chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles rash on her forehead and extending into scalp; Shingles rash on left eyelid; Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   On 07-JUL-2023, the patient received the 1st dose of Shingrix. On 09-JUL-2023, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: shingles rash on her forehead and extending into scalp), eyelid rash (Verbatim: Shingles rash on left eyelid) and shingles (Verbatim: Shingles). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the rash, eyelid rash and shingles were not resolved.   It was unknown if the reporter considered the rash, eyelid rash and shingles to be related to Shingrix.     It was unknown if the company considered the rash, eyelid rash and shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 17-JUL-2023 A Pharmacist reported that a patient received first dose of Shingrix on 07 July 2023. The patient stated that two days later she developed shingles rash on her forehead, extending into scalp and on left eyelid. Rash confirmed as shingles by her physician, and she was prescribed an antiviral medication. The Pharmacist states the patient is otherwise healthy and was not on any medications prior. The pharmacist spoke with the patient on 16 July 2023 and at that time, the rash was still ongoing. The reporter consented to follow up.
During post observation period after administration of the first dose of Pediatric Pfizer 0.2ml, pt seem to have fainted. Mother moved pt to the floor, and mother believed son had some sort of convulsions before pharmacist was able to attend. By the timepharmacist ran to the scene with the immunization cart, patient had already came out of syncope. 911 was called, and pharmacist administered 10ml (25mg) of oral diphenhydramine. Approximately 5 minutes after event occurred and was witnessed by sibling who also received their 1st dose of Pediatric Pfizer, sibling also stated she felt dizzy and sick, and maybe a little swelling around lining of mouth. Once ambulance arrived, the patient and pt sibling were checked out by paramedic staff. Blood pressure waswithin normal parameters. Patient was taken in ambulance to hospital for further observation. Will follow up with pt mother via phone.
Hospitalized for 8 to 9 hours; Could not walk; Whole body shutdown; Swollen arm; nostalgic; A spontaneous report was received from a consumer concerning a 77 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nostalgia, could not walk, swollen arm and whole body shut down, and hospitalized for 8 to 9 hours.  The patient's medical history included allergies to bee stings. Products known to have been used by the patient within two weeks prior to the event include: unspecified cholesterol medication, aspirin and unspecified hernia meds.  On 08 March 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 036a21a) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Mar 2021, the patient experienced nostalgia, could not walk, swollen arm, whole body shutdown and was hospitalized for 8 to 9 hours.   Laboratory details were not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of the report, the outcome of the events, nostalgic, could not walk, swollen arm, whole body shutdown and hospitalized for 8 to 9 hours,  were unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
cellulitis; tenderness; aches; chills; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than a week after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), injection site tenderness, pain and chills. The patient was treated with cefalexin (Cephalexine). On an unknown date, the outcome of the cellulitis, injection site tenderness, pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the cellulitis, injection site tenderness, pain and chills to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. The nurse reported that, the patient was diagnosed with cellulitis and within 2 days, experienced aches, chills, and injection site tenderness. The reporter reported that, the symptoms were still present as of day before reporting. The reporter stated that, 2 patients experienced reaction with same batch number(TT9BR), and was unusual from the facility's past experience with Shingrix. The reporter stated that, they were not going to use this batch any more. The reporter would fill out VAERS for patients who got a rash from Shingrix batch number (TT9BR). The reporter reported that, 2 out of 10 Shingrix doses resulted in a rash, they had 5 unused vaccines and had not heard back from 3 out of 10 Shingrix doses. The reporter consented to follow up. This case was 1 of the 3 linked cases.
STATES HAD AN AREA LOCALIZED RXN IN 5 CM DIAMETER WHICH WAS WARM AND TENDER FOR A FEW DAYS THEN WENT AWAY YESTERDAY (11/23/10) MOM NOTICED A BUMP WHEN SHE WAS EATING.
Symptoms began 05/01/2022, cough, fever, nausea and vomiting. Case was taken to hospital due to Type 1 Diabetic to have blood sugars stabilized.
Pt c/o  lightheadness and nausea.  vs 98.4, BP 102/74, HR 82, Bld sugar 115 evaluated by Physician and Nurse Practitioner; sent to the Clinic for further evaluation; given fluids.  Pt emphasized some change in mental status and sent to the Hospital for evaluation; evaluated treated with fluids and released back to the clinic.  7/15 vital signs stable, c/o slight pain at injection site; no other c/o  any issues  Later on 7/15 pt c/o sl chest pain and discomfort-examined. vital signs stables dx with controchondritis-treated.  No further c/o any problems after COVID injection 7/8 left the clinic and reunified with family
Patient had tenderness from the top of the shoulder down to shortly below the injection site.  Moderate to lge amount of swelling generalized around the site and within about 3 inches in diameter firm red swelling around the injection site.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date later in 2014, the patient was treated in a hospital for a severe vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Fever yesterday after immunizations and in following AM was given Motrin at 07:15 AM followed by seizure. Taken to ER. Given Tylenol Supp. in ER.
