chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). On 31-OCT-2013 the patient was vaccinated with a dose of GARDASIL (lot # J008423, exp. date 21-JAN-2016 (route and dose not reported) which was exposed to a low temperature of 29F for a total of 11 hours from 30-OCT-2013 until 07-NOV-2013. These excursions were not supported. No adverse effects were reported. This is one of several reports from same source. Additional information has been requested.
Symptoms: Symptoms: 1. Nausea Vomiting, 2. Syncope, 3. Cold sweats Suspect drug number 1 Dosing: one time dose.
This spontaneous report was received from a pharmacist concerning a 61 year old female patient. The patient's medical history included convulsion when she had chickenpox at 9 months of age (29-JAN-1957). The patient had not drug allergies, and concurrent conditions were not reported. On 03-MAY-2017, the patient was vaccinated with ZOSTAVAX subcutaneously at the left arm, lot number M037655, expiration date 29-NOV-2017 (dose was not reported) for previous history of chickenpox (prophylaxis). Another suspect therapy included sterile diluent (dose, route, lot number and expiration date were not reported). On an unspecified date in May 2017, the patient's injection site became warm and "enlarged". It was reported, that the patient received an unspecified treatment for the events. The reporter was going to contact the patient on 08-MAY-2017 to inquire about her status. At the time of reporting, the outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX and sterile diluent was not reported. Additional information has been requested.
Right thigh injection site rxn: 10x8 cm area of swelling and induration.
Red mark at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red mark at the injection arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ERYTHEMA (Red mark at the injection arm). At the time of the report, ERYTHEMA (Red mark at the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Antibiotic and Steroid Cream used as a Treatment Medication.
Suquela of mesenteric panniculitis.  Diagnosed Thursday 11/4/2021.  Don?t know the cause
Patient was crabby and tired on the day of his event. He was put to bed a few hours early. About 45 minutes later his father found him with red vomit surrounding him on all fours having a grand mal seizure. He was taken to the emergency room at Hospital where they did a strep test (with negative results). The next day he was taken to his pediatrician for a follow up.
DVT; Pneumonia; Pharmacist states the patient's death; forehead redness; forehead; crusting of the eyes; Ocular shingles; This case was reported by a pharmacist via call center representative and described the occurrence of unknown cause of death in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis.   Co-suspect products included erythromycin (Erythromycin Ointment) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Erythromycin Ointment at an unknown dose and frequency. In May 2019, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On 22nd May 2019, the patient experienced erythema, blister and eye crusting. On 15th December 2019, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and pneumonia (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and artificial tears nos (Artificial Tears). Erythromycin Ointment was discontinued. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting were unknown. The patient died on 15th December 2019. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be unrelated to Shingrix. It was unknown if the reporter considered the ophthalmic herpes zoster, dvt, pneumonia, erythema, blister and eye crusting to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix developed ocular shingles within one week. The medical team were unsure if it was herpes, but the chart notes not clearly bacterial or viral. Patient was prescribed erythromycin ointment for prophylaxis, then on 22nd May 2019 started getting forehead redness and blisters, crusting of the eyes, and she stopped erythromycin.The treatment was changed to artificial tears and started Valcyclovir 1g, 1 BID for 10 days. Patient had consult with ophthalmology and was treated with artificial tears. The consult noted "no evidence of herpetic uvelitis, keratitis, or retinitis in right eye and a treatment with antiviral medication was continue. On 15th December 2019, the patient died exact cause of death unknown. The patient had multiple issues including DVT and pneumonia, and patient elected for comfort care instead of treatment. Pharmacist states the patient's death does not appear to be related to Shingrix.; Reported Cause(s) of Death: Death
Previously in the hospital for head injury and UTI was discovered, so home health was already in the home and nurse noticed I wasn't feeling well by the Friday after I had the vaccine. She contacted by doctor and he had me to go to the ER. My UTI had cleared up. A CT Scan showed I was fine. I was extremely tired and achy. No issues with 2nd dose.
One week after flu vaccine, had fatigue and  sinusitis, and bronchitis. Treated with antibiotics, recovered and had recurrence of sinusitis in Feb.and bronchitis in late April. Has been in bed, off work with severe fatigue since February, 2005.
Patient received Pfizer vaccine on 12/21. On 12/27 she developed lymph node swelling on her neck. It has gotten worse over the last 3 days, tender to touch. She is treating with warm compress and ibuprofen/acetaminophen.
