chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/22/21 61-year-old male with past medical history of morbid obesity and diabetes who presents to the emergency department with shortness of breath after being diagnosed with COVID-19 and influenza A by his primary care provider through telemedicine visit earlier today. On arrival to the emergency department he is hypoxic to mid 70%, febrile, tachycardiac and tachypneic. ROS: Constitutional:  Fevers, Chills, Eyes: Does not report eye redness or discharge, HENT: Nasal Congestion, Sore Throat, Respiratory: Cough, Shortness of Breath, Cardiovascular: Does not report chest pain or palpitations, GI: Does not report abdominal pain, nausea, vomiting or diarrhea, GU: Does not report dysuria or change in urinary habits. Mus.
pt recv vax same day-2 diff legs;no side effect reported as of 10JAN97 10AM;
Nausea ? Nasal Congestion ? loss of taste ? Headache ? Cough
Dystonic reaction with pallor, full body shakes and fever to 102.7. Monitored in office for 1 hour. Shakes subsided after 50mg  diphenhydramine in 15 minutes.  Fever began to decrease after acetaminophen 1000 mg and left office with 101.6 temp.
Patient passed out and fell to the floor after standing up from a chair about 5-10 minutes after vaccine. She had low blood pressure, was pale, and had difficulty seeing clearly. EMS came to the scene to evaluate and her blood pressure recovered and she went home. She did not go to the emergency room, was just treated by EMS. She remained conscious and breathing and did not require CPR.
glass vial broke and was inside vaccine before reconstitution and was administered; glass vial broke and was inside vaccine before reconstitution and was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product contamination glass in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2TL27, expiry date 23-AUG-2025) for prophylaxis.   On 25-OCT-2023, the patient received Shingrix (intramuscular, left deltoid). On 25-OCT-2023, an unknown time after receiving Shingrix, the patient experienced product contamination glass (Verbatim: glass vial broke and was inside vaccine before reconstitution and was administered) and poor quality vaccine administered (Verbatim: glass vial broke and was inside vaccine before reconstitution and was administered). The outcome of the product contamination glass and poor quality vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist reported that a 62 year old female patient reached out to her because she was concerned that when she was getting Shingrix vaccine last week, a vial rolled off counter and fell prior to the pharmacist removing cap to reconstitute. The patient stated that she heard sound like glass shattering. She was concerned that glass from vial broke and was inside vaccine before reconstitution which led to product contamination glass and poor quality vaccine administered. The Pharmacist stated that the vial did not shatter. The dose was administered in the patient's left deltoid muscle. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, and headache. This report was non-serious.
Starting this morning (Nov. 21) at 0900 I started running a low-grade fever of 99.0 degrees F -- normal for me is 97.6-97.8.  Around 1100 I noticed a tightness in chest and realized that my heart rate felt elevated.  I checked my watch and it was registering 98-103 bpm, I'd been sitting with my feet elevated for at least an hour.  Then I checked my watch to see that it began showing elevated around 1045.  As compared to yesterday's recordings, my heart rate for this activity is generally around 78-81 bpm.  According to the watch my resting heart rate is 66.  As I'm typing this, however, my heart rate is registering 78-81 bpm.  Aside from these adverse events I feel minor aches in my legs/knees, which I'll assume is associated with the fever.
flare up of the herpes virus; This is a spontaneous report from a non-contactable consumer. This female consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 as 1ST dose, single for COVID-19 immunization. Medical history included ongoing herpes virus infection. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient stated that she had side effects from the first dose of the Pfizer vaccine which she received on 18Mar2021. Two weeks later she had a flare up of the herpes virus. She has not had any additional stress and was not been working. She wore her masks so she could only conclude the flare up (which she hasn't had in many years) occurred due to the vaccine. Her 2nd vaccine is scheduled for 09Apr2021. Treatment medication included an unknown antiviral and ongoing with it. Outcome of the event was reported as Unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
10/8/15 (L) leg shingles. VZV PCR (+) from lesion. Treated with acyclovir.
I21.4 ACUTE NON ST ELEVATION MI 10/12/2022 ARTHRITIS OF LEFT KNEE J96.00 ACUTE RESPIRATORY FAILURE 10/12/2022 ARTHRITIS OF LEFT KNEE I21.4 ACUTE NON ST ELEVATION MI 10/12/2022 ACUTE NON ST ELEVATION MI J96.00 ACUTE RESPIRATORY FAILURE 10/12/2022 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 10/12/2022 ACUTE NON ST ELEVATION MI J96.00 ACUTE RESPIRATORY FAILURE 10/12/2022 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 10/12/2022 HX OF CHF J96.00 ACUTE RESPIRATORY FAILURE 10/12/2022 HX OF CHF
gave an expired dose of Quadracel, no adverse event; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 6 years old female patient who was vaccinated with an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number: C5222AA and expiry date: 20-Jun-2019) via intramuscular route in the left deltoid on 25-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and no other medications or vaccinations were given.   It was a case of actual medication error due to expired vaccine used.  No adverse event reported following vaccination.  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.   Documents held by the sender: none.
