chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The subject is less than 18 years old, she was vaccinated in error. She was 16 at the time of the vaccine. .Subject and  Department of Health have been notified. As per CDC guidelines, subject will be given second dose after 28 days.
Information has been received from a physician concerning a 24 year old female pt with no known allergies or reportable medical history who on 10/6/06 was vaccinated IM with a 0.5ml dose of HPV. Several hours later, on 10/6/06 the pt called the office with complaints of swollen puffy eyes, some itching but no rash and blurry vision. The pt was seen in the office that evening on 10/6/06 and was given a dose of Benadryl and was sent home. The pt took a nap for the blurry vision and upon awakening the next morning the pt fully recovered. Blurry vision was considered to be disabling according to the physician since the pt was unable to perform her normal task. Additional information has been requested.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 17-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sore arm began about two (2) hours after shot.  Chills, fever, body aches, headache beginning about twelve (12) hours after shot. Significant improvement with ibuprofen.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included received Paxlovid from 10Aug2023 to 15Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began complaining of pain in arm by evening on day of shot. Over next several days she had complaints of Headache x 1, Vomiting x2, by 10/6/2018 patient was complaining of itchy rash on one arm and by 10/09/2018 the rash had spread to the opposite arm as well. She was  seen by the PCP and treated with ATARAX. The rash was described as dry bumps, no blisters, no discharge or weeping. Over the entire arm up to the shoulder. She did not report any fever.
Within 2 minutes of vaccine administration patient had facial flushing with diaphoresis, paraesthesia of face and arms, leg weakness.  Treated with Benadryl, Solumedrol and Pepcid.
This case was reported by a consumer and described the occurrence of sensation of fever in a 38-year-old female subject who was vaccinated with TWINRIX (Glaxosmithkline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions an concurrent medication were not known. On 1o August 2006 at 12:40 the subject received 1st dose of TWINRIX at 1 ml. The lot number and expiration date were not reported. By the end of the day on 10 August 2006, the subject reported that she was feeling feverish. The following day, on 11 August 2006, the subject developed a runny nose, watery eyes and a fever. She took ADVIL and by the end of the day on 11 August 2006, her symptoms had resolved. Follow-up received on 17 July 2007 via a regulatory authority indicted that the subject experienced conjunctivitis, rhinitis and fever one day after vaccination with TWINRIX.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 30-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 672 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Initial unsolicited report received from pharmacist on 29-Aug-2018. This case involves an unknown patient who was vaccinated with a dose of vaccine ADACEL and did not receive 10 year booster dose of TD (DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID) (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to missed dose (patient received ADACEL in 2011, did not receive ten year booster of Td per CDC recommendations). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Information has been received from a medical assistant referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported. On 18-FEB-2019, the patient inadvertently received an expired dose of M-M-R II (lot number: M047302; expiration date: 30-NOV-2018; dose, route were not reported) for prophylaxis. No adverse effects reported.
Patient developed a lump the size of thump on shoulder a day after the shot, after that it started to get red and got bigger and bigger and it turned out to be shingles.
nausea, diaphorectic. complained of some difficulty breathing, lump in throat. Nocturia.
2" swelling at Injection site that is somewhat hard, hurts only when pressed on, became itchy & rashy with a few bright red nodules and is persisting 10 days later.At some point a couple of days ago, I felt unwell, vsuddenly very sleepy as if I was having an generalized allergic reaction. I immediately took Claritin and a Sudafed tablet (followed a few hours later by another Sudafed tablet), and felt much better.
Mildly sore arm at injection site; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:15 (Lot number: EP6955) at the age of 55 years as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ARIPIPRAZOL; LAMOTRIGINE; BUPROPION; CALCIUM+D. Past drug history included: Neomycin, reaction(s): "Allergies to medications, food, or other products". Vaccination history included: Bnt162b2 (product, COVID 19, lot number, EL3247, dose number, 1), administration date: 03Mar2021, when the patient was 55 years old, for Covid-19 immunization.   The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 10:00, outcome "not recovered", described as "Mildly sore arm at injection site"; INSOMNIA (non-serious) with onset 25Mar2021 10:00, outcome "not recovered", described as "insomnia". Therapeutic measures were not taken as a result of vaccination site pain, insomnia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Yes I am the person who received the vaccine and I became aware of the side effects on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
The pt experienced a fever of 103 for over 3 days, listlessness, uncontrollable crying for 3 days. No appetite, and no sleep for 2 days.
