chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 101*F; Chills; Fatigue; dose 2 administration date 30Apr2021; Last menstrual date 24Oct2020, gestational period 27 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30 Apr 2021 00:00 Since the patient had received the vaccine during pregnancy there was maternal exposure during pregnancy, second trimester. On 01May2021, the patient experienced fever of 101*F, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of fever of 101*F, chills and fatigue were recovered on 01May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was getting the first HPV vaccine, stood up 2-3 mins after receiving the shot, and passed out falling onto his head w/ LOC for approx 30 secs per witnesses. Felt lightheaded just prior to the incident. In emergency department (where I evaluated the pt) pt c/o HA currently and vomited x1 in the ED. No h/o similar responses to vaccines/needles.
Received his second Pfizer COVID on 8/10/21 and developed fevers 6-8 hours later. Mom started giving 400mg Advil every 6 hour . Patient then subsequently developed NBNB emesis and diarrhea which continued through 8/14/41. Mom reports that patient also had some cough, but no rhinorrhea. Tmax was 101.5 temporal on 8/10  but mom reports daily fevers since vaccine. Presented to outside hospital with chest pain rated 8 of 10, three days after vaccine. Elevated troponins 2.04, with normal BNP, CBC, and chem panel concerning for myocarditis.   Patient was transferred to hospital on 8/14, and was gave ibuprofen Q6H, monitored troponin level which downtrended  x2 (1.01 and 0.43) and discharged on 8/15/21.
pt reported dry, hacky cough since 1OCT98 & still has the dry hacky cough;
sore arm; This is a spontaneous report from a contactable consumer reported for herself.  A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route at the left arm on 01Jan2021 at single dose and the second dose via unspecified route at the right arm on 21Jan2021 around 10am at single dose, for COVID-19 immunization. Medical history included depression. The patient is not pregnant. The patient had no covid prior vaccination and no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and birth control for awhile. On 01Jan2021 the patient experienced sore arm.  The event was assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the event was unknown  Information on the lot/batch number has been requested
I received the vaccine in middle school, recently I heard about the averse affects people have been reporting. Toward the end of middle school and beginning of high school I became very depressed, always fatigued, my body was achey and I became irritable with behavioral issues. I had numerous fainting spells and upon standing would nearly faint which still sometimes happens. I figured it was due to my age, maybe it was.
Pt received vaccines on 2/5/01 in the PM. Did experience fussiness and low-grade fever. Was treated with Tylenol. In the AM of 2/6/01, was found unresponsive.
Swelling of throut and tongue beginning about 3 hrs after injection, followed by full flu symptoms lasting till early next morning. Linguring effects continuing. No treatment sought, after doctor hours or I would have gone to my doctor.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 13-AUG-2014 the patient was vaccinated with (oka/merck) VARIVAX (dose strength and route of administration was not reported). No concomitant medication was reported. On 13-AUG-2014, the patient received the dose of (oka/merck) VARIVAX that was exposed to temperatures outside proper storage range. No adverse effects were reported. The outcome of received a dose of (oka/merck) VARIVAX that was exposed to temperatures outside proper storage was unknown. No PQC was involved. This is one of the several reports. Additional information has been requested.
Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator; Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) and PRODUCT STORAGE ERROR (Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) and PRODUCT STORAGE ERROR (Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) and PRODUCT STORAGE ERROR (Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that they found out that they dispensed two doses of a Moderna Covid vaccine past its storage and handling requirements. The reporter informed that it has been greater than 24 hours after the vials had been removed from the refrigerator.  Reportedly, the date the vial was initially stored in the refrigerator was 08-Feb-2022 and was removed from the fridge on 09-Feb-2022. The vaccine was administered on 10-Feb-2022. It was also reported that the vial didn't undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24-48 hours.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow-up received contains no new information.
ON 03/01/2023 PATIENT GOT A THIRD DOSE OF SHINGLES THINKING HE IS GETTING THE SECOND DOSE . PT IS DOING OK AND DOES NOT HAVE ANY ADVERSE REACTIONS OR SIDE EFFECTS FROM IT. PT CAME IN AND ASKED FOR A SECOND SHINGLES VACCINE . I THOUGHT HE IS LATE FOR A SECOND DOSE , STATE IMMUNIZATION REGISTERY RECORDS SYSTEM WAS NOT AVAILBALE DUE TO SYSTEM ISSUES . WHILE DOING COMPLIENCE CALLS FOR PATIENTS WE FOUND OUT THAT THIS PATIENT ACTUALLY GOT TWO PREVIOUS DOSES ON 11/02/2022 AND 03/23/22.
