chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE BRUISING; BLACK ARM; MOST OF THE VACCINE WENT DOWN THE PATIENT'S ARM; VACCINATED ONCE MORE; PAINFUL ARM/ ARM HURTS; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced painful arm/ arm hurts. On 08-APR-2021, the subject experienced injection site bruising. On 08-APR-2021, the subject experienced black arm. On 08-APR-2021, the subject experienced most of the vaccine went down the subject's arm. On 08-APR-2021, the subject experienced vaccinated once more. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from most of the vaccine went down the patient's arm, and vaccinated once more on 08-APR-2021, had not recovered from painful arm/ arm hurts, and the outcome of injection site bruising and black arm was not reported. This report was non-serious. This case, from the same reporter.
Pt reported some shortness of breath about one hour after receiving GARDASIL (2nd in series). Mother reported pt. was having something like hot flashes and sweating spells. Mom took her to ER at 8:30 pm where she was treated with DECADRON and BENADRYL by mouth and mom states within 10 mins she was better. Mom thinks dau. felt panic and got scared. Reports O2 was 100% heart rate normal. Went to school today (4/24/).
Injection given IN (R) Deltoid on 3/20/07. 4/9/07 Pt. phoned with c/o sore arm. Unable to Raise it above her head. Sent to ER for eval
Information has been received from a consumer concerning her son with no medical history or allergies who on 20-SEP-2006 was vaccinated with a dose of MERUVAX II. Subsequently the patient started to have problems where he was not being able to bring his hand up to his face, was shaking, and had developed immune system problems sometime after receiving MERUVAX II. The patient had been diagnosed at one point with pervasive development disorder (PDD) and organic brain syndrome. He was also noted to be in the autism spectrum. Lab diagnostic studies performed included blood work. He was improving at the time of reporting. The consumer also mentioned prior to receiving MERUVAX II, the patient received a dose of MUMPSVAX on 16-MAY-2006 and VARIVAX (Merck) on 07-JUN-2006, but no adverse event was noted after those two vaccines. The patient sought unspecified medical attention. Upon internal review, pervasive development disorder (PDD) was determined to be an other important medical event. No further information is available.
Tinnitus- ringing in both ears.  Started ear drops( carbamide peroxide 6.5%) after 8/18/2021 appointment with Dr.
Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 09-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine but still got shingles. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
After administration of Tdap, MENACTRA and Hep A patient immediately began to feel light headed, skin clammy/sweaty, nauseous. Condition progressed to patient complaining of tongue and throat feeling swollen, shortness of breath, numbness to extremities, pain to touch of skin, felt that eyes and nasal passages felt swollen. Patient was laid down on table, assessed by nurse, given cold compresses to head and arms. EMS was notified and responded for transport to the hospital.
Urinary incontinence. Pt wears a panty liner and cannot leave the house.
The pt developed "chills, headache and a fast heartbeat which started last night (12/13/01)". She still has a headache and chills and feel tired. "Fast heart beat is resolved. Called my family physician to report and then notified Employee Health."
Muscle twitching throughout body; Stomach pain; Numbness in finger tips; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8727) via an unspecified route of administration in the left arm on 12Apr2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take concomitant medications within two weeks of vaccination. On 13Apr2021, the patient experienced muscle twitching throughout body, stomach pain and numbness in finger tips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events muscle twitching throughout body, stomach pain and numbness in finger tips was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
weakness all over body, unsteady, leg buckling, trouble walking in straight line, trouble going down stairs, trouble speaking, headache, trouble with word finding
Information has been received from a physician concerning an approximately 4-month-old patient who in approximately April 2007, was vaccinated PO with the first dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of COMVAX, a dose of poliovirus vaccine inactivated and a dose of PREVNAR. The physician reported that in approximately April 2007, a day after being vaccinated, the patient developed vomiting and diarrhea. The patient subsequently recovered. It was noted that the patient's mother refused the second dose. Additional information has been requested.
Pain upon injections. Rash and swelling from pt. of injection to elbow. Starting to get better now (several days later) according to patient.
Pt recv vax on 12/30/98; 15 min post vax pt exp urticarial rx; tx=Benadryl & Solumedrol
About five to ten minutes after injection of HPV vaccine, my daughter said she felt like she was passing out. Her eyes rolled up into her head and her hands curled inward. She had a seizure and I helped her lay back on the table and on her side, as informed by nurse as she was present. Nurse put and cooling pack on patient's forehead. Nurse said it was a seizure and lasted less than 30 seconds.
