chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at the injection site). On 09-Feb-2021, VACCINATION SITE PAIN (Tenderness at the injection site) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided.    This case was linked to MOD-2021-043222 (Patient Link).
So I just got my 2 nd dose and now I am experiencing left ear pain.; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (So I just got my 2 nd dose and now I am experiencing left ear pain.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (So I just got my 2 nd dose and now I am experiencing left ear pain.). At the time of the report, EAR PAIN (So I just got my 2 nd dose and now I am experiencing left ear pain.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Case number PHEH2011US05600 is an initial spontaneous report received from a health care professional on 29 Sep 2011 and a follow up information received from a physician on 12 Oct 2011: This report refers to a 10 years old female patient. She was given only MenCYW 135 liquid conjugate component of MENVEO vaccine (batch number: M10062) intramuscularly into her right arm on 26 Sep 2011. On 28 Sep 2011 she developed circular raised erythematous lesion and raised urticarial periphery at the injection site which was 3cm in diameter and non-tender. She was given warm compression at the injection site, thrice daily for two days and oral BENADRYL was administered. The lesion disappeared in two days without treatment. Follow up information received from the physician on 12 Oct 2011: Updated vaccination date, event, treatment and outcome of the events.
patient given dose of Rotavirus (1st dose) at age 19 weeks & 5 days. Initial dose is supposed to be given between 6-12 weeks of age
Had previous COVID-19 infection following an exposure to a confirmed case in early December 2020, during which my symptoms were classified as moderate in severity. On 2/4/2021, received 2nd dose in the series at 11:40am, no acute adverse events in the 15 minutes post-vaccination and returned home. At 3:00pm that day, developed noticeable fatigue, myalgia, nausea, experiencing 1st episode of vomiting at 3:20pm. On 2/5 at 1:00am, woken up with new onset fever (102.2F), chills, rigors, sweats, systemic joint pain, skin sensitivity, left arm pain and prominent axillary lymph node swelling. On 2/6 at 2:00am, headache onset, Tmax now 102.7F. On 2/7 at 7:30am, woke up with minimal arm soreness, resolution of other symptoms
double vision, dry eye, swollen eyelids, irritated itchy eyes, reduced vision. Also increased heart rate, and difficult to sleep. Several months of failed treatments and unremarkable MRI of brain. Given blood screening for Grave's Disease (07/15/2021)   Tested Positive; Awaiting 1st visit with Endocrinologist (most in my area are booked months out or not taking new patients)    Also notable; the injection was given very high up on the right arm, the needle went into the shoulder joint. I could feel the needle and fluid going into that area.
Third dose of RabAvert was given on day 13 instead on day seven; Case reference number US-BN-2022-002160 is a spontaneous case report initially received on 30-Aug-2022 from pharmacist (reference number: USBAV22-1220) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 17-Aug-2022, the patient was vaccinated with first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not provided) at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies.   On 20-Aug-2022, three days after the first dose, the patient was vaccinated with second dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not provided) at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies.  On 30-Aug-2022, 13 days after the first dose, the patient was vaccinated with third dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not provided) at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received from Bavarian Nordic on 30-Aug-2022 included local case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with third dose of RabAvert,13 days after the first dose (three days after the first dose, the patient was vaccinated with second dose of RabAvert), at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with third dose of RabAvert,13 days after the first dose (three days after the first dose, the patient was vaccinated with second dose of RabAvert), at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Herpes Zoster on nose. Itching, pain, blisters. Happened with both 2nd dose and booster shot.
Mom calls states child woke from nap screaming - Rt leg red, hot to touch, lump and swollen, all of Rt leg, mom states can not comfort child, no difficulty breathing - mom is advised to bring child right in to be seen, when mom and pt arrive at clinic, pt is not crying and leg is not swollen or red, Dr. seen pt and advised mom TYLENOL for next 24hrs.
Pfizer vaccine that was administered was improperly stored in the freezer for greater than 14 days.
6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases; This spontaneous case was reported by a physician and describes the occurrence of TACHYCARDIA (6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TACHYCARDIA (6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases). The patient was treated with MAGNESIUM for Tachycardia, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 05-AUG-2015), the patients had been administered doses of improperly stored VAQTA lot # K018182, expiration date reported as 12-FEB-2017, lot # L002717, expiration date reported as 02-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Nearly immediately patient didn't feel well with general malaise. He took that afternoon off work and the following Tuesday off as well (May 10 and 11). He went back to work Wednesday (May 12) and complained of being tired and having a hard time breathing. He took Thursday off and only worked a  couple of hours on Friday (May 13 and 14 respectively). He described a heaviness on his chest. On Saturday, May 15 he experienced chest pains while mowing the lawn. He told people he was in a lot of pain and thought he was having a heart attack especially at night when he would lie down to sleep. He was drinking lots of water and was checked by a men's health clinic with a handheld ECG on Monday, May 17. They reported his heart was healthy but he continued to experience shortness of breath and tightness in his chest. He worked a few hours each day Monday through Thursday, May 17-21, but continued to indicate he didn't feel well.
