chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OM 1/27/05 pt had a Hep B vaccine. On 1/19/05 mom called about no BM in 48hrs. On 1/20 blood in stool noted then developed diarrhea. On 1/27 looks good at well visit. On 2/1 mom calls saying she isn't feeling well today. 2/3 sees Ped surgeon not obstructed. 2/3 admit, 2/4 Ped GI comes in. 2/4 transferred to hospital , benign hypotonia, etiology unk. On 3/3 Mom says she doesn't want any more Hep B vaccine because she stated acting funny the day after hep B vaccine given.
At 1500, after receiving 1st dose Moderna, pt reported feeling tongue tingling and feeling a little dizzy and sweaty.  Pt placed on cont. Pulse ox monitoring sats 94-97%.  We suggested administering Benadryl which she declined. After further discussion and reassurance that it will not interact with Moderna vaccine, she agreed to take Benadryl IM.  Vital Signs: 1503- 175/106 HR 89 O2 96% 1509- 175-98 HR 74 O2 95% 1513- 168/90 HR 86 O2 94% (Benadryl IM given) 1525-156/93 HR 70 O2 95% ( At this time, pt reported feeling better)  We offered to take her to car via wheelchair, but she declined. She walked out of clinic with husband to drive her home.
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 19-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
Vaccine was improperly stored upon arrival to facility. Pt had no adverse symptoms from receiving the vaccine.
rt inguinal adenopathy & local discomfort a wk p/booster dose; 5MAY95 no response to f/u request;
Itchiness on site, hard muscle, rashes, left arm aching and radiating pain on shoulder and left back
Sweating and itchy rash during the night, then the rash continues during the day a little, then got worse around 5pm the next day.
This spontaneous report was received from a 48 year old female patient, reporting on herself. The patient had a prior history of getting shingles on her spine every three months since she was 30 years old. The patient's concurrent conditions included compromised immune system. The patient did not have any drug reaction, allergy or concomitant therapy. On an unknown date, at the age of 48 years, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (lot #, expiration date, site and dose were not reported). On an unknown date, the patient experienced a breakout. The pain she experienced put her down for days. She was unable to wear clothes because the pain was so bad. The patient sought medical attention and was hospitalized due to the event (start date and duration of hospitalization were not reported). She was treated with acyclovir, FAMVIR and VALTREX for the event. However, according to the patient, none of these drugs worked. The outcome of herpes zoster was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the patient refused to provide her physician's contact details.
About 10-15 minutes after vaccination, patient reported that she was feeling dizzy and was breaking out in a rash. Upon examination, a maculopapular rash was observed on upper chest and arms. No localized symptoms at injection site were reported. No breathing abnormality was reported. Patient was placed under further observation and vitals were taken by RN at facility (BP: ~113/100, HR: 105). Patient was observed for another 15 minutes, patient reported her dizziness was still present, rash was not worse at this time. No breathing abnormality was reported at this time either. Medical services (which were called for a different patient) also evaluated this patient and the patient was then taken to local ED for further evaluation.
Fatigue; Slow thinking; Sore arm; This is a spontaneous report from a 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: EN6199), via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the left arm on 11Mar2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 11:00, the patient experienced fatigue, slow thinking and sore arm. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue, slow thinking and sore arm was not recovered.   No follow-up attempts are needed. No further information is expected.
Vial was diluted with 0.18ml instead of 1.8ml.  0.3ml of the reconstituted dose was administered to patient.
This spontaneous report was received from a Registered nurse refers to a patient of unknown age. Patient medical history and current condition was not reported. On 08-MAY-2015 the patient was vaccinated with MMR II (lot # K009192 and expiry date reported as 27-JUN-2016) which underwent an unsupported temperature excursion via intramuscular route. No adverse effects reported. The outcome of the event was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Soreness in arm throughout the experience Fatigue 10 hours after injection (1/17/21) Body aches and chills on the morning of the day after the injection (1/18/21) Fever of 100.5 at 2:00PM (1/18/21) Fever gone by 9:00pm (1/18/21)
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289731, 2018SA289688 and 2018SA289702. This case involves a 15 years old male patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. 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 sender: none.
Patient under age 18 was vaccinated with Johnson and Johnson/Moderna, which is a vaccine error.  (If the person may receive a second dose, it will be per policy off-label use for a 17-year old). Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away. Parent validated age as 18. Unreported as error, found in data mining.
A non-serious spontaneous report of "a patient received expired FLUMIST" was received from a registered nurse concerning a 13-years-old male. The patient's medical history and concomitant medications were not reported. The product expired on 05-Jan-2011. The patient received the expired FLUMIST on 14-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 08-Apr-2011 and incorporated into case: no late occurring adverse events.
Increased redness and pain and itching at injection site. Noticed small redness at injection at time of vaccine. It keeps spreading and becoming red and painful and itchy. Now two weeks later it keeps spreading and increasing in discomfort.
dose administered > 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 016B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (dose administered > 12 hours post-puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-406032 (Patient Link).
Pt traveled to Africa & became ill w/ diarrhea 5 days into the tour. Returned to USA still ill w/ diarrhea & flu symptoms. Lab tests done; dxed w/ Hepatitis A.
