chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to PCP clinic on 04/29/2021 for c/o immunization site reaction. Pt received Kinrix to Right Deltoid on 04/27/2021, grandmother states they noticed redness and pain to side yesterday, she cleaned site w/ ETOH. 04/29/2021 pt developed cluster of clear fluid blisters measuring a circumference of 2.0 cm, surrounding tissue darker in color measuring a circumference of 4.5 cm, surrounding tissue red in color measuring a circumference of 7.5 cm.  Patient evaluated by APRN on 04/29/2021 who consulted wit Health Center Medical Director. Patient treated with steroid taper and close clinical follow-up in 1 week.  Discussed worsening symptoms to report and when to go to ER. Grandmother and Dad verbalized good understanding.
a patient received a 0.5ml dose of Tubersol instead of TDAP vaccine; patient received 0.5ml of Tubersol via intramuscular route into the right deltoid; patient received 0.5ml of Tubersol IM into the right deltoid; right arm was hurting at the injection site, all the way up into her neck; Initial information and additional information was received on 16-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional (Physicians Assistant).  This case involves a 55-year-old female patient who experienced right arm was hurting at the injection site, all the way up into her neck (pain in extremity), while she was tested with TUBERCULIN TEST [TUBERSOL] and received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDap].  Medical history, medical treatment, vaccination and family history were not provided. No concomitant therapies were given.  On 12-Jun-2020, the patient was tested with a 0.5 mL TUBERSOL (TUBERCULIN TEST) (lot number: C5588AA, expiry date: 17-Jun-2021) via intramuscular at the right deltoid for Tuberculin test. On an unknown date, the patient received a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer), (lot number and expiry date not reported) via unknown route at the left deltoid for prophylactic vaccination.  On 15-Jun-2020, the patient was complaining that her right arm was hurting, all the way up into her neck (pain in extremity), three days following the first dose intake of TUBERCULIN TEST.   It was also a case of overdose and an actual medication error due, wrong product administered, inappropriate route of vaccination. The patient was tested with 0.5 mL TUBERSOL via intramuscular at the right deltoid (overdose and incorrect route of product administration). This event was assessed non-serious event.  It was reported that, patient received 0.5ml of TUBERSOL, rather than the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. When the mistake was realized, the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE was properly administered in the left deltoid.   Details of laboratory data not reported.  Final diagnoses was pain in extremity.  It was not reported if the patient received any corrective treatment.  The event outcome was not reported for pain in extremity.  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.  There will be no information available on the lot number for this case.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 25-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
This pt received vax on 12/13/99 and subsequently experienced a mild case of chicken pox around trunk and arms in 01/00. She was also noted as having a fever of 100.6. Medical treatment sought. It is unclear if 4 weeks had past from time of vax until onset of infection.
Severe temperature regulation issues after first dose Lot number 037k2oa , severe Tremors  in hands 2 weeks  days after second dose, lost 40 pounds over the course of 7 mths after dose, Mast Cell Activation Syndrome, atypical severe clotting and tissue release during  periods , irregular periods, tingling in nose and  lips, facial tingling, tingling in the buttocks, intermittent hives on back and arms, severe atypical fatigue, Erthyromyalgia diagnosis, feel better when laying flat, bulging veins, high platelet count, high d-dimer, insomnia and inability to fall asleep without medication post vaccine, heart racing, exercise intolerance, heat intolerance, I had hormonal migraines routinely for 27 years  during my period and those have stopped completely post vaccine. new food allergies
Shortness of breath; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 12-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath). On 13-Jun-2021, DYSPNOEA (Shortness of breath), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-223938 (Patient Link).
4 days p/vax pt devel a vesicular eruption overlying induration & erythema;vesicles very superficial;tx w/burn dressing;
NUMBNESS IN THE ARM; MINOR INJECTION SITE PAIN; VERTIGO; 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 past medical history included vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced vertigo. On an unspecified date, the subject experienced numbness in the arm, and minor injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo on JUN-2021, and the outcome of minor injection site pain and numbness in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210726264.
