chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered Daptacel that expired on Sep 18, 2019, no AE; 10 years old patient received Daptacel, no AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a health care professional (X-Ray Technician).  This case involves 10 year old male patient who was vaccinated with expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 25-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Lot C5254AA, expiration date: Sep 18, 2019 via unknown route in the left upper arm.  It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration.  At the time of the report, 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  List of documents held by the sender: none
she felt queasy; felt fatigued; Her arm was also sore; headache that lasted 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was also sore), HEADACHE (headache that lasted 12 hours), NAUSEA (she felt queasy) and FATIGUE (felt fatigued) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), SIMVASTATIN, METOPROLOL, HYDROCHLOROTHIAZIDE, LORAZEPAM, VITAMIN D NOS, VITAMIN B NOS, PHYTOSTEROLS NOS (CHOLESTOFF ORIGINAL), MAGNESIUM, VITAMIN K NOS and PSYLLIUM [PLANTAGO AFRA] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm was also sore) and HEADACHE (headache that lasted 12 hours). On 12-Mar-2021, the patient experienced NAUSEA (she felt queasy) and FATIGUE (felt fatigued). At the time of the report, PAIN IN EXTREMITY (Her arm was also sore), HEADACHE (headache that lasted 12 hours), NAUSEA (she felt queasy) and FATIGUE (felt fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 2-JUL-2021 ,Outcome of the events updated to recovered/resolved.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 20-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number N025428 and expiry date 19-JUN-2020 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 36 to 46 degrees Fahrenheit (°F) (35.9 °F) for a time frame of 16 hours and 22 minutes. There was a previous temperature excursion at 36°F to 46°F for 10 hours and 25 minutes; and 32°F up to 35°F for 3 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of thirteen reports from the same reporter. Sender's Comments: US-009507513-1811USA008122: US-009507513-1811USA008130: US-009507513-1811USA004452: US-009507513-1811USA008125: US-009507513-1811USA008126: US-009507513-1811USA008127: US-009507513-1811USA008128: US-009507513-1811USA008129: US-009507513-1811USA008121: US-009507513-1811USA008120:  US-009507513-1811USA008119: US-009507513-1811USA008123.
This spontaneous report as received from a pharmacist refers to own child (age and gender not reported). On an unknown date at the age of 2, 4 and 15 month the patient was vaccinated with a first, second and third doses of PEDVAXHIB (dose, route, lot numbers not reported). On an unknown date the patient received the fourth dose of PEDVAXHIB (at the age of 3 year and 4 months). Additional information has been requested.
This spontaneous report received from a consumer refers to her 5 year old granddaughter who, on 04-JUN-2013, inadvertently received the ZOSTAVAX single dose, 0.65 ml, subcutaneously and on 04-JUN-2013 began experiencing itching at the injection site. Medical attention was not sought for the 5-year-old female and she was reported to be recovering from the event. Additional information has been requested.
83 y/o female, PMHx of Afib, HTN, DM, colon CA, presenting with worsening SOB and weakness related to Covid19 infection. Pt was diagnosed with Covid on 1/22/21 and managed symptoms at home. Was sent to ER by home health due to low O2 sat without oxygen. Hypoxic at 86% on admission. Pt treated with supportive measures. Pt was discharged to skilled nursing facility on 2/1/21.
sinus infection; ear ache on the left side; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry Date: Not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history included Type 1 diabetic. Concomitant medications were not reported. On an unspecified date, the patient experienced sinus infection, and ear ache on the left side. Patient second dose (vaccine) would be next day Wednesday (24Feb2021), don't have any cough, no fever, anything like that. Some doctors said OK, some said to wait. Reporter queried that if she had to wait to receive second dose since the doctor said to wait 1 week and would that be ok, if she gets (vaccine) when you have an infection, would it lessen the strength of the vaccine, not full protection or it could worsen symptoms. she needs to know if she should cancel that second appointment for tomorrow because if she does, she would lose her spot. Therapeutic measures were taken as a result of the event sinus infection which included an antibiotic 5 days ago. Outcome of the events was unknown.  Description of Product Complaint: Caller is calling about the Pfizer COVID 19 vaccine. She had a question; she received the first vaccine 3 weeks ago. She is a Type 1 Insulin dependent diabetic. She seen her doctor for a sinus infection, and she started an antibiotic 5 days ago and she is scheduled for a second appointment. She does not have fever just like more of an earache on the left side. She is getting mixed information because she has multiple doctors, some say yes get the vaccine and some say they are not sure about when you are on an antibiotic, she asks does it lessens the effect of the shot? She actually has another doctor appointment, and she has been on hold for 2 hours the other person told her that she was going to someone who could answer her question, only because she needs to know if she should cancel that second appointment for tomorrow because if she does, she will lose her spot. When she is transferred, is she going to be like number 27 in line again? she does not have time to wait.   No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Freezer temperature warm by atleast 2 degree C for 4 days; Never reached an acceptable range and was warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was warm by at least 2 degree C) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was warm by at least 2 degree C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was warm by at least 2 degree C) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Vaccine administered in LA, SQ on 10/29/15 at 16:15.  Patient noted itching 24 hrs later and rounded localized large erythemic lump at injection site.  Noted headache, but may or may not be related.  No fever, SOB or other symptoms.  Patient noted throbbing of left arm, warm to touch until Rx of Keflex given for cellulitits diagnosed by NP (5 mg BID x 10 days).