nausea; diarrhea; poor appetite; This is a spontaneous report from a Contactable Nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 27Jan2021 at 08:00 am as single dose for covid-19 immunisation.  Medical history included Vertigo, high cholesterol. Patient had known allergies: Penicillin. The patient's concomitant medications were not reported.  The patient previously took first dose of BNT162B2 (Lot number: EL0140) in left arm on 08Jan2021 at 08:00 am for covid-19 immunisation and experienced mild diarrhea without nausea for 48 hours. Patient did not receive other vaccine in four weeks. Patient had unspecified other medications in two weeks. The patient experienced nausea, diarrhea, poor appetite on 28Jan2021 at 20:00. The patient reported that the next day after the 2nd dose of the vaccine I developed nausea, diarrhea and poor appetite that of this date has still not resolved. I have lost 12 pounds. No other member of my family has any of these symptoms. I cannot definitively say the vaccine caused these symptoms, but it did start the day after my second dose. I also experienced mild diarrhea without nausea for 48 hours after my first dose. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination.  Patient had covid test post vaccination. No treatment was received. The patient underwent lab tests and procedures which included Covid 19 PCR: negative and Nasal Swab: negative on 10Feb2021. The outcome of the events was not recovered.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Sustained coughing fits. Woke up every 5-25min from approx 2am on. Chills, Whole body soreness,  so tired couldn't work at all.
pt recvd vax;feeling stiffness, low grade T,noc sweats, arm & shoulder hurt until could not get out of bed or bath tub;saw rheumatologist & given pred;
22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Date the vial initially stored in the refrigerator was unknown. It was reported that 2 doses were administered on 05-Apr-2022, 13 doses were administered on 06-Apr-2022, 2 doses were administered on 07-Apr-2022, 4 doses were administered on 08-Apr-2022. The vial did not undergo any temperature excursions. The patient received second booster dose. No treatment drug was reported.
The patient received an expired dose of Act-Hib vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via global medical information (GMI) (Reference number- 00674336) and transmitted to Sanofi on 08-Jul-2021.  This case involves a patient with unknown demographics who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).    Medical history, medical treatment, vaccination, family history and concomitant medications were not reported.  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot UJ327AA, expiry date: 28-Jun-2021, diluent expiration date: 30-Sep-2021, other dosing details were not reported] for prophylactic vaccination. (expired product administered) (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.  It was reported that, reporter did not have any additional information, she was handed a box and requested to make call regarding validity of vaccine. (reporter wanted to know if this vaccine is considered viable or not)  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 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.
flare up of Trigeminal Neuralgia within 24 hours of vaccination, had not had flare up in over 7 years Frequent headaches over the past several weeks which have become at times unbearable.
Vaccine administered 10-9-09 in afternoon that evening, area began to hurt and throb. The next day elbow to shoulder was in pain and area where vaccinated was red. Monday (10-12) area was 7cm in diameter, hard and red. Today (10-15) redness, swelling is decreasing.
Reported burning down the arm.  Developed into soreness beyond typical for IM injection lasting for a month afterward.
It began as swelling at the injection site with a few small welts leading from it until it slowly spread from right leg to belly, left leg up the torso and onto all arms, legs, face. Also two small dry spots looking like eczema appeared on both elbow areas on right and left side.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt recieved flu then covid vaccine, said she didnt feel good and fainted. LOC for 6 seconds, woke up with nausea. Pt given juice and water and ice pack. Pt felt better after 15 minutes.  Pt reported N/V, tinginling in fingers, flushing of face, loss of color to face, and ears felt on fire.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medications were not reported. No previous drug reactions/allergies were reported. On 09-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017 (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports reported by the same reporter. Additional information has been requested.
