chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Lot number: fk9729) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2020 as dose 1, single (Lot number: 025J20-2A), in Jan2021 as dose 2, single (Lot number: 029L20A) and in Aug2021 as dose 3 (booster), single (Lot number: c09021A) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing); "Iodine based dyes" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
It was reported that an 18 year old female received a Menomune A/C/Y/W-135 vaccination on 6/12/00. Reportedly, on 6/13/00, the pt developed a headache, fever, general malaise and a mild local reaction. Recovery status unknown. Further information requested. From additional correspondence received on 7/12/00, it was reported that on 6/15/00, the pt was dx'd with mono. Reportedly, the pt recovered from this experience. No further information is expected, case is closed.
Itchy rash on chest/abdomen starting 12/18/10. Still remains now.
Mom states that patient developed at temp that evening of 99, then the following day 100.6.  Treated with acetaminophen.  Patient developed large red welts on back of thighs, and down front of legs, but deny being located around the infection site. Patient has a cough and runny nose, and mom dx with strep just previously.
Pt states noticed some stiffness & weakness in elbow joint & arm muscles following shot; unsure of day of onset; persisted p/2nd shot had to use heating pad on elbow joint & elevated arm in order to sleep;
Following last immun pt had inc temp of 103 for 3 days; unable to be comforted for 24 hrs; Pt was seen by pvt MD;
I administered an expired vaccine.  The expiration date was 1/2020 and the date of administration was 2/5/2020.  I let the patient know by phone call and advised him to report any adverse events to either us or the VAERS.
Patient fainted after a few minutes after dose. Patient came to and his blood pressure was low and he was sweating and shaky. Patient's blood pressure improved over the next 10 min. Patient reported being fine after a few more minutes and left for home.
Clinical system was down therefore had to use instore event , the Pfizer  CDC  label on refrigerator and Pfizer box had use by 10/21/2022   the immunization was given  and going to add the immunization in clinical services, it was found the Pfizer Pediatric  immunization  expired 9/30/2022
In 7/98, the pt developed varicella and sought unspecified medical attention. No further information is available.
Pt recvd 3 dose of Hep B vax on 27NOV91 & by dinner time, pt exp fatigue, malaise & devel diarrhea; There was no fever or abdominal sx; w/in 24 hrs pts sx resolved;
Pain, redness, fever peaks at the site of application, until today March 5. Pain from the left shoulder that extends to the elbow. Today I had an episode of Migraine with aura.
shortness of breath, heart beating faster, self-resolved with supportive care, pt. refused transport
Following vaccine, patient became clammy, chills and shaky. C/O arms tingling, chest pressure, and lightheaded. Temp was 100., other VS normal, SaO2 100%. No respiratory distress. After period of time, patient still was not feeling well and "couldn't feel her arms". Decision made to go to the ED. 911 called and transferred
soreness of left arm ,fatigue, chills, muscle aches, and sinus symptoms.
patient was hot and sweaty, passed out, came around and felt better over next 15-20 minutes, patient's parent contacted ems but when they arrived patient was much improved
I would not report this event as a adverse one, but as a benefit. As stated in my patient information, my autoimmune condition Alopecia areata universalis caused all of my hair on my body fall out in a 2 month period in early 2019. I was under a dermatologist's care, but he was unable to stop the hair loss. Since that time, I have not grown any hair nor have I had the need to shave my head or beard. About 3 weeks after my first dose of the Pfizer, I started to notice very light, patches of fine hair growing all over my head and a few beard hairs growing. The small patches of hair continue to grow and expand. I'm not sure if this is in any relation to the Covid-19 vaccine, but it was only after the first vaccine that any hair growth has been on my body since I lost all of it in 2019.
I woke up with a terrible back ache the 1st morning and I was extremely tired and lethargic. I continued to feel that way for 3 more days. On the 4th day, I was sneezing a lot and I am still sneezing a lot.  I have had chills, and then I am extremely hot.  My head felt very clouded throughout the 4 days after the vaccination.
