chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age who on 18-MAR-2013, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # 671786/0254AE) that was expired. The vaccine expired on 08-MAR-2013. No adverse effects were reported. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 9:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 9:32 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 74.61   Concomitant products were not provided.  On 12-Jan-2021, Excursion time was 08 AM and 09 AM, temp was 34, total doses given for the day was 30, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vial was moved to clinic. Vaccine BUD date was 07-Feb-2021.  Vial was stored on cooler 1, on 12-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 34, 11 AM: 37, 12 AM: 40, 1PM : 40, 2 PM : 40, 3 PM: 41, 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
tongue and both lips swollen. skin falling off my face from below nose all around my lips to my cheeks and to top of my chin. Lasted for approx 30 days
Mom called and stated that at approx 10pm that child started vomiting x5 and then started shaking and have seizures shortly after. Mom reports that they then took child to nearby ED who then transferred child to a local Hospital.
This happened a long time ago but this is the only time I found out about this adverse event reporting system. I was still in active duty service and they gave us this "Flu Mist" thru the nasal passage at around 2013 and 2014  Few days after this flu mist, I felt so dizzy every time I lay down or in supine position. There was a time that I can still feel the dizziness even when I was half awake in bed. It was a really frightening experience. I am a very healthy person and this is the first time I ever experienced that. I really felt the vaccine latched in to my brain thru the nasal passage and messed it up.  After so many years it the symptoms disappeared then lately this year, the symptoms came back. I am not 100% sure if that vaccine was directly causing my dizziness or it made me more vulnerable to become dizzy after being triggered by another mechanism.   I was so mad at that time because I think we were used as a guinea pig for that new "Flu Mist" vaccine.
I believe I was very early on in my pregnancy (as in, implantation or first week after conception) when I received the second dose of the vaccine. EDD was January 9th, 2022. I had brown spotting every day for the duration of my pregnancy, obviously concerning and something I paid attention to (though not altogether unusual in early pregnancy). I ended up miscarrying naturally at 6 weeks. I am strongly in favor and appreciative of this vaccine and would be surprised if there was a direct link, but I do know there is a growing conversation about its impact on women's menstrual cycles. I wanted to submit my experience just in case it was in fact a trend for other trying-to-conceive or early pregnant females.
mom states pt vaxed 21SEP95 230PM;23SEP95 pt started getting congested;mom noticed a pinball size lump lt leg was bruised & hard; 25SEP95 very irritable mom thought it was a spider bite but MD said it was probably a rxn to immun;
Pt came in for a TDAP because he has a new grandchild coming soon and the staff pulled a DTAP instead of TDAP and it was expired..  Pt has had no problems and the provider was made aware and said we could have him come back in 2 weeks for the correct medication.
Developed UTI; Blood in the urine; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Developed UTI) and BLOOD URINE PRESENT (Blood in the urine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in the urine). On an unknown date, the patient experienced URINARY TRACT INFECTION (Developed UTI). The patient was treated with MELOXICAM (MOBIC) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Developed UTI) and BLOOD URINE PRESENT (Blood in the urine) outcome was unknown.            No relevant concomitant medications were provided. Concomitant medications reported included antibiotics which patient had not started at the time of reporting.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received included no new information.
9 days p/vax fever 104.8 R poss 2 sz; @ 11 days measles-like rash, cough; @ 13 days ataxia started & has persisted; has had episodes of grimace, tremor, eye rolling, loss language;
Information has been received from a consumer concerning his 15 year old daughter who was vaccinated with GARDASIL. After the patient received the first dose of GARDASIL the patient had a headache. The patient was hospitalized after the second dose of GARDASIL with a lymphadectomy, lymphadenopathy of the neck and the heart, a thyroid lesion, intracranial hypertension and was hospitalized. The patient was 17 years old at the time of reporting. No further information is available.
Client's mother called clinic and reported that within 24 hours of receiving vaccinations the child developed redness in the right upper arm and a hive-like rash that extended into the child's right armpit area. She reported that she called the child's doctor and they advised her to give the child a dose of BENADRYL. She reports that the symptoms disappeared after the child took the BENADRYL.
Following vaccine during observation period, pt reported feeling faint. Team examined pt. VS taken BP 140/90,BGL 134, ECG Sinus Bradycardia with PVCs. Health team called 911, responded and initiated care of paint. Health team departed.
This spontaneous report was received from a certified medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication was provided. On unknown dates, multiple unspecified patients received doses of improperly stored GARDASIL 9 lot# M003659 with expiration date: 20-SEP-2017 and lot# L025737 with expiration date: 28-JUL-2017 (dose and route of administration were not reported). Administered doses of GARDASIL 9 underwent temperature excursions at 31 Fahrenheit degrees, for 189 hours (7 days and 21 hours) (2 cycles). There was no previous temperature excursion. 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.
