chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 05-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In 2006, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated at a skin institute for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is not recovered/not resolved. The causality of the events is related. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010106, intramuscular for prophylaxis. On 24-AUG-2017, 5 days after onset of therapy the patient experienced injection site erythema, arthralgia, vomiting, nausea, injection site pain and injection site discomfort. The outcome of injection site erythema, arthralgia, vomiting, nausea, injection site pain and injection site discomfort is unknown. Sender's Comments: US-009507513-1708USA012002.
A report has been received from a Health Professional concerning a 29 year old, Male subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 17-Dec-2013. It was reported that patient was administered an expired FLUMIST QUADRIVALENT which started on 17-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
PARTIAL DOSE OF VACCINE WAS ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced partial dose of vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose of vaccine was administered was not reported. This report was non-serious.
shivering; This non-serious case was reported by a physician via sales rep and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: shivering). The outcome of the shivering was not reported.   It was unknown if the reporter considered the shivering to be related to Shingrix.     It was unknown if the company considered the shivering to be related to Shingrix.   Additional Information: GSK Receipt date: 12-JUL-2023 The physician reported about a patient who received the first dose of Shingrix and experienced Shivering. The reporter was did not consent to follow up.
I started seeing stars in my right eye, which continued to blur my vision as I developed a severe headache in my left temple. I felt dizzy and nauseous. I had to have two people help me walk, because I couldn't balance myself. It felt as if someone was controlling my right leg when I walked, and I was concerned I was having a stroke.
Day after shot: achy, tired, fever 100.1, ringing in ears, and localized reaction at injection site.  After 48 hours, feeling better, except localized reaction at injection site (lasted about a week) and ringing in ears (still occurring).  Saw healthcare provider on April 22 for ringing in ears.
I developed some blisters on my back and they were like white fluid filled. And it started out in one small area and was very painful and then spread to my right hip. Then went up on my right side. It was blistery and red. It started the 1st of December or the end of Nov. I went to the doctor and the Nurse looked at it and asked if I was familiar with Shingles. The Doctor looked and said I had Shingles. They prescribed an antiviral medication and it helped with the pain and the virus in general. A week later it got infected and I had to go back to the doctor and they gave me antibiotic cream for the area. I'm still having underline pain. A couple of weekends ago I got sick again and ended up in the hospital with a UTI and they put me on another drug.
Information was received from a physician regarding a 14 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL while sitting on an exam table. The reporting physician stated the patient was not in his practice and he learned of the case through his work with a law office. It was reported that the patient was left in the office unattended by the nurse following the vaccination and subsequently, the patient experienced a syncopal episode and fell off the exam table. The reporting physician stated he was not sure if patient lost consciousness but reported that the patient was brought to the hospital. The physician stated he believed the patient was fine but reiterated that he was not the patient's physician and he did not have the patient's chart. The physician stated that the child's mother was attempting to sue the physician's practice because the child was left unattended in the exam room on the table after receiving the GARDASIL injection. The physician stated that he does not relate this event to the HPV vaccine; he believed the mother was trying to make some money. Additional information has been requested.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional Information: Reporter stated that there were people having adverse reactions to the covid shots but only 2-3 days later they were feeling better but it was all over the news that after 2-3 days most people had a reaction; has no further details to provide for any other patient other than his niece and has no specific patient details, dates of their covid vaccines, lots, expiry dates or dates of administration to provide. His niece had a reaction and she was actually a nurse too and she was took her vaccine and actually caught covid and it was not a severe case of covid and states he thinks she had covid before she had the Pfizer covid vaccine but she was sick for 2-3 days and took her shot and it was a really bad reaction 2-3 days later but the reaction she had is unknown by the caller but he does know she was pretty sick for a couple of days. He does not have any other details for his niece or her dates of administration of the Pfizer covid vaccine or lots, expiry dates or NDC numbers but she did get real sick.     The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a 9 year old male patient with asthma. The patient's medical history included respiratory infections. On 04-MAR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H010916, expired date 15-FEB-2014) (0.5 ml, intramuscular in the right arm). Concomitant medication was asthma medication. The patient was schedule to receive the PNEUMOVAX23 prior to an unspecified immune workup (titers were scheduled to be drawn approximately 4 weeks after the PNEUMOVAX23 was given). The patient did not have an acute illness at time of the administration of the PNEUMOVAX23. The patient had received PNEUMOVAX23 at 5 years old on an unspecified date and it was well tolerated. Initially on 04-MAR-2013 the patient was fine. The next morning, 05-MAR-2013, the patient complained of significant pain at injection site. On the night of 05-MAR-2013, approximately 24 hrs after receiving the PNEUMOVAX23, the unspecified patient complained about pain around injection site. There was slight redness at injection site and the patient had a low grade fever. The unspecified patient was seen in the physician's office on 07-MAR-2013 for medical attention, and the injection site was significantly red with swelling and pain. Physician diagnosed symptoms as cellulitis with induration. Patient had also experienced a fever of 104F on the night of 06-MAR-2013. Patient did not have a fever on 07-MAR-2013. Patient was coughing and wheezing as well. Patient had a history of asthma. Physician prescribed amoxicillin, AUGMENTIN for cellulitis and acetaminophen and ibuprofen as needed for discomfort as well as cool compresses on affected area. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The action taken and causality were not provided. Additional information has been requested.
fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a sponsored program (143231). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, chills, achy, flu symptoms - headache - lasted approximately 24 hours and soreness at injection site on right arm (PREVNAR) only for about 4 days.
Insomnia; Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 17:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took cefazolin sodium (ANCEF) for an unknown indication on an unknown date and experienced allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 00:00, the patient experienced insomnia and metallic taste. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of insomnia and metallic taste was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP/OPV developed seizures approx 7.5hrs after vax. No problems after lst set of shots at 2mo.
Nausea; Vomiting; Chemical taste in throat; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EP6955) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DYSGEUSIA (non-serious), outcome "unknown", described as "Chemical taste in throat".  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning an 8 week old white male (weight 20# 13 oz., height 27.25") with no known drug allergies who on 30-APR-2007 was vaccinated with the first dose of Rotateq (lot #656188/1238F), oral. Concomitant medication was not reported. On 30-APR-2007, the patient's mother reported that the patient experienced diarrhea for 24 hours. Subsequently after 24 hours, the patient recovered from diarrhea. Additional information has been requested.
COVID reaction; COVID reaction; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID reaction (drug ineffective). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, soreness, sensitivity and redness at the injection site that started about 24 hours after vaccination. Swelling and redness increased in size over the next few days. Soreness and sensitivity decreased starting on Day 4, and around that time the injection site became itchy. Swelling subsided by Day 7, but itching persisted. In Day 8, swelling and redness returned. On Day 10 the rash was large and round, measuring about 4 inches across. On Day 11 the redness and itching subsided considerably, and over the next few days the skin returned to normal.
My left arm and shoulder began to hurt a lot right after this injection (same day).  This continued to get worse over the next several weeks, to the point where I had severe pain and limited range of motion in my left arm and shoulder.  When I had my blood pressure taken on 01/07/2022, I felt excruciating pain in my left arm as the cuff was inflating.  Right after that, I made an appointment with Dr. , an orthopedist who specializes in upper extremities, but had to wait until 02/09/2022 for the first available new patient appointment.  He took an x-ray and diagnosed me with a frozen shoulder.  He gave me a cortizone injection and referred me for physical therapy, which I began the following week and finished on 04/08/2022.  I still have some limited range of motion and pain, but it is much better overall.  I continue to do home exercises.  Dr. said it would take about two years to get completely better.
GIVEN A DOSE OF THE JANSSEN COVID-19 VACCINE THAT WAS EXPOSED TO TEMPERATURES BELOW AND ABOVE THE RECOMMENDED STORAGE TEMPERATURE/TEMPERATURE EXCURSION; INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 18-NOV-2021, the patient experienced given a dose of the janssen covid-19 vaccine that was exposed to temperatures below and above the recommended storage temperature/temperature excursion. On 18-NOV-2021, the patient experienced incorrectly stored vaccine administered. On 18-NOV-2021, the patient experienced vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrectly stored vaccine administered, given a dose of the janssen covid-19 vaccine that was exposed to temperatures below and above the recommended storage temperature/temperature excursion and vaccine stored outside of the acceptable limits was not reported. This report was non-serious.
tinnitus; immobile literally for  6 days; This is a spontaneous report from a contactable consumer (patient).   A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced immobile literally for 6 days and ended up at the specialist and the ER, the consumer also asked if tinnitus was a side effect or an allergic reaction, patient received the first dose of Pfizer 5 weeks ago yesterday as of report, and stated that couldn't get the second shot for medical reasons patient was having. Outcome for events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received both doses of the Pfizer COVID vaccine on 1/20/2021 and 2/10/2021.  She tested positive for COVID 19 (collected 7/18/2021 in urgent care), then presented to the ED on 7/20 with asthma exacerbation, bronchitis, and fever thought to be related to the COVID diagnosis.  She was admitted 7/21/2021 and discharged 7/22/2021 after improvement of symptoms.
