chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling and itching at the injection site to an area of 10 x 10 cms in diameter. Patient c/o pain on pressure to the area.
FLUBLOK and FLUZONE QUAD packaging are VERY similar. FLUBLOK is not indicated under 18 and is preferred product in those over age 50. The identical packaging of these products results in confusion when pulling an appropriate product since they are indicated for different age ranges.
Right deltoid injection site with approximately 2"x2.5" diameter red raised area. Warm & firm on palpitation with mild discomfort.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration is given as 19-Aug-2021. No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-364522 (Patient Link).
dizziness and headache, pre-medicated with meclizine because she has had this happen before with moderna, dizziness/ light headed lasted for 3 hours then a headache treated with ibuprofen
I thought it was part of the expected symptoms until a conversation with someone else that had these symptoms noted that they were considered adverse: Received vaccine on a Saturday. As soon as I sat down after receiving the vaccine I felt dizzy, and shaky but wasn't shaking. continued throughout 15 minute wait time, and left stopped to get something to drink at a pharmacy, but still felt lightly dizzy and not stable, but was not having problems walking, did not stumble, etc. When I got home by heart was racing, this symptom lasted for a couple hours post vaccine. The other symptoms including diarrhea last from Saturday until late Sunday with most subsiding by Monday.  A vaccine received years ago resulted in welts and hives upon the entire body that last several months. All of this information was shared at the clinic before receiving the vaccine stating it would be safe to receive. I am concerned about receiving the second dose.
vaso-vagal reaction Narrative:  Approximately 5 minutes into the15 minute observation period, patient experienced lightheadedness, nausea and dry heaves. Blood Pressures were within normal range. Observation period extended to 1 hour and all symptoms resolved.
Ten minutes after immunization, presented with flushed face and pale red rash over chest and abdomen. Vital signs BP 154/90, Pulse 60, Respiration T 98.6, medicated with Benadryl 50 mg PO.
Red, raised, itchy area surrounding Menactra vaccine site (L deltoid). After 2 further days, area is less raised, less itchy, but remains red. Further follow-up pending.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/.1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 02-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
The patient said she passed-out in the parking lot on the way to her car after receiving the vaccine. She was not injured. Her husband helped her into the car and she recovered within a few minutes.
This spontaneous report was received from a consumer regarding his 32 year old wife. Medical history and concurrent conditions were not reported. On 30-JUN-2014 the patient was vaccinated with VARIVAX (Merck) dose 1, subcutaneous (lot number and expiration date unspecified). Concomitant medications were not reported. On an unknown date the patient has taken a home pregnancy test that is showing "positive" for pregnancy. Patient sought no medical attention. There was no Product quality complaint involved. The outcome of event was unknown. Additional information has been requested.
Sore arm after first shot; Tired after first shot; Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first shot), FATIGUE (Tired after first shot) and CHILLS (Chills after first shot) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after first shot), FATIGUE (Tired after first shot) and CHILLS (Chills after first shot). At the time of the report, PAIN IN EXTREMITY (Sore arm after first shot), FATIGUE (Tired after first shot) and CHILLS (Chills after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.  No concomitant medications were reported.   This case was linked to MOD-2021-405853, MOD-2021-405921 (Patient Link).
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 21-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166 expiration date 29-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
Rash on trunk and arms.  PT took Benadryl at onset of symptoms.  Symptoms resolved over following 4 hours without recurrence.
Intermittent SOB and tight chest, no more than 2 minutes, instantly cleared with going outside and getting "fresh air".  No residual cough or chest pain between episodes.  Getting less frequent with time.  Seen in the office on 1/27 and had normal exam.  Only one episode on 1/27 and felt more like claustrophobia than SOB.
arm was sore; huge, bright red lump on left arm; started as big bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (started as big bruise), PAIN IN EXTREMITY (arm was sore) and SWELLING (huge, bright red lump on left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BZIA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CONTUSION (started as big bruise) and SWELLING (huge, bright red lump on left arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, CONTUSION (started as big bruise), PAIN IN EXTREMITY (arm was sore) and SWELLING (huge, bright red lump on left arm) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
CHRONIC JOINT PAIN. HYPERPIGMENTATION AND THIGHTENING OF THE SKIN. SWELLING ON HANDS AND FEET. BAD BLOOD CIRCULATION. WALKING DIFFICULTY AND STIFFNESS.
