chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   No Treatment information was reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However, the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021   This case was linked to MOD-2021-367076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received included no new information
Inadvertent administration before age 18; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertent administration before age 18) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertent administration before age 18). On 29-Dec-2020, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertent administration before age 18) 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 medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: initial additional document received 13 Jul 2021 and contains No New Information.
Erythema on Right upper arm, minimal swelling.  Pt stated mild shortness of breath.
pt recvd vax;arm hurting immediately p/vax;arm sore throughout wk end,could not use arm;pain cont for wks afterwards
No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sought care in Emergency Dept. on 11/14/16 and transferred to ICU on 11/17/16 with diagnosis of Guillain-Barre. Had fallen several times at home prior to ED with history of generalized weakness, nausea, diarrhea, and inability to walk. LP on 11/16/16, plasmapheresis started 11/17/16.
Severe headache started about 20 minutes after injection. Advil 2 tabs per mouth taken about 60 minutes after injection. Additional Ibuprofen 400mg given at 16:00.
A report was received from a healthcare professional on 10/07/2003 concerning a 28 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The practice doctor and a co-worker who administered the vaccine were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insuffcient information to determine the reporter's causality assessment. Follow up pending.
Patient experienced swelling and pain in right arm 24 hours after vaccine.  Patient now has hard knot at vaccine site and has all over itching.
nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration in the right arm on 08Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included ongoing ideopathic neuropathy and high cholesterol. Concomitant medications included duloxetine (DULOXETINE), acetylsalicylic acid (ASPIRIN BP), and simvastatin (ZOCOR). The patient experienced nerve pain which began in feet, arms and hands on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the event was not recovered.
RPH asked patient to stay in the store for 15 minutes after he administered her first covid shot, 5 minutes later she passed out in the store, Ambulance was contacted, patient  got conscious by the time ambulance came,, they took her to the hospital, been trying to contact her and but she is not answering her phone
Erythema and induration @ the site the size of a silver dollar.   Mild pain.  A week later erythema and an induration increased and the size increased times two. Lasted only a couple days still some mild pain but nothing serious
Received Pfizer vaccines on 3/27, 4/17, 8/19/21 COVID-19 positive by PCR on 12/22/21 admitted to Hospital on 12/30/21-1/14/22 d/t ARDS d/t COVID-19, onset of symptoms 12/19/21. Expired on 1/14/22. Underlying malignant colon cancer, on chemo; morbid obesity
7 days after to see my platelets drops; A very mild case of Poison Ivy/started and got little worse; A very mild case of Poison Ivy/started and got little worse; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported for herself that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in left arm on 27May2021 as single dose for COVID-19 immunisation. Medical history included Idiopathic thrombocytopenic purpura (ITP), ongoing poison Ivy (got this last year). Concomitant medications included vitamins and supplements (unspecified). Patient was supposed to get the second dose of the Pfizer Covid-19 Vaccine 18Jun2021 or 19Jun2021 (today or tomorrow) but she has a very mild case of poison ivy and she was asking if she could still get the second dose or if that will matter to get the second dose. She has it now, probably Poison Ivy started maybe 3-4 days ago in Jun2021. She said it started and got little worse, she did put some cream on it but she got this (case of Poison Ivy) last year too. Started with the same cream that the Doctor gave her and it was little better now. She had platelet check for her ITP before she got the first shot and 7 days after to see her platelets drops in Jun2021. Also tested Complete blood count (unknown results) on an unspecified date. The outcome of the event very mild case of poison ivy/ started and got little worse was reported as recovering; unknown for another event.  Information regarding the Lot/Batch number has been requested.
Heart palpitations throughout the day made me cough. Felt it more if I laid on my back. It happened everyday for about a week in a half. Cardiologist told me to stop with caffeine intake (coffee) and the palpitations subsided.