I woke up at 2am with a fever of 102.3, body aches, chills and headache. The fever lasted for 24 hours and the headache lasted 48 hours.
Allergic Reactioin.  Tightening in the throat, urticaria, respiratory distress, swelling of lips/tongue
Hives, very jittery about half hour after receiving. Diarrhea (about 4 hours after receiving).
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 18-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Bleeding in right ear, not continuously bleeding; Arm was bruised, dark bruise, right arm; Arm soreness, right arm; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Sep2021 (Lot number: EW0150) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "stents placed", start date: Sep2021 (unspecified if ongoing), notes: was in hospital from 07Sep2021 to 20Sep2021 and had 3 stents placed; "stroke", start date: Sep2021 (unspecified if ongoing); "broke out in red hives" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergic to flu shot for Allergic to flu shot. The following information was reported: CONTUSION (non-serious) with onset 25Sep2021, outcome "not recovered", described as "Arm was bruised, dark bruise, right arm"; PAIN IN EXTREMITY (non-serious) with onset 25Sep2021, outcome "recovering", described as "Arm soreness, right arm"; PYREXIA (non-serious) with onset 25Sep2021, outcome "recovered" (2021), described as "Fever"; EAR HAEMORRHAGE (non-serious) with onset 26Sep2021, outcome "recovered" (26Sep2021), described as "Bleeding in right ear, not continuously bleeding".  Additional information: Patient stated she confirmed with her doctor that it would be alright for her to take the vaccine. She took the vaccine last Saturday. Patient stated she thought the blood thinner contributed to the extreme bruising. Patient did not know what blood thinner she was on, or an NDC, Lot number or expiration date. Patient wanted to get her doctor's approval because of her health issues and was allergic to the flu shot, so that played a part also. Her doctor told her it was alright to get the Covid vaccine. She just wanted Pfizer to know her experience for people that are in a similar situation, who take blood thinners.  Follow-up attempts are completed. No further information is expected.
per the EUA we have to report when the patient is admitted to hospital after vaccination. Patient was positive for COVID-19 Pneumonia
A report has been received from a Health Professional concerning a patient, Female subject who had been receiving Unknown FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 17-Nov-2015. It was reported that the patient experienced inadvertent off-label administration of FLUMIST. The outcome of the event of INADVERTENT OFF-LABEL ADMINISTRATION OF FLUMIST was unknown. The report was considered to be non-serious.
muscle aches in his upper legs at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 13Apr2021, for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscle aches in his upper legs at night".  Additional Information: It was reported that the patient brother took the COVID shot, and had taken the second shot and on his first one had muscle aches in his upper legs at night, the second shot didn't bother him.She was scared to take the second one.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was in for their 4 month Well Child Check (WCC). Patient hadn't received the rotavirus vaccine at the 2 month WCC, but received the first dose at the 4 month WCC. The first dose was given beyond the labeled 14 weeks and 6 days. Parents were informed and are willing to complete the series. No adverse event to date.
The first 15 minutes I got hot. 15 minutes after that which would be 30 min I started itching. I worked my 12 hour shit. I woke up 300am  and my body was hurting so bad, it felt like something was laying on my chest, shoulder arms and legs. I crawled out of the bed and took a Tylenol and that helped a little bit. at 600 am I took another 650 mg Tylenol. And my body has been hurting so bad and I've been itching. I took a bath yesterday about 6:00 and my body is on fire like I'm itching real bad. I don't think I should have took a bath, because that might have made the blood circulate more and my body aches like crazy, worse than before. The last time I took a Tylenol was 6:00.
She received the second dose of the COVID-19 vaccine yesterday.  Shortly after that she started to feel some strange sensation in her arm.  States her arm felt "heavy".  She went home and then felt like she had potentially some numbness and tingling up the right side of her face.  She did receive the shot in the right deltoid.  Patient states she has no weakness in her arms or legs.  But they do feel "heavy".  Patient states this morning she felt like the tingling sensation on the right side of her face had improved but it felt more swollen than it did yesterday.  She states her family members came over this morning and they also felt that she had some swelling to the right side of her face.   Patient was administered Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days then follow-up with PCP
?MAY92 pt recvd Engerix-B & immed exp an allergic reaction p/the inject described as an irritation @ inject site;
This spontaneous report as received from a Nurse refers to a 63 year old female patient. On 20-FEB-2015 the patient was vaccinated with an expired PNEUMOVAX23 (lot number J009689, expiry date 29-JAN-2015) 0.5 ml, intramuscularly in the right deltoid (Expired product administered). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX23 was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX23 was unknown. No product quality complaint was reported. This is one of the 2 reports from the same source. Additional information has been requested.
