chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, referring to a 45 year old patient of unknown gender. On 26-MAY-2017, the patient received second dose of RECOMBIVAX HB injection 2.5/0.5 (lot # L044707, exp. date: 06-OCT-2018) intramuscularly for prophylaxis, which was a pediatric version (adult use of a child product). No adverse effect was reported. No further information was provided.
Patient woke up feeling faint and cold.  She was light headed and complained at school to several people that she felt faint.  Then she did faint and she had a seizure that lasted 2 minutes.  She was taken to the hospital by the paramedics.  MRI, EEG all tests were normal.  No explanation for this event.  Next shot is June 2008. Patient appears immune-compromised.  She is constantly sick and complains of fatigue.  She returns to college. She is sick from Sept thru Dec.  No amount of antibiotics helps.  Her hair is falling out.  She is pale, listless, without energy.  On Dec 27, 2008, she passes out again, first thing in the morning after feeling cold and faint.  Again she suffers a seizure and is unconscious for 2 minutes.  She is taken to the hospital and no explanation can be found for this drop in blood pressure, syncope and seizure. Eleven months later she has another episode exactly like the first two.  Throughout the year she has suffered from unexplained drops in blood pressure.  She has never regained her energy level and is often sick with sinus infection like symptoms, but her sinuses are clear (x-ray) and no amount of antibiotics help.  When she received the second Gardasil shot she also received the Menactra vaccine. 12/29/09 Pediatric Medical records received for DOS 01/02/08-01/05/10.  PCP  notified by school that pt. had first seizure activity on 01/18/08 and was transported by ambulance to hospital. DC home to f/u with neurologist, MRI and EEG. Reported instances of seizure activity on 12/30/08,  01/01/09 and 11/25/09. Referrals to allergist, cardiologist and neurologist.
Fever blister; Doesn't feel 100%/I wasn't feeling well; kind of itchy; Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms; received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose), ORAL HERPES (Fever blister), MALAISE (Doesn't feel 100%/I wasn't feeling well), PRURITUS (kind of itchy) and RASH (Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced OFF LABEL USE (received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose). On an unknown date, the patient experienced ORAL HERPES (Fever blister), MALAISE (Doesn't feel 100%/I wasn't feeling well), PRURITUS (kind of itchy) and RASH (Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms). The patient was treated with CORTISONE for Itchy rash, at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] for Adverse event following immunisation, at a dose of 1 dosage form. At the time of the report, OFF LABEL USE (received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose), ORAL HERPES (Fever blister), MALAISE (Doesn't feel 100%/I wasn't feeling well), PRURITUS (kind of itchy) and RASH (Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.       Patient called on 16Feb2021 stating she got her 1stdose on 14Jan2021 and was scheduled for 2nd dose 11Feb2021 which is now rescheduled to later date due to fever blister she got after 1st dose and her HCP recommended to postpone.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant follow-up received, events added and treatment medications added On 02-Jul-2021: Significant follow up received , event was added On 02-Jul-2021: Non significant follow up; Sender's Comments: This report refers to a case of Off label use for mRNA-1273, lot # 012L20A. Regarding other events, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.
ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
PATIENT PRESENTED TO PHARMACY FOR AN ADULT COVID VACCINATION AND WAS GIVEN A PEDIATRIC DOSE OF THE COVID VACCINE. PRESCRIPTION WAS PROCESSED FOR THE ADULT DOSE BUT WHEN ADMINISTERED THE PEDIATRIC DOSE WAS INADVERTENTLY ADMINISTERED. PER RECOMMENDATIONS AN ADULT COVID DOSE WAS ADMINISTERD THE FOLLOWING DAY. PATIENT EXPERIENCED NO ILL EFFECTS. ADULT DOSE ADMINISTERED 10/3/23.
On 04/08/2021 pt. was found passed away in her bath tub. Pt. received her 2nd dose of the Covid vaccine on 04/07/2021 at 2:00 p.m. Family choice not to have an autopsy performed and death certificate was completed with cause of death "sudden cardiac arrest".    Note on 2/20/21 Pt. was transferred to Hospital with dx. of acute pancreatitis with elevated lipase and wbc.
Case previously recorded as MA2009-3457. Initial case report received from a health care professional on 02 NOV 2009. The patient, age and gender was unknown, was vaccinated intragluteal with 0.5 ml FLUVIRIN (batch no. 100813P) on 28 OCT 2009. The patient received the vaccine intragluteal instead of intramuscular. No adverse event was reported The reporter was unsure on the date of vaccination, unable to provide any additional information and not willing to provide contact information for the party reporting the incident to her.
