chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a field representative refers to a 15 month old female patient with allergy to lactose, egg, cheese, hemp milk. The patient was also allergic to dogs. On unspecified dates, the patient was vaccinated with the entire vaccine series of ROTATEQ (lot#, dose not reported) orally. No concomitant medications were reported. On 04-APR-2013, the patient was admitted to an unspecified hospital with a diagnosis of rotavirus. The patient was discharged from the unspecified hospital on 08-APR-2013. Diagnostic studies and treatment given while in the hospital included; an abdominal ultrasound, unspecified lab work, a stool culture, unspecified intravenous fluids and TYLENOL and MOTRIN. Patient sought medical attention. Approximately on 28-MAR-2013, the patient had experienced an unspecified allergic reaction a week before going into the hospital which included facial swelling. The patient had been prescribed prednisone for the facial swelling. On an unknown date in 2013, the patient had recovered from facial swelling and unspecified allergic reaction. The outcome of rotavirus was reported as recovered on 12-APR-2013. Therapy with ROTATEQ was not discontinued. Additional information has been requested.
Information has been received from a registered nurse concerning a 28 year old female employee with no allergies who on 06/15/2004 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast)(lot#643399/0367P). There was not concomitant medication. On 06/21/2004, the patient developed a red, raised rash on both forearms and thighs. There was no itching or pain. On 06/28/2004, the patient was seen by the nurse. The rash was fading with brown spots slightly raised. Calamine (+) diphenhydramine hydrochloride lotion (Caladryl) was used on these areas by patient. The patient told the nurse she ate a lot of strawberries recently. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning a patient of unknown gender and age. On an unspecified date in 2006, the patient was vaccinated at an unspecified clinic with a dose of ZOSTAVAX (dose, route and lot# not provided). On 20-OCT-2015, the patient visited an unspecified community based outpatient clinic and was inadvertently given a second dose of ZOSTAVAX (dose, route and lot# not provided). No adverse event was reported. Additional information is not expected as no reporter details were provided.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient might have been vaccinated with a dose of improperly stored ROTATEQ lot # M038728, expiration date 25-APR-2018 oral for prophylaxis, VAQTA lot # reported as M038572, expiration date 11-MAR-2018, GARDASIL 9 lot # M0347890, expiration date 15-APR-2019 or PNEUMOVAX 23 lot # M022086, expiration date 09-OCT-2017. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 2 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number; the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product) and NO ADVERSE EVENT (No adverse event). At the time of the report, TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product) 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 TRANSCRIPTION MEDICATION ERROR (a patient who received a dose of the Moderna COVID-19 vaccine from lot number 065K21A/may have documented the incorrect NDC number which does not correspond to this lot number) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (the assumption is that the 53 year old patient may have been administered the 6-11 year old Moderna product).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Within a few minutes after receiving her injection, the patient reported she felt like she may pass out.  She was dizzy and weak and said she felt it was from anxiety about getting the shot.  Her father who was with her said she?s felt faint after getting vaccines in the past.  Within a few more minutes, after lying down with a cool cloth on her head and relaxing, she seemed fine.  She waited a little longer then said she was fine and left.
Arm soreness radiating from my shoulder to elbow after the injection.; Woke up in the middle of the night with chills; sweating; feeling achy; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date were not reported), via an unspecified route of administration, in Arm Left on 23Feb2021 at 10:00 AM (age at vaccination: 32-years-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccine prior to COVID-19 vaccine with in four weeks. The patient was not allergic to any medication. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date were not reported), via an unspecified route of administration, in Arm Left on 28Jan2021 at 09:00 AM (age at vaccination: 32-years-old), as DOSE 1, SINGLE for covid-19 immunisation. On 23Feb2021, at 11:00 AM the patient experienced arm soreness radiating from his shoulder to elbow after the injection. He woke up in the middle of the night with chills/sweating and felt achy. He continued to feel achy the following day. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Parent reports child extremely fussy, difficult to console x 2 days - 16-17 days after receiving vaccines.
This spontaneous report as received from a pharmacist refers to a 17 year old male patient. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date in August 2016, the patient was vaccinated with RECOMBIVAX HB (10/1.0 mcgr/ml), for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects reported. No further information provided. Additional information has been requested.
Double menses cycle . Swollen lymph nodes in arm pit. Wet cough not going away 3wks. Spontaneous bruises random spots over body.