The day after injection I had a red welt with a small knot,  and sore arm. This lasted a couple of days. Day 7 my arm started itching and the welt came back larger and had a hard knot, with feverish feeling in the red area.
Rash 2 days post 2 nd dose of Pfizer Vaccine.  Treated with Prednisone taper and Benadryl
Left arm swelling, erythema, cellulitis of entire left arm and breast extending to scapula. Severe left arm pain, limited ROM extending to numbness in hand and fingers. Axilla, cervical, lymphedema. Fever (102.3), chills, abdominal pain
Headache, Fever, Diarrhea, MALAISE,RESTLESSNESS Narrative:  Other Relevant History:
Dveloped rash under left arm which progressed in 4 days to left breast and left scapular area. Visited employy health RN. Sent to PCP. Diagnosed with shingles on 10-3-16 by PCP.
Information has been received from a consumer concerning a 5 year old male patient with a reaction to sulfa and no past medical history who in September 2002, was vaccinated with a dose of hepatitis B vaccine recombinant. There was no concomitant medication. Shortly after vaccination in approximately September 2002, the patient began to experience severe pain, bouts of sickness, headaches, chills, candidiasis, trouble with urination and his bilirubin level elevated. Unspecified medical attention was sought and the patient had CAT scans. As of 2/14/03, the patient was suffering from occasional GI pain, diarrhea, he continued to experience severe pain and he was gong to be taken to a hematologist. Due to the sicknessess, the patient was unable to participate in the basketball season. Upon internal review, severe pain was considered to be an other important medical event (OMIC). Additional information has been requested.
Right arm swollen, red and heat.  Size 4.5x2 3/4 inch.  Arm painful to move.
Patient called to report symptoms:at 3:30pm face redness, hot ears, "lump" in her throat (feels like closing), breathing is normal.  Took 25mg benadryl at 3:30pm and 25mg benadryl at 3:37pm. Called patient every 10 minutes to make sure she was feeling ok and to call 911 if symptoms got worse.  She reports being fine at 4:00pm.
Patient called our office approx 30 minutes after getting ZOSTAVAX injection. "on her way home stated she felt like on. she got a shot of morphine". Warm sensation. Informed patient to call her physician, if any breathing problems to E.R. called patient after 2 hours. Stated it didn't last long and she did not see or call M.D.
sicker than a dog; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves patient of unknown demography who was sicker than a dog(illness), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickness (illness) (unknown latency) following the administration of INFLUENZA VACCINE (reported as flu or no flu, makes him/her sicker than a dog)  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event illness.  There will be no information on the batch number for this case.
Pt recvd 2 doses of Hep B vax on 11FEB92 & 16MAR92 & exp  lightheadedness, dizziness, vertigo, nausea, pressure & ringing in ears, blurred vision & inability to stand;
Site: Pain at Injection Site-Medium, Systemic: numbness in arm-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient received vaccine in 5/2021. Still complains of pain and numbness in arm, or other exermities. She is not quiet sure, but will see precriber.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. In December 2021, less than a year 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 details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got shingles vaccine over the summer but broke out with shingles again this week of reporting. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Left arm swollen with 2 big hives, painful arm, itchy, red, and headache. Benadryl and Ibuprofen taken. Symptoms improving.
Patient woke up the next day with severe muscle pain, and swelling in hands and feet.  Subsequently developed insatiable itching in hands and feet that is still occuring today (4/13/21).
