chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 173 doses were administered with Lot number 070H21A. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
Information has been received from a registered nurse concerning a 7 year old male with attention deficit disorder, no other medical history and no known allergies who on 08/14/2001 at 2pm was vaccinated with a dose of varicella vaccine SC in the left arm. There was no specified illness at the time of vaccination. Concomitant therapy inlcuded ritalin and an unspecified antibiotic. On 08/15/2001, the pt's mother phoned the doctor's office and reported that the "child is not feeling well." It was reported that the pt recovered. It was noted that the pt did not experience any adverse events following previous vaccinations. No further info is expected.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown). On an unspecified date, the subject experienced hepatitis B antibody negative. The subject received 3 doses of TWINRIX and was tested for protection within the appropriate time frame after the 3rd dose. The nurse reported that he was not protected against hepatitis B per the results. The subject also reported that his father had not responded to hepatitis B vaccination (see case ID A0880973A).
Vomiting on 9/29/2019 followed by fever ranging from 101-103 for the next 4 days. No other symptoms with fever.
Information has been received from a healthcare worker concerning a 12 year old male with seasonal allergies and no other medical history who in March 1993 and October 1995, was vaccinated with a first and second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included loratadine.  In 2004, the patient had a titer which showed no mumps seroconversion.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.  The healthcare worker also reported that the patient had a varicella titer of 0.03 after therapy with a varicella virus vaccine live.
Itching, swollen, pain, rash, redness at injection site (L) arm.
Headache followed by sore throat, muscle ache, fever, fluid retention, loss of appetite, dizzy and disoriented. chest congestion.
1/ 2 booster dose.Strong Headache, throbbing eardrums, chills, vomiting (just once),sore arm,  weakness and body aches , no sleep, still feel lousy
30 min post vaccination patient stated he had itchiness in upper body, SOB, and body ache. MD ordered IM benadryl & solumedrol. Pt was kept in observation and after 28 mins he began having weakness, nausea, dry heaving, SOB, and continued to c/o of itchiness.  pt was sent to ER via fire rescue.
fever; body pain; This is a spontaneous report from a contactable consumer (patient's son). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0169 and expiration date was reported), via an unspecified route of administration in arm (reported as shoulder), on 18May2021 between 14:00 to 15:00 (at the age of 40 years old) as second dose, single for COVID-19 immunization in the patient's home. The vaccine was not administered in a military facility. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731 and expiration date was reported), via an unspecified route of administration in shoulder, on 26Apr2021 (at the age of 40 years old) as first dose, single for COVID-19 immunization. No other vaccinations was administered within four weeks prior to the first dose of the COVID-19 vaccine. The patient experienced body pain on the night of 18May2021 and fever on 19May2021. The patient events did not require emergency room (ER)/physician's office. The outcome of fever was unknown and body pain was not recovered at the time of report.  No follow attempts are possible; no further information is expected.
pain in upper jaw and hip; having difficulty in chewing; pain in upper jaw and hip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (pain in upper jaw and hip), MASTICATION DISORDER (having difficulty in chewing) and ARTHRALGIA (pain in upper jaw and hip) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high, Blood pressure high and Thyroid disorder.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN JAW (pain in upper jaw and hip), MASTICATION DISORDER (having difficulty in chewing) and ARTHRALGIA (pain in upper jaw and hip). At the time of the report, PAIN IN JAW (pain in upper jaw and hip), MASTICATION DISORDER (having difficulty in chewing) and ARTHRALGIA (pain in upper jaw and hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medication, high blood pressure medication and thyroid medication.  The patient reported that two years ago, she took antibiotic ciprofloxacin and she had same pain in jaw and back and that was last in three days.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Description: The patient had pain in upper jaw and hip at same time. She thought it was related to tooth so she went to dentist and did X-ray. She was having difficulty in chewing.  Doctor asked the patient to take acetaminophen if its paining but she mentioned she did not take any medication.  Action taken with mRNA-1273 in response to the event was unknown
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt fainted about 10min after administration of vaccine. He shaked (seized) for a few seconds and then awoke. 911 was contacted
Severe stomach cramps for 8 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide, quinapril hydrochloride (ACCURETIC) and atorvastatin (MANUFACTURER UNKNOWN), both taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced severe stomach cramps for 8 hours. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event severe stomach cramps was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
On 11-12-05 in AM noted a painful lump in armpit.  On 11-16-05 was worse and was seen by second physician who put her on Keflex 500mg qid x 10 days.  Resolved as of 12-5-05.
