chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 031L20A and 027A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medication was reported.    No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced fever on the day after. The patient asked that if she/he need to take anything for fever.
Patient had extreme localized swelling, redness, and fever around the injection site which was later diagnosed as a Staph infection.
Bladder cancer; This case was reported by a pharmacist via call center representative and described the occurrence of bladder cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced bladder cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the bladder cancer was unknown.   It was unknown if the reporter considered the bladder cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient would be receiving chemotherapy for bladder cancer in November 2019. It was unclear whether the patient was diagnosed with bladder cancer before or after receiving the Shingrix. The pharmacist stated he was receiving the information second hand and limited details were available. The reporter did not consent for follow up.
Initial unsolicited report received from a non-healthcare professional (office staff) on 25 September 2015. This case involves 2 unknown patients (age and gender not reported) who were vaccinated with 0.5 ml dose of FLUZONE QIV (batch number, route and site of administration not reported) on an unspecified date. The medical history and concomitant medications were not reported. On an unspecified date within a short period of days after the vaccination the patient had experienced contracted flu type B. Laboratory investigations and corrective treatments were not reported. The event outcome was not reported. Documents held by sender: none. Sender's Comments: This is a very poorly documented case of influenza B virus infection few days post INFLUENZA QUADRIVAL A-B VACCINE administration. Time to event onset, detailed medical investigations including serology, viral culture, etc.. have not been provided. Based on the available information, a role of the vaccine cannot be established.
Pain, stiffness, and decrease in range of motion following injection. Evaluated by Nurse Practitioner on 9/9/2020. Recommended Orthopedist visit for 9/14/2020. Determined that there was injury to the rotator cuff. Treatment should consist of physical therapy.
Left upper arm burning, hurting; large red welt on entire left; Swelling/welt grew to about two inches long by one inch across; Redness; Covid arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE URTICARIA (large red welt on entire left), VACCINATION SITE SWELLING (Swelling/welt grew to about two inches long by one inch across) and VACCINATION SITE ERYTHEMA (Redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy and Drug allergy (Aleve). Concomitant products included MAGNESIUM for Foot cramps, BOSWELLIA SERRATA, CURCUMA LONGA, DL-PHENYLALANINE, NATTOKINASE (CURAMIN) for Inflammation, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 20-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling/welt grew to about two inches long by one inch across) and VACCINATION SITE ERYTHEMA (Redness). On 18-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (large red welt on entire left). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left upper arm burning, hurting). The patient was treated with CORTISONE for Allergic reaction, at an unspecified dose and frequency. On 28-Feb-2021, VACCINATION SITE URTICARIA (large red welt on entire left) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling/welt grew to about two inches long by one inch across), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Left upper arm burning, hurting) outcome was unknown.            Treatment also included other anti-itch lotions.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up was received on 18-MAY-2021 which contained the contact Information of the patient.. On 25-Jul-2021: Patient information, allergy details, suspect product dosage details with lot number and facility information updated. New events left upper arm burning, hurting and large red welt on entire left were added. Concomitant and treatment medications were updated.
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with the second dose GARDASIL and fainted. The outcome was unknown. The patient sought unspecified medical attention in the office. Additional information has been requested.
Patient Received a higher concentration of the Covid vaccine than intended.  Patient reported side effects of 100.3F fever, headache, chills and muscle aches.  One day later, around 3am, she woke up and reported heartburn and nausea.
A spontaneous report was received from a consumer concerning a 78-year-old female, who was administered 2nd dose of Covid-19 vaccine and experienced vaccine leaked out of arm during administration. The medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, patient received first of the planned doses of (Batch number not provided) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, patient received second of the planned doses of (Batch number not provided) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, the vaccine leaked out during the administration. Action taken in response to the events was not applicable. The outcome of the event, vaccine leaked out of arm during administration, was resolved on 04 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and Vaccination site discharge for.  There were no reported adverse events associated with this case.