Dizzy; Cant  walk very well; Memory issue; weak/ falling down; Vomiting; Headache; Pyrexia; Vaccination site erythmea; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer since 25-Dec-2007. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (Pyrexia), VACCINATION SITE ERYTHEMA (Vaccination site erythmea) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), GAIT DISTURBANCE (Cant  walk very well), MEMORY IMPAIRMENT (Memory issue), ASTHENIA (weak/ falling down), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Pyrexia) had not resolved and VACCINATION SITE ERYTHEMA (Vaccination site erythmea) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. Not Provided          Dose 2 case. Dose 1 case: MOD-2021-039583
Employee describes intense pain in (L) deltoid immediately at the time of the injection - by clinician (LPN) at the flu clinic.
pt recv vax 23AUG95 & on 17NOV97 pt devel lesions;18NOV97 pt had 20-30 lesions, a few vesicular;
7 days after 1st dose of Pfizer vaccine upper right thigh/hip area (skin sesitivity) burning sensation that resembles Shingles-but with no rash present.  I had Shingles back in 2019 on (R) buttocks area-same skin sensitivity burning sensation.
Fell ill Saturday evening and was not able to get out of bed until Tuesday afternoon.  Did not eat during this time.  Slept most of time. Symptoms were chills, high fever, nauseous,  body aches, SEVERE headache, all symptoms lasted until Tuesday afternoon.
Energy loss, fatigue muscle, depression, insomnia, memory loss, back pain, muscle and joint pain, mood swings, skin itching, vision problems, libido loss.
arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "arm sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea for two days (12/23-12/25) and sore arm is persistent since 12/23
Patient began to experience upper thigh pain approximately 3/16/2021 - 3/18/2021.  Can't remember which leg, reports the pain as a stabbing and aching pain. Leg was painful whether walking or not. Rates pain 4-5 on the pain scale with 10 being the worst pain ever experienced. Doesn't recall redness, swelling, or warmth to area of the leg. The pain lasted approximately 2-3 days . Patient did not contact her PCP.  Also reports headache to back of the head which lasted around one day. Typically has sinus headaches.  Recommended she contact PCP immediately so he/she can follow-up
This case was reported by a physician and described the occurrence of vaccination failure in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date(s) the subject received 1st dose and 2nd dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced rotavirus infection and vaccination failure. At the time of reporting, there were no additional details available. This case was assessed as medically serious by GSK. The physician considered the events to be possibly related to ROTARIX vaccine. At the time of reporting the outcome of the events were unspecified. Follow up was received from a nurse on 7 October 2013. The nurse stated that her practice needs additional subject details to identify the subject. No details were made available to GSK therefore no additional details provided.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Mom reports pt @ about 11AM appeared to be in a deep sleep & staring straight ahead w/eyes open; Reports no jerking movements until @ MD office; Temp to 104;
Patient returned to the pharmacy on 11/12/19 two days after vaccination. Patient presented her left arm and it was red and swollen from the should down to the elbow. Patient described that she did not experience symptoms until she was about to go to bed on 11/10/19, she stated that the next day she was unable to lift her arm more than a 30 degree angle.  She used ice packs to keep the swelling down. She explained and presented that it is no longer as bad and she is able to lift her arm up now. I asked if she experienced any fever or other side effects and she denied that she has.
Dizziness, disoriented, hot, headache. Injection site soreness, stiff and unable to lift arm above shoulder. (started 1 hour after injection/ rested through out day). General achiness and and stiff muscles in neck, shoulder and arms, fever. (started 1 hour after injection and continued for the following 2 days / took oxycodone on evening of 10/13/2009 to ease pain and sleep). 10/20/2009- started to notice extreme heat (like sunburn) in chest area between breasts and on inner sides of breasts. Redness. 10/21/2009-current. Extreme itchy, hot, bumpy (almost gritty looking), moist skin, hypersensitivity. When scratched it turns into a raised red rash. Constant itch and penetrates intense heat. Sensitive and reacts to hot water and causes another extreme itchiness. Did not spread anywhere else on chest. (treated with 2 containers of otc Benadryl anti-itch creams. No change in rash/limited itch relief) 11/01/2009- current. Both under eye lids began to itch and 2 red patches have appeared on the under eye sensitive skin area. By 11/02 it was too sore to touch or treat. Left alone and careful not to let anything irritate the dry red patches. 11/04/2009 - used pHisoderm anti-blemish wash with salicylic acid and it seemed to start to heal. Raised areas became flat and redness started to go away. Itch seemed to improve. Lasted 1 day. Flared up again on 11/5 but itch does seem to be improving still. Red patchy areas are now flatter and less bumpy appearing. Dr. Appt. is scheduled for 11/16/2009.  NOTE: I was given the seasonal flu shot.    Fluvirin Prefilled Syringe 0.5ML Novartis. NDC # 66521-0112-02 REF # 09293391464902   I suspect an adverse reaction to thimerosal is the cause. I was not asked about egg allergy (not aware of any) and there was no information about preservative-free injections. I had no idea that it existed or didn't exist.
