chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constipation; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Apr2021, reported as "today" between 10:15 and 10:30, as a single dose for COVID-19 immunisation. Medical history included handicap, broken hip and cane use, all from unknown dates and unknown if ongoing. Concomitant medications were not reported. The patient reported receiving the first dose of BNT162B2 "today" (as of 18Apr2021) between 10:15 and 10:30. She called to inquire if constipation could be a side effect of the vaccine, further reporting she usually had a bowel movement after lunch. She reported her doctor told her if she didn't have a bowel movement she could have some "BENEFIBER." The event was reported as non-serious. The clinical outcome of constipation was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed allergy to:  gluten (moderate to severe) tingling fingers, skin sensitivity.  Depleted of enzymes and very low on potassium .  Pancreatic issues (producing little enzymes).  Taking CREON to help with these issues.  Over time intolerance to other foods (grapes as an example) are emerging.
This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA001032: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
pt recv vax;fever 101 R;bruising lt thigh from side down to ankle;thigh enlarged;kept in ofc for 1 hr, did not get worse;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 07-NOV-2017, the patient was vaccinated with an improperly stored PNEUMOVAX 23 lot # M037533 with an expiration date 17-MAY-2018. No adverse effect was reported. The administered dose of PNEUMOVAX 23 experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 7 hours and 50 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA007177: US-009507513-1712USA004521.
Patient developed severe body aches and headache starting the day after vaccination. Patient states that 2 days after vaccination she felt slightly better. By 8/17/19, the patient's body aches and headache had worsened and she developed diarrhea. She was sent at a urgent care and transferred to the ER via ambulance. She was sent home under the impression that she had a viral infection. She had a follow-up doctor's appointment on Monday (8/19) and was admitted to hospital because her condition was worsening and her BP was dangerously low. Menengitis was suspected but CSF culture was not taken. Infection was found to be bacterial. Patient was treated with targeted antibiotics and released from the hospital on 8/23/19.
FEELING COLD; HIGH FEVER/ SWEATING FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced high fever/ sweating fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever/ sweating fever, and the outcome of feeling cold was not reported. This report was non-serious.
Her back felt like it was about to break; Sinus was messed up; Feeling really bad; Her muscle still feels kinda sore; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who experienced her muscle feeling sore (myalgia), sinus was messed up (sinus disorder), feeling really bad (malaise)  and her back felt like it was about to break (back pain).  The patient's medical history included shingles. Concomitant products known to have been used by the patient, within two weeks prior to the event, included iron, vitamin B12, spironolactone, vitamin C, zinc, vitamin D, and rosuvastatin.  The patient received their first dose of mRNA-1273  on 11 Jan 2021 for prophylaxis of COVID-19 infection.  On 11 Jan 2021, after the patient received her vaccine, her back felt like it was about to break, her muscle still felt like it was sore. The patient's sinus was messed up and she felt really bad.    Treatments of these events included paracetamol, acetylsalicylic acid and pseudoephedrine.    Action taken with mRNA-1273 in response to the event was unknown.  The outcomes of the events, muscle feeling sore, feeling really bad, sinus messed up and back felt like it was about to break were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received fro ma registered nurse.  The event occurred in an eight grade adolescent male.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
fever (Tmax 102.5F) w/ myalgias. fever resolved with 1 dose of Tylenol. no ongoing symptoms
Patient received monovalent Pfizer vaccine instead of the intended Pfizer bivalent booster. Called patient to notify patient of error. Patient does not speak the language. Her caregiver said it was okay since she can come back and get her booster in 2 months.
A dose of Moderna COVID vaccine was inadvertently given to a 17 year old when EUA for Moderna vaccine is only for 18 years and older. No reaction to the vaccine. Tolerated well.
The pt received a Td booster shot on September 28, 2004 and 24 hours later experienced diffused body pain, myalgia, fatigue, a temperature of 99F and her blood pressure was 114/74, low for this pt as she normally has high blood pressure. Her pulse was 82 and it is normally in the 60's. Two days later the pt's temperature was 102 F but she was feeling better with less myalgia and fatigue. October 1, 2004 the pt's temperature dropped to 99.2 F but her pulse was still elevated. However, she has a good appetite. The following day, October 2, the pt had fully recovered. Her temperature returned to normal and her pulse dropped to 74. MD seemed to think the reaction was viral syndrome related to the vaccine, it did not seem like an allergic reaction, as there was no itching. His concern was, what to do, in 10 years time when this pt needs another booster.
While sleeping the night of my 2nd injection, I had a headache develop and chills.  My rapid beating heart woke me up at 5:00 AM the next morning.  I had a Fit Bit watch on and my heart rate was 108. This was my heart rate just laying in bed and not getting up at all. My normal resting heart rate is 65.  My heart rate ranged from 89 to 108 all morning laying in bed.  I had a severe headache, muscle pain, and was nauseous.  My rapid heart rate lasted most of the day.  My head hurt so bad I could barely open my eyes.  I had hot flashes and chills.  I took 2 Advil around 10:00 AM on an empty stomach because I was so nauseous I couldn't eat anything.  I finally was feeling well enough to get out of bed at 12:30 PM and took a shower.  I had 2 pieces of toast and that was all I ate all day.   I was up and about for 3 hours and then back on the couch at 4:00 PM.  From there I developed chills again and had on 5 blankets trying to stay warm.  At 9:00 PM, things reversed and I got hot flashes.  I had hot flashes/sweats through the night where I had to change my nightgown.  I still had a slight headache and hot flashes the next morning.  That is where I am at right now.  This is day 2 after my vaccination.
