chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 25 Adult patients (age and gender not reported), who experienced due to temp excursion product was not acceptable for use/calling about stability for two separate coolers/lowest temp was -2.2 degrees C for 45 min and a 2nd temp excursion lowest temp was -1.9 degrees C for 1 hour/lowest temp was -1 degree C for, while he/she received vaccines ADACEL, MENACTRA, IPOL, ACT-HIB, QUADRACEL, PENTACEL, DAPTACEL and TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5432AB. On an unknown date he/she also received a dose of the same vaccine lot C5463AA. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect IPV (VERO) lot number not reported. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5948AB. On an unknown date he/she also received a dose of the same vaccine lot U5986AA. On an unknown date he/she also received a dose of the same vaccine lot U5848AA. On an unknown date he/she also received a dose of the same vaccine lot U6015AA. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA. On an unknown date he/she also received a dose of the same vaccine lot C5546BA. It was a case of actual medication error due to incorrect product storage because for stability and due to temp excursion product was not acceptable for use. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. List of documents held by the sender: None.
Bilateral lower extremities weakness. Dizziness, nausea, unsteady gait, vomiting. Elevated blood glucose - 221 fasting. Patient extremities reported "cold". Patient reported these symptoms starting around 10AM.
I experienced fever, chills, exhaustion, body aches within the 24 hour period following my vaccination.
Patient reports lots of swelling in left hand one day after receiving the moderna booster. Patient reports swelling lasted one day and he had no other lingering issues.
TWENTY-FIVE MINUTES AFTER ADMINISTERING VACCINE PATIENT STARTED TO ITCH AND SKIN TURNED RED. BENEDRYL WAS ADMINISTERED AND PATIENT WAS ASKED TO STAY AN ADDITIONAL 5-10 MINUTES (TOTAL 35 MINUTES)  PATIENT STARTED TO FEEL BETTER BUT WAS STILL SOMEWHAT ITCHY AT TIME OF DEPARTURE.
pt recvd vax & w/in 1 minute post vax felt faint, went slump, head swung back, pt twitching, tongue protruded, exp decorticate posturing x 15seconds;disoriented & confused x 5mins;ER MD was required;pt was given 02 & adm to hosp;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patient received an expired dose of PNEUMOVAX 23 sometime in August 2012 or September 2012. The PNEUMOVAX 23 had an expiration date of 12-DEC-2011. No symptoms reported. The outcome of the event was unknown. The event was not related to PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Pain in neck, could not turn it all the way from side to side; Pain in neck, could not turn it all the way from side to side; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Pain in neck, could not turn it all the way from side to side), NECK PAIN (Pain in neck, could not turn it all the way from side to side), FATIGUE (Fatigue) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (Pain in neck, could not turn it all the way from side to side), NECK PAIN (Pain in neck, could not turn it all the way from side to side) and FATIGUE (Fatigue). On 22-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (Pain in neck, could not turn it all the way from side to side) and NECK PAIN (Pain in neck, could not turn it all the way from side to side) had not resolved and FATIGUE (Fatigue) had resolved.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality with Humira for the events of fatigue, pain in neck, could not turn it all the way from side to side and fever was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
left arm swelling, appeared within one hour of second vaccine dose. Swelling progressed with soreness of arm. Swelling worse day after. Started abating by Thursday 2/25/21 evening. Advised ice pack on arm, but pt. said it was too sore on day after dose given (Wednesday) to apply. Pt. took one aspirin on Wednesday morning. Advised her she could take a second later in the day. (Yesterday pt. stated she had taken a Tylenol. Today upon review she realized that she took an aspirin. Ibuprofen is also available. Advised pt. take an ibuprofen now over the phone as I waited. Taken at 8:13pm EST. No further medication taken on Wednesday. (Also encouraged ice pack on neck Wednesday for ongoing strong headache / neck pain yesterday. Pt. does not remember if she tried that. Head/neck pain resolved today.) Pt. states swelling today (Thursday) is mild-to-moderate, less than yesterday, but still noticeable. Doesn't hurt as much as it did yesterday, she says. She can now lift her arm without pain.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting/ falling - patient was responsive-Medium, Additional Details: After receiving both COVID Bivalent booster and Flu Shot patient fell fine. While walking around store patient went dizzy and fell backwards. Upon arrival pharmacist found patient conscious and responsive. Mother took him to primary doctor to be checked out and doctor indicated it was response to vaccines.
