chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patients did not experience any symptoms; patients were vaccinated with improperly stored varivax between 11/15/2019 and 11/25/2019; This spontaneous report was received from a medical assistant concerning seven unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. The patients' concomitant therapy included sterile diluent(STERILE DILUENT).   On unknown date in November 2019, (reported as a date between 15-NOV-2019 and 25-NOV-2019), seven unspecified patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S021927, expiration date: 15-JUL-2021; lot # S006647, expiration date: 05-MAR-2021 and lot # S004119, expiration date: 11-FEB-2021) for prophylaxis (strength, anatomical location, dose and route of administration were not reported) (product storage error). The outcome of the event was unknown. Patients' did not experience any symptoms. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This case has been considered as non-valid due to lack of patient' identifiers.  Lot number S006647 is an invalid lot number for varicella virus vaccine live (oka/merck).  As of 26-MAY-2020, all telephone attempts trying to obtain additional information has been unsuccessful.  Follow up information has been received from another medical assistant on 28-MAY-2020.  The medical assistant stated that, the physician preferred to have in writing of the request for patient identifiers and dates of administration of the varicella virus vaccine live (oka/merck) (VARIVAX) that had undergone temperature excursion.  Follow up information has been received from the medical assistant on 10-JUN-2020 refers to a patient of 4 year old male patient. On 15-NOV-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) of lot# S004119, expiration date reported as 11-FEB-2021.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2006USA004158:
Information has been received from a healthcare worker concerning unspecified number of patients of unknown age. In July 2014, the patients were vaccinated with VAQTA (dose, route and lot # not provided), that had been exposed to 1 degree centigrade for 84 hours (temperature excursion was reported as "supported"). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Pain in arm where vaccine was administered, and continually ongoing pain up until current date of 01/29/16.
I have developed eczema, dry earlobe, and a crust on my scalp that is making my hair fall out
This spontaneous report was received from a registered pharmacist refers to a 56 year old female patient. The patient had no drug reactions or allergies. Current conditions included diabetes and shingles. ON 07-NOV-2012, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX, (lot number, expiry date not reported) while having shingles and while on VALTREX. Concomitant medications included acetaminophen, ENDOCET and VALTREX. Soon after the vaccination with ZOSTAVAX the lesions crusted over. But now approximately on an unknown date in December 2012, the patient developed shingles again on face, mouth, throat, sides and arms. It was unspecified if laboratory studies were performed. The outcome of the event was reported as not recovered. The patient sought medical attention (unspecified). Additional information has been requested.
Patient called me today, Monday, 10-8-18. She said on Friday, (10/5/18), the day after she got the shot, she had one of the worst headaches she's ever had, she said she can't remember ever having such a bad headache. She also had about a 3" circle around where the shot was given, that was painful and hot to touch. She said when she had her 1st SHINGRIX shot (2 months ago) she didn't have any reactions. She said on Saturday her headache was gone.
The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label; No adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse reaction) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label).    Concomitant products were not reported.  It was reported previously unvaccinated patient (6 months of age) was to receive Dose 1 of their vaccine series 0.25mL from vial with blue cap and gray bordered label. The child was mistakenly given 0.2mL from the pink-capped vial with yellow ribbon label.  Treatment medications were not reported.   This case was linked to MOD-2023-723728 (Linked Report).; Sender's Comments:  MOD-2023-723728:9-Months-old Infant case
Information has been received from a registered nurse referring to a 62 year old female patient. Information regarding concomitant medication and drug reactions/allergies was unknown. The patient had the diagnosed of an unknown immunoglobulin disorder prior to receiving PNEUMOVAX 23. On an unknown in May 2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, dose and route were unknown). On an unknown date in 2016 (reported as "recently"), the patient was seen by an unspecified physician who was planning treatment (unspecified) for the unknown immunoglobulin disorder at the reporting time. It was unknown if the condition of unknown immunoglobulin disorder changed or worsened since May 2016. The causality between the event and the vaccine was not reported. Additional information has been requested.
