chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Feb. 2021 Occasional bilateral foot cramps. April 2021, severe foot and bilateral lower leg cramps almost daily, lasting up to 30 min. Pt. tried stretching, wearing supportive shoes. May and June much more intense. Unrelieved by Magnesium supplementation. Only improved with water intake increased to 200 ounces per day. Middle of June developed URI symptoms. 06/13/21 left lower leg edema and mild pain noted. 06/14/21 went to PCP Dr.. L leg venous Doppler study completed. Dx DVT. Started on Eliquis. ER 06/25/21 for worsening left leg pain and swelling. Doppler study repeated, L clot had extended. Presence of chronic DVT in R leg where previously noted, and chest CT revealed a small PE in RLL. Referred to cardiologist. 07/16/21 symptoms continue to improve with only moderate swelling of left leg when standing and ambulating for large portions of the day.
Pt. was walking dog, felt hot, dizzy, nauseous, sob.  Went to Urgent Care and received an injection of a steroid, symptoms improved within 10-20 minutes. Pt received Prevnar 13 in right deltoid and Fluzone High-dose in left arm. Has had flu injection in past with no adverse reaction.
redness; swelling; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination.     No medical history was provided by  the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 29-Jan-2021, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
1) Localized circular rash below injection site; started day after vaccination and disappeared after 1 day  2) Itchy and burning raised skin rashes (hundreds of small dots) -  started on both arms and spread to hands, neck, face, and ears. Rashes started 5 days after vaccination and have lasted now for 10 days (has not yet resolved).
strange senation on tinger tips especially when using warm water as  when washing dishes, hands and face.  not a tingling just a strange sensation felt even when typing or touching  finnger tips.  no treatment , began about 5/2 in am .  did  not seek med. atten. just bringing it to your attention.    question should I receive 2nd dose?
Headaches and pain in sinuses  Dizziness persisting  "Brain fog" trouble concentrating/memory clumsiness, balance problems possible vertigo
Patient has ongoing pain in his arm since receiving the FLUZONE immunization on 8/27/12.
Flu shot caused me to wheeze, have a croupy cough, and have difficulty breathing.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Medium, Additional Details: Patient became unresponsive. We gave cold compress to help with this. Blood pressure was 76/46.  This happened at 10:57 am.  We ask if patient was a diabetic she said no. Follow up phone call was completed around 4:30pm but no response.  VM was left for patient to call back with update.
headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (reported as 73, unit unknown) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". Additional information: Patient received the first dose of the pfizer covid 19 vaccine and did fine. patient stated that she received the second dose three weeks ago and has had a headache on an off for three weeks and wanted to know is headache a reported side effect  and want to know how long will the headache last. She mentioned that her doctor told her the headache could be antibodies building up. Caller wanted to know how long does the body build up antibodies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M041181 / expiration date 31-MAY-2018, dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003854: US-009507513-1709USA003853: US-009507513-1708USA009093.
Reaction: Started with bright red skin with hives, racing heart, and difficulty breathing triggering an asthma attack, then started severe itching all over body, and swelling in the face. Treatment: Breathing treatment and two benadryl.
patient complained of dizziness and vitals were taken and bp was 179/47, spo2 99% on room air with numbness and tingling in left arm.  retake of blood pressure was 194/47 and pt was transported to urgent care via wheel chair.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves a 57 years old female patient who was vaccinated with 0.5 ml twice dose of FLUZONE QUADRIVALENT (lot number: UJ041AA and expiry date: 30-Jun-2019, dose in series and route of administration were not reported) in left arm on 26-Sep-2018 and 21-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none. It was a case of actual medication error due to extra dose administered. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by the sender: none.
Warm itchy red rash just below injection site, started 1 week after vaccination. Mostly resolved after 2-3 days
Pt recv vax on 7/28/97; on same day pt exp raised area at vax site x 2-3 day; reddened to macular rash w/ edema & itching spread to Rt arm, LA, Lt leg & chest; tx=Prednisone. Pt exp eczema 1 wk post med completion
Vaccines received 3/13/2006. MD called 3/15/06 stating child's entire (R) shoulder to injection very red, swollen, black/blue, from site to elbow very red, entire arm upper arm very hot to touch. Saw PMD DX infection at site prescribed antibiotic.
