chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little or no upper arm soreness but persistent; Mild Flu symptoms; sore joint persisted longer; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 2 via an unspecified route of administration on 19Feb2021 09:28 (at the age of 76-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included, Allergic to bee sting from 10Sep1989 to an unknown date (Stop date: Unknown, visited ER on 10Sep1989, given Benadryl, carry Epi-pen). Concomitant medication(s) included levothyroxine sodium (THYROXINE) taken for an unspecified indication from 1999 and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from 15Mar2020 and ongoing; tamsulosin (TAMSULOSIN) taken for an unspecified indication from 10Jan2018 and ongoing. The patient previously received first dose of BNT162B2 (Batch number: EL9261), administered in deltoid left on 22Jan2021 at 21:30 (at the age of 76-year-old) for COVID-19 immunization and experienced Mild flu-like symptoms, Sore upper arm/Pronounced soreness near injection site, vivid dream, body ache, fever mild, muscle sore and joint sore. Reported that as a secondary note (after receiving 2nd Pfizer dose [EN6200], I had a much stronger reaction to 2nd dose. Little or no upper arm soreness, but persistent, initial moderate and then mild flu symptoms (2 to 3 days post), sore joint persisted longer (2021). No surgical treatment needed for the events. The clinical outcome of events little or no upper arm soreness but persistent and sore joint persisted longer was not recovered and another event outcome was recovering.  No follow-up attempts are needed. No further information is expected.
39 days between first and second dose; Child 17 years old at time of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child 17 years old at time of second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (39 days between first and second dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child 17 years old at time of second dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (39 days between first and second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child 17 years old at time of second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (39 days between first and second dose) had resolved. Not Provided          concomitant product used was not provided. treatment information was not provided. DOB of the consumer was incorrectly captured.   This case was linked to MOD-2021-078006 (Patient Link).
I broke out in hives after my first vaccine shot. They cleared up after a week, but then I broke out again after my second shot (administered on 4/22/21). Now, 7 weeks after my second shot, I'm on two antihistamines and still covered in hives.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age group was not provided, but it was taken as adult, as per vaccine indication. The patient had reported experiencing redness and swelling at the injection site and at the time of this report, the injection site was hot to the touch. No additional details provided by the sales representative. The health care professional office could not be immediately reached for additional details.
Pt states the day after vaccination he started with runny nose, coughing and headache from 9/29/13 - with still experiencing 12/20/13. Pt states no fever and nothing requiring a visit to MD, but believes it is directly related to the vaccine.
Pt. c/o pruritus, red rash on rt. arm and stomach area. Denied any respiratory problems. No speech impairment.
Pt. states that after receiving the 3rd dose of Moderna 10/25/2021, started experiencing symptoms 11/01/2021 of frequent hair loss *thinning. Primary communications (suggestions of Age-Related).
Patient came in for his 2nd COVID vaccine. He received his 1st dose at another location and did not present his CDC card at check-in. Before my technician gave him the shot, he verified with the patient that it was in fact his 2nd Pfizer dose that he was receiving; patient agreed. Patient went out to his car after the shot and brought back his CDC card which in fact stated that he previously received Moderna.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Administerd adult hep B, instead of adult Tdap. Patient advised, and correct vaccine administered.
fainted/passed out in the doctor's office after administration of the vaccine; This spontaneous report was received from a consumer, which is also a company representative, and the patient's mother, regarding a 12-year-old female patient. The patient's medical history, concomitant medications and drug reactions or allergies were not provided.   On 03-AUG-2020, the patient had no eaten breakfast and was vaccinated with the second and last dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route, lot # and expiration date were not provided). It was unknown if the patient received any other vaccinations at the same time.  On 03-AUG-2020,after administration of the vaccine, the patient fainted/passed out (syncope) in the doctor's office and sought medical attention. No treatment was needed. Later, the patient was perfectly fine and she was able to leave the doctor's office. The patient's mother wondered if as the patient had not had breakfast, this was the reason why she fainted.   On the same date, the patient had blood drawn, however no test or results were mentioned.   The reporter did not assess the relatedness between fainted/passed out and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Upon internal review, the event faint/passed out was determined to be medically significant.
Noticed that my urine was cloudy the night after the vaccination, then turned red with blood in urine, and very dark, also achy in shoulder joint.
1-25-2020  6:40 pm chest pain/heartburn, 9 pm  itchy skin, 10:30 heartburn still active and not relieved by tums. Itchy skin and rectum, Tiredness  1-26-2020  2:30 am welts on upper legs, face, elbow, knuckles. Heartburn - took baking soda. 3:30 am took 50 mg benadryl, applied Caladryl to skin, kept cool. 12 pm reapplied Caladryl, groggy and woozy. 4 pm itching increasing. took 25 mg, reapplied Caladryl. 10:30 pm woozy and tired. took 25 mg benedryl.  1-27-2020 7 am hands itching, applied Caladryl, 7 pm heartburn felt in chest and back took 25 mg benadryl and simethicone. foot itching, applied Caladryl. hemorroidal itching  1-28-2020 7 am knees itching and welting, applied Caladryl. 9 am ankles itching, took 25 mg benadryl. 7 pm heartburn, took simethicone. 10 pm anal itching, applied preparation H suppository, took 100 mg fanitodine  1-29-2020 7 am itching behind knees, upper arms, andles, ears - applied Caladryl. headache and hemorroidal itching, applied preparation H. 6 pm heartburn and mild itching continues
CHILLS THAT COULD NOT WARM UP; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 200 pounds, and height was 69 inches. The patient's concurrent conditions included: diabetic, alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient is on blood pressure pill. The patient experienced nauseous and sick when treated with cefalexin for drug used for unknown indication, and diarrhea and throwing up when treated with potassium citrate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced chills that could not warm up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills that could not warm up on 09-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20211152000.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.  Patient received dose from vial refrigerated on 07-MAY-2021.