Breakthrough COVID-19 case:   Reason for Hospitalization: Patient is a 51 y.o. female presents with worsening COVID symptoms. Symptoms started around christmas. Main symptoms are fatigue and cannot completely care of herself. Over the last few days, pt reports increased fatigue and DOE. Reports could only walk short distances then would have to stop to catch her breath. Denies n/v, sore throat, muscle aches. Reports fevers. No diarrhea. Hasn't been eating or drinking much lately due to fatigue. Pt presented to the ED with the above symptoms. O2 sat was 79% on room air, improved to 94% on 3-4L NC.    Hospital Course by Problem List:  51 yo female with COVID symptoms since christmas, presents with worsening DOE and fatigue. CTA of chest on admit, 1/11/22, no PE.    #acute hypoxemic respiratory failure from COVID 19 pneumonia:  -decadron, had three days in the hospital, will finish 7 days at home  -remdesivir  -supplemental oxygen  -overall pt has improved and believes she can care for herself, reports can ambulate in the room without DOE. Pt is requesting DC today. Pt is willing to pay for home oxygen as she does not have insurance. Appreciate RT arranging home oxygen.    #new dx of DMII:  Hba1c: 8.1%  -will dc pt on metformin and have pt follow up with PCP for further mtg    #hypokalemia -replaced    #hypomagnesemia:  -replaced   #depression:  -cont paxil daily    DNR/DNI    VTE ppy: lovenox
body aches; feels a little sore in left arm; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: SP8448), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 (at the age of 21-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. No Patient History was reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (Batch/lot number: FC3180 Expiration: unknown) via an unspecified route of administration, administered in Arm Left on 16Aug2021 around 0900 (at the age of 21-years-old) as dose 1, single for covid-19 immunisation. On 08Sep2021, the patient experienced body aches, feels a little sore in left arm and not feeling well.  The patient wanted to know if she could take tea and Theraflu for her body ache she was having. When the patient took the shot she was fine then started feeling pain from 10pm-midnight and early morning around 1am and 6am. The she felt a little sore in left arm. The body aches come and goes, right now she was fine.  She received treatment with tylenol around 6am. She was at work. Clarified she was not having a fever. When she took first dose she was fine but for some reason the second dose affected her. Outcome of the events were unknown.  Follow-Up (09Sep2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported new information included date of birth, height, weight, event onset date, first dose information and clinical information.
Patient informed the technician that she has an extensive hx of passing out after getting blood drawn and occasionally receiving vaccines. Patient laid on the ground after administration of all vaccines and technician brought patient a cool napkin, water, and a fan. While laying down the patient became unconscious for a total of ~8 seconds. The technician brought me, the pharmacist, into the room for first aid. I walked in and tapped the patient's elevated foot lightly, and she became conscious (opened her eyes, started talking, etc.). The patient took her time sitting up while the technician and I stayed in the room with her to provide support. The patient stayed an additional 15 minutes under the eye of the technician before standing up and leaving the pharmacy.
Dizziness, respiratory distress, BP 137/88 (pulse 72), O2 sat 97%
Breakthrough case of covid.  PCR test on 9/1/2021 resulted positive lab
Patient noted to have liver hematoma (post liver biopsy 4/02/2021) on 4/14/21 MRI (ordered to evaluate cancer bone metastatic lesions). Patient told to report to ER based on imaging findings. Patient clinically stable per ER note and discharged without intervention
Second dose administered more than 35 days of Primary dose; No adverse event; Vaccine was administered beyond use by date to 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 061B22A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 09-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose).    Individual vials or unbroken cartons: 1 vial. Vial size: 5 ml. The vial was initially stored in the refrigerator on 1-Aug-2022. The vial had not undergone any temperature excursion. No concomitant medications was reported. No treatment medications was reported.
Patient complains that her arm hurted for 2 weeks and after that she had trouble moving her arm.
