chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; nausea; chills; Sore left arm; stomach problem; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm) and ABDOMINAL DISCOMFORT (stomach problem) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Question:Was there parental vaccine exposure?Answer:No.     On 13-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm) and ABDOMINAL DISCOMFORT (stomach problem). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), NAUSEA (nausea), CHILLS (chills) and VACCINATION SITE PAIN (Sore left arm) had not resolved and ABDOMINAL DISCOMFORT (stomach problem) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had taken all previous shots were Moderna COVID-19 vaccine, First Primary monovalent dose on 20-JAN-2021 (Lot# 028L208A & Exp. Date: unknown), second Primary monovalent dose on 7-FEB-2021 (Lot# 031L20A & Exp. Date: unknown) and First Monovalent Booster (Dose 3) dose on 22-OCT-2021 (Lot# 039D21A & Exp. Date unknown).   This case was linked to MOD-2022-687759 (Patient Link).
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and past drug history was unknown. On 30-JUN-2015 (reported as "on either 30-JUN-2015 or 01-JUL-2015"), the patient was administered (Oka/Merck) VARIVAX, 1 vaccine, lot # L002214, expiration date 21-JAN-2017 (dose, frequency and route of administration were not provided), for immunization, after it had a temperature excursion. That was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient would ever get (Oka/Merck) VARIVAX again and the outcome of (Oka/Merck) VARIVAX being given after an excursion was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states that on 4/24/20  her left arm became achy and sore  and stated that her joints are sore . Joints that are  sore mostly on her left side and include knees and hips . On Saturday patient stated that the pain hurt on back of neck and was hard to open her mouth. Patient took IBU and placed cool wash cloth on site. States site looks a little swollen. Patient states that symptoms are better today 4/28/20 and was advised to monitor for changes , push fluids and take Tylenol.
They said it was an ovarian cyst rupture; Around 8 pm she started screaming in pain; feeling nauseous; feeling nauseous and dizzy; This is a spontaneous report from a contactable consumer (patient).   A 15-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jun2021 12:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 2, SINGLE for covid-19 immunisation. Administered is Pharmacy or Drug Store. Medical history included asthma and no known allergies. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 1, SINGLE for covid-19 immunisation. After her 1st covid shot on 30May2021 and then had her period on 02Jun2021. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps. It maybe a coincidence. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported.  After her 2nd covid shot on 20Jun2021 around 12 noon. Around 8 pm she started screaming in pain, hunched over, feeling nauseous and dizzy. Patient had clinic visit, ended up taking to ER where they gave her morphine for pain. They started IV, did bloodwork, ultrasound and ct scan with contrast all on 20Jun2021. They said it was an ovarian cyst rupture. Patient was only 15 years old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun21 and pray it's not as bad as last month after the shot. They do believe in science, but also think should study menstrual cycles with this shot. They pray this was just a fluke, but patient has never experienced pain or severe periods like this until shot. Treatment received for all events. The outcome of events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested
Swollen lymph nodes; Painful swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in left arm on 03Mar2021, at 09:30 hours (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and epstein Barr virus. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), norvasc (MANUFACTURER UNKNOWN) and acebutolol (MANUFACTURER UNKNOWN), for an unknown indication. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination patient had not been tested for COVID-19. The patient had penicillin allergies. On 14Mar2021, the patient experienced very painful swollen lymph nodes under arm and up to shoulder (4 days after shot and not much relief). The patient did not receive any treatment for events. The clinical outcome of the events swollen lymph nodes under arm and up to shoulder and painful lymph node was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
1 1/2 hours after shot intense pain down back muscles of left leg to the point of not being able to stand. Lasted until next morning. Now just soreness behind knee. Nasal congestion lasted 3 days. Now runny nose Sore throat lasted 2 days. Mostly recovered
She got her vaccine, she started with flu and was throwing up bile, she was on the street about  a week after she got the vaccine.  She had a hernia on her stomach and was having pain and went to the hospital and found to have two blood clots.  She was also anemic on top of it.  She needed a blood transfusion and that's when she was diagnosed with the two blood clots.  One on her leg and the other on her arm.  She was given some pills for her stomach, she said she has been so drugged up it's unreal.  They did a colonoscopy and endoscopy and has IV's in both arms.  She was in the hospital for a week.  She is now in a nursing home, she is now recovering, and giving her iron pills as her iron level was so low.  She had shooting pain that when up her leg from the blood clots.  She was put on blood thinners for the blood clots.  She was bleeding internally so they decided not to do the IVC filter.  She is supposed to be discharged home on the 30th.
