chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath, swollen lymph nodes, headache, irregular heart beat, severe fatigue, muscle aches, swelling in feet, joint pain, fever, rapid heart beat.  Symptoms have not yet gone away and it's been months.
It was reported in a newspaper article that a 17 year old female who on 09 February (year unknown) was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported) and a dose of MENACTRA. Subsequently the patient experienced digestive problems, rashes, severe muscle pain. The patient's mother reported that the patient was in pain every day. The patient had to drop out of a major skating competition because she can no longer land jumps or handle a four-minute routine. The patient was seen by several physicians. The patient agreed that something catastrophic must have happened to cause the extreme nausea that put the patient on acid blockers, the muscle pain that at one time required morphine, and that "roaming paralysis" that sometimes cramped her hands into claws and numbed her feet. Finally, in April, a rheumatologist wrote that the patient most likely was suffering from positive fatigue syndrome. Without explaining, the rheumatologist wrote that "it was possible" but "not very likely" that the patient's Feb, 9 GARDASIL and MENACTRA immunizations triggered the symptoms. The patient's mother was convinced that GARDASIL caused her daughter's symptoms. Upon internal review, paralysis was determined to be an other important medical event. This is one of several reports from the same source. No further information is available.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with sulfa allergy. On 24-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot number and expiration date not reported). In September 2013 the patient had developed an injection site reaction. The affected area was red, hot and swollen. The patient sought medical attention -called pharmacist. The outcome of injection site reaction, affected area was red, hot and swollen was reported as not recovered/not resolved. Additional information has been requested.
Fever, chills, myalgias, fatigue, headache. Began 8 hours after the vaccine and lasted for 48 hours.
Sore arm where the shot was given; This spontaneous case was retrieved on 19-Oct-2022 from non-health care professional via Agency (reference number: SEQW22-04712) and concerned a 71-year-old female patient.   The patient's medical history and concomitant medications were not reported.   On 18-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On the same day following vaccination, patient developed sore arm where the shot was given.   At the time of initial reporting, patient reported that arm was sore at night ands still is.  The outcome of event was not recovered.  The reporter assessed event as related to influenza vaccine. As reported, patient have been getting flu shots for over thirty years and never had any reaction other than a sore arm where the shot was given.   The case was assessed as non-serious.  This case is linked with case 202205916 (the same reporter and patient).  Company comment: A 71-year-old female patient was vaccinated with influenza vaccine. On the same day following vaccination, patient experienced sore arm where the shot was given. Causal role of the suspect vaccine is assessed as possibly related, due to suggestive temporal relationship and biological plausibility.; Reporter's Comments: Patient have been getting flu shots for over thirty years and never had any reaction other than a sore arm where the shot was given.; Sender's Comments: A 71-year-old female patient was vaccinated with influenza vaccine. On the same day following vaccination, patient experienced sore arm where the shot was given. Causal role of the suspect vaccine is assessed as possibly related, due to suggestive temporal relationship and biological plausibility.
Felt chilled, fever, achy body for about 24 hours starting on 10-23-2021 and very sore arm for a few days.  On 10-25-2021 Rash and itching started and continued to worsen. I developed bumps/hives all over body and they are STILL ITCHING WITH A RASH THREE WEEKS LATER. I am mostly unable to sleep due to itching. On 11-2-2021 I had a virtual visit with Dr, and he prescribed Prednisone 5mg for 5 days with no result. On 11-9-2021 I saw my Dermatologist Dr,  in office and prescribed Prednisone 20mg for 5 days and Triamcinolone Acetonide Cream USP 0.1% twice daily. Three days later still no relief of symptoms.
The patient is a 76-year-old male, who presented from home to the emergency room for more shortness of breath and fatigue and his pulse ox dropping.  In the emergency room, he was positive for active COVID (he has 2 immunizations from "Evusheld."  He is an ex-smoker with a history of non-Hodgkin's lymphoma, diagnosed 6 years ago and his last chemotherapy was about 6 months ago.  He denies chest pain and his blood pressure is low, though he has a history of hypertension.  His sodium was low as was his white blood count.  He has a history of coronary artery disease with prior myocardial infarction, gastrointestinal bleeding, and hyperlipidemia. Additional information for Item 18:  HOSPITAL COURSE:  The patient was seen in consultation by Dr. from Infectious Disease and Dr. from Pulmonary.    The patient was treated initially with his usual medications including intravenous fluids, electrolytes, oxygen, respiratory bronchodilators, and was started on dexamethasone and Remdesivir.  Dr. directed COVID therapy.  Dr. requested a TSA and cortisol level, which was drawn. He improved symptomatically.  His inflammatory markers improved significantly and he was subsequently discharged home on 10/14/2022 to follow up with Dr. from Oncology and Dr., his primary care doctor.
Nasal and throat congestion within 1/2 hr of administration of vaccines difficulty in breathing due to congestion.
