chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 20Jan2021 at 02:45 PM as a single dose for COVID-19 immunisation, lot number: unknown. Medical history was not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications in two weeks prior to the vaccination included cetirizine hydrochloride (ZYRTEC ALLERGY), curcuma zanthorrhiza (CURCUMEN TUERMERIC), ubidecarenone (CO-ENZYME Q10) and Beet roo (as reported). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 21Jan2021 at 06:15 AM patient experienced pain at injection site when she woke up this morning which had lasted through the day. No treatment was received for the event. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event, at the time of the report.  Information on the lot/batch number has been requested.
Patient stated she was dizzy, blurred vision, ears were clouded after about 10 minutes after the Covid-19 Janssen vaccine.
Developed ear pain evening of 4/21/2021 (side unknown), ear pain continued and worsened. Early AM on 04/25/2021, developed facial drooping on same side as ear pain. Medical exam consistent with Bell Palsy.  Grade !!!.Valtrex was prescribed along with eye drops.
following a day of some mild flu-like symptoms (severe headache and joint pain), by day  three after injection I developed a rash on the back of my right hand that, over the course of days 4 and 5 post-injection has spread to my left hand, right thigh, and belly. There is currently only one blister, and that is on my right hand.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 17-MAY-2018, the patient was vaccinated with expired dose of PNEUMOVAX 23, lot # M038216, expiration date 09-MAY-2018, for prophylaxis (dose and route of administration were not reported). There was no adverse event reported.
Bell's Palsy began 11/4/2022, numb feeling face and then face droop, admitted and stroke ruled out, MRI with contrast 11/3/22 showed inflammation in the area of the right 7th cranial nerve, treated with prednisone and briefly for lyme disease with doxycycline until confirmatory lab come back normal.
On May 2, 2021 I started to feel weird. I started to feel weepy and emotional. My body started twitching. I kept having involuntary movements in my legs, arms, and head. I went to the ER, and they told me I was having a panic attack. It happened again 2 days later. So I went back to the doctor but I just left because I waited for 5 hours in the waiting room. I am also twitching in my sleep. My doctor referred me to a neurologist for a MRI scan.
Patient came in for follow-up for an 8cm x 11 cm 2 days after being vaccined with 4 vaccines.  The area of redness was at the site where he had received a Varivax.  Pt was advised by Dr. to use Tylenol/Motrin for pain and come back if no better.
THE MORNING AFTER MY VACCINE MY TOES AND LEGS WERE NUMB AND TINGLY AND FELT HEAVY AND FELT WEIRD WALKING. I HAVE NEVER FELT THIS FEELING BEFORE, IT WENT  AWAY PRETTY MUCH AFTER A COUPLE DAYS AND THEN  CAME BACK A WEEK LATER E VEN WORSE THEN BEFORE AND STAYED FOR AT LEAST 3 DAYS SO I WENT TO URGENT CARE AND THEY SAID IT WAS NOT A BLOOD CLOT AND THEY DIDNT KNOW MUCH ABOUT THE VACCINE.  NOW OVER 3 WEEKS LATER I STILL HAVE NUMBNESS IN MY TOES AND LEGS. IT COMES AND GOES, SOME DAYS ARE WORSE THAN OTHERS.
This spontaneous report as received from a nurse refers to a 11 year old male patient. Nurse reported two patients (brothers) received first dose of VAQTA 25/0.5 intramuscular on 06-FEB-2013 and the second dose of VAQTA 25/0.5 (lot# unknown) intramuscular five months after the first dose on 02-JUL-2013. No co-suspected medicine reported. No concomitant medication reported. No adverse effect reported. The outcome was unknown. Action taken not provided. This is one of several reports from the same source. Additional information has been requested.
pt recv vax 31JAN97 in good hlth;found dead in mom bed on 5FEB97;post mortem found no apparent cause;
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 7th of 40 adult patients described by the reporter.  No concomitant product was reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacy intern reported that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
MS; fever; chills; head soreness; sore throat; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 12Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine on 12Mar2021. He's had fever, chills and head soreness on an unspecified date. He's had a sore throat on an unspecified date. He has MS (multiple sclerosis) and is on dialysis on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
ITCHING/ FEET ITCHING; BURNING OF THROAT; RIGHT ARM SWELLING/ FEET SWELLING; FEET BURNING; RASH; LOW GRADE HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known medications. The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced itching/ feet itching. On 09-APR-2021, the subject experienced burning of throat. On 09-APR-2021, the subject experienced right arm swelling/ feet swelling. On 09-APR-2021, the subject experienced feet burning. On 09-APR-2021, the subject experienced rash. On 09-APR-2021, the subject experienced low grade headache. Treatment medications (dates unspecified) included: paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching/ feet itching, burning of throat, right arm swelling/ feet swelling, low grade headache, and feet burning. This report was non-serious.
