chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 72-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 31st January 2020). The patient's past medical history included respiratory disorder and infection (in an out of hospital with unspecified infections). Concomitant products included SINGULAIR, Diltiazem, DUONEB, NORCO, PROAIR HFA, XANAX, ZANAFLEX, ZOCOR and hydrochlorothiazide + losartan. On 6rh March 2018, the patient received SHINGRIX. On 7th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site mass, injection site pain and injection site erythema. The patient was treated with BACTRIM and MEDROL. On an unknown date, the outcome of the injection site mass, injection site pain and injection site erythema were unknown. The reporter considered the injection site mass, injection site pain and injection site erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient reported that soreness and pain at the injection site of the SHINGRIX injection, which was the left arm. The patient also reported a knot on the injection site and redness. The patient went to the physician, and was given BACTRIM and MEDROL dose pack.
Injection site arm pain, extreme fatigue on next day, left armpit lymph node swelling, hive on bottom of left foot, brain fog for 7-10 days.
At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up into the left shoulder and down the left arm. A numbness and tingling sensation has continued in the left arm and then all over the body- bilateral upper and lower extremities intermittently since time of injection until current. The sensations are occurring randomly about every 1 minute. No associated muscle weakness or any other neurological changes. Patient has been referred to a neurologist for further evaluation and management.
MOC called & reported that pt was shaking & feeling cold & was talking out of head; was taken to ER where temp was 104 & had convuls related to fever;
Dose administered after more than 1 temperature excursion; Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes 1 hr or 1.5hr approximately, temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 72.67 No concomitant medications were reported. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 36 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. Temperature excurtion time was reported as 9A, Temperature as 34. Vial was stored on cooler 1 , on 27-FEB-2021, Excursion duration At 8AM: 38 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM : 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5PM: 41  No treatment information was provided.
Dizziness, lack of pupillary response, rapid heart rate, swelling and elevated heat at and around injection site.
Very shortly after my H1N1 vaccine. I had increase thirst, increased urination, weight loss, blurry vision. I had no increase in my blood sugars. Went to dr. Diagnosed with Type 1 Diabetes secondary to a virus killing my pancreas. This was all within weeks of shot.
on 04/25/21 patient complained of cold like symptoms, mild fever, upset stomach, headache, and shortness of breath 04/26/21 tested positive for Covid
A report has been received from a Pharmacist concerning a 10 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 29-Nov-2013. The patient experienced expired FLUMIST which started on 29-Nov-2013. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 21-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # L008574, expiration date 22-NOV-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
When getting ready for bed, we noticed his left upper arm was red, swollen, and hot.  When asked if his arm hurt, he said it did.  He appears to move it fine, so it is not acute pain.
03Apr or 04Apr2021 had first surgery to remove the skin cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6199) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "allergies: bactrim"; Ativan, reaction(s): "allergies: ativan". The following information was reported: SKIN CANCER (hospitalization, medically significant), outcome "unknown", described as "03Apr or 04Apr2021 had first surgery to remove the skin cancer". The event "03apr or 04apr2021 had first surgery to remove the skin cancer" required physician office visit. Therapeutic measures were taken as a result of skin cancer. Clinical course included on 03Apr or 04Apr2021, patient had first surgery to remove the skin cancer at doctors.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139170 same patient/drug/reporter, different dose;US-PFIZER INC-202300293267 same patient/drug/reporter, different dose;US-PFIZER INC-PV202300150867 same patient/drug/reporter, different dose;
Information was received on 04-FEB-2019 from a lawyer and a male consumer regarding a case in litigation. In or around 2017 the patient was inoculated with ZOSTAVAX (lot number and expiration not reported) as recommended for routine adult health maintenance for the prevention of shingles. Shortly after receiving the vaccine the patient suffered a heart attack. As a result the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the defective ZOSTAVAX, the patients symptoms and diagnoses have results in physical limitations not present prior to using the product. As a result the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Upon internal review, heart attack was determined to be a medically significant event. Heart attack was determined to be disabling. Additional information has been requested.
It was like a head cold or sinus infection. I had a runny nose, congestion but no fever. I had some mucus buildup but no mucus. Seemed like a sinus infection to me.
