chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.
I had arm pain, chills, and a cough. The cough keep continuing off and on for about 3 weeks. I also had a fever, chest pain and body aches. I went to urgent care. They gave me a steroid shot there. They prescript me steroid medicine. They also tested me for Covid-19, Flu, and Step, negative on all those.
Red and raised bump on tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Red and raised bump on tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TONGUE DISORDER (Red and raised bump on tongue). At the time of the report, TONGUE DISORDER (Red and raised bump on tongue) outcome was unknown.            no concomitant medications are provided. treatment to the event not reported.  she went to the doctor and it was a blood blister on the tongue. Action taken with mRNA-1273 in response to the event was not applicable.  She advised that no further follow-up is needed.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information is received it does not contain any new information.
Collapsed coming out of bathroom could not move spent 8 day less then 6 months in hospital.
Myalgia, Arthralgia, Fatigue, swollen lymph nodes Narrative:  Other Relevant History:
Case number PHEH2016US023674, is an initial spontaneous report from a medical assistant received on 14 Sep 2016. This report refers to a 62 years old female patient. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml, intramuscularly on 09 Sep 2016. It was reported that, 8 patients received expired FLUVIRIN vaccine from last year over several days. It was reported that, the patient tolerated the vaccine in the past. No adverse event was reported following this administration error (expired product administered). This case was assessed as non serious by the medical assistant. Follow up report received from a medical assistant on 18 Oct 2016: Updated suspect drug information (anatomical location) and reporter comments on vaccine tolerance.
Received vaccine on April 7, 2021 and didn?t have any side effects.  Woke up October 19, 2021 and couldn?t move due to severe back pain.   After going to the hospital er and seeing my family dr twice then a rheumatologist I was told I have rheumatoid arthritis and have been on medication ever since and will most likely always be on it.  It has effected my everyday living
Ringing in ear; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported same event for himself and other two patients. This is the third of three reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced ringing in ear after getting the COVID vaccine on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007848 same reporter/drug/event, different patient;US-PFIZER INC-2021009229 same reporter/drug/event, different patient
Feeling week; light headed; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male 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 17Apr2021 at 17:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to foods like tree nuts, apples and others. Concomitant medications included rosuvastatin calcium (CRESTOR) 20 mg, piroxicam (PAXIL) 30 mg and cetirizine hydrochloride (ZYRTEC) 10 mg all for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021, the patient felt weak, light headed and exhausted for the past three days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events feeling weak, light headed and exhausted for the past three days was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment (04Aug2021): This follow-up report is being submitted to amend previously reported information: reporter's fax number added, Vaccine Facility Information added, con-med Paxil/Zyrtec recoded.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
medical hx for atrial fibrillation, chf, hx of cardiac arrest, CAD, hypertension, prostate cancer, hypothyroidism, presents to ER after an episode of inability to move for over one hour, unable to move extremeties but was able to talk.   reported that had a cough on friday but no sob or hypoxia and did not report fever or chills to hospital, although did report those to investigator. Discharged on 6/3/2021.   symptoms of fever, chills, runny nose/congestion, sore throat and cough began on 5/25, none of these symptoms present upon hospitalization on 6/1/21.
After Flu vaccine was given @9:56am, pt presented with swelling @ injection site. Pt. was AOx3. BENADRYL 20ml given as ordered by mouth. Pt stable and was being closely monitored by (RN, MA) for  any s/s of allergic reaction to vaccine. At  10:17am pt. c/o wheezing, dizziness, and itchiness. MD  notified and pt. was assessed by MD. Emergency 911 was called @10:20am by MA. Pt. AOx3 at this time, but also began to show signs of swelling of the mouth. Prednisone 15ml given as ordered by mouth, EPIPEN 0.15mg given as ordered IM in Left thigh, and breathing treatment started via nebulizer using Albuterol Sulfate 2.5mg as ordered by MD. Vitals taken @ 10:30am: T: 98.0; BP: 119/76; P: 86. Rescue arrived @ 10:30am. Pt. was AOx3 with no s/s of allergic reaction. Pt transported to Hospital via stretcher for further evaluation; accompanied by mother.
