chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented for second dose Moderna COVID-19 vaccination. The needle/syringes provided as part of the ancillary kit had issues related to the lure-locking system. At the time of the nurse administration of the dose, the needle/syringe separated causing the vaccination to run down the patients arm, therefore not receiving the full dose. Moderna provider support was contacted regarding this, with information supplied. Information was discussed with medical provider, and patient and decision was made to provide a 'redose' of vaccination. Patient did not experience an adverse reaction, this was a dosing scenario.
He had a fever, sore throat, headache, and cough. He also had diarrhea. I took him to the Doctor Tuesday, the 21st. No medications, just ride it out for the ten days in isolation.
This spontaneous report was received from a medical assistant referring to a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were unknown. On 25-JUL-2016 the patient was inadvertently vaccinated with both PNEUMOVAX 23 (lot # M005286 with expiration date: 08-OCT-2017, 0.5 ml once, intramuscular) and PREVNAR 13. No adverse effects were reported. Additional information has been requested.
SAYS HE WOKE UP THE NEXT MORNING FEELING DIZZY AND HE EXPERIENCED SOME VOMITING.
Death   5/30/2021 Causes of death listed on death certificate: 1) Covid 19 Pneumonia  2) colo-vesical  fistular  3) Heart failure  4) chronic  uti
The day after the shot her left leg started hurting. Mainly in the knee and on down the leg. Feels like a "sledge hammer". After a couple of weeks, her right leg began hurting as well. And a week after that, her left arm began hurting.
Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-003208 is a spontaneous case report initially received on 15-Sep-2022 from a nurse via Bavarian Nordic and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose or site of administration, administered intramuscularly (explicitly coded as 'incorrect route of product administration'). After the vaccination, the patient was observed for approximately 20 minutes and no adverse event occurred.  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from Company on 15-Sep-2022 included Company ID and indication for Jynneos, and is blended in the case narrative.  This case is linked with the case US-BN-2022-003207 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.
For 2 nights including first had fever of 101 degrees. On 9/22/2022 through 9/25/22 had severe diarrhea not responding to Imodium or Pepto bismol. Had headache and very fatigued.
5-30mins p/vax pt exp pallor, nausea, abdo cramping, h/a; taken to hosp; Pt noted faint, raised rash on cheeks; sent home; 8OCT low grade fever; dx'd vaso-vagal response;
Information has been received from a health professional concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed hugh large welts at the injection site. No medical attention was sought. The pts outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient experienced bleeding as well as swelling/inflammation/slight bruising at injection site. Began immediately after immunization administered. Swelling began to decrease but still present after 20 minutes. Patient not experiencing any pain, dizziness, or sign of an allergic reaction.
Employee described "itchy" at upper arm on 12/3/10 as we were passing in hall.  Later, on 13/13/10- Employee states the upper arm became red and increased with redness, gradually. While employee working she called- via phone the Emergency Room on 12/05/10 and consulted with staff asking what they thought- at which time it was suggested that employee take Benadryl; however, employee did not take Benadryl, and redness gradually subsided.  I personally assessed the arm today- faint redness noted below deltoid area.  I also noted a small (1cm x 0.5cm)partially open area with partial scab 3 inches or greater below deltoid.  Employee " I'm not sure where she got that from." Note: itching, per employee, began 3 days after immunization (Tdap- Sanofi Pastuer)
Information has been received form a registered pharmacist concerning a 64 year old male patient with allergy to aspirin, who on 05-JAN-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 665307/1171Y) SQ. The pharmacist stated that the patient came into her pharmacy "a couple of months ago" and told the pharmacist that he had broken out in shingles in September 2010. It was reported that an unspecified treatment was given for the adverse event. The patient was fully recovered at that time. Follow up information has been received from the pharmacist concerning the patient with no noted illness at time of vaccination who on 05-JAN-2010 was vaccinated with a first dose of ZOSTAVAX (Lot # 665307/1171Y) in the left triceps, at the pharmacy. In October 2010 the patient had symptoms of outbreak and went to primary care for follow up with his physician. Additional information is not expected.
Contracted COVID; contracted COVID; fatigue; nasal congestion; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 02Jun2022, outcome "recovering", described as "Contracted COVID"; DRUG INEFFECTIVE (medically significant) with onset 02Jun2022, outcome "recovering", described as "contracted COVID"; COUGH (non-serious) with onset 02Jun2022, outcome "recovering"; FATIGUE (non-serious) with onset 02Jun2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 02Jun2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, fatigue, nasal congestion, cough. The patient has no Seriousness criteria for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Mild symptoms were reported. The patient did not diagnose with COVID-19 prior to vaccination. The patient has been tested for COVID-19 from the vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
14.5cm redness, 30cm swelling right arm. Treated with Motrin and Benadryl.
