chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an extra dose of Engerix B pediatric dosage; By mistake instead of HepA, HepB was administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 3-year-old male patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (completed the HepB primary series before 20th May 2022).   On 20th May 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 20th May 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2022 Reporter's Comments: The pharmacist reported that a pediatric patient received a dose of Engerix B when Hepatitis A vaccine was needed. The pharmacist reported that patient received by mistake instead of HepA (Hepatitis A), HepB (Hepatitis B) was administered.  The Vaccine Administration Facility is the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The pharmacist reported that a pediatric patient received extra dose of Engerix B vaccine instead of Hepatitis A vaccine, which led to extra dose administered and wrong vaccine administered.
Fever (>102 for 24 hours.  Nausea, dizziness, and vomiting for 1 month. Low grade fever (>99.5F) for 5 months. Tinnitus for 5 months.
Normal thermia but clammy and sweaty.  Injection site is raised, red, and hot to the touch.
Information has been received from an office manager, concerning a female patient who "recently" (in approximately 2008) was vaccinated with the first dose of 0.5 mL GARDASIL (Lot # not available) and later developed cellulitis. The patient was brought to emergency room and was admitted to the hospital. It was unknown whether the patient was still in the hospital or how long was the hospitalization. There was no product quality complaint. Additional information is expected.
Approx 1 wk after immunizations were given pt broke out in a rash/whelps. Mom brought the pt in for a follow up appt and noticed the whelps.
Information has been received from the mother of a two year old female (date of birth was May, 1999) who in November 2000, was vaccinated with the first dose of MMRII.  In May, 2001 the pt was diagnosed with autism.  On 04/08/04, at the age of 4 years and 11 months, the pt was vaccinated with the second dose of MMRII (#646556/0813N).  Subsequently, the pt's mother stated that the "child is worse than before".  Upon medical review, autism was considered an other important medical event (OMIC). Additional information has been requested.
Information has been received from a registered nurse concerning a 77 year old female patient with hypertension. In September 2014, the patient was vaccinated with ZOSTAVAX (dose, strength and lot# were not reported, subcutaneous). Recently (in approximately March 2015), the patient was diagnosed by an unspecified physician with adenocarcinoma of the lung. There was no treatment given for the event. The adenocarcinoma of the lung was reported as not recovered. Causality between the event and ZOSTAVAX was not reported. Upon internal review, lung adenocarcinoma was determined to be medical significant. Additional information has been requested.
Redness, warmth to upper arm with pain "like electric shocks" from her neck to elbow that started 8 days after vaccination
The patient had left the room after vaccination and within 3 minutes had passed out, was shaky, sweating profusely. He was only out for a few seconds, came back to, and had stomach pain with nausea. I gave the patient water and glucose and he slowly improved over time. For 15 minutes he was sitting on the floor and had some mild chest pain that passed within a few minutes. No issues breathing. He stayed for 30 minutes and left with his grandmother with some persistent nausea.
pt recv 1st vax; devel flu-like sx;11oct94 2nd dose,devel d,neck pain,abd pain,skeletal pain,arthritis & severe fatigue;at time of rpt sx persisted;pt reported would not get 3rd dose;also had several Rubella vax & failed to seroconvert;
Had a headache.  More symptoms occurred Sunday evening to include: SEVERE headache (1-1/2 days), chills, aches, barely move, neck stiffness, sight issues.
Patient was given the monovalent Pfizer vaccine for their first COVID-19 vaccine dose after it was mandated to receive the Bivalent series only.
5/1/22   I started having increased blood pressure issues and increased ocular migraines. On 7/1/22, I wound up in the ER with hypertensive crisis. It took 11 hours to get it under control and I was sent home with a change in medication, Amlodipine. I was back in the Emergency Room on 7/4/22. It took about 5 hours to resolve the high blood pressure and I was sent back home with an increase in Amlodipine.  Through all of this my ocular migraines were still being troublesome to the extent I had never had before. Since July it has been a round robin of medications to get my blood pressure in control. On 3/28/23 I had an MRI which for the migraines which showed an injury from when I was a child, nothing new.  Yesterday at the optometrist they discovered a swelling on my left retina nerve that could be affecting my vision and linked to my high blood pressure and ocular migraines. This morning my Lisinopril was decreased trying to straighten things out. I have a follow up with my doctor and neurologist trying to get the ocular migraines and blood pressure under control.
chills; headache; aches and pain; feeling nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), MYALGIA (aches and pain) and NAUSEA (feeling nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, ESCITALOPRAM, LEVOTHYROXINE SODIUM (SYNTHROID) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (chills), HEADACHE (headache), MYALGIA (aches and pain) and NAUSEA (feeling nausea). At the time of the report, CHILLS (chills), HEADACHE (headache), MYALGIA (aches and pain) and NAUSEA (feeling nausea) outcome was unknown. Not Provided          The patient did not receive any treatment.