She got bells palsy; Monkeypox; Cowpox; Light blindness; She was 180 pounds but went down to 90 pounds; Inappropriate age; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: She got bells palsy) (serious criteria GSK medically significant), monkeypox (Verbatim: Monkeypox) (serious criteria GSK medically significant), cowpox (Verbatim: Cowpox) (serious criteria GSK medically significant), blindness (Verbatim: Light blindness) (serious criteria GSK medically significant), weight loss (Verbatim: She was 180 pounds but went down to 90 pounds) and inappropriate age at vaccine administration (Verbatim: Inappropriate age). The outcome of the bell's palsy, monkeypox, cowpox and blindness were resolved and the outcome of the weight loss and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the bell's palsy, monkeypox, cowpox, blindness and weight loss to be related to Shingrix.     It was unknown if the company considered the bell's palsy, monkeypox, cowpox, blindness and weight loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAY-2023 This case reported by the patient for himself. The reporter reported that she received Shingrix and had monkeypox on her toes and cowpox on her legs. She also stated that she got bells palsy and light blindness after the vaccine but had now resolved. The reporter reported that she was currently pregnant with fraternal twins. The reporter stated that she lost 90 pounds she was 180 pounds but went down to 90 pounds. The reporter did not consent to follow up. The reporter was a poor historian and during the conversation she talked about conspiracy theories of kidnappings, killings and cannibalism.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing), notes: asthma; allergy (unspecified if ongoing). The patient's concomitant medications not reported. The following patient experienced back pain/backache, cough/bad cough, and throat irritation/scratchy throat, with of outcome unknown. Therapeutic measures were taken as a result of back pain. Additional information: The patient stated a few days after getting the first dose she was hospitalized. Later confirmed patient was not hospitalized because of asthma. Right now, she had a bad cough and currently taking prednisone. She mentioned that tomorrow would be her second scheduled dose. She would like to know if it was ok for her to take the second dose. Again, she confirmed she was not hospitalized. When she got her shot, she was ok. Her only problem was asthma. She wondered because she was taking the prednisone due to a backache (further clarification unknown), as prescribed by her  doctor. She took her last pill on Monday. She was wondering if it would have any effect since. She had cough and asthma/scratchy throat. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient was in clinic to get her booster pfizer 5-11 vaccine. The peds pfizer 5-11 was taken out for at least 15 minutes. The vaccines was not yet diluted because the clinic was very busy and we hadn't had time to mix it. One of the staff members had grabbed the patient and went to drew up the vaccine not realizing that it wasn't diluted. RN gave the vaccine at 8:07 am today 07/08/2022. When I went to dilute the vaccine I realized someone had given a dose of ped pfizer 5-11. I quickly informed my manager on what happened. I called the pharmacy to see what the effects would be if any so I could call the parents and let them know. The pharmacy had me call pfizer to verify adverse reactions that may happen. I also spoke to the patients primary care provider (pediatric doctor). The pharmacy, Pfizer, and Dr. said that the patient should be just fine, she just basically got a more concentrated dose but to watch for any adverse reactions at the site it was given and to just watch her for the next couple days. I called mom and explained everything and answered all her questions to the best of my ability. I gave mom my clinic managers name and number if she had any other questions.
Information has been received from a Nurse Practitioner (NP) via company representative concerning to herself, a non pregnant female patient over "65" year old. No medical history or concurrent conditions were reported. Concomitant therapies included PREVNAR 13 vaccine. The reporter stated that on an unknown date, after receiving a PNEUMOVAX (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis, she got the PREVNAR 13 vaccine, on an unknown date and subsequently got hives on her body. No product quality compliance was involved. At the reporting time, the outcome of hives was unknown. The relatedness between hives and PNEUMOVAX was not reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication taken in 2 weeks. Patient treated with Paxlovid (nirmatrelvir tablets; ritonavir tablets), co-pa (from 17Feb2023 to 22Feb2023)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
30 hours after 3rd injection, raging diarrhea lasting 4 hours with fever lasting 8 hours
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, LOCAL LYMPHNODE TENDER/SWELLING, SORE THROAT Narrative:
PERSISTENT CENTRAL NERVOUS SYSTEM INFLAMMATION; BILATERAL PERIPHERAL FACIAL WEAKNESS; This spontaneous report was received from literature. This report concerned a 39 year old male of an unspecified race and ethnicity. The objective of this study was to report a case series of 3 patients who developed neuro-inflammation following administration of the J and J vaccine. Spinal cord was involved in all 3 patients, brain in 2, and peripheral nervous system involvement (facial nerve enhancement, radiculitis) in 2 patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after ten days of vaccination, the patient experienced persistent central and peripheral nervous system inflammation, bilateral ascending numbness, gait instability, urinary hesitancy/urgency, and bilateral peripheral facial weakness. Laboratory data (dates unspecified) included: CSF (Cerebrospinal fluid) test results showed lymphocytic pleocytosis and elevated protein, with no oligoclonal bands Extensive serum, and Magnetic resonance imaging (MRI) bilateral facial nerve enhancement, patchy cervical and thoracic cord and cauda equina enhancement. Patient developed recurrent symptoms during steroid taper 3 months later; MRIs (Magnetic resonance imaging) showed persistent enhancement and enlarging lesions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the persistent central nervous system inflammation and bilateral peripheral facial weakness was not reported. The authors concluded that central and peripheral nervous system inflammatory involvement without clear alternative explanation can rarely be seen in close temporal relationship to administration of the J&J COVID-19 vaccine. Unusual feature of case was clinical/radiographic worsening and persistent enhancement several months after initial presentation. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20221218576 and 20221219559.; Sender's Comments: V0: 20221219487-Persistent central nervous system inflammation and Bilateral peripheral facial weakness. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Insomnia; Sore throat; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). On an unknown date, the patient experienced INSOMNIA (Insomnia). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and INSOMNIA (Insomnia) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details was reported. No treatment medication details was reported.