Information has been received from a physician concerning a 15 year old female who on 21-JAN-2010 was vaccinated with the third dose of GARDASIL. The mother called the physician indicating that on 21-JAN-2010 the patient suffered a nose bleed after vaccination. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested
Vaccines were administrated beyond use date after the thaw process.; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administrated beyond use date after the thaw process.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown if patient had acute illnesses at the time of vaccination and up to one month before.  It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.  It was unknown if patient had chronic or long-standing health conditions.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administrated beyond use date after the thaw process.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administrated beyond use date after the thaw process.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years and 2 months.  No concomitant medication information was provided.  It was reported that there was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medication were provided.
Eight days after my vaccination, my arm at injection site started really itching and became hot and swollen. Called NP and sent her a picture of my arm. Didn't recommend that I come in but to keep an eye on it. It was just red, warm for several days and then started to get better. It was just strange that it happened 8 days AFTER my vaccination.
nauseated; fever; diarrhea; achy; my sinuses is clear today than normal; This is a spontaneous report from a contactable consumer (Patient) based on the information received by Pfizer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nauseated, fever, diarrhea, achy and my sinuses is clear today than normal. Patient stated that my sinuses is clear today than normal. Patient reported that he received his second dose of the Pfizer Covid Vaccine on Saturday and on Sunday he started to feel nauseated (with no vomiting), fever, diarrhea, and achy. Patient reported he is fine now. The outcome of event my sinuses is clear today than normal was recovering and all other events were recovered on an unspecified date.   Information on the lot/batch number has been requested.
Patient was given VARIVAX on 1-24-2017. She reported redness, mild swelling, and pain at injection site on 1-26. I contacted CDC for advice and told pt. to use ice cold compress, anti-inflammatory, and antipruritic as instructed by CDC. I told patient to contact primary care MD or proceed to ER if worsens. I have been following up with patient.
Red ring has gotten worse; left sore arm; red ring around injection site; left sore arm; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (left sore arm), VACCINATION SITE ERYTHEMA (red ring around injection site), VACCINATION SITE REACTION (Red ring has gotten worse) and the second episode of PAIN IN EXTREMITY (left sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Jan-2021, the patient experienced the first episode of PAIN IN EXTREMITY (left sore arm). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red ring around injection site) and the second episode of PAIN IN EXTREMITY (left sore arm). On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Red ring has gotten worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red ring around injection site), VACCINATION SITE REACTION (Red ring has gotten worse) and the last episode of PAIN IN EXTREMITY (left sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided/unknown. Treatment medication included Benadryl.
PATIENT MESSAGE SENT TO HEALTH CARE PROVIDER: I had severe effects from Phizer BioNTech vaccine on 6/5, at 3:20 pm, from Walgreens on Mill Plain & 136th. According to the VSafe app I use daily, it said these need to be reported to my care team, who in turn would report to the Vaccine Adverse Effects agency.  Started out tolerable, mild headache on 6/5, soreness & swelling at injection site. I treated with ice packs &/exercised arm, still painful, but tolerable.  June 6 - the headache worsened, I took Tylenol. Also I developed a mild fever of 99.3, & body aches & pain.   June 7-  fever, headache continued to worsen, & body aches and pain got worse.  6-8 @2am- began the worst case of Diarrhea ever experienced. I was stuck on toilet for hours.  1st time I was able to leave it, took 3 Imodium AD. Diarrhea continued instantly, could not get to bathroom in time, nausea & vomiting began. Excuse grotesque details - important to know - the golden pure liquid diarrhea continued unabated while I threw up in the garbage can. Finally, I thought both had quit, I was exhausted as this had started at 2 am, crawled into bed, & quickly slept. Only to be awakened by diarrhea?s return, could not get to the bathroom in time. The vomiting -dry heaves now - continued.  My fever at 8 am was 100.1. At10 am, it was 101.4.   HEALTHCARE OFFICE FOLLOWED UP WITH PATIENT: 6/9- Patient reported that she is feeling much better today. The nausea, vomiting and severe diarrhea have gone away. Body aches and headache has lessened. Hasn't had an episode since around 3pm yesterday. Doesn't think it was related to anything she ate and believes it was a side effect of the COVID vaccine. Patient expressed her concerns regarding dehydration and states that she is trying to drink enough fluids. Reports no fever today, highest her fever reached yesterday was 101.3F and took some Tylenol which brought it down to 99.8F. Stated when diarrhea got really bad that she took 3 Imodium right away and drank a lot of water. Imodium did not help much.  Reports she is now able to keep fluids and solids down. Patient also stated that her blood sugars were elevated during this and that she had to take short term insulin twice due to the elevated BS. Thinks it was due to the stress of the whole situation. Reported she ate two fried eggs this morning and had no problem after.  Advised patient to try and eat small and simple but frequent snacks/meals. Also advised patient to let the office know if symptoms return and if they worsen to be seen. Patient verbalized understanding and agrees with POC.
