chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020353 and expiration date 28-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
This spontaneous report as received from a nurse refers to unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date and dose unspecified), oral. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Feb-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. patient was still pregnant when she got the first vaccine and then gave birth before she got her second vaccine. On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.
Drug ineffective; Treatment of COVID-19; vaccine brand other=Moderna; vaccine dose number=4/ vaccine brand=Pfizer / BioNTech; vaccine dose number=5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ongoing treatment for bladder cancer (BCG instillations)" (ongoing), notes: other medical history: Ongoing treatment for bladder cancer (instillations). Concomitant medication(s) included: LISINOPRIL, start date: Jan2019; TAMSULOSIN, start date: Sep2022. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Oct2022, outcome "unknown", described as "vaccine brand other=Moderna; vaccine dose number=4/ vaccine brand=Pfizer / BioNTech; vaccine dose number=5"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered"; COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 04Feb2023 to 09Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a licensed practical nurse regarding multiple unspecified patients of unknown and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of (Merck) PROQUAD, (dose, route, lot # and expiration date were not reported). There were no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Redness at injection site began the morning after the injection.  Redness continued getting worse the following day.  Swelling and pain occurred as well.  Red area was approximately 2-3 inches in diameter.  The reaction was reported to the prescribing physician.  Patient took diphenhydramine and acetaminophen to treat the reaction.
covid vaccine breakthrough case  dose 1 on 3/10/21  EN6205 dose 2 on 4/1/21  ER2613
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The diagnosis was hypervolemia.
pt recvd vax & exp fever x 3 days; pt taken to ER for elevated fever; 19JAN94 exp rash, vomiting, diarrhea;
Vaccine given 12/01/2004 12/11/2004 - eye irritation, vomited and URI symptoms. 12/12/2004 - right side of face drooping. 12/12/2004 - seen ER Dx: Bell's Palsy
pneumonia; a hard time breathing; coughing up dark yellow phlegm; coughing up dark yellow phlegm; This is a spontaneous report from a contactable consumer (patient's sister). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 medical history was not reported. The patient's concomitant medication included tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from Oct2020 to an unspecified date, at 11 mg for an unspecified indication. On an unspecified date the patient experienced pneumonia, had a hard time breathing and coughing up dark yellow phlegm and was admitted to the hospital. The patient was treated with antibiotics for pneumonia. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Area at site of injection became swollen, reddened and hot to the touch.  This inflammation area measured about 3-inches by 4-inches, oval shaped; and was painful.  It appeared similar to a burn.   This lasted three days and faded.
Red mark three weeks after shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: ERYTHEMA (non-serious), outcome "recovering", described as "Red mark three weeks after shot". Therapeutic measures were not taken as a result of erythema.  Additional information: The lot number was unknown as the reporter was unable to locate.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient had received the shot but still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Neck and chest flushing/rash Lightheaded/dizzy Racing heart (-160 bpm) Throat began to swell
Patient started having fatigue 8/3/21.  Started feeling warm 8/7/21-8/8/21.  Diarrhea started  8/10/21.  Feeling feverish with fever to 101.9F  8/11/21-8/15/21.  Sweating, feeling generally ill.  Patchy skin redness.
Pt called to say she became hoarse about 6 hours after receiving 2nd dose of hep B. Coughs when she exerts her voice. Saw her PAC who told her she had laryngitis. He did not feel the vaccine caused this reaction she said.
Complaint of rash and swollen on both thighs after MMR and Varicella vaccines.
So the first symptoms were frequent urination for about 24 hours without any abdominal pain, but I started to see blood in my urine and then particle's of blood clots in my urine, went to Dr. and he stated he could see both blood and white cells in my urine, stated it was not to severe and waited to see what the cultures showed and they showed E=Coli, and was prescribed and antibiotic nitrofurantoin which I took 10 capsules for five days twice a day.
