chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HAVING NIGHTMARES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced having nightmares. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of having nightmares was not reported. This report was non-serious.
1/3: near syncope about 4 hours after receiveing vaccine 1/4: near syncope around 6pm, followed by joint paint, chills, fatigue, nausea, headacheInjection site extremely sore on movement.
redness at injection site; raised area at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2020, the patient received Shingrix. On 10th February 2020, 31 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were resolved with sequelae.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient experienced redness and a raised area at the injection site after the injection. The follow up consent was granted.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8732) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing); "ear problems" (unspecified if ongoing), notes: She has never had ear problems in her entire life. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). Vaccination history included: Zoster vaccine (Dose 1, The first one was kind of nasty and the second one was really nasty. It wasn't anything unusual, it was exactly what they said, the body aches, fever, and everything.), administration date: 2016, for shingles immunization, reaction(s): "body aches", "fever"; Zoster vaccine (Dose 2, The first one was kind of nasty and the second one was really nasty. It wasn't anything unusual, it was exactly what they said, the body aches, fever, and everything.), administration date: 2016, for shingles immunization, reaction(s): "body aches", "fever"; Zoster vaccine (Dose 1, she had her first shingles vaccine years ago and it didn't work), administration date: 2016, for shingles immunization, reaction(s): "it didn't work".  The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
not feeling well due to being constipated; not feeling well due to being constipated; This is a spontaneous report from a contactable consumer via sponsored program COVAX.   A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Feb2021 (in the last 24 hours), patient was not feeling well due to being constipated. Patient wanted to know if could reschedule her second dose of the covid vaccine, scheduled for 12Feb2021. The Doctor prescribed a medication that would empty out her bowels for constipation. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
After getting the vaccine within 5 minutes patient got seizures. we called 911 the patient was able to stabilize in 5 minutes,  we had the patient sit on the chair when EMT's arrived they took over the treatment.
Flublok that was frozen was administered in error, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 33-year-old female patient who received 0.5 (unit not reported) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2006, Expiry date 22-May-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 14-Sep-2020, that was frozen (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  This was an actual medication error case due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  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.
About two of three minutes after the injection. I suddenly felt flushed, even a bit light headed. But those sensations passed after about a minute or so.  Injection site is definetly sore and slowly healing.
Varicella - Information has been received on 21 Mar 2000 from a healthcare professional concerning a male with a history of varicelle exposure who was vaccinated with one dose of varicella virus vaccine live within the last 1-2 years (unknown site ).  Subsequently the patient experienced a mild case of chicken pox consisting of bumps with some vesicles. The reporter indiciated that the patient was afebrile.  It was noted that the patient had an exposure to wild type virus two week ago.  The patient sought unspecified medical attention.  Follow up information received on 28 Apr 2000 from a healthcare professional indicated that the student caome down with a mild case of chicken pox after exposure some 20 days prior and that the varicelle virus vaccine live was given more than 1 year prior.  No further information is available.
itching /  Itching on lower legs / Itching on scalp; dizzy/lightheaded; rash on his chest, shoulders, both arms, on calf area and mid-back.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy/lightheaded), PRURITUS (itching /  Itching on lower legs / Itching on scalp) and RASH (rash on his chest, shoulders, both arms, on calf area and mid-back.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ibuprofen allergy, leading to stomach bleeding.) and Pollen allergy (sneezing, runny nose) since May 1956. Concomitant products included ACETAMINOPHEN, SILDENAFIL, METRONIDAZOLE and PROBIOTICS NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (rash on his chest, shoulders, both arms, on calf area and mid-back.). On 03-Mar-2021, the patient experienced DIZZINESS (dizzy/lightheaded). On an unknown date, the patient experienced PRURITUS (itching /  Itching on lower legs / Itching on scalp). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form. At the time of the report, DIZZINESS (dizzy/lightheaded), PRURITUS (itching /  Itching on lower legs / Itching on scalp) and RASH (rash on his chest, shoulders, both arms, on calf area and mid-back.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient treated himself with lotions. It was not very effective. The patient feeling good as of now with no adverse effects.   This case was linked to MOD-2021-100762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up received: Medical history updated, concomitant medications updated, corrective treatment updated. Event terms and clinical course updated.
