chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed visiting nurse concerning a 63 yr old female pt who at the end of Sept or beginning of Oct 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red and looked like cellulitis. Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the pt's injection site swelling, erythema and cellulitis were considered other medical events (OMIC). The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards and was released. The nurse also reported 4 additional pt's who developed injection site swelling, erythema and cellulitis post vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USA01334, 0410USA01622, 0410USA01623, 0410USA01625). Additional information has been requested.
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-009507513-2104USA003215: 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-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. No medical history and current conditions were reported. The nurse reported that on an unknown date unknown number of patients were inadvertently vaccinated with VAQTA (unspecified dose and route) lot # J000366 expiry date 22-AUG-2015. On an unspecified date the vaccine had been improperly stored. The outcome of event was unknown. No adverse effects reported. Product quality complaint (PQC) was not reported. No further information provided. This is one of several reports received from the sane reporter. Additional information has been requested.
Not immunocompromised received a third dose of the Moderna covid 19 vaccine,; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Not immunocompromised received a third dose of the Moderna covid 19 vaccine,) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Not immunocompromised received a third dose of the Moderna covid 19 vaccine,). At the time of the report, EXTRA DOSE ADMINISTERED (Not immunocompromised received a third dose of the Moderna covid 19 vaccine,) had resolved.            No concomitant medications was reported. No treatment drug details was reported.  Patient was not immunocompromised.
Sore arm of course but sharp shooting pain in right thigh, then hour later, right breast, then sore armpits.
possible zoster 1 week after getting first COVID vaccine.  Cluster of blisters/lesions on left side of scalp and a few on forehead, hyperesthesia, pain, malaise, swollen/painful lymph node behind left ear.  No Eye involvement.  Treated with Valacyclovir, now resolved.
3 y.o., Patient scheduled to receive 2nd dose of Moderna vaccine on Friday, July 28 2022. At approx 1550 nurse attempted to administer the vaccine as an intramuscular injection into the L vastus lateralis. Parent appeared to use appropriate comfort restraint method and control of the limb of the injection site. After the nurse injected the needle into the thigh but prior to the vaccine being administered with plunger into the leg, 3 y.o. patient made a sudden jerk movement and released the needle, the syringe was inspected and confirmed that the dose of 0.25ml vaccine remained in the syringe. The needle and syringe were discarded immediately into the sharps container. A bandaid was placed on the puncture site. A clinic nurse and lead nurse was immediately notified to assist with the vaccination of the 3 year old, assisting with guidance and education to parent on providing comfort restraint for the patient to remain safe during administration of the vaccine. Another vaccine syringe and needle were prepared for the patient. After properly using a different comfort restraint method, the nurse was able to safely administer the vaccine on the R leg, vastus lateralis, without incident. Patient was observed for the required time and satisfactorily completed the appointment. Mom, was aware of the incident throughout the entire time, understood the reason for re-vaccination, agreed to the vaccination. Mom had no additional questions, was given the vaccine fact sheet and given information and instructions on what to do if patient were to develop vaccine reaction related symptoms.
Student came in requesting his booster (Pfizer). Had Pfizer vaccines 1 and 2 on 3/26/21 and 4/19/21 at the local Health Department. He met the criteria to receive the booster. Pfizer booster given on 11/1/21 by  APNP. When I went to enter the booster in database, I then noted student had received a Moderna booster on 10/30/21 (2days prior) at another Pharmacy in another location. We called the student back and he stated that he did receive the Moderna booster and it was all a "mis-understanding".
swollen raised bump a week later at the injection site, it was red, lumpy and a large area of her arm
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with paxlovid and treatment start date: 30Mar2023 and treatment stop date: 03Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Kaleidoscope like visual disturbance, geometric shapes black and silver that appeared to shimmer.  Appeared for 5-10 minutes.  I took Tylenol/aspirin/caffeine combo OTC when I got home about an hour later in case was precursor to a migraine.  Dull headache that worsened with bending my body so my head was below my waist started about an hour after taking the medication.
No adverse event; Received second dose more than 36 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose).    No concomitant medications were reported.  On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine), batch no. 028A21A.  Patient was not sure if he got a monovalent or a bivalent vaccine. There was concern that it could have been a bivalent vaccine.  No treatment information was reported.
- Increased aura activity within a few weeks after taking the vaccine - First seizure in 13 years post hippocampectomy - First tonic clonic seizure ever in July 2021 - All previous seizures were partial complex seizures  - Full tonic clonic seizures first started on July 20, 2021, I had another in October 2021, November 2021, February 2022. - I have had partial complex seizures in 2005 to 2008 but they stopped after a right side hippocampectomy in November 2008
12/8/2021 - In ER from nursing home with altered mental status/sepsis (unclear source). Temp 101.7, HR 135, resp 22, BP 106/64,sat 92%. Covid + on admit with UTI. Chest xray revealed bilateral infiltrates. 3L fluid given - patient BP remains low. Started in Cefepime, flagyl, and vancomycin. Remdesivir, multivitamins, D dimer 360.  12/10 - started on decadron and Lovenox. On room air. 12/11 - patient is awake and alert. Antibiotics/Lovenox/Decadron continued. Started on 2LNC O2- she uses at night at home. SPO2 94%, RR16, HR 73, BP 110/72, Temp-97.8 12/13 - Sepsis resolved. Nursing home requires completion of quarantine before return.  12/20 - Covid negative 12/19 - Discharged back to nursing home.
