chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a nurse refers to 4 year old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 02-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
4/10/21, 6pm upper left was very painful 4/11/21 upper left arm still very painful, lymph node in left armpit swollen 4/12/21 upper left arm less painful, lymph node in left armpit swollen to the point where it is painful to move left arm
Information has been received from a consumer through the Merck pregnancy registry concerning a 16 year old female who on 01-FEB-2008 was vaccinated with the third dose of GARDASIL (lot# not reported). Concomitant suspect therapy included VARIVAX (Oka/MSD) (MSD) (lot# not reported). Other concomitant medication included VENTILAN (albuterol) and prenatal vitamins. Per the reporter, the patient found out that she was pregnant about a week after receiving the third dose. Before she was known to be pregnant, the patient had a pap smear that was irregular, so a biopsy of the cervix was performed. Per the reporter, "I don't know if this made her more fertile. Also, before her pregnancy, when she received her first dose, she experienced an irregular menstrual cycle." The patient sought unspecified medical attention. Additional information has been requested.
was so sick; super bad intense headache for 2 days; muscle pain; joint pain; chills were horrible; nausea; couldn't eat; temperature of 102 for 2 days; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible) and NAUSEA (nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Pre-diabetic.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible), NAUSEA (nausea), FEEDING DISORDER (couldn't eat) and PYREXIA (temperature of 102 for 2 days). On an unknown date, the patient experienced ILLNESS (was so sick). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (super bad intense headache for 2 days), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills were horrible), NAUSEA (nausea), FEEDING DISORDER (couldn't eat), PYREXIA (temperature of 102 for 2 days) and ILLNESS (was so sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) temperature of 102 for 2 days.  Her temperature broke after one day.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned   Additional information provided they provide lab data for body temp. and current conditions as a fibromyalgia and pre-diabetic  patient had super bad intense headache for 2 days, muscle pain, joint pain, chills were horrible; it lasted 2 days.  patient was over weight,
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients of unknown race and ethnicity.   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 and expiry: Unknown ) dose and start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient diagnosed with suspected covid-19 infection (Suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210835200-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Shingles outbreak on right forehead, scalp and eye lid. Shooting pains at right eye, sore through . Back pain, headache
Patient reports ongoing shooting pain and arm soreness since vaccination. Discussed OTC treatment options and potentially seeing primary care physician for monitoring.
Soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness). At the time of the report, MYALGIA (Soreness) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.   The patient reported adverse event via chatbot.
Case number PHEH2015US027169, is a combined initial and follow up spontaneous report received from a pharmacist on 23 Dec 2015 and 24 Dec 2015. This report refers to a 13 years old female patient. Past medical history and concomitant medications were not reported. This 13 year old female patient was vaccinated with FLUCELVAX (batch number and expiry: not reported) on unknown date. No adverse event was reported following this administration error.
arm sore; adhesive capsulitis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) and PERIARTHRITIS (adhesive capsulitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore) and PERIARTHRITIS (adhesive capsulitis). At the time of the report, PAIN IN EXTREMITY (arm sore) outcome was unknown and PERIARTHRITIS (adhesive capsulitis) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional event (NS)
STUFFY NOSE; HEADACHE; SORE THROAT; RIGHT HIP ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805050, and batch number: 1805050 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced stuffy nose. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced sore throat. On 08-MAR-2021, the subject experienced right hip ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hip ache, and was recovering from stuffy nose, headache, and sore throat. This report was non-serious.