Received COVID-19 Moderna vaccine on 12/28.  Developed nausea, vomiting, diarrhea, fever, and hypoxia at facility the day follow vaccine administration (12/29).  He was sent to the hospital on 12/29 and admitted for post vaccine fever where he had a chest x-ray that showed infiltrates but WBC count was normal and fever resolved upon admission to hospital.   Provider documented "expected reaction to vaccination in a patient with previous COVID exposure".  He returned to the  facility on 12/30.
Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.
SVT - treatment ongoing . Pain, swelling, tenderness, knotting in upper thigh. Pain and swelling in same lower leg. Became noticeable about one week after and symptoms increased. Went to ED for initial dx. Surgery being recommended.
feverish, achey, diarrhea, headache for 10 days culminating in migraine (vomiting/diarrhea)
After one week, pain in left ankle.  Within a month  pain spread up leg through hip, swelling in knee.  Suffered with discomfort for a couple weeks before seeing doctor 7/16.  Went to two prescribed physical therapy sessions but pain had spread to right leg and through shoulders with hand swelling.  Xrays taken of ankle and lower back; MRI of ankle.  With lower back xray, doctor sent me to emergency room for back MRI.  That showed bulging but not on nerve to cause pain.  Many blood draws and tests run for tick borne illness, all negative.  ER took fluid from knee, found crystals, diagnosed psuedogout.  I was admitted to hospital for pain management.  Saw my primary after release, he referred me to spine specialist  who determined that bulging was not causing pain; referral to rheumatologist for possible PMR  (no appointments until Jan). Still swollen hands and limited shoulder mobility.  In my most severe time I was unable to move my legs, needed assistance with every motion.  Pseudo gout medicine (colchicine); pain relievers celecobrix and tramadol.
My vision was blurred and I saw everything like a warercolor painting. I could only see very up close items clearly.  I do use nonprescribed readers for reading up close but have never had major vision issues like what I had today. It was scary. I returned to bed and rested for another few hours. My vision got better with rest but it is still not 100% normal. I was going to go to an emergency clinic but once I saw more rest had improved it somewhat, I decided to stay home.  I will continue to let time pass to see if I am back to normal by Monday.  Other symptoms I continue to have are stiff/sore neck, body aches, chills, and fatigue.
Initial report received on 12 November 2009 from a health care professional. This case (involving a 55-year-old female) is part of a cluster of three cases received from the same reporter with the same product and lot number. Information regarding the other two patients is reported in cases 2009-04810 and 2009-04930. A 55-year-old female patient, who had no concurrent illness, had received an intramuscular right deltoid injection of H1N1 (lot number UP009AA) on 09 November 2009. Shortly after vaccination, the patient reported having a strong metallic taste in her mouth and she smelled a metallic scent. The patient stated she "felt funny", "disconnected", and "lightheaded". The patient was going to be prescribed Prednisone, but called the doctor office two days later and stated she felt better. No relevant diagnostic tests or laboratory data were performed. At the time of this report the patient had recovered. Follow up information received on 18 December 2009 from a health care professional. The patient has a history of hypothyroidism. Concomitant therapy included SYNTHROID, ZYRTEC, and MIRALAX. The patient did not receive treatment. The patient's date of recovery was 12 November 2009. Documents held by sender: None.
Had a 20 inches red induration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Had a 20 inches red induration) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Had a 20 inches red induration). At the time of the report, VACCINATION SITE INDURATION (Had a 20 inches red induration) 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 assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-021564, MOD-2021-010050 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 24-MAY-2015, the patient was treated at emergency department by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed oxycodone and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 11-week-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Redness in left leg after Influenza a immunization Dtap also given in same leg.
Information has been received from a health professional concerning a 9 year old female who on 24-JUL-2007 was vaccinated subcutaneously into the right deltoid with a second dose, "booster shot" of varicella virus vaccine live (Oka/Merck) (Lot # 657757/0641U). Concomitant therapy included a first dose of hepatitis A vaccine (inactive) GSK) (Lot # AHAVB1634B), intramuscularly into the left arm. On 24-JUL-2007, the patient developed a 3 cm vesicular area right upper arm, with a 9 X 12 cm surrounding red, hard, painful, swollen area around the blister. The patient was started on (on an undisclosed date) amoxicillin (+) Augmentin. As of 27 JUL 2007 the patient was reported as doing better. There was no product quality complaint. Additional information is not expected.