24 hours after receiving Yellow fever vaccine, Pnuemovax and Influenza pt reports severe migraine headache and considerable body/joint pain with low grade fever. Took Acetaminophen for pain relief. 36 hours after Vaccination patient reports she is feeling almost back to normal
Patient developed significant, dark purple bruising under the arm (axilla) on same side as injection but also significant bruising  on left breast. Also with hives on abdomen.
My daughter also had delayed rash reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 16Jul2021, outcome "not recovered", described as "My daughter also had delayed rash reaction". The event "my daughter also had delayed rash reaction" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional Information: Patient mother saying that her daughter also had delayed rash reaction. The worst of the rash lasted a month and still experiencing small areas of rash on arms. She was also still experiencing terrible fatigue and seeing a naturopathic doctor. The AE treatment was Supplements/homeopathic remedies. Patient had no Covid prior vaccination and tested post vaccination.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (18Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
PATIENT HAD A RED SKIN RASH AROUND INJECTION SITE. AREA WAS WARM TO THE TOUCH AND THERE WERE 2 SMALL BUMPS (ONE AT TOP AREA AND ONE BELOW AREA.
This spontaneous report was received from a medical assistant and refers to an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour); and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 02-JAN-2018. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
It was reported by phone that a 46 y.o. female PT received Imovax IM lot #R0789-2, expiry 9/2/02, administered in the left deltoid as the 4th dose in a Rabies Post Exposure series. Administration date 8/4/01. PT developed reaction on 8/5/01. Left arm was red and swollen 3x3 cm area. Benadryl was administered w/success. Antibiotics started, 6 hrs later left arm again presented with redness & swelling, again Benadryl alleviated.
Information has been received from doctor's office nurse concerning an over 60 year old female patient with a history of injection site reaction after received a dose of Tdap one month ago (approximately on 15-OCT-2010), who on approximately 07-NOV-2010 (the previous week) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided). It was reported that the patient developed an injection site reaction after receiving ZOSTAVAX (Merck). At the time of this report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the doctor's office nurse concerning the 68 year old female patient with sulfa allergy, high cholesterol, osteoporosis, hypertension, Parkinsonism, Mitral Valve Prolapse, hypokalaemia and a red slight warm rash at the time of vaccination. The nurse reported that on 11-NOV-2010, the patient was vaccinated subcutaneously in the left deltoid with a first dose ZOSTAVAX (Merck) (Lot# 665530/0697Z). On 11-NOV-2010, the patient developed left arm red slight warm rash with early vesicles. The patient's outcome was not reported. The patient did not seek medical attention. Additional information has been requested.
cellulitis; A regulatory report  was received from a Non-Health Professional on 16Feb2021, which refers to a 87-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 027L20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 19Jan2021, the patient experienced cellulitis. As a result, she was hospitalized on 11Feb2021 and then again on 15Feb2021.  She was treated with antibiotic IV infusion.  The Non-Health Professional did not declare any relatedness between cellulitis and Moderna COVID-19 Vaccine.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
At 10:47 am client complained of nervousness and heart palpation.  Client was attended by onsite EMS and released home after stating she felt better.
Menstruated one week early; Menstruated one week early with increased pre-menstruated symptoms; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT) for unknown indication on an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 20Mar2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 00:00, the patient experienced menstruated one week early with increased pre-menstruated symptoms. Therapeutic measures taken were not reported. The clinical outcome of the events menstruated one week early with increased pre-menstruated symptoms was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54 years old male patient titer was done that showed 0.1 (showing immunity less than 0.1 below detection unit), while he received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis b vaccine (hepatitis b vaccine), japanese encephalitis vaccine (japanese encephalitis vaccine), polio vaccine inact 3v (vero) (ipol [polio vaccine inact 3v (vero)]) on 06-Oct-2017 and measles vaccine, mumps vaccine, rubella vaccine (MMR), hepatitis b vaccine (hepatitis b vaccine), AFLURIA, TYPHIM VI and hepatitis a vaccine inact (havrix) used as product used for unknown indication on 08-Sep-2018 via unknown route of administration and unknown site. The patient received three shots series 0.5 mL dose of suspect RABIES (HDC) VACCINE (lot M12962M), expiry date:12-Jun-2018 via unknown route in the right deltoid on date 08-Sep-2017, 15-Sep-2017 and 06-Oct-2017 respectively. On an unspecified date, the patient was performed titer that showed 0.1 (showing immunity less than 0.1 below detection unit) (antibody test negative) following the administration of RABIES (HDC) VACCINE. Other relevant tests included no lab test done. Final diagnosis was antibody test negative. It was not reported if the patient received a corrective treatment. List of documents held by sender: none.