Found 5 small red, blistered-like bumps on the right side of my abdomen. Was itchy and painful to scratch. Was under the impression it was a spider bite, but over time I am concerned it could've been shingles.  I have had shingles before in the exact same location as these bumps, which makes me skeptical it was a spider bite. The bumps occurred approximately 4 days after my 1st shot. Bumps are nearly healed now and I did not seek medical treatment.
kind of pretty rough headache; Kind of feeling nauseous; This is a spontaneous report from a contactable consumer, the patient. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular on 28Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 30Mar2021, the patient had a kind of pretty rough headache and was kind of felling nauseous. The outcome of the events headache and nauseous was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient scheduled for 1st Dose of Pfizer vaccine on 2/12/21.  After vaccine given patient was entered into PASIIS - where records showed patient recieved the Moderna vaccine on 1/28/21.  On 1/28/21, patient was scheduled for 2nd dose of Moderna on 2/25/20 at 1000.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 23-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's medical history included three previous pregnancies resulting in one elective abortion and two normal full-term live births.  The subject had not been using contraception prior to becoming pregnant.  On 8 September 2011 the subject received a dose of Boostrix (.5 ml, intramuscular, unknown site), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal and date of last menstrual period was 22 December 2010.  Estimated date of delivery was 29 September 2011.  Prenatal testing, including ultrasounds performed on 11 May and 31 August 2011, and maternal serum alpha-fetoprotein on 07 April 2011 revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds performed on 11 May and 31 August 2011 revealed no evidence of a defect. Maternal serum alpha-fetoprotein on 07 April 2011 revealed no evidence of a defect.
JOINT PAIN IN LEFT SHOULDER, CONTINUING. (Feels like pulled muscle or tendon).
The patient came in on 6/19/19 at 5:30pm and told me he'd had extensive bruising and soreness in his right arm after receiving vaccines at our pharmacy on 6/5/19. He said he sought treatment at the ER but didn't specify when or what treatment he received there. His right arm was still mildly bruised when I examined it. He believes the administering pharmacist "twisted the needle" when withdrawing a needle after giving one of the vaccines. He did not ask for medical advice, he simply wanted to let me know about the incident. I alerted his PCP, Dr, about the incident. She did not recommend further treatment.
I have a very regular 28 day cycle. After the 2nd COVID vaccine my period started (approximately 48 hours later), but I was not schedule to start for another 2 weeks. Not only did I start early, but the blood loss is excessive and will not stop. I used a Diva cup that measures by ounce. I typically lose 1.5 ounces every 3 hour or 12 ounces of blood per day /24 hour period. When my doctor prescribed birth control the bleeding stopped for approximately 2 weeks and then started again. The newest pack of birth control has not stopped the bleeding. I am now so lathargic I am only awake 3 to 4 hours per day unable to work.
Pt. dad called today stating that patient had vaccines 12/14/17. 12/17/17 rash to face and neck with some fatigue, no other symptoms. I recommended that he take her to be seen by her physician. He was thankful for the call.
Received a merk diluent  that was reconstituted with the Shingrix; Received a merk diluent  that was reconstituted with the Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-May-2022 Reporter's comments: Merck's diluent that was used to reconstitute MMR and varicella vaccines was reconstituted with the Shingrix and administered to the patient.  No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email. Additional Supportive Information: The Shingrix was reconstituted with Merck's diluent and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case was linked with case US2022082843 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082843:Same Reporter
Developed shingles (herpes zoster); typical rash; nerve pain; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 02:30 (Batch/Lot Number: EN6206) (at the age of 71 years old) as single dose for COVID-19 immunization. Medical history included asthma and known allergies: penicillin and multiple foods. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 09Mar2021, the patient experienced developed shingles (herpes zoster), typical rash and nerve pain. The condition shingles was diagnosed at an urgent care center. The patient had a typical rash and nerve pain. The event resulted in emergency room/department or urgent care. Treatment for the event included Acyclorvir. No COVID prior vaccination. The patient was not COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Refridgeration excursions identified; No Adverse Event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022 at 5:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 5:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.   Dose 4 vaccine administered through deltoid.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. No adverse reactions reported for any of these patients.  The Nurse reports a temperature excursion that has occurred in a refrigerator at her clinic containing both monovalent and bivalent Moderna Covid-19 vaccines. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   The Nurse was now calling about Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   No information was available on that patients at this time.   It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.  The patient had received moderna vaccine doses 1, 2, and 3 intramuscularly and at the deltoid site of the body.  No treatment medications were reported.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 31 year old female. 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: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219731, 20211219686, 20211220537, 20211220233, 20211219807, 20211220948 and 20211221158.
about 30 minutes after receiving the covid vaccine pt reported feeling dizzy and tightness in her chest.  She was coughing occasionally when talking.  EMS was immediately called and vital signs were as follows 160/100 HR 83 RR 24 02sat 99, pt reported having "locked jaw" which is consistent with her previous allergic reactions. At 1008 pt given one dose of epipen in right leg, she reported some relief after 3 min. and refused Benadryl. EMS arrived at 1013 report given to them, o2 applied by nasal canula and EMS requested second dose of epipen to be given. at 1014 second dose of epipen given in left leg. pt was able to move with assistance to stretcher, pt's family notified and pt transported to hospital by EMS. pt's belongings given to pt. Pt denied any anaphylaxis to any injectable medication prior to vaccine administration. Plan to contact pt for outcome of incident.
Itchy, redness, swelling, for 10 days.  fatigue, dizziness, presyncope ongoing 3 weeks later
pt recvd vax & 24 hrs p/vax exp diarrhea & nausea;