Child was inadvertently given Adult Hep B dose. No complication arose with the child.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient had no history of having chicken pox. No additional medical history, concurrent conditions and concomitant therapies were provided. On 22-SEP-2017, the patient was vaccinated with ZOSTAVAX injection, subcutaneous (dose, lot # and expiration date were unspecified) for prophylaxis. On unknown date in September 2017, the patient experienced a large red welt 3 inches in diameter near the injection site, which was red and warm. The patient experienced also pain between the injection site and her elbow. The patient sought medical attention by calling pharmacist. On unknown date, the patient consulted the symptoms with an unknown healthcare professional, who prescribed diphenhydramine hydrochloride (BENADRYL) (unknown dose and frequency), acetaminophen(TYLENOL) (unknown dosage and frequency) and external compresses (unspecified). The outcome of adverse events was reported as currently unresolved. The relatedness between adverse events and ZOSTAVAX injection was not reported.
not all dose was administered. when injecting, the patient moved suddenly and most of the dose came out.
I am feeling v unwell today; previously I had Pfizer vaccines; bad tummy; Aches everywhere; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (I am feeling v unwell today), ABDOMINAL DISCOMFORT (bad tummy), MYALGIA (Aches everywhere) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously I had Pfizer vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had Covid-19, 6 months before the Pfizer vaccine.). Previously administered products included for COVID-19 vaccination: Pfizer vaccines and Pfizer vaccines. Past adverse reactions to the above products included No adverse event with Pfizer vaccines and Pfizer vaccines.  On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ABDOMINAL DISCOMFORT (bad tummy) and MYALGIA (Aches everywhere). On 20-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously I had Pfizer vaccines). On 21-Dec-2021, the patient experienced MALAISE (I am feeling v unwell today). On 20-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (previously I had Pfizer vaccines) had resolved. At the time of the report, MALAISE (I am feeling v unwell today), ABDOMINAL DISCOMFORT (bad tummy) and MYALGIA (Aches everywhere) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
temperature excursion 0.5 C and product was administered to patient with no reported adverse event; Initial information was received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA277620.  This case involves a 11 years old male patient to whom temperature excursion 0.5 c, meningococcal A-C-Y-W135 (T CONJ) vaccine  [Menquadfi] 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 29-AUG-2023, the patient received an 0.5 ml, once dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U7852AA, expiry date: 31-Oct-2025, strength: standard) via intramuscular route in Left deltoid for Immunization and temperature excursion 0.5 c, product was administered with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
This spontaneous report was received from a physician and medical assistant and refers to a patient of unknown age and gender. On 15-JUN-2017, the patient was vaccinated with one dose of expired GARDASIL lot # M014929 (expiration date 27-MAY-2017) for prophylaxis. No adverse effects was reported. Additional information has been requested.
CARDIOGENIC SHOCK 12/8/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
COVID breakthrough cause Diagnosed 12/29/2021, was tested due family member who test positive prior to me getting tested. Three weeks to recover used over the counter. Sinus Infection meds called in.
after recv vax on 11/95 pt devel varicella on 3/98
This spontaneous report as received from a Licensed Practical Nurse regarding a 5 year old female patient. There was no information regarding concurrent condition and historical medication. On 02-AUG-2018, the patient was vaccinated with VARIVAX lot # R002051 dose 1, subcutaneous in the right deltoid for prophylaxis and M-M-R II lot # N024703 dose 1, subcutaneous in the left deltoid for prophylaxis. Medication error occurred in the storage in clinical practice (product storage error). Digital data logger was involved.
Received shots on 4/22/13. Large knot on 4/24/13 in area of vaccine with redness.
Patient had Covid 19 Pfizer dose Ped <5 on 9/28/22 and by mistake gave the second dose of Moderna vaccine
fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown.  No follow-up attempts are possible. No further information is expected.
The Monday morning after the shot (Friday afternoon) I woke up with with my right hand and arm very itchy. I broke out into hive all over my body. I went to the Urgent Care Monday afternoon. I was unable to sleep that night and wound up going to Hospital ER early Tuesday morning.
