chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. OSIB22A, 011J20A, 011J20A and 011CZIA) for COVID-19 prophylaxis.     The patient had no allergies. The patient had no acute illnesses at the time of vaccination and up to one month before.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2022, SARS-CoV-2 test: Positive.         Concomitant product use was not provided by the reporter. Patient height was reported as 6 and weight was 247 (Units Unknown). The patient had not received prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.  No treatment information was provided   This case was linked to MOD-2023-719642 (Patient Link).
Rash swelling left arm, body aches, weakness, dizziness, rash itchiness. Narrative:
per pt wife, pt was experiencing vomiting at 12 am post first vaccine dose. spoke to pt today says that vomiting overnight and that he is fine now. told pt to go to the doctor and get it checked out. pt is drinking fluids. pt will do so. So far pt only has sore arm.
pt recvd vax & devel soreness at inject site LT deltoid radiating to neck & down arm lasting several days;
Onset swelling, ecchymosis, heat, tender to palpation - 3 cm area at injection site tx - seen at clinic. Follow up calls.
sneezing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced sneezing (non-serious) on an unspecified date. Caller received first and second dose and mentioned she was sneezing every now and then but other than that she's fine. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician who mentioned that a local pediatrician (name unspecified) had a now around 4 year old patient who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed herpes zoster. At the time of reporting, the outcome was unknown. The pediatrician wanted to know if this patient should get a second dose. The patient sought unspecified medical attention. Additional information is not expected.
"staff member experienced hives and rash over 50% of body 30 hours post second dose of covid vaccine   Sought medical treatment and was prescribed dose of steroids.
Swelling around the elbow; chest was broken out a little bit/her chest started itching yesterday; rash; This is a spontaneous report from a contactable consumer. This 78-Year-old female consumer reported for herself.  A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Left arm (left shoulder) on 12Mar2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included Lupus from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On 15Mar2021, after 3 days of vaccination, the patient experienced Swelling around the elbow, chest was broken out a little bit/her chest started itching yesterday. On an unspecified date on Mar2021, the patient also experienced rash The reporter reported that she got vaccinated on Friday and her arm is swelling around the elbow from the front to the back and stated it is a big knot. She said that it is in the area of where you get blood drawn, but she did not have any blood drawn. She said that her shot was in the upper arm on her shoulder, but the swelling is in the middle of her arm. She stated that she has lupus and sometimes she gets a rash from stuff. She stated that she has not had a rash in a long time, but currently her chest was broken out a little bit. She has a ointment, Triamcinolone, to put on her rash. She said that she put it on her chest and her arm. She said that the swelling started this weekend after she got the shot. Caller clarified that she noticed it yesterday, 15Mar2021, and stated that the swelling has gone down a little bit. She stated that her chest started itching yesterday, 15Mar2021. It started on one side of her chest, and it has spread to the middle. She put her ointment on and it works good for her rash. She said that it does not itch as much when she uses the ointment. The patient also reported that chest was broken out a little bit was reported as worsened. She stated that she had a MRI to check her back. She also had a EMG/NCS nerve study on 10Mar2021. Reporter said that these tests were scheduled prior to her receiving the Covid-19 Vaccine. Treatment was given for chest was broken out a little bit/her chest started itching yesterday and rash as Triamcinolone. The patient received treatment for chest was broken out a little bit/her chest started itching yesterday and rash. The patient underwent lab tests and procedures which included electromyogram (EMG/NCS), on 10Mar2021 and on 15Mar2021 magnetic resonance imaging with results of unknown. She said that her next dose is scheduled for 02Apr2021. The outcome of the event swelling around the elbow was recovering, event rash was unknown and the event chest was broken out a little bit/her chest started itching yesterday was not recovered.   No follow-up attempts are possible. No further information is expected.