2" redness on ZOSTAVAX (L) arm. 10-12" redness/inflammation from underarm to below elbow on R PNEUMOVAX side.
My left arm was very sore within an hour of the vaccinator.  Stiffness in my right knee began two days later on Sept. 10th in the evening.  The day of Sept. 11th I awoke with severe stiffness in both knees and my wrists and shoulders.  The stiffness and pain became so intense I needed assistance to get up after sitting.  Walking was reduced to short distances at a very slow pace.  The extreme stiffness and swelling progressed to my elbows, both hands (knuckles initially and then thumbs), and shoulders.  The knees proved to be most debilitating.  I visited my Primary Care physician on Monday afternoon and was prescribed Ibuprofen, 800mg tablets; previously I had been taking over the counter Tylenol and Ibuprofen.  I took these until Wednesday when I again contacted my Primary Care physician and requested steroids as the Ibuprofen wasn't having much effect.  I am presently on the third day of the Methylprednisolone 4mg DosPak 21s and am improving.
VACCINE WAS ADMINISTERED PRIOR TO PATIENT LOSING CONSCIOUSNESS. PATIENT REGAINED CONSCIOUSNESS AND REPORTED DIZZINESS AND BRUISING ON HEAD. 911 WAS CALLED, AND EMS ATTENDED TOPATIENT.
Very painful arm between elbow and shoulder Slept 18 hours after taking Tylenol on first day Slept 20 hours on second day (no Tylenol) Still very sleepy but not really tired.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th March 2019, 1 days after receiving SHINGRIX, the patient experienced fever, injection site swelling, injection site warmth, injection site redness and injection site itching. On an unknown date, the outcome of the fever, injection site swelling and injection site warmth were recovered/resolved and the outcome of the injection site redness and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site swelling, injection site warmth, injection site redness and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the patient's injection site reaction to first SHINGRIX vaccine dose. The patient had a fever, a warm, swollen, red and itchy injection site. In March 2019, the outcome of the fever, injection site swelling and injection site warmth were recovered/resolved. The pharmacist stated that all the events were resolved except for redness and itching at the site. The pharmacist provided the consent for follow up.
COVID-19 INFECTION; ANTIBODIES VERY LOW; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart issues (serious). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection, and antibodies very low (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 antibody test Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection and antibodies very low was not reported. This report was non-serious. This case was associated with a product quality complaint: 90000251245.
Developed slightly raised itchy rash on body, mainly trunk area but has spread to chest with some on inside of arms.  Started taking 25mg of Benadryl last evening (2/8), doubling up to 50mg during the night and continuing this morning.
Hearing problems in left ear; This is a spontaneous report from a contactable consumer, the patient. A 59-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 14Jun2021 at 09:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included dupuytrens disease and osteoarthritis. It was unknown if the patient had known allergies to medications, food or other products. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), ubidecarenone (COQ10), boron (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), vitamin e (MANUFACTURER UNKNOWN) and vitamin b (MANUFACTURER UNKNOWN), all were taken for unknown indication, on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021 at 19:00, the patient experienced hearing problems in left ear. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event hearing problems in left ear was not resolved at the time of report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included neck injury. and concurrent conditions included migraines, non-smoker, and non-alcohol consumer, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache. This report was non-serious.
This spontaneous report was received from a physician, via company representative, regarding a 68-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, lot/batch number and expiration date were not provided) for oropharyngeal warts. There was improvement of her symptoms.
Off-label use; Booster / dose received: 3; Slight fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 10:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the COVID vaccine. Concomitant medication included influenza vaccine (FLU) for an unknown indication on an unknown date in 2021. The patient previously 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 09Mar2021 at 10:00 (at the age of 65-years-old) and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Feb2021 at 09:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021, the patient experienced slight fever, chills and muscle ache. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events slight fever, chills and muscle ache were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Welt at inject site size of pimple, by 8/11 became irregular oval about half inch by inch slightly raised mottled red.
Soreness at the injection site that run up to the neck; Little itching at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site that run up to the neck) and INJECTION SITE PRURITUS (Little itching at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included heart pace maker. Concomitant products included IRON for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site that run up to the neck) and INJECTION SITE PRURITUS (Little itching at the injection site). On 18-Feb-2021, INJECTION SITE PAIN (Soreness at the injection site that run up to the neck) and INJECTION SITE PRURITUS (Little itching at the injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Allergy medication, Medication for asthma & Medication that helps her to breathe are taken as concomitant medicines.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
neck stiff and sore within 10 minutes, knees stiff and sore within 30 minutes. still having stiff sore joints that pain increases with activity
This patient was given a dose of Td and Boostrix (one dose each arm).  Parent was notified.