chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 069H21A, 048C21A and 021C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth 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 (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 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 (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication 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, diarrhea, acute pharyngitis, abdominal pain, vomiting. ZOFRAN was given on 8-12-16 for vomiting. She presented with fever. It is described as felt hot. The symptom is sudden in onset. The symptom started 1 days ago. The temperature is 103 degrees (maximum temperature) and 99 degrees (minimum temperature). Disease exposure includes no sick contacts. Important triggers include activity pt got MVC4 vac done on 8-11-2016 in left arm.
Moderna COVID-19 Vaccine EUA Itching, hot, red swollen, raised area of about 8 inches by 4 inches  on arm injection site.  Took benadryl and  put ice on it.  Lasted about 48 hours.
I administered Flulaval IM at 11:30 AM to pt. in his left Deltoid. At 11:35 the pt., who was seated, c/o feeling weak and placed his head between his legs. He became unresponsive, and I leaned him back in the chair to prevent him from falling. His back began to arch, his eyes were open and glassy, and respirations became slow and shallow. He did not respond to voice or painful stimuli. His skin was pale and clammy when I was checking for a pulse. He appeared to be having a seizure until his face became very red and respirations ceased. I could not detect a pulse and there were no respirations. Other female staff assisted me in lowering him to the floor to start CPR. We put him down hard in our haste, and he began breathing again. At this point, his color was pasty gray and he was extremely diaporetic. 911 was called, and by the time the paramedics arrived at approximately 11:48 AM, the pt. was able to respond to their questions. He was very weak and tremorous and had been incontinent of urine. He was transported to the ER for further evaluation.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 20-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Patient complained of severe pain in the arm where the shot was administered.  Within several seconds, patient passed out.
Patient was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No complaints when asked during observation. Released.  Subsequently, vaccine clinic staff learned from the patient's supervisor that on Jan 4, 2021 that the patient had expired on Jan 2, 2021. By report from the supervisor, the patient was found dead at his home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6, 2021). Electronic Medical Record without any information since the vaccination.
Information has been received from a pharmacist concerning her 15 year old daughter who plays sports, with a penicillin allergy and sulfonamide allergy and no pertinent medical history who in August 2007, was vaccinated with her first dose of Gardasil. On 11-OCT-2007 the patient received her second dose of Gardasil. On 21-OCT-2007, ten days after receiving her second dose, the patient developed myalgia. The patient had unexplained muscle pain which started from her shoulder and traveled to her back and then to her chest. This event was considered to be a significant disability, as she was not able to play basketball. Laboratory tests included: complete blood count, sedimentation rate, lyme disease titer, and a rheumatoid arthritis test (results not reported). The patient's myalgia persisted. Medical attention was sought, the patient saw the physician. Additional information has been requested.
BLOOD SUGAR LEVEL INCREASED; VOMITING 10 TIMES; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included type-1 diabetes for last 32 years, taking insulin Humalog 15 iu bd and Lancetan 40 iu once daily, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use, no alcohol consumption and no smoking.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609) dose was not reported, frequency 1 total, administered on 20-MAR-2021 09:00 for prophylactic vaccination on right arm. Concomitant medications included insulin lispro for type 1 diabetes, and plantago major extract. Blood Sugar level was tested on (Saturday) March 20, 2021 with test result 86, (Sunday) March 21, 2021 with test result 79 and 106 and (Monday morning at 7 am) March 22, 2021 with test result 286 On 22-MAR-2021, the patient experienced blood sugar level increased. On 22-MAR-2021, the patient experienced vomiting, chills, nausea and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the nausea, vomiting, headache, chills and blood sugar level increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210342051-COVID-19 VACCINE AD26.COV2.S - Blood Sugar Level Increased. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.
Information has been received from a physician concerning a 4 year old female patient who on 03-MAR-2010 was vaccinated with the first dose of VARIVAX (Merck) (Lot # 665587/1203Y). The physician reported that the patient received all 4 years old vaccines. On an unspecified date, the patient experienced chickenpox and the patient was given BENADRYL and CALADRYL. At the time of this report, the patient's outcome was unspecified. Additional information has been requested.
