chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received as additional information to initial version and  I-narrative supplement updated.
Swollen at injection site and red. Under the same arm in the axillary position was swollen the size of a baseball.  These symptoms lasted 8 days.
5 days, post vax, developed chickenpox with papulo-vesicular lesions in groin and buttocks.
Information has been received from a consumer concerning her 68 year old husband with prostate cancer who about four months ago, in approximately April 2010, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included simvastatin (MSD), finasteride (MSD), losartan potassium-HCTZ (MSD), SYNTHROID, niacin (manufacturer unknown) and vitamins (unspecified). The representative reported that about a month ago, on approximately 03-JUL-2010, her husband noticed papules on his legs and trunk, primarily his legs. The consumer believed the patient had breakthrough chickenpox. The patient went to the physician who was not sure what the issue was. The patient then went to a dermatologist who thought they were spider bites. The patient did some research and believes her husband had breakthrough chickenpox and erythema. The patient's papules started to get better then they reappeared. At the time of the report the patient was not recovered. Additional information has been requested.
Red, itchy rash on right arm; Red, itchy rash on right arm; Red, itchy rash on injection site; Red, itchy rash on injection site; Body ache; Pain in injection site; soreness in the injection site; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red, itchy rash on right arm), RASH ERYTHEMATOUS (Red, itchy rash on right arm), MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site), CHILLS (Chills) and PYREXIA (Fever). On 05-Jan-2021, the patient experienced VACCINATION SITE RASH (Red, itchy rash on injection site) and VACCINATION SITE PRURITUS (Red, itchy rash on injection site). On 06-Jan-2021, the patient experienced RASH PRURITIC (Red, itchy rash on right arm) and RASH ERYTHEMATOUS (Red, itchy rash on right arm). On 01-Jan-2021, MYALGIA (Body ache), VACCINATION SITE PAIN (Pain in injection site; soreness in the injection site), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, RASH PRURITIC (Red, itchy rash on right arm), RASH ERYTHEMATOUS (Red, itchy rash on right arm), VACCINATION SITE RASH (Red, itchy rash on injection site) and VACCINATION SITE PRURITUS (Red, itchy rash on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medication included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Narrative: 74yo male patient with diagnose of left sided transitional cell ca of kidney died on 9/27/21. Pt treated at outside facility. Pt had received covid vaccines on 1/29/2021 & 2/19/2021 from outside hospital. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-MAR-2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
sore arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 19Apr2021 08:30 (Lot number: EW0164) at the age of 66 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Borderline AODM" (unspecified if ongoing), notes: no meds. Concomitant medications included: LOSARTAN; ATORVASTATIN; ASPIRINE. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EP 7533), administration date: 31Mar2021 08:30, when the patient was 66 years old, for COVID-19 immunisation, reactions: "Sore arm", "Nausea", "vomiting". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Apr2021, outcome "recovered" (20Apr2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Additional concomitant medication included MVI (as reported). The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
I had tachycardia the morning after I received my second dose of the vaccine. It started around 8 am, and my heart rate continued to be above 100 bpm for the next 3 hours. Heart rate was measured using Apple Watch. When I submitted this report, my heart rate was still beating at more than 100 bpm.
Heart rate +20-30 bpm Fever +2.5 degrees Fahrenheit  Chills Body aches, to the point of not being able to sleep  Nausea, diarrhea, stomach discomfort
Information has been received from a consumer concerning her 17 year old daughter who was vaccinated with the three doses of GARDASIL in 2007 (March, April and September). In March 2007 she started to have seizures. She had a total of 7 seizures in 2007. She had no history of seizures prior to receiving GARDASIL. Her daughter had another seizure last month (August 2008). She has been taking unspecified medication for her seizures. The patient sought medical attention at the emergency room. The patient's mother also indicated that the patient was hospitalized. Patient's mother stated: "My daughter started having seizures when she received GARDASIL and I don't know why. She has never had seizures before and I told the doctor the only thing that was different was she received GARDASIL". "I don't know how to tell my daughter that this was because of GARDASIL". "She can't get her driver's license because of her seizures". "She's now taking a medication for her seizures which would cause birth defects if she tries to have children in the future". Additional information is not expected.   10/23/2008 10/23/2008 PCP records received. WCC 3/20/08 with normal exam except c/o heavy periods and passing large clots.  Seen for hospital f/u after 3 episode of vasovagal syncope. 2nd HPV dose given 34 days after 1st. Another syncopal episode reported by mom. Seen 6/19/07 for Amenorrhea x 3 months. Seen 6/25/07 with c/o intermittent  mid-sternal chest pain x 2 weeks. Assessment costochondritis. Syncopal episode with head twitching, amnesia and post-episode grogginess. Referred to Neurology. Neurology records received beginning 8/8/2007 to 8/27/2008 with DX: Seizures.  Pt initially presented to neurologist after several episodes of passing out. First 2 likely episodes likely syncope, the 3rd episode of unresponsiveness more likely seizure or psuedoseizure. After several more, started on Trileptal. No episodes until 8/5/08 but mother reports forgetfulness, and grades have dropped. No menses x 3 months. Obn 8/5/08 pt found unresponsive on ground with teeth clenched, eyes fluttering. Returned to baseline after 1.5 hrs. 2 additional ER visits for dysmenorrhea and near fainting-uncertain cause.
Vertigo....wait for it to subside....heavy dizziness for about 6 hours....stayed quiet for day, and better after 24 hours from time of vaccination
1st dose 07-JAN-2022. 2nd dose 28-JAN-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 28th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 28th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter reported for herself. The patient received 1st dose of Shingrix on 7th January 2022. The patient received 2nd dose on an unknown arm. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
At midnight started with chills, shaking in his shoes.  Got up the next morning, was not feeling good.  Went out for a little while and realized that he was cold.  Went to bed for about 30 hours with a little nausea, but not feeling right.  Took Tylenol every 6-7 hours during that interval of time.  Feels good now.