3rd dose of HPV given to otherwise healthy 17 y/o female, L deltoid. Patient notes mild pharyngitis at time of injection, recovering from a previous URI.  Gradual onset over the following 24 hours of pain, swelling, erythema, and warmth at injection site, approx 7 cm wide and 15 cm long heading distally. Also notes deep-seated pain in forearm but CR < 2 sec, sensation/strength intact.  Patient has been icing and there has been some improvement.  Motrin, Benadryl, ice x 48 hours was prescribed.
feels worse after getting the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (feels worse after getting the first vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported.  Concurrent medical conditions included Neurological symptoms NOS and Lyme's disease.    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 ADVERSE EVENT (feels worse after getting the first vaccination). At the time of the report, ADVERSE EVENT (feels worse after getting the first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.  Upon internal review on 21-May-2021, the age was corrected to unknown.   Reporter did not allow further contact
report a temperature excursion which was not covered by the extended stability data with no reported adverse event; reports that 6 patients received ipol after it experienced a temperature excursion with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case involves 6 patients with an unknown age and unknown gender and the reporter report a temperature excursion which was not covered by the extended stability data with no reported adverse event and reports that 6 patients received IPV (VERO) [IPOL] after it experienced a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for immunization and report a temperature excursion which was not covered by the extended stability data with no reported adverse event (product storage error) (latency: unknown) and reports that 6 patients received ipol after it experienced a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day)     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 the 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.
pt had a positive COVID test on 1/18/22 and was admitted to hospital for 4 days; treated with Remdesivir and ABX; dc'd; back to hospital 2/3 - 2/9/22 with AMS and continued hypoxia/hypercapnia; dc'd; back to hospital 2/11/22 still showing a positive COVID test; c/o weakness and SOB; found to have a positive UTI in ED; started on ABX; O2 supplementation via NC; respiratory and mental status continued to worsen; family decided to pursue comfort care; pt passed away in the hospital
Red, itchy rash. Anthrax #3, 2 wks prior resolved with Benadryl / triamcnolone
patient received covid booster shot, became unresponsive.  Bystanders initiated CPR with AED. Shocks administered. EMS paged with paramedic intercept. Patient intubated, I/O placed. arrived to ED.  Pronounced at 1754
Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine; Arm sore after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine) and VACCINATION SITE PAIN (Arm sore after vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030a21a and 019b21a) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy. Concurrent medical conditions included Arthritis since 2003 and Blood pressure abnormal (Under control with Meds). Concomitant products included QUINAPRIL HYDROCHLORIDE (ACCUPRIL), ALLOPURINOL, VITAMIN B12 NOS, COENZYME Q10 [UBIDECARENONE], VITAMIN D NOS and CELECOXIB (CELEBREX) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced SKIN DISCOLOURATION (Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine) and VACCINATION SITE PAIN (Arm sore after vaccine). The patient was treated with ARNICA MONTANA FLOWER, CERAMIDE, GLYCOLIC ACID, NICOTINAMIDE, PHYTOMENADIONE, RETINOL (DERMEND MOISTURIZING BRUISE FORMULA) for Adverse event, at an unspecified dose and frequency. In June 2021, SKIN DISCOLOURATION (Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine) and VACCINATION SITE PAIN (Arm sore after vaccine) had resolved.            The patient post receiving their both doses of the Moderna COVID-19 vaccine has felt fine until the beginning of last week. The patient reported that their left arm where they received the vaccine was sore and looked like it had a broken blood vessel. The patient said the affected area was towards the top of their shoulder that was higher than the vaccine site and the top of their arm was now black and blue. The patient also reported that it has been almost 2 months since the patient received the 2nd dose.  On 30-Jun-2021, the patient informed that approximately, month to two months after the second dose, the patient noticed a large black and blue mark from top of their left shoulder to elbow and their arm was sore. The patient treated with dermend and it decreased and turned yellow and then vanished. The patient felt some soreness and that was all.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up was received on 30-Jun-2021. Updated the patient demographics. Added Medical history of the patient.  Added the concomitant medications and Treatment information. Updated the event outcome.