A nurse reported that an adult female received expired FluMist vaccine on an unspecified date. There were no adverse advents reported. No other information was available at the time of report. The reporter causality is not provided. Information received 06/23/2006. Adverse Event onset date/time, lot number of vaccine, and vaccine administration date/time are unavailable.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included artificial cardiac pacemaker user. Concomitant products included propafenone hydrochloride (Propafenone) and digoxin. On 13th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th November 2018, 1 days after receiving SHINGRIX, the patient experienced ear buzzing, fatigue and shoulder pain. In November 2018, the patient experienced joint pain, tenderness, chills, sensation of pressure in ear and cold. On 16th November 2018, the patient experienced dizziness, ear infection viral, foreign body in ear and increased blood pressure. The patient was treated with methylprednisolone (Medrol). In November 2018, the outcome of the joint pain, tenderness and chills were recovered/resolved. On an unknown date, the outcome of the ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear and increased blood pressure were not recovered/not resolved and the outcome of the shoulder pain and cold were unknown. It was unknown if the reporter considered the joint pain, tenderness, chills, ear buzzing, fatigue, sensation of pressure in ear, dizziness, ear infection viral, foreign body in ear, increased blood pressure, shoulder pain and cold to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient indicated that 4 to 6 hours after receiving SHINGRIX the patient began to feel achy in every joint, sore to the touch, and chills. Approximately 24 hours after receiving the vaccination, these symptoms had resolved. During the middle of the day the patient developed a buzzing in his ears. Also in the evening he started feeling sore and fatigued in his upper shoulders, which had been occurring every evening since it started. He also began to feel like there was pressure in his ears like when he got a cold. On the reporting day, he woke up feeling dizzy. He went to an ear, nose, throat specialist physician and was told that he could have the virus in his ears. The physician also saw crystals in one ear. When the nurse took his blood pressure, it came back with a value of 168/80. He had been taking his blood pressure throughout the day and the upper number has gone down to 135 but has then gone back into the 160s. He said that he had never had blood pressure issues before. The reporter gave consent to follow up. The reporter gave permission for his physician to be contacted.
I don't have my vaccination card and don't have the lot number. in May of 2022 I did not know what was going on and visited my doctor because my increased heart rate and BP went up. I used to have low blood pressure. Mine heart rate sometimes goes up above 100 up 120. I dont have the date.
Patient presented to clinic for COVID-19 booster following receipt of J&J for primary series. Full-dose Moderna was administered by mistake. Unable to reach patient by phone to notify of dosing error. RN left voicemail.
fever; ache; sore arm; sore arm, red; arm swollen; lethargic; sore arm, hot; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE WARMTH (sore arm, hot), PYREXIA (fever), MYALGIA (ache) and VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE WARMTH (sore arm, hot), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (sore arm, red) and VACCINATION SITE SWELLING (arm swollen). On 21-Aug-2021, the patient experienced PYREXIA (fever) and MYALGIA (ache). On 22-Aug-2021, LETHARGY (lethargic), VACCINATION SITE WARMTH (sore arm, hot), PYREXIA (fever), MYALGIA (ache), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (sore arm, red) and VACCINATION SITE SWELLING (arm swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 101 (High) Body temperature 101 and 101 (High) Body temperature 101. On 21-Aug-2021, Body temperature: 99-99.5 (High) Body temperature 99-99.5. On 22-Aug-2021, Body temperature: 101 Body temperature 101.         Reportedly, Patient did not visit Healthcare Professional. He stated that when his fever was high he was afraid to visit Hospital due to COVID-19.  Treatment product information was not provided.   This case was linked to MOD-2021-294106 (Patient Link).
This spontaneous report as received from a county health nurse/registered nurse refers to 7 patients of unknown age and gender who on unspecified date were vaccinated by the physician with improperly stored GARDASIL (route of administration, dose, frequency, lot # and expiry date were not reported). No adverse effect was reported at this time. This is one of several reports received from the same reporter. Additional information is not expected because there is no consent to contact the reporter.
urticaria; full body macular papular rash; This case was reported by a nurse via call center representative and described the occurrence of urticaria in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA199A, expiry date 30th September 2020) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXA14BA, expiry date 31st March 2021) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Menveo (intramuscular) .5 ml and the 1st dose of Bexsero (intramuscular) .5 ml. In January 2020, less than a week after receiving Menveo and Bexsero, the patient experienced urticaria and maculopapular rash. On an unknown date, the outcome of the urticaria and maculopapular rash were unknown.   It was unknown if the reporter considered the urticaria and maculopapular rash to be related to Menveo and Bexsero.  Additional details were received as follows: The reporter stated that the patient received a dose of Menveo and Bexsero on the same day and had a full body macular papular rash and urticarial.
Patient's arm has swelling, red, warm and tender under the vaccine injection area. Patient reports that her arm does not hurt, but has a predominant red area that is under the vaccine injection site. The first night her arm was sore, but the next day she work up to the red blotch.
pt broke out w/rash 15MAY98 PM;no other sx;pt brought to Er sx w/varicella;tx acyclovir;
Pt recvd vax & the next day hands were swollen & fiery red from what looked like a vasculitis; also had swollen feet, puffy eyelids & edematous injected conjunctivae about 9 months ago; now has necrotic fingertips & has been dx by 1 rheumat