chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M022402 with an expiration date 01-NOV-2017 or lot# M035690 with an expiration date 06-FEB-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effect were reported. Administered doses of PROQUAD experienced the temperature excursion of 7 degrees Fahrenheit, reported also as from 6 degrees Fahrenheit to 14 degrees Fahrenheit (and as from -14 degrees Celsius to -10 degrees Celsius) for 30 minutes. A digital data logger was involved. There were no previous excursions reported. Product quality compliant (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012359: US-009507513-1703USA012358.
Pt had mild flu like symptoms, including sniffling, mild nausea, headaches, weakness, and dizziness.
Runny nose; Stuffiness; Feels like she has "one heck of a cold; This is a spontaneous report from a contactable consumer (patient reported herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Mar2021, as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced runny nose and stuffiness on 07Mar2021. Also, she stated that she feels like she has one heck of a cold on 07Mar2021. she stated that she wanted to know if this is a possible side effect of vaccination, since she had only seen it listed as a covid symptom. The seriousness criteria of the events were reported as non-serious by the reporter. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) 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 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800 to 900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that they got 10 vials Moderna vaccine (037C21A) delivered on 24-May-2021 and immediately placed the vaccine into refrigerated storage. Then stated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use. Reporter reported that the vaccine was given unknown amount to patient past 30-day beyond use date (BUD). Patient did not report any adverse events or symptoms.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to (Patient Link).
COVID 19 positive on 08/02/2022. Side effects; sore throat; nasal congestion; headache; fever 100.6-degree; malaise; body ache and chills; runny nose and occasional sneezing. On 08/05/2022 I had a telehealth appointment and was directed to the ER to get a monoclonal antibody shot. I feel that I have recovered at this point.
Persistent high fever (101.7-103.6 dF) lasting >24hrs and not responsive to Tylenol; chills; body aches; persistent abdominal pain after eating and drinking lasting one full week (through current and not resolved at time of report)
After receiving the vaccine I had a low grade fever, and it lasted for about 6 or 8 hours.
She administered one intramuscularly instead of subcutaneous with no reported adverse event; Initial information received on 15-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves an unknown age female patient who was administered one intramuscularly instead of subcutaneous with no reported adverse event while receiving vaccine yellow fever vaccine -  [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine (Typhim) for Prophylactic vaccination.  On 15-Apr-2022, the patient received suspect yellow fever vaccine - at a dose of 0.5 ml once (lot number, form, strength: not reported) via intramuscular route in unknown administration site on left side for immunization.  On 15-Apr-2022 the patient was administered one intramuscularly instead of subcutaneous with no reported adverse event (incorrect route of product administration) (same day latency) following the administration of yellow fever vaccine - .  Action taken: not applicable.  Outcome: Unknown.   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.
Patient came back to the pharmacy after about 15 minutes complaining of chest pain and asked us to call 911. I had him chew an aspirin and medics arrived on the scene. He had no reaction to the first shot and no past heart issues. He did not believe the symptoms to be from the vaccine.
Rash on face and trunk with scabbing of some lesions. No itching, no fever. Have continued to break out over past few days.
after injection that night around midnight , I felt fluttering in my chest. First time every experiencing this . Now it comes and goes.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Underlying condition. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was admitted to Intensive case unit as she was diagnosed with covid-19 infection after she had received the Janssen Covid 19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of the Suspected Covid-19 infection and Suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210827058- covid-19 vaccine - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210827058 - covid-19 vaccine-Suspected Covid-19 infection. This event(s) is considered unassessable. 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).
This case was received from a health care professional on 22 June 2009.  A 43-year-old female, with a history of environmental allergies, penicillin allergy, anemia, and hypothyroidism, received an intramuscular left deltoid injection of ADACEL on 27 May 2009 (lot number UF460BA, Sanofi - Pasteur Ltd. lot number C3066).  Approximately 24 hours post-vaccination, the patient complained of severe flu-like symptoms, including lethargy, shortness of breath, rash on the torso, chills, body aches, and headache.  She also complained of redness, warmth, and tenderness at the left deltoid.  She was seen in the office on 29 May 2009, and her physician prescribed increased fluids, an ice pack to the injection site, and ALEVE as needed.  She was subsequently described as feeling 20% better.  Follow up information received on 07 July 2009 from a health care professional.  The patient recovered and did not require additional treatment.  No additional information was provided.  Follow up information received.
