chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 2hr p/vax pt exp itching & burning predominately on arms, thighs, hips & legs;rash devel 9subdermal raised) on extremities upper & lower;pt self treated w/aloe lotion & oatmeal baths;
Reactivation of GBS symptoms - numbness, tingling, pain from toes to thighs. Extreme pain that gabapentin did not control. Numb fingertips.
After the shots, the baby started to cry inconsolably and after five minutes, mom called the nurse stating that the left leg is becoming very red at the site of injection and she thinks that the baby may be having an allergic reaction. Benadryl 2mL PO was administered and 2mL PO of infant Tylenol for pain. Baby was continuously high-pitched crying and erythematous hives spread all over his body. The baby's eyes became swollen and the heart rate was over 200. Within 15 minutes, IM epinephrine 0.1mg was administered, after which  all symptoms resolved. The rash was gone and the baby was calm. Pt. was taken for observation to the nearest emergency room by ambulance.
Patient developed sporadic hives in different parts of the body 2 days after vaccination. Hives come and go away periodically. Patient eyes and face are also swollen. Patient was given benadryl on an as needed basis for comfort.
Mar 12-13 - very tired, achy - no fever Mar 15-18 - lymph nodes under both arms swollen, tender, painful Mar 20-21 - extreme stiffness in all joints, difficult to open and close hands, difficult to walk (normally I have no joint issues)
Patient in clinic for second dose COVID vaccine. Reported she received Pfizer as first dose and marked consent for as Pfizer for previous dose. Patient did not have her vaccine card at time of appointment. This LN administered Pfizer vaccine for patient. Patient waited 15 minutes and reported feeling fine. At time of charting, this LN learned that patient actually received Moderna for her first dose.  Patient notified, Dr/health officer notified, Director notified.
my arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Lot number: EL9266) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: I am on High blood pressure medicine. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "my arm is sore".  Additional information: It was reported that, when asked whether had any reaction, the consumer further stated, no, she didn't, her arm was sore like it was when she got her first shot. Stated that, the consumer was informed with the role of Pfizer medical Information. Date of first vaccination: Consumer stated, her first one, was there any reaction if she was on blood thinners, if there was something that she would be looking for. Stated that, she was again informed with the role of Pfizer medical Information. Further stated that, so they give her number to another. Stated that, they couldn't connect her to them and she was provided with the appropriate response. Further stated that, so, if they could give the number, she could call them later. Stated that, the date of her first shot was on 26Feb2021 (Confirmed as 26Feb2021). Consumer was informed about the role of Pfizer drug safety. Consumer was provided with the contact# of Pfizer medical information as (phone number withheld). Mailing address: (Mailing address withheld) (Not clarified further hence not captured). Stated that, she don't use that much but she could give it to them, its (Email address withheld) (Not appropriately clarified hence not captured in tab). Stated that, her height was 5, 5' and she weigh about 160. (Weight not confirmed hence not captured in Tab). Stated that, she was (Ethnicity withheld). Stated that, the LOT# for first dose was EL9266. Expiration date: Consumer stated that, the only thing she had, she didn't had expiration date, she didn't see it anywhere on the card. Other medication or medical condition: stated that, she was taking medication (Further clarification unknown hence captured as unspecified medications). Stated that, she was on blood thinners and a half medication (Further not clarified hence not captured) and she was on High blood pressure medicine (Further not clarified hence not captured in tab) and aspirin (Further clarification unknown) so that's why she thought they never asked her about her medications or whether she was on blood thinners and when she read that this morning, she got a little concerned that, they know what if she was on blood thinner, what was gonna happen or what were the chance they know and what are the side effects. Stated that, so she could be they know be onboard know what to look for. QR Comment: Reporter type was not probed hence it was captured as consumer or non-healthcare professional by default.  Follow-up attempts are completed. No further information is expected.
