chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:27 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 81.75 years for dose administered on 28-Feb-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit at 09:00 AM and 01:00 PM respectively. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Experienced flu-like sx including cough, runny nose, sore throat & fever to 102 to 103 & rash;
Afternoon of injection and next day: Tired, no energy, stomachache, dull headache, arm soreness - tool 2 Tylenol vomited next day.
arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration on 21Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included seasonal allergy and mild jackfruit allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included finasteride and testosterone. The patient experienced arm pain and fatigue on an unspecified date. Clinical outcome of the events was unknown.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The dose number was reported as second booster dose.  No concomitant medication information provided.  HCP mentioned that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates have been extended.  Patients received expired doses from the lot numbers: 013f21a, 031h21a, 059h21a.  No treatment medication information provided.  HCP didn't have more information at the time of the call.
pt recv vax JUN96 & 23DEC96 pt devel chickenpox on face, torso, fingers & neck consisting of approx 35 vesicular lesions;
Deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell (serious criteria life threatening). On an unknown date, the outcome of the unwell was unknown.   It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Meningococcal vaccine, the patient got deathly ill. For the tolerance of 2nd dose, refer linked case US2020AMR119686.
Menstration started the next day, May 11 and has continued as of this date, May 27th.  It is accompanied with bloating, cramping, bright red blood, spotting, and clots.  This is not normal for my cycle.
Hard to walk; Injection site area is sore/pain at injection site; Feel achy muscles; Lil fever; very very tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Hard to walk), INJECTION SITE PAIN (Injection site area is sore/pain at injection site), MYALGIA (Feel achy muscles), PYREXIA (Lil fever) and FATIGUE (very very tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced GAIT DISTURBANCE (Hard to walk), INJECTION SITE PAIN (Injection site area is sore/pain at injection site), MYALGIA (Feel achy muscles), PYREXIA (Lil fever) and FATIGUE (very very tired). At the time of the report, GAIT DISTURBANCE (Hard to walk), INJECTION SITE PAIN (Injection site area is sore/pain at injection site), MYALGIA (Feel achy muscles), PYREXIA (Lil fever) and FATIGUE (very very tired) outcome was unknown.      Concomitant product use was not provided by the reporter.  Treatment medication included paracetamol 650mg one dose on 18 Feb 2021 at noon time.
attempted to inject it didn't go into the patients with no AE; he attempted to inject it didn't go into the patients but went all over his hand with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient for whom attempted to inject it didn't go into the patients but went all over his hand with no AE [Underdose] and [Exposure via skin contact], while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history was not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT 6686NA; Exp date: 30-Jun-2020] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to vaccine underdose and Exposure via skin contact.  It was unknown if any adverse event occurred.  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 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.
Patient reports that she began to have pain, swelling and redness on the morning of October 3, 2009. She denies any reaction to the vaccination prior to this date
Soreness at the injection site; This is a spontaneous report from a contactable consumer for her husband. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EH9899, Expiration date: Unknown), via unspecified route of administration, administered in left arm on 05Jan2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history. Concomitant medications were not reported. On 05Jan2021, after the vaccination, the patient experienced soreness at the injection site for 1 day. Outcome of the event was recovered on 06Jan2021.  Follow-up attempts completed. No further information expected.
This literature marketed report as received from a physician refers to a 4 year old girl who had received her first dose of VARIVAX (Merck) in March 2009. She was diagnosed with acute lymphoblastic leukemia (ALL) in March 2011. At that time, she was varicella-zoster virus (VZV) immunoglobulin G (IgG)-positive. On 10-APR-2012, the girl was exposed to a mildly ill cousin who developed a varicella rash 2 days later (12-APR-2012). The episode was reported to the child's oncologist after 13 days. The girl was prescribed 7 days of oral acyclovir (manufacturer unknown) and concurrently began her scheduled chemotherapy, which included a 5-day course of dexamethasone (manufacturer unknown) (prednisone equivalent dose of 23 mg/day). Twenty-two days after her varicella exposure (01-MAY-2012) the girl was taken to an emergency department for fever and abdominal pain. She was treated symptomatically; her caretakers were instructed to discontinue chemotherapy and to follow up with her oncologist. Two days later on 03-MAY-2012 the girl returned to the emergency department with a generalized rash. She was hospitalized and treated with intravenous acyclovir (manufacturer unknown) and antibiotics. However, she developed multi-organ failure and died on 07-MAY-2012. Varicella was confirmed by polymerase chain reaction testing, and no alternative diagnoses were found for her acute illness. This patient's fatal varicella likely was the result of profound immunosuppression, resulting in part from the chemotherapy and corticosteroid treatment. Additional information has been requested.
On yesterday I had my first dose of the vaccine Moderna for Covid 19 and within two hours I had an allergic reaction. I experienced itching at the site where I was injected and swelling and tenderness. Later, at night I experience severe myalgia my legs and joints were spasming and it hurt so bad.    Today, The site where I was injected has some swelling and tenderness.Do you recommend that I get the second dose?
