chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen/dark red lymph node in right groin area that bleed when touched; Swollen lymph node in right groin area; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE HAEMORRHAGE (swollen/dark red lymph node in right groin area that bleed when touched), VACCINATION SITE PAIN (soreness at injection site) and LYMPHADENOPATHY (Swollen lymph node in right groin area) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 14-Apr-2021, the patient experienced LYMPH NODE HAEMORRHAGE (swollen/dark red lymph node in right groin area that bleed when touched) and LYMPHADENOPATHY (Swollen lymph node in right groin area). On 26-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, LYMPH NODE HAEMORRHAGE (swollen/dark red lymph node in right groin area that bleed when touched) and LYMPHADENOPATHY (Swollen lymph node in right groin area) had not resolved.            No concomitant medications were provided.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079449 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079449:Dose 1
The first time I got your vaccine, my joints were COMPLETELY pain free for a week and a half after. The second time I got your COVID vaccine, my joints have had ZERO pain for 9 days and counting.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic joint pain" (unspecified if ongoing); "Ehlers-Danlos" (unspecified if ongoing); "Dercum's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The first time I got your vaccine, my joints were COMPLETELY pain free for a week and a half after. The second time I got your COVID vaccine, my joints have had ZERO pain for 9 days and counting.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, Diarrhea, congestion Narrative:
Delayed rash at inject site - showed up one week after shot  No other pain/side effects to note - feel normal otherwise - really not even sore, just red and raised at shot area
pt c/o h/a, chills, abd pain, nausea, malaise, shakes post typhoid;
After a hot bath I had swelling everywhere that lasted a short time. the week after I had some swelling all over as well that wasnt very noticeable but I know my body so I could tell I was swollen. the injection site was intensely itchy and the itchy site is hot and a large welt. the arm around the injection site is hot and soooo itchy and red.
Patient is under the age of 18 and was provided Moderna vaccine.  Per CDC guidance and in consultation with medical director, the patient was provided a second dose of Moderna vaccine off-label. The patient conferenced with our leadership at the site before the second vaccination to discuss the recommendation before proceeding. Patient is doing well post vaccination.
Day 1 Fever, chills, lethargy, headache, injection site pain Day 2 headache, lethargy, injection site stiffness Day 3 no side effects Day 4 light headedness, fever, stomach ache Day 5 light headedness, fever
Information has been received from an unspecified reporter referring to a 20 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with  PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Patient had tingling in fingertips and itching in left leg within 15 minutes of vaccination.  Patient improved and was released to home.
pt recv vax & 1wk post vax exp a positive urine bilirubin;ER or MD visit was required;
Admitted on 12/8/2021 with chest pain that woke her from her sleep.  STEMI protocol initiated.  HC - cors clear.  Code blue arrest x2 following - intubated, pressors required.  CT found splenic ruptures - providers do not feel this was related to CPR at this time.  AKI.  Liver failure.  Now on multiple pressors, ETT, CRRT running, GI bleeding, and now also has positive blood cultures.
I first got symptoms of tiredness, runny nose, sneezing, and cough. The cough was persistent and a dry cough but not very deep, more like an irritated upper respiratory issue. I received a positive COVID-19 test at a testing facility. The coughing lasted for 2-3 weeks.
Pt called this evening stating that since yesterday has had slight headache, slight body aches, and temperature of 99.8F. His doctor told him to call us to see if it was from YF vaccine. I told him that it is possible but we are in the flu season so he should see his doctor to be evaluated. He was thankful for the discussion.
pt given vax 17SEP92 & mom reports 5 hrs of uncontrolable crying; MD contacted on Sunday & pt seen in office; PE neg, mom reports eating better & sleeping better, low grade temp;
Pt received the vaccine around 11 am/12pm and woke up around 1 am with a swollen tongue that did not respond to BENADRYL or an expired EPIPEN.
Information has been received from a dentist concerning a 38 year old female dental office worker with no pertinent medical history or drug allergies who in 2005 was vaccinated IM with her second 1.0 ml dose of Recombivax HB.  There was no concomitant medication.  In 2005 the patient experienced shoulder pain and flu-like symptoms.  The patient did not see or call a physician when she had the symptoms.  No labs or diagnostic studies were performed.  Subsequently, the patient recovered several days after vaccination.  It was noted that the patient did not have any reaction on her first vaccination.  She also did not receive the third dose.  There was no product quality complaint.  Additional information has been requested.
arm pain that has radiated to her breast with pain; dizziness; chills; nausea; arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain), BREAST PAIN (arm pain that has radiated to her breast with pain), DIZZINESS (dizziness), CHILLS (chills) and NAUSEA (nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 20-May-2021, the patient experienced BREAST PAIN (arm pain that has radiated to her breast with pain), DIZZINESS (dizziness), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm pain), BREAST PAIN (arm pain that has radiated to her breast with pain), DIZZINESS (dizziness), CHILLS (chills) and NAUSEA (nausea) 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 concomitant medications were provided
ADMINISTERED EXPIRED JANSEEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 50 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced administered expired janseen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired janseen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017536, 20211017519 and 20211017116.