Immediately after administering HBV and Menactra patient said he was getting dizzy. Pt. placed himself on the floor and I gave him Spirits of Ammonia to smell. He then thought he was going to vomit so placed him upright with his head forward into waste receptacle. He fainted and then had a seizure with his eyes dilated , tongue twisted, clonic contractions of his arms and then tremors of his arms. He had apnea and heart rate was slow. Color was extremely pale. This lasted about a minute. Pt. had no history of seizures prior to this although had fainted several times before. When sizure was over he quickly became aware of his surroundings and vital signs showed BP 160/80 and AP 60®ular O2 was administer Blood sugar was 70. Paramedics were called and pt. was transported to hospital. Mother was called and she said she had had the same reaction to a Mantoux test several years ago and no reason for the seizure was found except for fear of shots. Blood work at the hospital as normal and he was released home with instructions to follow-up with his family physician
Resident noted with loss of appetite on 8/8/21 and resident expired on 8/10/21
Pt was administered with afluria by pharmacy intern. Pt reports on consent form that he feels "mostly just lightheaded/dizzy" with vaccines. Pt had a sudden reaction where he felt like he fainted for a moment and not know what was going on. After a few seconds, he was oriented in place and time. He did not actually faint, but he felt like he was fainting per pt. This incident happened while the intern was finished administering the vaccine and was putting on a band-aid. Pt was given water and a snack by immunizer Rph and monitored for 15 minutes or longer. Pt was with his mother and felt fine when he left. Counseled on any further rxn to return to pharmacy if in store or to ER. However, pt states that he has a little tingling feeling in both his arms. Counseled on having him monitoring and following up with a doctor and let them know that this rxn had happened. Pt did not need EpiPen administration after assessment by immunizer Rph.
A total of 140 PTs were vaxd; 23 PTs did not respond p/a series of 3 Engerix-B vaxs & 1 pt was a borderline responder (see also EBU910660);
Patient came down with mononucleosis in July 2015 (4 months after the last dose of Gardasil).  She moved to college and started complaining of having anxiety and panic attacks. Her hair started falling out and she started getting nauseous when she would eat. She couldn't drink water due to the nausea.  We had to move her home and try to get her into school close by. She saw a gastroenterologist who diagnosed her with gastritis. He put her on an acid reducer (Pantoprozal) and it gave her side effects so she stopped it. She only took it for about 2 days. He also sent her for an ultrasound of her stomach and gall bladder. It came back normal. We were also sent for a stomach emptying test which showed the first 2 hours of digestion were slowed. February 2016 she was hospitalized with a heart rate of 150 bpm and a very low blood pressure. They kept her overnight, gave her fluids and got everything under control. Four days later they called to tell us that she had mono again. Our days were spent trying to keep her alive, rushing back and forth to the hospital with racing heart, etc. One such trip they gave her a turkey sandwich and sent us home. These girls aren't being taken seriously. The vaccine insert says to consult your health care provider if you have any adverse effects. Well, the health care provider had no idea how to handle this. We are being left to figure this out on our own. Her list of symptoms she has experienced over the past two years include: Hair loss Gastritis  Nausea after eating Nausea after drinking (even water) Weight loss  Rapid heart beat Shortness of breath Extreme lethargy Mononucleosis (twice) Dehydration (for which she was hospitalized) Sudden development of false allergies  Contact dermatitis Sudden allergy to metals Panic attacks Anxiety Constipation Joint pain Neck pain Eczema  Irritability Lack of concentration Poor immune response Hot flashes And she feels like an 80 year old woman
This spontaneous report as received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The reporter stated that since 06-JUL-2014, those patients were administered (Oka/Merck) PROQUAD (dose, units, route of administration, anatomical location, lot number were not reported) which was not stored properly. No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
rigors (intense chills with shaking and chattering), high fever (over 101-102), severe muscle cramping in legs, severe headache, muscle pain throughout body, significant swelling at injection site (about the size of a grapefruit) with pain and redness and itchiness, nausea, and deep fatigue.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #74802) for COVID-19 vaccination. The patient's past medical history included Shingles and Nerve damage. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (fever) and NAUSEA (nausea). At the time of the report, PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.
blood sugar levels began to be about 20% higher than normal within about 24 to 48 hours after the injection and have stayed that way for over two weeks.  No other symptoms have been experienced aside from soreness at the injection site for less than 8 hours after the shot.