Pt recvd 3 doses of Engerix-B vax on 5OCT90, 1NOV90, & 1APR91 & did not respond;
He developed an itchy rash after the 2nd dose; Still have the rash and itching; Still have the rash and itching/ waking up scratching all the time; Still have the rash and itching/ waking up scratching all the time; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), second dose via an unspecified route of administration on 03Feb2021 (at the age of 84 years) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration on 14Jan2021 as single for covid-19 immunisation. On unspecified date of 2021 after the 2nd dose patient developed an itchy rash. Patient had been seen by his HCP and they gave given him 2 doses of Prednisone, hydroxide for itching, as well as Zyrtec. Patient states that "none of it helps. Still have the rash and itching. Not as bad but still there and waking up scratching all the time." Patient is "wondering if there is someone at Pfizer that can indicate what he can be taking that may help the rash." patient states the problem is he is not sure the doctors know what to do with the vaccine being so new. patient states he is not sure going back and forth to the doctor is going to help and questions if the health department would possibly know more. The adverse events involved visit to physician office. The outcome of the event still have the rash and itching/ waking up scratching all the time was unknown, while the rest of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt stated that she couldn't hear or see. couldn't feel anything.  she was shaky and dizzy.  epi-pen was given to her. i had her lay down flat with legs up. she was able to see and felt a lot better after shot. she said she could breathe again.
Information has been received from a health professional concerning a 25 year old female who on 28-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported).  On 07-APR-2008 the patient experienced hives all over her body, mildly itchy.  She called the nurse on 08-APR-2008 to report the hives.  The patient has no medication or food allergies, but mild lactose intolerance.  She has not been exposed to any new things.  She was taking antihistamines and the hives were improving; no trouble breathing or swallowing.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008.  GARDASIL Vaccine (lot # 659435/1265U). On 06-APR-2008 the patient experienced hives all over her body, midly itchy. She called the nurse on 08-APR-2008 to report the hives.  She was taking antihistamines and the hives improved on 10-APR-2008; no problem breathing or swallowing. The decision was made to not continue with the series. No additionla information is expected.
Pt developed a red rash around the injection site that measure 1&1/2 inches in length.  No pain or irritation noted.
voice hoarseness; throat clearing; This is a spontaneous report from Pfizer-sponsored program  from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 24Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on Wednesday (24Feb2021) and after getting the first dose he was experiencing voice hoarseness and throat clearing in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
9/14/09 after shot arm pain. 24 hours fever, body aches. 72 hours still fever, arm red, welts, warm to touch. This arm received PNEUMOVAX.
pts mother states she developed a red hard rash the size the palm of her hand around the injection site.
temp 100.5;arm swelling from shoulder to elbow of lt arm across chest;swelling lasting 48hr;arm also, red;
Pt complained of severe headache the day after vaccinations. Headache lasted 24 hours and then improved.
numbness on my left cheek; left hand was week; vision in my left eye was blurry; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my left cheek), MUSCULAR WEAKNESS (left hand was week) and VISION BLURRED (vision in my left eye was blurry) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness on my left cheek), MUSCULAR WEAKNESS (left hand was week) and VISION BLURRED (vision in my left eye was blurry). At the time of the report, HYPOAESTHESIA (numbness on my left cheek), MUSCULAR WEAKNESS (left hand was week) and VISION BLURRED (vision in my left eye was blurry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
I had a weird throbbing sensation in right hand, it then started tingling, and went to left hand also and to my feet.  The the tingling started coming up my legs and down my arms after a couple of days. Then my face started tingling. Now it is up my back and there is now a tingling sensation basically over my entire body.  I tried taking Benadryl and it has not helped.
It started the following day. It was a tingling sensation on my scalp and my face. I have had it before so I knew it was shingles. I still have it today. I am currently on Valtrex to treat it.
Patient felt lightheadedness, dizziness so he sat down on the floor.  He was alert and conscious the entire time.  He said he did not eat this morning.   He said that he gets nervous and anxiety with vaccinations and blood draws.   I gave him water and Coconut water to drink.  I offered him a snack but he declined.  He felt better after several minutes.
High fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had Covid 2 months before vaccination and completely recovered from it.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
sore arm; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported. Treatment medication included 3 tablets of 200mg Ibuprofen. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-098007 (Patient Link).
administered liquid portion only; administered liquid portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa902a, expiry date 28th February 2025) for prophylaxis.   On 26th January 2023, the patient received Menveo. On 26th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 26-JAN-2023 Reporter comment: The reporter reported that, the MA (Medical assistant) administered Menveo liquid portion only. The adverse event contained all reported information. The health care practitioner gave consent for safety team follow up. The reporter consented to follow up. Additional Supportive Information: The Medical assistant administered Menveo liquid portion only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a physician concerning a patient who was vaccinated with the second dose of ROTATEQ 12 weeks after the first dose.  The patient was not experiencing any known symptoms.  There was no product quality complaint.  No further information is available.  No further information is available.
Patient received her first dose on february 2020-had not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details reported were as follows: The age at vaccination was not applicable for this report. The patient received her  first Shingrix vaccine and had not received the second dose till the date of reporting, which led to incomplete course of vaccination. The reporter was looking for guidance regarding second dose. The reporter did not have any further information regarding the first vaccine
p/vax pt devel a few rashes on face;looks like pimples but never crusted over;pt has had these sx 11-14 days now;pt began rubbing nose & later had a red mark & then it looked like a pimple;
Headache, nausea, vomiting, redness and swelling at injection site, low grade fever, paresthesia in lower arms. (Symptoms for 5 hours nausea vomiting, headache paresthesia), redness and swelling 5 days. Naproxen taken 200 mg.