chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks; The mass is hot to the touch; Swelling/firmness below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks), VACCINATION SITE WARMTH (The mass is hot to the touch) and SWELLING (Swelling/firmness below injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (cephalosporins) and Allergy (Wasp). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI FE 1.5/30) from 01-Jan-2012 to an unknown date for Birth control pill.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced VACCINATION SITE MASS (Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks), VACCINATION SITE WARMTH (The mass is hot to the touch) and SWELLING (Swelling/firmness below injection site). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. On 30-May-2021, SWELLING (Swelling/firmness below injection site) had resolved. At the time of the report, VACCINATION SITE MASS (Large swollen mass below injection site on the Right Dominant arm /Stayed swollen for approximately 2 weeks) and VACCINATION SITE WARMTH (The mass is hot to the touch) outcome was unknown.            Patient also took pain killer cream along with other treatment products to help relieve side effects.     Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Patient demographic details were updated, relevant medical history was added, concomitant medication was added, event outcome for swelling updated to recovered/resolved.
Body completely covered in hives, itching, rash, etc...took Benadryl and Claritin. 4 days before they cleared
Shots given 5-9-06. That evening, began having pain, redness and swelling of upper Left arm and fever of 100. Mom gave tylenol and cool compresses. Swelling and redness were worse on 5-10-06 involving area from shoulder down to elbow-area was also hard, so they went to Nurse Practitioner. Temp in office was 98.9. Told to continue tylenol around the clock while child was awake and to add ibuprofen if fever went up and that if fever became high or swelling became worse, to go to emergency room, and to return to office Monday if not getting better.  When I called the Mom on 5-15-06, she said that Thursday night(5-11-06), they had noticed a red streak down the arm to the elbow and had taken child to emergency room. Child was placed on Amoxicillin and sent home. Mom stated that arm was beginning to get better, now with less swelling, redness, hardness and pain noted.
tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body; numbness in her feet/tingling and numbness in her that rotates around her body; itchy feeling/worsen with stress. She describes it as an "itchy feeling; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (numbness in her feet/tingling and numbness in her that rotates around her body), PRURITUS (itchy feeling/worsen with stress. She describes it as an "itchy feeling) and STRESS (Stress) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (has a longstanding heart problem which she clarified as a pericardial episode.), Pregnancy and Surgery. Concurrent medical conditions included Chronic kidney disease stage 3 and Congestive heart failure (has a longstanding heart problem which she clarified as a pericardial episode and congestive heart failure during pregnancy years ago.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (numbness in her feet/tingling and numbness in her that rotates around her body), PRURITUS (itchy feeling/worsen with stress. She describes it as an "itchy feeling) and STRESS (Stress). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in her hands/tingling in her feet/tingling and numbness in her that rotates around her body), HYPOAESTHESIA (numbness in her feet/tingling and numbness in her that rotates around her body), PRURITUS (itchy feeling/worsen with stress. She describes it as an "itchy feeling) and STRESS (Stress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient plan to see a neurologist. Concomitant medication was not provided.   This case was linked to MOD-2021-339160 (Patient Link).
devel hives which broke open & wept; also had resp & gastro-Intestinal sx; seen by MD
Shortly after receiving  the second dose, i started feeling like i had a sore throat. I got sick with what felt like a cold/flu for almost ten days. Finally recovered after multiple po otc modalities (meds) then a week after that i got sick again. Currently i feel like my glands are swollen, URI type feeling, with this hacking cough that sounds like a smokers cough/bronchitis with feelings of congestion. I've never been sick back to back and definitively cant figure out why this cough wont go away. I do not feel like myself in terms of fighting this illness. I will seek medical attention after today for a possible x-ray.
