chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient Information regarding the patients' drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 31-AUG-2020, the patient received a dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot # S038701, expiry date 01-DEC-2021, for prophylaxis (reported as "well check")(concentration, dose, dose number, route of administration and frequency were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-9 to 8 Celsius degree) (-6.1 Celsius degree) (multiple excursions). Time frame was unknown by reporter. Data logger was involved. There were no previous excursions reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved.  It was also reported that improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355 has been verified to be a valid lot number, expiration date: 14-OCT-2021 (formulation, strength, exact dose, route of administration and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-14 to -10 Celsius degree) (-6.1 Celsius degree) for 13 hours. Time frame for 129 hours. Data logger was involved. There were no previous excursions reported.
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX for prophylaxis. On 1st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. In September 2018, the patient experienced fever, bedridden and chills. On an unknown date, the outcome of the injection site swelling, injection site pain, fever, bedridden and chills were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, fever, bedridden and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. His brother was a pharmacist and administered the vaccine to him. Within a day of receiving the vaccine, the patient experienced significant swelling at the injection site on his left arm. He could not roll over on his left side at night because the injection site was painful.  Also, the patient experienced a fever of 101 degrees Fahrenheit, and chills, making it so he had to stay in bed for two days. All symptoms resolved within 2 to 3 days. The reporter gave consent to follow up. Field representative thought she had 48 hours to report adverse events. Counseled that she needed to report these events within 24 hours. The reporter gave permission to be contacted. The reporter was unable to provide any additional information.
some with severe SOB ongoing; loss of taste and smell; loss of taste and smell; and had some symptoms on covid of flu dose; This is a spontaneous report from a contactable consumer. This is the first of 2 reports from the same reporter involving the same patient. The patient experienced adverse events with both 1st and 2nd dose of the vaccine. This is for the first dose of the vaccine. A 46-year-old (age at vaccination) patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9261), via intramuscular, at arm on 05Feb2021 at 10:20 as single dose for COVID-19 immunization. Medical history included Muno-Epstein Bar from Feb2020 it was ongoing (Pertinent details: ongoing fatigue resolved Aug2020), shingles 3x from 19Mar2016 (Pertinent details: Shingles 2x in 2016 and again in 2017 after vaccination). Concomitant medication included ibuprofen (IBUPROFEN ABECE) from Oct2010 to Apr2021 for EVLT procedure, progesterone (PROGESTERONE) and pregabalin (LYRICA) taken for Shingles from 2016 and it was ongoing. On an unspecified date, after vaccination with first dose the patient experienced severe sob ongoing, loss of taste and smell and had some symptoms on covid of flu. The patient underwent lab tests and procedures which included computerized tomogram: PE ruled out on 16Dec2020 COVID, computerized tomogram: PE ruled out on 17Feb2021 (COVID set back), electrocardiogram: stroked ruled out on 19Feb2021 (Ruling in POTS), magnetic resonance imaging: stroked ruled out on 19Feb2021 (Ruling in POTS), mast cell activation syndrome: unknown results on 14May2021, SARS-COV-2 test: negative on 16Jun2020 (Dr. indicated way for early likely COVID), SARS-COV-2 test: unknown results on 01Oct2020, SARS-COV-2 test: unknown results on 03Oct2020, SARS-COV-2 test: unknown results on 08Oct2020, SARS-COV-2 test: unknown results on 16Oct2020, SARS-COV-2 test: positive on 29Oct2020, tilt table test: + fo-positive on 15Apr2021 Covid induced POTS, ultrasound scan: stroked ruled out on 19Feb2021 Ruling in POTS , X-ray: PE ruled out on 16Dec2020 COVID set back PASC DX, X-ray: PE ruled out on 17Feb2021 COVID. Outcome of the events was unknown.
Large red rash and itching.  No treatment.  Lasted 5 days.  Still slightly itching.
Vaccine administered 10/03/13. Presented next day with warmth and redness at site and extending approx 1 1/2 inches below site. Later on second day, at approx. 5:00 PM experienced whole body, intensive itch, lasting approx. 4 hours. Slight erythema remains today, 10/7/13.
Syncopal episode with spontaneous recovery.  Second syncopal episode associated with 15 seconds of asystole on cardiac monitor.
Arm is sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm is sore at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (Arm is sore at injection site). At the time of the report, INJECTION SITE PAIN (Arm is sore at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sore at injection site-feels like muscle is sore deep ache. Pain has continued from 10/16/08 to 11/03/08. Tender to palpation at injection site- no bruising or redness noted.
Headache and major fatigue same day following shot, by late evening arm had "covid arm" rash and significant pain, to the point where I could not sleep properly night one. The swelling has gone down a bit as well as the soreness, but the rash and ache is still prevalent. I am certain it will continue to fade and am unconcerned, simply reporting in the side effect for records purposes.
Redness, 4 x 3 inch red, hard and significantly swollen site on upper left deltoid. Swelling is so severe that arm cannot be lifted lift past 90° to vertical.
Local reaction.  Red, swollen, warm to touch.  Swelling from injection site to the elbow.