Severe arm pain (stabbing pain, not soreness) for 5 days following vaccination. Had difficulty moving arm for Almost 3 weeks, had stabbing pain when moving arm in certain ways. Continue to have sudden pain at the injection site a couple times a week.
Observation team received client with mom in the pediatric observation area at 1:42PM. 8 minutes later, client?s mother stated that clientnis nauseous and vomitted in moderate amount. Client asked to rest back on chair, legs were elevated andnice pack was applied to back of neck. Vital signs initated. Client complained of mild headache. Temperture taken and a reading of 100.8 F was collected. Water and lolipop were given. After 30 mins of observation, client verbalized feeling better and able to stand up without feeling nauseous or dizzy. Advised mother to give more fluids to client and to call PCP if symptoms return. Client walked out of the vaccine hub with mother in stable condition without any assistance.
I was tingly; felt overcaffeinated; was extremely thirsty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6208) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Sulfas" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "I was tingly"; EUPHORIC MOOD (non-serious) with onset 2021, outcome "unknown", described as "felt overcaffeinated"; THIRST (non-serious) with onset 2021, outcome "unknown", described as "was extremely thirsty".  Additional information: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Administration time of dose 1 was provided as 10:30. After the first dose, the patient was tingly, felt overcaffeinated and was extremely thirsty.   No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to 9 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored oral, ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
myocarditis; This is a literature report.  A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19  immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: C-reactive protein: Elevated; Echocardiogram: LVEF 66%, no RWMA, normal diastolic function, notes: On presentation; LVEF 69%, no RWMA, abnormal tissue Doppler, notes: suggestive of diastolic dysfunction (Follow-up); Ejection fraction: 66 %, notes: On presentation; 69 %, notes: Follow-up; Electrocardiogram: sinus tachycardia, notes: On presentation; Sinus arrhythmia, notes: Follow-up; Electrocardiogram ambulatory: Normal; Exercise test: Normal; Magnetic resonance imaging heart: NA, notes: On presentation; Absence of acute edema. Focal subepicardial late, notes: gadolinium enhancement. Imaging suggestive of history of acute myocarditis (follow-up); Troponin: unknown results. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200088740 Same article/drug/event; Different patient;
Headache, tiredness, stiff neck, chills, no appetite, slight dizziness, slight buzzing in head
Within Hours of the Pneumonia shot my arm was hurting. By 10:00 pm I was in such pain I was crying, I could not raise my arm. On 10/25 I went back to the doctor. He gave me Prednisone for 10 days which did not help. He then sent me to an Orthopedic Dr. he put a shot of cortisone in my shoulder and by the next day I could move my arm, still had pain. Was out of work for 3 weeks.
Localized pain, swelling, muscle stiffness, itchiness, and redness around vaccination site.
Stiffness on his neck and shoulder; Soreness; a red spot on his arm 6 inches below the injection site which now is getting bigger; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness on his neck and shoulder), PAIN (Soreness), VACCINATION SITE ERYTHEMA (a red spot on his arm 6 inches below the injection site which now is getting bigger) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event since an unknown date.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness on his neck and shoulder), PAIN (Soreness), VACCINATION SITE ERYTHEMA (a red spot on his arm 6 inches below the injection site which now is getting bigger) and PYREXIA (Fever). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness on his neck and shoulder), PAIN (Soreness), VACCINATION SITE ERYTHEMA (a red spot on his arm 6 inches below the injection site which now is getting bigger) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Case is fully vaccinated and died from COVID related issues. Case's wife reported her husband's onset date was 7/25/21, mostly felt low-grade temp and respiratory symptoms. Was hospitalized on 7/27/21, only received oxygen. Passed away still in the hospital on 08/07/21. Hasn't traveled and pre-existing medical conditions are p anca vasculitis, lungs and kidneys were effected, chronic autoimmune disease for 9 years. Fully vaccinated, Pfizer 1/15/21 and 2/05/21.
Nausea the next day for 2 weeks. Then I came down with sore throat, cold, cough, tiredness, and to the day I am still coughing- have been sick for over a month so far.
Patient had red, raised area at site of injection which was warm to the touch. Treatment: Levofloxacin 500 mg every day.
Feels dizzy; Achy; Tired; Having a runny nose; Sore left arm; dehydrated; His left shoulder felt sore; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Zoster vaccine (DOSE 2), administration date: Jul2022, for immunisation; Zoster vaccine (DOSE 1), for immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 14Nov2022, outcome "not recovered", described as "His left shoulder felt sore"; PAIN (non-serious) with onset 15Nov2022, outcome "unknown", described as "Achy"; DIZZINESS (non-serious) with onset 15Nov2022, outcome "unknown", described as "Feels dizzy"; RHINORRHOEA (non-serious) with onset 15Nov2022, outcome "unknown", described as "Having a runny nose"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2022, outcome "not recovered", described as "Sore left arm"; FATIGUE (non-serious) with onset 15Nov2022, outcome "unknown", described as "Tired"; DEHYDRATION (non-serious) with onset 15Nov2022, outcome "unknown", described as "dehydrated".  Additional information: the patient was not sure if the events were delayed vaccine side effects after 24 hours. He can't remember if the side effects started a few hours after or 24 hours after. He never had COVID. He had his second shingles vaccine in Jul2022, by that night around 9 pm, he started getting side effects, they were bad but COVID vaccine was nothing like that. He asked if these side effects were normal or these were something he should get checked out. His sore left arm was reported to worsened. It was progressive similar to any vaccination he has got. It was not terrible and he was outside moving garden hoses. He clarified the dizziness, a little dehydrated and was feeling out of it, and started about an hour ago before the call and it might pass. He called to find out the progression of the side effects.He was just trying to find out if what he was experiencing was normal. Since timing was coincidental that it would be because of the vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Started with itchy throat first I took a pill of Cipro 500mg for the UTI, then I started coughing. After that came the sore throat, fever, body aches, and head ache. By 7:30PM I was vomiting unable to get out of bed due to body shakes and body aches, also had eye discharge with redness and puffyness to both eyes. All these symptoms lasted for the rest of the night. The next morning I still had the same headache and facial swelling around my eyes, nose, and upper lip. I took two benadryl 25mg and Ibuprophen 600mg.
Reported symptoms day after injection.  Instructed to take Tylenol and Ibuprofen and monitor.
Extremely itchy rash over arms,chest, stomach,back,upper legs,butt, skin feels like I walked into spider webs naked and is itching everywhere. Very fine in some areas and hive like in other areas. Creams  do not help and benadryl helps for short time. Have doctor's appointment on Thursday 8/12/2021. I also have felt brain fog almost like a dazed feeling this comes and goes.
Patient had severe swelling and some pain in the arm of the injection site.  It resolved with no treatment after two days.
her arm was a little sore; This is a spontaneous report from a contactable consumer reporting for herself. A 25-year-old female patient received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 10Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she and her husband both took the Covid-19 vaccine on the 10Jan2021. She stated that she did not really have any problems after the receiving the vaccine, but her arm was a little sore on an unspecified date. Outcome of the event was unknown.  Information regarding lot/batch number has been requested.
Fever and chills 9 hours after  Ibuprofen taken within 2hours and fever broke by 2am and was completely fine to work the next morning  They requested feedback so this may qualify as anticipated reaction and not adverse but I wanted to give feedback as I know many people will not
Patient received Pneumovax right deltoid intramuscular on 10/24/2006.  Patient had complaints of pain at injection site that night and a fever the following morning of 99.5 F.  Patient also developed "red streaks" on bicep of right arm with swelling and tenderness.  Patient has been taking Tylenol for pain.
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 07-OCT-2014 the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 07-OCT-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No medical history was reported. On an unknown date the patient was vaccinated with PROQUAD (Merck) (lot no. J013436, exp date: 24-APR-2015)(injection, dose and frequency not provided). No concomitant therapy was reported. Healthcare worker stated that since March improperly stored PROQUAD (Merck) were administered to unspecified patients. No adverse events were reported. The outcome of the events was unknown. The events were considered to be not related to PROQUAD (Merck). No product quality issue was involved. Additional information has been requested.