Narrative:  COVID infection following COVID vaccine series 06/07 Janssen, dose #1 08/30 COVID swab, result: detected 08/28 pt cc: chills cough, fatigue, rhinorrhea, dyspnea exposure: wife
pt states his left arm was sore for 2 days and then he started having lower back pain that comes and goes.  On1/31/2021 pt woke up and could not hardly get out of bed  due to extreme lower back and hip pain.  Pt went to Urgent Care on 2/2/2021 and he was given a shot for spasms.  Pt is better but still in a lot of pain and will FU w/ PCP if he doesn't get better.
Crabby, redness at shot site. Temp max 101. Right thigh size of 50 cent piece. Warm.
She came with her mom to get  flu vaccine.  She fainted  after  administration, when they were walking out of vaccination room to the waiting area . He mom grabbed her . I was going to call 911, her mom said she is pediatrician and no need to call. this has happened before too. She was fine  soon after.
Pt (DOB 11/13/2008) reported feeling nauseous to EMT Observer at 12:45 after receiving the 2nd dose COVID vaccine (Pfizer, Lot # FC3183) in the left arm on 08/23/2001. EMT observer took client vitals, transferred client to zero gravity chair, provided emesis bag, provided water bottle, and reported findings to Co-lead RN. Vitals were taken by EMT at 1248 with BP 128/88 in L arm sitting upright, HR 100, and O2 saturation level 98%. Co-Lead assessed client who presented A&O to person, place, time and situation. No loss of consciousness occurred. Client denied SOB, trouble swallowing, numbness, and tingling. No redness or swelling observed. At 1250 client reported she last ate at around 8am and felt an onset of mild dizziness. EMT provided client granola bar. Client reported that she did not have any adverse reactions to the first dose Pfizer vaccine. Client reported to Co-Lead that "this feeling is similar to when I have anxiety". Client ate granola bar and finished 1 bottle of water, client was provided another bottle of water. At 1252 patient stated her stomach and dizziness was getting better. Client has no hx of fainting or dizziness with previous vaccines. Client has NKDA and no hx of chronic health conditions. At 1:05 the client reported she felt a tightness in her throat and stated it was "a little hard to swallow water". Co-Lead assessed client's throat and observed no swelling. Co-Lead offered IM benedryl and provided mother of client education. Client's mother was spanish speaking and required assistance of translator. Client's mother provided consent to administer IM benddryl to client and provided client's weight of 110 lbs. At 1:10 EMT prepared 1mL syringe of benadryl and Lead called EMS. At 1:15 Co-Lead administered 1mL of IM benadryl to client in the right arm. At 1:18 EMT took client vitals with BP 118/84 in L arm sitting upright, HR 84, O2 saturation level 99%, and RR 18. At 1:20 EMS arrived on-site and assumed patient care. Client's mother denied additional medical services AMA. Co-Lead recommended an additional 30 minutes of observation time from when client received benadryl. Client's mother consented to staying for additional observation time. At 1230 client reported she was feeling better and denied dizziness, trouble swallowing, and SOB. Co-Lead educated about V-safe information, ER precautions, and when to follow up with PCP.  Patient ambulated with even and symmetrical gait when leaving site with her mother at 1:45.
First dose given 7-15-09 DTaP- high fever and child spacing out. 2nd dose 9-16-09 under blanket in crib - ? stopped breathing. DC records received 10/8/2009 for 9/17/2009. DC DX of altered mental status. 4 month old immunized with multiple vaccines 9/16/2009, presents to ER 9/17/2009 with c/o's cyanotic episode and difficulty breathing witnessed per mother. Consult with cardiologist was negative, placed on Cardiac monitoring with no abnormalities.
Baseline tinnitus got much louder, headaches, intermittent nausea, sore throat
ARM SWELLING , BASEBALL SIZE LUMP WHERE INJECTION WAS, RED, HOT AROUND AREA. HIVES DEVELOPED ON BODY.
Fully vaccinated patient admitted for COVID PNA after trip.  CTA positive for PE, dx with "subcutaneous emphysema and peneumomediastinum COVID19 infection."  Required high flow oxygen, antibiotics, decadron.  D/C home on 3L/NC and antibiotics for pseudomonal pneumonia and Eliquis for PE.