HYPOTENSION; PACKAGE INSERT WAS BLANK; This spontaneous report received from a health care professional concerned multiple patients (five patients) of unspecified age and sex. The patient's height and weight were not reported. The patient's medical history or concurrent conditions were not reported. The reporter stated that, none of the 5 patients had a history of cardiovascular issues. The patient's received JANSSEN COVID-19 VACCINE Ad26.COV2.S (suspension for injection, unspecified route, batch number: 1805022 expiry: 25-MAY-2021), dose was not reported, administered on 11-MAR-2021 for COVID-19 vaccination. No concomitant medications were reported.  On 08-MAR-2021, it was noted that, the package insert was blank. On 11-MAR-2021, five patients experienced hypotension, and were hospitalized. A public health manager reported that, she had 5 cases of hypotension after administering Janssen COVID 19 vaccine. The action taken with COVID-19 vaccineAd26.COV2.S was not reported. The patients were recovering from hypotension and the outcome of package insert was blank was not reported. The report was associated with product quality complaint number 90000172674. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 Based on the reported information, the event of hypotension is considered related at this time. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event than the vaccine. Additional information has been requested.
experienced dizziness and tinnitus; developed a mild headache; experienced dizziness and tinnitus; Initial information received on 14-Oct-2019 regarding this unsolicited valid non-serious case received from a physician.  The case involved a 62 years old female patient who experienced dizziness and tinnitus (Dizziness), developed a mild headache (Headache) and experienced dizziness and tinnitus (Tinnitus), while she received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2019, the patient received a dose of suspect influenza quadrival A-B vaccine lot number not reported via intra-arterial route in the left arm.  The patient developed a non-serious experienced dizziness and tinnitus (tinnitus), a mild headache (headache), a non-serious experienced dizziness and tinnitus (dizziness) following the administration of influenza quadrival A-B vaccine.  Final diagnosis was mild headache and experienced dizziness and tinnitus.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as recovering for experienced dizziness and tinnitus, as recovering for she developed a mild headache and as recovering for experienced dizziness and tinnitus.  Information on the batch number was requested.
itchy at the injection site; rash at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PRURITUS (itchy at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included EZETIMIBE (ZETIA), ZINC, VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PRURITUS (itchy at the injection site). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) (topical) in January 2021 for Adverse event, at a dose of UNK dosage form. On 03-Feb-2021, VACCINATION SITE PRURITUS (itchy at the injection site) had resolved. At the time of the report, VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included natures "bounty hair skin and nails". The patient got the rash at the injection site 1 week after vaccination. Itching went away after 2 weeks. It was reported that Benadryl cream helped.   This case was linked to MOD-2021-033065 (Patient Link).
I had fever, oral temp 100; severe body aches; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: Gh9702) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Mitral Valve prolapse" (unspecified if ongoing); "Nodular gastritis" (unspecified if ongoing), notes: Nodular gastritis; "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose Number: 2, Batch/Lot No: B2021092934, Manufacturer: Sinopharm), administration date: 18Nov2021, when the patient was 26-year-old, for COVID-19 immunization; coviD-19 vaccine (Dose Number: 1, Batch/Lot No: B2021093198, Manufacturer: Sinopharm), administration date: 21Oct2021, when the patient was 26-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 20Sep2022, outcome "recovered" (Sep2022), described as "I had fever, oral temp 100"; HEADACHE (non-serious) with onset 20Sep2022, outcome "not recovered", described as "headaches"; PAIN (non-serious) with onset 20Sep2022, outcome "not recovered", described as "severe body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, headache. Additional information: There was no known allergies. About 12 hours after receiving the vaccine the patient had fever, oral temp 100, severe Body aches and most notably severe adverse event Body aches and most notably severe Headaches. Fortunately, fever stopped almost 36 hours after vaccination. But unfortunately, the patient was still having headache even though he took vaccine five days. At first the headache was severe but at the moment it was mild to moderate but he still had It.
I haven't been able to stop this headache and this nausea.  Not sure if it's the Sickle Cell or the vaccine.  Just know that Tylenol is not working.
Pt experienced 2nd seizure 4 days after 2nd GARDASIL vaccine. Pt also taken to ER. Awaiting ER report.
Gave 2nd dose PENTACEL too early (was supposed to get PCV13).