Two days after receiving Kinrix, the child's right arm turned very red and swollen all the way to right elbow and tender to touch. Mom took the child to hospital and was diagnosed as MRSA infection to right arm on the same day starting IV antiboitic treatment for two days. The child was released with oral antibiotic for another 5 days at home. No more swelling or redness to right arm since March 11th, 2011.
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 10th of 15 reports. A patient (of an unspecified age, gender and race/ethnicity received PREVNAR 13 lot number N4385, expiry date 31Oct2017) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Patient received MMR#2 and a PPD on 9/2/08. As she was leaving her whole head started to pound. She did not say anything but went home. She continued to have a pounding head ache bilaterally, experienced light sensitivity and  felt irritable. She denies nausea or fever.  She took 2 extra strength Tylenol. On 9/3 and 9/4 her head ache was on the right side only above her temple.  The pain would come lasting 5-6 minutes with an intensity of 8-9 then it would go and she would feel fine.  She also c/o hot flashes associated with the head ache.  She came in 9/4/08 and reported her symptoms. BP 128/70 She was advised to start taking the Tylenol as directed.  She was advised to go to the ER if her symptoms got worse, and have someone else drive her.  She was advised to see her own physician the next day if her symtoms continued as they were.
Pt recvd 3 doses of ? Engerix-B & did not respond;
localized skin reaction; red patches on the arm/shoulder near injection site; subcutaneuos swelling; mild pain/discomfort; mild pain/discomfort; This is a spontaneous report from a contactable physician. This report was received via a sales representative. An 80-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was living in an care facility. She received her first COVID 19 shot and within a few hours experienced what was thought to be a localized skin reaction. She experienced red patches on the arm/shoulder near injection site, subcutaneous swelling, mild pain/discomfort. This did eventually subside with antihistamine and time. The HCP was concerned about her proceeding with the second shot. The outcome of the events was recovering.    Information on the Lot/batch number has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site tingling in a patient who received BEXSERO. In July 2016, the patient received the 1st dose of BEXSERO. In July 2016, less than a month after receiving BEXSERO, the patient experienced injection site tingling. On an unknown date, the outcome of the injection site tingling was recovered/resolved. It was unknown if the reporter considered the injection site tingling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The sales representative stated that, the nurse told her that the patient experienced tingling in the vaccinated arm for several days after vaccination with BEXSERO. The sales representative did not know the patient details. No further information was provided.
Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL. Subsequently the patient experienced swelling on her hand. Unspecified medical attention was given. Lot number was not available and no further information was available. Additional information has been requested.
After the 1st vaccine, my menstrual cycle (because I'm pre-menopausal) - about every three or four months.  Before the vaccine, I get heavy bleeding for a few minutes and then it stops and then it goes to spotting. But this time, after the vaccine,  it was  so extremely heavy that I had to leave work. I had huge clots coming out - I had to change not even an hour later. And had to change again, not even an hour later than this. I went to change again another time and felt the blood gushing out again. I work construction and I had to tell me foreman that I had to leave. I bled heavily for about five days. I was scared but didn't go to doctor. I  don't have  medical insurance. I started drinking Iron due to the blood loss.  After the five days, it was spotting so that was pretty normal. On the 26th of June, I had the second Pfizer of June. I felt horrible pain, on my upper left lung - that was two days after the second vaccine. It felt like a shooting pain. It hurt when I tried to take a deep breath or when I tried to move my arms. Slowly it moved to center of chest and then it disappeared. Tuesday,  I started bleeding again - extreme bleeding. I told myself that I would go to ER but it seemed to calm down overnight. But I let my supervisor know and he had let me off early after I told him what was going on again. Wednesday, started bleeding again again heavily when I was at work. I went through four super tampons and  four super pads and bled through my period panties and I had put a beach towel on my car seat and I had bled on that towel. I went to ER. The doctor at ER  - I told her the pain I was having on my lungs. The week I had started bleeding again,  I  had noticed my right lung hurt on Monday and the next day is when I had gotten my period and it was just so heavy. Chest lining that was swollen. They gave me ibuprofen for the swelling and the bleeding. She told me to keep on taking Iron supplement. They won't put me on hormones because there is breast cancer history in the family. I have never bled like this or have clots like this. She did two Ultrasounds= Kidneys, liver, external and bloodwork for testing things and  ovaries. I am still getting on and off chest pain and I get tired really easily. The chest pain happened one day out of the last week.  I'm in shape - I swing dance and workout and workout. I work in construction and so I have a physical job. Ever since the vaccine, I feel like I get tired a lot faster - and that is still going on. I'm afraid to get my period right now because I don't know how it's going to be. And I'm afraid to be physical anymore and I have to be super cautious with wearing super pads in case it happens.