3AM 17OCT98 arose from sleep to get dressed;became very dizzy, could not stand & fell to the floor;climbed back into bed still dizzy & went to sleep;awoke 2hr later was still unsteady;later it passed off;
pt recv & had a rash w/red blotches of varying sizes-not raised, but spread on the entire body;pt was extremely upset, screaming & hollering while having blood drawn also;given DPH;
4 hours post vax, the pt woke up screaming unconsolably with bilateral lower leg redness, heat and possibly swelling. The pt was rushed to ER. Crying and redness resolved in approximately 15-30 minutes.
Patient reported knee pain at the end of march 3/28/2021 she was seen by a doctor on 4/14 and thought to have arthritis prescribed NSAIDS. Patient had no history of arthritis or chronic prescription use or chronic health conditions. She was referred to an orthopedic and when no arthritis was found she was referred to ER to check for a blood clot on 5/10/2021. Patient was diagnosed with a DVT on 5/10/2021 with no previous history of clots or other risk factors known.
Information has been received from a Registered Medical Assistant (R.M.A.) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. No concomitant medications were provided. The R.M.A. reported that on 11-SEP-2015, the patient was vaccinated with the first dose of the 3 dose serious of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not provided). Subsequently, on 17-AUG-2016, the patient was vaccinated with the second dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not provided) (product use issue). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous prospective pregnancy report as received from nurse pracitioner (mother of patient) refers to a 27 year old female patient. The patient was allergic to codeine (also reported as none). The patient's pertinent medical history was none. On 11-SEP-2014 the patient was vaccinated with GARDASIL (dose/frequency: 0.5 ml) intramuscularly mistakenly instead of unspecified tetanus vaccine when her gestation age was 27 weeks and 3 days (also reported as for vaccination). Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of approximately 06-MAR-2014 and EDD of approximately 11-DEC-2014. Initial exposure to GARDASIL was at 27 week and 3 days. Lab diagnostic tests performed were done. The patient sought medical attention and no treatment was provided. No adverse effects reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Developed a rash on face about 1 hour after receiving the Moderna COVID vaccine.  Patient presented to ER, examined by MD and administered Depo-Medrol 40 mg IM X1 dose in ER.
Patient received the Moderna COVID vaccine and 24 hours later her eyelids were puffy. She had also experience puffy eyelids when she had COVID. At that time, she sought medical guidance  and everything else was ruled out. No itching and no watery eyes.
01/10/22 presents to ED for "shortness of breath". PMHx of "obesity, leukemia"
acute immune thrombocytopenia; blood spots (hematoma); .immune thrombocytopenic purpura; This spontaneous case was reported by an other health care professional and describes the occurrence of HAEMATOMA (blood spots (hematoma)), IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) and IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenia.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced HAEMATOMA (blood spots (hematoma)) (seriousness criterion hospitalization) and IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). On 05-May-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Mar-2021 due to HAEMATOMA. At the time of the report, HAEMATOMA (blood spots (hematoma)), IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) and IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count decreased: decreased (Low) platelets are as low as 3*1000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 05/Mar/2021, the patient experienced several blood spots on tongue (hematoma). The tiny red spots growing on face and body. The patient thought might have internal bleeding or blood disorder and decided to drove ER (emergency room).  On 06/Mar/2021 got admitted, the physician run more than 30 blood draws, the platelet was 3x 1000 it was 240x1000. It was a disease called acute immune thrombocytopenia. No treatment drug information provided.No concomitant drug information provided.  This case concerns a female of unknown age hospitalized with serious unexpected events of immune thrombocytopenic purpura, acute immune thrombocytopenia and haematoma. Event latency 10 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age hospitalized with serious unexpected events of immune thrombocytopenic purpura, acute immune thrombocytopenia and haematoma. Event latency 10 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Intense pain and slight swelling at injection site. Overall body aches and joint pain. Fatigue. Intensification of shoulder pain from previous injury.
Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours and are improving.
ON 2/11/23, child taken to ED by parents.  Per ED documentation, patient presented to the ED "for 3 episodes lasting 10 seconds, with 10 seconds of resolution in between, where the patient stopped breathing and became stiff, was initially pale and then turned purple around his face."