chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child was inadvertently given 2 IPV in 2 different sites 9-16-16. Provider notified and stated was fine but to mark IPV #1 and IPV #2 and give Hep B #2 next visit. Contacted manufacturer for whom supplies both vaccines and states this had happened many other times and was ok but to monitor child for any adverse effects and call them if this should occur. Spoke with grandmother as she states mother's phone was out of minutes and she had left with child 9/18/16 to stay at a friend's house whom has no phones. She states child had no problems with 1st set of shots and was doing well. She will have her mother call when she returns but didn't known when this would be.
Patient received first Pfizer COVID-19 vaccination at vaccination Center on 5/5. She began to feel nausea, stomach discomfort, lightheaded, have sensation of throat swelling, and felt short of breath as well. Staff attended to her; she was given 2 doses of epinephrine and 25 mg IM Benadryl at the convention center. Then EMS gave patient 10 mg IV dexamethasone en route.  Upon arrival at the Emergency Room, patient had significant improvement in her symptoms though tongue still felt large, normal phonation, clear lungs, normal BP and HR.  Patient has history of anaphylaxis with other medications and honey bee venom. She has previously been hospitalized for 1-2 days due to the severity of her allergic reactions. No history of asthma or any features of bronchospasm. Patient remained stable after 2 hours of observation. She was provided a prescription for an epinephrine pen and discharged home. If the PCP for this patient is not able to provide additional details (ED provider) may also be able to provide additional details.
bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressure; workouts much more difficult.; This is a spontaneous report from a contactable consumer (patient).   This 59-year-old male consumer reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 03Feb2021 at 14:00 (at the age of 59-years-old) at single dose for COVID-19 immunization. No other medications in two weeks.  Medical history included high blood pressure. After receiving the second shot, bad chills and shaking that night. Fatigue for 2 days. For the next month, higher than normal sleeping heart rate, higher blood pressure, workouts much more difficult. No treatment received. Outcome was Recovering. No Covid prior vaccination and no Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 20-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Continued pain at the injection site since the day after the injection so currently with 3 months of injection site pain. No skin changes noted, no neuro symptoms. Mild swelling. No signs of infection.
Information has been received from a registered nurse (RN) concerning a 5 year old male, with a history of failure to thrive (FTT) at nine months of age, and no reported drug reactions or allergies, who on 15-APR-2002 he was vaccinated subcutaneously with 0.5 mcg of Varivax (Merck) (lot number 640491/0973L). On 12-DEC-2006 the patient developed a macular papular rash, approximately 20 lesions, on his abdomen. The patient was afebrile, but complained of itchiness. There was no concomitant medication. The patient had not yet recovered at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. No further information is expected.
Area around injection site became red and swollen. Noticed some redness on 11/05/21, but was obvious on 11/06/21.  Propted a follow up with doctor on 11/08/21.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (shingles outbreak on New Years Eve, 31st December 2010). Concurrent medical conditions included nickel sensitivity (Nickel allergy and allergy to Ibuprofen and aspirin), drug allergy (allergy to Ibuprofen and aspirin) and fish allergy (reaction to bad fish - toxin ciguatera about 20 years ago which could affect her nervous system). Concomitant products included LUNESTA, Hydroxyzine, TYLENOL and VAGIFEM. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, ear pain, localized erythema, neck pain, fatigue and feeling bad. The patient was treated with Cortisone Topical Cream and antihistamine. On an unknown date, the outcome of the pain in arm, ear pain, localized erythema, fatigue and feeling bad were recovered/resolved and the outcome of the neck pain was not recovered/not resolved. The reporter considered the pain in arm, ear pain, localized erythema, neck pain, fatigue and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that her ear pain started within a day or so. The patient experienced really sore arm and a huge red area approximately 3.5 inches by 3.5 inches. The patient claimed that she felt lousy for four days and was exhausted during the day. The patient's neck and ear hurt where she had the shingles vaccine 7.5 years before the date of reporting. The patient had to cancel everything because she felt really bad. The patient was able to sleep because her physician told her to use Cortisone cream and take an antihistamine. The patient's arm pain lasted 5 to 6 days. She felt tired for 4 to 5 days. The patient had denied permission to contact their physician.