Following the 2nd vaccine, he missed 2 days of work with chills, body aches and no energy. On the morning of 5/27/21 he had repetitious sneezing, coughing, clearing his throat and then hiccups that lasted all day at work. As well as, facial paralysis, slurred speech, memory loss, disorientation, and rude behavior that was observed when he got home from work on  05/27/2021. He was admitted to the ER around 9:30 PM on 05/27/2021 and moved to the hospital the morning of 05/28/2021, After Occupational and Physical Therapy Assessments, along with imaging and blood work, doctors determined he had a mild stroke. He is currently struggling with Aphasia and receiving speech cognitive therapy. His Primary Care Provider has still not approved him to return to work as of 10/31/2021
The morning after the injection I woke up with a slight fever (99.0 degrees), body aches, and a headache. The fever lasted for about 4-6 hours and the body aches and headache lasted until mid-day the following day.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 at 12:00 as dose 3 (booster), single (Lot number: EW0177), in left arm and on 09Feb2022 at 12:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Liver cancer Rx Keytruda" (unspecified if ongoing), notes: Liver cancer Rx Keytruda. Concomitant medication(s) included: DOXAZOSIN, start date: Jun2017, stop date: 24Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Negative, notes: negative antigen test on 21Jun2022; (25Jun2022) Positive, notes: Positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medications within 2 weeks of vaccine.The device date was reported as 25Jun2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Initial dose 1/4/2021 second 1/29/2021. I was a little over 8 weeks pregnant when I had a miscarriage on or around 2/09.  I was not aware that the baby did not have a heart beat at that time but learned at an ultrasound on 3/9. I had an d and c. The baby was due on 9/23/2021.
Red itchy rash appeared below injection site.  Large Knot in arm where the itchy rash is.   No more rash or itchy but can still feel knot/lump
low tittes, less than 10mIU/ml; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 26-year-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: low tittes, less than 10mIU/ml). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 13-MAR-2023 Reporter's Comments:  Pharmacist reported that patient completed the series of hepB vaccines but had low tittes, less than 10mIU/ml. No additional information provided. Pharmacist was in a hurry and did not provide patient's data, facility information where vaccination took place, when the doses where given. It was not asked if follow up was ok.  Did not mention that previous HepB vaccines were Engerix B but did want to verify if administer Engerix B as a booster dose.
a 73 years old patient received a dose of Fluzone High Dose on 02OCT2019 who had received the vaccine earlier from another facility within 30 days/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 73 years old female patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 02-Oct-2019 lot UJ238AA via intramuscular route in the left deltoid who had received the vaccine earlier from another facility within 30 days.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to extra dose administered  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
headache; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for an unknown indication.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Mar-2021, the patient experienced HEADACHE (headache), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HEADACHE (headache), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        Patient wanted to know if it was true that if someone does not have side effects from Moderna vaccine that person will not be protected against the virus (read that in social networks). Patient thinks that symptoms are due to not sleeping well night before getting the vaccine.
FLUVIRIN shot administered Thursday October 6th. Pt. noticed swelling in the hand and wrist of the same arm as the flu shot only on Sunday 10/16. This resulted in pain and continued swelling Monday and today. A Dr. was seen and Rx's filled for an antibiotic and pain meds. (Dr. suspects alcohol swabs)
The first day after injection displayed temperature of 99.4, body aches and tiredness. Patient was already experiencing back pain and this increased.  By March 1st, patient was bedridden with extreme sciatic pain radiating from disk L4/5 down right outer leg.  Currently awaiting epidural cortisone to address extreme pain.
The pt experienced pain at the upper left arm. Physician informed the pt to place a cold ice pack at the area and to take Tylenol every 4 hours.
This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017; lot L024993, expiration date 17-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 33.6 degrees Fahrenheit for 49.5 hours and 34.8 degrees Fahrenheit for 7 hours. There was no product quality complaint involved. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact physician. Sender's Comments: US-009507513-1610USA010976.
No additional AEs; temperature excursion Product administered; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion with -10 Celsius degrees for 59 minutes. There was no previous temperature excursion.  On 26-APR-2023, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (1x dose, lot # W035464, expiration date 06-MAY-2024; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Patient received Pfizer vaccine as second dose in primary series when Moderna was received for the first dose in the primary series.
an expired Daptacel vaccine is given to a patient/No side effects reported; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA124198, 2019SA124199, 2019SA123826 and 2019SA124200 (same reporter).  This case involves a 17 months old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Suspension for injection) lot C5171AA, expiry date-23-Mar-2019 via unknown route in the left thigh on 02-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   It was a case of actual medication error due to expired vaccine used.  No side effects reported.  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.  Documents held by sender: none.