Chicken pox onset 3/16/03 post Varivax. Fever control Benadryl
Shortly p/vax pt c/o pain @ site, h/a & body aches; fever to 103; devel overnight w/vomiting x 3; rx Tigan & APAP;
Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 03Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, the patient experienced diarrhea. Adverse events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event diarrhea was unknown at the time of report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A HCP called to report a data logger discrepancy in which he was not able to report what temperature doses of administered VAXELIS and VAXNUEVANCE were maintained at. No additional AE information was able to be provided; This non-serious spontaneous safety report, with reference number, was received by a partner on 18-JUL-2023 and forwarded to agency on 19-JUL-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "A HCP called to report a data logger discrepancy in which he was not able to report what temperature doses of administered VAXELIS and VAXNUEVANCE were maintained at. No additional AE information was able to be provided." was assessed as not applicable due to the nature of the event.  Further information is expected.  Significant Follow-up information was received by the partner on 31-JUL-2023 and forwarded to agency on 01-AUG-2023, from a HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event "A HCP called to report a data logger discrepancy in which he was not able to report what temperature doses of administered VAXELIS and VAXNUEVANCE were maintained at. No additional AE information was able to be provided." was assessed as not applicable due to the nature of the event.  Further information is expected.
2:37pm Patient reported feeling shortness of breath after walking to car after 30 minute recovery post vaccine administration. Patient was wearing  two N95masks. Patient reported having a history of shortness of breath recently and went to pulmologist yesterday for an eval. RN advised patient to remove masks for better oxygenation. Patient declined removing both masks and removed just one N95 mask. RN asked patient to take deep breaths and self administer inhaler as prescribed by provider. Patient refused to use inhaler at vaccine clinic setting. Vitals-135/71, HR-97, Pox-93-95%, RR- 24 pox after 15 minutes after removing mask- 96%. Patient reported feeling better and reported she would use inhaler when she arrived to home.
administered to patient post excursion with no reported adverse event; product storage error temperature too low (with no reported adverse event); Initial information received on 16-Feb-2023 regarding an unsolicited non-valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733, 2023SA057309 and 2023SA068949.  This case involves adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
blood work results 04/20/2021- GFR rate = 46.1 . Prior GFR rate 11/24/2020 was 56.9 . Subsequent testing on 05/21/2021, GFR rate = 56.9 and on 08/20/2021 GFR rate =50.8  Treatment between April and May blood work was to stop the Metformin and the Ramipril After the May blood work both drugs were resumed at the prior dosing.  Action was a referral to a nephrologist, kidney doctor.  Onset occurred  09/14/2021 ( that's when we became aware it , date of consult.) No, have not recovered from the AEs because the blood work is coming back low again.
Day 1: Ten hours later: exhaustion, body ache, fatigue without being able to sleep, diarrhea, headache Day 2: Extreme body ached and headache Day 3: spaciness and exhaustion Day 4: Joint cracking with movement Day 5: Mild/nothing Day 6: Fever and chills
Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated like normal. About 5 minutes after administering the vaccine to the patient, he stood up and came to the window to tell the technician on duty that he was not feeling well. He appeared sweaty and pale. The technician immediately advised the patient to sit down and called for the pharmacist on duty. The pharmacist went into the vaccine area and when she reached him, he went into a seizure-like state. He was foaming at the mouth, his hands were spasming, and he went stiff. The technician immediately called 911 and advised them of the situation. The employees stayed with the patient until the emergency services arrived approximately 7 minutes later.
From Dr's Note: Patient took Vaccine and after 2 weeks, she has been itchy. Went to Emergency one at night. Was prescribed Permethrin and Ceterizine. After finishing, it started again. Has been occurring again. Sleeps in bed with husband and he has no rash. The rash is on stomach, back and chest. Began on back. Now on legs, abdomen, arms.
This spontaneous report as received from a pharmacist refers to a 52 year old female patient. On 05-JUL-2017, the patient was vaccinated with ZOSTAVAX lot number reported as M0374655, for prophylaxis. In July 2017, the patient experienced injection site mass. The outcome of injection site mass was reported as not recovered/not resolved.
A week after the vaccine (1/28 9 pm) overnight on 2/5/21  I got a severe stomach bug. It started with a severe headache, heartburn and bloating. (At first I thought it was food poisoning because it came on suddenly within hours of eating. The severe discomfort was Followed by a fever of 100.5, and body aches. I took Tylenol. The next day I took gas-x and Mylanta. The next day my temp was down to 99.5 and I had severe diarrhea all day. The 3rd and 4th days I hydrated and tolerated soft foods.  6 days later I am feeling better and started  eating more solid foods. I got tested for COVID on Tuesday 2/9/21 ans got the results today that I tested negative.  I?m not sure if this was a vaccine Rection or a separate bug. I?m relieved that it wasn?t COVID.
10/21/2003: Noticed right upper arm red, warm and swollen.  given decadron 10mg IM.  Better on 10/22/2003.