Diarrhea about 6 hours after vaccination.  Feeling off much of the rest of the day.  Fever started about 15 hours after vaccination with chills and shaking followed by sweating.  Used Ibuprofen to bring fever down and it would break after a couple hours.  Then took Tylenol hours later in the morning to try to ward off the fever.  Fever returned when these wore off.  Had fever again yesterday afternoon and last night - again taking Ibuprofen to break the fever both times and Tylenol in the morning to try to head off the fevers.  Sluggish feeling and lots of body aches.  Not as bad as the actual COVID disease probably but reminiscent of those symptoms except not getting the coughing I had when I had COVID in October (I was sick for 3 weeks when I had it with fever over 2 weeks solid).
Maternal exposure during pregnancy; Very sore arm; Couldn't lift arm more than 80 degrees; Mild fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Very sore arm), LIMB DISCOMFORT (Couldn't lift arm more than 80 degrees) and FATIGUE (Mild fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. On 09-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Very sore arm), LIMB DISCOMFORT (Couldn't lift arm more than 80 degrees) and FATIGUE (Mild fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 10-Mar-2021, PAIN IN EXTREMITY (Very sore arm), LIMB DISCOMFORT (Couldn't lift arm more than 80 degrees) and FATIGUE (Mild fatigue) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment details were reported.
right jaw pain; stiff right jaw; difficulty in chewing; difficulty in brushing her teeth; difficulty sleeping at night; felt achy; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (felt achy) and FATIGUE (felt tired). On 12-Mar-2021, the patient experienced PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night). On 12-Mar-2021, MYALGIA (felt achy) and FATIGUE (felt tired) had resolved. At the time of the report, PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced difficulty in brushing her teeth. No concomitant information was reported. No treatment information was reported.
8 mo infant rec'd immunization on 24JAN91. On 27JAN developed fever; Hospitalized w/Hemophilus Meningitis. Baby doing fine.
Diagnosed day after 2nd shot with opthalmic artery thrombus causing vision loss/change in left eye.  I did get shot series on 12/22/2020 #1 and 1/10/2021 and was diagnosed with Covid-19 on 12/13/2020.  My internist MD did not feel the vaccine caused the thrombus /Stroke but I wanted to report it as it was associated with the vaccine administration (symptoms of vision loss within 24 hours of the vaccine #2 administration).
/o weakness for 4 days, diarrhea, Loss of appetite, tested POS for SARS-CoV-2
Chills, Body Ache, Shaking Cold, Sweating, Fatigue, Difficulty Breathing . Changing clothes' due to excessive sweating, light headed, shortness of breath.
Information has been received from a nurse practitioner concerning a 54 year old female with diabetes, hypothyroidism, hypercholesterolaemia, and drug allergies to aspirin and ACTOS who on 13-MAR-2007 was vaccinated subcutaneously in the left arm with a 0.5 mL dose of Pneumovax 23 (Lot# 651406/0620F).  There was no concomitant medication.  On 14-MAR-2007 the patient developed an injection site reaction.  It was reported that the development of the reaction was unclear, but on 14-MAR-2007, the patient was seen in the office and the injection site was red, swollen and hot to the touch from the shoulder to the elbow.  There was no fever.  The patient was treated with ice applied to the site and unspecified nonsteroidal anti-inflammatories and BENADRYL.  The reaction started to resolve on 18-MAR-2007 and the patient was considered to be recovering.  Additional information has been requested.
About 3 hours after receiving the , vaccine on April 5 at 3:15 pm, I had uncontrollable shivers and chills, shaking violently through my whole entire body.  I was freezing cold to the bone.   I felt nauseous and threw up my entire dinner.  That didn't make the nausea go away - I continued to throw up that evening 5 or 6 more times.  The nausea continued the next day making me throw up 3 more times.  And yet the nausea persisted for a whole entire week.  I had a horrible headache that night that has stuck with me these last ten days.  My muscles ached and shot strange pangs through my body.  I was exhausted.  I could not stay awake.  I was so weak and tired.  I had no energy and just laid in bed for a solid four days. My throat hurt, my neck hurt, my head hurt, my arm where the shot went in hurt so bad.  Very strangely, my stomach was constantly bloated and hurt inside like a bad stomach ache - even if I hadn't eaten anything it still bloated and hurt.  The painful stomach lasted seven or eight days.  I had diarrhea for those seven /eight days.  I was completely dehydrated.  The diarrhea lasted way too long - it was difficult to return to work.  The second day after the shot I woke up to my left eye red, like some blood vessels had burst.  It took four or five days for my eye to go back to normal.   my heart has a stabbing feeling randomly all the time now and it is hard to breathe.  I wheeze and cough all the time.  It is very uncomfortable.  This heart issue has persisted the entire time since getting the vaccine.
Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass; She felt funny; This spontaneous case was reported by a pharmacist and describes the occurrence of METAMORPHOPSIA (Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass) and FEELING ABNORMAL (She felt funny) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced METAMORPHOPSIA (Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass) and FEELING ABNORMAL (She felt funny). At the time of the report, METAMORPHOPSIA (Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass) and FEELING ABNORMAL (She felt funny) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient took unspecified headache medication for treatment. Patient had distorted vision for 1,5 days, mainly on her left eye.
Varicella Vaccine was expired 4/16/23 and administered 4/26/23. Per patient no adverse reaction was reported.
At 4:30 AM approximate 36 hours after vaccine, constant shooting pain and nerve pain in right arm, upper back/neck area on right side,  pain and nerve pain spreading down in to right forearm.  As of now, approximately one week after onset, very little change
PATIENT HAD SYNCOPE IMMEDIATELY UPON RECEIVING THE INJECTION IN HER LEFT ARM. PATIENT REPORTED HISTORY OF FEAR OF NEEDLES AND WAS NERVOUS PRIOR TO RECEIVING THE VACCINE. PATIENT DID NOT FALL OR HIT THEIR HEAD. PATIENT REGAINED CONSCIOUSNESS WITHIN SECONDS. BLOOD PRESSURE WAS CHECKED AND OK.
This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N020352 and expiration 10-APR-2020 (dose, frequency and route were not provided) for prophylaxis. The vaccine was stored at a temperature below 32 Fahrenheit degrees (30.7) Fahrenheit degrees, time frame of 1 day, 12 hours and 30 minutes with no previous temperature excursion. Digital Data logger was involved.
8/26 call from provider DR., right leg was red, swollen, raised and warm to touch in area where vaccine was given. No fever. Mother took pictures, Drs office was to email to Health Dept but have not received them to day. 8/12 Rash started itching, no fever. 8/15 call from parent - allergic reaction - taken by other staff member. 8/31 - still itching getting better still random spots - may leave scarring.
Received first dose RotaTeq on 09-17-2007.  Very early morning 09-21 Child started getting sick, vomitted and by morning mom noted fever, which eventually got as high as 101.  Diarrhea, fever and vomitting (a total of 4 times thru the entire course of the illness) were noted thru 09-23, gone by 09-24.  Symptoms never progressed to where mom couldnt handle them at home.  There are 3 other children at home, none of them became ill.
Within 2 days after first vaccination, swelling appeared along my clavicle bone on left sie and a knot appeared in lymph node.  I went to Med. Ctr. on 2/18/21 to have it checked because swelling subsidfed some, but knot remained. They examined my neck, too blood and ordered ultra sound(done on 3/4/21). The following week, I was advised by phone that results were all negative. I had the 2nd. vaccination on 3/10/21 and had no further symptoms, but there is still slight swelling and the knot remains in my lymph node.
first dose 13 months ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 13 months ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the first dose of the Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reported VARES details pertains to 1st dose.
On 11/16/22, he had a light cold with a runny nose, rash, and a cough. He was a little more snuggly than normal, but that is it. He had super red cheeks and that traveled down to his chest. Then, on 12/24/22, he has lots of congestion, runny nose, fatigue, and a terrible cough. This developed into an ear infection. We contacted his doctor and was prescribed dexamethasone. I also gave him ibuprofen and ZYRTEC. He is feeling much better now.
3/26/21, Covid shot in morning. By afternoon, bicep hurt moderately for about 24 hours...No biggie.  4/1/21, morning, left hip joint popped and did not support me for 24  hours.  4/5/21, morning. Left  rotator cuff did not work w/o pain for 24 hours.  I have osteo-arthritis on a daily basis, in different joints, mostly hands, ankles and knees. These two  flare ups were particularly debilitating and unusual.
Patient is a 96 year old MALE with pmh colon cancer s/p resection 25 years ago, chronic urinary retention in the setting of prostate cancer with chronic foley, CKD 3b, HTN, HLD, hypothyroidism, left frontal lobe stroke on plavix here for hemoglobin of 5.9 on labs. Pt reports that he was drawing some bloodwork for renal follow up in 2 weeks and was told to come into the ED for evaluation due to low hemoglobin levels. Patient smear also contains schistocytes, more concerning for hemolytic process at play.
Tinnitus, in both ears. Started within a couple days of the vaccine and has not gotten better since.
Headache, Myalgia, NauseaVomiting, Fatigue Narrative:
pt recvd vax; inconsolable crying for 36 hrs; no fever; apap w/out help;
fatigue; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. This patient of unspecified age and gender received first dose of BNT162B2, from an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient experienced fatigue the day after the first dose. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.