chrisvoncsefalvay/vaers-outcomes huggingface dataset:
local reaction; swelling; patient received two flu shots accidentally (one on 18Sep2020 and one on 01Oct2020); patient received two doses of Fluzone Quadrivalent total (one on 18Sep2020 and one on 01Oct2020); Initial information regarding this unsolicited valid non-serious case via Medical Information (MI) (reference number: 00298451) was received from a nurse and transmitted to Sanofi 02-Oct-2020.  This case involved a 5 years old male patient who experienced local reaction, swelling after accidentally receiving two flu shots of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Extra dose administered and Inappropriate schedule of product administration).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On 01-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7041NA via intramuscular route in the left thigh (Extra dose administered and Inappropriate schedule of product administration).   On an unknown date, the patient is having more of a local reaction and swelling, unknown latency, following the administration of INFLUENZA QUADRIVAL A-B VACCINE that he received on 01-Oct-2020 (Extra dose administered and Inappropriate schedule of product administration).  Relevant laboratory test result was not reported.  Final diagnosis was Not Applicable patient received two flu shots accidentally, Not Applicable patient received two flu shots accidentally, swelling and local reaction.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events, local reaction and swelling.  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.
five minutes after vaccine given, patient fainted.  Patient pale , diaphoretic, weak.  Placed in supine position, cold cloth to head, vital signs done, sugar containing drink given.  Patient recovered back to normal conditon in twenty minutes and was able to walk out of clinic.
Patient received the 2nd dose of Pfizer vaccine earlier in the day on 5-9-22. Later that evening, mother was "popping" the child's back because the child enjoys this activity.  They enjoy doing this together as a calming routine. The patient lies down prone on the floor and mom places pressure on her back to "pop her back." Mom turned her around after doing this and the patient "looked stiff and her eyes had rolled back in her head." She was "not responsive" and "bluish" for about 30-60 seconds. Unclear if she was apneic at that time. Then she "came out of it" and was acting alert/interactive within about 5 minutes. Mother called the after hours exchange for our pediatric office. By that point the patient was acting at baseline, so ER assessment was deferred. Patient has a history of CHARGE syndrome with a prior abnormal EEG, but no definitive seizures in the past. She is followed closely by pediatric neurology.
feels like he always ends up getting the flu; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. When the patient got the flu vaccine, he felt like he always ends up getting the flu. The reporter did not consent for follow up.
Pt. states that left shoulder has swelling and lump is present at injection site. Pt. states she was fine day 0, 1 & 2. Slight tenderness at injection site only.  Symptoms worsened on day 3&4. Called HD on 03/19/2013 to report adverse event. States she is treating symptoms and I advised her to follow up with PCP if symptoms persist or worsen.
Information has been received from a physician concerning an Gardasil (lot# 655327/1287U) pre-filled syringe. The physician reported that the pre-filled syringe's safety mechanism failed to activate. The physician feels this increased stress and pain for the patient. The physician states she fully depressed the plunger and it failed. The SR# is 1-2166964843. No further information is available.
Symptoms: severe stiffness and swelling, followed by redness around injection site. These symptoms increased in strength to excruciating pain due to any movement of right shoulder. Used ice packs, heat, Tylenol, ibuprofen with no relief. I suffer from chronic pain of the back, so I am used to dealing with pain. This pain is severe and debilitating. Any movement of the arm or shoulder is excruciating. The only relief comes from immobilizing the area, and then it's only temporary.
I took Tylenol about an hour after getting the vaccine. Started getting a headache, and rash on my arm, arm became very sore, and rash spread all the way up and down my upper left arm.   Woke up that evening freezing with chills, and a 100.4 fever, even with taking Tylenol every 4-6 hours.  Extreme fatigue - unable to stay awake, or function.   These symptoms lasted until Sunday (2.5 days after receiving the vaccination).
weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck; feel my lymph nodes are swollen in my neck; arm is sore but its normal; it is still not comfortable; right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot; had a headache yesterday evening but it went away; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable) and PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable), PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) and HEADACHE (had a headache yesterday evening but it went away). At the time of the report, HYPOAESTHESIA (weird numbness feeling in my body/numbness all over body,numbness is from my shin down, including my thighs to all the way down to my foot,numbness in front torso,numbness in arms,numbness in neck), LYMPHADENOPATHY (feel my lymph nodes are swollen in my neck), PAIN IN EXTREMITY (arm is sore but its normal), DISCOMFORT (it is still not comfortable), PARAESTHESIA (right side of my lip and tongue started getting tingly which is about 4 hours after getting the shot) and HEADACHE (had a headache yesterday evening but it went away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains non-significant information.
