chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild neck pain; Swollen lymph nodes; A little tired; Received second vaccine outside dosing window; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second vaccine outside dosing window), NECK PAIN (Mild neck pain), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (A little tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second vaccine outside dosing window). On 01-May-2021, the patient experienced NECK PAIN (Mild neck pain), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (A little tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second vaccine outside dosing window), NECK PAIN (Mild neck pain), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (A little tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had some reactions after her first dose and turned away due at her second dose due to that reaction. Then after consulting her health care professional she had her second dose and the next day she experienced mild neck pain, lymph node swelling and a little bit tired.  Concomitant medications were not reported.
Onset of shingles symptoms. Only previous exposure to varicella virus was from Varivax immunizations given in 1996.
She felt the COVID-19 vaccines made her MS worse; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient. Other Case identifier.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years for COVID-19 immunisation. The patient's relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing); "Skin cancer" (unspecified if ongoing); "Lumps in right breast" (unspecified if ongoing), notes: Had outpatient procedures twice; "Irritable bowel disease" (ongoing), notes: Had it whole life; "60% hearing loss (left ear)" (unspecified if ongoing); "Double vision" (unspecified if ongoing); "Nerve damage in the right eye" (unspecified if ongoing); "Use glasses with prism" (unspecified if ongoing), notes: For double vision (nerve damage in the right eye); "Bowel problems" (unspecified if ongoing); "Bladder problems" (unspecified if ongoing), notes: Has to focus and push; "So many lesions on neck" (unspecified if ongoing), notes: About 20 lesions per CT scan; "So many lesions on spine" (unspecified if ongoing), notes: About 20 lesions per CT scan; "So many lesions on brain" (unspecified if ongoing), notes: About 20 lesions per CT scan; "Sleeping difficulty" (unspecified if ongoing); "Headaches once in a while" (unspecified if ongoing); "Occasional falls" (unspecified if ongoing), notes: Bouncing into the walls, trip up the steps; "Anxiety" (unspecified if ongoing); "MS" (ongoing), notes: Multiple family members with MS (from mother's side). Concomitant medications included: HYDROXYZINE; MELOXICAM; CANNABIDIOL. Vaccination history included: BNT162b2 (batch/lot number: unknown, as dose 1, single), administration date: 04May2021, when the patient was 55-year-old, for COVID-19 immunisation, reaction: "Made her MS worse". The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "She felt the COVID-19 vaccines made her MS worse". The patient underwent the following laboratory tests and procedures: Biopsy breast: Unknown result, notes: Past medical history; Computerised tomogram: About 20 lesions. Clinical course: The patient reported that she refused the booster because she felt the COVID-19 vaccines made her MS worse. Her doctor said that the COVID-19 vaccines would "probably" not help her, but recommended she get them.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300053297 same patient, drug, and event; different dose;
After the 2nd dose, I had increased pain in my joints, arthritis, bursitis, tendonitis, in my shoulders in my hip area. The pain became so intense that I went to an orthopedic doctor. An MRI was taken. There had been no injuries. It was simply inflammation in the joints. Over the counter Ibuprofen was suggested for pain management. If necessary, steroid shots would be administered.
Patient developed bruising on her lower arm about 12-24 hours after her dose of Pfizer covid 19. She reported a bruise on her leg after her first dose which has not gone away (3 weeks ago).
Pt exp both arms appear w/edema & red, t39C, rash on both arms & abd;
The vaccine was on 11/08/2022. I had a scheduled surgical procedure on 11/14/2022 and at that time, I was on the operating table and I was going to have a vein procedure. Apparently, I began to cough off blood and they stopped the procedure. We were going to try again on the 12/14/2022. The EMT came before I was released from the hospital after this incident and they looked through all my sinuses to make sure there was no apparent reason for this happening and they noted it could have just been a nose bleed. In December, during pre-op, they noted my blood pressure was 198/105 and my heart rate was 198. I was hospitalized to determine why I was in stroke range and called off the procedure. They told me I needed to be seen by a cardiologist and a nephrologist. My kidney had showed reduced function. I have a sleep study coming up in February. I am not symptomatic of heart palpitations or irregularity. What I feel is complete exhaustion. I can't tell when I'm getting episodes of possible a-fib. None of this was apparent back in April and August boosters. We're trying to figure out what the causes are. I am not aware when I'm in a-fib, but I just feel total exhaustion. I've assumed since this diagnosis that it could be structural. I am now taking metoprolol and ELIQUIS until this is controllable. Everything is uncertain at this time. I've taken my blood pressure on and off during this time, and I've never seen anything abnormal. I also had a bad COVID-19 infection back in April and events throughout this time have gotten worse. I've spent 9 months since April experiencing symptoms heart related, both blood pressure and heart rate. Nothing has been caught until these recent surgical dates. Heart related events began to stack up. The sleep study can confirm if there is a-fib. I am currently wearing a heart monitor for 30 days for evaluation.