A report has been received from a Health Professional concerning an 8 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The patient experienced expired FLUMIST/administration of expired FLUMIST which started on 13-Jan-2014. The outcome of the event of expired FLUMIST/administration of expired FLUMIST is unknown. The report was considered to be non-serious.
pt recv vax 13JAn97 & devel a fever 38hr p/vax 38.9;pt tx w/APAP to lower the temp;
no adverse effect; pediatric VAQTA were administered to a nineteen yera old patient; This spontaneous report was received from a Medical assistant regarding to a 19-year-old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 13-SEP-2019, (also reported as today) the patient was vaccinated with pediatric hepatitis a vaccine, inactivated (VAQTA) 2 doses of 0.5ml vials(route was not reported) lot # S002505 and expiry date 04-APR-2020, for prophylaxis (product administered to patient of inappropriate age). No product quality issue and no adverse effect reported.
Slight rash appeared on Monday, 4/26. By the next evening it was more pronounced. This evening it?s about doubled in size, has a slightly raised texture, and the area is warm to the touch. It?s starting to tingle a bit and is mildly sore. I have had a headache for several days as well, but could be unrelated.
Information has been received from a physician concerning a 20 year old patient who in 2007, on an unspecified dates was vaccinated with the three doses of GARDASIL (Lot # and route not reported). It was reported that on 01-MAR-2009, the patient presented low grade squamous intraepithelial lesion (LGSIL) with high risk of human papilloma viral infection and low risk human papilloma viral infection and on 18-DEC-2009 these same results were found also. At the time of the report, the outcome of the patient was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
sz 3 1/2 months p/last vax & 3rd dose; treatment unk-unable to contact parent;
After my first COVID shot on March 24, 2021, my pulse began racing.  I thought it was a panic attack and took my panic attack medication but it didn't help.  My pulse was remaining above 90 even at rest (it did drop into the 70's when I slept) and peaking between 135-150 bpm for about a week.  I spoke with my allergist and my primary doctor's clinic and both encouraged me to get the second vaccine.  I got the second vaccine on April 22, 2021.  My heart rate climbed again and so did my blood pressure this time.  My normal BP is around 110/70.  After the vaccine my BP went up to 157/110.  I saw my doctor again and we decided to see if the BP would come down on it's own.  After about 2 weeks of staying in the range of 150-130/110-90, it finally returned to normal but the tremors in my hands that I thought were caused by the high heart rate and blood pressure have not gone away.
03/15/2021 at 14:55 Patient c/o dizziness, nausea, and anxiety. Patient requested to lay down. Patient moved to the floor into supine position. BP 98/60, HR 66 bpm, SpO2 97%, temp 97.4 F, room air. After approximately 5 minutes, patient said he felt better. Gave patient a water bottle, patient moved back to chair. Advised patient to wait 30 minutes before leaving for extra observation. 15:25 pm. BP 110/78, HR 64, Sp02 99%, temp 97.3 F. Patient reported feeling better no more dizziness, nausea, or anxiety at this time. Patient walked independently and left facility.
Seasonal Flu Vaccine Administered in Left Arm.  Developed shingles rash with T6 dermatome with severe pain itchiness and inability to function due to pain, was started on Famvir by on call emergency doctor.  Rash extended and Neurontin 300 mg tid and Famvir continued for another 7 days.  Has severe shingles pain interfering with sleep and functioning.  Seen by PCP.
This case was reported by a pharmacist and described the occurrence of rash in a 14 year old female pt who received Engerix B. On an unspecified date, the pt received a dose of Engerix B (dose number not specified). On an unspecified date following the administration of Engerix B, the pt experienced a "mosquito bite like" rash. The pharmacist "got the impression that the rash was not localized" but was not sure where the rash was located. The pt was seen at a physician's office and was treated with diphenhydramine. The event resolved on an unspecified date. The vaccination with Engerix B.
After he received the MENACTRA and ADACEL, he started to c/o nausea. Shortly after that( 3-5 min) he became pale. About 2 minutes later he said he could not see but could still hear. He was sitting in a chair while this was occurring and had oxygen being delivered at 6 liters/min. He got back on the table with a little help where an was lying down with his feet elevated. Before he got on the table his glucose was checked on the residual in the CBC tube and was found to be 74. His lips pinked back up while lying down. His heart rate was around 58-62 per Sat meter and the oxygen was turned down to 2 1/2 liters/min while maintaining his saturation. An ambulance was called to transport him to the hospital. BP while lying down was 84/50.