Unexpected, severe genital herpes outbreak following the vaccine. Has had for 25 years but pt typically has an outbreak every 2-3 years, last time before this being 1.5 years ago. Nothing else has changed in her life (ie stressors, etc) and typically she gets other symptoms to warn her that she will get it (like itching) but this one came on fast, hard and with blisters right away. Worst outbreak she's has in 20 years. Treated with VALTREX the day it was noticed and it has not resolved to date.
covid vaccine details: administration date=08Mar2021, administration time=01:30 PM; pain/stiffness in all knuckles- esp- middle finger; pain/stiffness in all knuckles- esp- middle finger; Unable to bend middle finger at all or grasp for 2 weeks; R hand swelled- esp knuckles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 13:30 (Lot number: ER8727) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "envir. allergy" (unspecified if ongoing); "depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "cold sores" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; MONTELUKAST; NEFAZODONE; VIT D [VITAMIN D NOS]; ACYCLOVIR [ACICLOVIR]. Past drug history included: Bactrim, reaction(s): "Known allergies:Bactrim"; Keflex, reaction(s): "Known allergies: Keflex"; Lisinopril, reaction(s): "Known allergies: Lisinopril", BZDs. Vaccination history included: Bnt162b2, administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 immunisation, reaction(s): "Hand swelled"; Bnt162b2, administration date: 08Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Swelled especially knuckles", "Swelled especially knuckles", "Pain in all knuckles especially middle finger".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "covid vaccine details: administration date=08Mar2021, administration time=01:30 PM"; PERIPHERAL SWELLING (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "R hand swelled- esp knuckles"; PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering" and all described as "pain/stiffness in all knuckles- esp- middle finger"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "Unable to bend middle finger at all or grasp for 2 weeks". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, musculoskeletal stiffness, loss of personal independence in daily activities.  No follow-up attempts are possible. No further information is expected.
Client fainted and fell off the chair in waiting area after receiving vaccines. Client's legs raised while client was lying down. BP 130/80 HR 70. Ice compress placed on head. Provided juice and crackers, which client ate and drank. Client stated she bumped her head when she fell. Client walked to back area after stating she was feeling better. Vitals retaken. Supine: 134/79 HR 69 Sitting: 129/84 HR 62 Advised client and parents of signs of concussion and what to do if signs/symptoms appear . Client voided before being released at 30 minute mark per NP's advisement.
Client was mistakenly given Moderna as a third dose, and it should have been Pfizer. Client was informed of the error and we discussed the approval of Agency's approval of different Covid Vaccine's as a booster. Incident report was filed.
No additional AE reported; expired PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not reported.  On 31-JAN-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U022984, expiration date: 29-JAN-2023 (strength, dose, anatomical site of administration and route of administration were not provided) administered for prophylaxis (expired product administered). No additional adverse event (AE) reported (no adverse event). No temperature excursion reported for affected pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prior to or at current call time.
This spontaneous report as received from a consumer via company representative refers to her aunt, a 68 year old female patient with lupus. Medical history was unspecified by reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection, strength, dosage, dose number, lot # and expiration date not reported). Concomitant medications were not reported. The reporter stated that the patient developed shingles on an unspecified date after receiving the ZOSTAVAX. It was unknown if the patient sought medical attention. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Symptoms started 5/10/05 at 3:30 PM. Symptoms were red, swollen, and hot to touch left arm. The deltoid area.
Drug ineffective; Suspected COVID-19; My thoughts were my child got vaccinated and still got long covid so I question the accuracy of this ad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "My thoughts were my child got vaccinated and still got long covid so I question the accuracy of this ad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Autoimmune Flare Muscle aches times one week, swelling left upper arm, itching left upper arm, diarrhea, joint pain, fatigue, weakness, nausea, headache
I started to notice that I was only talking through my mouth and not using my jaw to talk.  Then my jaw became very stiff and difficult to move around.  It eventually got better but still, weeks after, my jaw still feels weird when I am eating.  The best way to describe it is that it feels like I have TMJ while eating.
Patient experienced rash shortly after administration.  Felt hot. Patient took zyrtec.  Was having a little bit of difficulty breathing.  Symptoms except rash resolved after 30 minutes of observation.  Patient discharged home from the vaccination clinic.
pt recv vax 12JAN98 & by 18JAN98 pt devel a few scattered pustules-papules on shoulder, abd, very high fever;fussy;pt mom called ER for advice;
10-15 min. After shot, throat felt slightly tight, heart beating fast, slight itch in inner right ear. Given Benadryl. After about an hour, felt better to go home and rest. Two days after injection, left foot-big toe goes numb periodically.  That?s occurred a couple of times now. Today I?m very fatigue, heart beating fast, at times hard to catch my breath.