chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 11-DEC-2018 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. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, the patient's healthcare provider at a medical center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2017, the patient was treated by a healthcare provider at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Patient brought to the cot area from past vax at approximately 9:21am. Parents state she was scratching the arm where she was vaccinated.  Arm was red past the elbow. No other rash noted.  Mouth examined, no signs of tongue swelling or blisters. Good air exchanged noted, no signs of cyanosis. Child was crying and putting her fingers in her mouth. Parents stated this was normal soothing behavior, as her pacifier was recently discontinued. Pulse 138 pulse ox 97%. Child monitored for 30 minutes, redness receded and crying stopped. Parents encouraged to follow up with primary care provider.
Arm is quite sore and red and hot; Arm is quite sore and red and hot; Arm is quite sore and red and hot; Her arm has been getting less inflamed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is quite sore and red and hot), VACCINATION SITE PAIN (Arm is quite sore and red and hot), VACCINATION SITE ERYTHEMA (Arm is quite sore and red and hot) and VACCINATION SITE INFLAMMATION (Her arm has been getting less inflamed) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcer colon. Concomitant products included GOLIMUMAB (SIMPONI) for Colitis ulcerative.    On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE INFLAMMATION (Her arm has been getting less inflamed). On 26-Dec-2021, the patient experienced VACCINATION SITE WARMTH (Arm is quite sore and red and hot), VACCINATION SITE PAIN (Arm is quite sore and red and hot) and VACCINATION SITE ERYTHEMA (Arm is quite sore and red and hot). The patient was treated with IBUPROFEN in December 2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm is quite sore and red and hot) and VACCINATION SITE PAIN (Arm is quite sore and red and hot) had not resolved and VACCINATION SITE ERYTHEMA (Arm is quite sore and red and hot) and VACCINATION SITE INFLAMMATION (Her arm has been getting less inflamed) was resolving.            Non drug treatment include icepackinet. Patient reached out to her doctor and had an appointment on 28 Dec 2021. Patient treated the inflammation with Tylenol and icepacks.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received include Patient demographic details, medical condition, concomitant medication, treatment medication and updated outcome to recovering, added event - vaccination site inflammation.
Headache, Myalgia, Fever, NauseaVomiting,  Injection site soreness, nausea, fatigue, fever, chills, headache 1-5-21 to 1-6-21  Narrative:
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced cellulitis, huge rash probably like a whole foot long, swelling, very red and warm to touch, severe pain at the injection site that went all the way up to the back of their neck and all the way down to their hands. The events were described as cellulitis, pain at the injection site, large redness and swelling with hotness, radiating pain both to the neck and all the way down to the hands. The patient went to the Emergency Room where she was diagnosed with cellulitis and they put her on antibiotics. The outcome of events was unknown.
fever; severe headache; severe myalgia; This is a spontaneous report from a contactable physician. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration on 23Jul2020 (last Thursday) at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced a 'severe reaction'. The patient developed a fever the next day (on 24Jul2020) along with severe headache and severe myalgia. The fever lasted one day, but the headache had persisted along with severe myalgia and it had been 5 days. He had to take ADVIL 800 mg every 6 hours. The physician would like to know how long the severe headache and severe myalgia will last. The outcome of the event fever was recovered on 25Jul2020. The outcome of the rest events was not recovered.   No follow-up attempts are needed. Information on Lot/Batch and expiration date could not be obtained. No further information is expected.
Fever of 101 F and severe body chills throughout the night. Malaise and headache throughout the whole day after vaccination. Have taken Tylenol 500 mg PO q6h for treatment of fever. At this point, fever and chill have seized, but malaise and headache persist.
Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021). In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021) outcome was unknown.            No concomitant medications were reported.  In 2021, the patient experienced sore arm after covid 19 injection. On an unknown date, sore arm after covid 19 injection resolved. Moderna was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Local cellalitis at injection site, fever. Treated with Cephalexin. Resolved in 5 days.
Body Pain; Cold Sweats; Cough; Joint Soreness; Head Pounding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding). The patient was treated with MORPHINE at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (Body Pain), COLD SWEAT (Cold Sweats), COUGH (Cough), ARTHRALGIA (Joint Soreness) and HEADACHE (Head Pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information also included Nausea Tablet.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information included primary reporter information and patient demographics.
Tiredness; headache; muscle pain; nausea; overall unwell feeling; lymph nodes under my right arm where injection was given, swelled to the size of a baseball, and was tender and uncomfortable; lymph nodes under my right arm where injection was given, swelled to the size of a baseball, and was tender and uncomfortable; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number ENG202), via an unspecified route of administration, in Right Arm on 10Mar2021 at 09:45 AM(at 52 years) as single dose for covid-19 immunisation. Medical history included possibly allergy to sulphuric a long time ago. Concomitant medications were not reported.  On 10Mar2021 at 08:45 PM, the patient experienced tiredness, headache, muscle pain, nausea, overall unwell feeling; her lymph nodes under right arm (where injection was given) swelled to the size of a baseball and was tender and uncomfortable. No treatment given. The final outcome of the events was not recovered.No follow-up attempts are possible. No further information is expected.
Hair loss after second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss after second vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss after second vaccination). At the time of the report, ALOPECIA (Hair loss after second vaccination) outcome was unknown.            No Concomitant medications were reported.  No Treatment medications were reported.