Child received H1N1 inj vaccine provided at her school on 11/2/09. Symptoms started on 11/9/09. Comparable with Bells Palsy.  11/13/09: Immunization record card and [pediatrician office medical record for date of service 11/11/09 received. Diagnosis: Left Facial Palsy  Patient presented with complaint of problems with left side of face and difficulty opening eye since receiving H1N1 vaccine. Consult requested.  11/18/09: Neurology consult for date of service 11/13/09 received. Diagnosis: Facial Weakness  The patient presented with complaint of facial weakness. Three or four days earlier, the patient experienced not being able to close right eye perfectly and the next day noted that facial appearance was different and smile appeared crooked. The event occured approximately six days after receiving H1N1 vaccine. Examination revealed facial weakness of right face and findings suggested seventh cranial nerve palsy. The record noted that patient had been prescribed Steroids and acyclovir by the pediatrician. The patient was instructed to use eye drops and to keep the eye covered. MRI of brain to be scheduled.
administered expired Adacel to a patient, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 58 years old male patient who was inadvertently vaccinated with an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number: C5263AA, expiry date: 12-Sep-2019 via unknown route in the left arm on 01-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU); and HEPATITIS A VACCINE INACT, HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).  It is an actual medication error case due to expired vaccine used.  At the time of report, no adverse event occurred.  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.
Wednesday 1/6: I had welts on my eye lid to the back of my scalp. I thought it was bug bite or rash. It didn't itch just sensitive to touch. I took some Tylenol. By 1/10/21, it still didn't go away and I took a Zyrtec and Tylenol. It was stinging and sensitive to touch. When I got up from my nap, I took a Valtrex before I went to work and the welts are seemed to be going down. I believe it is a shingles-like reaction to vaccine.
Per ED provider notes.  34 y.o. female who presented to the emergency department for Shortness of breath. Patient states that she received her second monitor and a shot yesterday. She was feeling achy and sore yesterday evening but is significantly gotten worse today has generalized myalgias, fever, shortness of breath and feels that she cannot take a deep breath. Now feels like her chest is very tight. She denies similar symptoms in the past. Denies history of bleeding or clotting disorder. States that with her first shot she did receive a injection and then had swelling about her arm but denies similar issues or problems.  After fluids and medication patient feeling much better at present time. Discussed feel this is likely combination of immunologic response to vaccine as well as patient feeling very anxious secondary to shortness of breath which has precipitated worsening symptoms. She is feeling much better now recommended continued supportive care at home and close monitoring.
Patient came in for her "6 month" immunizations. Chart was prepped incorrectly saying patient needed PEDIARIX, PREVNAR, Rotavirus and Hib. Our facility uses PEDVAX HIB and a dose at 6 months is not appropriate. Patient received dose at 6 months which is an error at the 10/24/16 office visit.
Received Heplisav-B Dose 4 Days Ago, Tested Postive For Hepatitis B Antigen; Initial Report Received on 06-Feb-2023  A registered nurse reported that a patient (age, gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and tested positive for hepatitis B antigen four days after the vaccination.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B vaccine (details not provided). Four days after the HEPLISAV-B vaccination, the patient was screened for hepatitis B and tested positive for the hepatitis B antigen.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
PATIENT EXPERIENCED FATIGUE, FEVER, AND INCREASED SWELLING AT THE SITE OF INJECTION
Patient had no immediate effects from the vaccine, but died approximately 8 hours after receiving first dose of vaccine.
Approx 6-8hrs post 2nd vax experienced a flu-type illness w/sore throat, diaphoresis, URI, & h/a; Rec'd 1st dose of vax 22FEB90 w/out adverse effect;
Information has been received from a physician concerning an 80 year old female patient with no drug reactions or allergies and no pertinent medical history who in 2007 was subcutaneously vaccinated with a dose of 0.65 mL of ZOSTAVAX (Merck) (Lot# and expiration not reported). Concomitant therapy included ATIVAN, ACTONEL, NEXIUM and PRISTIQ. Physician reported that the patient was administered ZOSTAVAX (Merck) in 2007 and about a month ago, in approximately May 2011, the patient developed herpes zoster and was hospitalized for severe pain. It was reported that the patient also had post herpetic neuralgia. At the time of reporting the patient had not recovered. Additional information has been requested.