patient received Bexsero expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th August 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 09-Nov-2022 Reporter's comment: On 11th November 2022, the vaccine coordinator reported that on 26th August 2022 the patient received Bexsero expired dose.  The consent to follow-up was granted. The follow-up was accepted by email. The patient´s details were not available at the moment of the call. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Headache; Light fever; Soreness at injection site; Swelling and pain in lymphnodes; Swelling and pain in lymphnodes; This is a spontaneous report from a contactable other hcp. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number: EN6201, expiry date: unknown) dose 2 intramuscular, administered in Arm Left on 23Feb2021 08:30 AM as DOSE 2 SINGLE, for covid-19 immunization (age at vaccination:44-Year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, (Batch/Lot Number: EL9264, expiry date: unknown) on 02Feb2021 08:30 AM intramuscularly in left arm as DOSE 1 single, for covid-19 immunization. On 25Feb2021 10:00 AM the patient experienced headache, light fever (pyrexia), soreness at injection site (vaccination site pain), swelling and pain in lymph nodes (lymphadenopathy) and swelling and pain in lymph nodes (lymph node pain). The patient had not received any treatment for the events.The outcome of all events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Altered taste occurred 1 day after shot was received and then 3 days post shot I developed a case of Bell?s palsy.  Being treated with prednisone and Valtrex. Paralysis is improving slightly but right side of face is still mostly paralyzed.
Joint pains,Headache.Nausea,Tiredness low grade fever Time approximate 17 hours
Ran fever of 102 for 2 1/2 days Could not eat  Everything made me sick Extreme fatigue Headache Extreme pain in injection site
Chills, Fever (101.0), Achy, Sore muscles, Stiffness, injection site pain, mental fuzziness, Headache
Jaw pain/headache on the Left side  Started at 4Pm on 6/7/21, mom gave ibuprofen  and it resolved.
ACUTE RESPIRATORY FAILURE 12/6/2022 CANCER METASTATIC TO PLEURA  ACUTE RESPIRATORY FAILURE 12/6/2022 CERVICAL CANCER, UNSPECIFIED
Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose#1 04/01, Pfizer, dose#2 11/23, Pfizer, dose#3 12/27 COVID swab, result: detected 12/25 pt cc: chills, cough, fatigue, fever, myalgias, nausea, rhinorrhea, dyspnea sore throat exposure: unknown 1/1 clinically resolved
Rec'd Dtap on 7/5/06 Mother called 7/6/06 and stated child's arm was red, swollen. Dr advised Tylenol, ice 24-48 hrs.
Had COVID 19  08/2020. Symptoms were sinus congestion and post nasal drainage. Sense of smell and taste was only dulled.   Following the vaccine- my sense of smell was gone and the tinnitus is constant in a waxing and waning intensity. Just this past month my sense of smell gives me brief light smells, then gone again.
initially, headache, cough, and congestion with shortness of breath.  Significant shortness of breath persists
patient is coming in to get a second dose/first dose almost 2 years ago (7/17/2019).; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient had received 1st dose of Shingrix almost 2 years ago, till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. Pharmacist was unable to provide vaccine details. The reporter did not consent to follow up.
Rash on my neck and upper chest within 6 hrs of vaccine; Rash on neck burns; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Right arm on 10Apr2021 14:00 (at the age of 59 year old) as dose 2, single for COVID-19 immunisation. Medical history included allergies to Sulfa products, doxycycline and was sensitive to epinephrine. Concomitant medications included alprenolol hydrochloride (ATENENOL); duloxetine hydrochloride (CYMBALTA); levothyroxine sodium (SYNTHROID) and metformin all for an unspecified indication.  Prior to vaccination, patient  was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 20Mar2021 13:45 (at the age of 59 year old) as dose 1, single for COVID-19 immunisation. On 10Apr2021, within 6 hours of vaccination, at 18:00, patient had rash on neck and upper chest, where rash on neck burns. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the event rash was not recovered and of burning sensation was unknown.  No follow-up attempts are needed. No further information is expected.
22 year old male was given PROQUAD for second MMR dose and first varicella dose.
This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water) and NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5714B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Fruit allergy (Allergic to mango), Reaction to monosodium glutamate and Allergy to plants (Allergic to sage). On 15-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water), NAUSEA (nauseous), HEADACHE (extreme pain at the back of the head and this is not the regular headache), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (body aches on the hip). At the time of the report, MOBILITY DECREASED (can't lift arm, can't put pressure on it), VACCINATION SITE PAIN (extreme left arm pain), PAIN IN EXTREMITY (can bend it but it hurts when bent, body aches on the feet), VOMITING (threw up water), NAUSEA (nauseous), HEADACHE (extreme pain at the back of the head and this is not the regular headache), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (body aches on the hip) had not resolved. No relevant concomitant medications were reported. On 29-JAN-2021, patient received first dose of Moderna vaccine, lot number 007M20A. On 25-FEB-2021, patient received second dose of Moderna vaccine, lot number 010A21A. On 17-DEC-2021, patient received third dose (first booster dose) of Moderna vaccine, lot number 013F21A. It was reported that AE dose not cause patient to seek medical care and patient does not experienced a similar event in the past. Treatment medication was not provided by the reporter. Reporter did not allow further contact.