67 y.o.   Admit Date:  7/21/2022   Discharge Date:  7/28/2022    Principal Dx/ Final Dx: Chemotherapy induced diarrhea   Relevant Inpt Dx: Principal Problem:   Chemotherapy induced diarrhea Active Problems:   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin   History of pulmonary embolism       Follow-up Recommendations: #1 please take medication as prescribed #2 please keep follow-up appointments   HPI: As per Dr Note:  "Patient is a 67 y.o. male with a history of diarrhea on immunotherapy for metastatic melanoma with complaints of worsening diarrhea since he stopped steroids. Patient was discharged on by mouth steroids on July 8, 2022.  Complains of multiple episodes of watery diarrhea. Oncology recommended admission for stool studies and possible steroids if the stool studies are negative. Not sure what makes symptoms better or worse. Denies any fever, chills, shortness of breath, abdominal pain or any other concerning symptoms. Admitted for further evaluation."   Hospital Course:   Patient presented with acute diarrhea. Infectious etiology was ruled out with negative C. difficile, ova/parasite, and stool cultures. Patient was seen by oncology and diarrhea was attributed to immunotherapy for malignant melanoma. Patient was started on oral prednisone and gradually his diarrhea improved. With improved symptoms he wanted to go home. He was recommended follow-up with oncology early next week for further adjustment of his prednisone dose. During his hospital stay he was also treated with Remdecivir for COVID-19 infection. On admission he was found to have supratherapeutic INR. Was given vitamin K which later on required Lovenox bridging until Coumadin dose was adjusted with pharmacy's help. At discharge pharmacy recommended 3.75 mg Coumadin dose daily until follow-up INR next week.     Unresolved issues requiring follow up (w/ labs or studies): None
Shortness of breath, fatigue, chest pain was found to have large pericardial effusion after a week of vaccination, the second shot
This initial spontaneous report as received from a nurse concerning a 6-year-old child of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were unknown per reporter. On 28-OCT-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, Lot # and expiration date not reported) for prophylaxis. It was reported that later, on an unspecified date in 2021, the patient developed spots that appeared as papules and not vesicles and had "5 chicken pox like spots that were not open and healed as of 11-NOV-2021". It was stated that after speaking with the nurses that day it was verified that the child did not seek medical attention and there was never a confirmed case of chicken pox. The nurse's supervisor stated that she did not think it was chicken pox and instead Hand-foot-mouth disease. The nurse also reported that they had spoken to the state immunization advisor about this situation and that the advisor was not considering this to be a confirmed case of varicella as there was not Polymerase Chain Reaction (PCR) testing performed. At the time of the report, the outcome of rash papular and hand-foot-and-mouth disease was unknown and the outcome of rash macular was recovered as of 11-NOV-2021. The causal relationship between the events and vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. This is one of several cases from the same source. Sender's Comments: US-009507513-2112USA005506: US-009507513-2112USA005507.
Patient describes redness, hardness and pain. She could not lift arm for 2 days. Symptoms have been occuring since administration. Symptoms are getting better.
Extreme fatigue from 8-10 am (one week to the day after shot one) followed by severe throat pain while swallowing for the rest of the day. Throat pain did not last more than 24 hours.  Low throat pain while drinking water. Pain while eating or drinking anything else (tea, OJ, eggs, an apple) felt like I was swallowing fiberglass.
Around 1:00 pm, loss of appetite; by 3:30 - loose bowel, requiring bathroom break every 20-30 min. By 4:30 or 5:00 pm - upset stomach.  Symptoms continued all evening and into the next day.
The covid vaccine vial was opened on August 5, 2022 and should have been disposed of after 12 hours. Instead it was given to a patient on August 8, 2022. It was refrigerated the whole time. The patient had no symptoms or signs. Our pharmacy is also reaching out to the manufacturer.