Sore arm for 2 days.  Shingles virus 6 days after first dose.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: PT CAME TO PHARMACY COMPLAINING ABOUT REACTION SHE GOTTEN AFTER VACINATION INFORM HER TO GO TO HOSPITAL OR URGENT TO GET CHECK
temp 102 ax;body flushed;throat red, vomiting;DPH, pedialyte, clear liquids, no throat culture done;dx rxn to immun r/o strep throat
The patient states that the vaccine was given very high on her arm. She said it hurt more than normal and she is still in pain today.
cellulitis and lymphadenitis Narrative:  emp developed redness and axillary lymphadenopathy in her lt axilla
Right Supraclavicular and axillary lymph swelling with pain began on day 6 post vaccination . No treatment. Does not interfere with ADLs
Person noted at time of injection, felt discomfort at site. Localized discomfort continued since and now has increased to where she has discomfort when trying to raise left arm above shoulder height.
Possible adverse event. Insomnia, headache, fatigue, dizziness, loose stools, fever, inability to focus vs mono-like illness.
We did not discard the extra volume in the vial during our initial clinics.  I came to realize this was not authorized under the EUA after the fact and ceased the practice after the first four clinics on 3/10, 3/11, 3/12 and 3/13/21. When we reported the extra doses, we were advised to cease pooling doses and report to VAERS, citing EUA guidelines. We gave 9 extras doses on 3/10/21 but no adverse reactions have been reported related to this issue.
Patient had swelling on her right arm, pt stated that she had pain as she moved her arm around.
stroke-like symptoms, reacting like he "had a stroke" following their vaccine; Feels like a vegetable; A spontaneous report  was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of stroke-like symptoms, reacting like he "had a stroke" following his vaccine and current condition is "like a vegetable" which lead to the hospitalization of the patient.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On unknown date, prior to the onset of the events, the patient received their dose of mRNA (Batch/Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On unknown date, patient experienced event reacting like he "had a stroke" following their vaccine. Following severe symptoms, patient was subsequently hospitalized and had been transferred twice since. Reporter said their current status is "like a vegetable". The events are medically significant.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) stroke-like symptoms, reacting like he "had a stroke" following their vaccine and current condition is "like a vegetable" were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Patient called a few hours after vaccine complaining of soreness, swelling, and stiffnes in left arm. Patient stated she took ibuprofen and didn't feel relief yet.  We advised patient to follow up with doctor or urgent care and she went to urgent care that evening.  Per patient, she was given a shot of toradol in hip and was prescribed ibuprofen, tramadol, and doxycycline by urgent care doctor.  He advised her to follow up with her doctor if not better.  We spoke to the patient next morning and she stated she felt a little better and was going to speak with her doctor.  We advised her to contact us if the doctor suggested further treatment and we would contact her in a few days to see if continuing to improve.
She is feeling sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 51 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN., Dose Number:Unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She is feeling sick".  Additional  information: I am calling about adverse effect, adverse side reaction for COVID booster. I am a Pfizer colleague. I am required by corporate compliance to call if I hear of any adverse effect, that's what I am doing right now also need me to give feedback, it's a way, this is recorded right? Okay, hold on! way too long for me to actually talk to somebody. I gave way too much information. If I was the one that was actually having an adverse event side reaction, I don't think I would like to sit there and 'listen' all that information. Given much information on that recorded robot line that's not what somebody who is feeling sick from the vaccination booster is going to  want to sit there and listen to, okay? Get that feed. So, I guess my sister got the vaccine booster and she is feeling sick. So, there you go. Reporter stated, "Yeah, I mean, I have two report, one is for my sister and one is for her co-worker. I don't have a coworker's name. My sister feels sick, the coworker has a rash all over her body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On  the 8th, I woke up with what I thought was a bug bite on my middle left side of my back. It grew - a rash - over the weekend. April 12, I saw a physician and was diagnosed with Shingles. Treatment: Anti-Viral to take for seven days - Acyclovir. I took that for  7 days and by April 16th the rash was dried/scabbed over and my symptoms were tiredness and pain. I did take a couple days off work.  I had a follow up appt on April 16th and she said it looked like everything was healing and I was starting to feel better.  Pregnancy history - I have had two miscarriages in the past year - August 2020 and February 2021. I just took a positive pregnancy test on April 9th, 2021.  Estimated date of delivery - December 15, 2021.
Received the first shot on Friday 3/5/2021. about a week later I started developing a rash and then it started to blister up. I will see my family doctor today 3/15/2021
Patient complained that she has swelling under her arm at the lymph nodes. She experienced this about 4 to 6 hours after injection.
Severe red itchy rash/blisters on right arm and right hand, fever blisters on lips.
