chrisvoncsefalvay/vaers-outcomes huggingface dataset:
enlarged lymph nodes/swollen lymphnodes; Pain especially under right side of my breast; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (lot number: EN9581) as dose 1, single and via an unspecified route of administration on 03Mar2021 (lot number: EN6205) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date and unknown if ongoing. Concomitant medications included vitamins NOS taken for an unspecified indication, start and stop date were not reported. The patient experienced enlarged lymph nodes/swollen lymphnodes on an unspecified date in Feb2021 and pain especially under right side of my breast on an unspecified date in 2021. It was reported that the patient developed swollen lymphnodes after the first dose. They continue to be swollen. She had an emerge lymph node and they said it was probably due to Pfizer. She had her second shot on 03Mar2021. They thought it was reaction of it because of the vaccine. Ever since then they had to call her every 8 week or every 6 weeks, the lymph nodes were still enlarged so she just need to see how during trial she should expect them to be enlarged. The exact date, she had to look it up it and said it was couple days after she got her first shot, she went for her mammogram she had to look that again and said it was probably around 15Feb roughly but she does not have the exact date. The patient added that she thought it got worse to be honest. She still has pain especially under right side of her breast. The patient underwent lab tests and procedures which included mammogram: unknown results on 15Feb2021 and ultrasound scan: unknown results on 2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Chills, shivering from 10:00 p.m. to 5:00 a.m.
Two hours after site became red, hot, swollen and itching. Hives developed on left arm and chest. She had URI 2 weeks prior. Has chronic smokers cough. Wheezing returned after flu shot. Advised her to see her physician, use cold packs, ibuprofen for pain, hydrocortisone for itching. By 11/29/2001 had 5 inch indurated area, had not called or seen doctor.
Event occurred > 30 days but < 60 days since vaccine administration.  Severe unanticipated event in otherwise healthy 15 yo First dose 6/1/21 (Pfizer) Neurological - Evaluated for stroke;  Dizziness,Headache,Loss of consciousness,Seizure Hemorrhagic stroke 15-year-old female with no significant past medical history brought in by EMS as a stroke alert.  Per EMS, patient was at school playing lacrosse and fell to the ground.  There was no reported trauma prior to incident.  EMS was activated approximately 30 minutes prior to arrival.  Last known normal is approximately 8:45 AM.  Patient unable to provide additional history at bedside as she is actively vomiting.  As far as EMS is concerned, patient was otherwise in usual state of health.  Fingerstick euglycemic prior to arrival. Acute distress, ill-appearing, toxic-appearing Neurological:     Mental Status: She is alert.     GCS: GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6.     Cranial Nerves: Cranial nerve deficit and facial asymmetry present.     Motor: Weakness present.   Received critical notification from CT technician that patient has an acute bleed- Life flighted to Hospital.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-SEP-2016, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot number, dosage and route of administration not provided). On or about 21-MAR-2017 and 17-SEP-2018, the patient was treated by two physicians for shingles and neuropathy, respectively. The patient was diagnosed with shingles and neuropathy 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 the 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 including care for hospitalization (dates unknown), 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 (unspecified); lost wages; loss of earnings capacity, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, neuropathy was determined to be medically significant. Additional information has been requested.
Presents to clinic 6/19 for well check. Vaccines administerd. On 6/26 c/o fever, rash, neck pain, sore throat and adenopathy. Treated and released. Instructed to follow up if condition worsens. 6/28 presents to ED c/o fever and unable to move neck. Admitted to hospital for observation.
7 days, post vax, pt had fever of 103.4F, night sweats, muscle aches, severe headaches and neck stiffness. Seen by MD and Rx'd ibuprofen and pain meds. Improvement after 2 days without further problems.
Slight swelling, redness about 2 inches across at injection site, arm hurts a bit.  Was fine for a week, started hurting Thursday evening after receiving vaccine exactly one week prior
within 10 minutes of 2nd vaccine - I got extremely dizzy and felt as I had a cloud around my head - after a little while I told nurses on duty they took me in the back and watched my vital signs until normal range.  Then on Saturday morning noticed a rash/hives on neck and upper collar bone area.  Sunday evening did a call to see what I could take/do for the itchiness as the antihistamine that I take daily for allergies wasn't helping at all!  Suggested I add topical cortisone cream.  Monday 6/14/21 contacted my allergist as now I also have the rash/hives on arm,  he suggested I take an additional dose of either Claritin or Allegra to help and if have trouble breathing go to ER. Tuesday 6/15/21  evening noticed additional rash/hives on either side of hip area and stomach area.   I continue to have this rash/hives - although it does seem to be going away very very slowly with the added antihistamine
Site: Pain at Injection Site-Mild, Systemic: patient pushed needle from injection site resulting in abrasion-Mild, Additional Details: Patient pushed needle with hand and had superficial abrasion at injection site. Needle was intact. Covered in bandage. Full dose administered.