Itching, redness at site. Reported to vaccination on 11/11/05 @ 08:50 am.
Mother states child had vaccination on 7/16/13. On 7/17/13 he woke up warm, red at thigh. 7/18/13 area enlarged to 5 inches x 5.5 inches.
No further details provided. No other AEs reported; a 9 month old patient received a dose of VAQTA; This spontaneous report has been received from a medical assistant, concerning a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-JUN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T035721 with expiration date 15-APR-2022, (dose, frequency, route and anatomical location were not provided)  for prophylaxis (product administered to patient of inappropriate age). No further details provided, no other adverse events reported.
Stiff neck and shoulder muscles, mild soreness and stiffness at injections site, headache resulting in migraine, moderate nausea, stomach ache with occasional sharp gas pain, feeling despair.  Most symptoms lasted 2 days; sharp gas pain 3 days about 1-2 episodes /day.
Per Client on 2/20/2021 received second dose of COVID 19 vaccine in left deltoid at 2:10 pm. On 2/21/2021 at 1230 pm developed a red, raised, bumpy, itchy rash on right arm, middle chin area and bilateral jaws. Per Client rash is not painful, no airway concerns, left arm site and right arm also slightly swollen. Per Client all symptoms are still presenting. Per Client have not taking anything for rash and has not been in contact with a medical provider. Recommended that Client follow up with the PCP and monitor if symptoms worsen, to seek medical emergency attention if needed.
Covid vaccine loss of eyesight in lower half of eye  Loss of eyesight in lower half of eye within 7 days of vaccination, unsure if related, tests pending
I have a primary care office the Medical assistant give by mistake vaccine for 5 days old which suppose to be given at 2 months the vaccines were given PEDIARIX Hib, PREVENAR, ROTATEQ. Can please let me known if anything need to be done.
Hospitalized for respite care on 2/8 as unable to get out of bed and put on Hospice.
Patient received vaccination with a vial that had been punctured for 31 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccination with a vial that had been punctured for 31 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccination with a vial that had been punctured for 31 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccination with a vial that had been punctured for 31 hours) outcome was unknown.        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.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting Chills, Pain/Redness/Swelling @ injection site
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves an adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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 the 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.; Sender's Comments:  01495347 (SAD20230220001440):Identification number of the report 01495415 (SAD20230216001803):Identification number of the report
Case number PHEH2017US005436, is an initial spontaneous report received from a consumer on 15 Feb 2017. This report refers to a 44 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unspecified date in Oct 2016. On 07 Feb 2017, the patient experienced flu, fever, cough/cough lingers, headache, weakness and flu type A. The patient received TAMIFLU for flu and flu Type A. The outcome of fever was reported as complete recovery on 09 Feb 2017 and event cough was reported as condition improving. The outcome of headache and weakness was reported as complete recovery on 10 Feb 2017 and event flu and flu Type A was reported as complete recovery on an unknown date. The seriousness of the event flu and flu Type A was not reported and rest of all events was reported as non serious. The causality of the events was not reported. The seriousness assessment of influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Sore, stiff muscles and joints all over.  Injection site warm and swollen with itcheness night after shot and feeling flushed.  second day injection site warm and swollen, with some joint pain.
Cellulitis L upper arm.  Td B.  KEFLEX 500 TID x10d.
7/4/2022 fever in the evening peaking at 99.  At home COVID 19 test Negative.  7/5 still had fever.  Test results positive.  7/6 fever continued, stuffy nose, and a cough.  Televisit with Doctor prescribed Paxlovid.  Symptoms improved steadily through 7/11 when they disappeared.  Slight Fatigue remains.
3 weeks after Moderna injection (8/19/21) and one week after flu shot (Flucelvax Quad-09/2/21)  began experiencing vertigo in the morning and night while in bed and dizziness and unsteadiness throughout the day.  Symptoms began on 09/09/21. I am scheduling an appointment with my PCP for evaluation.
pt. has history of anaphylaxis with allergy shots, possible sulfa. Was asked to stay in observation / 30 minutes rather than standard 15. Was asked to tell us if she had tingling in mouth while in observation. At 425p pt reports tingling in mouth. Dr called & arrived at 428. Claritin lot 1/22 given BP - 130/90, pulse 90, sats 97%, 98% R= 16. Per Dr. - lungs clear no visual swelling in the mouth. EMS arrives - 430p. Dr. & EMS w/patient 440 - sats 98%, pulse, R = 16 445 - pt states she feels less anxious, tingling seems to be gone 450 - Dr - lungs clear, no visual swelling in mouth okay to discharge to husband is just outside facility 452 - pt agrees she can discharge aware to call 911 if any new swelling in mouth occurs
I developed severe joint pain in fingers, wrist, elbow, shoulders.  I was given a two week prescription of Prednisone which took the pain and stiffness away immediately.   Pain came back as soon as the two weeks were over.
Kinrix given to 16 month old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Kinrix dose was given to the patient at 16 months of age, which led to inappropriate age at vaccine administration. No other details of the vaccine was provided. The reporter consented to follow up.
Temp 101 F x 2 days of markedly swollen (L) arm, shoulder and elbow x 4 days. C/O decreased appetite and lethargy x 2 days.
Patient was given PCV13 on left deltoid. Pt got an immediate reaction. He developed a rash and swelling. Gave BENADRYL 3.75 ml po given.