Severe pain from shoulder to wrist, restricted ROM shoulder and elbow, numbness and tingling elbow to fingers.
Moderna was given to child age 15. Moderna not approved for age group younger than 18 years old.  No negative adverse side effects noticed during wait time of 15 minutes. Mother of child notified of medical error and advised to return for 2nd dose of Pfizer at 28 days.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac arrhythmia" (unspecified if ongoing). The patient's family history included: "Covid-19" (unspecified if ongoing), notes: My family all had covid 19 at the same time, and three other family members. Concomitant medication(s) included: PROPRANOLOL; DILTIAZEM. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27May2022, outcome "unknown", COVID-19 (medically significant) with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative, and then a day later, covid symptoms returned rapidly and in full force; (unspecified date) Positive, notes: I am now testing positive for Covid-19 again after testing negative; (27May2022) Positive; (01Jun2022) Negative; (05Jun2022) Positive; (06Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient reported that she suffering from moderate Covid-19 rebound symptoms after completing a 5 day course of Paxlovid. She was fully vaccinated/boosted, and believe Paxlovid extended and worsened my covid-19 illness instead of making it better. Her family all had covid 19 at the same time, and three other family members who did not take Paxlovid are back to normal routine, testing negative. she took Paxlovid for 5 days. Felt better. Tested negative, and then a day later, covid symptoms returned rapidly and in full force, and are actually WORSE than before she took the Paxlovid. She was now testing positive for Covid-19 again after testing negative. Tested positive for Covid-19 on 27May Started Paxlovid 27May Symptoms resolved 29May Completed Paxlovid 01Jun Tested negative for Covid 19 04Jun Symptoms returned on 05Jun and positive Covid test on 05Jun and 06Jun. Symptoms more severe on 06Jun - 07Jun than they were on 27May before taking Paxlovid. Paxlovid lengthened my illness and also caused worse symptoms with the rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from the patient's father. The patient was vaccinated with a dose of M-M-R II last week(on approximately 25-FEB-2013). The vaccine expired in November 2012. No adverse experience reported. Additional information is not expected.
This case described the occurrence of dizziness in a 64-year-old female who received hepatitis A inactivated and hepatitis B recombinant vaccine (TWINRIX) for prophylaxis.  This report was received from the patient and has not been verified by a physician or other health care professional. The patient's medical history included hypertension.  Concurrent medications included lisinopril.  The patient stated that the lisinopril dosage was doubled on 07/03/2003.  On 07/03/2003 at 16:00 hours, the patient received the first injection of Twinrix.  On 07/04/2003, "late" in the day, the patient began to experience dizziness, upset stomach, "feeling like throwing up", flushing, and "hurting in her abdominal cavity".  On 07/07/2003 at 02:00 hours, the patient experienced "difficulty breathing because her throat was very dry."  The patient stated that she had talked with an "advice nurse", who told her that "the vaccine in combination with the increase in blood pressure medication could be causing her symptoms."  The dizziness, upset stomach, nausea, flushing, and abdominal pain were unresolved as of 07/07/2003.  The difficulty breathing resolved on 07/07/2003.  The outcome of the dry throat was unknown as of 07/07/2003.
severe lumbosacral myalgia about 3 days p/vax 3NOV98;on the 24NOV recurrence w/severe labyrinthitis (including vertigo, nystagmus & nausea);
Pt presented with redness and urticaria approximately 4cm from injection site of MMR on (R) thigh and varicella on (L) thigh. (no reaction around) gave BENADRYL and applied cold pack (flu shot). Improved w/in 20 minutes.
6NOV98 640Pm arm sl swelling w/ache, @ bedtime arm more swollen applied moist heat;APAP given;lips swollen, red & chapped;tingling of fingers on & off;
Infant was alert/awake and suddenly lost consciousness. She became limp and would not respond to my efforts to awake her (picked her up and was loudly talking to her in attempts to keep her conscious). She remained unconscious for about 7 minutes as I drove her to urgent care and then awoke about 2 minutes after we arrived. Temperature, BP and heart rate were all considered normal.
HYPERTENSIVE URGENCY, BLOOD PRESSURE UP TO 200/110 RANGE AT TIMES, WITH SINUS TACHYCARDIA UP TO RATES OF 130 BY PATIENT REPORT
Employee reports that about 10 minutes after receiving the flu vaccine her ears got hot and she started itching behind her left ear on the left side of her neck.   Whelps and redness appeared near the left ear and her left wrist.  She took Benadryl 25mg and the redness, whelps, itching and heat went away.
Nausea, vomiting, dizziness, fever (increased to 103 degrees), chills, rigors. (Took flu medicine).
flu like symptoms fever for 3 days, dizziness, headache rash/burning sensation, allergic reaction to knee implants knees swollen, cant walk, light headedness, hand and arms immobile/burning, extremely fatigued,