Moderate ankle pain left x 1.5 days Hamstring cramping moderate x 1 day Fatigue - moderate x 1 day
increased HR; This is a spontaneous report from a contactable Other Health Care Professional. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3302) via intramuscular route of administration, on 09Feb2021 at 11:00 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. Medical history included hashimoto's disease, hypotension and depression. Concomitant medications included duloxetine, bupropion and pregabalin. The patient allergies were unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) as dose 1, single for COVID-19 Immunization. It was unknown if the patient was pregnant. On 09Feb2021 at 11:05, the patient complained of increased heart rate approximately 15-20 minutes after vaccine was given. Facility type vaccine: Public Health Clinic/Administration facility. Patient notified observer, and medical called to area. Patient taken to the first aid area for assessment. At 11:10 the patient's blood pressure was 116/76, heart rate 88, Respiratory rate 18, oxygen saturation was 98 percent on right arterial (RA). The patient alert and oriented (A & O) was x3, Skin assessment (pink, warm and dry) P/W/D, moves all extremities well (MAEW) was x4. Radial pulses 3+. It was reported that the patient reassessed by provider on duty nurse and emergency medical services (EMS) includes: blood pressure 112/72, heart rate 82, respiratory rate 16, oxygen saturation was 99 precent on RA. The patient did not received treatment. It was unknown if the patient received other vaccine in four weeks. It was unknown if covid prior vaccination and it was unknown if tested for covid post vaccination. No further symptoms noted at that time and provider cleared patient for discharge home. Patient was monitored until approximately 11:40 and the outcome of the event was recovered on 09Feb2021.  No follow-up attempts are possible. No further information is expected.
I started experiencing chest discomfort; Something was wrong; I don't feel as much but it is still there; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender reported that he/she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. Medical history of the patient included 3 stents placement in heart from an unknown date in December and unknown if ongoing. The patient's concomitant medications were not reported. On an unknown date the consumer stated, that he/she received the first Covid vaccine and about midday, patient started experiencing chest discomfort, not pain, not that patient had a heart attack but just something was wrong. Patient would say, it was little better, a lot better, patient did not feel as much but it was still there and nothing was going on prior to receiving the vaccine. Patient did not find the cardiologist because patient did not think it was that severe but was worried about getting the second one. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number.  Limited information was available over the call.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. On an unknown date, less than 5 months after receiving SHINGRIX, the patient experienced injection site cellulitis and fatigue. On an unknown date, the outcome of the injection site cellulitis and fatigue were unknown. It was unknown if the reporter considered the injection site cellulitis and fatigue to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient reported that she developed cellulitis on her arm at the site of the injection. The patient also experienced fatigue. During the report, the patient also reported that her pharmacist, who also had a SHINGRIX dose, felt sick refer case US2018GSK167939. No specific details were shared at the time of report. The patient had denied permission to contact their physician. The reporter did not wish to answer questions for a safety report.
Pt given COVID19 (5-11y) 10mcg / 0.2ml via IM. RN noticed immediately, notified MD who advised another dose not needed per CDC guidelines. Mother notified. Patient waited 15 minutes to monitor for any reactions the left clinic.
Moderna 3/18/21, 4/15/21, 12/26/21. Positive on 1/23/23
One of 3 pts that devel inject site rxn with redness, warmth & pain with 2-3 inches in diameter, after vax. Lot # 4978188.
THE PATIENT HAD RECIEVED 2 DOSES OF PFIZER BRAND VACCINE PREVIOUSLY ON 1/21/21 AND 2/2/21. NO ADVERSE EFFECT EXPERIENCED, PT IS AT BASELINE
To ED on 1/17/2022 with shortness of breath and fever. COVID (+) on 1/17/2022. Admitted for IV Remdesivir and steroid treatment. Received 5 days of treatment and continued to decline. Respiratory status declined with oxygen increased to BIPAP 100% and progressed to need for intubation/vent. Coded on 2/6/2022 with Ventricular Tachycardia. Family contacted and Code called after 1 hour without response to CPR/ACLS measures.