Severe skin reaction after given PROQUAD, IPOL, and HAVRIX; given BENADRYL for the allergic reaction and patient respond well to it
she had been tested positive after the first dose of Covid-19 vaccine.; she had been tested positive after the first dose of Covid-19 vaccine.; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had been tested positive after the first dose of COVID-19 vaccine. Outcome of the events was unknown.  Information about lot/ batch number has been requested.
Nausea, vomiting, diarrhea, headache beginning about 11 hours after vaccination
24 hours post vax, the pt experienced swelling in the leg and redness and tenderness from the groin to the knee associated with fever.
44 yo male w/ hx of PE (presumed provoked; dx'd in July 2021), previously fully vaccinated against COVID with Pfizer (completed Pfizer series in March 2021),  reported left calf pain that developed 2 days  after receiving Moderna COVID booster. Patient was subsequently dx'd and treated for a DVT (confirmed on compression US). Pt was subsequently placed on therapeutic Xarelto at time of DVT suspicion. Patient was treated successfully as an outpatient. Will be on life-long anticoagulation given new DVT in setting of recent PE.
hot; nauseous; heart was racing; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 25May2021 at 12:00 (at the age of 46-years) as single dose in the left arm for covid-19 immunisation. The patient's medical history included hypothyroid and had food allergies. The patient's concomitant medications included levothyroxine sodium (SYNTHYROID), Cetrizine from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021 at 12:00 within 10 minutes of receiving vaccine the patient experienced hot, nauseous, and heart was racing. Patient stated that pharmacist gave me two doses of Benadryl and one of Tylenol. After a bit the symptoms abated. Patient scheduled an appointment with my PCP to discuss this reaction. She advised to continue and get the second dose. She had the second dose and the onset was faster and more severe. She had the shot and with 3 minutes she was dry heaving, very congested, throat felt tight. She could still breathe. This all happened even though she took Benadryl and a Tylenol 45 minutes prior to her injection. Again, the pharmacist gave a dose of Benadryl to help with the effects of the vaccine. She would like to know what is in the vaccine. Patient stated that she had food allergies and this reaction is frightening. Ae resulted in clinic visit and ER visit. The outcome of the events was resolved.  Information on Lot/Batch number was available. Additional information has been requested
fever; headache; muscle aches; pain at injection site; heartburn; upset stomach; pain in upper chest; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th November 2019, 1 days after receiving Shingrix, the patient experienced fever, headache, muscle pain, injection site pain, heartburn, upset stomach and chest pain. On 5th November 2019, the outcome of the fever, headache and muscle pain were recovered/resolved. On 6th November 2019, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the heartburn, upset stomach and chest pain were recovering/resolving.   It was unknown if the reporter considered the fever, headache, muscle pain, injection site pain, heartburn, upset stomach and chest pain to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Patient feeling lightheaded and has a rash on his back. RN stated go to ER for evaluation. Stated no other symptoms, breathing fine, no edema of face or lips. Patient took Benadryl, the rash is gone and he no longer feels lightheaded. Patient feels much better today.
HOT TO THE TOUCH; FEELING COLD; FATIGUE; TEMPERATURE; CHILLS WITH SHAKING; ARM PAIN AT INJECTION; This spontaneous report received from a consumer concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included non smoker, and concurrent conditions included 4 times per year alcohol use, cats/dogs allergy, pollen allergy, and different metals allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm pain at injection. On 18-MAR-2021, the subject experienced temperature. On 18-MAR-2021, the subject experienced chills with shaking. On an unspecified date, the subject experienced hot to the touch, feeling cold, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain at injection on 19-MAR-2021, was recovering from chills with shaking, had not recovered from temperature, fatigue, and hot to the touch, and the outcome of feeling cold was not reported. This report was non-serious.
Chills, aches, sweating, headache, lassitude, weakness - feebleness,  like the onset of a bad flu episode. Awoke in the night with symptoms, like at 2:00 am
pt recv vax;exp urticarial rash on both cheeks 1 day p/ vax;rash itches;no oth sx;dph given & hydrocortisone cream;
My child received the MMR shot and had both a high fever for three days (7 days after shot) and also got a rash all over the trunk of her body which lasted 2 days.