Syncopal episode, lightheadedness, dizziness. Patient was unresponsive for approximately 30 seconds to 1 minute. She became responsive and was alert and oriented x 3.  Her vital signs remained stable. EMT was called and she was taken to the emergency department.
HA 6-28 and 6-29. (R) deltoid had red area hot to touch.
developed small red bumps all over his body/it came to his arm and now it's all over the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 12:30 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH PAPULAR (non-serious) with onset 03May2021, outcome "recovering", described as "developed small red bumps all over his body/it came to his arm and now it's all over the body".  Additional Information: Patient took his first Pfizer Covid vaccine dose on 27Apr2021 and states "a couple of days later" he developed small red bumps all over his body. Patient said that he took the first dose of vaccine last week on Tuesday. He forgot the exact date. He is just now experiencing what he would say is an allergic reaction. He is getting a lot of red bumps all over the body. It started 3 days ago on his back and he had his wife rub alcohol on it. Yesterday it came to his arm and now it's all over the body. Patient had not taken prior Vaccinations (within 4 weeks)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHHY2015US069160 is an initial spontaneous report received on 03 Jun 2015. The author discussed about the safety profile of pregnancy exposures to the quadrivalent human papillomavirus vaccine (qHPV) by acquiring and analyzing post marketing data on pregnancy outcomes from GARDASIL/SILGARD pregnancy registry. The registry enrollment criteria included an identifiable patient, exposure to human papilloma virus vaccine within one month prior to the date of onset of last menstrual period (LMP) or at any time during pregnancy, identification of health care provider and residency in a country where the registry was active. This report refers to a 32 to 33 weeks old neonate whose gender was not reported. Past medical history and concomitant medications were not reported. The baby's mother was vaccinated with qHPV (other manufacturer, batch number: not reported) on an unknown date when she was pregnant (see related case number: PHHY2015US068689). It was reported that the exposure to human papilloma virus vaccine occurred 1 week and 5 days from LMP. The baby's mother concomitantly received influenza virus vaccine (manufacturer and batch number: not reported), ferrous sulphate (unknown manufacturer) and cannabis at 8 to 9 weeks of gestation. The baby's mother had twin gestation and the baby and the twin was delivered at 32 to 33 weeks of gestation. The baby was born live with no abnormalities. The death of the twin occurred at 22 weeks of gestation which was diagnosed at 28 weeks and there were no abnormalities on autopsy. The author concluded the article stating that the rates of spontaneous abortions and major birth defects were not greater than the general population rates. Due to the nature of voluntary spontaneous reporting, no definitive conclusions could be made about the potential effects of exposure to qHPV vaccine during pregnancy and hence qHPV vaccine was not recommended for use in pregnant women.
Mother called 12/9/10 to report child had experienced an event Tues evening.  she did not know if it was a reaction to vaccines received that day or just a coincidence.  To celebrate child's birthday, she had given her a cupcake with a lighted candle.  Child reached for candle, felt heat and immediately withdrew her hand.  No sign of a burn.  Child did cry, but a normal cry.  Her color turned a deep purple, she quit breathing, her head fell back, she went limp, and her eyes opened and shut and rolled back.  Just as mom was about to call 911, child started to recover.  She seemed a little dazed and whimpered a little.  Child remained awake a couple of hrs after event and behaved normally.  Mom has noted no other unusual behavior, no rashes, and no fever.  This child is mom's 4th - other 3 children received vaccines and may have needed a Tylenol or Motrin but otherwise had no problems.  This child has responded differently - fussier and needed more attention after her vaccines.
arm slightly inflamed; big red blotch about 3' in diameter; Arm ached; This spontaneous case was reported by a patient and describes the occurrence of INFLAMMATION (arm slightly inflamed), VACCINATION SITE PAIN (Arm ached) and VACCINATION SITE ERYTHEMA (big red blotch about 3' in diameter) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concomitant products included ENALAPRIL for Hypertension.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm ached). On 04-Feb-2021, the patient experienced INFLAMMATION (arm slightly inflamed) and VACCINATION SITE ERYTHEMA (big red blotch about 3' in diameter). The patient was treated with NAPROXEN SODIUM (ALEVE) on 04-Feb-2021 for Pain, at a dose of 2 UNK. On 21-Jan-2021, VACCINATION SITE PAIN (Arm ached) had resolved. At the time of the report, INFLAMMATION (arm slightly inflamed) and VACCINATION SITE ERYTHEMA (big red blotch about 3' in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
Local skin abscess at flu vaccine injection site. Treated with warm compresses and topical antibiotic ointment.