Cellulitis left upper arm. Swelling began night of vaccination and skin became red, hard and shiny; associated with tenderness. Seen in urgent care 2 days later and admitted to hospital. Site warm to touch; patient afebrile. The hospital discharge summary received on 2/25/04 states positive rechallenge.
pain /muscle pain all over my body; injection site is warm; fever / high fever /feverish; Injection site pain; Became sicck; Muscle pain all over the body; redness /my arm is red / injection site redness; swelling at injection site / swollen all the way down to my elbow; chills /shiveriing; slite headaches; This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020, the patient received Shingrix. On 16th January 2020, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, chills, headache, erythema of extremities, fever, injection site pain, sickness and generalized muscle aches. On 17th January 2020, the patient experienced general body pain and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, general body pain, fever, injection site pain, sickness and generalized muscle aches were unknown and the outcome of the headache, erythema of extremities and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, chills, headache, general body pain, erythema of extremities, injection site warmth, fever, injection site pain, sickness and generalized muscle aches to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On Thursday night at 9 pm, the patient experienced chills, headache, fever, shivering, pain ,redness and swelling at the injection site and muscle pain all over the body. On Friday 17th January 2020, the patient could not get out of bed because of fever, body pain and chills. The reporter stated that, till the time of reporting the patient had the injection site red and warmth. The patient stated that, the arm was swollen all the way down to the elbow and was feverish till the time of reporting. The patient had slight headache at the time of reporting. The patient asked, if this was ok or should worry.
Beginning 2 hours after shots, child cried for about 10 days.  Any change of position, cried.  Injection sites negative.  T max 100.9.
Rash on chest and Neck; Intermittent headache; Diarrhea; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 14-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0168, expiry date: unknown), via an unspecified route of administration, administered in left arm on 21May2021 11:00 (at the age of 14-year-old) as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. On 23May2021 12:00, the patient experienced rash on chest and neck, intermittent headache, diarrhea and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Outcome of all the events was not recovered at the time of reporting.   Follow-up attempts are completed. No further information is expected.
Mom believes child got Bells Palsy from vaccine. 8/29/07-records received from neurologist. 5/22/07-Left sided Bell's Palsy. Experienced a severe headache on 5/20/07-with subsequent loss of taste. Next morning 5/21/07-could not close left eye but was able to raise the left eyebrow and move left side of nose. On 5/22/07-lost all left sided sensations and function. Ill with upper respiratory infection 1-2 weeks prior to onset of the 5/20/07 headache. Received first dose of HPV 3 months ago. Visit on 6/4/07-Minimal improvement after course of Prednisone. Continues to have difficulty closing left eye as well as raising left eyebrow and left side of mouth. Sense of taste to left side of tongue has returned and eating and drinking without difficulty. Schedule MRI in one month. Mother canceled follow up appointment said daughter was doing well
He was given VARIVAX #2 developed hives all over, swelling of face, wheezing and tachycardia.
By 4/13 my blood pressure was up almost 30 points and pulse was over 120, anxiety, flushing, no appetite lost 19 lbs in 3 weeks, whole body was shaking at times I felt completely awful and had no idea what was happening.  Saw cardiologist and endocrinologist then for help.  Endocrinologist ran blood work my thyroid was way off hypo.  Cardiologist platelets were way off.  April 26 started vaginally bleeding which lasted 40 days with heavy clotting.  Had biopsys which were negative but bleeding continued.  Also had multiple blood tests and vaginal sonograms.  Mostly determined by doctors that just would have to ride it out.  Still to date not completely better still being treated for low iron levels and getting thyroid stable with medicine.
Covid Shot Reactions  The arm of injection was swollen shoulder to the elbow and later I had hives, but then came the horrible itching and welts. These even went to the shoulder and underarm and turned into some runny, oozie type and left scars and if I got warm the itching would start over again. Calling into for medical appointment only yielded Benadryl and antihistamine products recommendations if my breathing was ok.  I read about Covid Arm- I think I had Covid toes  something just tingled and hurt afterwards and this was not going on before. I have had sensations in my fingers like nerves and still some flesh-crawling feelings.  I only had the heart flutters after the 1st dose. Some headaches, itching, tired
This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 79-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis. On 28th December 2021, the patient received Engerix B pediatric. On 28th December 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On 29th December 2021, the outcome of the underdose was unknown. On an unknown date, the outcome of the adult use of a child product was unknown. Additional details were provided as follows: The vaccine was administered in left deltoid. The reporter reported that Engerix B pediatric administered to an adult, which led to underdose and adult use of a child product. The reporter consented to follow up. The permission granted for safety to follow up. No additional details were available at time of reporting and no further information given upon callback.
temp up to 102.7,joint & muscle pain & weakness (esp feet,ankles,running up back of legs,knees,fingers,elbows,x 6 1/2 wk,inc sed rate,liver & kidney tests abn but improving slowly,reynauds disease can't walk,tired,hoarse voice
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: The patient received antiviral for treatment of COVID-19 as other medication in 2weeks. The start date of the treatment was reported as 06May2022 and stop date was 10May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.