As per RN documentation, Pt with hx of anaphylaxis with the 4th infusion dose of Rotuxin a couple years ago.  PCP discussed benefit to prevent complications of COVID vaccine outweighs risk to get COVID vaccine.  Discussed this as well with patient.  She agrees to get the vaccine.    I stayed with the RN and patient for 30 minutes post vaccination and she had no symptoms other than BP and Pulse elevated further to 150s/90s. P upper 80s.    She was transitioned to anther office with plan to continue observation for another 15 mins and recheck her BP.    About 45-50  mins post vaccine, she reported her lower arms and right side of her neck felt swollen but had no SOB or mouth swelling or itching.  She was talking in normal sentences.   Her face became more flushed as well as the posterior aspect of her forearms and she said the neck felt more swollen.   Epi Pen was administered at 8:40 am and EMS was contacted.   Her BP was 160/100, pulse ox 96%, RR 26, Pulse 88.     Transferred to ED.
fatigue; headache; fever; This is a spontaneous report from a contactable nurse (patient). A 38-year-old patient of an unspecified gender received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021, 07:45, at single dose (right arm) for COVID-19 immunization.  Medical history included asthma, atrial septal aneurysm, anxiety and migraines. The patient had known allergies. Concomitant medications were not reported. Patient had other unspecified medications in 2 weeks. The patient previously took first dose of bnt162b2 on 21Dec2020, 07:45, right arm for COVID-19 immunization. On 11Jan2021 at 22:00, the patient experienced fatigue, headache and fever. The patient had no other vaccine in four weeks. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering.  Information about lot/batch number has been requested.
By report, EpiPen given at 1410  and repeated at 1430.  VS at 1413 HR-145; BP-137/89; RR-20; O2 sat 100%.  Other vitals taken through 1431;  BP - 121/74; HR - 110; RR - 14 and O2 sat 100%.  1424 - "fingers on left hand tingling"; 1428 - "nausea, throat burning, breathing better, chest heaviness less tightness".  1435 - "rescue squad arrived".  Reporter was not present at this event.
Pt came to ER c/o weakness, SOB, exertional dyspnea.  Onset 3 days ago.
Arm had a little bulge, had grouping of welts, also arm was painful ice to reduce swelling, compression if able, acetaminophen if painful.
Rash on neck and trunck, following my severe hypotension, loss of vision a few minutes after leaving urgent care clinic (~10 minutes after injection administered).
Red, itch rash on forearm of the vaccinated arm, on 1/11/2021 the rash came back and was also on neck.
shot given 1600(Sun) by 1100 next day(mon) 1/2" lump on right arm also entire arm and hand swelled,fever 99.5,weakness,extreme headache. Fever throught out night accompanied with itcy skin entire body, went to military sick call, told I am havinf severe allergic reaction to dtap, given loratine 10 mg for swelling and itching. stayed in bed next day felt better went to office, by noon fever started again. went home. layed in bed fever increased to 101.0 and headache much worse and now very sore neck. fever will not go down even after taking otc pain releiver. will return to Dr tommorrow if fever persist which will be 4th day after shot.(Thur) Currently at 7pm Wed, fever 99.5 neck very sore and very pinpointed headach in left side of head about 2 " above ear.
Sore arm; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Administration time=12:00 PM, Vaccine location=Left arm, Dose number: 1), administration date: 22Mar2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "Sore arm"; HEADACHE (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "headache"; CHILLS (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "chills". Therapeutic measures were not taken as a result of pain in extremity, headache, chills.  Additional information: Facility type vaccine was workplace clinic. Patient neither had COVID-19 prior to vaccination nor was covid tested post vaccination, also patient did not had any other vaccine in four weeks. In response to the query regarding the awareness dare of the events and the patient who took the vaccine, the reporter reported that she (reporter) did not received the vaccine in this case, and she was reporting for my husband (Patient). Reporter also told that the date she wrote is the date when her husband (patient) told her about the adverse effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother reported patient had hives/itching about 2hrs. after vaccine administered. Gave 1 tsp of Benadryl with good results. Next day only small area of hives- no itching.