7 days post vax the pt developed an atypical rash on her neck and scattered on her face, jawline, her right eyelid, left cheek and 5 larger crusted areas at the sternoclavicular area in a necklace pattern and bilateral sides of neck. One lesion was noted at the injection site. The rash was described as discrete, pink and varying in size with no vesicles. Crusting was apparent with no more than 25 lesions noted. Pt was afebrile and pruritic. The pt sought unspecified medical treatment.
Information has been received from a physician concerning a 47 year old female pt who on 9/30/02 was vaccinated with pneumococcal vaccine 23 polyvalent (640744/0994L). The reporter indicated that within 24hrs (approx 10/1/02) of vaccination with pneumococcal vaccine 23 polyvalent, the pt's arm, which had been injected, developed "swelling" and was "hot to touch." The reporter called the event "extreme." The pt was treated with a 40mg IM injection of Medrol, and an unspecified dose of IM Benadryl. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
48 hrs after DTaP Imm. infant sleepy for 24 hrs with taking only few oz. of formula - Afebrile developed erythematous rash on thigh surrounding shot - warm to touch but leg not painful.
I received my second Pfizer COVID-19 booster on 4/30/2022. At 7 AM on 6/21/2022, I woke up and took a home antigen test, because I had developed symptoms during the night, and the test response was positive. I had a sore throat, sinus congestion, and fatigue. We were on vacation at the time, so we notified the hotel where we were staying, and we agreed that I would self-isolate from my family during my stay there. The first day was the worst, because the sore throat, sinus congestion, and fatigue were especially intense. After the first day, the symptoms gradually improved, though I did develop a mild cough a few days later. The cough lasted for only a couple of days. After the fifth day, I left my isolation. During this time, I didn't really self-medicate much. I just used an OTC nasal spray. I took multiple tests during this time, and the first time I got a negative result was about 7/1/2022. Overall, I made a quick recovery and had no residual symptoms.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L036851, expiry date 23-SEP-2017 and lot # M008589, expiry date 16-FEB-2018 (albumin status, dose, route of administration and anatomical location were not specified). On 11-OCT-2016, 12-OCT-2016 and 21-OCT-2016, the patients were vaccinated with improperly stored doses of M-M-R II injection, lot # L032044, expiry date 24-AUG-2017 (albumin status, dose, route of administration and anatomical location were not specified). The administered doses of M-M-R II underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit degrees for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (with unknown demographic) who received HIB (PRP/T) VACCINE  lot UI901AAA (Expiry date17-Sep-2019) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5101AA (Expiry date26-Nov-2018) via intramuscular route in the right thigh, PREVNAR 13 (lot number: T36366, exp date: 28 Feb 2020) 0.5mL, injection intramuscularly left thigh and TRUMENBA that had a cold chain deviation on 03 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. 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.
Numbness in toes, then pelvic area and upper extremities. Muscle soreness in arms, legs, chest wall. Headaches. Fatigue. Blood in stool for 2 days. Symptoms have not lessened, and additional symptoms developing with time.
Information has been received from a health professional concerning her 16 year old daughter who on 10-AUG-2007 was vaccinated intramuscularly with GARDASIL (Lot # not reported). There was no concomitant medication. On 30-AUG-2007 the patient developed bilateral joint pain in most joints up to and including her neck. The pain has caused a lack of sleep leading to fatigue. X-rays of her joint were normal. Blood work results are pending. She has been taking Naprosin 500 mg twice daily for pain. The patient's bilateral joint pain in most joints up to and including her neck persisted. The patient sought unspecified medical attention. Additional information has been requested.
Pt reports onset of h/o - neck/shoulder (L) pain 1 wk after receiving PREVNAR 13 vaccine. No fever and chills. No neuro deficit. Seen at my office 12/29/15.
hospitalized with 10/9/21 with covid. covid symptoms were GI in nature as well as weakness.