Local injection site redness, swelling & itching starting Day2 & continuing throughDay8. Local redness & swelling 3 inches in diameter.
High fever 39.8C; shivers, fast heart beat, high blood pressure, veins on the forehead significantly pulsating and very visible, pain and headache
I had extreme fatigue. I went to the doctor on 11/26/2021. They said I had an urinary track infection. I was prescribed antibiotics for nitrofurantoin 100mg 2xday for 7 days.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 12-year-old patient who received Hepatitis A vaccine (batch number 3397T) for prophylaxis.   On 20-FEB-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient has agreed to repeat this vaccine dose and has scheduled to return on 4/21/2021.
An MA reported that a 39 year old male received an injection of TD Toxoids Adsorbed, Purogenated on 6/19/00. That evening, he developed fever and memory loss. He was seen by the physician on 1/20/00. His temperature was 102F, with 45 minutes, it rose to 104F. The pt vomited. He was found to be dehydrated and was treated in the physician's office with 850 mL IV 0.9% sodium chloride. Blood culture and unspecified "lab work" were performed. Liver function tests were found to be abnormal. The pt was sent home. He was recovering as of 6/22/00. Follow-up received on 8/28/00, indicated that the pt's blood cultures were negative. The pt recovered.
My arm hurt for 1-2 days. The first day was pretty extreme muscle pain and I felt slightly tired. The unusual thing was I had 10 days of heavy cervical mucus discharge.  I have never had anything like this, but especially not at 41 years old.  After that, my period started 10 days late.   My period is very normal and predictable usually.  These two events were not normal for me.
Rash at injection site starting day after vaccination and continuing past 72 hours after vaccination.  Worsening to a solid rash at day Five.
Information has been received on 08DEC2014 from a physician regarding a patient (gender not reported). The physician reported the patient received two dose of PNEUMOVAX23 on unspecified dates, before age 65 year (see MARRS # 1501USA005342). This statement was unable to be further clarified. Physician additionally stated he knew of other unspecified physicians who routinely vaccinated their unspecified patients over 65 years with PNEUMOVAX23 every 5 years. regardless of their situation. No adverse effect reported. No additional information provided. Physician needed to disconnect call before AE collection was initiated, therefore all fields are NA. Additional information has been requested.
almost 24 hours later, redness, swelling, soreness, fever, and cold chills
Initial report was received on 20 November 2013 from a health care professional who is also the patient. A 52 year-old female patient with a history of allergies to penicillin, DEMEROL, codeine, SUDAFED, betadine and contrast dyes had received on 30 October 2013 an intramuscular left deltoid injection of Influenza vaccine (manufacturer and lot number not reported) and 12 days later on 11 November 2013, experienced headaches and hypertensive crisis. The patient was hospitalized for several days (dates not reported). The patient also reported experiencing chest pain, pain radiating down arm and a flushed face during the "hypertensive crisis". Treatments were not reported. According to the reporter, "many lab tests and other tests" were performed but all have been negative. The patient is currently on bedrest most of the day, taking her own blood pressure every hour, self medicating as directed by physician and is able to be up after 1400 when blood pressure returns to normal. The patient received on 12 October 2012 an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and "about two weeks later", experienced headaches and hypertensive crisis. The hypertensive crisis would follow a daily pattern in which blood pressure would be elevated from about 0800 to 1400 and was elevated to as high as 280/150 but after 1400 to 1500 she would be ok until next AM. The symptoms lasted for eight weeks. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Area of redness 1 1/2" x 2" on (L) deltoid, slightly warmer to the touch; itchiness noted.
Main event was multiple rounds of vomiting  spaced 5-15 minutes apart, in total lasting from approximately 2:00am to 3:20am.  There were several less impactful effects as well. There was a subtle tingly feeling in limbs and worsening of my existing cough about 3 hours prior to the vomiting. A feeling of low energy lasted 2 days past the vaccination.
Fever, irritation, small red bumps to right arm began to appear the day after vaccination.  Mom describes rash as big, round and circular at first then got smaller.  Mom states patient started to complain of headaches days after vaccination.  Mom states was given VIS form on day of vaccination (07/18/2003).  Child alert, active, plan to start school next week.
No adverse effects for the patient; A patient was administered one separate dose of an improperly stored vaccine, MMR II; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age an gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 02-MAY-2019, the patient was vaccinated with an improperly stored separate dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R001659, expiration date: 17-JAN-2020 (dose, strenght and anatomical location were not provided) administered subcutaneously for prophylaxis. The vaccine was reconstitued with a properly stored sterile diluent (lot # N030415, expiration date: 13-JUL-2020).On an unspecified date, the patient also received  an improperly stored dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX).   Both vaccine underwent a temperature of 42.26 fahrenheit (F) degrees during a time frame of 45 minutes as recorded by digital data logger. It was reported previous temperature excursion of 50.396 F for 1 hour and 15 minutes (on 29-APR-2019). In addition, diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX), also underwent a temperature of 33.6 F for 45 minutes (during the month of December 2018). No adverse effects were reported to the patient.