EXPIRED Narrative:  86 y/o male who received first dose of COVID-19 vaccine (Moderna) 1/22/21 and never returned for second dose. COVID-19 clinic alerted the pharmacist that patient expired prior to receiving second dose. Unknown reason.
elderly gentleman with a history of diabetes hypertension hyperlipidemia and BPH presented with worsening shortness of breath over the last several days.  He has been COVID-19 vaccinated and both him and his wife have been suffering similar symptoms.  He presented to emergency room and was noted to be hypoxic with chest x-ray revealing bilateral infiltrates suggestive of COVID-19.  COVID-19 was found to be positive per discussion with ED provider.  He was intubated and placed on a ventilator shortly after admission to this hospital.  Patient did show nurse his COVID vaccination verification card.  He was vaccinated in January and February 2021.  Patient was treated with dexamethasone and remdesivir.
Scratchy throat within 2 hours of vaccine inoculation, a raging headache started within 3 hrs of Johnson & Jonson (Janssen) vaccine, massive muscle cramping starting at 1800 and continuing through the night - I drank a gallon of water between 6 PM and 9 PM on 04/06/2021 and then 3 more 1/2 liter bottles during the night. None of it came out in the usual manner -- I had cramping of my left side muscles across my rib cage between 4 PM and 6 PM on 04/06/2021 and then massive lower leg cramps starting at about 10 PM 04/06/2021 lasting until 0300 AM 04/07/2021
I woke up this past Friday morning, with my sinuses feeling like they were burning. I have a history of sinus problems, but this was unusual in how it felt. I coach a team and we're in close proximity. I was worried about it. I was tested at urgent care for COVID 19. Since that Friday, I have had a headache up until today (it's a little bit better today) and that's very unusual for me. It is the very same headache that I got right immediately after each of the Moderna vaccines. After each of the Moderna Vaccines - I just felt groggy and would have a headache - which was unusual for me. Yesterday, I started taking an allergy medication. urgent care - antibiotics and Flonase - prescription - filled that Flonase and took it each day since but I didn't take the antibiotics as I wasn't feeling worse. I still don't feel 100% but I do feel that the headache isn't as bad today.
Pain and weakness in flu shot arm.  It's now 3+ wks after the shot and although gradually getting better, still painful.  Originally so weak that I would lift my flu shot arm with the good arm as if it was broken.  Constant sore and painful achy feeling at injection site with occasional sharp shooting pain.  The shooting pain is if I'm actively using the arm.
Vertigo; Pain / Sore arm; Redness / red whelp at the injection site; Vomiting; Shivering; Sweats; This case was reported by a consumer and described the occurrence of vertigo in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meniere's disease.   On 2nd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 36 hrs after receiving Shingrix, the patient experienced vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema. On an unknown date, the outcome of the vertigo, pain in arm and injection site erythema were unknown and the outcome of the vomiting, shivering and sweating were recovered/resolved.   It was unknown if the reporter considered the vertigo, vomiting, shivering, sweating, pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received  first dose of Shingrix and approximately thirty six hours later, she had severe Vertigo and Vomiting for three hours, and then it resolved. The patient stated she then had Shivering and Sweats for one hour. She reported that she had pain as in a sore arm and redness or a red whelp at the injection site  The reporter consented to follow up.
Patient complained about sore arm after injection. About 2 hours patient started getting body aches, fever, chills and sleepy. She said slept most of 2 days. Sometime the first 24 hours she develops diarrhea that was still an issue 4 days later.  She also reports she developed a "Bladder" infection with burning and pain about 4 days after injection.  She did have her husband buy phenazopyridine 95mg tabs for the bladder pain.
injection site redness; injection site warm; she had a little soreness in the arm the first week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had a little soreness in the arm the first week), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE WARMTH (injection site warm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE WARMTH (injection site warm). On an unknown date, the patient experienced PAIN IN EXTREMITY (she had a little soreness in the arm the first week). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she had a little soreness in the arm the first week), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE WARMTH (injection site warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol and Advel
Raspy cough, onset 6/9/12. Imms given 6/5/12. DTaP & HIB, second dose of each. Doing better today per mom.
Patient begin to report feeling lightheaded. Client was diaphoretic and given PO carb and juice.  Client begin to report feeling better but just weak. 911 called, client assessed. client refused further treatment and left clinic without need for assistance.
Left arm swelling similar to large localized reaction. Resulted in viral syndrome and dehydration. Admitted for IV therapy fluids. 10/19/09 Discharge summary received for dates 10/6/09 to 10/7/09. DC DX: viral syndrome, dehydration, reaction to fluzone. SX: c/o HA, cough x3 days, night sweats, fever, nausea, myalgias, arthralgia. Assessment: pt. was treated one day ago by outpatient with IV therapy/hydration. Pt. did not improve. Admitted for further treatment and supportive care. Pt. dc home 24hrs later improved condition.
Client states his wife noticed his arm was swollen on 5-5-11. States put alcohol on it and a warm compress. States his arm hurt for one week. States his arm is sore at the end of the day.