COVID19 Research      Pt requesting covid test. States rapid was postive yesterday.      HPI Patient presents emergency Department secondary to body aches, loss of taste and smell, headache. Patient's husband positive with Covid. Patient took a rapid test yesterday which was positive. She is here today for official testing as her rapid test was a home test and she needs documentation for work. She denies any nausea vomiting. No respiratory distress.
Within minutes after receiving the vaccine, the patient became dizzy, lightheaded and had blurred vision.  Additionally, her skin tone was pale and she was sweating.  At roughly the 5-10 minute mark, her blood pressure was 120/80.  I gave her an ice pack to place on her forehead and neck.  As she started to feel better, I gave her crackers to snack on.  After about 40 minutes, she stated that she was doing  much better and left with her fiance.
swelling and tightness under his left armpit; swelling and tightness under his left armpit; felt achy all over; arm hurt real bad at first like someone punched him real hard/ arm pain (in the injected arm); This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles a while back). Previously administered products included Moderna Covid shots with an associated reaction of adverse drug reaction (received 2nd dose on an unknown day and had more side effects with dose 2 than dose 1) and Moderna Covid shots with an associated reaction of adverse drug reaction (received 1st dose on an unknown day and had side effects).   On 8th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a week after receiving Shingrix, the patient experienced local swelling, axillary pain, general body pain and pain in arm. On an unknown date, the outcome of the local swelling and axillary pain were not recovered/not resolved and the outcome of the general body pain and pain in arm were recovering/resolving.   The reporter considered the local swelling, axillary pain, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for himself. The patient stated that his (left) arm hurt bad at first like someone punched him real hard.  The arm pain has improved but it still hurt a little at the time of reporting. He states he felt achy all over. The achiness has improved but he still feels (somewhat) achy.  The patient had swelling and tightness under his left armpit which has not resolved. The swelling and tightness under left armpit had a later onset than the sore arm and achiness. The patient did not have the lot number/expiration date however he did provide his pharmacy contact information (where the shot was given) who should have that data on file.  The reporter did not consent to follow up and did not want to share his physician contact information. He indicated that he would call GlaxoSmithKline later if he has any change in his mind.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193306:same reporter
Patient was 16 years of age and received the Moderna COVID-19 Vaccine, which is indicated for patients 18 years of age and older. Patient had no adverse reaction to the vaccine and feels normal.
No adverse event; Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3833D) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received his Spikevax 2023 2024 vaccine after Moderna Direct called the Pharmacy and told the patient that the vaccine was a bad batch" bad to use.).    No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743073 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743073:Bivalent dose
Patient was given Hep A 0.5 ml, right arm and Hep A 0.5 ml, left arm.  Patient showed no signs of adverse effect.  Parent was notified.
This spontaneous report as received from a physician refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. In October 2012, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot# and expiry date were not reported). The reporter stated that the patient showed in the office on 17-JUL-2015 to receive her second dose of GARDASIL (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality issue involved. Additional information has been requested.
Rash around injection site and then went across the top part of back on to her other arm and itchy.
Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt informed to sit after receiving vaccine mom walked away then pt got up and started walking and passed out in aisle walking to mom and scraped his elbow. pt seated and had something to drink, felt dizzy and felt vision was blurry upon awake. Informed mom we could call paramedics but mom felt he was okay. Observed for 30 min after fainting incident, felt much better, vision no longer was a problem and no longer light headed. Mom told to call Dr. in case pt hit head, said to observe him
Extreme sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (extreme sore shoulder) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A23A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-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 ARTHRALGIA (extreme sore shoulder). At the time of the report, ARTHRALGIA (extreme sore shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-387033, MOD-2021-386605 (Patient Link).
Pt developed swelling and redness at the site the day after the vaccination. She visited the pharmacy to show the reaction to the pharmacist on duty within the first week after having both vaccines. The pharmacist suggested she take IBU and ice the spot. She came back today and the redness is gone but there is still a sizeable hard knot that she says hurts when touched or bumped. Pharmacist who gave shots suggested she didn't get them in the same arm.
About 8 hours after injection, swelling and extreme pain/aching to the point unable to sleep