chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Saturday evening noticed lump on clavicular area, more swollen Sunday, ultrasound showed four large lymph nodes on R side. Headache starting Monday, lasted till Thursday, continues swelling in clavicular area.
Patient said that she had redness, and swelling from her elbow up to her shoulder on her arm.  Patient counselled to take benadryl and ice the area and to seek medical care if does not improve in a day or so.
Pain following vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain following vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Pain following vaccination). At the time of the report, MYALGIA (Pain following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by reporter No treatment details was reported by reporter.   Reporter did not allow further contact
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed chickenpox. The number of lesions was not specified. The patient may have possibly been hospitalized after the symptoms appeared. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
After first shot, major bile duct constricted; hospitalized for stent placement. Stent removed. After second shot, extreme biliary duct constriction in liver; hospitalized for second stent placement. Multiple biopsies for potential cancer in pancreas and liver; all negative. MRI's showed beading of bile ducts, leading to potential diagnosis of liver failure or possible autoimmune conditions of PSC or autoimmune cholangeopathy. Finally treatment of Prednisone reversed the condition over 8 weeks. This comprises a time course from March to August 2021. Covid antibody test had negative results.
Patient developed Severe redness at injection site (warm to touch & painful), High Fevers x 3 days, Nausea w/vomiting & diarrhea that lasted from Saturday to Monday 9/9/2019.
Woke up w a torso rash.  Lessened within 24 hours but is still slightly present/itchy
Extreme fatigue, nausea, dull headache, body aches, neck pain.
Dizziness; Fever; Muscle aches like muscle soreness; severe vomiting; violent headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6204, Expiry date: unknown) (age at the time of vaccination was 17 years), administered in Arm Right on 14May2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient experienced dizziness, violent headache, fever and chills, muscle aches like muscle soreness, fatigue. The patient received treatment included pain relievers like Tylenol, like acetaminophen stuff and that is the only medication I had took. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Client is a 2yo who moved when vaccinator went to vaccinate the child.  She was pricked with the needle but no vaccine was administered.  Dose discarded and new vaccine administered in other arm.
Generalized pruritic rash; started on 11/ 28/2021 and present at time of encounter. Started on TCA doxepin and prednisone taper.
Rash and redness at injection site wrapping around to under arm, warm to touch and painful.
Breakthrough case admission after two vaccines: Moderna 2/24/21 Lot# 010A21A;  Moderna 3/24/21 Lot# 017B21A.
Patient was given ZOSTAVAX vaccination in place of VARIVAX vaccination.  No adverse s/s occurred.
severe vomiting and diarreah initially, later in evening-Chills, shakes,
Her arm is sore; Shook it vigorously; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Her arm is sore) and PRODUCT PREPARATION ERROR (Shook it vigorously) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT PREPARATION ERROR (Shook it vigorously). On an unknown date, the patient experienced VACCINATION SITE PAIN (Her arm is sore). On 27-Oct-2021, PRODUCT PREPARATION ERROR (Shook it vigorously) had resolved. At the time of the report, VACCINATION SITE PAIN (Her arm is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
bone pain; severe body aches; Fever; headache; shaking; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 18:15 (at an unknown age) as a single dose for COVID-19 immunisation. Medical history included was not reported. Patients had no past drug history. The patient previously 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 08Apr2021 at 18:15 (at an unknown age) as a single dose for COVID-19 immunisation. Patient did not taken any concomitant  medications within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 02:00, the patient experienced fever, headache, severe body aches, bone pain and shaking. The clinical outcome of the events of fever, headache, general body pain, bone pain and shaking were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a 35 to 40 year-old0female nursing student who was not accepted entrance into school because "the college will not accept the titers for the patient". There was no further clarification on what "unacceptable titers" means. It was possible that the patient received measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child but this can not be confirmed. Medical attention was sought. On an unspecified date, recently, the patient received a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The titer status after this administration was unknown. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
developed red rash below injection site  statring 24 hours after injection, still growing at 96 hours after injection
SORENESS FROM THE NECK DOWN AND AT THE ADMINISTRATION SITE AND STILL WITH A LOT OF PAIN; This spontaneous report received from a consumer 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, expiry date: UNKNOWN) dose was not reported, administered on 17-MAR-2021 around 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAR-2021, around 06:00 the subject experienced soreness from the neck down and at the administration site and still with a lot of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness from the neck down and at the administration site and still with a lot of pain. This report was non-serious.