This vaccination was administered to the patient as a booster but the patient is under 18 years of age. No adverse events were reported in response to the vaccination, but it was provided to the patient in error as the vaccination is only approved for individuals > 18 years of age
Pancreatic insufficiency. Irregular bowel movements: orangeish color, loose or diarrhea starting on 4/20 and continuing to present. Abdominal discomfort and roiling starting on 4/20 and continuing intermittently to present. Very low pancreatic elastase I result: 17 and then 87 but with normal "fecal fat" test.
soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female 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), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296760 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296759 same patient/event, different vaccine doses/event.
Information has been received from a physician and a nurse practitioner concerning a 12 month old white male patient with no known allergies and no pertinent medical history who on 8/2/04was vaccinated SC with a dose of varicella virus vaccine live (lot # 647715/0190P). There was no concomitant medication. On 8/12/04 at 07:30, the patient presented to the physician's office with two dozen chicken pox, described as a rash of scattered macules and fluid filled papules on his trunk and spreading to the legs for 12-24 hours. He also had a low grade fever for three days. The rest of the patient's physical examination was negative. There was no recent family illness. No laboratory tests performed. The patient's recovery status is unknown. There was no product quality complaint reported. Follow up information indicated that the patient recovered on 8/12/04. Unspecified medical attention was sought. Additional information is not expected.
Breathing problem, SOB, Itching all over, sweating. 12 hrs after shot pt got itching and sweating. 2 hrs later she got SOB. Pt went to hospital got EKG and other test. Took long. She felt better and left and called her cardiologist.
Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture; no adverse event; patient received the vaccine after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (no adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the vaccine after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 08-Oct-2022 at 9:15 am and was administered at 10-Oct-2022/The vial was stored in fridge post puncture).    Concomitant medications were not reported. It was reported that the 2.5 ml sized monovalent individual vial was initially stored in refrigerator on 05-Oct-2022 and was stored in refrigerator itself post puncture. The vial was first punctured on 08-Oct-2022 at 09:15 am and was administered to pediatric patients on 10-Oct-2022 at 10:45 am, 11:15 am and 3:30 pm. It was also reported that the vial did not undergo any temperature excursion and was exposed to room temperature for less than 10 minutes. No adverse events were reported after the vaccine was given. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657611, US-MODERNATX, INC.-MOD-2022-657614 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-657611:same reporter. US-MODERNATX, INC.-MOD-2022-657614:same reporter.
I have developed vertigo. It began on the morning of December 30 and was transient. It now is more persistent (but worse in the morning) and associated with nausea. It is positional as changing positions quickly make it worse.
Vial  was stored at room temperature of 69 for 23 hours.; Vaccine administered to 2 patients more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic disease, Hypertension and Cardiomegaly. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) and AMLODIPINE for an unknown indication.    On 17-Jun-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Jun-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 15Jun2022 . Date(s) and time(S) vial was first punctured :16Jun2022 at 2:00 PM. The vial was  stored  at room temperature around 69 F post puncture . The vial did not undergo any temperature excursion. No treatment medication was provided.
PD Patient who underwent DBS 10/2020.  All was ok until significant right side tremor and inability to walk due to right leg not responding/dragging which started 4/6/2021.  (7 days after 1st  dose. ) .   DBS stimulation was  increased +0.2 on right side 4/9/2021 to try and help but tremor persist.   Doctor has said some patients have had transient worsening of PD symptoms.   Today: 4/14/21  it is slightly better but we're not sure if because of lessening effects or additional stimulation.
Patient states she developed severe shortness of breath after receiving PNEUMOVAX23 inj. on 6/26/13. She saw her physician on 7/3, 7/5 and 7/22/13. She has been treated with ZITHROMAX, albuterol MDI and nebulized prednisone.
After I got my first shot on 4/13/21 I got my period as expected, but it was very light. I got my second shot on 5/11/21 and got my period seven days early, on May 30th, and it hasn't stopped. I have had my period now for almost 4 weeks, which has never happened to me before. Prior to getting vaccinated, my period was always regular and lasted 4-6 days.
Pfizer Bivalent vaccine was administered by Medical Assistant per Dr. orders. Vaccine was administered using a TB syringe 27Gauge by 1/2 inch in left deltoid instead of using a 25G by 1 inch.  The clinic lead noticed this happening and reported it to the nursing team.