Fever, night sweats, pain in all joints, unable to sleep due to joint pain and sweating, very sore arm at injection site. Mentally, I felt like I was unable to think clearly and quickly. Lasting for three days. Feeling better on fourth day but arm still sore.
On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night.  I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued.   I had to stay up all night, any attempt to lie down triggered more vomiting.  By 3 in the morning I was ?on empty? and by 6 am could lie down.  Nausea took three more days to leave completely.  Muscle pain is resolving, almost gone.  I am resuming my meds [everything that went down before came right back up].  The only tummy pain was after hours of vomiting [muscle strain].   Today is the 25th and I?m still tired and a bit foggy but otherwise feel better.  I had a call with my doctor about this and she said I should report it so that?s what I?m doing.
Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.
5/28/19 Immunizations given 5/29/19 Per mom child woke up with red, hot spot on left leg that was hot to touch and approximately 2 inches by 2 inches in diameter. 5/30/19 Per mom redness had gotten larger and opened and was draining yellow fluid and was crusty; size was approximately 4 or 5 inches in the center with about 1 inch open. Child was taken to a provider and diagnosed with cellulitis and placed on antibiotics.  6/4/19 Per mom open area is scabbed over, red size about 2 inches in diameter.
Patient received Janssen vaccine on 5/10/2021, developed lymphadenopathy in the groin and was subsequently found to have metastatic large cell carcinoma, biopsy proven.
Woke up in March, 2021 with a grittiness and waxy feeling on all of my teeth.Has beeen on going. Been to my dentist 3 times and he has no idea what is causing it. Had an endoscopy as I thought it could be due to GERD. But that proved negative. Been to a local Dental school and they have no idea either.
she is now a very sick woman; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "she is now a very sick woman".  Additional Information: Please see report. The information provided was published online in a news website called (Site Name). The translation of the text follows. There is also a link with a video that contains the report and relevant video. Kindly acknowledge receipt. Shocking testimonies of women about the side effects of the Pfizer vaccine. A young woman and a mother of a girl in adolescence are the two witnesses who appear on the (withheld) show and testify their personal experience of the side effects of the Pfizer vaccine. But it is not a simple narrative. We are dealing with a shocking description of how a woman and a teenage girl, suddenly, unjustifiably and inexplicably saw their lives fall apart. She is the teenager you is not able to speak and instead her mother explains the facts and tells the story. The narration begins from the first moment of receiving the vaccine and follows a five-month progression of the side effects that, based on the facts, they were caused by the Pfizer vaccine. The young woman, who has been working as a health care professional, has been in and out of hospitals and testing center for five months, trying to get an answer about what is happening to her. From a perfectly healthy person she is now a very sick woman. With the girl things are much harder. Within days of her vaccination, all the systems of her body began to collapse. In this broadcast of (withheld) station, a senator is attending these testimonies. Watch the testimonies and hear the cry of these two women: (site name) (screenshot withheld) families discuss adverse reactions to covid-19 vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizzy; The bleeding has increased from the next day but ended in a week; headaches; cold-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp.   A 31-years-old female patient received bnt162b2 (BNT162B2) (Formulation: Solution for injection, Batch/Lot Number: EW0171; Expiration Date: Unknown), dose 2 Single, via an unspecified route of administration, administered in Arm Right on 27May2021 13:30 (age at vaccination was 31 years) for covid-19 immunisation. Medical history included seasonal (hay fever) from an unknown date and unknown if ongoing. Historical vaccine was (Formulation: Solution for injection, Batch/Lot Number: EW0153; Expiration Date: Unknown) dose 1 Single, via an unspecified route of administration, administered in Arm Right on 07May2021, 01:30 PM (age at vaccination 31 years) for covid-19 immunisation. After dose 1 patient experienced Abnormal bleeding from uterus. My period started on the day I took my 1st dose as a normal cycle, and instead of ending in 1 week,occasional heavy bleeding, anaemia like dizziness, fatigue, bloating, less appetite. The patient's concomitant medications were not reported. No Covid prior to vaccination. No covid tested post vaccination. No other vaccine in received within four weeks. On 27May 2021 the patient experienced headaches, cold-like symptoms, on 28May2021  the bleeding has increased from the next day but ended in a week, on Jun2021 patient experienced dizzy. The patient underwent lab tests and procedures which included blood test normal region   on 2021 I took a blood test, but results were all in normal region.  The outcome of events headaches, cold-like symptoms,  the bleeding has increased from the next day but ended in a week, was recovered on unknown date in 2021, but the outcome of event dizzy was unknown.    Follow-up attempts are completed. No further information is expected.