This case was reported by a healthcare professional and described the occurrence of nausea in a 15-year-old male subject who was vaccinated with ENGERIX B, VARIVAX, MENACTRA and ADACEL. No relevant medical history, concurrent medications or adverse events following previous vaccinations. On 1 October 2007 the subject received 2nd dose of ENGERIX B (10 mcg, left arm), 1st dose of VARIVAX (unknown) , 1st dose of MENACTRA (unknown), and 1st dose of ADACEL (unknown). One day after vaccination with ADACEL, ENGERIX B, MENACTRA and VARIVAX, the subject experienced nausea, stomach ache, headache, lethargy and sleeping a lot. The nurse reported that she did not know what caused the nausea, stomach ache, headache or lethargy. The nausea, stomach ache, headache and lethargy resolved on 04 October 2007 and the outcome of sleeping a lot was unspecified. Follow-up information was received on 11 April 2008 via a nurse, who reported that the adverse events occurred on 03 October 2007. The nurse stated that the events were resolved at the time of this report, but the exact date of resolution was unknown since the subject reported the adverse events two months after their occurrence. The reporting healthcare professional considered the events to be possible related to vaccination with ENGERIX B, but indicated that the events were not serious.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 26-JUN-2015, the patient was vaccinated with improperly stored dose of GARDASIL lot #K011325, expiration date 08-APR-2017. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient is a88y.o. year old male who presented to the ED 10/26 s/p fall. Hx dementia, chart reviewed. Found to have AKI, NSTEMI COVID testing +, on 3L NC O2 sat 94%. Per registry, s/p Moderna vaccine 1/25 and 2/22 Also was seen by urology due to retention, s/p foley catheter placement.    Afebrile, appears comfortable Recent hospitalization : 9/2021 for fall
getting blisters on his hands and fingers that he never get that before; they are getting bigger instead of smaller; getting blisters on his hands and fingers that he never get that before; they are getting bigger instead of smaller; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07May2023 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD; "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown Manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2; Unknown Manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 3; Unknown Manufacturer), for covid-19 immunization. The following information was reported: BLISTER INFECTED (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "getting blisters on his hands and fingers that he never get that before; they are getting bigger instead of smaller". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blister infected, condition aggravated.  Additional information: Getting blisters on his hands and fingers that he never gets that before; they are getting bigger instead of smaller was reported as worsened. Consumer stated, "The first two were the COVID-19 Shot but I do not know if this is another booster or not because they want me to come back for another one. That's what I mean, the information is not right. How many shots you are supposed to take for this". Consumer stated, "I am just telling you I am taking the medications. I am not going to sit here and go through all my medication list. "I did blood work 2 weeks ago. All I have is blood drawn."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Got vaccine on 12-29 @ 9:40 , same day around 8pm had a rash with bumps from back of right arm down to wrist with little bumps, really red...had on left arm as well. next day on 12- 30 around 1:30pm co worker told me my neck was really red. I told her I was just hot from working, but by 3pm I had bumps, itchy, big raised red spots....right side was worse then left side but it did cross my whole neck. my arms cleared up but when I get hot it comes out enough to see where it was located. on sat Jan 2nd the bottom of my right ear swelled and had like a white like bump....but, as soon as I cooled off because I was hot it totally went away. today is Mon Jan 4th and my neck looks like the bad rash area has burned into my neck....I have been taking Benadryl crème on neck and Friday Dec 1st I started Benadryl pills but stop taking pills after sat Jan 2nd because I was just to tired.