Received Hepatitis vaccine 4/16/04, developed high fever and chest pain. 4/18/04- rash 4/19/04. Fever  lasted 3-4 days pt was given a course of Zithromax on 4/19/04 for a pharyngitis but throat culture was negative for Strep A
Beginning 100 days after vaccine, experienced an episode of sensory disturbances of the skin diffusely over the whole body to include the trunk, face, and limbs.   Symptoms inluded: electric shock-like brief painful sensations, pricks, and itchy skin.  Symptoms were consistent with Idiopathic Non-Length-Dependent Small Fiber Sensory Neuropathy.  Symptoms were most acute on the first day and progressively improved over 8 weeks.
He has acute gout attack; some pains in the toes; left foot full blown gout attack happened; This is a spontaneous report from a contactable physician (patient). A 45-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported potential side effect of the vaccine. He had acute gout attack. On the 1st week he had experienced some pains in the toes - left foot full blown gout attack happened. He wanted to know what to do if he will continue on getting the 2nd dose since he did not want to experience another episodes of flare ups. He asked if it had aluminum adjuvant on the vaccine. The events were reported as non-serious. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Uncontrollable shivering began at 4:00 a.m. Patient also could not get warm. This continued for 6 hours. After shivering stopped, patient had extreme headache (which required a trip to express care clinic), joint pain, rubbery legs, fatigue, dizziness. Also, the injection site was very swollen and red. 3 days later, he is still unable to work due to fatigue and dizziness (requiring another trip to the physician).
expired TENIVAC was administered  with no reported adverse event; Initial information received on 15-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2022SA340295(CLUSTER).  This case involves a 73 years old female patient to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Jul-2022, the patient received a expired 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection, once, (strength: unknown)  (lot U5856AA: expiry date: 26-Jan-2020) via intramuscular route in the right arm for Immunization was administered  with no reported adverse event (expired product administered) (latency; same day)  Action taken : not applicable.  Outcome : Unknown.   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 guidelines. 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.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 08-MAR-2011, the patient was vaccinated with ZOSTAVAX at by a licensed practical nurse (LPN)  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided).  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 04-NOV-2011, the patient was treated by physician  for a vesicular outbreak that was diagnosed as severe shingles. On or about 12-AUG-2012, she was treated by physician for dermatologic conditions, secondary to shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome of shingles was not recovered. The outcome of dermatologic disorder was unknown. Additional information has been requested.
Fever, backache and headache began 12 hours after vaccination. Fever has resolved and headache improving after 36 hours post vaccination.
Sever body aches in the back and joints that lasted for approximately 20-30 minutes.
Patient received the Covid-19 vaccine. She reports symptoms of Other: anixious, "quezzy", SOB. Pt reported that she was anxious prior to arrival.   I have observed No acute distress.  Treatment/intervention Vitals taken 12:53 169/100  P. 85 Spo2 97% 1:02 160/89  P 87  Spo2 95% 1:06 169/95  P  91 Spo2 95%  No distress noted. Vitals signs with no improvement.   Pt taken to ED
felt cold and hot; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (felt cold and hot) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 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) 1 dosage form. In February 2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (felt cold and hot) and HEADACHE (headache). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (felt cold and hot) and HEADACHE (headache) outcome was unknown.            The patient had her second dose. She went to bed early the previous night of reporting and stated that she felt cold and hot. The next morning she had a headache.  No concomitant medications were reported.  No treatment information was reported.
Received vaccine at approximately 1040. Patient then went to the self monitoring area where approximately 5 minutes later stated she felt "slight puffiness in lower lip and tingling on tongue". Patent was removed from the self monitoring area and brought to our First Aid room. Vitals remained stable BP 138/70 HR 80 and respiratory rate 16.  After 5 minutes within the First Aid area  patient stated " the tingling and puffiness of lower lip is extending to the back of my tongue and throat". EMS was called and patient was transported to SVMC ED.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, and concurrent condition was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, oral liquid, lot # L033693, expiration date 31-MAY-2017; lot # L033343, expiration date 16-JUN-2017, orally, (dose and concentration were not reported). Concomitant medications were not provided. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two cases from the same reporter. Additional information has been requested.
An outreach vaccine clinic was set-up at a community center.  It is estimated that (1-4) people received an undiluted doses of Pfizer vaccine.  The team of 2 physicians, a pharmacist and a dentist evaluated what took place.  The 30 people who received the vaccines that day were divided to 3 groups.  Group 1) (8 people) was determined as most likely received undiluted doses.  Group 2) (9 people) was determined as less likely received an undiluted dose. and Group 3) (13 people) was determined as not likely received an undiluted dose. Group 1) and 2) were talked to and a follow-up was done the next day.