Diabetes, uncontrolled.  (I was prediabetic before.  But, now it is uncontrollable.)
headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 94 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills". Therapeutic measures were taken as a result of headache, chills.  Additional Information: Patient's caregiver (who was not nurse) stated that events was possible side effects of second dose of the vaccine. She didn't want to call 911 because she did not feel it was that big of an emergency. It was not easing up. Caller gave her a Tylenol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination/shingles 3/16/12. 3/18/12 Headaches, nausea. 4/27/12 Vertigo, went to hospital, still seeing ENT doctor. 5/2/12 Brain MRI - normal. 5/30/12 Massive migraine starts. 6/6/12 Dr. neurology; got meds but no relief! 8/2/12 Headache clinic. Migraine ceased after diarrhea in mid to end of July 2012. Still very weak & fatigued plus TMJ from migraine.
Starting the evening after administration the patient noticed dizziness and chills/shivering before going to bed.  When she woke up the following morning her temperature was 100.6.  She had arm soreness and muscle aches.  She took acetaminophen for soreness/aches/fever.
Patient started feeling warm and was flushed. Then patient stated she had trouble breathing. Within 5 minutes of vaccine administration.
10/27/2022 after about 12 hours, after my other vaccine as well, I begin to run a fever. I was sick for about 24 hours and that was it. I am fine but I just have a headache and it is due to shingles that I had at Christmas. I am taking Gabapentin.
allergic reactions to it; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA297164 (same reporter).  This case involves a patient of (unknown age and gender) who had allergic reactions (hypersensitivity), while received Influenza Vaccine.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient had allergic reactions (hypersensitivity), (latency: unknown) following vaccination.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Delayed (9 days) injection site erythema (hives)/itching -2 inches.
As reported by mom. " 24 hours later, whole arm above elbow swollen and red", fever. Swollen for one week. Irregular movement, tones. In 48 hours swelling began to subside. Hot to touch. Nausea, vomiting, and diarrhea. Resolved in 7 days.
Significant Malaise; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Significant Malaise) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Significant Malaise). At the time of the report, MALAISE (Significant Malaise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.
Headache, chills, body aches, nausea and the started to have drooping on the left side of his face.
Information has been received from a nurse practitioner concerning an 8 year old male with food allergies including peanuts and no past medical history, who on 21-JUL-2001 was vaccinated with a dose of VARIVAX (lot# 638495/1904K) 0.5 mL. The patient was also vaccinated with a dose of MMR II (lot# 635922/0015L) on an unspecified date. The nurse reported that the patient, after receiving VARIVAX, experienced chicken pox. At time of reporting, the patient had recovered. There were no lab diagnostic studies performed. The patient sought unspecified medical attention. Additional information has been requested.
THE PROBLEM OCCURRED WHEN I ADMINISTERED THE  VACCINE, I INADVERTENTLY PICKED UP THE PREVNAR AND GAVE IT SUB-Q (I THOUGHT I HAD MY ZOSTAVAX IN MY HAND) ....I REALIZED THE MISTAKE IMMEDIATELY AFTER GIVING THE VACCINE. WE THEN CALLED PFIZER AND CONSULTED WITH THEM. THEY SAID THEY HAD ADMINISTERED SUB-Q DURING CLINICAL TRIALS AND IT WAS "WELL TOLERATED", ALTHOUGH THE RECOMMENDATION IS TO GIVE IM...WE PROCEEDED TO GIVE THE FLU VACCINE AND SHINGLES VACCINE CORRECTLY AND HAD THE PATIENT WAIT IN OUR VACCINATION AREA FOR A PERIOD OF TIME. UPON LEAVING ALL SEEMED FINE WITH HIM, WE WILL BE FOLLOWING UP WITH HIM THIS EVENING AND OVER THE NEXT TWO  DAYS TO ASSURE THAT HE IS FINE.
Sx onset 6/29/2021 with fever, chills, sore throat, headache & muscle aches. Tested positive for COVID-19 on 6/30/2021.