chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a State Immunization Official and refers to multiple patients (exact number unspecified) of unknown age and gender. The patients' concurrent conditions, drug reactions or allergies, concomitant therapies and medical histories were not provided. On multiple unspecified dates, the patients might have been vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # L013192, expiration date: 19-JAN-2017, orally (doses were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 29.3 degrees Fahrenheit (F) for 2 hours 56 minutes, 28.8 F for 7 hours 6 minutes, 34.7 F for 26 minutes, 34.5 F for 27 minutes, 33.6 F for 1 hour 13 minutes , 30.6 F for 5 hours 55 minutes, 31 F for 3 hours 30 minutes, 33 F for 1 hour 59 minutes, 33.4 F for 2 hours 20 minutes, 32 F for 4 hours 15 minutes, 32 F for 3 hours 52 minutes, 32 F for 4 hours 4 minutes, 30.1 F for 4 hours 53 minutes, 31.7 F for 4 hours 5 minutes, 32.5 F for 2 hours 21 minutes, 33.2 F for 2 hours 16 minutes and 33 F for 1 hour 23 minutes. Digital data logger was involved. There were no previous excursions reported. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014169: US-009507513-1612USA014170: US-009507513-1612USA009918:
Day # 5 of illness that started immediately on return from a trip, where he collected air samples for his grad program. Initially he had diarrhea and fever of 101, started Cipro and on day 3 diarrhea improved but he had fever to 102. Yesterday, day 4 he stopped the diarrhea but this AM was so exhausted he couldn't get out of bed, had a fever or 101 and a severe 8/10 headache and a stiff neck. He was sent to ER on the same day of 11/22/2013 and admitted to hospital and discharged on  11/24/2013. Rx of Aspec meningitis, LP sample sent to CDC and compatible.  He has been completely recovered.
Information has been received from an office manager concerning a 24 year old female patient who on 30-MAY-2007 was vaccinated with a dose of Gardasil.  On approximately 02-JUN-2007 the patient developed "peeling in the mouth".  Medical attention was sought.  The patient had not recovered.  Additional information has been requested.
freezing cold; blood pressure going down; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiration date was not reported),via an unspecified route of administration, administered in Arm Right on 01Mar2021(at the age of 75 years) as dose 1, single for covid-19 immunisation. Medical history included blood pressure, Vitamin D low, Triglycerides, digest food (Has been taking for 6-7 years). Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCT) taken for blood pressure (100/12.5 mg daily ); atenolol  taken for blood pressure from 2001 and ongoing 25mg daily ; amlodipine besilate taken for blood pressure from 2015 and ongoing(5mg daily); fish oil taken for blood triglycerides from 2006 and ongoing (1000 units daily); vitamin d nos  taken for vitamin d abnormal from 2011 and ongoing(15,000 units per week ); probiotics taken for dyspepsia from an unspecified start date and ongoing. On 01Mar2021 the patient experienced freezing cold, blood pressure going down. Her weight a few months ago was 153 lbs. She has been trying to lose weight. She walks daily. She was unable to state if her blood pressure going down was ongoing or if it has resolved. She read on the internet to drink water to bring the blood pressure up. Should she call the doctor and let her know about effects. Last night she was freezing terribly. It was a 10 on a scale of 1-10. She does not have any soreness. Heart problems run in her family. She will call her doctor. She monitors her blood pressure. She has used her husband monitor to compare. She is scheduled to have a steroid shot in 3 weeks. Can she get it? She is scheduled to get the second Covid vaccine on 24Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement reading was 106/57 (high blood pressure), 108/55, After moving around and having dinner her blood pressure this evening 113/61, (Normally top number is 130), investigation scale it was a 10(Normal low 1 Norm high 10), weight: 153 lbs. The patient received treatment for blood pressure going down (hypotension). She is on four different types of blood pressure medications for high blood pressure. The outcome of vent freezing cold was recovering and blood pressure going down was unknown.  No follow-up attempts are possible. No further information is expected.
Vertigo, which recurred off and on for two days.   After I took Benadryl, it went away.
approx 15min p/vax father reported coughing & runny nose;child was wheezing, tight cough, rhinorrhea, hives;
Narrative: pt passed away within 42 days of receiving the vaccine - unknown as to what lead to death
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is related to case- 2019SA088989, 2019SA089330 (same reporter). This case involves a 24 months old male patient who received a 0.5 mL expired dose of DAPTACEL vaccine. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13; and HEPATITIS B VACCINE on 27-Mar-2019. On 27-Mar-2019, the patient received a 0.5ml dose of suspect DAPTACEL (lot: C517AA, expiry date 23-Mar-2019) via unknown route in the thigh NOS. It was an actual medication error due to expired vaccine used. The patient did not experience any adverse reaction after the injection. 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 and Module VI of the 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.