Information has been received from a physician referring to a patient of unknown gender and age. No concurrent condition, medical history and concomitant medication were reported. On 13-JUL-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dosage and route were not reported), who was supposed to receive ZOSTAVAX. At the time of the report, there was no adverse effect reported. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Less than 5 mins after injection, patient blacked out and fainted to the ground and hit his head in the process. patient experienced mild seizure/movement after fall and regained consciousness after about 10-15 seconds later after pharmacist rolled patient to his side. patient reported similar events after having his blood drawn.  ambulance was called and EMT team came to check out patient. patient reportedly felt fine, but after advise from EMT, patient drove himself to ER to get checked out.
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4.  Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well.  I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
T101.3 x 1 day; 99.4 x 3 days; hot & cold chills x 2 days; aching intense x 6 days; aching sl x 4 days; Itching, swollen, redness arms & legs x 4 days intermittant h/a x 2 days;
Hives.  Took Zyrtec-D on night of 10/1/2010.  Hives disappeared on morning of 10/2/2010.
4hr p/vax pt started high pitched crying, very fussy, temp of 102.7, leg red & swollen, unable to console
Grand maul seizure on September 17 2021. Lasted 16 minutes. Memory loss, repeat myself and can?t remember the names of specific items. Left Shoulder dislocation during violent seizure resulting in muscle and joint damage. currently taking 1500mg of Keppra daily.
Spoke with the patient 2 weeks after the immunization was given. The Immunization was given on 9/21/18. That was the 2nd dose of the Shingrix given to this patient. The patient did not have any reaction after the 1st dose. The patient reported that she had a rash about 1 inch in diameter around her naval and also a sore arm. The patient did not seek any medical attention or inform her doctor. The patient self treated herself with Cortisone-10 and the rash cleared up after 3 days.
Moderna COVID?19 Vaccine EUA About a week after the injection, the injection site started swelling and got worse over days 7-9. The injection site swelled to what feels like a knot under the skin and is warm to the touch and red.
the patient was supposed to receive the 2nd dose of the primary series of the COVID vaccine in the Pfizer brand. what the patient actually received was the updated booster dose in place of that vaccine.
I had shoulder injury due to vaccine administration when getting the PREVNAR 13 vaccine at a local pharmacy. The vaccine was administered too high on the arm, hitting a nerve or going into bursa. This resulted in a swollen painful arm for 4 days. According to an article in a news paper, much more severe injuries can result from inappropriate placement of an intramuscular vaccination too high on the arm. This needs to be publicized nationwide since it is related to a medical practice and not to any one particular vaccine.
Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history. On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who had children who had had similar experiences as her daughter (MARRS number: 1703USA003781). The experiences reported included:  pyrexia, helicobacter infection, leg pain, feeling abnormal, neuralgia, body temperature fluctuation, hypoaesthesia, neuropathy peripheral, fatigue, muscular weakness, abasia, paraesthesia, vomiting, nausea, stomach pain and influenza. The outcome of the events and the relatedness between the events and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the abasia and the helicobacter infection were considered as medically significant events.  This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004619.
Approximately one week after my first COVID shot, a cyst that had been present for decades on my right breast without any problems swelled up and abscessed.  Wound cultures were negative for any growth, so it appears to have been some sort of inflammatory issue, possibly a Sjogren's flare triggered by the COVID shot.
pain, big knot on bicep, fever, redness, states could not get out of bed/walk the day after
I know 4 other women with injuries ER8731 all neurological Bad Batch; I know 4 other women with injuries ER8731 all neurological Bad Batch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8731) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), INJURY (non-serious), outcome "unknown" and all described as "I know 4 other women with injuries ER8731 all neurological Bad Batch".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200642436 same vaccine/reporter/AE, different patient;US-PFIZER INC-202200642437 same vaccine/reporter/AE, different patient;US-PFIZER INC-202200642438 same vaccine/reporter/AE, different patient
This spontaneous report as received from a Medical Assistant via a company representative, concerning an 11 year old female patient. The patient's concurrent conditions included migraines and other unspecified medical history. Information regarding drug reactions/allergies were unknown by the reporter. On 05-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M043731 and expiration date of 22-JUN-2019, intramuscularly for prophylaxis as part of a vaccine for children program ("VFC") (dose was not reported). On the same date, immediately after receiving GARDASIL 9, in the Health Care Professional's (HCP's) office the patient experienced blurry vision. There was no treatment given for the adverse event and none laboratories were performed. At the time of reporting the patient did not recover from vision blurred. The causal relationship between the event and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Swelling to right arm axillary- golf ball sized- no pain or discharge at site  - Benadryl- with observation and instruction to contact medical staff for any further issues.