Initial solicited case received on 01 May 2017 from a Consumer. This case involves a patient (unknown age and gender) who was vaccinated with FLUZONE HD on an unspecified date (route and site of administration, batch number, expiry date, dose, were not reported). The patient's medical history and concomitant therapies were not reported. On an unspecified date, (unknown latency), following the vaccination the patient developed fibromyalgia, Muscle pain, brain fog. The patient reported that "flu shots made the subject ill. The subject had fibromyalgia and a flu shot flattened the subject for a week. The subject also had muscle pain, brain fog". The lab data and corrective treatment details were not reported. The outcome of the events was not reported at the time of report. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Neck/shoulder muscle and joint pain and loud ringing of the ears within first 8 hours. Fever, chills, foggy brain, and whole body pain within the first 12 hours. Highest recored fever 101.6. Fever, chills and whole body pain continued until approximately 23:30 on 09/11. The pain then centered in the shoulder joints and was significant preventing sleep. Ice and heat) did not resolve the pain. I took over the counter Tylenol with helped slightly. Ringing of the ears continued and got louder. by 16:30 on 09/12 the pain in my shoulder joints decreased. Whole body fatigue is  still present as is the ringing of the ears.
Patient began experiencing chest pain, shortness of breath, dizziness, and nausea hours after vaccines were administered. Mom took patient to emergency room around 11:30pm on date of vaccine administration. At the Emergency Room patient was given ondansetron and ibuprofen for symptom management. Patient was discharged home around 1:40am on 4/14/22.
No additional AE information reported; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-NOV-2022,  doses of varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent a temperature excursion of -12 Celsius degrees for 5 hour and 10 minutes. The vaccines underwent 2 previous temperature excursion.  On the same date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot #W004027, expiration date: 02-AUG-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.  This one of several cases reported by the same reporter.
I had diaherra, fever that reached 105.3, chills. I went to urgent care 04/04/2021 COVID test was negative. Ended up in the ER 04/05/2021.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion. Total of 102 doses were given from LOT 026C21A. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow information received on 08-Jun-2022. Reporter details was added.
the patient experienced flu; Patient did not feel well after fourth Moderna covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (the patient experienced flu) and MALAISE (Patient did not feel well after fourth Moderna covid 19 vaccine) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. In 2022, the patient experienced MALAISE (Patient did not feel well after fourth Moderna covid 19 vaccine). On an unknown date, the patient experienced INFLUENZA (the patient experienced flu). In 2022, MALAISE (Patient did not feel well after fourth Moderna covid 19 vaccine) had resolved. At the time of the report, INFLUENZA (the patient experienced flu) was resolving.            No concomitant medication was reported.     On an unknown date, the patient received first dose of Moderna vaccine (Intramuscular). On an unknown date, the patient received second dose of Moderna vaccine  (Intramuscular).  On an unknown date, the patient received third dose of Moderna vaccine  (Intramuscular).  MPID for Moderna was reported as 4782589.  The reporter's causality for the events of the patient experienced flu and patient did not feel well after fourth Moderna Covid 19 vaccine with Adalimumab (solution for injection) was no reasonable possibility.  No treatment information was reported.
Pt describes swelling with pain at injection site last night at 5:00 PM, then 2/2/12 at 2:00 PM pt began to develop a red rash on the upper portion of her body.
This spontaneous report as received from a physician via a representative refers to a 60 years of age or above male patient at the time of event. Approximately 2 years ago, approximately in December 2011 the patient was vaccinated with ZOSTAVAX (lot# and expiration date unknown), dose reported as single standard injection, subcutaneous for prevention of shingles. The patient had received KENALOG (manufactured/dose unspecified) 2 months prior to the ZOSTAVAX vaccine, approximately in October 2011. The patient developed a non-painful rash immediately after vaccination with ZOSTAVAX that occurred on one side of the patient's back, approximately in December 2011. The patient visited doctor's office at time of event. No treatment was given for the event. The patient was recovered on its own (date unspecified). Additional information is not expected.
Rash; This is a spontaneous report from a contactable consumer (patient sister).  A 56-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number and Dose number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The medical history and concomitant medication were not reported. On an unspecified date, patient experienced rash after developing symptoms. The outcome of the event rash was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Myopericarditis for 3 days. Came to hospital for 3 days of stabbing substernal chest pain
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 24-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment currently. Also reported that no adverse reactions were experienced by any patients.
Severe Middle Chest  Pain Pain in right lower jawline  30-45 min in duration