Patient received first dose of Moderna vaccine.  He was sitting in the observation area and after about 10 minutes, he fell over and onto the floor.  He said he hasn't ever passed out from vaccine before.  We gave him some water and after a few minutes, he got up and sat back in the chair for another 20 minutes.  He said he was fine and didn't feel the need for any medical treatment or ambulance.
Initial case was received on 16 August 2010 from a healthcare professional. A 22 year old female patient received on 10 August 2010 an intramuscular injection of IMOVAX Rabies (lot number D1111-1) (pre-exposure series) and a subcutaneous injection of IPOL (lot number E0123-1). The patient reported to the healthcare professional that she "began to break out in large hives" 4-5 hours post vaccinations. The healthcare professional reported "angioedema", but the patient was not seen by a healthcare professional at the time of the hives. The patient got on a flight. She self medicated with BENADRYL 25 mg orally (frequency unknown) and was not evaluated by a physician at any time. The patient reported that 48-72 hours post vaccination she had a low grade fever (no temperature recorded) and vomited once. The patient received 2 previous doses of IMOVAX Rabies (lot number D0792-1) on 19 July 2010 and 27 July 2010 with no reactions. The patient experienced hives post final dose of Japanese encephalitis vaccine in 2007 but none post first 2 doses. Patient did not have an illness at the time of the vaccinations. Concomitant medication included MALARONE. The patient is allergic to BACTRIM and CEFZIL. No other pre-existing medical conditions were reported. At the time of this report the outcome status of the adverse events was not reported.
Patient received BIVALENT Pfizer vaccine for dose #2 instead of the Monovalent Pfizer vaccine. NO REACTION OCCURRED AT TIME OF ADMINISTRATION OR AFTER .
The week after the first dose of the vaccine, I had extreme pain in my arm pit and numbness in my left arm. My arm was cold to the touch. I went to Urgent Care after the pain lasted for over two hours. They did all sorts of tests to check my heart, lungs, blood pressure and everything was normal. I had a lump under my armpit and also swollen lymph nodes in my elbow. They thought the swelling of the lymph nodes were due to the vaccine. The pain in my arm pit went away after 48 hours, but the pain in my elbow still exists. I will be seeing an orthopedic doctor next week on April 13, 2021.
Injection site became infected approximately 6 days after receiving vaccine. Area around the injection site was hot to the touch, swollen and itchy and the actual infection spot is no visible and can be felt which it wasn't the first few days after the shot. In addition I was tired, had muscle aches and a headache lasting a couple of days.  I spoke to the Physicians Assistant at my doctors office and she prescribed a 3 - 5 day course of antibiotics (Augmentin).  The swelling has gone down and the the heat and itching have lessened, the other symptoms of being tired, achy and having a headache have mostly abated.
tender swollen lymph node in her armpit; This is a spontaneous report from a contactable consumer. This consumer reported for a 17-year-old female patient (Daughter). A 17-year-old old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: unknown), via unknown route of administration on 10Apr2021 (at the age of 17 years old), DOSE 1 SINGLE for covid-19 immunisation. The patient did not have Known allergies and other medical history. The concomitant medication of the patient was not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient experienced a very tender swollen lymph node in her neck (same side as the shot) beginning a day or two after the first vaccine. The patient did not teste for COVID post vaccination. At the time of this report the outcome of the event was unknown.  Information on the lot/batch number had been requested.
Patient said that 2 hours after the vaccination, she started having tingling in her legs and her balance got worse.  She has had multiple sclerosis for years, and she knows that the reaction was not from her routine medication.  Today marks 7 days after her vaccination and she can still feel tingling in her legs, must has gotten a little better.
DIZZINESS; NAUSEA; LOSS OF SMELL; LOSS OF TASTE; JOINT PAIN; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid19, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies and had no breastfeeding. The patient had emergency room for an allergic reaction 10 years ago. The patient took an unspecified high blood pressure medication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 04-JUL-2021) dose was not reported, administered on 28-MAY-2021 18:30 for prophylactic vaccination. No concomitant medications were reported.  On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 29-MAY-2021, the subject experienced loss of smell. On 29-MAY-2021, the subject experienced loss of taste. On 29-MAY-2021, the subject experienced joint pain. On 30-MAY-2021, the subject experienced dizziness. On 30-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of smell, loss of taste, and joint pain on 29-MAY-2021, and had not recovered from dizziness, and nausea. This report was non-serious.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: pt had similar symptoms upon second dose but about a week after receiving. Third dose she exhibited symptoms that day or next. still has swollen eye, voice sounds like she has a cold. dr was called but did not want her taking any antihistamines
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB with lot number K002327 with expiration date of 07-FEB-2016 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 34 F (1.111111111 Celsius). The sum of hours in excursion was 368 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion was reported as "Refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient received 1st dose of Pfizer Covid vaccine on 3/3/2021 without any apparent problems; was monitored for 15 minutes and discharged. Patient was reportedly found lifeless in his apartment by his mother on 3/11/2021.