Chills & fever of 101.7 8hrs after shot.  Fever rose to 102.1 during night.  At daylight or 18hrs after shot, fever began dropping & was totally gone by 22hrs after shot.  Just achy & wiped out the remainder of day 24hrs to 34hrs post shot.  All gone by 42hrs after shot
During injection the needle broke; Felt the vaccine leaking on her arm; A spontaneous report was received from a consumer regarding her mother, a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that the needle broke during injection, and felt the vaccine leak down her arm.  The patient's medical history was not provided. Concomitant product use was not provided.   On  19 Jan 2021,  prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.    On 19 Jan 2021, when the patient was receiving her first dose, the needle was broken and felt like some of the vaccine  leaked down her arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to events were not reported.  The outcome of the events, during injection the needle broke and felt the vaccine leaking on her arm were considered resolved on 19 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Swollen, painful injection site (size of half a golf ball), erythema began 12/31/05 and grew to approx 6" long and 4 " wide around injection site by 1/2/06.  Site warm.  Fever 99.7.  Erythema and fever began 4 days after vaccination.  Swelling and pain began 12/30/05.  Resolved by 8 days post vaccination.
Immediately after receiving vaccines Patient walked about 10 ft over to table and began having a seizure. Seizure lasted less than 30 seconds- fell to ground from standing, hit head/face on table, circumoral cyanosis, eyes fixed. EMS assessed child and she was stable, they recommended she be evaluated by a doctor. Mom transported child to Hospital for further evaluation. No prior history of seizures.
sore arms right now; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received second dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number; unknown) via intramuscular on 09Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she had her second shot today 09Feb2021 asking how long after she can have the possibility of adverse reaction. She stated that, she is experiencing a sore arms right now on an unspecified date in 2021 and consulting what activities she needs to be avoided or chances of getting sick. Outcome of the event was unknown.  Information on about lot/batch number has been requested.
experienced redness and itching at the injection site (localized to the arm).; experienced redness and itching at the injection site (localized to the arm).; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness and itching at the injection site (localized to the arm) after she received the first dose of the vaccine. She received Benadryl. The reporter was asking if her employee should receive the 2nd dose if she developed a site injection reaction following the first dose and any premedication to give. Outcome of events was unknown.  Information on Lot/Batch number has been requested.
Patient received the 2nd dose of Moderna vaccine on Friday 4/16/2021 in his left arm.   He developed an itchy rash on his left hip 3 days later, which appears as a cluster red papules measuring 4 cm in diameter.   He cannot think of any new exposures that would cause the rash other than the vaccination.
Client reported that about one hour after the 1st COVID vaccine Pfizer he developed numbness on his right cheek and around the right side of his lips. The client stated he could move his face equally bilaterally and sensation to palpation was in tact. The client stated the numbness lasted about 1.5 - 2 weeks. The client did not follow up with any providers and did not take any medications for his symptoms. The client denied any shortness of breath or dizziness. The client denied any chronic conditions, medications, or known allergies.
Mother want to ED on 05/22/01 because of a 2cmx11/2 cm indurated site.  The physican treated child for a cellulitis - child placed on keflex 05/24/01 - Follow-up visit with Primary care MD site slightly bigger - however PMD didnot feel that it was a cellulitis but continued on antibiotic. Attached report reviled chief complain: right leg redness and swelling. History of present illness: The patient is a 2-year-old female who was seen by her primary care physician yesterday for a well child check.  She got her prevnar and hepatitis A vaccines at that visit.  Her mother reports that she noticed the injection site to be a little bit swollen last night.  When the patient's mother returned home from work to day at about 6:15 p.m. she noticed an area of redness and increased swelling around the injection site.  She called her primary care physician and was told to draw a circle aroun the readness and to come to the Oregon Health Sciences University Emergency Department for evaluation.  The patient's mother reports that in the last one to two hours since drawing the circle, the redness has continued to expand. The patient has had some upper respiratory infection systoms for the past three to four days including runny nose, mild cough, and sore throat.  She was tested for streptococcal pharyngitis three or four days ago.  That test was reportedly negative.  she has not been febrile at home but did have a fever to 38 degrees here in the emergency department.  She has had good appetite and normal energy today.  she has been a little bit fussier than usual.  She has had no rash or other symptoms noted.