Headache, Myalgia & Fever muscle aches, GI distress, fever and chills, headache 1/27 and 1/28
c/o stiffness & pain to lt arm x 2 days noticed rash-redden from elbow down to wrist; felt warm to touch; no fever recommended to go to MD or ER & refused; applied warm compress w/good result;
Swelling of (L) hand. Initially had pain in hand the night vx given then swelling that lasted approx 4-5d. Suspect rheum issue. W/U in progress.
Painful neck and shoulders, right arm, followed by chills. Also lightheadedness and slight dizziness. Temp 90.1 degrees (at highest). Total lack of energy and appetite. Next day, lethargy and some diarrhea (not bad). side effects lasted from Feb. 7 evening to Feb. 8 evening. On Feb. 9, just some lightheadedness.
I was achy; Ran a fever; Felt nauseous; I was up all night feeling miserable; This is a spontaneous case, initially received from other non-health professional (consumer) via Communication (reference number: SEQ19-06120) on 04-Nov-2019, concerning a patient, of an unspecified age and gender.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not reported.  On an unspecified date in 2019, the patient was administered with INN influenza vaccine [influenza vaccine, subunit influenza virus vaccine polyvalent; batch number: 259814, route of administration, anatomical location and expiration date: not reported] for an unknown indication.  On an unspecified date in 2019, reported as on the following night, the patient was achy, ran a fever and felt nauseous. The patient was up all night feeling miserable. It was reported that this year was the first time the patient got a reaction.  The outcome of the events of ache, fever, nausea and feeling miserable was resolved, on an unspecific date.  The reporter did not provide seriousness or causality assessment to Flucelvax Quadrivalent.  Non-significant follow up received from other non-health professional (consumer) on 13-Nov-2019: Reference number (SEQ19-06574) added. No changes were made to the narrative.  Company comment: The patient experienced pain, pyrexia, nausea and feeling abnormal after vaccination with the suspect product INN influenza vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pain, pyrexia, nausea and feeling abnormal after vaccination with the suspect product INN influenza vaccine. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
The vaccinee's attorney alleged that the child was "born healthy and with normal Apgar scores". The pediatrician's summary sheet indicated that there were no problems during pregnancy. The infant was delivered vaginally. In the hospital's nursery, the infant had "possible" jaundice. Concurrent conditions and medications at the time of immunization were not provided. The child received injections of Engerix-B on 5/18/94 (lot ENG1334B2), 6/24/94 (lot ENG1364A2) and 11/18/94 (lot ENG1472A2). He also received an injection of Hep-A vaccine on 1/21/98. The pt also received DTAP vaccine adsorbed (Tripedia) on 7/29/94, 9/22/94, 11/18/94, 12/7/95 (lot 5K61015) and 5/27/98. He received Haemophilus influenzae type b conjugate vaccine (ActHib) on 7/29/94 (lot 4H51107), 9/22/94 (lot 4L51052), 11/18/94 (lot 4A61108) and 5/16/95 . He received oral poliomyelitis virus  vaccine (Orimune) on 7/29/94 (lot 0700B), 9/22/94 (lot 0707D), 2/14/95 (lot 0717A), and 5/27/98. The pt received MMRII on 9/6/95 (lot 0623B) and 5/27/98. He also received varicella vaccine (Varivax) on 5/27/98. The pt's attorney alleged that the child "had been developing normally and meeting his age-appropriate developmental milestones. He began to regress at 18 months of age, however, and now suffers from disintegrative autism or Autism Spectrum Disorder (ASD) caused by mercury toxicity". The attorney alleged that the source of the mercury was the thimerosal preservative contained in the vaccines the child received. The attorney stated  that the pt "is currently receiving medical treatment to remove the mercury from his body. As the mercury levels in his body have decreased, the (parents) have noted some improvement in his symptoms. Despite this improvement, however, his severe neurological and other ASD related disorders are permanent in nature." The pediatrician's medical records indicated that the physician assessed the child's developmental, behavioral and emotional progress to be "abnormal". The only dx recorded in the medical records forwarded by the attorney was pervasive developmental disorder. This report of autism, mercury poisoning, neurological injury and pervasive developmental disorder is considered "Medically Serious".
Outbreak of AGU or Lipschütz ulceration (non?sexually acquired genital ulcers (NSGU), also referred to as vulvar aphthous ulcers) within 48 hours of second dose of vaccine shot. Received three rounds of testing for all STDs to rule out that possibility and tested negative across the board. Confirmed that the ulcers were an auto-immune response to the vaccine. Ulcers were extremely painful and disappeared exactly 14 days after second shot was received.  (No such outbreak occurred after first shot of the vaccine.)