This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot numbers M018957, expiration date 22-NOV-2017; M018958, expiration date 03-MAR-2018; M035455, expiration date 22-APR-2018) for prophylaxis. The temperature was between 0°C and 2°C, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions:  1. between 0°C and 2°C for 32 hours; 2. between 0°C and 2°C  for 30 hours; 3. between 0°C and 2°C for 29 hours; 4. between 0°C and 2°C for 36 hours. Data logger was reported as yes. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA008609: Original Case : 1701USA008041 US-009507513-1701USA008611: Original Case : 1701USA008041 US-009507513-1701USA008608: Original Case : 1701USA008041 US-009507513-1701USA008610: Original Case : 1701USA008041
First time seizure 6 days post vaccination GTC w/ post ictal state. Unknown duration of seizure.  Back to baseline in ER
Received flu vax. 8-9pm same night. General of not feeling well, had slight hint of queeziness, along with discomfort. by 11pm same night, had temp with ears and neck warm. Had sudden muscle twitching, teeth chattering, with chills, felt overheated. When checked temp at 11pm, temp was 101.2. Took 1000mg (generic tylenol) aphedaminesine to ease the fever. Temp at midnight, was still 100.0-101.0. Slept most of the next day. On following day, temp had decreased to 99.0. Still was weak and could not do much. On 11.15.20 checked temp and it was normal.
Day after vaccine (>24 hours) fever to 102 with focal area erythema at site. 2 day later continued fever, 6cm area induration, tension. Pain to move shoulder. No respiratory symptoms, no itching. Isolated axillary. Suspect cellulitus more than reactions.
Tinnitus; Tremors; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and TREMOR (Tremors) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 17-Feb-2021, the patient experienced TINNITUS (Tinnitus) and TREMOR (Tremors). At the time of the report, TINNITUS (Tinnitus) and TREMOR (Tremors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 13 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 18-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-SEP-2021, the patient experienced off label use. On 18-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218297, 20211218731 and 20211218731.
My shoulder feels like it is going to fall off.; This is a spontaneous report from a non-contactable consumer or other non hcp. A 35-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:30 (at the age of 35-year-old) as dose 1, single for COVID-19 immunisation. Medical history included allergy with Sulfonamide Derivates, Cephalosporins and Sulfa Antibiotics. Patient did not receive other vaccine in four weeks. Patient received medications in two weeks. Patient did not receive covid prior vaccination. On 09Mar2021 13:30, the patient experienced my shoulder feels like it is going to fall off. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a healthcare professional referring to an unspecified number of patients of unkonwn age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # L000718 with expiration date of 28-APR-2017, L009445 with expiration date of 01-JUN-2017 and lot# L007559 with expiration date of 01-JUN-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This was the booster 0.25ml of Moderna  vaccine given 10 months after second dose. I experienced worse side effects than with 2nd dose. They were similar to 2nd dose SED chills, fever 101, severe headache, muscle weakness. Started 12 hrs after administration of booster. These lasted about 24 hours. But reason reporting is I experienced COVID arm, which came up about 72 hrs after administration. Large ,big red round circle on vaccinated arm, very warm to touch. Has lasted about 4-5 days. I experience this with the first dose and reported it. I expected the SED that were similar to 2nd dose but much worse and half of dose of vaccine given. This is just for your information. I am fine.
No adverse  reaction occurred as of yet.  My employer requires VAERS reports for vaccine administration errors.  Patient received a flu vaccine both on 11/10/2022 and 11/09/2022 at our facility by mistake.  She also received a COVID bivalent booster 11/09/2022 but had COVID 10/03/2022, so it was earlier than recommended.
Hep A gave adult dose of 1.0ml instead of giving 0.5ml.