Within 2 hours after receiving smallpox and anthrax vaccinations in L upper lateral arm, began L uppper arm muscle pain - has progressed over the next 8 months to L arm muscle pain with use, aching with rest, and weakness of L arm. Has seen PCP 2x in this period, no tx or dx or testing done; has now come under VHC care, testing in progress.
8/10/21 - pt preents to ED with cough, fever, urinary incontinence and SOB for about a week or 2 - tests pos for COVID 19 - pulse ox: 96%, normal resp rate, blood pressure, and renal fuction - troponin elevated at 47 and White count of 3.9 - admitted d/t elevated troponins and weakness 8/11/21: start decadron and remdesivir 8/14/21: discharged to home in stable condition
Twenty minutes after I received the vaccine, I was home and started to feel dizzy, light headed, and numb. My body felt extremely cold and I had to sit in the car with the doors closed to feel hotter under the weather. I probably stayed in the car close to 10 minutes. Then, I went into the house and I started feeling waves of cold so I immediately went and sat in the yard for another 15 minutes. This was one of the worst times. I could not move my face, arms, fingers, or legs and I was literally crying and trying to breathe. There was a numbing sensation that stretched from my finger tips to my arms, legs, toes, and across the chest (like a "u" shape). I told my dad at the time to get the phone ready to dial 911 just in case. This was very similar but slightly worse reaction when compared to the first vaccine I got 28 days earlier. I moved back into the house and had to be under blankets for the next 10 minutes. It was very difficult because my entire body was numb, like it was locked up in one posture. After another 15 minutes, it started getting better but it felt like my heart had taken a pounding.   Later this evening, I started feeling chills again with my teeth clattering. I had to go under blankets. I had my watch on and it said my HR was 80. I used my dad's oxygen device and it said 97%. My heart felt heavy again, as if it had done a lot of work.
Pain in back of left thigh. The next two nights pain was in both thighs (and much more severe on third night).
they are red; They feel itchy; my eyes started swelling a lot. They were huge!; my eyes were puffy; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 04May2021 at 15:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 33-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 COVID vaccine. On 05May2021 at 06:45, when the patient woke up 15 hours after the shot, eyes were puffy. On 05May2021 at 13:45, 22 hours after the shot, the eyes started swelling a lot. They were huge. On 06May2021 at 15:45, 48 hours after the shot, the swelling had subsided a little and they were red and they felt itchy. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events eyes were puffy, they were red and they felt itchy was not resolved while the outcome of the event eyes started swelling a lot was resolving at the time of report.  No follow-up attempts are possible. No further information is expected.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an Unspecified date the patient was previously treated with covid-19 vaccine from unspecified manufacturer (Dose Number in Series: 1) for prophylactic vaccination and did not report any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 23-AUG-2021) dose was not reported, (Dose Number in Series: 2), 1 total administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced expired vaccine administered (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211108380.
No Adverse Event; Patient vaccinated with product incorrectly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknow age or gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAR-2022, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U021995, expiration date: 13-JAN-2023) was stored incorrectly for a time frame of 24 hours at a temperature of 0.4°C. There was also a previous temperature excursion.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose regimen details not provided, lot #U021995, and expiration date: 13-JAN-2023) administered for prophylaxis. No adverse event was provided. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007068:
1422pm pt c/o itchinees of her throat and soreness of the right side of throat with tingliy around her lips.  RN with pt assisting pt. Bp- 110/82 P- 70 SaO2- 98%  1426pm breath sounds clear with good air exchange per, RN  1430pm  administered Benadryl 25mg L del IM per standing order, RN P-74 SaO@-98% Dr called to assess pt  1438pm Dr here to assess pt..  lungs are clear bilat with good air exchange.  no swelling of lips or throat. pt states that throat itchiness and tingling of lips is starting to go away. per Dr observe pt for 15 minutes and then repeat vitals and assessment. BP- 110/78 P- 98 SaO2- 79%  1448pm pt c/o feeling a little sleepy.  advised to call for ride home after Benadryl injection.  pt called for cousin to pick her up.    1458pm BP-118/80 P-70 SaO2- 97% Dr here to assess pt again. lungs clear bilat with good air exchange.  no swelling of the throat or tongue. pt reports that the itchiness/soreness of her throat and the tingling around her lips has resolved. ER precautions for severe reactions given to pt.  precatuitions given to pt regarding Benadryl injection administered.  pt verbalized understanding.  1520pm Pts cousin arrived to drive her home.  pt states symptoms have resolved except she is a little sleepy.  pt again reminded of precautions for Benadryl.  pt verbalized understanding. ...................................................................RN  April  2, 2021 4:19 PM