chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 71 year old male patient with depression, no drug reactions or allergies. On 17-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H015749, exp date 02-JUN-2014) dose 1, intramuscular (dosage and anatomical location unspecified). The physician reported that on 17-APR-2013, patient developed an injection site reaction after vaccination with PNEUMOVAX23. The patient developed a rash, hives, induration, pain and possibly cellulitis at the injection site. He also had a cough. At the time of the report the outcome of injection site reaction, rash, hives, induration, pain and possibly cellulitis at the injection site and cough was reported as not recovered. Patient sought medical attention by visiting the office and received treatment with warm compresses, BENADRYL, CLIRITIN and triple antibiotic cream. Additional information has been requested.
Pfizer Primary dose was administered beyond the use date.  Vaccine was moved from dry ice, to refrigeration on 8/8/2022. Beyond Use Date was 10/17/2022.  Vaccine was administered 10/25/2022 No reported adverse effects.  Pfizer was notified and reports of the incident were emailed on 10/26/2022 Patient is a resident of a long term care facility. Vaccination occurred at a Vaccine clinic at that location on 10/25/2022 Patient also received an influenza vaccine on the same date, administered by the Long Term Care facility personnel
Patient had a vasovagal response after shot given. Patient diaphoretic, pale and dizzy, never lost consciousness about 5 minutes after administration of vaccine. Patient was placed in supine position with knees bent, vital signs stable, water given. Patient made full recovery in 10 minutes after laying supine with with stable vital signs.
Wed 2/22/06 bruising and pain. Thursday improved painful with movement. Friday no discomfort or pain. Pain returned Saturday with pain and movement upon movement. Muscle knot present (Pt massage site everyday but Friday). Pt saw Dr this am. Dr does not feel pt pain to be associated with any nerve damage or infection. Will have pt return if still painful with movement after one more week.
Past 36 days for 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past 36 days for 2nd dose) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past 36 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past 36 days for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Information has been received from a female consumer via a letter concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. According to the reporting consumer, on an unspecified date, the patient "nearly died," At the time of this report, the patient's outcome was unknown. Upon internal review, "nearly died" was considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient. No further information is available.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 10:00 (Lot number: FF8839) at the age of 36 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "Covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19:Yes. Concomitant medication(s) included: IMITREX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 17Aug2021, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "severe headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Sep2021 10:00, outcome "unknown", described as "administration date= 17Aug2021, previous dose administration date= 29Sep2021"; RASH (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Bad skin rash"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Have trouble breathing at night"; THROAT TIGHTNESS (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Throat closes up"; PHARYNGEAL SWELLING (non-serious) with onset 2021, outcome "recovered with sequelae", described as "Throat swelling"; SLEEP DISORDER (non-serious) with onset 2021, outcome "recovered with sequelae", described as "I am now awaiting a sleep study". The events "bad skin rash", "have trouble breathing at night", "throat closes up", "throat swelling" and "I am now awaiting a sleep study" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, dyspnoea, throat tightness, pharyngeal swelling, sleep disorder. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hospitalization Prolonged reported as No. Treatment received for the adverse event with Prescription pain relief and steroids, sleep study. Since the vaccination, patient had not been tested for COVID-19. Known allergies reported as No. Follow-up attempts are completed. No further information is expected.
Patient went to hospital with complaints of tachycardia and tachypnea, also complained of lethargy and chills. Patient does have baseline shortness of breath and atrial fibrillation.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium
adult patient was administered pediatric dose of EngerixB; adult patient was administered pediatric dose of EngerixB; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number fb9rh, expiry date 21st January 2024) for prophylaxis.   On 27th May 2022, the patient received Engerix B pediatric. On 27th May 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 31-May-2022 Reporter's comment: The registered pharmacist reported that an adult patient was administered pediatric dose of Engerix B. The reporter wanted to know how to proceed. The reporter consented to follow-up. Additional supportive information: The patient received the pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Pts (8-10) recv vax on unknown day; post vax pts exp red knots in legs
Inappropriate schedule of vaccine administered; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007821A and 003A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy, Pilonidal cyst, Non-tobacco user and Ex-alcohol user. Concomitant products included ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No treatment medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623819.