Sore left shoulder at point of vaccination; trouble sleeping; felt chills then hot.  Temperature of 100.2. Called nurse hot line to report symptoms.  Told to monitor fever and call back if it gets worse.  Listened to recording of treatment advice.
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 15-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
A few days after my shot, I started feeling tightness in my chest out of nowhere. It lasted 2 days and worsened on the second day. I could still carry on with my daily tasks and was breathing normally. But I did feel heart palpitations sporadically throughout this period. I went to the doctor who was convinced stupidly that I just pulled a muscle (how would I have done that???). They did an EKG, an X-ray, and took my blood pressure. They said everything looked normal and to take some Motrin and massage my chest . It went away for a few days and came back. Chest is tight, pain in mild but noticeable.
Received intranasal vaccine 11/13/09. Had weakness, dizziness at 4pm that afternoon. Severe episode of vomiting, couldn't stand up for ~ 15-20min. Drank Gatorade and felt better. No subsequent vomiting.
Pt recvd 3 doses of Engerix-B & 10MAR92 Hep B antibody was neg; no tx given;
The injection site was sore. I woke up at 4:00 AM the next morning achy and  with a bad headache and fever ranging from 99.6 to 100.9 that lasted approximately 48 hours. When I woke up on the second day, I had a red rash, mostly on my arms and legs. I took Benedryl twice that day and it seemed to help. The achy feeling continued for approximately three days.
Red rash at injection site and soreness.  Upset stomach.  Fatigue.    Blister on bottom of right foot behind small toe.  After walking on foot a large black/blue area formed on bottom and top of foot near the small toe.  This is day  six after shot and all is much better.
Bleeding Narrative: internal bleeding post oocyte retrieval. received 2 units pRBC's. gel foam embolization of bilateral uterine arteries and right ovarian artery performed by IR.
Localized reaction- bicep region area 10cm w x 13cm L no systemic signs.
She has been informed of similar adverse effects with other implant recipients (implants became infected); This spontaneous case was reported by a consumer and describes the occurrence of DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Breast prosthesis implantation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) (seriousness criterion medically significant). At the time of the report, DEVICE RELATED INFECTION (She has been informed of similar adverse effects with other implant recipients (implants became infected)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment:  This case concerns a  female patient with no reported medical history who experienced serious unexpected event of device related infection, reported as breast implant became infected, that occurred after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a  female patient with no reported medical history who experienced serious unexpected event of device related infection, reported as breast implant became infected, that occurred after the 2nd dose of the mRNA-1273 .  The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
10 days p/vax had fever of 104;did reduce to 101 w/APAP;took to MD next day exam showed no physical problems rxn to shot;fever lasted 2 days;second day was lower;
Have hot flashes and it's been like a month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset Mar2021, outcome "not recovered", described as "Have hot flashes and it's been like a month".  Additional information: The patient had hot flashes from the first dose and it's been lasting 4 weeks now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
inadvertently administered expired dose of IPOL today with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00546482) and transmitted to Sanofi on 02-Apr-2021.  This case involves a 4 years old female patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 02-Apr-2021, the patient received a fourth 0.5 mL dose of suspect IPV (VERO) lot R1B251M, expiry date-13-Mar-2021 via subcutaneous route in the right thigh for prophylactic vaccination.  It was a actual medication error due to expired vaccine used (latency same day).  HCP called because they have a patient who was inadvertenly administered an expired dose of IPOL, to see when it is recommended to repeat the dose.Practice is planning to repeat the dose.  At the time of report there was 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 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.  There will be no information available on the batch number for this case.
Pt was here for a "3rd dose."  It was unclear at the time of her true 2nd dose if more or less than half got into the arm, but nevertheless was scheduled for a make up dose on 2/10 and received it. At the time of her visit there was no reported adverse events.
I had got COVID-19 started feeling bad 4/6/22 but I also had a root canal, so I thought that's why I felt bad. By Saturday and Sunday, I couldn't get out of bed, really bad congestion, sore throat, tired, achy. It felt like a really bad flu I was in bed from Saturday through Monday and wasn't able to work until Tuesday. I had dizzy spells but didn't lose my sense of smell.