felt tingling in my hands; dizzy for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy for 4 days) and PARAESTHESIA (felt tingling in my hands) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112204) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy for 4 days) and PARAESTHESIA (felt tingling in my hands). At the time of the report, DIZZINESS (dizzy for 4 days) had resolved and PARAESTHESIA (felt tingling in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment provided for the event was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter first and last name updated for spelling, email added, and new event of tingling in hands reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 35 years old female patient who received vaccine FLUZONE QUADRIVALENT lot number UJ069AA, expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was reported that to give a nonpregnant female patient her flu shot 0.5 ml IM in the left deltoid and some drops came out. They are concerned she didn't get her full dose. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 39-year-old female patient who received TWINRIX Adult. Co-suspect products included TWINRIX Adult, TWINRIX Adult and TWINRIX Adult. On 9th December 2016, the patient received the 1st dose of TWINRIX Adult. On 16th December 2016, the patient received the 2nd dose of TWINRIX Adult. On 30th December 2016, the patient received the 3rd dose of TWINRIX Adult. On 9th January 2017, the patient received the 4th dose of TWINRIX Adult. On 9th January 2017, not applicable after receiving TWINRIX Adult, TWINRIX Adult and TWINRIX Adult, not applicable after receiving TWINRIX Adult, TWINRIX Adult and TWINRIX Adult, not applicable after receiving TWINRIX Adult, TWINRIX Adult and TWINRIX Adult and an unknown time after receiving TWINRIX Adult, the patient experienced drug dose administration interval too short. On 10th February 2017, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too short were unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX Adult, TWINRIX Adult, TWINRIX Adult and TWINRIX Adult. Additional details were provided as follows: The age at vaccination was not reported. The patient was following TWINRIX Adult accelerated schedule. On 9th January 2017, the patient received 4th dose of TWINRIX Adult in error, which led to shortening of the vaccination schedule. On 10th February 2017, blood titer was drawn and it was leading the patient to be a therapy non responder. The healthcare professional did not want to give patient's demographics and did not have vaccine lot and expiration dates for vaccines.
" Prior taking the vaccine I had a cold, but nothing serious. After taking the vaccine, I had a slight headache throughout the weekend. Starting Monday, I had chills weakness, muscle cramps and shortness of breath.   Now, all the symptoms have resolved"
The day after the initial vaccination, lesions started erupting from the knee to the ankle on both legs. This progressively worsened. For the next 6 months in a lot of pain with no answer. Visits to the wound doctor up 3 times a week. Two ER visits for pain. In March 2022 she had 2 strokes. She is now living with me, her daughter. It was not until July, going to see Dermatologist Dr. were we given a diagnoses for her legs. The local Heart Institute was able to manage her heart failure with different medications. She is also anemic.
Developed mild chest pain about 9-days post receipt of primary SPV. While in route to facility, patient had chest pain and shortness of breath "on and off" on 25 July.  He also noted significant tenderness and some swelling in his left armpit, but denies fever, chills, fatigue or body aches.  He also denied palpitations, diaphoresis, N/V or radiation of pain. On a pain scale, his pain was never >2/10.  It did not get worse with deep breaths, but seemed to get worse when lying back and better when sitting or standing. He reports catching a mild cold from his wife around 24 Jul (nasal congestion, PND and mild sore throat).  No cough or earache or chest congestion. No rashes. On 25 Jul, patient sought evaluation at Urgent Care.  No labs were drawn and nothing was prescribed, but patient was told he could take Ibuprofen as needed.  Patient has not experienced chest pain and shortness of breath since evaluation. He did take Ibuprofen 400mg 3x/day for 24 hours.