My menstrual cycle has been significantly different since my vaccinations. I have bled on and off for 4-5 days at a time since Pfizer shot 2.; I have bled on and off for 4-5 days at a time since Pfizer shot 2; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0172), via an unspecified route of administration (at the age of 35-years), administered in arm left on 26Apr2021 at 12:00 as dose 2, single for COVID-19 immunization. Medical history included premenstrual dysphoric disorder (PMDD) from an unknown date and unknown if ongoing. Concomitant medications included citalopram hydrobromide (CELEXA [CITALOPRAM HYDROBROMIDE]) taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration (at the age of 35-years), administered in arm left on 05Apr2021 at 16:45 as dose 1, single for COVID-19 immunization. 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. The patient had no known allergies to medications, food or other products. On 30Apr2021, since vaccination, the patient experienced my menstrual cycle has been significantly different since my vaccinations. I have bled on and off for 4-5 days at a time since Pfizer shot 2. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome for all the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
shingles on the upper part of face; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the upper part of face).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 13-OCT-2023 A physician reported that in the past few weeks she had a case of shingles on the upper part of her face.  This patient are over 65 years old, according to the doctor, this occurred about one or two weeks after this patient are administered, according to the physician, the first dose of shingrix.  For this reason and had knowledge of this claim by the physician, he/she proceed to report it. The reporter agreed to follow up from GlaxoSmithKline. This case was linked with case US2023AMR14359, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR143597:Same reporter.
Patient vaccinated 3/19/2021, 2/10/2021. Hospitalized with COVID 1/7/22.
Client received first dose of Moderna Vaccine at 13:02 pm.  Began reporting symptoms of lips tingling and itching, tongue thickness, chest tightness and difficulty swallowing at 13:07 pm. Reported this to observer at 13:10 and Notified onsite EMS paramedics. 1320: B/P 154/74; Pulse 96. 13:24: B/P 155/104; Pulse 84, 13:24--APRN administered Benadryl 25 mg/0.5 ml IM Right Deltoid. 13:29--B/P 153/97; Pulse 90, O2 94; 13:33 administered 1:1000 Aq. Epinephrine via epi pen in Left AL thigh X 1. 13:38--B/P 154/114, pulse 85, O2 saturation at 94%; O2 per non-rebreather mask started at 13:39 @ 8L/min. Ambulance called for transport @ 13:39. B/P 153/103, Pulse 86, O2 saturation at 100%. EMS transport unit tranported at 13:47.
Pt daughter brought her back in Monday to show us her arm. Her left arm from shoulder to elbow was red and warm.
Sleep apnea diagnosis; Not sleeping; Snoring all his life; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP APNOEA SYNDROME (Sleep apnea diagnosis), INSOMNIA (Not sleeping), SNORING (Snoring all his life) and FATIGUE (Tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea and Sleep apnea on 02-Jul-2021. Concurrent medical conditions included Hypertension (High Blood Pressure), Cholesterolosis NOS and Restless leg syndrome. Concomitant products included ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for Cholesterolosis NOS, LOSARTAN and MELOXICAM for Hypertension, ROPINIROLE for Restless leg syndrome.   On 09-Sep-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2020, 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 experienced SLEEP APNOEA SYNDROME (Sleep apnea diagnosis), INSOMNIA (Not sleeping), SNORING (Snoring all his life) and FATIGUE (Tired). The patient was treated with Surgery for Sleep apnoea syndrome. At the time of the report, SLEEP APNOEA SYNDROME (Sleep apnea diagnosis), SNORING (Snoring all his life) and FATIGUE (Tired) had resolved and INSOMNIA (Not sleeping) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received a surgery in 02-JULY-2021 for sleep apnea. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Significant follow up. Relevant medical history added. Outcome of events has been updated.Product indication for concomitant medication MELOXICAM has been updated
PAIN IN SHOULDER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced pain in shoulder. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in shoulder on 04-APR-2021, was recovering from fatigue, and the outcome of headache was not reported. This report was non-serious.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult female patient of unspecified age. This refers to 80th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Called to lobby where client was sitting upright in chair after receiving J&J vaccine.  She had brought her own ice pack from home and stated when she gets shots she sometimes feels like the room is going black and feels faint.  Patient requested to lie down.  Myself and nurse assisted patient to wheelchair and assited her to exam room 2 where she got on the exam table with our assistance.Patient did not lose consciousness but was pale and clammy.  B/P at 16:06 82/56, P 65, spo2 98% on RA. Patient voiced she felt a little better.  V/S at 16:09 B/P 88/62, P 86,spo2 98% on RA. Patient then became restless and began to complain of not being able to feel her tongue and her fingers, noted decorticate posturing and patient complained of feeling like she needed to vomit. Pt. remained conscious. I had nurse call 911 and I administered EpiPen 0.3mg in Right thigh.Nurse to room to assist and administered Benadryl 50mg in left VG. Supplemental 02 was provided by NRB initially and then via nasal cannula at 6L/min. Pt. voiced she could feel her tongue again and felt some better.  EMS arrived and patient was