Patient developed itching of tongue and upper lip swelling after receiving the pfizer COVID-18 vaccine. The patient developed symptoms while in the monitoring phase after vaccination.  Employee waited 30 minutes after vaccination and then spoke with POD physician explaining the symptoms. POD physician recommended taking some benadryl.  The employee was planning to drive home so a 25 mg table of benadryl was given to her to take with her/take on way home. Patient did not take the medication at the POD.  Patient stated the symptoms had improved.
My son is 10 months and breastfed he's been sick and has not slept since the shot.
Pt presents on 1.22.20 states that she felt sick to her stomach. She felt that she was going to her stomach. She felt that she was going to vomit. Also, Tongue is discolored. side of tongue hurts and redness, sore
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency, route of administration were not reported) lot # N021571 with an expiration date on 29-APR-2020 for prophylaxis. No adverse effects were reported. The vaccines underwent temperature excursion of 32 to 35 degrees Fahrenheit (F) (34F) for 102 hours and 47 to 77 degrees Fahrenheit (F) (47F) for 18 hours. No previous temperature excursion was reported. A digital data logger was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1811USA001803.
Infectious disease; tingling along the trigeminal nerve / started at the neck and going up to the head / occasional tingling behind the ear; Trigimenal nerve pain; fatigue; myalgia; headache; being unable to work for approximately 4 months, due to symptoms; This case was reported by a nurse and described the occurrence of infection in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   The patient's past medical history included shingles (active Shingles infection). Concurrent medical conditions included genital herpes.   On 9th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced infection, tingling, nerve pain, fatigue, myalgia, headache and inability to work. On an unknown date, the outcome of the infection, nerve pain, fatigue, myalgia, headache and inability to work were recovered/resolved and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the infection, tingling, nerve pain, fatigue, myalgia, headache and inability to work to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The reporter reported that onset of symptoms was between 9th August or either 17th August or 19th Aug 2019. The patient experienced severe headache, tingling along the trigeminal nerve, tingling started at the neck and going up to the head, fatigue and myalgia. The reporter went to the emergency room 4 or 5 times, as well as s her primary care physician, who referred her to infectious diseases.  The patient was unable to work for approximately 4 months due to symptoms.  All symptoms were resolved with the exception of occasional tingling behind the ear. The patient had not yet received the second dose of Shingrix. The reporter asked timeline between getting a vaccine because that was when a lot of people really find out about the shingles vaccine was once they had it and then they need to know how long they need to wait after active infection to get the vaccine.  There were no studies on if you only went for one dose, would you have been any protection at all. The reason for not getting the second dose could have been the physician said no, because of the bad reaction. The reporter also asked, was it not recommended for patients who had a history or herpes. The reporter consented to follow up.
This case was reported by a other health professional via sales rep and described the occurrence of erythema in a adult female patient who received Seasonal Influenza vaccine. On an unknown date, the patient received the 1st dose of Seasonal Influenza vaccine. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the erythema to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient (receptionist in nurse practitioner office) was told to sales representative that she had reaction to flu vaccine (unknown if this was a GlaxoSmithKline vaccine) for 2 consecutive years. On an unknown date, several years ago, the patient received 1st dose of flu vaccine and experienced redness down her arm. Then, in next year after receiving 2nd dose, she experienced hives all over her body (refer case US2016GSK087187). The patient said that is was fine if GlaxoSmithKline wants to contact her directly. It was unknown if the event caused the patient to be hospitalized overnight or prolong an existing hospitalization. It was unknown if the reporting healthcare professional considered the event to be life threatening, to result in persistent or significant disability and incapacity as well as congenital anomaly or birth defect. The patient did not die due to the event. It was unknown if the event required surgical or medical intervention.
Pregnant; This spontaneous prospective pregnancy case was reported by a non-health professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-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 24-Sep-2020 and the estimated date of delivery was 06-Jul-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 29Jun2023 and stop date 03Jul2023).   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) : US-PFIZER INC-202300249719 same patient, different drug/event;
little headache; This is a spontaneous report from a contactable consumer (patient). A 5-decade-old (her late 40's, as reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Feb2021, the patient experienced little headache which could be related to the vaccine, but she reported that this was all a very small price to pay for protection. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medications were not reported. On 06-Dec-2021, they placed LOT 012H21B vials in the refrigerator, upon receiving. Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of LOT 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose.
Intense lower back pain; Pain radiating down to her leg; Problems lifting her leg; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced low back pain, leg pain and mobility decreased. On an unknown date, the outcome of the low back pain, leg pain and mobility decreased were unknown.   It was unknown if the reporter considered the low back pain, leg pain and mobility decreased to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The nurse reported that one of her patients work at their institution. The patient was complaining of intense lower back pain with pain radiating down to her leg. The patient had problems lifting her leg to get into the car because of the patient. This patient also spoke to her coworkers that received the same vaccine on the same day and some of them experienced the same symptom. This is report 2 out of 2 adverse events on the patient's coworkers. No additional information provided. This case is 1 of the 4 linked cases, reported by the same reporter.
Tingling lips and tongue accompanied by sore throat. I took 50mg of Benadryl and adverse event reversed/stopped within a couple hours.
Patient stated that she had bad burning in her arm. She had a rash on her arm. Pain in her shoulder. Further down her arm was swollen. Started getting nausea and dizzy. Patient also started experiencing chest pain. She called 911. they took her to the hospital. the text came back normal. She started to feel better. Spoke to pharmacist who advised patient not to take second shot until she has seen cardiologist.