Client had J&J vaccine for Covid in March, 2021.  Was admitted to hospital on 11/16 with severe abdominal pain and diarrhea x 3 weeks and diagnosed with colitis.  Tested for Covid as routine on admission.  PCR + for Covid 11/16.
SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN URINATING; 4 FALLS; FELLS LIKE SOMETHING IN THROAT; BEDRIDDEN; REDUCED ABILITY TO PERFORM DAILY ACTIVITY; MEMORY PROBLEMS; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation when urinating. On 2021, the subject experienced 4 falls. On 2021, the subject experienced fells like something in throat. On 2021, the subject experienced bedridden. On 2021, the subject experienced reduced ability to perform daily activity. On 2021, the subject experienced memory problems. On 2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced severe body aches. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced extreme fatigue. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced burning rash. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea on 22-APR-2021, was recovering from burning rash, and nausea, had not recovered from extreme fatigue, memory problems, flu-like symptoms, and severe body aches, and the outcome of 4 falls, burning sensation when urinating, bedridden, reduced ability to perform daily activity, fells like something in throat and tinnitus was not reported. This report was non-serious.
Pt started feeling tingling in fingers and numbness in mouth after vaccine adm. She states it initially got worse but is getting better after 30 min. Pt also complained of nauseous during observation. Nausea resolved after 10 min Pt believed symptoms are from anxiety. Pt given water and felt better by d/c.
Rash and some itching appeared on trunk and left arm (admin arm) on 9/18/09 around 3 hours after injection.  Treatment antihistamine.
Patient has redness on injection site 1 week after receiving the vaccine. Patient states is warm to touch and is slowly going down and has applied ice to the area.
Vaccine given after being drawn up more than 12 hours before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up contains No new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-251523:MOD21-118851, MOD21-118852, MOD21-118853
This spontaneous report as received from a Register Nurse refers to an unspecified amount patients of unknown age and gender. Concomitant medication, pertinent medical history, drug reaction and allergies were not reported. On an unknown date, unspecified amount of patients were vaccinated with GARDASIL, which underwent a temperature excursion, 0.5 ml, intramuscular (lot number was not provided). No adverse effect reported. Additional information has been requested.
Red circle found 8-10 days after vaccine which started with itching and then arm pain.  Redness continued to spread.  General MD prescribed antibiotic and red circle dispersed 2 days later.
Immediately after vaccination @16:47 pt reported that he was light headed and had "fainting like symptoms". Vitals: 109/69, 77, 18, 100%, 98.7F Pt stable and released from the vaccination site @17:27
Information has been received from on 02/28/02 from a physician concerning an 11 year old female who 02/22/02 was vaccinated with a dose of Varivax (site unknown). On 02/26/02, it was reported that the patient was "crooping with chicken pox" all over body, and had a fever. The child was referred to a dermatologist who determined it was varicella. The patient was started on Acyclovir. Additional information has been requested
Kidney stone; patient was also treated for sepsisduring her admission; This spontaneous report from was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was found to have a kidney stone and was treated for sepsis.   The patient was diagnosed with urinary tract infection (UTI) before receiving the first dose of the vaccine. Products known to have been used by patient, within two weeks prior to the event, included antibiotics.   On 08-Feb-2021 the patient received her first dose of mRNA-1273 (Lot number: 011M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.    The patient continued having the UTI after receiving the first dose and was started on antibiotics. The patient was found to have a kidney stone and was admitted to the hospital for kidney stone removal surgery on 24-Feb- 2021. Patient was also treated for sepsis during her admission at the hospital. Patient was scheduled for second dose on 08-Mar-2021 and would like to know if it was okay for her to receive the second dose.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events kidney stones and sepsis were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Approximately 10 minutes after the vaccine was administered, mom notified staff that she saw a red/blotchy rash across her chest and upper arms.  No other symptoms noted: no swelling, no vomiting, no other complaints.  Mother and child stayed in the waiting area and patient was given a fruit punch juice box and scooby doo snack pouch.  By 5pm, approximately 31 minutes after administration of vaccine, no rash or redness was seen on patient.  No other complaints noted. No medications were given.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.
030L20A 1/22/2021 039K20A 2/20/2021 051F21A 11/8/2021  6/4/2023 - 6/14/2023 (10 days)  DC to SNF tx: Remdesivir & ceftriaxone azithromycin -HTN -HLD -CAD s/p  CABG -s/p  stents -chronic systolic and diastolic heart failure with last known ejection fraction of 30-35% with grade 2 diastolic dysfunction in February 2023