This spontaneous report as received from a Medical Assistant. Medical Assistant mentioned an unknown number of patients have received ROTATEQ (route, dose, lot# and expired date were not reported) from the office's private stock and VFC stock that were contained in the foil wrap in which the glue is disintegrating and detaching of the foil wrap. PQC filed. Additional information has been requested.
No adverse event; Patient received his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS71678) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.   The patient received 4th COVID-19 vaccine and his card states that they administered 100 MCG / 0.5 ml.  The patient had requested the Bivalent Booster and got the Monovalent vaccine.   No treatment medications were reported.   Reporter did not allow further contact
1. Extreme worsening of Narcolepsy symptoms - severely fatigued, excessive day-time sleepiness, very frequent cataplexy, hallucinations, night terrors, sleep paralysis  2. Breakthrough blood clots between menstrual cycle
Information has been received from a licensed practical nurse concerning a patient with no known drug reaction/allergies; who on an unspecified date, was vaccinated with ZOSTAVAX (Merck). The reporter stated that the patient had a shingles like rash 3 days after the vaccine was given. At the time of the report, the patient had not recovered. The patient sought medical attention and contacted the nurse's office. No further information is available.
This spontaneous report as received from a medical assistant refers to 4 patients. On unknown date, the 4 patients received VARIVAX (Merck) (lot H017010 exp 12-SEP-2014) which was exposed to refrigerator temperatures not greater than 46F for an unknown period of time. VARIVAX (Merck) was not supported due to inability to determine the length of time of the excursion. The medical assistant stated she would call back with the administration dates of the 4 patients. No adverse symptoms reported. This link is linked with 1311USA000101 as received from the same source. Additional information has been requested.
Pain in right shoulder joint.  Difficulty with range of motion and limited range of motion with right shoulder due to pain.  Applying ice, heat and taking advil around the clock. Scheduling appointment to have it evaluated.
insides started felling jittery; having a hard time breathing; was having some kind of oxygen detoxification; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (ongoing), notes: Since she had migraines for all those years, they kept a detailed journal and has it written down when this all started. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FEELING JITTERY (non-serious), outcome "unknown", described as "insides started felling jittery"; DYSPNOEA (non-serious), outcome "unknown", described as "having a hard time breathing"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "was having some kind of oxygen detoxification". The events "insides started felling jittery", "having a hard time breathing" and "was having some kind of oxygen detoxification" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, the patient had second shot about 6 months ago for Covid. One week later, her insides started felling jittery and was having a hard time breathing. Was really bad in the morning time. They had been going to the doctors and she was having some kind of oxygen detoxification and they were putting her in a chamber but that has not been helping. Patient also had migraines and had not had migraines a long time before taking that Covid shot. Since she had migraines for all those years, they kept a detailed journal and has it written down when this all started. Was a week after the last shot, she was having migraines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an RN concerning a 2nd grade male student who on 04/14/1997 was vaccinated with a dose of varicella virus vaccine live. In mid December the child developed Chickenpox in mid December of 2004. According to the school nurse 58 other elementary school students who developed chicken pox and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present status of the student. No product quality complaint was involved.  Addition information    has been requested.
OBSTRUCTIVE SLEEP APNEA 4/12/2023 ATRIAL FLUTTER, UNSPECIFIED
Information has been received from a physician concerning a 19 year old female who on 05-AUG-2008 at 1:45 PM was vaccinated intramuscularly with a third dose of GARDASIL (lot #660620/0571X) in her left arm. There was no illness at time of vaccination. On 05-AUG-2008 at 1:46 PM, one minute after vaccination, the patient fainted, turned pale, had a catatonic reaction and her teeth clenched. The patient was diaphoresis, "blacked out" and needed Oxygen for about 7 minutes. 911 was called. The patient had incontinence. No laboratory diagnostics studies were performed. On 05-AUG-2008, the patient recovered. The physician considered the patient's events to be other important medical event. Additional information is not expected.
Soreness, chills, 101.5F fever, loss of consciousness, difficulty breathing, pain in lungs. Worsened over two days, then recovered on third.
Severe chest pain lasting at least 2 hours. I thought I was dying, seriously. One sharp pain on right side and rest all in center of my chest.
About 2 hours after Moderna vaccineI get my period, heavy for about 10 minutes. Then stops. I was nor expecting my period for at least 2 weeks.  Day 5 after Moderna vaccine my period start again super heavy with all period symptoms way worse that I ever experience. Pounding headaches, cramps and heavy bleeding and hot flashes. I have a menstrual disorder and period is tough on me but this was off the chart. Day 6-7-8 after Moderna vaccine I also had low grade fever on an off (101-102 F). Not sleeping, not eating and very tired buy day 11 I hit bottom and by day 12 I started to feel better. Going to see my doctor to discuss treatment before my second Moderna vaccine dose.
1st dose of Moderna vaccine administered at 9:47 am. At 10:15 am patient complained of throat swelling that progressed to SOB, and complaining of  sensation of tongue swelling. No significant lip or tongue swelling noted. Epipen (0.3mg/0.3mL) administered to L thigh at 10:15 am. Benadryl 50mg/1mL administered to R deltoid at 10:16 am. Patient was placed on 2L of O2 via nasal cannula. Vitals monitored and remained stable with no hypotension or bradycardia. Symptoms improved after 2-3 minutes. Patient was transported via ambulance to ER for further evaluation and monitoring.