unable to get 2nd dose of vaccine until 50 days after 1st dose.; got very sick; bronchitis; sinusitis; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to get 2nd dose of vaccine until 50 days after 1st dose.), ILLNESS (got very sick), BRONCHITIS (bronchitis) and SINUSITIS (sinusitis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to get 2nd dose of vaccine until 50 days after 1st dose.), ILLNESS (got very sick), BRONCHITIS (bronchitis) and SINUSITIS (sinusitis). At the time of the report, PRODUCT DOSE OMISSION ISSUE (unable to get 2nd dose of vaccine until 50 days after 1st dose.), ILLNESS (got very sick), BRONCHITIS (bronchitis) and SINUSITIS (sinusitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Headache, NauseaVomiting, Fatigue & chills Narrative:  Other Relevant History:
slightly ill; achy; chills; A SPONTANEOUS report was received concerning a male patient who received Moderna's COVID-19 vaccine SHOT-2 on  23-feb-2021(mRNA-1273) and experienced slightly illness, achy and chills,     The patient's medical history was unknown / not provided     Event or Problem is unknown After the second shot, Ihe became slightly ill, achy, chills (went away after a day).     Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were Recovered.
tired; fever; chills; aches/achy; swollen lymph node under arm; This is a spontaneous report from a contactable other hcp. This report was received via a sales representative. A 29-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. It is reported that 13 hours after administration on 16Jan2021, patient experienced fever of 101.9 (degree), chills, aches, swollen lymph node under arm. One day later on 17Jan2021, patient was tired and achy. Outcome of the events was unknown. Information on the lot/batch number has been requested.
I received a flu shot on 10/10/19 at 09:00 in my left arm.  About a week later I started having symptoms with my right arm and hand.  Upon waking, my arm is numb and I couldn't make a fist with my right hand.  I couldn't (this still occurs) squeeze toothpaste onto my toothbrush with my right hand because my hand was weak and it caused a low level of pain.  I took ibuprofen off and on and this has helped with the discomfort. As the day went on I could close my hand into a fist, but I didn't have strength in my hand.  Every day I would check to see if I could close my right hand when I woke up. I thought my symptoms were going away, but on Sunday 11/3/19 in the evening my right hand was so cold and numb, I put a heating pad on my hand.  I noticed the end of my pinky finger was blue from the joint below my nail to the fingertip.  It appeared to be bruised from an injury and my finger was swollen, but I didn't remember injuring the finger.  Today (5 days later) the discoloration and swelling in my pinky is much improved (it is still cold to the touch). I have noticed numbness and tingling in my middle, ring and pinky fingers in the morning while putting on my makeup. I am concerned about the numbness, cold to the touch and tingling in my fingers/right hand.  A co-worker mentioned similar symptoms, so I wanted to document my symptoms.
Breakthrough case admission after 4 vaccines Moderna 1/26/21 Lot# 032420A;  Moderna 2/23/21 Lot# 011M20A;  Moderna 10/29/21 LOt# 939904;  Moderna 5/20/22 Lot# 0043M21A
I had striated rash on my trunk and lower abdomen. It really did not itch. It was raised a little and doctor said it was pityriasis rosea. Doctor thought it might have been activated by vaccine but was not sure. I applied some clobetasol propionate (steroid cream) and it stopped itching and went away in a couple of weeks.
Unexplained brain bleed with potential mass underneath it. Symptoms (focal seizures) started on September 16, 2021.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # K019100, expiration date 15-MAR-2016 and lot # K020750, expiration date 30-APR-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Patient received vaccine and 15 min later had decreased air entry and reported tight chest with wheezing. Patient pale. Patient received Epinephrine 0.3mg IM in office at that time and an albuterol 0.083% nebulizer treatment. VS stable with BP above 100 systolic and pulse Ox 100%. Patient breathing improved immediately and patient observed for 2.5 hours more with VS remaining stable for the duration of reaction and treatment. Patient discharged home with mother by MD at 1700.