Severe Soreness at injection site (>24 hours) Mild weakness in arm (injection arm)
Reports red, swollen, very sore local reaction. Redness and swelling extended to elbow. Soreness was very intense. On 12/2/02 reports experiencing asthma attack, was very SOB/difficult breathing. Was seen by NP and prescribed erythromycin. Was bed ridden the entire week and seen again last in ER 12/8/02. Diagnosed with pneumonia. Was doubled in dosage. Local reaction resolved.
Within 30-40 mins, I had a raised red mark starting at the base of my throat  running up to my left nostril. There was a lighter red mark on the right side that stopped just above my chin.  There was no burning, itching or soreness associated just the raised red marking.   It started to dissipate within 2 hours
Temp 104.3 24 hours after receiving Pediarix, irritable and fussy.
Hives on left arm close the injection site. Hives and skin redness on upper chest between breasts
No Adverse Event; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was reported. 190 patients (9 different lot numbers) received a vaccine past the beyond used by date. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No treatment medication was reported. This case pertains to the 55th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
08/15/06 vaccines given DTaP, IPV, MMR. 8/17/06 call from Dr saw pt 8/17 for total reaction, 5cm redness around injection site which was Rt deltoid. No treatment. Dr gave antibiotic prescription to parents to fill if needed they were traveling on 8/17/06.
Fever, vomiting, avoiding walking, bilateral foot and leg pain, restless, leg weakness. She has been dx with GUILLAIN BARRE syndrome and is currently in hospital on IVIG. (This maybe post flu and not related to shots).
Pain in shoulder; The patient received 2 vaccines (influenza and covid vaccines) in the same arm; One was too high/he did receive vaccine too high; This spontaneous case from the United States was retrieved on 27-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1697391-1), reported by other health professional and concerned a 78-year-old, male patient.   The patient's medical history and concomitant medications were not reported.  On 28-Oct-2021,the patient was vaccinated with non-company co-suspect Covid-19 vaccine (Moderna; dose: reported as three, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 004f21a.   On the same date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 312832. It was reported that one of vaccines were administered too high (explicitly coded as 'Product administered at inappropriate site').    On the same date, after receiving Fluad Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient had severe pain in shoulder and visited doctor who stated that the patient did receive vaccine too high and advise patient to report the incident.  On an unspecified date in 2021, the patient recovered from the event of 'shoulder pain'.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: Event 'shoulder pain' was considered as related to Fluad Quadrivalent, while the events of 'Product administration error' and 'Product administered at inappropriate site' were considered as not related to Fluad Quadrivalent.; Sender's Comments: Event 'shoulder pain' was considered as related to Fluad Quadrivalent, while the events of 'Product administration error' and 'Product administered at inappropriate site' were considered as not related to Fluad Quadrivalent.
Fever, sweats, chills, headache, severe muscle/body aches and pain, diarrhea, sore throat
This patient was on hospice, we are reporting this to VAERS at the Medical Directors request d/t patient's death within 48 hours of the second dose vaccine.  The death occurred the morning following his second dose of the Moderna COVID-19 Vaccination, vaccine received on 03/11/21 and patient date of death 03/12/21 at 9:41 am. This was a hospice patient with a terminal dx of CKD.  This is being reported at the request of the Medical Director for the hospice team, d/t the patient's death occurred within 48 hours of receiving the second dose of this vaccine.  The nurse case manager stated the pt was declining as they were on hospice for a terminal condition and had co-morbidities, Pt did show more decline after receiving COVID-19 vaccination and patient passed away within 48 hours of receiving second vaccination dose.