This case was reported by a healthcare professional and described the occurrence of possible cellulitis in an adult female subject who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. On 1 November 2007, in the late afternoon, the subject received a dose of Flulaval at 0.5 ml in the left arm. At an unspecified time after vaccination with Flulaval, the subject experienced injection site redness, injection site inflammation, injection site pain and injection site soreness. The reporter was concerned that these events might be progressing into cellulitis since they had not resolved or improved. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
No reactions occurred. Vaccine administered on 4-13-22, however due to it being kept in fridge it should have expired on 4-8-22, therefore pt received expired vaccine.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 11/23/2022 ANEMIA I95.9 HYPOTENSION 1/9/2023 ANEMIA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 11/23/2022 ANEMIA I95.9 HYPOTENSION 1/9/2023 ANEMIA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 11/23/2022 ANEMIA I95.9 HYPOTENSION 1/9/2023 ANEMIA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 11/23/2022 TRAUMATIC SMALL INTESTINE PERFORATION, INIT I95.9 HYPOTENSION 1/9/2023 TRAUMATIC SMALL INTESTINE PERFORATION, INIT
PERSISTENT TINGLING SENSATION ON BOTH SIDES OF FACE (MORE ON RIGHT SIDE) AND ON BOTH ARMS (MORE ON RIGHT ARM) GOING UP AND DOWN AND GETTING WORSE; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and knee replacement surgery, and concurrent conditions included arthritis, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 210A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the subject experienced persistent tingling sensation on both sides of face (more on right side) and on both arms (more on right arm) going up and down and getting worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent tingling sensation on both sides of face (more on right side) and on both arms (more on right arm) going up and down and getting worse. This report was non-serious.
Patient was given an incorrect dose of the Pfizer Covid 19 vaccine.  We were giving booster doses and the staff member administering patients vaccine though that Pfizer vaccine was like the Moderna vaccine and the booster doses were only half the amount of the initial and secondary doses.  Due to this error patient was given 0.6ml of Pfizer Covid 19 vaccine.  Her symptoms post vaccine were simiilar to her initial vaccine symptoms with temp, cough, stuffy/runny nose, nausea.
fever spiking from 99.1 to 101.6; discoloration at injection site (lighter color compared to her normal skin color); soreness at injection site; Nausea; vomiting; severe headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (severe headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (5 back surgery). Concurrent medical conditions included Depression and Knee pain. Concomitant products included VENLAFAXINE for Depression, GABAPENTIN for Knee pain.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (severe headache). On 18-Mar-2021, the patient experienced PYREXIA (fever spiking from 99.1 to 101.6). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration at injection site (lighter color compared to her normal skin color)), VACCINATION SITE PAIN (soreness at injection site), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (severe headache) and PYREXIA (fever spiking from 99.1 to 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: high (High) Multiple measurements taken by the patient. Initial value 99.1 to 100.2 to 100.6. Final value 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Soreness at the injection site if pressed; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 25Feb2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received birth control(unspecified) and allergy medicine (unspecified) within two weeks of vaccination. On 26Feb2021, the patient experienced soreness at the injection site if pressed. The adverse event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at the injection site if pressed was resolved on an unknown date in Feb2021.   No follow-up attempts are needed. No further information is expected.
2/10/21 -  I am writing to report that yesterday, at 10:00 AM, I received my first Pfizer Covid19 vaccination.  Prior to receiving my vaccination I reported that while I have had no adverse reactions after receiving flu, shingles, or other previous vaccinations, in the past, I have had strong allergic reactions after consuming mollusks or foods that have come in contact with mollusks.  I was advised that I would be required to wait on site for 30 minutes after my Pfizer vaccination so that I could be monitored for any adverse reaction from it.  After waiting 30 minutes, my husband and I were cleared to go home.    At 2:30 PM, I started to experience a swelling of my tongue and throat.  I immediately took three 25 mg Benadryl tablets as I have done when I experienced past allergic reactions.  I also began to consume significant amounts of water to help with swallowing.  I then called my husband and asked him to come home.    At about 3:30 PM, the swelling of my tongue began to diminish and by 4:30 PM I began to swallow more easily and was able to reduce consumption of water.     I had a very light dinner at 5:30 PM, and went to bed at 8:30 PM.  At 10:00 PM I went to sleep.  I slept somewhat restlessly and woke at 5:00 AM as I usually do.     Today, though tired, I'm okay.
Ear lobes, eyes, and chin itchy 24 hrs after booster to the exact hour.  Dr office visit 10/4/21.  Started on Benedryl, zyrtec and motrin.  No relief with symptoms.  Symptoms increasing to entire body. Stopped previous medications ans started Prednisone 10/10/21 as prescribed by physician.  Saw Dermatologist 11/2 since no relief of symptoms.  Diagnosed with  Dermatographic uticaria.  Prescribed Alegra and Zyrtec.
A non-serious spontaneous report of fever, vomiting, chills sore throat, and runny nose has been received from a nurse concerning a four- year old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither past medical history nor concomitant medications were reported. The patient received FLUMIST on 25-Nov-2008. The patient woke up on 26-Nov-2008 with a fever, vomiting, chills, sore throat, and runny nose. The outcome was not reported. The events of fever, vomiting, chills, sore throat, and runny nose resolved on approximately 03-Dec-2008, within one week after the onset of the events. Additional information received 08-Jan-2009 and incorporated into the case outcome and resolution date.