Pt states that the needle hit the bone. States that she had symptoms of deltoid pain/shoulder/arm pain immediately following the vaccine. No home measures done to help the pain, pt rested in her chair for 4 days after the vaccine and was unable to lift arm due to pain. States that there was swelling to shoulder/arm and redness the first day along with pain.  States the excruciating pain and swelling lasted 3-4 days.  Experienced loss of appetite/fatigue the first day. Fever/night sweats started 3-4 days after vaccine was given. Cough started 5-6 days after vaccine was given. Arm remained sore x 12 days with pain progressing into left breast down rib cage to the side of chest wall.  Experienced a rash to the back of the arm 6/11/17 slightly red and bumpy/itchy.
In June the patient started experiencing dry mouth leading to increase fluid intake. This has lead to extra fluid retention and the need for extra dialysis runs.
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 19-Mar-2021, SINUSITIS (sinus infection) had resolved.            No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Client called today on Friday 4/2/10 client developed pain and swelling in (L) foot and ankle; (L) knee and (L) hand and writs with numbness in (L) hand. She states she had a golf ball size node behind (L) ear also. Denies fever and other illness.
AE: Patient started feeling itchy on the arms, redness and swelling in the right forearm  seen 28 minutes after vaccination. Tx: n/a, water improved rash outcome: patient rash improved spontaneously without medication.                        patient  was discharged home.
2nd dose delayed beyond 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) in a 66-year-old female patient 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 PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose delayed beyond 42 days) had resolved.        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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
severe abdominal cramping and ongoing pain; appendicitis; This is a spontaneous report received from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for SARS-COV-2 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 for COVID-19 immunization. On 12Apr2021 15:00, the patient experienced severe abdominal cramping and ongoing pain that would not subside. She went to the Emergency Room where they did a CT scan and blood work which confirmed she had appendicitis. Since then, she had eaten and wasn't at immediate risk for appendix rupture; her surgery was done on 12Apr2021 in the evening. There were no complications and she stated later in the call that she was ambulatory and home by 2100 on 12Apr2021. She was never admitted into the hospital. Since the surgery, she has met with the surgeon. The surgeon said that upon examination, the surgeon did not think the caller had any sort of ongoing appendicitis before this event. Vaccination facility type was clinic. The outcome of the event 'appendicitis' was recovered on 12Apr2021 and the outcome of the event 'severe abdominal cramping and ongoing pain' was unknown.  Information on lot/batch number was not available. Additional information has been requested.
WITHIN 12 HOURS OF RECEIVING FLU VACCINE, PATIENT BEGAN HAVING SUBCUTANEOUS SWELLING IN NECK BILATERALLY, BUT WITH MORE EDEMA ON SIDE WHERE VACCINE WAS GIVEN.  EDEMA DID NOT CAUSE DISCOMFORT.  NO REDNESS OR SWELLING NOTED OVER THE SITE OF INJECTION.  NO PAIN OR PRURITIS.  EDEMA LESSONED OVER NEXT 24 HOURS, BUT CONTINUES 4 WEEKS LATER.  NO SYSTEMIC COMPLAINTS.
Body aches and fever caused me to be unable to open my eyes. The next day I started to feel that my armpit became swollen for about 4 days long. On the 27th, I was unable to close my left eye, and on the 28th my mouth was numbed on the left side. I went to the ER and they stated I had high blood pressure and was given medicine to treat it. Treated as a stroke however, MRI and CT Scans showed no stroke symptoms and stated that I have Bell's Palsy. I still have paralysis and it will take a few months to recover from it. No more swelling in arm areas.
kidney pain- not like a UTI, pain in lower abdomen that wraps around back when urinating  swollen right eye- woke up swollen from a nap on 10/26 at 5:30pm and remained swollen throughout the evening/night and was still swollen on 10/27/21 once awake at 5:45am.
Right upper arm - redness and swelling 13cm x 11cm above redness bruise 2cm x 1cm, mild tenderness. Left upper arm - erythema, 15cm x 12cm, mild tenderness. Bilateral normal strength, ROM, and sensation. Tx MOTRIN, cool compresses.
Pain, swelling, stiffness at injection site - afebrile.  Ice applied.
Itching rash on arms, legs, and torso. Small patches.  Looks almost like insect bites. Each spot last about 1 day, then fades and then another 1 or 2 pop up in another spot. This started one or two days after receiving the vaccine and is more prolific now than at any time.  I am scheduling a visit with my physician.