Patient given a expired (BUD) vaccination. Patient informed and advised to have another vaccination ASAP.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 29-FEB-2016, the patient was vaccinated orally with a dose of ROTATEQ oral liquid, lot # reported as L023936, expiry date 15-MAR-2017 (dose was not specified). The administered dose of oral, ROTATEQ underwent temperature excursion at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Very sore throat lasting 7+ days and trouble breathing in and out throughout those 7 days
I had symptoms and a Positive COVID test on 01/25/2022. I was exposed from my daughter. It did aggravate my Asthma and I had excess phlegm and Mucous. I was using my inhaler every 4 hours. It felt like pressure on my chest. I had Asthma my whole life and I needed to increase my use of my Inhaler. I did have itchy throat, some coughing, sore throat. There was one day I threw up and that was just one time. I didn't even feel sick and I have never felt like that ever. It was mostly mucous. I did have a tele-visit with my PCP who offered to prescribe steroids. I did not need feel I needed. I was told to take Flonase and continue to use my Inhaler every 4 hours PRN. My symptoms lasted a good 10-14 days.
Started as L arm pain, progressed to severe headache 10/10 all evening.  Could not sleep.  Next day intense headache persisted, developed nausea and vomiting , dry heaves for 12 hours.  + low grade fever. Took aleve 2 tabs - developed abdominal pain, no change in headache.  Day 3 arm pain gone, headache and stomach pain intense, no appetite. Nausea persisted.  Day 4 - minimal appetite, nausea, abd pain with eating.  Headache .  No other meds taken aside from aleve single dose.  Last two days - headache present but less intense.  Abdominal pain only when eating.  Appetite still low.
This spontaneous report was received from a pharmacist refers to a two week old patient. On 05-FEB-2014, the patient was vaccinated with a dose of GARDASIL mistakenly instead of RECOMBIVAX. No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
Pt noticed around 3AM 9/6/13 arm pain, hot arm and swelling at site of injection and redness both arms also achy feeling all over. Benadryl given 50 mg.
Onset of headache and fatigue around 8pm 4am: woke up and has extreme headache, arm so sore unable to move it w/o pain, whole body aches, chills, low grade fever  8am: extreme fatigue, fever, chills, body aches, body so heavy feeling unable to leave bed for any extended amount of time Sat. 4/2 Headache still present but not as extreme, arm still very sore but able to move it, fever broke, fatigue  Sun. 4/3 Slight headache, sore arm, minor cough, dry throat, tired but not fatigue  Mon. 4/4 Headache upon waking, Headache subsided, arm sore, dry cough, heavy feeling in upper chest/throat Tues. 4/5 *same symptoms Monday Wed. 4/6 *same symptoms  Thurs. 4/7 *same symptoms
Patient requested ZOSTAVAX, was administered FLUZONE - No problems following vaccination just wrong product.
Felt dizzy and lightheaded. No syncope but near syncope while still in the exam room. Blood pressure was monitored, given apple juice. After sitting felt fine and left.
Missed period after getting vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Aug2021 at 00:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 14Aug2021, the patient missed period after getting vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. On 03Sep2021, the patient underwent COVID-19 rapid test via nasal swab and the result was negative. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event missed period after getting vaccination was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MILD HEADACHES; BILATERAL LEG PAIN/ WORSE ON RIGHT LEG; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced bilateral leg pain worse on right leg. On an unspecified date, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral leg pain worse on right leg, and mild headaches. This report was non-serious.
Parent falsified DOB on vaccine consent form in order to get first two doses of Pfizer covid vaccine at age 4.5, when it was not yet approved for under age 5.  We administered the age 5-11 Pfizer vaccine based on the date reported by parent.  The DOB was again falsified when he came in for second dose on 12/3/2021.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a physician, recommended and or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-SEP-2012, a healthcare provider (unspecified healthcare professional) administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 24-MAY2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of itching in a 58 year old female subject who was vaccinated with Engerix-B plus a separate injection of Vaqta for prophylaxis. On 24 April 2006 the subject received 1st dose of Engerix-B (lot AHBVB156AA) and an unspecified dose of Vaqta. ON 24 April 2006, less than one day after vaccination with Engerix-B and Vaqta, the subject experienced itching. The subject was seen in an emergency room and was treated with Benadryl and Claritin. The healthcare professional considered the event to be clinically significant (or requiring intervention). The immunization series with Vaqta was discontinued. On 1 May 2006, the event resolved.
Pt states the same night vaccine administration she had pain in knee. 48 hr after vaccine admin little blister w/ fluid in it. Both symptoms went away 48 hr on its own. Minor scars were left but Pt fine and okay.