Patient reports elevated heart rate of 147 (normal: 70-120) and dizziness about 20 minutes after receiving vaccine.
Second dose was given 46 days after the first dose instead of the recommended 2-6 months.
headache; body ache; fatigue; armpit ache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable other health care professional (patient). A female patient of an unspecified age received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the Covid19 vaccine on 05Feb2021 and was having symptoms such as headache, body ache, fatigue and armpit ache on unknown date in Feb2021. She wanted to know if she can take acetaminophen (TYLENOL). Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Swelling in both cheeks and soreness about 15 minutes after H1N1 Flu Mist. Started resolving within 15 minutes. Took 50 mg oral benadryl and reported event to Employee Health Services
pt recvd vax & became edematous w/swelling of feet,legs,scrotum,& penis & proteinuria;hands have been a little stiff but no joint swelling or pain;urine has been foamy;aching in legs was found to have nephrotic synd of uncertain etiology
swelling at injection site/ silver dollar size; redness at injection site; Arm was sore; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and pain in arm to be related to Shingrix.     Additional Information: GSK receipt date: 28-NOV-2022 Reporter's comment: The reporter stated that patient had swelling it was silver dollar size ((1/4 cm in height) and redness at injection site which lasted 2 to 3 days. The patient's arm was sore No other side effects was reported and no medical attendance needed.
Pt rec'd her vaccine at public clinic at 515pm on 9/17. She noted that site was mildly itchy at bedtime. At 6am when she was getting into shower she noticed an area of induration approx 3" x 2" that was reddened and warm to touch. She reported to the school nurse who contacted me. I spoke directly to patient today. Area of induration remains unchanged.
I had a sore throat, congestion, irritation in sinuses, high fever of 103.4, temperature dropped to 95, chills, body aches, brain fog, and fatigue. I tested positive for COVID-19. I spoke to my doctor, and they prescribed me Paxlovid. The brain fog lasted for 2 weeks, and the fatigue lasted for a week and a half.
Case number PHHY2011US35344 is an initial spontaneous case received from a nurse on 22 Apr 2011. This report concerns multiple patients (exact number of patients unknown) who were vaccinated with MENVEO (batch number: 100001) intramuscularly on unspecified dates. The batch was not stored properly. The temperature of the vaccines reached below 2 C (0 or 1 C) multiple times in Jun 2010, 4 times in Aug 2010, 1 time in Sep 2010 and 3 times in Oct 2010. The temperature reached -1 C, 2 times in Oct 2010.
a patient received a 0.5 ml dose of Fluarix Quadrivalent in error instead of Fluzone High Dose/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old patient (gender unknown) who a 0.5 ml dose of INFLUENZA VACCINE INACT SPLIT VIRION 4V [FLUARIX QUADRIVALENT] not produced by Sanofi Pasteur lot E5C24 via intramuscular route in the left deltoid on 10-Oct-2019 in error instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to wrong vaccine administered.  At the time of report no adverse event was reported.  Treatment: received guidance from their corporate and reached out to the consumer.   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.
light ringing in both ears; Pain in foot; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (light ringing in both ears), PAIN IN EXTREMITY (Pain in foot) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-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 TINNITUS (light ringing in both ears), PAIN IN EXTREMITY (Pain in foot) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, TINNITUS (light ringing in both ears), PAIN IN EXTREMITY (Pain in foot) and VACCINATION SITE PAIN (arm was sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  The patient had pain in foot and ended up getting a steroid injection for foot. Might be because of it went away.   This case was linked to MOD-2021-386085, MOD-2021-386089 (Patient Link).
The pt developed varicella within 10 days of varivax dose. She is still ill.
sore throat x1 day then soreness @ inj site;on 30MAY97 pt came to office;lt elbow was hot to touch & swollen in about a 4 inch area;totally resolved on 2JUN97;swollen arm on lt where had pneumovax inj;erythematous & edematous;allergic rxn;
stomach ache @5:35 pm which lasted for 2 hrs.  Arm sore @ 10:00 pm which lasted for 3 days.