02/23/22 presents to ED for "generalized weakness and slurred speech". PMHx of "seizures on phenytoin, tongue CA, pancreatectomy with type 2 DM, frequent falls, left Bell's palsy, and ataxia"
Next, after I got the Vaccine I got a lump, red and swollen in my right arm, fatigue, low energy, tonsils are swollen and pain, body aches, chills,  nausea, dizziness, ear pain and light head. Up to today I still don't feel good.
Patient reported that she can barley move her arm... Serve pain from her left arm going in her neck... very very sleepy..
This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 17 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.
Patient experienced immediate and severe nausea and then tachycardia ~140 bpm within 30 minutes of dose  monitored by nursing home physician assistant and sent home from work.
Tingling on the arm on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling on the arm on the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling on the arm on the injection site). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling on the arm on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Patient asked was  tingling on the arm on the injection site a common side effect and how long does it last
my arm at site was painful & sore for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "my arm at site was painful & sore for a week".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
person came to pharmacy saying she had never had the covid shot before and had no insurance.  so administered the first moderna shot on 07/21/2021  Got a call from home office saying that the person had insurance and that she had also already got the J&J shot at pharmacy 3/21. They said i had to do a report since this is a repeat dose and she shouldn't have gotten it. To my knowledge she didn't have any side effects to the vaccination.
Information has been received from a health professional concerning a 79 year patient who in November 2003, was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reactions which included injection site swelling, soreness and erythema. The pt was treated with Benadryl and cold compresses. As of 03DEC2003, the pt's adverse events abated. There was no product quality complaint involved. The reporter indicated that three other patients and had similar experiences following exposure pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Pt had shots on yesterday and now comes in today to the office c/o rapid breathing and high temp of 104 degrees tympanic  Dr Dx Pt with Reaction to Shot Possible the Pediarix
pt recv vax; screaming, high pitched cry, started 3 1/2 hr p/ vax, lasted 4 hr;
Patient states she was feeling dizzy and was advised to stay for observation.  Patient states that she was feeling better and decided leave ,but upon leaving, she felt dizzy again and started having left sided numbness and tingling in her hand and leg. patient vitals were taken 165/71 P84  02 99%. Patient states having history of stroke and HTN and blood pressures medications. Patient was transferred to the ED for observation and evaluation via w/c.
Within 5 minutes became dizzy and my vision changed.  Went inside car and became flushed and hot. Lips and nose started to swell.  Re-entered Pharmacy and they gave me Benadryl.  It took a couple of hours for the swelling to go down.  I was fine the next day.
pt recvd vax; exp swelling of upper arm p/ vax; swelling inc over 24 hr period,upper arm swollen from elbow to shoulder;
felt like he was freezing; sweating of chest and neck area; too immobilized; terribly weak; generalized body aches; muscles and joints from neck down; general muscle and joint pain; significant chills/teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak) and PAIN (generalized body aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak), PAIN (generalized body aches), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering). At the time of the report, FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak), PAIN (generalized body aches), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) probably had slight temperature.         Reportedly, the same type of symptoms with the 2nd dose which received on 06Mar2021. At the time, Patient ignored the symptoms, had the same side effects, but just plowed through it. In both the booster and second dose, the symptoms started about 11-12 hours after administration of the vaccine. Reported no problems with the first dose. Patient reports he is on quite a bit of concomitant medications, but did not share which ones.   This case was linked to MOD-2021-402836 (Patient Link).
shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On an unspecified date in 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's vaccine inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of the events was unknown. Causality assessment was related.  Additional information has been requested.
Another FLUZONE QUAD prefilled syringe from the box had to be used to complete dose with no reported adverse event.; vaccine started to drip out from underneath the luer lock but at the top of syringe FLUZONE QUADRIVALENT prefilled syringe caller reports that it leaked during injection with no reported adverse event.; The liquid got on the patient and on the reporting pharmacist that was injecting with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via Agency (Reference number- 00898016) and transmitted to Sanofi on 14-Dec-2021.  This case involves an unknown demographic patient (unknown age and unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] another dose from the box had to be used to complete dose (extra dose administered), the liquid got on the patient and on the reporting pharmacist that was injecting (exposure via skin contact) and vaccine started to drip out from underneath the luer lock but at the top of syringe fluzone quadrivalent prefilled syringe caller reports that it leaked during injection (syringe leak).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ778AB, expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to extra dose administered, syringe issue and exposure via skin contact (latency: same day).  At time of reporting, no adverse event 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.