This is a spontaneous report from a contactable consumer (patient). A 34-years-old male consumer received first dose of bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number - EP7534; Expiration date: Unknown) via unspecified route of administration in left arm on 22Mar2021 at 08:15 AM (at the age of 34-year-old) as SINGLE DOSE for COVID-19 immunization. The medical history of the patient was not reported. The concomitant medication included Nasacort, Equate Allergy Relief (generic to Zyrtec). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Nasacort, Equate Allergy Relief (generic to Zyrtec) within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, Prior to vaccination. Patient has been tested for COVID-19, Since the vaccination. On 28Mar2021, patient experienced cold like symptoms, cough, fever chills. On 29Mar2021, patient had positive nasal swab test. Patient did not receive any treatment for the adverse event. Patient received positive COVID-19 test on 31Mar2021. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
crying, unconscious, convuls, t101; took to MD; hospitalized for admission seen by MD;
DEATH; HEART ATTACK; This spontaneous report received from a patient via a company representative via Social Media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after two days of vaccination, the patient experienced heart attack then slowly went down hill and died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated that  "Hey Johnson and Johnson my dad got the shot and 2 days later had a heart attack. Then slowly went down hill and died. Thanks a lot for killing my dad. You will pay for what you've done." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on an unspecified date,  and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-20220237253 -COVID-19 VACCINE AD26.COV2.S-Death, Heart attack. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Turned red and had rash all over. Developed cough. Large, red knot came up at injection site.  Benadryl IM, Epinephrine IM, and Prelone Syrup PO given in ER.
Pain at Right armpit and R shoulder not controlled with 400 MG advil x 1 dose. Pain began in the evening and had continued the next day. Pain rated 6 on a 1-10 scale on 5-7-14 at 10:45 AM.
Feels tired but not bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 16Mar2022 (Batch/Lot number: unknown) as dose 4, (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose: 1), for COVID-19 Immunization; Moderna (Dose: 2), for COVID-19 Immunization; Moderna (Dose: 3), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 18Mar2022, outcome "unknown", described as "Feels tired but not bad". Therapeutic measures were not taken as a result of fatigue.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial unsolicited report received from a consumer on 12 October 2015. This case involves a 65-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, dose, dose in series, expiry date were not reported) intramuscularly in left deltoid on 23 September 2015. The patient's illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known allergies, fibromyalgia, peripheral neuropathy feet. Previous medication included TRAMADOL HYDROCHLORIDE (Tramadol) and HYDROCODONE BITARTRATE/PARACETAMOL (Vicodin) for pain management. Concomitant medications were not reported. Laboratory data and corrective treatment was not reported. On 23 September 2015, the patient's injection site became red, warm and swollen two days after the vaccination. The patient's symptoms abated two days after vaccination and began having tingling of left hand, shooting pains from elbow to fingers in left arm, aching, increased with movements. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The outcome was reported as not recovered. Patient's pain persisted since 48 hours after vaccination. List of documents held by sender: none.
1/17/22 45yoF with PMH HTN, Seasonal Allergies, Obesity (BMI 46) here for evaluation of possible COVID19. Reports 2 days of runny nose and awoke with bitemporal headache and sore throat this morning. Called into work who advised she call employee health, who then instructed her to come for evaluation. Feels her allergies have flared since recent blooming of fall flowers (has most notable allergies to pollen and molds). Educated a patient last week (with masks) who subsequently was admitted with COVID19, but otherwise no known sick contacts. Is s/p both doses of Pfizer vaccine >6 months ago.  Review of Symptoms:   Review of Systems  Constitutional: Negative for chills and fever.  HENT: Positive for congestion, sinus pain and sore throat.   Respiratory: Positive for cough. Negative for shortness of breath.   Musculoskeletal: Positive for myalgias.
Information has been received from a pharmacist concerning a female with a latex allergy who was vaccinated with MMR II. Subsequently the patient experienced an anaphylactic reaction and had a negative titer for rubella. Upon internal review anaphylactic reaction was determined to be an other important medical event. Additional information has been requested.
Pt experienced dizziness, nausea, vomiting. Recalled that after his first dose he had mild dizziness and nausea but did not think anything of it. Treating symptoms with OTC meclizine.