16 year-old was administered the first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old was administered the first dose of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old was administered the first dose of Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old was administered the first dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  Action taken with mRNA-1273 in response to the event was not applicable.
pt devel severe arthralgia following 1st vax of hepta B. no other doses had been admin.
Within a minute of patient recieving her second dose of Pfizer, patient slumped down in her chair , her head went down to the side and her eyes rolled back and closed. I immediately  tried to get her to respond kind of shaking her shoulders and saying her name.  For about 10 seconds she didnt respond to us. I asked tech to call 911 and she already had started calling. Patient started to open her eyes then and slowly sit up. Patient was pale. She w.as able to say her name and when EMS asked she said she was breathing normally, no health conditions or stomach pain I asked if patient felt like she might  vomit so we got her a trash can. Patient coughed up just a very small amount of liquid/phlem. We also got her an ice pack because it was hot in the booth. At that time she was talking to us and smiling. Then EMS arrived and they assessed her and took her BP and glucose. As they were doing that patient said she was feeling faint again. EMS reccommended she go to Emergency Dept since she had had a second felling of faintness but she did not loose consiusness again. ANd since her Bp was very low at that time. EMS transported patient and mother went to hosp to meet them.
SORE ARM; A LITTLE FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 11-MAR-2021 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 11-MAR-2021, the subject experienced sore arm. On 11-MAR-2021, the subject experienced a little fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and a little fatigue on MAR-2021. This report was non-serious.
Intense pain in left arm (injected arm)- tricep, posterior shoulder, and ulnar nerve distribution. associated with numbness and pain and possibly some muscle weakness
Swelling, Erythema, tenderness and induration appearing 24 hours after the booster varicella vaccine.
Administered expired vaccine to patient-vaccine expired on 3/28/21 and was administered on 3/31/22 by our facility, no adverse events or reactions to vaccination
arm soreness at injection site; Body aches; chills; sore throat; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), intramuscularly on 17Dec2020 10:15 at single dose on left arm for COVID-19 immunization. The patient's medical history reported as none and no known- allergies. Concomitant medications received within 2 weeks of vaccination included colecalciferol (VITAMIN D [COLECALCIFEROL]), thyroid (ARMOUR THYROID), zinc vitamin, magnesium vitamin. The most recent COVID-19 vaccine was administered at Hospital. On 19Dec2020 19:00 (07:00 PM), the patient's arm soreness at injection site for 2 days. Body aches and chills and sore throat. No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
Red maculopapular rash appeared on abdomen 1 day after receiving vaccines. Faded without treatment after 2 weeks, but spread to both legs. On 12/3/2021 several red bumps appeared on right proximal forearm, spread to right wrist and hand within 2 days. No fever, no pain, no itching. Baby was evaluated in PCP clinic on 12/6/2021.
Rash, itching, swelling, pain Diagnosed with Herpes Zoster - Shingles on 05/29/21 at same medical facility Treated with Rx medicine Valacyclovir
No immediate adverse effects noted on 1/13/21. Patient was tired on the morning of 1-14-21.Her pulse was noted to be 106 at approx. 7:30am. She had a 10 minute tonic clonis seizure at approx. 8:15am. She was post ictal until 10:30 am. After the seizure, her O2 was 90% and she was noted to have a temp of 100.4. She was also very tired and confused.She went to ER by ambulance approx. 8:45am and they did a CT, Labs and a urine analysis. No significant findings reported. She returned to the residence at 4:37pm on 1-14-21 and was on vitals every 4 hours. Her vitals have returned to baseline.
High grade fever, chills, body aches. All which would not be broken by tylenol or a bath. This started at approximately 0600 on 1/16/2021. I went back to bed and woke up at approximately 1400 with the same symptoms.
administered expired fluzone hd/ no side effects reported; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 71 years old female patient who administered expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medication.   On 23-Apr-2019, the patient received a 0.5 ml  single-dose, prefilled syringe, without needle of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported expiry date: 09-Apr-2019 via unknown route in the left deltoid.  It was an actual medication error due to expired vaccine used. No side effects reported  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 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.  List of documents held by sender: none
pt recv vax 18FEB99 & 3 days later devel pain in one knee & that evening in other knee;unable to bend or bear weight;tx Ibuprophen;has revolving arthralgia;
Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliquis blood thinner. Currently in treatment phase with symptoms basically the same.
The patient states that she has been experiencing constant dull pain in the arm that the FLUZONE HIGH DOSE was admiistered since the date of administration. She states that she is unable to fully rotate her arm. Her range of motion is limited. She states she took ibuprofen and used hot/cold compress but she is still in pain.
Patient states swelling at injection site on same day. Swelling got progressively larger day by day. On 4/21, patient was at gym and felt a tingly sensation around swollen arm. Patient has not seen a physician. They have an appointment tomorrow with doctor.
Immediately I heard some sort of fluid flowing, figured that was what ever. Within minutes I had a metallic taste, which I figured was no big deal where I was then released. Within minutes after I had some malaise all throughout the rest of the day which lead to eventually feeling extremely tired and worn out. Today I'm feeling very ill and sore still, with some abdominal pain on my left side and I'm tasting a lot of blood which started up around 10 am.