Joint pain. Aches. Treated with extra strength tylenol with no help. No aches noted morning of August 10, gradual progression of joint pain starting around 11am. Continued onto 8/13/2021.
Patient waited 15 minutes after administration of vaccine. No adverse reactions at that time. Later in the evening, approx 6:30pm, patient's mother called on-call physician and stated she was developing hives all over. "Brief" episode of shortness of breath per mother, symptoms faded after an hour. The next morning, hives returned along with "pimple" like bumps sporadically showing up on the face where the hives where. Patient stated the bumps hurt and are itchy. Benadryl and hydrocortisone cream were recommended. No difficulty breathing or any other sx noted. Will continue to monitor reoccurrence of hives/bumps.
Swelling, heat and tenderness (day 2) and then itching  along with other symptoms. (day 3)
rash @ inj site & rash to face;saw MD;order not to administer anymore hep b;
This spontaneous report was received from a health professional and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route of administration, lot # and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Patient age 16 was administered Moderna vaccine on unit.  Age limit for Moderna is 18.
Information has been received from a healthcare worker referring to an unspecified numbers of patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. From late February 2016 to 12-MAY-2016, the patients were vaccinated with unspecified doses of improperly store PNEUMOVAX 23 (lot # L010598 with expiration date of 06-AUG-2016; dose and route unknown). The vaccines were exposed at 32 Fahrenheit (F) as lowest for 1395 hours (58 days) as worst case scenario. The temperature excursion was cumulative since late February 2016 per manual recording system. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 22-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # H022280, expiration date: 16-JUL-2014 (dosage and route unspecified). PNEUMOVAX23 had not been exposed to any temperatures outside of the recommended range. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Fever, chills, sore achy joints, night sweats, excessive urination, insomnia. Got some temporary relief with Acetaminophen. Symptoms lasted about 14 hours.
pt recvd vax; several hrs later, devel fever of 105; swollen lt leg & cried unconsolably; to MD next day;tx ped motrin & liquiprin,cephalin liquid & cold compress to lt leg;
Initial and follow up information was received from a pharmacist concerning a patient (age and gender not reported) who on 06-SEP-2013, was vaccinated with a dose of ZOSTAVAX (Lot No. J003483, exp. 29-JUN-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
couldn't move her arm; so sore; stiff arm; hurt so bad to move the arm; hurt from her shoulder to her elbow; she fell backwards and it has started hurting more to move it since her fall.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm) and PAIN (hurt from her shoulder to her elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DICLOFENAC POTASSIUM (VOLTAREN ACTI) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.) outcome was unknown.
1/8/21: received vaccine left arm.  1/14/21: left axillary lymphadenopathy & swelling of vaccine injection site, mild myalgia & arthalgia. 1/15/21: Fever 101. 4, very severe arthalgia, mild myalgia, increased swelling of left upper arm & lymphadenopathy (visibly different than right side). 1/16/21: No more fever, but above still there. Covid test Negative. 1/17/21: Very bad headache. 1/18: improving. Note: arthralgia & myalgia persists since vaccinated day until now about 2/10 (0-10, 10=worse). On 1/15/20: arthalgia was 8/10 (10=worse). No previous joint/muscle pain at baseline.
she currently has sinus infections and is taking antibiotic; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She was scheduled to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Apr2021 (Thursday). The patient currently had a sinus infection on an unspecified date and was taking antibiotics. The patient would like to know if she could receive the vaccine while taking antibiotics and also wanted to know if there were any trials in people taking antibiotics for the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient was referred to her health care professional (HCP). The outcome of the event was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a consumer refers to a female (who is her sister) of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. The patient was in the physicians office and was late for her third dose of GARDASIL, which was scheduled to be administered in december 2012. No adverse event was reported. Additional information is not expected.
Same as the first dose but significantly worse. First, I was so tired I couldn't wake up and then I was sick, vomiting and in a lot of pain because of muscle spasms in my back. As I mentioned in my previous submission, chronic back and neck pain makes all levels of vomiting exceptionally painful because it triggers muscle spasms. Increased vomiting in quantity and/or severity increases the pain caused by muscle spasms, which was what happened with this dose. It took longer to recover, I had to take a day off work, but was still able to return by the following Monday. I also got a booster shot on 12/10/2021 and explained these symptoms to the pharmacist. He told me a lower dose prevents the adverse reactions and still provides necessary protection and proceeded to provide a lower dose. My reactions to this third shot were minimal at best. No vomiting or excessive tiredness, just a general feeling of being on the edge of getting sick - like a cold or the flu was beginning but not fully started yet. That went away by the next day.
sick; splitting headache; chills; fever wasn't too high; foggy head; migraine; This is a spontaneous report from a contactable consumer. This consumer (patient mother) reported for her 50-year-old male patient (reporter's son) that:  A 50-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm on 02May2021 09:00 as DOSE 1, SINGLE for covid-19 immunisation. Second dose was scheduled for 30May2021. The patient medical history included lyme disease. The patient concomitant medications were not reported. On an unspecified date, the patient was real sick for a week, splitting headache, chills; he went to a doctor, fever wasn't too high, but wasn't well enough to go to work; told her his head was killing him, had migraine headaches for couple days, foggy head. Caller almost thought he had COVID, the extreme reaction almost crossed with symptoms to COVID but it was not COVID, they told him it was just a reaction to the Pfizer Covid-19 Vaccine. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Developed wheezing: "tight throat" - "closing up," hives and redness to face and chest approximately 30 minutes post vaccine administration while in car, mom gave Tylenol and Albuterol inhaler, and returned to clinic. Here in clinic: Room air O2 sat 100%, B/P q 5" WNL, (1515 gave Benadryl 50mg PO: 1525 Epi 1:1000 0.3cc x 1; 1540 Epi repeated; some improvement with redness to upper torso noted so (1555 Epi repeated. Released (1700 to home). 6/21/07-records submitted with VAERS form: 6/14/07-12 year old with moderate persistant asthma who does not usally take control medication was treated for an acute exacerbation about 3 months ago and more recently had a second course of steroid for acute wheezing episode. Seen in clinic for complaint of cough/congestion with fever times 5 days. Allergy to soy protein producte, allergy to milk. Impression:asthma moderate persistent with couple of recent exacerbations of symptoms, currently under treated.  6/21/07-received additional med rec. At 1530 developed itching and wheezing after vaccines administered at 1400. treated with epi 1:1000 and benadryl. recovered in clinic.
Sepsis; Gall bladder stone; the bile was blocked in the gall bladder; A spontaneous report was received from a Consumer concerning a 49 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis, bile was blocked in the gall bladder and gall bladder stones.   The patient's medical history was included Down's syndrome and he had gall bladder problem from 5 years. No relevant concomitant medications were reported.    On 05 Mar 2021, prior to the onset of the events, the patient received their first of the two planned vaccine doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly in an unspecified location for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced Sepsis, the bile was blocked in the gall bladder with Gall bladder stones with the seriousness criteria hospitalization.  Laboratory details were not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, sepsis, bile was blocked in the gall bladder and gall bladder stones, was recovering, but still in the hospital at the time of report.; Reporter's Comments: Based on the current available information and lack of temporal association between the use of the product and the start date of the events, the events were assessed as Unlikely Related to study drug. The subject's underlying five year history of gall bladder disease can be a confounding factor as gallstones can lead to inflammation of gall bladder and blockage of bile ducts which can then lead to infection and ultimately, any complication can cause sepsis.; Sender's Comments:  MOD21-047715:mother case
23OCT95 930PM t100.2,large amount of yellow oral secretions;1215AM large amount of emesis,t103.5,P140,R44,02 on;MD notified DPH given & APAP supp given
Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: pt  called back on dec 11th complaining about severe chest pain. pt  counseled to go see primary care md/emergency room/cardiologist.
about 24hr p/vax pt had brief episode (2-5min) of tonic posturing & jerking x3 about 1 1/2-2hr apart
AFTER APROX 2 MIN. AFTER HPV VACCINE PT GOT OFF TABLE FELT DIZZY AND PASSED OUT.
pt recvd vax; pt devel fever; t 104; APAP given to pt; pt taken to pediatrician; pt had also diarrhea;
12-21-05 erythemia at injection site and pain on axilla-clarinex 5mg x 7day on Amoxicillin for dental infection.
6/25/99 pt in office for frequent vomiting;sx progressed to abd pain & some bloody diarrhea on 6/26/99;pt was adm to hosp from ER on 6/26/99;
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 22-MAY-2017 and 23-MAY-2017 (also reported as prior 25-MAY-2017), the patients were vaccinated with improperly stored doses of VAQTA lot # L015460, expiration date 20-JUL-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 13 hours and there were no previous excursions (also reported that administered doses of vaccines with experienced the temperature excursion twice on 22-MAY-2017 of 35 degrees Fahrenheit for between 45 - 60 minutes). Digital data logger was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1705USA013714: US-009507513-1706USA008772: US-009507513-1706USA008773:
March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symptoms that had been in remission were now present. no strength in left injection arm, all muscles weakened. slight headache.  All subsided about ten pm.