SHOULDER PAIN; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (SHOULDER PAIN) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ARTHRALGIA (SHOULDER PAIN). At the time of the report, ARTHRALGIA (SHOULDER PAIN) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Chills (lasting 5 hrs), fever (lasting about 16 hrs), headache, dizziness, muscle ache, fatigue, sore vaccinated arm and other arm, too
Angio edema, treated with prescription benadryl and steroids administered intravenously
I began to experience shortness of breath, head pressure and heart arrhythmia of some sort.  These symptoms increased in intensity from Tues-Wed, then reduced with an increase in chest pain. I sought medical care on Friday, Dec 24th at Urgent Care , where diagnostic tests were run. Everything came back normal.
Pt describes sx consistent with is current hypothyroidism including generalized fatigue and muscle aches that have been ongoing for several months after vaccination.
10/28/18 9:00 PM flare-up of acid reflux. Have taken omeprazole for years and no flare-ups for at least a year before vaccination. Took two days to get it under control with omeprazole, TUMS, and ranitidine. 11/4/18  4:00 AM flare-up of gout in left foot. Had not had flare-up for five years previous. Took prednisolone MEDROL pack to control the gout.
muscle soreness at greater injection site; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number=EJ1685), intramuscular in left arm on 20Dec2020 16:00 at a single dose for Covid-19 immunization. Medical history included diabetes and hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has no allergies to medications, food or other products. The patient's concomitant medications included prescribed medication (unspecified). The patient experienced muscle soreness at greater injection site on 21Dec2020 at 06:00 AM. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered.
YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 53 years old female patient and yf-vax(YELLOW FEVER VACCINE - ) was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) all for Immunisation.  On 14-Jul-2022, the patient received a dose of 0.5 ml of suspect YELLOW FEVER VACCINE - lot UJ602AA, expiration date:13-Jul-2024, via intramuscular route in the left deltoid as Immunization. The patient used the product previously.  On 14-JUL-2022 the yf-vax was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event (incorrect route of product administration) same day following the administration of YELLOW FEVER VACCINE - . Caller would like to know if the dose was valid. This situation was reported as a medication error.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (YF-VAX was administered to a patient through the intramuscular route instead of the subcutaneous route with no adverse event).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a licensed practical nurse concerning her friend's 17 year old daughter, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced pain and redness at the injection site. It was reported that "she had a raised area at the injection site." The patient did not seek medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Red area on arm below injection site; Swollen area on arm below injection site; The area is sore; The area gets itchy; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2021, the patient received the 1st dose of Shingrix. On 6th October 2021, 2 days after receiving Shingrix, the patient experienced erythema, swelling, pain and pruritus. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the erythema, swelling, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the erythema, swelling, pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received the first shot and the next day and had the side effects.  The third day the patient developed a red swollen area on my arm below the injection site. The patient applied ice periodically, it was sore and got  itchy.  The patient asked if this was an allergic reaction.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  Pharmacist received vaccine on 28-MAY-2021 and used on  27-JUN-2021 after refrigeration. She never used the lot until the vial was used on twenty patients.Pharmacist quarantined them as unusable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 6-JUL-2021 contains no significant information. On 07-Jul-2021: Follow-up details were received and does not contains any significant information: patient details were updated.
Patient experienced rash/inflammation in arm day after receiving vaccination. Doctor diagnosed inflammation as originating from infection. Infection resulting from injection highly likely. Patient was prescribed cephalexin.
Pt. reported achiness, soreness around the injection site. Red, inflamed area on the biceps. Went to ER just in case - MD suggested ice, TYLENOL and CLARITIN.
Both lower legs extreme rash and now going to upper leg; This is a spontaneous report from a contactable consumer (patient)  A no pregnant current 66-year old female patient received bnt162b2 ( PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age of 65 years via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EN5318) as 1st SINGLE DOSE for covid-19 immunisation  . No other vaccine in four weeks;No Other medications in two weeks. Medical history included Heart attack (2 stents) , penicillin allergy, walnuts allergy from an unknown date and unknown if ongoing.     The patient experienced both lower legs extreme rash and now going to upper leg on 12Feb2021 12:00 with outcome of not recovered.The event was treated with cream Follow-up attempts completed. No further information expected.