Patient received her second dose of her Pfizer vaccine. While still sitting in the IMZ chair, patient started to bleed through the barrier bandage.  Tech went to get another bandage to help with the bleeding, patient saw her own blood and got light-headed.  Tech immediately grabbed RPh to come assist.  Patient then laid her head down on the table and looked as though she was going to faint.  RPh instructed other RPh to call 911, store management.  Patient never fainted but remained light headed and nauseous.  RPh took blood pressure (86/58) and HR 68.  Applied a cool compress to the back of the patient's neck.  Patient was able to continue to answer questions about herself, family, etc.  Patient never vomited nor fainted.  EMS arrived and we allowed them to take over. Patient's family came to pick her up.  Patient never went to the hospital.
Feeling sick; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-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 26-Apr-2021, the patient experienced MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills). On 28-Apr-2021, MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) was resolving.            Concomitant medications were not provided.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-066061 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066061:First dose
When I had the vaccine, the next day, I was a little sore at the injection site and was very tired. About a month or so later, I had a little rash on the back of my neck and on my right side. I had hives on my legs arm and stomach. I didn't know the rash had moved down my back to the top of my butt, down my legs, my shoulders up into my hair and in my groin (on the skin) I went to the doctor who sent me for blood work. The blood work showed I had ANA. I was then sent to a rheumatologist. They said they did not find anything conclusive. They said I had nothing to worry about, it was not any underlying condition. My PCP sent me to a dermatologist that gave me something topical. It had aluminum in it, and I do not use aluminum, so I did not use it. I was sent to another dermatologist who did a biopsy of the rash. They couldn't figure out what it was. My PCP sent me for more blood work which came back with nothing again. I was tested for Lyme disease which was negative. I was told to take prednisone, but I did not take it because I was determined to be highly sensitive to pharmaceuticals and drugs. I also tried Benadryl at one point which gave slight relief. I was given a cream which I used, and it helped for 15-20 mins. I used some natural remedies such as plantain and yaro paste as well as calendula flower which heled the most. I have also stopped eating red meat. I went to an allergist where I was tested, and nothing was different. I also stopped my blood pressure medication. When I did, my heart started doing something different. I wore a heart monitor, and I was told I might have a heart murmur but nothing to worry about. I also had a stress test done which I did well on. I haven't taken any medication or the past months now. I do still have some hives but not as much as initially. This has been traumatizing for me because I am getting older and I am afraid of taking medication. Also, the rash lasting this long has affected my quality of life severely. I also have pictures of the rash and hives if needed.
given shot at 5:00 p.m. on 9-04-2008 on 9-5-2008 at 7:12 a.m. he had a siezure that lasted 1 minute and 47 seconds and right after siezure his temp was 97.1. he had another siezure at 9:28 a.m. it was 3 minutes and 45 seconds long. we had to give phenobarbitall to him to stop the siezure this is the second time he has had seizure after getting a vaccionation.
broke out in hives on R arm. called pharmacy and they advised that it could last up to 8 weeks. they subsided around week 6.  on feb 1, 2021- i started itching again and i was positive for covid.  to this day, when i have stress or dont feel well, the hive start up again. i am never without benadryl spray or cortisone cream
Onset time of adverse event is unknown. Pain at injection site accompanied by chills and fatigue. Patient reports on 2/12/2016 injection site had hard bruised (purple color) area and this was accompanied with loss of appetite in addition to previously cited symptoms. Today, 2/17/2016, patient presented to clinic with increased redness and swelling at injection site that extended from shoulder to elbow.
Approximately two minutes after vaccinations, patient said they were feeling dizzy.  The patient lost consciousness and appeared to have a seizure.  This lasted approximately 20 seconds.  The patient then opened his eyes and asked what happened.  I explained that he had passed out.  He then lost consciousness again and appeared to have another seizure.  At this point, I called for help from other nursing staff and called 911.  We then got the patient to the floor where he came around again. He then lost consciousness again and appeared to have another seizure.  We turned the patient on his side and started oxygen.  The paramedics arrived and he was conscious at that point.  He was not recovering very quickly and the paramedics sat with the patient for 20 minutes before deciding to take the patient to the hospital emergency room for further examination by a physician.