Yesterday after the vsafe check in, I went to the doctors, two instances came to my mind. One was, in august 2022, there was a growth and had a biopsy squamous cell carcinoma (cancer). I noticed the growth in July 2022. It was in the morning; it wasn't dark, but it grew like a narrow dome shape. One other thing that caught my attention was my pacemaker. I got it checked in 2021 before the vaccination, and I was 2 percent dependent. Now, I am 98 per cent dependent on the pacemaker and I will be getting forth pacemaker scheduled in spring 2021. I do a remote transmition.
her right eye to eyelid start to swell down; her right eye to eyelid start to swell down; hives through her body; lips swell; hands itchy; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hands itchy on 12Mar2021, hives through her body and lips swell on 13Mar2021, her right eye to eyelid start to swell down on 14Mar2021. It was reported that patient had her hands itchy, but she did not give too much importance. Then on 13Mar2021, she had hives through her body and her lips swell. On 14Mar2021 she went to the emergency room because her right eye to eyelid start to swell down. She was treated there with steroids and Benadryl. On the day of this report, she did not take the Benadryl and got hives again this morning. Outcome of hives through her body was not resolved; outcome of remaining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Skin very sensitive / The skin is very sensitive yet; Burning body; when touching with nails he had red marks on skin; Itching a lot; itchiness in the head; Allergic symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Skin very sensitive / The skin is very sensitive yet), BURNING SENSATION (Burning body), ERYTHEMA (when touching with nails he had red marks on skin), PRURITUS (Itching a lot) and PRURITUS (itchiness in the head) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SENSITIVE SKIN (Skin very sensitive / The skin is very sensitive yet), BURNING SENSATION (Burning body), ERYTHEMA (when touching with nails he had red marks on skin), PRURITUS (Itching a lot), PRURITUS (itchiness in the head) and ALLERGY TO VACCINE (Allergic symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Skin very sensitive / The skin is very sensitive yet) had not resolved, BURNING SENSATION (Burning body), ERYTHEMA (when touching with nails he had red marks on skin), PRURITUS (Itching a lot) and ALLERGY TO VACCINE (Allergic symptoms) outcome was unknown and PRURITUS (itchiness in the head) had resolved.            It was reported that reaction started after two weeks and it had been a month since then. Patient saw a doctor five days after the symptoms started.  No concomitant medications were reported. Treatment medications also include another drug for allergic reactions, similar to "quartelli".
Patient complained of severe muscle aches in both arms in which vaccines were administered. Received FLUVIRIN. Received PNEUMOVAX.
Rt thigh with approx. 5 size pink/elevated/blanching nodule.
Pt recvd 2nd dose of Hep B on 5MAY92 & approx 1/2 hrs following vax pt exp sweating, lightheadedness, flushing, severe migraine h/a, hypertension, nausea & vomiting;
Right leg swelling of thigh (proximal anterior) 4 x 14cm erythema with no induration. Acral erythema (arms and legs). Child limping.
01/09/22 presents to ED for "slurred speech". "Without significant medical history"
Seen 2/20/08 for red, itchy rash that started 2/19/08.  Varicella exposure.
Diziness, Nausea, vomiting. Hypotension. Symps resolved after 10 mins.   BP 90/50 70 18 O2 sat 99% RA
An upper respiratory infection that started with congestion and and a sore throat it lasted for two weeks then came back for two more weeks even worse this time with swollen lymph nodes and fatigue. It was actually three different occasions where this would return the last time being the worst.
pain went from arm to the neck-severe, ongoing and worse at night; Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose; arm sore; severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l), NECK PAIN (pain went from arm to the neck-severe, ongoing and worse at night), PRODUCT DOSE OMISSION ISSUE (Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose) and PAIN IN EXTREMITY (arm sore) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and LISINOPRIL for Blood pressure, TRAZODONE for Sleep disorder, OMEPRAZOLE for Stomach pain, ALPRAZOLAM (XANAX) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l). On an unknown date, the patient experienced NECK PAIN (pain went from arm to the neck-severe, ongoing and worse at night), PRODUCT DOSE OMISSION ISSUE (Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose) and PAIN IN EXTREMITY (arm sore). At the time of the report, VACCINATION SITE PAIN (severe pain in the arm where vaccine was administered/ the pain went up a notch/ sore arm/ the worst pain they had after a vaccination but not incapacitated/ The repain in the arm getting better in the last 3 days, but they still feel a little sore l), NECK PAIN (pain went from arm to the neck-severe, ongoing and worse at night), PRODUCT DOSE OMISSION ISSUE (Second dose of Moderna COVID-19 vaccine not received 37 days after the first dose) and PAIN IN EXTREMITY (arm sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took Tylenol as treatment medication   This case was linked to MOD-2021-098669.
Arm soreness, can not lift arm without pain in left arm, can't sleep on left side, some times cold/numb hand.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209: