chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.Total duration of the excursion refrigerated temps for max of 4 hrs; Accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 06-Oct-2021, vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. It was reported that the vaccines were shipped in refrigerated temps and then re-frozen for storage once arriving the facility. The vaccine was partially thawed/liquid and underwent temperature excursion for maximum of 4 hours.   No treatment information was reported.
The next morning when I woke my arm was sore and I felt aches, tired. I had no fever or coughing. I did not need to see my doctor.
Arm was incredibly sore and I had difficulty lifting it above my head for 2 days post vaccination. I experienced chills and was light headed and dizzy prior to leaving clinic.
Initial report was received from a health care professional on 23 August 2011. A 34 year-old female patient with no known allergies, had received on 20 August 2011 a first dose intramuscular right deltoid injection of ADACEL, lot number U3979CA (sanofi pasteur ltd lot number C3915). On 23 August 2011, the patient experienced redness, swelling and a mass at the injection site. The patient was evaluated by a physician and treated with antibiotics and topical steroid cream. The patient had no illness at the time of vaccination. NO further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Swollen lymphnodes in the armpit of injection area; right armpit. Shot was the 2nd Booster for Covid. All shots were Moderna.
DIZZINESS, VOMITING, DIARRHEA, DIAPHORESIS, DECREASED CONSCIOUSNESS.
Patient's parents reported that later that evening child had a vomiting episode and a low grade fever of 99.0
Information has been received from a healthcare professional (reported as health worker) referring to a patient of unknown age and gender. On 26-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route were unknown, lot # K021624, expiry date: 07-FEB-2016). No known adverse effects were reported. Additional information has been requested.
She also had flushing with 3 of them; Half her face swollen from all of these vaccines; her lip and face were a little swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: EM9809, Anatomical location: Right arm), administration date: 11Feb2021, when the patient was 72-year-old, for COVID-19 immunisation, reaction(s): "She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one", "Half her face swollen from all of these vaccines", "her lip and face were a little swollen"; Bnt162b2 (DOSE 1, SINGLE, Administration date: 21Jan2021 or 20Jan2021, Lot number: EL1283, Anatomical location: Right arm), for COVID-19 immunisation, reaction(s): "She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one", "her lip and face were a little swollen", "Half her face swollen from all of these vaccines". The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "She also had flushing with 3 of them"; SWELLING FACE (non-serious), outcome "recovered", described as "Half her face swollen from all of these vaccines"; LIP SWELLING (non-serious), outcome "unknown", described as "her lip and face were a little swollen". The events "she also had flushing with 3 of them", "half her face swollen from all of these vaccines" and "her lip and face were a little swollen" required physician office visit.  Additional information: It was reported that half of her face was swollen from all of these vaccines. It was her left side and recovered completely. It took a long time for the face to be normal. It was not swollen real big, but her lip and face were a little swollen. The first one she had, the doc onsite said to take Benadryl and she told him she already takes allergy pills. She took Benadryl when she got home. She also had flushing with 3 of them. Just right cheek would flush real red. She had with the first 3, she could have had for the last one. She took her normal medications.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173786 same patient/drug/events, different dose;
Received vaccine on 02/01/03 at approx 09:00 in the right tricep. Immediately after the vaccination there was severe shooting pain in the tricep area. On 02/02/03 a lump appeared above the right elbow about 2.5" in diameter. Since then the pain has spread down the arm all the way to the wrist and around the upper arm into the bicep. Skin is red, itchy and warm to the touch.
Swollen skin around injected area, dizzines, fever. nausea, pain in arm.  Taking Benadryl
Approximately 7 hours after receiving the single dose of the Janssen Covid-19 vaccine,  symptoms such as muscle aches, fatigue, and fever set in. Symptoms rapidly worsened over the next few hours, with the fever reaching a max temp of 103 degrees Fahrenheit. This required monitoring and the use of ice packs to keep the fever under control. Muscle aches were severe, and were particularly prominent in the lower back region and the injection site. Fever remained in the 100-103 degree range for the duration of the night and by the next day, temperature returned to around 98 degrees.
