 90/60, HR 78, o2Sat 92% on RA, RR-16, Sitting   1550: Medical team called; patient brought to first aid by wheelchair 1600: Verbalized feeling "much better" denies feeling flushed, nausea, vomiting, SOB, dizziness, some diaphoresis noted to forehead-cool rag applied.  1600: VS: b/p: 110/80, HR 95, O2Sat 96% on RA, RR 16, Sitting 1610: Provider on duty in attendance; assessed patient cleared for discharge home. Pt states she feels "much better" and is goo to go home. denied any further or new symptoms.
Patient felt weak, lightheaded, confused, tongue tingling, doubled over herself. Called 911 and took BP 118/57, Pulse 56, Temp 79,9. When paramedics arrived, her BP was much lower and they took her to the ER to administer fluids and further observation.
Ringing in ear, mostly right ear, did not have the ringing before the booster shot. Now the ringing is there every day.
PT arrived to ED via EMS from urgent care with complaints of throat swelling. Pt stridorous and lethargic upon arrival to ED.  Pt given two EPI pens at urgent care, 50 mg of benadryl IM by EMS, 20 mg of pepcid and 2 mg of ativan in ED. Pt still undergoing treatment in ED.
-Acute onset of fever, headache, and body aches. Fever to 103. No sore throat, cough or other URI sx to suggest influenza.
Improper vaccine reconstitution with 1ml saline and 0.5cc given. RN was in the home for at lease 45 post vaccine for in home assessment. Client was called in the afternoon and notified of the improper dosage. Was not having any effect post injection. Client was called the following day 4/3/21, client reported a sore arm at the site. Client was called  4/5/21 and the sore injection site resolved. No other immune response reported.
No adverse effect reported; Inadvertently administered intramuscular route instead of subcutaneous route; Information has been received from a physician assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.  On 06-MAY-2019, the patient was inadvertently administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number: N032750 and expiration date: 20-NOV-2019; dose, and strength unspecified) by the intramuscular route instead of the subcutaneous route (Incorrect route of product administration), for prophylaxis. No adverse effect reported.
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
24 hours post immunization, pt developed fever of 101, felt weak, passed out in shower. Treated with Tylenol and bed rest for 24 hours
She developed redness, soreness, pain and hot to touch; She developed redness, soreness, pain and hot to touch; She developed redness, soreness, pain and hot to touch; It hurt a little when injected; This spontaneous case  was received on 29-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02580) and concerned a female patient of unknown age.    The patient's medical history and concomitant medications were not reported.   On 18-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was 276569, expiry date: 30-Jun-2021. The patient stated the vaccine hurt a little when injected.  On 19-Sep-2020, one day after receiving Flucelvax QIV, the patient developed redness, soreness, pain and hot to touch.    The outcome of events was not reported.   The reporter assessed the events to be related to Flucelvax QIV. The pharmacist called to report adverse reactions to Flucelvax QIV.   The reporter assessed the case as non-serious.  Company comment: The patient developed skin warm, pain, erythema and vaccination site pain one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The pharmacist called to report adverse reactions to Flucelvax QIV.; Sender's Comments: The patient developed skin warm, pain, erythema and vaccination site pain one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Information has been received from a physician concerning a 27 year old female who about 1 week ago, on approximately 22-Sep-2008, was vaccinated with an unspecified dose of GARDASIL (lot#0373X), intramuscularly. Subsequently on an unspecified date the patient experienced sever arm pain at the site of her last GARDASIL vaccination. The patient sought medical attention in the office. At the time of reporting her symptoms had continued. This is one of two reports received from the same source. Additional information has been requested.
Feels like crap; Body itches in different places; blood pressure 170/110; Headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included high blood pressure; he has had high blood pressure before, but his medication keeps it under control. The patient's concomitant medications were not reported. The patient developed headaches. This morning at 2am, he had a really bad headache and checked his blood pressure and it was 170/110. He did not specify what blood pressure medication he was taking. He stated he felt like crap. The patient further stated that he had the itch, clarified that his body itches in different places. He has had high blood pressure before, but his medication keeps it under control. He got a Covid shot on Wednesday morning. Yesterday morning he got a headache (05Aug2021), and he woke up at 2am this morning (06Aug2021) with a really bad headache so he thought he better check his blood pressure, and it was 170/110. He asked could the Covid vaccine make it to where the blood pressure medicine can not do the job it needs to do. He stated that he felt like crap. Stated that this may all be normal, he just wanted to be sure that high blood pressure could be a side effect of the shot. Stated that his doctor's office was closed on Fridays, or he would call them. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Patient states the day of the vaccine she developed a headache and noticed swelling below where the vaccines was given. The next day the swelling was worse and seemed to have moved to her under arm area and side of breast on right side (same side vaccine was given). Since then the swelling has continued to decrease and improve. She also experienced some tenderness in the areas that were swollen which has also improved. On the night of 07/26/2022 she reported worsening of her headache and a  spike in her blood pressure overnight. She states diastolic pressure was 101. She then measured with a wrist blood pressure monitor in the morning which showed 141/71. Since the headache as resolved and her blood pressure has lowed she is not seeking medical care at this time but will if she notices a similar spike again. Swelling also has continued to improve, patient has been applying ice. States she prefers not to take NSAIDs if she can avoid it.  Patient requested  a report be filed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
The patient had swelling and redness in his left arm.  He was advised to use acetaminophen , an ice pack, and benadryl to help relieve his symptoms.
Day 1:  Mild soreness at injection site, no symptoms otherwise for the next ~30 hours Day 2:  At approximately 30 hours after injection:  body aches, headache, chills, low fever, swollen lymph node under left arm pit which was the injection site. Day 3: Same as day 2, symptoms began to fade by evening except for swollen lymph node which was worse than day 2 Day 4-6 (today):  Swollen lymph node continues, but is mostly subsided from peak swelling  NOTES:   This was my first injection I had covid starting Dec 27th.  Mostly recovered after day 6 except for a lingering cough that lasted for over a month.
No additional adverse event reported; Nurse reports the administration of expired GARDASIL 9 and inquiring viability information pertaining to administered dose.; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender. Information regarding the patient's concomitant medications, pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 02-MAY-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) for prophylaxis (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number T007035 has been verified to be valid, expiration date reported and established as 01-MAY-2022) (expired product administered).   The reporter inquired viability information pertaining to administered dose. No additional adverse event reported (no adverse event).
Following 2nd vaccination shot, at about 3 months later, routine check up found High Blood pressure when I have never had this before.
Received vaccine on 1/8/21. On 1/9/21 developed rash on neck (red dots not warm/hot to touch appeared on right neck, left neck). Self treated using hydrocortisone and the rash went away initially and then came back a few days later. Treated again with hydrocortisone. Also injection site was raised, hard. Denies fever.
pt recvd vax & devel chills, a fever of 103 & was throwing up; Blood work revealed pt had hepatitis B & C; pt's MD felt that hlth problems had nothing to do w/ receiving the vax;
lt thigh red, swollen & hot started 23AUG; ER MD gave DPH & Cephalexin x 10-14 days; 23AUG was size of fifty cents piece & on 25UAG in ER redness from groin to knee; redness & swelling lasted 2 days p/started meds;
Vaccines had an expiration date of 03/27/2022. This specific batch/lot number was taken out of the freezer April 1st. No cases of adverse reactions reported.