Patient was administered vaccine on 2/17/22 that expired on 2/12/22.
joint pain; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 22Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient stated: "I am having muscle... I guess is joint pain?" The patient stated that she received her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 22Dec2020 and also stated it was strange that she's experiencing those side effects on the left arm because she received the injection in the right arm. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from the Merck Pregnancy Registry via a mother concerning her 17 year old daughter with no pertinent medical history who on 21-AUG-2007 was vaccinated with a 0.5ml second dose of GARDASIL. There was no concomitant medication. Subsequently the patient "came to know she was pregnant". A blood test was performed, results unspecified. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Follow up information received from a healthcare professional from an OB/GYN office, indicated that the patient was a 17 year old female with no prior pregnancies, allergic rhinitis, and a past history of depression, obesity and occasional smoking, who on 06-MAR-2007 was vaccinated with the first dose, and on 21-AUG-2007 was vaccinated with the second dose, 0.5ml, of GARDASIL (lot # for both doses: 654510/0962F). The patient's date of LMP was stated as "31-DEC-2007," with an estimated delivery date stated as "29-NOV-2008." On 06-NOV-2007, a vaccination of influenza virus vaccine (FLULAVAL) was administered. During delivery, "fetal intolerance with non-reassuring fetal tracings, brady x 2 - 30's, multiple bradys into 60's" were detected, as well as a "nuchal cord x 1." Active range of motion was monitored for 6 1/2 hours with "NEC." On 03-DEC-2007, at 40 weeks gestation, a Cesarean section was performed due to the symptoms of fetal intolerance, non reassuring fetal tracings and bradycardia. The mother gave birth to a normal female infant (no congenital anomalies or abnormalities), birth weight, 6 lb 15.202 ounces, length 19," head circumference 33cm, and Apgar score of 6 - 9/9. Upon internal review, "fetal intolerance with non reassuring fetal tracings, brady x 2 - 30's" was considered to be serious as an other important medical event (resulted in Cesarean section). Additional information is not expected.
information has been received from a licensed practical nurse concerning an 8 month old male who on 01/20/2001 was vaccinated with varicella vaccine. The nurse reported that the pt received varicella due to exposure to varicella. This does not comply with the recommended dosage schedule. The nurse reported that the pt was exposed to a babysitter who had chicken pox and subsequently developed a few pox marks. The pt received medical attention for his experience. No additional info is expected.
@ 0930 3JUN98 devel rash-face, chest, abd, back, arms, legs, buttocks-fine red papules separate & confluent-afeb @ 1130AM;no edema noted;active w/nl appetite;
Patient reports her arm swelled and felt hot. Swelling went down after a day. Reported 9 days later she felt like she was coming down with the flu (aching muscles, sore throat and runny nose). Told patient to get in contact with her primary physician.
pregnant and received vaccine; Received second dose of vaccine 42 days after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant and received vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose of vaccine 42 days after first dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025I20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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 01-Oct-2021. On 01-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant and received vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose of vaccine 42 days after first dose). On 01-Feb-2021, EXPOSURE DURING PREGNANCY (pregnant and received vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose of vaccine 42 days after first dose) had resolved. Not Provided
Diarrhea, abdominal pain, vomiting, intussusception noted on abdominal ultrasound.
Pt complained of extreme pain at the site of injection.  Unable to move his arm.  He had to go to the emergency room for the pain.
Swollen arm, redness, warm to touch, pain radiating up to shoulder; getting worse each day instead of better.
rapid heartbeat, weakness, tired/fatigue, sinus symptoms such as facial pressure around the eyes, sneezing, cough (at bedtime) and diarrhea.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On 05-MAR-2018, the patient was vaccinated with second dose of GARDASIL 9 (lot # L045700 and expiry date: 22-FEB-2018) (strength, frequency, dose and route not reported) for prophylaxis (Expired product administered). No adverse event was reported. No further information was provided. A product quality complaint was not present.
minor stridor that is slowly resolving; I was vaccinated while pregnant with him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-month-old male patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The mother's relevant medical history was not reported. The mother's concomitant medications were not reported. The following information was reported: STRIDOR (non-serious), outcome "recovering", described as "minor stridor that is slowly resolving"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "I was vaccinated while pregnant with him".  Additional information: A potential AE has been reported to the Pfizer Clinical Trials Contact Center. It was reported that she had a 12 month old son and I would love for him to be a part of this trial. He had no health conditions, aside from minor stridor that is slowly resolving. He hasn't had COVID (that we know of) but she was vaccinated while pregnant with him.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202200732536 Maternal case
This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose ROTATEQ (dose, lot# and route of administration were not reported). The vaccine had been exposed to 33F for a maximum of 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Per mom went to check on pt in bed. Pt with large jerking movements of both arms. Then opened eyes but was "blank". Temperature 103 - Parents took to ER and temp was 103. Diagnosed with possible febrile seizure.