The patient was found deceased; This is a spontaneous case, initially received from pharmacist via Med Communication (reference number: SEQW20-01021) on 28-Aug-2020 with two additional documents received on 31-Aug-2020 (being processed together), concerning a 78-year-old female patient.  The patient's medical history was not reported.  The patient's concomitant medications included mycophenolate, simvastatin, alopurinol, furosemide, prednisone, gabapentin, Humalog (insulin lispro), Lantus (insulin glargine), Synthroid (levothyroxine sodium), potassium chloride, metoprolol, amlodipine, azathioprine, bumetanide and metolazone, all for an unknown indication.  On 26-Aug-2020, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; batch number: 279734, anatomical location: deltoid, dose: 0.5 ml, route of administration: intramuscular and expiration date: 04-May-2021] for an influenza prophylaxis.  On 28-Aug-2020, two days after taking Fluad (TIV), the patient died. The cause of death was unknown and it was unknown if autopsy was done.  The case was assessed as serious due to seriousness criteria of death and medically significance.  The reporter did not provide causality assessment to Fluad (TIV).  Company comment: A 78-year-old female patient was administered Fluad (TIV) vaccine. Reportedly, the patient died two days after vaccination. The cause of death was not provided. It was unknown if autopsy was performed. Patient's advanced maternal age may have contributed to development of the event. More information regarding medical history and autopsy results is needed. With information available, causality is unassessable.; Sender's Comments: A 78-year-old female patient was administered Fluad (TIV) vaccine. Reportedly, the patient died two days after vaccination. The cause of death was not provided. It was unknown if autopsy was performed. Patient's advanced maternal age may have contributed to development of the event. More information regarding medical history and autopsy results is needed. With information available, causality is unassessable.; Reported Cause(s) of Death: Unknown cause of death
This case was reported by a healthcare professional and described the occurrence of injection site hives in a 3 year-old female subject who was vaccinated with HAVRIX. Previous vaccinations included HEPATITIS A vaccine (manufacturer unspecified) given on an unknown date. There were no concurrent medications. On 10 June 2008, at 10:30 - 11:00, the subject received 2nd dose of HAVRIX at 0.5ml (720 elisa units) in an unknown thigh. On 11 June 2008, 1 day after vaccination with HAVRIX, the subject experienced hives initially around the injection site and then the trunk and arms. The subject experienced a systemic reaction. It was noted that the subjects 1st dose of HEPATITIS A vaccine previously received was from another manufacturer other than GSK based on the lot number. The subject returned to the physician's office on 13 June 2008 and was advised to take Benadryl. At that time, the hives were improved. The healthcare professional considered the hives were probably related to vaccination with HAVRIX. Follow-up information was received on 18 July 2008 via a healthcare professional, who reported that the subject received the 2nd dose of HAVRIX on 10 June 2008. On 11 June 2008, the subject's mother noticed hives at the injection site, which scattered to both arms, both legs, and on the subject's trunk. The hives were reported to be very itchy, but the subjects did not experienced a fever. As of 17 June 2008, the events were resolved. The reporting healthcare professional considered the events to be related to vaccination with HAVRIX.
Pain at injection point immediately; pain using right arm for routine tasks for the following 6-8 hours; injection site remains sore to the touch after 72 hours. No other pain the day of injection. Day after injection (approximately 18 hours later) the entire right arm ached; then the aching moved to the lower back and eventually both legs. Pain resolved at approximately 30 hours after injection; ache never affected left (non-injected) arm.  Minor headache seemed to be forming, but never progressed past the initial indications. Was extremely tired the day following the injection; took two naps (1-2 hours each) and slept 12 hours that night (i.e., injected Friday, tired all day Saturday and slept longer than normal Saturday night). Aside from soreness at injection point, no further signs/symptoms on Sunday (i.e., resolved around 36 hours after injection).
The first few days after receiving the vaccine there were complications breathing, chest pains and having shortness of breath. I was also suffering from headaches. The chest pains have stopped along with the breathing issues but I have since been suffering from migraines on a daily basis.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) from another doctor's office.  Then shortly after, the patient had developed shingles.  It is unknown if the patient sought medical attention.  The physician reported that the patient had recovered.  This is one of two cases from the same source.  Additional information has been requested.
HAD SEIZURE IMMEDIATELY  AFTER SHOT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight, past medical history or concurrent conditions were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, with frequency1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had seizure immediately after shot and reporter thought that patient was going to die. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had seizure immediately after shot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614044-COVID-19 VACCINE AD26.COV2.S-had seizure immediately after shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Chicken Pox; The first day I had chills and malaise, then I broke out in a rash. I am an RN and work with NPs; we all agreed it was CP. I had CP at age 16.
This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 8th November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus and erythromacular rash. On an unknown date, the outcome of the generalized pruritus and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the spouse of the patient. The patient had a history of shingles but he was not suspicious of shingles. About 2 weeks ago, he started having itching all over his body and about a week ago he started noticing strange little red dots that itch all over his body.
January 30, 2021, began experiencing Bell's Palsy type symptoms.  Went to ER on February 1, 2021 where I was diagnosed and prescribed Prednisone, Valacyclovir and Artificial tears.
During vaccine administration, needle came dislodged from the syringe resulting in the needle remaining in patient's arm after the dose was administered. Needle was then manual extracted by the vaccinator. This resulted in no patient harm or wasted dose.
redden big circle around inj;hot to touch, hard in middle where inj is;hurts but is very very itchy;
Immediately following vaccination:  Initially sore arm, woke up from dream with pain.  08/08/2021 at 1600 presented with Stroke.  Leg weakness, slurred speech, blurry vision, loss of fine motor control hands.  Symptoms cleared 2hours later at 1800.