5 days prior to admission on 5/16/21, he received a first Pfizer COVID vaccination.  The day after the vaccine, he had neck pain and stiffness.  He subsequently developed fever, diarrhea, and vomiting.  The day prior to admission, he developed a diffuse popular rash.  He was seen in clinic on 5/20 and lab work was obtained, which was consistent with MIS-C findings (elevated troponin, elevated fibrinogen, elevated CRP, hyponatremia, relatively low absolute lymphocyte count).
Pt experienced erythema, tenderness to right arm. Treated with Benadryl.
Caller is experiencing fever, chills, severe headache, pain in right hip, shallow breathing and shock like symptoms.
Got shingles vaccine prior, virus blast out/Suspected vaccination failur; Virus lives in body, got triggered, blast out; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-Mar-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient received Shingle vaccine prior by about 2 years.  So patient think the virus lives for years in our body then it gets triggered to blast out. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
10:30 pm-- muscle body aches 11:pm - chills 12:am 5/11 - fever over 100. Fever dissipated by 4am. Chills lessened by 6 am. No sleep til after 6am. Hot chest and head, no sweat, little sleep, no food until 4pm. Started pedialyte in addition to my water intake at 5pm. Ate crackers. Slept few hours at a time, each drenched in sweat.  By 10am, 5/12 major symptoms (severe body aches) gone and slight appetite returned.
Started with aches and tiredness, then into headache (severe), fever/chills, nausea and vomiting with diarrhea. Aches and pains started about 12-18 hrs after inoculation. Nausea and vomiting and fever persisted for about 36 hrs, with residual headache/body ache remaining for over 48 hrs.
This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 18-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
10/5/2021   Chief Complaint:  SOB. "Cardiac rehab sent me her for my low 02"   Source of Information:  Patient   History of Present Illness:  This is a 52y.o. female with a PMH of resistant HTN, NSTEMI with recent hx of cardiac cath, and hypertensive urgency presents to the ED with shortness of breath. Patient was starting her first day of cardiac rehabilitation when she was noted to have a low 02 saturation. On 09/01/21 patient was seen for exertional chest pain. During this hospitalization pt underwent cardiac cath for NSTEMI. Angiography was unremarkable and no stents were placed. Patient was discharged on Hydralazine 75mg TID, Nifedipine XL 90mg, Lopressor 100mg BID, and Imdur 30mg daily. Pt describes fatigue, diminished exertional capacity, orthopnea since 09/01 and diarrhea since 09/08 to present. Pt has difficulty describing any symptomatic change over time. Patient was never COVID tested during her last hospitalization. She admits to being covid vaccinated. Denies any  pleuritic pain, abdominal pain, nausea, vomiting, fevers or chills.   ED course: BP 130/77  | Pulse 60  | Temp 97.7 °F (36.5 °C) (Temporal)  | Ht 165.1 cm (5' 5")  | Wt 90.7 kg (200 lb)  | SpO2 (!) 85%  | BMI 33.28 kg/m²    Covid +  ABG 7.52/33/79/27 WBC 12.6 w/left shift 0.32 and dohle bodies Potassium 3 Ddimer 7598 Troponin 0.01x2, 0.02 Platelet 464 CXR notable for right basilar airspace disease ECG sinus rhythm with PAC 90
Large red rash around injection site, which appeared approximately one week after the injection. Rash was slightly warm to the touch. Initial rash was about 4 x 3 inches, but then increased in size to about 4 x 7 inches, elliptical in shape. As of 2/27, rash is still present. Contacted my PCP, who suspects cellulitis and has placed me on a regimen of antibiotics for one week--Cephalexin, 500 mg, 4x daily.
I developed a raised red rash that started under my chin and has spread up my face, all down my neck, around my ears, down my chest, and in my groin. The rash burns and itches.