Approx 5 minutes after administration pt complained of racing heart, nausea, tingling fingers, and clamminess. Her breathing was not labored, and blood pressure was 138/78 with pulse of 90. 911 was called. Paramedics arrived and checked her out. Her blood pressure normalized to 118 over 70. Paramedics advised her to go to hospital, but did not take her in the ambulance. Reaction was suspect to be anxiety/adrenalin reaction. Pt then left the store.
feeling weak; tired; pain in body joints; 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 ASTHENIA (feeling weak), FATIGUE (tired) and ARTHRALGIA (pain in body joints) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ASTHENIA (feeling weak), FATIGUE (tired) and ARTHRALGIA (pain in body joints). At the time of the report, ASTHENIA (feeling weak), FATIGUE (tired) and ARTHRALGIA (pain in body joints) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.
Patient presented to the ED and was subsequently hospitalized for atypical pneumonia within 6 weeks of receiving covid vaccination.
This spontaneous report was received from a medical assistant concerning a 18 year old patient of unknown gender. The patient's concurrent conditions, medical histoy, historical drugs and concomitant medications were not reported. On 21-AUG-2016,  the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported) and on 23-JAN-2017, was vaccinated with GARDASIL 9 intramuscularly (lot number M034780, expiration date 15-APR-2019, dose was not reported) both for prophylaxis. No adverse effects and no product quality complaint were involved. Additional information has been requested.
Hospitalized 11/6/2021; COVID-19 positive 11/6/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 11/6/2021 Discharge Date: 11/10/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia. Patient is a 80-year-old female admitted with acute respiratory failure with hypoxia secondary to COVID19.  She has a past medical history for end-stage renal disease on dialysis Monday Wednesday Friday, coronary artery disease, chronic obstructive pulmonary disease, hypertension. She presented to emergency room on 11/06 with dyspnea and chest pain. She was found to be hypoxic requiring 3.5 L of nasal cannula for support. Her COVID PCR was positive.  Chest x-ray showed changes consistent with COVID pneumonia. She had missed several dialysis sessions because she was feeling unwell likely from COVID. Of note patient did receive COVID-19 vaccination, most recently a booster shot.  She was admitted to Medicine Service further assessment and management. Nephrology were consulted for dialysis.  Patient was started on Decadron. She was monitored on continuous pulse oximetry. She was dialyzed per her regular schedule. Following dialysis patient experience some improvement in her symptoms. She was discharged with home health per her and family wishes (PT/OT recommended SAR) on home O2 of 3L NC and will temporarily need to get dialysis on Mon, Wed, Fri at 7:45am until out of COVID19 isoliation.
ARM WAS SORE FOR 24 HOURS THEN FINE 7 DAYS LATER,  (MARCH 18) INJECTION SITE STARTED TO ITCH ALL DAY.  BY MIDDLE OF NIGHT, PAIN IN ENTIRE ARM WOKE ME AND SITE WAS RED AND SWOLLEN
Patient developed syncope episode immediately following administration of his immunization and while being prepared for blood drawing. Pt has a hx of syncope during blood drawings.
has a cold; Her sugar is high; sick; coughing; runny nose; doesn't feel good; not feeling well; headache; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21May2021 as 1st dose, single dose for covid-19 immunization. Patient didnt receive any another products. Other investigational assessment was not performed. The patient medical history and concomitant medications were not reported. Patient was scheduled for her 2nd dose today but she is not feeling well and has a cold. Transfer agent reports that the caller got her first dose on 21May2021, and she was calling to reschedule her 2nd dose appointment. Transfer agent states that she informed the caller that she needed to call the facility for the reschedule. Caller says, so can she come in next week for her 2nd dose? She does not understand. Her sugar was high, she has a cold and she doesnt feel good so can this agent give her another date for her second dose. She needs another appointment. Caller says she got her 1st dose at (Withheld). She exclaims, oh my goodness. (Withheld) didnt give her a paper with their number on it. She called the phone number on the paper that (Withheld) gave her, what is their number? So this agent can schedule her another appointment and send an email with the appointment to her? Maybe tomorrow she will feel better. When she took the vaccine, she got sick, she got a cold, coughing and cold, runny nose and a headache. The caller states that she called because she cannot go to her appointment today, so she needs a new appointment. This is the second number she has called and no one can help her. The patient underwent lab tests and procedures which included blood glucose increased: high. The outcome of events was unknown.  Information on the lot/batch number has been requested.