On 10/9/07, the patient received 4 vaccinations: polio, DTaP, MMR, and Varicella. That night, he developed pain at the site of injection without any visual signs. The next morning, about 20 hours after the injections, he was erythematous from the elbow to the shoulder. He took 2 doses of diphenhydramine with no improvement in symptoms. Two days after the injections, the erythema had increased and spread to involve the forearm and his right hand became edematous. He started to experience pain and had decreased range of motion of his entire arm, including the fingers. When he presented to the ED 3 days after the injections, the right arm was swollen from the shoulder to the hand. It is indurated, erythematous, blanching, and warm to touch, with hyperesthesia. There was an area of localized vesicles close to the antecubital site and about 4 cm from the presumed site of injection. The patient was admitted to the hospital and treated with clindamycin, diphenhydramine, ibuprofen, and acetaminophen. No follow-up information is available. Evaluation. Generalized varicella-like rash (4-5%), cellulitis, secondary skin infections are commonly reported after Varicella Virus Vaccine injections (Lexi-Comp). Summary. Local varicella rash and cellulitis with possible superinfection.  12/1/2007 MR received for DOS 10/12-13/2007 with DX: Acute Febrile Illness.  Upper extremity Cellulitis. Pt presented to ER with c/o injection site pain, erythema, and edema of the R hand. ROM decreased in arm.  Pt initially txd with Benadryl with no improvement. On PE swelling noted on R arm from shoulder to hand. (+) Induration, balnching, warmth, hyperesthesia.  Localized vesicles noted in AC area.  Txd with IV abx and d/c'd.
Tues - red, swollen, sore back left arm. Wed - nauseous. Thurs - fine.
Information has been received from a pharmacist referring to a patient of unknown age. Information about medical history, concurrent condition and concomitant medications was unknown. On an unknown date the patient was vaccinated with M-M-R II (lot#, expiration date, strength, dose, frequency and route were not reported), which might have been reconstituted with diluent (lot#, expiration date, manufacturer unspecified) other than diluent supplied by Merck (product preparation error). No adverse effects were reported.
It was reported by a physician concerning a 53 year old male vaccinated with a dose of Fluzone SV 2002-2003 USP (lot number E31972GA) IM on 9/28/02. On 10/14/02, the patient developed sepsis. The physician also indicated that the patient developed pancytopenia due to polyclonal gammopathy, which required plasmaphoresis to remove the gamma globulin. The concomitant medications include Glucophage XR, Nizoral, Glucotrol XL, and Daypro. The lot number provided for Fluzone is not an valid lot number. Further information is requested. A 15-day follow up report received 02/20/2003 adds: From follow-up #1 correspondence received on 02/12/2003: The correct lot number for Fluzone is U0981AA, not E31972CA as previously reported. The pt's name and responsible physician's name was provided. No additional information was received. A 15-day follow up report received 9/30/2003 adds: From additional info received on 09/12/2003 from the reporting physician, it was reported that the duration of the adverse event lasted one month and that the pt has fully recovered. Reportedly, no hospital records or lab work could be obtained at this time. No further info is anticipated, this case is considered closed.
17APR92 fever "temp not taken" felt warm -not hot; lethargic 17APR & 18APR alert & responsive "laid around x 2 days; lt arm from immun, site to elbow pink & swollen-very tender; tc 6MAY92 mom states that pt is fine;
Lower abdominal cramping followed by diarrhea lasting for 2 days; then lower abdominal cramping followed by loose non-watery stools lasting for an additional 5 days.
None other than pain, was seen in office 11/21/2011 states 2-3 pain as dull ache in left lateral upper arm, with numbness, no fever, redness seen again 12-29, dull ache rated 2, no numbness redness, fever, tingling, or loss of sensation, normal range of motion, no edema.
Swelling, erythema and induration at injection site 1 day after vaccine admin.
Information has been received from a physician via company representative referring to a 68 years old female patient. On 20-FEB-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). In 2016 (reported as "about a year after receiving ZOSTAVAX") the patient experienced shingles. On 20-JUN-2016 the patient went to her physician's office where it was confirmed the patient had developed shingles. The outcome of the adverse event was unknown. Reporter's causality was not reported. Additional information has been requested.
Localized rash at injection site that is "red", "warm" and "tender"; Localized rash at injection; Localized rash at injection site that is "red", "warm" and "tender"; Localized rash at injection site that is "red"; Soreness in left arm; A spontaneous report was received from a consumer concerning a 39-year-old, female patient, who received Moderna's COVID-19 Vaccine and experienced soreness in left arm, localized rash at injection site that is red, warm and tender.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their dose of mRNA-1273 (Batch number: Unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient experienced soreness in left arm. On 31 Dec 2020, Thursday the patient experienced localized rash at injection site that is red, warm and tender.  Treatment for events localized rash at injection site that is red, warm and tender included Benadryl and hydrocortisone.  Action taken with mRNA-1273 in response to the events soreness in left arm, localized rash at injection site that is red, warm and tender was not reported.  The outcome of the events soreness in left arm, localized rash at injection site that is red, warm and tender was not reported.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product, the known safety profile of the vaccine and the start date of the reported events, a causal relationship with the events cannot be excluded
Frozen shoulder one day after SECOND dose of vaccine;  limited range of motion; severe pain; continued to get worse until cortisone shot in September; continuing course of physical therapy
Painful arms at inj. site - warm to touch.  T. 98.3 Rx with pain mid - ice.