This spontaneous report was received from a physician and refers to three unspecified patients of unknown age and gender. Information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was not provided. On an unknown date, the patients were vaccinated with the first (of two) dose of ROTATEQ orally (dose, lot # and expiration date were not reported). On an unknown date, after the patients were vaccinated with ROTATEQ, all three patients vomited. The patients sought medical attention, they were in the physician's office. No treatment was given to them for the event. Therapy with ROTATEQ was discontinued on an unspecified date. The outcome of vomiting was reported as recovered (date unspecified). The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
I had a headache, I was running a fever, chills that lasted for 2-3 days. Also, completely bedridden. My right leg would not work, I really can't descript it, but I just could not move it at all. It took me about 45 minutes to get it moving. These symptoms continued with dose 2 as well as dose 3.
the patient was administered a dose of VARIVAX, MMRII, Flusone and ADACEL while the patient was pregnant; the patient was administered a dose of VARIVAX, MMRII, Flusone and ADACEL while the patient was pregnant; This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unspecified date, the patient became pregnant. The dates of last menstrual period (LMP), approximate date of conception, and estimated date of delivery (EDD) were not provided and were unable to calculate. Pregnancy outcome was pending. On an unknown date in 2019, while the patient was pregnant, she was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (contraindicated products in pregnancy) for prophylaxis (doses, route of administration, lot numbers and expiration dates were not provided). Other suspect therapies included influenza virus split virion 3v vaccine inactivated (FLUZONE) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) (doses, route of administration, indication, lot numbers and expiration dates were not provided). The outcome of the events was unknown.
On January 12, 2022, patient visited primary health provider. Complained of "tingling sensation in different parts of his body, arms, abd that comes and goes."  (This is a quote from the health provider notes in the patient's medical records."  Received 2nd dose of Pfizer/BioNTech shot on the same day.  Lot number EK9231. Site of injection is not recorded in the medical records.  Altogether, patient received a total of five Pfizer shots and one flu shot between 12/22/2020 and 9/16/2022. Here is the info for these additional shots: January 12, 2021; Pfizer/BioNTech; Lot EK9231 September 29, 2021; Pfizer/BioNTech; Lot 3014SB4 April 10, 2022; Pfizer/BioNTech; Lot FP4554 September 16, 2022; Pfizer/BioNTech Bivalent: Lot GH9694
Child awoke at approximately 9:45 pm and vomited. Parent took temperature rectally 10:15 PM; reading of 101.7 degrees farenheit.  Child was fussy, had severe stomach cramping with crying & squirming after vomiting & passed gas at approximately 10:30 PM. At approximately 10:30 PM parent attempted to administer ibuprofen to bring temperature down but child began gagging and only 1/2 dose was administered.  Child's temperature climbed to 102.6 by 11:00 PM and her torso's skin temperature was very hot (same as forehead). At approximately 11:10 PM parent identified that joints in legs (knee & ankle) were hot to the touch & were tender. By 11:45 PM arm and shoulder joints were also hot to the touch. High skin temperature eventually spread to all limbs, by approx 12:30 AM, and joints were no longer hotter than the skin around them. Child's skin was sensitive to the touch & parent interpreted child's sensitivity as moderately painful as child would push parent's hands away from/off of her body. At about 12:30 AM parent called nearest military facility emergency room to speak with a nurse for advice on whether or not to bring child in. (Because the child was not experiencing any breathing problems parents did not bring her into the emergency room).  Child's temperature continued to fluctuate between 101.5 and 102.7 until about 04:00 AM. Between 12:30 AM and 02:00 AM child experienced twitching (twitched as if she were falling) about once per minute. During this time her breathing continuted to be normal and she was able to doze throughout. By 07:00 am the fever was at 100 degrees Fahrenheit and continued to drop throughout the day.
This is a spontaneous report from a sponsored program. This consumer reported for a 63-year-old male patient that. A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as dose 1, single for covid-19 immunization. Medical history included none. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced then got covid a week later. Patient had not yet received his second dose so he has also passed for 42 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2021 got Covid, sars-cov-2 test: negative on 19Apr2021, sars-cov-2 test: negative on 07Jul2021. Therapeutic measures taken as a result of then got covid a week later (covid-19) included C-Pak (Captured as verbatim however intent of Z-Pak). The outcome of the event then got covid a week later (covid-19) was recovered on 19Apr2021.   Follow-up attempts are completed. No further information is expected.