3/13-3/14  Fever up to 101.2 F; headache, chills, body and joint aches, fatigue; 3/15  Fever over 100 F; chills, body and joint aches, fatigue; 3/16 - Present Daily fever between 99 F and 99.9F; chills, fatigue; severe body aches, burning pain in back, knees, legs, ankle, and other areas until treated with increased duloxetine and prednisone, which lasted about a month.
Type of dose gave after expiration date and date second booster; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 70-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose number: 2, Moderna 17Jul2021, with lot number 092E21A,), administration date: 17Jul2021, when the patient was 69-year-old, for Covid-19 immunization; Bnt162b2 (Dose number: 1, first dose Pfizer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3 (Booster), first booster on (state name) not in the system), for Covid-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 07Apr2022, outcome "unknown", described as "Type of dose gave after expiration date and date second booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacy technician concerning a currently 6 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 09-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Client returned to facility, stating she received fu shot on 9/6/12 and is now having a reaction. Nurse reports site is red, slightly raised, warm to touch, tender and approx. 5cm in diameter. Patient advised to use Tylenol/ibuprofen as needed.
Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was received from a consumer, concerning herself, a 76-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation.    The patient's medical history was not provided. Concomitant medications reported included telmisartan, nebivolol hydrochloride, ezetimibe, valaciclovir, buspirone and alprazolam.   On 21 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 [lot number 011L20A] intramuscularly for prophylaxis of COVID-19 infection.   On 21 Jan 2021, following the administration of vaccine, the patient experienced a burning sensation in the chest, vomiting sensation and symptoms of a bowel obstruction. These side effects were worsened until the patient was admitted for bowel obstruction relief. Additionally, event symptoms of a bowel obstruction was considered life threatening. Treatment for the event included bowel obstruction removal. No side effects were existing at the time of this report.  The second dose of mRNA-1273 was delayed in response to the events.   The outcome of the events symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation were considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
A consumer report has been received. The report concerns a 12 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 16-Oct-2012. The patient experienced fever, GI symptoms, vomiting, diarrhea and feeling ill which started on 06-Jan-2013. The patient recovered from the event of fever, GI symptoms, vomiting, diarrhea and feeling ill on 10-Jan-2013. The report was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune on 07-Mar-2013 from consumer: event of Influenza B deleted, events of fever, GI symptoms, vomiting, diarrhea and feeling ill added. New reporter added, event stop dates and outcomes added. Narrative updated.
Situation: Patient, 15M  had an appointment for 2nd dose Pfizer (Lot#: EW0187) today. Shortly after receiving the vaccine, the patient became dizzy and pale.  Background: Patient is allergic to antibiotics. Pt has history of appendectomy, absent sz and childhood epilepsy. He Was brought in to room  via wheelchair after receiving second vaccine, Pfizer. Mother with pt. Pt already had 2 juice boxes. Pt complaining of increased dizziness and starting to get pale Assessment ( RN):  @0753 68/48 (54) 113 97.1F 100%RA. Placed on supine position. Pt felt better when he was laid flat. @0800 90/51 (64) 73 18 100%RA @0803 88/61 (70) 58 18 100%RA @0807 91/62 (68) 55 18 100%RA @0815 104/58 (76) 55 18 99%RA, slightly dizziness @0820 109/55 (82) 57 16 99%RA, increased HOB to semi fowlers @0825 104/66 (80) 57 18 99% RA @0830 100/65 (80) 58 16 100%RA ? Pt intermittently gets dizzy and pale. Encourage increase intake. Pt drank another juice and cup of water. @0835 108/77 (89) 61 18 100%RA ? Increased HOB. Denies dizziness with position change. Color is baseline @0840 109/69 (83) 74 16 99%RA @0845 120/74 (91) 62 16 99%RA ? sat pt up in bed. Able to reposition self well. Mild dizziness upon sitting. @0848 113/69 71 18 99% - Denies dizziness. Able to drink another juice box and ate crackers. Conversing well with staff and mother. @0850 ? sat on the edge of the bed with nurse assist. Tol well. Denies dizziness or difficulty @0857 ? slight dizziness when standing up. Assisted back on sitting on the edge of the bed. VS117/77 (84) 66 16 99%RA @0904 ? 111/72 (85) 16 90 95%RA @0909 ? Assisted patient on standing up. Able to stand well. Denies any dizziness with position change. Able to take a couple of steps around. Pt stated that he feels back to baseline. Pt and mother felt confident that pt can go home. Assisted pt to wheelchair. Instructions discussed with pt and mother to hydrate and rest. Both verbalized understanding @0913 ? Wheeled patient out to car with mother.  Recommendation: Increase hydration and rest. Patient and mom verbalized understanding. Patient able to go home.