Minor received Moderna vaccine.  Minor is 16 years 11 months old.  He was accompanied by a parent.
Headache in the middle of forehead (not a migraine),  right leg cramps that are aggravated when touched, stomach cramps that worsen when eating, sore throat, lowgrade fever, general feeling of discomfort.
Headache and malaise. Lasted 24 hours. Took ibuprofen.
This spontaneous report was received from a pharmacist referring to a 78 years old patient of unknown gender. The patient's concurrent conditions included diabetes. The patient's medical history, drug an allergy history were not reported. It was reported that before the patient was 65 years old, the patient received the first dose of PNEUMOVAX intramuscular injection, 0.5 ml (lot # and expiration date were not reported) for prophylaxis; In 2009, the patient received the second dose of PNEUMOVAX and the third dose of PNEUMOVAX intramuscular injection, 0.5 ml (lot # N010109 and expiration date on 20-NOV-2018) was administered on 08-SEP-2017 (inappropriate schedule of drug administration). The patient's concomitant therapy was not reported. No adverse effects were reported.
Sore arm, knot at site, lethargy, high fever (104.4), weakness, red skin (rash) on torso.
Fever 100.8, intense headache, muscle aches, loss of appetite, vomited once, slight pain at injection site.
Information has been received from a nurse practitioner concerning a 31-year-old female patient who on 20-JUL-2006 (previously reported as 12-JUL-2006) was vaccinated with a dose of MMR II (lot #649240/0031R). Her LMP was on 22-JUN-2006 and her estimated date of delivery was 29-MAR-2007. The nurse reported that the patient became pregnant on approximately 03-JUL-2006. The patient was vaccinated about four and a half weeks after her LMP. It was noted that the nurse did not know the patient was pregnant as she had told the doctor that she was going to try to get pregnant in the fall of 2006. The patient was seen in the am of 20-JUL-2006 and was told that her pregnancy test was positive. Additional information has been received from the nurse practitioner. Medications taken during her pregnancy included prenatal vitamins and a folic acid supplement. Her obstetrical history was unknown but she was follow by an OB/GYN. The patient had an elective termination 20 weeks from her LMP, on approximately 10-NOV-2006. The fetus had a congenital anomaly described as Jacosen syndrome (11q23 deletion). Upon internal review, induced abortion was considered to be an other important medical event. Additional information has been requested.
A few days after receiving vaccine, a recurreance of a-fib, at irregular periods and irregular length, began. After two years of no such events. The breakthroughs went mostly away and then began again a few days after the second dose was administered on 2/23/21. This may have nothing to do with the vaccine but may be a recurrence but it seems more than coincidental, timing wise.
Vaccination at 1039 1057 reported itchiness at site. 1059 10mg Claritin oral given 1111 itchiness resolved denied: SOB, throat tightness, scraty observation extended to 30 min returned to work feeling well
Blood Pressure went up and down. Heart Rate highest 136 after several hours went to 125-128.  Around 4:p.m. I Started feeling better. Episode started around 4:00am  lasted till around 4;00p.m.. Was dizzy and light headed. Felt faint. Still feel weak .
HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: Unknown) dose was not reported, (dose number in series 1), 01 in total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received additional non-company suspect vaccine bnt 162 (form of admin, route of admin were not reported, batch number: FH8020, expiry: Unknown) dose was not reported, (dose number in series 2), administered on 11-NOV-2021 for prophylactic vaccination On 07-JAN-2022, the patient experienced headaches (dose number in series 2). On 08-JAN-2022, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Negative.  On 10-JAN-2022, Laboratory data included: COVID-19 rapid POC (Point of care) test (NR: not provided) Negative. The outcome of headaches was not reported (dose number in series 2). This report was non-serious.