Received immunizations on 8/25/06...that evening had fever of 103-105 and had febrile seizure.  Taken to Er that evening by parents.  Ever since then patient averaging 1 x/month.  Seen at primary clinic 3/7/07 with concerns.  Referral to pediatric neurologist given and patient has upcoming appointment.
pt reported to have been mildly irritable the day & the day p/vax;on the 4th day p/vax pt had bottle in AM (8AM) & was put down for a nap around noon & was found dead about 30min later;
Pt stated experienced nausea 1 day post shot, and 2 days post shot she is now experiencing vomiting and chills
15 minutes after receiving her vaccination, she developed lightheaded and  photophobia. She was taken to a private section of the arena for monitoring. She had mild tachycardia with heart rate of 105 bpm. With subsequent monitoring, her HR  normalized. After 20 minutes of monitoring, her symptoms fully resolved.
RN was performing vaccination using a vanish point syringe.  The needle was in the person's right arm.  RN went to push in the vaccine and syringe malfunctioned, leaking the vaccine out of the hub of the syringe.  No vaccine entered in to the arm. RN took a different vaccine dose and then administered that dose into the right arm of the client.
had small rash on his chest; This is a spontaneous report from a consumer (patient) via a Pfizer-sponsored program COVAX US Support. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced had small rash on his chest. The outcome of event was recovered.  information about lot/batch no has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Redness, warmth, swelling, slight discomfort at site of injection.  Patient contacted us and was instructed to use ice packs, Tylenol/Ibuprofen for pain, and Benadryl for redness and itching.
The caller said they have a patient who had received a second dose of PNEUMOVAX 23 by mistake.; redness, swelling and pain at injection site; redness, swelling and pain at injection site; redness, swelling and pain at injection site; This spontaneous report was received from a customer referring to a 32-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  depression,  anxiety,  sulfonamide allergy,  latex allergy,  allergic rhinitis, and drug hypersensitivity to sumatriptan (IMITREX). Concomitant medications included methylprednisolone acetate (MEDROL), zinc gluconate, cyanocobalamin (VITAMIN B12), vitamin d3, iron , aripiprazole (ABILIFY), levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC ), venlafaxine hydrochloride (EFFEXOR), hydroxyzine embonate (VISTARIL), paracetamol (TYLENOL), multivitamins (unspecified), ondansetron (ZOFRAN), omeprazole (PRILOSEC) and ibuprofen.   On 10-DEC-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Then, on 18-MAY-2022, the patient went to the clinic and received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) instead of ''pneumococcal 15 or 20'' (interchanged of vaccine products).   Then on an unspecified date in May 2022, the patient developed redness, swelling and pain at the injection site (left deltoid muscle). On 19-MAY-2022, the patient went to the emergency room for these symptoms but it was confirmed that the patient was not admitted to the hospital. The patient was seen at the clinic on 20 and 23 of May 2022. On 23-MAY-2022, the patient recovered from the events of  redness, swelling and pain at the injection site.   The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Te patient reported no additional AE.; nurse practitioner inadvertently administered a dose of MMRII to a patient intramuscularly rather than the recommended subcutaneous route; This spontaneous report was received from a nurse practitioner (described also as a nurse prescriber) and refers to a 25-year-old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 26-AUG-2021, the patient was inadvertently administered a dose of measles, mumps, and rubella virus vaccine, live (M-M-R II) 0.5 ml intramuscularly (anatomical location, lot #, and expiration date were not provided) for prophylaxis. The recommended route of administration for the vaccine was subcutaneous route. The nurse stated the patient reported no adverse event.
headache above right eye; my nose/right nostril blood started pouring out. Hard time getting it under control; felt tired; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection; Lot number: EW0185, Expiry date: Not reported), via an unknown route of administration into left arm on 21Jul2021 at 11:15 AM as dose 1 single (Age at vaccination: 65-year-old) for COVID-19 immunization. The patient did not receive any other vaccine in four weeks of covid vaccine. The patient was neither diagnosed with Covid prior to vaccination nor tested for Covid post vaccination. Medical history included: PVC (Premature ventricular contractions), Seasonal Allergies and Known allergies to Penicillin. Concomitant medications included (within two weeks of vaccination): IC Flecainide Acetate tablet at 50 mg twice a day and magnesium lactate, pyridoxine hydrochloride (IC MAGNES). On 22Jul2021 around 7 pm, the blood started pouring out from nose/right nostril and had Hard time getting it under control. About 5 minutes later, it was under control and felt tired. On 23Jul2021, the patient had no bleeding but had headache above right eye. The patient stated that she does have seasonal allergies and they have been bad this year and mentioned of having headache above right eye when she went for vaccine. The patient reported that she never had a nosebleed before. Heavy blood. The patient was feeling ok today and was having just headache. The patient was ready to go to the ED (emergency department) when got it under control. The patient did not receive any treatment for reported events. Outcome of nosebleed was recovered on 23Jul2021. Outcome for tiredness and headache was recovering.  Follow-up attempts are completed. No further information is expected.