1st 2nd dose manufactured by Moderna/ booster dose manufactured by Pfizer; off label use; COVID-19; Skin disorder; Energy decreased; COVID-19;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240399-00 (AbbVie).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till 2021 at 40 mg (cf (40 mg,1 in 7 d)) for rheumatoid arthritis. Relevant medical history included: "RIGHT HIP SURGERY", start date: Jun2021 (unspecified if ongoing), notes: RIGHT HIP SURGERY; "LEFT HIP SURGERY", start date: Sep2021 (unspecified if ongoing), notes: LEFT HIP SURGERY. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose:2), administration date: 09Apr2021, when the patient was 61 years old, for Covid-19 Vaccination; Moderna covid-19 vaccine (Dose:1), administration date: 11Mar2021, when the patient was 60 years old, for Covid-19 Vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "1st 2nd dose manufactured by Moderna/ booster dose manufactured by Pfizer"; OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "off label use"; SKIN DISORDER (medically significant) with onset 2021, outcome "unknown", described as "Skin disorder"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "Energy decreased". The patient underwent the following laboratory tests and procedures: investigation: (2021) unknown; sars-cov-2 test: (2021) positive. The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient mother reported patient began to shake and she was unable to speak or respond. Upon observation patient was pale, awake, and clammy, responding appropriately . Pulse ox placed on patient O2 sats 98-100, pulse 57, BP 87/45. Patient oriented to person, place, and time.  Patient reported feeling weak, complains of headache and neck hurting. Patient reported tingling in her left hand and reported her tongue was tingling. . At this time ambulance was called to transport the patient to the ED.
Patient received Moderna vaccine for 1st dose and inadvertently given Pfizer for the second dose. No ASE's noted. No complaint of pain, dizziness, swelling, fever, chills, body aches, headaches or nausea.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of an unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with ROTATEQ oral (lot number, expiration date and dosage were not reported). Concomitant therapy was not reported. The reporter informed that on an unknown date the ROTATEQ, reached temperatures outside of the prescribing information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Soft tissue arm pain that radiates down arm to hand.  Hand feels weak at times. no improvement over 2 weeks.  No sign of infection or hematoma.  No indication of nerve pain.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot number: unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed eczema (bad eczema outbreak), and immune system disorder/immune system issues, with outcome of unknown. Therapeutic measures were taken as a result of eczema and immune system disorder. Additional information: Patient had to take a steroid (prednisone) this week as a result of events. Second dose of COVID-19 vaccine was scheduled on the 31st of March. Patient wanted to know if it was safe to take steroid close to vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 25.82  Concomitant products were not provided.  On 03-Apr-2021 Excursion time was reported at 09 am with temperature as 34 degrees Fahrenheit respectively , total doses given for the day was 210 , condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  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.
Varicella vaccine given 04/05/05- no reaction until 04/19/2005 (14 days later) awoke with red, itchy, swelling around site of vaccine. Denies other cause. Recovery stated as probable.
Given Gardasil vaccine dose #1 3/12/07. No adverse reaction reported. Collapsed and died on 3/26/07 secondary emboli (records unavailable). 4/3/07 Spoke w/investigating deputy who stated autopsy done at Medical Center.  T/C to physician at Medical Center who is actually a cardiologist, not pathologist, who had responded to the code & pronounced.  Spoke w/secretary who states from Death Certificate COD is sudden cardiac death and pulmonary embolism.  Echocardiogram revealed very enlarged right ventricle & small left ventricle as well as large blood clots within both the right atrium & right ventricle.  6/25/07 Received Autopsy Report which reveals following anatomic diagnosis: 1. Pulmonary embolism, occlusive     a. pulmonary trunk, left hilar & peripheral vessels     b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion & edema, bilatera    a. no evidence of anomalous coronary artery distribution    b. no evidence of ventricular dysplasia This is in follow-up to report(s) previously submitted on 6/11/2007. Information has been received on request from the FDA under the Freedom of Information Act and from a physician who presented at the "Global Advisory Committee on Vaccine Safety World Health Organizaqtion" concerning a 19 year female nonsmoker with no history who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of GARDASIL lot #655849/0263U). Concomitant therapy included oral contraceptives. There was no adverse reaction reported. Subsequently on 26-MAR-2007 the patient, while exercising on a field collapsed, began convulsing and died secondary to emboli. An autopsy was done and on the death certificate the following is documented "sudden cardiac death and pulmonary embolisem." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were alsor reported. Upon internal review convulsing was considered an other important medical event. The original reporting source was not provided. A standar lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expaned lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This report was filed with the FDA. The VAERS number is 275438.
p/vax pt woke up c/small red bumps on face; few on arms; rash was itchy; benadryl help itching & rash
cold sweats;slurred speech;tremors;lightheadedness;near syncope TIA like sx;
Shingles on Left side of  head/face, treatment with Valtrex and Prednisone, started as head pain then developed a rash post vaccine day 2, rash became darker on post vaccine day 4, rash started to blister post vaccine day 5. Treatment started after seeing primary care physician on post vaccine day 5.