HOT SENSATION IN LEG; SORENESS; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced soreness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced tiredness. On MAY-2021, the subject experienced hot sensation in leg. The action taken with covid-19 vaccine  was not applicable. The outcome of the hot sensation in leg, nausea, tiredness and soreness was not reported. This report was non-serious.
About 4 hours after the injection I developed terrible rigors.  I had a fever up to 102 degrees, but I was also under blankets at the time.  I continued to have a low grade fever for much of the next day and generally felt bad with headache and malaise.  On the second day after my vaccination, 3/28/2021, I felt fine.
Breakthrough COVID illness; Breakthrough COVID illness/ Suspected Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Jun2023, outcome "recovering", described as "Breakthrough COVID illness"; SUSPECTED COVID-19 (medically significant) with onset 30Jun2023, outcome "recovering", described as "Breakthrough COVID illness/ Suspected Covid-19". The events "breakthrough covid illness" and "breakthrough covid illness/ suspected covid-19" required physician office visit. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient diagnosed with COVID-19 prior to vaccination was unknown. The adverse event resulted in any of the following Doctor or other healthcare professional office/clinic visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She began having seizures, which I didn't identify as a seizure until she had a grand mal and I called the ambulance. After that she began having seizure at least once a week. Finally, after months of trying to get into a medical facility to run tests, we found there was no abnormal signs in the brain and really no physically medical reason she should be having the seizures. She's been on meds since we found Dr., which have helped somewhat. She missed a lot of school the past two years, but has maintained a good grade average with the help of a plan. She shakes upon wakening and often times during the day she can get disoriented, can't talk or control her face.  She has had to be assisted into the nurses office due to inability to communicate. Ambulance was called on a school outing to come get her from bus due to a seizure.
Fever (101 degree), headache, muscle aches, chills. Treated with tylenol and rest. So far it seems to be helping.
Approximately 10-15 minutes after receiving the below mentioned flu vaccine, patient states she felt nauseated, " clammy" and "felt like a hot flash". VS stable. Evening of 10-06-09 and day of 10-07-09, patient experienced temp. to 99.9 degrees, pulse to 106, body aches, decreased appetite, nausea, patient felt well 10-08-09 and returned to work.
States left arm was sore after injection. Everyday it was worse. Complained of left arm being red, swollen and itching from injection site to elbow but denies fever. Went to Urgent Care on 5/20/02 and was given prescriptions for Allegra 1 bid and Cephalexin 500mg 1qid. On 5/21/02, pt states it is much improved.
Began to feel fatigued with slight sore throat and headache approximately 7 hours after vaccination. Symptoms persisted into the evening feeling tired and as if it was the onset of cold or flu. Slightly elevated temperature (99.4 - typically my temperature is 97.6) at one point next morning. Symptoms remained on day 2 (Tuesday, Jan. 8) with mainly feeling tired, slight sore throat, headache. All were relieved with OTC severe cold and flu medicine and rest. By Tuesday evening I was feeling much better with symptoms abating to a great degree. By third day, symptoms have all but disappeared. I rested on Tuesday and did not go to work, more out of concern that I might have the flu or a cold, which I have no desire to share. I will return to work today since it is clear that I have not acquired the nasty cold that has afflicted my partner for more than three weeks.
Patient reported loss of hearing in the left ear for a couple days after vaccination and an "hot and swollen" arm. No more details were provided. Patient did report that he felt totally fine now and had no further issues.
experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema; he developed rash on his left ankle which kept growing inside out; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema) and RASH (he developed rash on his left ankle which kept growing inside out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced RASH (he developed rash on his left ankle which kept growing inside out). On an unknown date, the patient experienced RASH PRURITIC (experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema). The patient was treated with HYDROCORTISONE for Rash, at a dose of on hydrocortisone for 5 days. At the time of the report, RASH PRURITIC (experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema) and RASH (he developed rash on his left ankle which kept growing inside out) outcome was unknown. PCP told him they will treat that as eczema
Her entire body turned red with flushing; Her entire body turned red with flushing; she was very very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Her entire body turned red with flushing), FLUSHING (Her entire body turned red with flushing) and ILLNESS (she was very very sick) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Quadriplegia.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Her entire body turned red with flushing), FLUSHING (Her entire body turned red with flushing) and ILLNESS (she was very very sick). At the time of the report, ERYTHEMA (Her entire body turned red with flushing), FLUSHING (Her entire body turned red with flushing) and ILLNESS (she was very very sick) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had previous Moderna vaccines which caused severe reactions and she doesn't want to take any more Moderna. Treatment information was not reported.