This non-serious medically confirmed report (initial receipt 03-OCT-2014)  concerns a 39 year old female patient. On the 11-SEP-2014 at 16:00, the patient received AFLURIA (batch number 10249211A) 0.5 ml annually via the intramuscular route. ON the 11-SEP-2014 at 18:00, two hours later, the patient experienced a wheal at the injection site, with redness and itching. The patient took paracetamol which helped alleviate the symptoms. The symptoms  resolved midday within 24-28 hours. Outcome was recovered on 13-SEP-2014
Patient experienced localized swelling post-injection, which partially resolved with direct application of ice to injection site. The following day, experienced recurrence of pain at injection site as well as chills/rigors. At this time, patient has been advised to manage with home remedies (ice, OTC medications, etc.). No additional acute cares required.
p/vax pt states arm where pneumonia vax given is now red, hot & swollen; temp unk @ present;advised to apply cool compress;APAP given;
w/in 24 hrs started itching all over body; did not treat w/any OTC meds; has felt light-headed, dizzy, & nauseaus since immun; has not eaten past 3 1/2 days x/for liquids; site of immun painful, red, now bruised since warm to touch, swolle;
At injection site on (R) arm there was a 8x10 cm area of mild swelling and induration with warmth, mild erythema and mild tenderness. Skin was intact. No signs of cellulitis.
Intense pain and swelling to size of baseball around injection site. Injection was painful. Swelling started 1-2 hrs after injection. Pain/swelling lasted 3-4 days.
Injection site hard, red, swollen, spreading. Nauseous, trouble breathing, fatigued, fever, Dizzy.
Moderna Bivalent came from our facility.  On paperwork, beyond use date was labeled 4/5/23, but on bag that vaccine came in, beyond use date was labeled 5/15/23. Patient received vaccine on 4/21/23.  Clinical pharmacist checked with manufacturer and determined the doses that were administered were valid.
Swollen lymph nodes in left arm pit. Cannot move arm without extreme pain. Two days later it is super swollen still.
Atrial flutter; arm pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262), intramuscular, administered in arm right on 17Jan2021 16:00 as dose 1, single for covid-19 immunisation. The patient medical history included hypothyroidism from 05Jan1976 and ongoing, occasional atrial flutter from 02Jul2020 and ongoing 0x or 1x or 2x/ month and none on Apr2021, endometriosis from 1963 to 1990, caesarean section from 06Jan1976 to 06Jan1976, hip fracture from 02Jul2018 to 03Jul2018, and had surgery - 3 titanium screws inserted. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1976 and ongoing; metoprolol taken for atrial flutter from Jul2020 and ongoing; apixaban (ELIQUIS) taken for atrial flutter from Jul2020 and ongoing. The patient previously took DANAZOL for endometriosis from 1975 to 1990. On 28Jan2021, the patient experienced atrial flutter and arm pain. The patient underwent lab tests and procedures which included too many blood test: unknown results on an unspecified date. No covid-19 testing. The events were considered as important medical event by the reporter. No treatment was received for the events. The outcome of the events was recovered on 28Jan2021.
2 days after  2 shot severe shortness of breath; This is a spontaneous report from a contactable consumer (Patient). An 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: ep7534), via an unspecified route of administration administered in Arm Left on 23Mar2021 as 2nd dose, single dose for COVID-19 immunization. Age at the time of vaccination was 84 year. Medical history included atrial fibrillation (afib) and allergies (unspecified). The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: en6203) via an unspecified route of administration, administered in Arm Left on 02Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested with covid post vaccination. 2 days after 2 shot, the patient experienced severe shortness of breath (dyspnoea) on 25Mar2021. Event resulted in Doctor or other healthcare professional office/clinic visit and was treated with prescribed drugs for heart failure. Therapeutic measures were taken as a result of shortness of breath. Seriousness of the event was reported Disabling/Incapacitating. The outcome of the event was recovered with sequelae.