13 hrs post vaccination started with fever (101), body aches and chills. Today just fatigue
Pt developed worsening tinnitus after vaccination (this was preexisting but significantly worse starting about two weeks after vaccination).  Also developed cold sore on June 10th, and shingles outbreak on June 17th.
L leg pain starting 4/15/2021, symptoms similar to superficial thrombus he has in the same leg in 2017 . No recent injury.  J and J COVID 19 vaccine on 4/6/2021. Started on Eliquis on 4/16/2021. Improved but still having significant L medial thigh pain during follow up appt on 4/20/2021. Scheduled to be seen by PCP next on 5/10/2021.
Had redness; This case was reported by a consumer via call center representative and described the occurrence of erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient's spouse. The age at vaccination was not reported for this report. The patient received second dose of shingrix in 2019 and experienced redness. The reporter did not consented to follow up. No further information was available. This case is linked to the case US2021054416, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054416:Same reporter
Client received flu vaccine during drive thru exercise on 10-3-07 at park. She called today 10-4-07 at 11:25 and stated she was having tightness in her chest. She was referred to her Dr. to seek medical advice. 10-8-07 Follow up TC to pt. Pt. states that she felt better on 10-4-07 and no complaints since.
Swelling of the shoulder and immobility upon lifting the arm upward starting after the vaccination and persisting to 07/21/2019. Patient advised to follow up with primary care provider.
Day 2 - sore injection site; Day 3 - sore injection site, swollen glands near site of injection; Day 4 & 5 - HA  Narrative:
Headache, Myalgia & NauseaVomiting Narrative:  chills, flu like symptoms
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On 20-DEC-2012 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions(for prophylaxis). Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Progressive hypoxia with significant sputum production over weeks, with worsening progression 1 week PTA. History of HFpEF and feels legs are swollen but Chest xray shows stable unchanged right pleural effusion & BNP unchanged from previous. There is opacification of right lower lobe possibly due to mucus impaction & majority of right lower lobe is collapsed. Patchy nodular ground glass infiltrates throughout left upper lobe. Stable on 1LNC on admission, does not use O2 at home. Suspect combination of acute covid infection with bronchitis, mucus plugging (bronchiectasis? Aspiration? Unclear etiology), and potentially a component of CHF but this is less likely a significant contributor.  - Oxygen available, titrate to maintain SPO2 89 - 94% - See covid, CHF, & dysphagia for additional management   Infection due to 2019 novel coronavirus Symptom Onset Unclear, most likely 10/24/2022 but insidious - Oxygen: continue current support with O2 Device: Nasal cannula 1LPM, titrate to keep SpO2 between 89 - 94% - Labs: Daily COVID labs ordered x4 days (CBC, BMP, D-dimer, CRP).  Continue to trend after 4 days as needed.  - Breathing treatments: combivent inhaler four times a day scheduled;  - COVID-Focused Medications: Remdesivir, plan for 5 day course - Antitussive medications available
Recurring unexplained hives. The breakouts happen randomly and have increasingly gotten worse. Occasionally the hives are accompanied by wheezing, cough and swelling of facial extremities.
1 of 6 elderly pts to receive vax & devel inject site rxn.with swelling & erythema. Pt has had flu vax each of the past few yr.
Patient experienced headache; Body ache; Chills; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (First dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Patient experienced headache"; PAIN (non-serious), outcome "unknown", described as "Body ache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced severe dizziness, stabbing head pain/HA, nausea, and neck pain. She stated she almost went to the emergency room but was able to lie down and take OTC pain meds for relief
Patient received first dose of Moderna Covid vaccine and a few minutes later passed out and had what seemed to be a mini seizure. Patient was able to get into sitting position shortly after and was responsive, 911 was called, patient was transported by EMS.
Local redness, swelling. Treated for potential cellulitis with 3 day course cephalexin 500 mg TID, antihistamines.
Patient is a  84 y.o. female with dementia who resides in an assisted living facility.  She usually ambulates with a walker per her son.  She fell OOB almost 2 weeks ago and hit her right cheek - has a bruise there but seemed fine afterwards.  Her son reports she had some slurred speech on Sunday but by Monday it had resolved.  Caretaker had reported she seemed to be dragging one leg when she walked earlier this weak.  Today she was sent to ER for some confusion - her NIH stroke scale was 11 but some of the score was felt to be due to confusion with understanding directions.  An MRI shows acute stroke to the Left Posterior Parietal area and also small Left Lacunar infact adjacent to the left lateral ventricle.  She does not appear to be on any antiplatelet drugs or statins per her med list.  Her son reports she had trouble moving her left leg in the ER and trouble with speech.  she is able to follow simple commands for me.  There is no facial droop.  She does have expressive aphasia but pulls the covers up over herself and says "cold".  She easily lifts both legs off the bed for me on command and has good hand grips.     Hospital Course: Patient was admitted with expressive aphasia - Neurology was consulted - family requested hospice care as patient had little hope of improvement.  She tested + for Covid but was not requiring any oxygen.  She was made hospice care only on the Covid unit and died on 9/27/2021 at 10:01 AM
Rash started in groin/thigh area 3 days after vaccination. Assumed it to be fungal and tried treating with terbinafine topical. Went to urgent care 1 week after vaccination due to severe itch and redness and not responding to OTC antifungal treatment. Diagnosed as fungal rash due to location but was also not responsive to OTC terbinafine topical. Physician?s assistant advised to switch to OTC clotrimazole and prescribed 1 tablet of fluconazole 150mg. Rash continued to disseminate to many other parts of body in small clusters over next 3 days and rash was only getting worse. Called dermatology for consult. Rash spread to opposite side of groin, stomach, buttocks, both arms, under chin, back of neck. Sent photos via email to Dermatology and MD diagnosed as contact dermatitis. Prescribed clobetasol cream and prednisone taper over 12 days. Rash has been improving since starting steroids but still not completely gone after 5 days of being on prescribed steroids.
Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy", weakness, seeing stars.  Appeared pale and clammy.  Eased to floor to lie flat. B/P=92/62.  B?P after 5 min of being supine 102/64.  Able to sit up after 10 minutes.  Continued to rest for 30 minutes with slow consistent improvement in weakness and dizziness.  Left clinic within one hour with improvement.
Vaccine administered came from vial that was kept in fridge longer than manufacture recommended storage date. The manufacture informed us via written statement that patients "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination was not advised. We called the patient to inform them of the situation and the information we received from the manufacture. No adverse reactions were reported by the patient.
One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for the adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the diver clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
I had a dry cough, fever of 100, and sore throat. I tested positive for COVID-19 on the same day. I spoke to my doctor, and they prescribed me Paxlovid. I started feeling better on the evening of the 10th.
Redness, irritation around injection site that then migrated to the inside of the arm. There also appeared to be some fluid accumulation near the elbow.
ADULT DOSE PFIZER WAS PROVIDED INSTEAD OF PEDIATRIC PFIZER (PATIENT IS 11 YEARS OLD)
erythematous area 5x5 ", very painful; no fever; last dose greater than 10 years; 27MAR95 f/u recovery status unknown
Pat said she felt shaky and her chest hurt immediately after injection. No complaints weaken 20 min after injection.
Tested positive for Covid-19 , had a bad cough, very stuffy nose, fatigue
sciatica and arm pain that are becoming worse and progressive; sciatica and arm pain that are becoming worse and progressive; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (sciatica and arm pain that are becoming worse and progressive) and PAIN IN EXTREMITY (sciatica and arm pain that are becoming worse and progressive) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SCIATICA (sciatica and arm pain that are becoming worse and progressive) and PAIN IN EXTREMITY (sciatica and arm pain that are becoming worse and progressive). At the time of the report, SCIATICA (sciatica and arm pain that are becoming worse and progressive) had not resolved and PAIN IN EXTREMITY (sciatica and arm pain that are becoming worse and progressive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient reported on 3/12/18 that (R) arm starting hurting with redness and swelling stated it started at night of 3/9/18. Area assessed by RN and referred to urgent care.
Severe muscle pain Severe joint swelling and pain Tingling fingers and toes Flashing sweats and chills Advil/Aleve/Tylenol do not help the pain go away
Round circle size of quarter not raised & was red, spotted. No itchy, no pain. Rash is going away. Not sure when rash developed.
In January 2023 I noticed a lump on scrotum that I thought may be a spermatocele. I made an appointment with my primary care physician. He referred me to a urologist who ordered an ultrasound to of the lump on my scrotum to see the viscosity of the tissue, he also ordered bloodwork to check the levels tumor marker checking. The bloodwork came back negative for tumors, the ultrasound did show that I have spermatocele. I will have a follow up visit in three months.
rash onset 08/07/19; outcome: confirmed positive for varicella by PCR
Redness at injection site; Warmth at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient was taking Thyroid pill once daily. No treatment were provided.
blotches on her forearm/red spots; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious) with onset 18Mar2021, outcome "unknown", described as "blotches on her forearm/red spots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-AUG-2023 Nurse reported Bexsero vaccine exposed to a low temperature of 31.5 degrees Fahrenheit on 15June2023 was administered between 15Jun2023 and 21Jun2023. The reporter did not have specific date of administration for the patient. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The vaccine was kept out of the specified temperature which led product storage error. The reporter consented to follow up.  This case is one case among 4 linked case.; Sender's Comments: Nurse reports Bexsero vaccines from lot number 5AR2D exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated.  ~~~~~~~Consented to follow up. "The Vaccine Administration Facility is the same as Primary Reporter", Call Notes:Patient 3 of 4.  Reporter gave permission for follow-up. US-GSK-US2023105936:same reporter US-GSK-US2023105934:same reporter US-GSK-US2023105930:same reporter
Sever bilateral cramping in thighs, calves, shins & feet.  Started @ 4 PM -> at night bad.