Injection site felt hot; Swelling at the injection site; Injection site was red and spread down her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site felt hot), INJECTION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red and spread down her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 immunisation.     No Medical History information was reported.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site felt hot), INJECTION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red and spread down her arm). At the time of the report, INJECTION SITE WARMTH (Injection site felt hot), INJECTION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Injection site was red and spread down her arm) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.
Pt experienced severe pain at injection site & surrounding area along w/ red rash (lower than injection site), hot to the touch. Recommended pt to take BENADRYL. If not better w/in 24 hours to see Dr.
1030AM crying, swollen leg, erythema, 2PM warm to touch, wouldn't straighten leg; No elevation of temp noted by parent;
itchy rash.  Started 8 days after injection.  Lasted 3 days
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: 025-402), in left arm, on 18Apr2021 as dose 2, single (Lot number: 025-402), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
15 minutes to 30 minutes after vaccine, pt had hives and itching starting on face then rest of body. Initially some difficulty breathing.
high fever chill dizziness for 3 days. Dizziness last more then 2 months. I am still feeling weak, some time feel like i have hearing problem, sounds in ears, weakness not going away.
Client received KINRIX vaccine on 3/30/15 that had expired on 11/23/14.
Moderna COVID19 Vaccine   Acute hospital admission for Ileus,  Sigmoid colon volvus
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility was not able to download the digital data logger, they were put on hold by the State at the moment and could not administer the Moderna COVID-19 vaccine to patients, until an assessment by the State was made. There  were no power outages that would have impacted the Moderna vaccine. They needed to treat that issue as a temperature excursion. No adverse reactions were reported by any patients. No treatment medication were provided.
Pt had vaccine several years ago for Varicella. Going around outbreaks, in school sibling had outbreak and now pt with >300 lesions of Varicella for past few days.
hive became apparent on rt face w/in minutes of administring DTP/OPV; resolved w/in 1/2 hr;
bad headache; felt very dizzy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), taken from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 07:00, 2 weeks and 4 days following the second vaccine, the patient experienced a bad headache and felt very dizzy. The patient had to hold on to furniture and walls to avoid falling down, she had never experienced anything like that before and does not drink or take drugs. The dizziness lasted approximately 2 to 3 hours. Therapeutic measures were taken as a result of bad headache and included treatment with two Excedrin migraine pills and a glass of water. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dizzy was resolved on 11Apr2021, while the clinical outcome of the event bad headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were reported as follows: The reporter reported, she heard that her friend's niece received a SHINGRIX shot and later passed out in the shower. No further details were available from reporter.
Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22; Vaccine moved the freezer to refrigerator the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22) and PRODUCT STORAGE ERROR ( Vaccine moved the freezer to refrigerator the beyond use date ) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22) and PRODUCT STORAGE ERROR ( Vaccine moved the freezer to refrigerator the beyond use date ). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine/3 patients received expired vaccine from the lot # that had beyond use date of -1/20/22) and PRODUCT STORAGE ERROR ( Vaccine moved the freezer to refrigerator the beyond use date ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that No side effect was reported by 3 patients during the 15 minute observation time. Expire date based on once the vial was move from freezer was on 20JAN2022. Vial was initially stored in refrigerator on 21DEC2021. Vial did not undergo any temperature excursions.  No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2022-457589, MOD-2022-457576 (Patient Link).
Administration error. Patient received 3rd Varivax 8/24/07 but had received 2nd Varicella shot on 6/11/02 (No sequelae from vaccine).
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 7 month old male vaccinee was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
No additional AE reported; a pregnant patient received a dose of GARDASIL 9 today/given in error; a pregnant patient received a dose of GARDASIL 9 today/given in error; This spontaneous prospective pregnancy report was received from a nurse and refers to a 34 years old female pregnant patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 01-NOV-2021, the patient received in error a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687293, verified as valid, expiration date: 30-APR-2022) for prophylaxis (exact dose, route of administration and anatomical location were not reported). The patient became pregnant with LMP of 17-MAY-2021 and EDD of 21-FEB-2022. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 28 weeks. The pregnancy outcome was pending. The patient experienced vaccination error and exposure during pregnancy. The patient was not currently experiencing any side effects. No additional adverse events reported. The outcome of the events was unknown.
Pts elbow (on injection arm) was swollen, red and painful. Patient returned to primary care physician and was given an antibiotic, medication for itching and a steroid shot.
Approximately 15 minutes after patient received Pfizer vaccine #1 she began to experience shortness of breath, tachypnea, tachycardia, diaphoresis, and hives to upper extremities.
T ON 5JAN91; SAW MD 7JAN91 D/T T 103.5 (R), CORYZA, CONGESTION SNEEZING & MILD COUGH; WAS LETHARGIC; FEVER STAYED @ 103.5(R) W/TYLENOL & SPONGING; 8JAN91 DEV NAUSEA, VOMITING & DIARRHEA. MD SAID "VIRUS" GAVE KEFLEX; DX = SEV BRONCHOSPASM