Date of Vaccination: 12/10/2021, 3:30 PM  Date Adverse Event Started: 12/10/2021, 3:40 PM  Allergies: Clindamycin, Celebrex, Theraflu, Gabapentin, Polysorbate 80  Medications: Nortriptyline,  Imitrex, Percocet, Klonopin, Testosterone, DHEA, Pregnenalone, Finasteride, Flonase, Medical Marijuana, Levsin, Compazine, Flexeril, Nystatin, Diazepam, Omeprazole, Famotidine, Metoprolol, Melatonin, 5-HTP, Ibuprofen, Acateminophen, Benadryl, Excedrin Migraine, Lidocaine Pathes, Salt Capsules, Vitamin D, Magnesium Malate  Chronic Conditions: Ehlers-Danlos Syndrome (Hypermobility Type), Postural Orthostatic Tachycardia Syndrome, Migraines/Chronic Vestibular Migraine   I received my Moderna COVID-19 booster shot on 12/10/2021. I had received my first two doses of the same Moderna vaccine on 3/9/2021 and 4/6/2021; those both gave me extraordinary pain, muscles aches, headache, fever, and fatigue for about 48 hours, but then the symptoms started calming down. After a week or so, I was back to normal.  I had those same reactions after the booster shot, but even more intensely. Those symptoms did resolve after a week or so. This time, however, beginning just 10 minutes after the shot, I developed the most extreme dizziness and light sensitivity that I have ever experienced.  The nurse took my blood pressure, which was 150/100 ? the highest it has ever been. I have struggled with dizziness and what we suspect are chronic vestibular migraines since September 2013, but never of this intensity. The dizziness began to subside after a few days, but then came back even stronger ten days after the shot on 12/20/2021, and unfortunately the elevation in dizziness has stayed with me ever since. I can barely look at screens, I can?t watch videos if the camera is in motion, and even changes in temperature are enough to render me incapacitated for hours at a time.  Then on 12/23/2021 ? 13 days after the shot ? I woke up with profound tinnitus in both ears. This is the second time this has happened, the first being in 2015, which was suspected at the time to be Autoimmune Inner Ear Disease. Fortunately that abated over time, however, and I never had a severe episode like that again until now. I went to the ENT immediately on 12/23/2021, and my hearing test showed that I had diminished hearing in both ears, particularly in the upper frequencies (which is where my tinnitus was as well; prior tinnitus had all been at lower frequencies). The hearing loss in the right ear was far worse than the left, however, and an Auditory Brainstem Response test showed slowing on the right side compared to the left. I am a professional musician and composer, so this severe tinnitus (accompanied by hyperacusis) has prevented me from doing any of my work in the six weeks that have passed since.  I was put on 60 mg prednisone every day for two weeks, with a 15-day taper after that. This recovered some, but not much, of the hearing loss in my left ear, but not in my right ear. And I continue to have debilitating dizziness, tinnitus, and hyperacusis to this day.
A non-serious report of administered expired FLUMIST was received from a Registered Nurse concerning a seven-year-old male.  Medical history and concomitant medications were not reported.  On 22-Dec-2008, the patient received FLUMIST that expired on 10-Dec-2008.  The physician decided not to redose with FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  On 08-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events.  Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
AT 4PM FELT SOME DISCOMFORT, BY 6 PM IN INTENSE PAIN AND COULD NOT MOVE ARM, WENT TO EMERGENY ROOM AT HOSPITAL AND WAS SEEN BY MD.
Patient describes significant weakness in his left arm since receiving the shot 6 weeks ago. Has difficulty lifting anything with it that weighs over 5-10 pounds. He describes struggling to lift the tailgate on his pickup truck since receiving the vaccine.
Flushed; Achy body; Fever; Chills; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FLUSHING (Flushed), PAIN (Achy body), PYREXIA (Fever) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, FLUOXETINE and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Mar-2021, the patient experienced FLUSHING (Flushed), PAIN (Achy body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, FLUSHING (Flushed), PAIN (Achy body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included thyroid medications.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: symptoms began later that day after pt left. Pharmacist on duty, told to take Benadryl and follow up with Urgent Care/ER if unresolved. no noted shortness of breath.
On 6/11/01, DTAP #3 was ordered; DT pediatric given instead (lot 470641 Lederle). Discovered when the pt was here for #4 DTAP on 12/17/01. Vaccine DTAP was given. Called vaccines for Children and Health Dept for instructions. To give DTAP in 6 months (in 6/02), then next shot will be due prior to starting school at age of 4-6 years. Advised that there should be no adverse effects if booster given in June, 2002.
This spontaneous report as received from a 48 year old female patient with none of pertinent medical history and none of drug reactions/allergies. On 04-SEP-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (strength, dose and lot # were not provided) and FLUVIRIN. The patient experienced fever and couldn't lift arm after receiving the second dose of PNEUMOVAX23 and FLUVIRIN. The patient was given ALEVE (dosage unspecified) and TYLENOL (dosage unspecified) for the events. None lab diagnostics studies performed. No sought medical attention. The patient did not plan to get any future doses of PNEUMOVAX23. The outcome of events was reported as recovering/resolving. Additional information has been requested.
An adult male (unspecified age) receiving post-exposure series RabAvert for a dog bite, experienced a headache and dizziness.  Concomitant medications included acyclovir.  The patient had received two doses of RabAvert and was due for his third vaccination.   Twelve days ago, the patient noticed a friendly, collared dog in the woods by his rural home.  He went to corrale the god and was bitten on the cheek.  The wound was washed and medicine applied.  The patient complained of headache and dizziness after the first two vaccinations.  The patient was due the third immunization.
Employee reported to Employee Health complaining of reactions to COVID-19 vaccination. States she has chills, headache and "heart feels like it is jumping around". Denies chest pain. Is leaving work and going home. Instructed to rest, drink lots of water and to seek medical attention if needed.