Patient called the pharmacy to report that at the site of injection of PNEUMOVAX, rash appeared, patient informed that it was red, and spreading down, all over his right arm. No further reactions reported.
salty taste in my mouth; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication included: PRILOSEC [OMEPRAZOLE]. The following information was reported: DYSGEUSIA (non-serious) with onset 04Apr2021 11:00, outcome "not recovered", described as "salty taste in my mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: About a week or two after the first vaccination, the patient started having a salty taste in his mouth. The patient was not diagnosed with COVID prior vaccination, was not tested for COVID post vaccination and had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021483024 same patient and drug, different dose and event
Suspected Vaccination Failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that got the shingles shot and got shingles. The reporter further stated might be not as severe as could have but who knew. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Narrative:  30 yo MALE p/w chest pain. The patient states his pain started at 8 PM this evening. He states the pain is 5/10 intensity and described as a sharp type sensation that radiates vertically up from his epigastrium. He did receive his first Covid vaccination earlier today in his left arm. Ate some pizza earlier and wonders if that is related. Given GI cocktail for GERD On re-evaluation, the pain had resolved.
Shot given towards under arm, large swelling, large lump bruising very sore couldn't move arm lasted 2 wks right arm
Chills, aches, post dose 2 and left sick within 24 hours of receiving the injection but was fine approximately 16 hours post injection. On or about 2/03/2021 felt intense itching deeply in left flank area. On 2/52011 the pain became so intense that I missed work and went to the hospital, and had concerns there was a problem with my kidneys.   On 2/9  itching,  urning and pain in left flank area and later developed shingles for the first time.
Generalized body rash, small swollen gland lt ear, since 7AM 27MAR92; total body rash, fine-"head to toe" w/itching; denies SOB, dyspnea;
hot to the touch at injection site; sore arm at injection site; red at injection site; Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch at injection site), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch at injection site), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (hot to the touch at injection site), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  No concomitant medications were reported.  Treatment information was not provided.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were administered an unknown number of doses of PROQUAD (Lot # M022401, expiry date: 01-NOV-2017; Lot # M019233, expiry date: 17-OCT-2017; Lot # M004891, expiry date: 25-JUL-2017) that was exposed to 52.2F for 3.5 hours. No adverse effects were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
The caller said these products may have been administered after a temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Fluarix. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Fluarix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported storage error for Fluari, Pediarix and Rotarix. These products might have been administered after a temperature excursion. The excursion occurred in the refrigerator and reached a maximum temperature of 8.98C. The reporter said the excursion lasted for 30 minutes. The reporter did not have any patient information or dates of administration. No further information provided. No other adverse event, no product quality complaint..
Provider d/c note:  "Hospital Course: Elderly woman who recently underwent left 2nd toe amputation for diabetic foot infection presents with dyspnea and found to be hypoxic; she was found to be in acute CHF and concurrently newly infected with COVID.  She was admitted and treated with remdesivir, decadron and diuresis; she rapidly improved and tolerated room air.  Her rapid improvement was interpreted as indicating the cause of her respiratory failure to be CHF.  As she was tolerating room air and the steroids were interfering with her diabetes control, remdesivir was stopped and decadron were reduced.  She also had a silent troponin leak which cardiology consult interpreted as Type II strain related.  However, her EKG was uninformative as she has a chronic bifasicular block.  Cardiology recommended outpatient stress testing.  She was also on outpatient oral Cipro and Clindamycin for her amputation site which clinically appeared benign; in the context of her prior gastric bypass surgery these gave her severe esophageal pain and dyspepsia, which resolved with discontinuation of the antibiotics.  Patient improved to her prior baseline and requested discharge to home with home care to continue wound monitoring and CHF education and monitoring.  In retrospect it is thought that her COVID was incidental and the main precipitant of her hospitalization was her decompensated CHF."
Completed a course of Vivotif, which was never refrigerated; Spontaneous report received on 14FEB2020.  A pharmacist reported that a consumer "completed a course of Vivotif, which was never refrigerated" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. The consumer had completed a course of Vivotif in October but the consumer had never refrigerated it. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer completed vivotif course but vivotif was never refrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as possible.; Sender's Comments: A consumer completed vivotif course but vivotif was never refrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as possible.
Headache, Fever, FEELS LIKES ICE ON LEFT CHEST, FATIGUE, CHILLS, SALTY TASTE Narrative: EKG DONE
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. 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, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.