Patient called reporting to technician on 10/16/23, stating she feels like her arm is "broken" and is alleging tissue damage from a vaccine. She states she is going to have an MRI done.
The community stated this patient had 1 dose of the Pfizer vaccination on 1/19/21.. My team provided what was thought to be the second dose on 3/19/21 and upon billing discovered this was a third dose with the first dose being administered on 12/29/20.
Patient presented for COVID-19 booster.  Patient completed primary Pfizer series in 1/21, x2 vaccines. Booster was administered. Post vaccination, patient noted this was actually her "second booster shot". Patient noted she had also received a Pfizer booster shot in 10/21 as well.  Immediately post administration, patient has no complaints.
ARM SWOLLEN AND RED; ARM SWOLLEN AND RED; FELT TIRED; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (ARM SWOLLEN AND RED), ERYTHEMA (ARM SWOLLEN AND RED) and FATIGUE (FELT TIRED) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: DOXYCYCLINE, AMOXICILLIN and CODEINE. Past adverse reactions to the above products included Allergy with AMOXICILLIN, CODEINE and DOXYCYCLINE. Concurrent medical conditions included Drug allergy (AMOXICILLIN ALLERGY), Drug allergy (DOXYCYCLINE ALLERGY) and Drug allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (ARM SWOLLEN AND RED), ERYTHEMA (ARM SWOLLEN AND RED) and FATIGUE (FELT TIRED). In 2021, FATIGUE (FELT TIRED) had resolved. At the time of the report, PERIPHERAL SWELLING (ARM SWOLLEN AND RED) and ERYTHEMA (ARM SWOLLEN AND RED) outcome was unknown.            No concomitant medication was reported. In 2021, the patient experienced FELT TIRED and ARM SWOLLEN AND RED. In 2021, the FELT TIRED resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of FELT TIRED with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of ARM SWOLLEN AND RED onset in 2021 and ARM SWOLLEN AND RED onset in 2021 was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Erythema, induration (20cm x 10cm) at injection site. Painful with movement et triceps. Prednisone & BENADRYL & ice & close follow-up.
Information has been received from a nurse practitioner concerning a female (age not specified) who on unspecified dates was vaccinated with her first and second doses of GARDASIL.  The nurse practitioner reported that after the patient received the first dose of GARDASIL (date not specified), underneath her skin where the shot was given was hard and knotting.  The nurse practitioner also reported that when the patient came in for her second shot (date not specified) her arm still was knotting and hard so they gave her the second dose of GARDASIL in her bottom, and after being given the second dose of GARDASIL, where the shot was given became hard and knotty again just like the first time.  No further adverse event information was provided.  The patient did not seek medical attention.  The patient's outcome is unknown.  Additional information has been requested.
PATIENT'S MOTHER REFERS THAT APROXIMATELY 2 HRS AFTER VACCINATION A RASH APPEARED IN THE CHILD'S UPPER EXTREMITIES. DR. ORDERED BENADRYL.
Lost almost all control of her muscles; She can barely stand; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Lost almost all control of her muscles) and DYSSTASIA (She can barely stand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 029A21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Multiple sclerosis and Blood pressure high.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Lost almost all control of her muscles) and DYSSTASIA (She can barely stand). At the time of the report, MUSCULAR WEAKNESS (Lost almost all control of her muscles) and DYSSTASIA (She can barely stand) outcome was unknown.            Unknown concomitant medications were reported for Blood pressure and Multiple sclerosis Treatment information was not provided.   This case was linked to MOD-2021-364915 (Patient Link).
2 shots of Moderna +Pfizer booster; 2 shots of Moderna +Pfizer booster; 2 shots of Moderna +Pfizer booster; gotten Covid; gotten Covid; This is a spontaneous report from a contactable consumer. A patient (no qualifiers provided) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA) as dose 2, single and as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: off label use (medically significant), interchange of vaccine products (medically significant), immunisation (medically significant), outcome "unknown" and all described as "2 shots of Moderna +Pfizer booster"; drug ineffective (medically significant), suspected covid-19 (medically significant), outcome "unknown" and all described as "gotten Covid". Despite 2 shots of Moderna +Pfizer booster-last Wednesday patient tested positive for Covid. Symptoms minimal mostly scratchy throat that disappeared in hours-never any fever or loss of taste. Patient was isolating and mask wearing thankfully neither wife nor daughter was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 RT-PCR test: positive.  The lot number for BNT162b2 was not provided and will be requested during follow up.