No additional AEs; HBP called in and reported that teh improperly stored vaccine was administrated.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011622, expiration date: 06-APR-2024, administered for prophylaxis (dose, anatomical location, and route of administration were not provided). Administrated varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes, no previous temperature excursion were reported (product storage error).  There were no adverse events reported (no adverse event).  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005958: US-009507513-2210USA005639: US-009507513-2210USA005648:
Patient stated that they felt dizzy and had blurred vision. Manager on duty was notified and emergency personel was called to seen. Patient was asked to sit down and was monitored. Emergency personel arrived and proceeded to assist patient with questioning. Patient stated that they felt better. Pharmacist asked patient to stay longer to be monitored. Patient complied. Left 20 minutes later. Stated that they were feeling much better. Patient asked to contact pharmacist if they had any other issues or questions.
Injection site pain,  swelling,  redness and warmth.  (2 days post injection the site expanded and became very hard.)  Headache,  nausea,  exhaustion,  overall body weakness.  Continued 5 days post injection.  Tylenol used for minimal relief and used electrolyte drinks to maintain hydration. Mainly rested for the entire 5 days.
Death Narrative: already reported VAER for hospitalization on 3/3; the patient subsequently died once transferred to SNF
Super Heavy Periods and Bloodwork to check for autoimmune disease showed positive results for APS IGA.; Super Heavy Periods and Bloodwork to check for autoimmune disease showed positive results for APS IGA.; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (at 50 years old, not pregnant) (Batch/Lot Number: ER8733) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. No concomitant medications. The patient had her first dose of bnt162b2 on 19Mar2021 12:00 (lot: En6206) on left arm for COVID-19 immunization at 50 years old. Patient experienced on 19Apr2021 12:00, Super Heavy Periods and Bloodwork to check for autoimmune disease showed positive results for APS IGA. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in visit to Doctor or other healthcare professional office/clinic. No treatment for the events. The outcome of the events was unknown. No covid prior vaccination. Not covid tested post vaccination. Device Date: 15May2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Co-suspect products included VAQTA (batch number L009445, expiry date 1st June 2017). Concomitant products included VIVOTIF. On 24th June 2016, the patient received BOOSTRIX (intramuscular) .5 ml and VAQTA (intramuscular) at an unknown dose and frequency. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site pain (serious criteria other: As per reporter), injection site erythema (serious criteria other: As per reporter) and inappropriate reconstitution technique. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved and the outcome and the outcome of the inappropriate reconstitution technique was unknown. It was unknown if the reporter considered the injection site pain and injection site pain and injection site erythema to be related to BOOSTRIX. Additional information was provided as follows: On 24th June 2016, at 11:45, the patient received BOOSTRIX and 2 doses of pediatric VAQTA, in the same arm (right deltoid). The patient was at the healthcare professional's office for the pain, at the time of reporting. Inappropriate reconstitution technique was reported as an event, however, no details were reported if it was related to BOOSTRIX or VAQTA. The batch number reported for BOOSTRIX (7RJ98) did not exist and was updated to 7RJ9B as per the sales database.
Severe nausea and continuous vomiting for approximately 4 hours before seeking care. Nausea continued until 9am with dry heaving. Treated with banana bag and zofran.
No adverse effects reported; patient was administered Improperly stored rotateq; This spontaneous report was received from a physician, referring to an approximately 4-month old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    The vaccine underwent a previous temperature excursion on 25-FEB-2020 (at temperature above of 9°C) 9.3°C for 3 hours 33 minutes; and on 03-MAR-2020 (below 2°C) at 0.8°C for 11 hours 39 minutes, and on the same date, at 0.8°C for 5 hours and 9 minutes; on 04-MAR-2020 at 0.9°C for 11 hours. On 05-MAR-2020 at -1.3°C for 9 hours and 29 minutes.   On 05-MAR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dose, frequency and route were not provided; Lot number reported as 1658255 has been verified to be valid; expiration date reported and validated as 07-FEB-2021) for prophylaxis. The excursion was called by a digital data logger. The physician reported that the patient did not experience any adverse event.
FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s(Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced flu-like symptoms (Dose number in series: 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20211258986 (Dose number in series: 2, Booster dose) This case, from the same reporter is linked to 20211258107 and 20211258204.
redness to bilat elbows to forearms w/inc warmth also swelling & redness to both hands-occurred @ 28-24hr p/vax;