Pt recvd vax 14SEP92-to office 18SEP92  screaming since shots-crying episodes; temp never over 101;
Immunizations given at 7 PM. The patient complained of dizziness at 10 PM. At 3 AM the patient wet the bed (does not usually), Temp 103, vomiting. The patient's father called at 10:30 AM still vomiting, right arm reddened, no swelling. The mother reports on 01/22/01, the child is afebrile, eating well. The sister had vomiting on 01/17/01.
A female of unk age developed localized injection site tenderness, generalized muscle aches, fever, chills, headache, nausea, and low back pain after immunization with RabAvert. After receiving the second dose of a 3 dose series immunization of RabAvert on day 7th of immunization, 22Apr04, the pt complained of the aforementioned symptoms. Currently, adverse experiences are persisting, and limited information is available. Additional information received: 04May04 in additional to the initial reported adverse events, pt also experienced fatigue. Pt's medical history included possible allergic reaction to childhood immunization. Further clarification of events were obtained. Pt received first dose of RabAvert on 14Apr04 followed by second dose on 22Apr04. Twenty four hours post immunization, on 23Apr04, the pt experienced the aforementioned symptoms. Pt received treatment with Advil, and all adverse drug reactions were completely resolved on 25Apr04. Pt was to received final immunization later.
6/17/21-complained of constant headache in the AM- 6-7/10 located at temples and forehead , with mild light sensitivity In evening  during shower - rapid HR, pounding constant 116 bpm Since  afternoon  chest pain with deep breaths-midline and to the left , at nipple line , able to pinpoint location , worse with laying on left side . temp - 102.3 f .
Body aches, dry cough, headache, low-grade fever & they won't subside with Ibuprofen.
Patient came in on Saturday and showed me her arm, it was red and swollen, from elbow up. It was also hot to the touch. But she said it was looking better then the day before. I advised her to start taking benadryl  50 mg everhy 6 hours and ice pack it every couple hrs .
fatigue; malaise; I then noticed a set of flu-like symptoms; pain at injection site; muscle pain; joint pain; fever; chills; increased thirst; increased appetite; insomnia; This is a spontaneous report from a non-contactable consumer. This male consumer (patient) reported that: A 31-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 19Feb2021 at 11:45 as single dose for covid-19 immunisation. Medical history included known peanuts allergy. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included colecalciferol (D3) and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrim and experienced drug allergy. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 29Jan2021 at 11:45 as single dose for covid-19 immunisation. Patient reported shortly after the injection was administered on 19Feb2021 at 13:00, I experienced fatigue and malaise. I then noticed a set of flu-like symptoms that persisted for around two days. These included pain at injection site, muscle pain, joint pain, fatigue, fever, chills, increased thirst, increased appetite, insomnia. All have resolved except the pain at the injection site. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event pain at the injection site was recovering and all other events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
The pt broke out in rash on trunk 04/18/2002 7:30 am to legs and back by 6pm.
Stomach Cramps in the morining, then weakness and dizziness, and headache and nauseous. In the afternoon, a 102 degree fever and chills as well as aches in the back and blurred vision. Took two Advil for the aches.
Huge swelling in arm at injection site; Huge red area around injection site; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events huge swelling in arm at injection site, huge red area around injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced the event(s) huge swelling in arm at injection site, huge red area around injection site.  Treatment details included ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), huge swelling in arm at injection site, huge red area around injection site was unknown.
administered on 02/04/2021.an expired dose 1 of kinrix (expired on 02/02/2021); This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number X2X42, expiry date 2nd February 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 4th February 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 patient received an expired dose of Kinrix vaccine. The reporter would like to know what was the grace period and if needs to revaccinate. The reporter consented to follow up.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 5-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
slight fever; headache; slight rash; allergies; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever), HEADACHE (headache), RASH (slight rash) and HYPERSENSITIVITY (allergies) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TRAZODONE HYDROCHLORIDE (OLEPTRO) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever), HEADACHE (headache), RASH (slight rash) and HYPERSENSITIVITY (allergies). At the time of the report, PYREXIA (slight fever), HEADACHE (headache), RASH (slight rash) and HYPERSENSITIVITY (allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Vaccinated on 7/29/13. Started having fever that evening. 2 days later on 7/31/13 in AM woke up with a raised rash all over body. Mom described it as "looks like little pimples". Child continues to have a low grade fever and redness at inj. site.
This lot expired in the fridge on 1/17/2022, the vaccine was given after that date