malignant fast-growing skin cancer / site of surgical removal of skin cancer looked like a burn; injection site pain; injection site erythema; injection site edema; This spontaneous report was received from a pharmacist referring to a currently 84 year old male patient with glaucoma, high blood pressure, thyroid disorder, diabetes, cardiac disorder, and drug allergy to sulfa and morphine.   Concomitant therapies included glaucoma medication, blood pressure medication, potassium, thyroid medicine, diabetes medicine, digoxin, product for bowel and pain medicine.  On 01-FEB-2018, the patient was vaccinated in the same arm with  influenza virus vaccine (unspecified) and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscular route, for "vaccine" (dose, lot number and expiration date were not reported, for any of the suspect vaccines).     On an unspecified date, the patient experienced injection site pain, erythema and edema. The patient was seen by a Specialist, on unspecified date, and had a skin biopsy of the vaccination site.  On an unspecified date, the patient was informed it was cancer and subsequently the patient had surgical removal of the skin cancer.  The patient was diagnosed with malignant fast-growing skin cancer (skin cancer) at the vaccination site.  On 25-FEB-2020, the patient sought medical attention and was seen by a physician during an office visit and the vaccination site which was also the site of surgical removal of skin cancer, looked like a burn so the patient was prescribed silver sulfadiazine (SILVADENE) cream as a treatment.  At the reporting time, the patient had not recovered from the events.  The reporter did not assess the causal relationship between suspect therapies and the events.  Upon internal review, skin cancer was determined medically significant.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received form the healthcare worker. Patient information was updated. On 16-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). Additional information has been requested.
Back and chest pain for months. An EKG done showed probably LAE, non-specific ST-T abnormality. Chest and back pain would reliably come up with activity such as swimming and be relieved with rest. Around this. His heart rate started to rise precipitously with some heart rate levels well above 160 beats per minute.
On 12-1-05 received 3rd dose of hepatitis B in clinic. Client states 1 hours after started to get a headache also ran a fever. Shortly afterward started to get a stiff neck with pain on left side of neck radiating down to shoulder blades. Has had the pain in neck and back along with headache and intermittent fever since getting the vaccine.
Redness, soreness at site of shot instead of going away it is spreading into a larger area of arm and it has been 12 days  since receiving the shot  would like to know why, if its a problem and what to do.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for three patients. This is the third of three reports. An adolescent patient of an unspecified age and gender received TRUMENBA, intramuscular on an unspecified date at a single dose as protection from meningitis B. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, and swelling at the injection site on an unspecified date. It was reported that the patient was given meningococcal group B rlp2086 one day and the very next day the patient came back with the reaction. Outcome of the events was unknown. Information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018405597 same reporter, events, suspect product; different patient;US-PFIZER INC-2018405600 same reporter, events, suspect product; different patient.
On 10/29 Pt had 2 episodes of jerking at 6 pm and again the following day, no resp distress, no cyanosis and seemed alert. Taken to ER the evening of 10/30. CT & CXR (-), LP (-), RSV & Flu (-), WBC 22.6, ABG WNL.  Bld, urine & CSF cultures pending. Noted desat in ER decreased 80's, self recovered on increase  . Admitted to hospital for poss Sz activity. EEG WNL, Boca virus (+). Discharged 11/1 - see attached.
Within 1 minute, developed quarter size wheal/hive at IZ site of Varivax (left arm).
Pt. received her Adacel booster and 1st dose of Gardasil on Wednesday August 19, 2009 @ the Health Department.  She began to ran a temp of 104.8 on Friday, August 21,2009.  She ran a temp of 103 in the early morning of Saturday, August 22, 2009.  She came to our practice, and was seen by Dr. Her symptoms consisted of mild URI symptoms, purulent PND, as well as the high fevers.  He treated her with a ZPac as well as encouraged patient to rest and take in plenty of fluids.
This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On 4th August 2018, the patient experienced fever, headache and general body pain. SHINGRIX was continued with no change. On an unknown date, the outcome of the fever, headache and general body pain were recovered/resolved and the outcome of the injection site pain and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. However, it could be 51 or 52 years old. The patient experienced soreness at injection site and swelling at injection site. 1 day after receiving SHINGRIX, the patient experienced fever (the patient's body temperature was recorded as 102 degrees), headache and body aches. The patient was referred to her physician.