pox lesion; temperature excursion; This spontaneous report was received from a registered nurse concerning an 11-year-old male with no pre-existing allergies, birth defects, or medical conditions. There was no illness at the time of vaccination. There was no concomitant medication.  On 16-AUG-1996, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose were not provided; Lot# was 617260/0563D and expiration date was not reported but upon internal validation as 01-NOV-1997) subcutaneously for prophylaxis.   On an unknown date (reported as subsequently), the patient developed approximately 20-30 apparent pox lesions per telephone report from the mother. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccination. The outcome was reported as recovered.  It was also noted that the patient's brother developed varicella after vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) (WAES # 0503USA00122).  Follow up information was received from a medical assistant on 09-APR-2021. On 07-APR-2021, the patient was vaccinated varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not provided; lot# was T017685 and expiration date was 21-MAY-2022; lot# was T027303 and expiration date was 12-AUG-2022; lot# was T010311 and expiration date was 24-MAR-2022; lot# was T017681 and expiration date was 21-MAY-2022) involved a temperature excursion for prophylaxis (product storage error). The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.  This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002475: US-009507513-2104USA002470: US-009507513-2104USA003265: US-009507513-2104USA003268: US-009507513-2104USA003266: US-009507513-2104USA003267:
Sore, throbbing pain in left knee. I had no activity prior to this event. 7pm..On phone..Simply sitting in chair and laying on bed. Symptoms grew so bad by 11pm could barely bend knee and almost impossible to walk.
1 inch diameter induration with 2 in wheal on LA surrounding VARIVAX adm site. Normal pulses. bilat.
Patient received H1N1 vaccination at the clinic following signed consent.  Following immunization at about 11:50 am she started complaining of feeling warm at about noon.  She was alert, oriented and without distress.  Vitals:  BP 130/80, T- 97 degrees F. Pulse and heart rate regular.  She rested and we observed her.  At 12:10 pm BP 130/80, HR 80, RR 18 and no distress.  At 12:20, vital signs the same, C/O tingling feeling on hands, on and off and started complaining of dry mouth.  Taken to rest in health office bed with legs elevated.  At this time, BP 150/100, respiration rate normal, verbal and alert.  Dr. was contacted.  Pt. compained of dry mouth, throat and difficulty swallowing.  Emergency medicine administered: Epinephrine and Benadryl as per protocol.  Emergency Medical Services was activated (911 was called, arrived and took over care.
Diarrhea resolved within 3 days, redness around administration site about 12 inches in diameter still present 4 days after administration but decreasing in size
GI problems; This is a spontaneous report from a contactable consumer (patient).   A 46-year-old female patient (weight 74.39 Kg) received the first dose of BNT162B2 (Pfizer-Biontech covid-19 vaccine, Lot. EK5730) on 18Dec2020, in the left upper arm, at single dose, for COVID-19 immunisation. Relevant medical history included thyroid disorder. Concomitant medications were unknown. On 18Dec2020, the patient experienced gastrointestinal (GI) problems. Clinical outcome of the adverse event was unknown at time of this report.
Having trouble BREATHING. Lower lungs feel tight & constricted. Can't breathe in deep without cough. Can't catch breath. It's day 5. Scared.  Had Chills on day #2 for about 3-4 hours. Had soreness & swelling at injection site. No problem.
48 hrs fever at 101 degrees Vomiting Bodyache Fatigue Chest pain Nausea
Pt was sitting in chair and "fell over" with convulsions. He was unconscious 1 1/2 minutes. No respiratory arrest. Pt recovered after 2 1/2 minutes and was taken to ER where she was found to have temp 102F (per parent's statement).
Client arrived at vaccinator's table for vaccine slightly anxious. Vaccinator administered Pfizer vaccine. When vaccinator went to sign client's vaccine card she noticed that the client had previously received a dose of Moderna on 2/13/2021. Leadership was notified and the error was explained to the client. Client stated that she understood. Client had a 30min observation period and no adverse events were noted during this time.
Initial case was received on 06 October 2010 from a consumer/patient. A 51 year old female patient received on 05 October 2010, a subcutaneous injection of FLUZONE (lot number UH184AB). On 06 October 2010, the patient experienced a red, warm, tender and hard injection site the size of a fifty cent piece. The patient had no illness at the time of the vaccination and no vaccinations within 4 weeks. She had no pre-existing medical conditions, no allergies and no concomitant medications. No treatment was prescribed. The outcome was unknown. Documents held by sender: None.
Low grade fever (100.8F), severe chills (until 4:00 AM next day)), total body aches (ongoing), headache (resolved), fatigue (ongoing).  Patient took Nyquil.