Client had just received MMR on 10/25/14, then was given FLUMIST 11/5/14. Had not been 30 days in between live immunizations.
Flu shots make me sick; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious social media case from patient via social media.  This case involves a patient of unknown demographics who reported that flu shot made sick (illness) while the patient received INFLUENZA VACCINE.  The patient's 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 INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, patient reported that flu shots had made sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE. The patient had received the vaccine while being at work.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Swelling on injection site; Fatigue; Joint pain; Vaccinated subcutaneous instead of intramuscular; A spontaneous report received from a Consumer concerning, unknown age, female patient who received first dose of the Moderna COVID-19 vaccine subcutaneous instead of intramuscular. /MedDRA PT: [Incorrect route of product administration] and experienced swelling on injection site, fatigue, and joint pain.   The patient's medical history was not included. Patient's concomitant was not included.   On 13 JAN 2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient stated she received the Moderna COVID-19 vaccine subcutaneous instead of intramuscular on 13 JAN 2021. Patient stated she experienced swelling on injection site, fatigue, joint pain. Patient stated that the swelling came back in her arm on 21 JAN 2021.    c dx Patient stated she was put on antibiotics for treatment.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a patient of unknown gender and age  who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Incorrect route of product administration associated with vaccination site swelling, fatigue and arthralgia. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Itchy rash at site of injection today is 2/8/21 and it is still warm and itchy on the site.
Left swelling/inflammation and pain in the left supraclavicular lymph nodes starting approximately 6 days after administration.
Complaining of left arm pain 2 weeks started after 2nd dose of COVID-19 vaccine. She states pain radiates down left arm and feels like nerve pain. She denies any chest pain, shortness of breath or any exertional dyspnea or increas pain with activity. Pain worse with movement of left arm
Patient said that the evening after his shingles vaccination he developed an itchy rash in the upper arm.
Child fell ill, taken to hospital. Moved to cardiac unit; Child fell ill, taken to hospital. Moved to cardiac unit; This is a spontaneous report from a contactable physician. A 14-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 14-years-old) for COVID-19 immunization. It was reported that the "child fell ill, taken to hospital. Moved to cardiac unit" on 06Jun2021. The outcome of the event was unknown. The event was considered as serious (hospitalization). The event resulted in Emergency room/department or urgent care. Unknown if patient was tested for COVID prior vaccination and if COVID tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Excessive sleepiness. Was diagnosed with narcolepsy by a neurologist. Treatment has included amantadine, NUVIGIL, ADDERALL XL.
Right arm has a lump on it; The right arm got sore; Right arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen). At the time of the report, VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) Seems to be an abscess.         Patient was on concomitant medications blood pressure medications and  diabetes medications.  Treatment medication was not provided
Started within 2 hours of vaccination. Chills, fever, dizziness, nausea, widespread itching,/rash, swollen arm, joint pain, abdominal pain, diarrhea, tingling in arms and legs, tongue.
Elevated Temperture to 104.6  within 4 hours following injuections.  Temperature did not go below 102 with acatamenophen(q4 hrs)and tepid baths for 16 hours. Child became very irritable, no vomiting, seizures, or lethery. Temp resolved on the way to the doctor's office.
Dose received: 3; Serious shortness of breath frequently during the night of receiving the Pfizer COVID-19 booster shot. I also had shortness of breath as I woke up in the morning; Very painful to stand up for about 24 hours after receiving the booster shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 at 15:45 (Lot number: FH8028) at the age of 26 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (ongoing) and "Seasonal allergy" (unspecified if ongoing), notes: known allergies: seasonal allergies. Concomitant medication included: FLOVENT INHALER taken for Asthma as needed. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0182; Anatomical site: right arm; Route of administration: unspecified), administration date: 03May2021, when the patient was 25 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0187; Anatomical site: right arm; Route of administration: unspecified), administration date: 26May2021, when the patient was 25 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 at 15:45, outcome "unknown", described as "Dose received: 3"; DYSPNOEA (non-serious) with onset 01Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Serious shortness of breath frequently during the night of receiving the Pfizer COVID-19 booster shot. I also had shortness of breath as I woke up in the morning"; PAIN (non-serious) with onset 01Dec2021, outcome "recovered" (02Dec2021), described as "Very painful to stand up for about 24 hours after receiving the booster shot". Therapeutic measures were not taken as a result of dyspnoea and pain.  Additional information: 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 COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.