SUFFERED BAD REACTIONS; INTENSELY INTERNAL COLD FEELING; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: Unknown) 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 suffered bad reactions, and intensely internal cold feeling. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suffered bad reactions and intensely internal cold feeling was not reported. This report was non-serious.
Pt passed out after receiving vaccines- 15min after vaccines given.  Put in sapine position, gave OJ + crackers, responded, sat up and then again became pale faint.  EMT called BP had gone down to 88/62.  Parents took child (over)
Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality was involved. Additional information has been requested.
Started same day as immunizations temp 100.1, puking, diarrhea, pt had same symptoms with last shots on 5/24/16.
At 12:28- this adult was accidently given  dose of the children's pfizer vaccine (lot # FL0007 by RN. The client did not have any signs or symptoms of an adverse reaction anytime after the vaccine. We continued monitor closely and I recommended that she waited 30 minutes to ensure if an adverse event were to occur, nurses will be able to help. I was clinical lead for this clinic and I immediately called another clinical lead with more experience and they stated "this is the first time this type of medical error had occurred at our vaccine clinics."  I sent an email to get further information on what steps to take next. No adverse reactions occurred in observations and I ensured that I would call her to follow up on how she if feeling and what steps to take next.
Bilateral Feet Swollen for five months now ever since the Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 15:30 (Lot number: FC3182) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PERIPHERAL SWELLING (disability) with onset 24Aug2021 14:00, outcome "not recovered", described as "Bilateral Feet Swollen for five months now ever since the Covid-19 Vaccine". The event "bilateral feet swollen for five months now ever since the covid-19 vaccine" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of peripheral swelling.  Clinical course:  The patient experienced Bilateral Feet Swollen for five months now ever since the Covid-19 Vaccine. Ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. The patient received second dose of bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 12:15 (Lot number: FF2588) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no known allergies. No other vaccine was received in four weeks and no other medications in two weeks.  Follow-up attempts completed. No further information is expected.
This spontaneous report has been received from a physician referring to a 14-year-old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with PROQUAD for prophylaxis (strength, dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported) (inappropriate age at vaccine administration). No adverse symptoms were reported.
03/13/2021: Presented to the emergency department with cough and shortness of breath. The patient was admitted for pneumonia based on CT of the chest showing bilateral infiltrate on the upper part mainly on the right side along with bilateral pleural effusion mainly on the right. The patient is still admitted and has undergone a thoracentesis. Covid-19 negative.
Patient developed itching all over her body at 10 AM after receiving her vaccine at 7:07 AM.  Patient states she has a scratchy throat and tongue as well.  Was prescribed prednisone 40 mg daily for 10 days and famotidine 20 mg BID. Patient is taking Benadryl for the symptoms 50 mg, which does help, but has to take every 3 hours.
3:45 - C/O hoarseness and fullness in throat with scratchy feeling; 3:55pm Benadryl 50mg IM, followed by NEB Rx with ALBUTEROL; 4:05pm scratching some; feels a little tighter than normal in throat. 4:10pm SOLUMEDROL 125mg IM.
peristent cough that is lasting and causing urine incontinence; Low grade fever; nervousness &anxiety (abnormal); nervousness &anxiety (abnormal); eye dryness; severe fatigue; dry-mouth; lethargy; intense headache; loss of appetite; peristent cough that is lasting and causing urine inconstinence; This is a spontaneous report from a contactable consumer. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 27Feb2021 at 12:30 (at the age of 68 year) as dose number unknown, single for COVID-19 immunisation at Other. Medical history included controlled hypertension & cholesterol both in normal range from routine Prescriptions. Patient had known allergies to codeine. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient was not pregnant at time of vaccination. Concomitant medication(s) included benazepril; ezetimibe; triamterene. The patient previously took codeine and experienced drug hypersensitivity. On 28Feb2021 at 10:00 patient experienced Low grade fever, nervousness & anxiety (abnormal), eye dryness, severe fatigue, dry-mouth, lethargy, intense headache and loss of appetite (which has not currently retuned) persistent cough that is lasting and causing urine incontinence. The patient received treatment for events which included OTC anti-inflammatory/Tylenol 500mg. The outcome of events was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.