Within one hour had knot at injection site & had pain in arm. Next AM. my arm was swollen from 3 inches above my elbow to top of my shoulder and half of arm front to back. Red, hot, hard, and painful. Two weeks later, skin sloughing off and no sensation of touch at injection site.
Only sore arm during 1st week.  Since having second  vaccine I have had episodes of dizziness, heart palpitations, ear aches and I sneeze every day multiple times.  These symptoms were not present prior to the vaccine.  I go to Dr once per year and fill out a full health status report and have never checked these symptoms.
I noticed the month of August 2021 that I completely skipped my menstrual cycle. My menstrual cycle has been really inconsistent since having dose the J and J vaccine. Every month since then, I start my flow early, it is heavier and lasts much longer. I spoke with my doctor in April 2022 and she said that these symptoms are being reported often after vaccination and to just wait it out.
VACCINE EXPOSED TO TEMPERATURE OUTSIDE OF RECOMMENDED STORAGE RANGE, UNKNOWN POTENCY AND VIALBILITY PER MANUFACTURER.
Pt rec'd Spikevax and FluzoneHD in RT arm. Arm became inflamed and hot the next day and continued to increase in size. Pt was advised to seek medical attention. Spikevax was administered below the FluzoneHD. The area of inflammation was in the lower area.
At 213pm I walked into my bathroom, my legs started shaking, I heard a buzzing sound in my left ear. I fell to the ground striking my head against the wall and hearing the sound of my body hitting the scale on the floor. I sat up and sat still for what seemed like 30 seconds wondering what happened. I looked at my watch and the time was 217pm.
Patient presented to the ED and was subsequently hospitalized for abscess of groin within 6 weeks of receiving COVID vaccination.
This spontaneous report was received from a nurse refers to  7 unspecified patient of unknown age and gender. On 09-AUG-2016, the patients were vaccinated with improperly stored doses of VARIVAX, lot#: l046887, expiry date: 23-NOV-2017. No adverse reactions reported. No further information was provided. Additional information has been requested.
The patient is a 77 years old male patient of MD, with history of chronic pancreatitis, diabetes insipidus, type 2 diabetes mellitus, squamous cell carcinoma of the tongue, atrial fibrillation, benign prostatic hyperplasia, diabetic neuropathy presented to the hospital with with confusion concern for overdose, complicated by COVID-19 infection ,atrial fibrillation with rapid ventricular rate, initially managed with Cardizem drip now on Eliquis and aspirin. Was consulted tonight for profuse bleeding from the oral cavity while on Eliquis and aspirin.  Patient was subsequently intubated for airway protection. Case was discussed given the patient was scheduled to have surgery on his squamous cell carcinoma of the tongue on 4/11/2023, and no available ENT on call this weekend Accepted to be transferred over   Discharge Diagnoses: Profuse bleeding from the oral cavity with clots squamous cell carcinoma of the tongue. Atrial fibrillation with rapid ventricular rate Type 2 diabetes mellitus. Hyperglycemia. Hyponatremia. COVID-19 infection.
Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored doses (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # K011085, expiration date 08-AUG-2016). No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not grant permission to contact them or physician.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: EN6201), in left arm, on 05Mar2021 as dose 2, single (Lot number: EN6198), in left arm and on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ovarian cancer" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Age related macular degeneration" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Patient had dizziness, pain (left shoulder, injection site). Felt lightheaded + foggy, alert & oriented. Placed in Trendelenberg position with good effect. Provided orange juice. Patient dizziness/lightheadedness resolved, stable, released from vaccination site.
Mildly sore arm for 12 hours; This is a spontaneous report received from a contactable consumer. A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.   The patient's concomitant medications were not reported.  The patient experienced mildly sore arm for 12 hours on 15Apr2021 with outcome of recovered.  No treatment for the mildly sore arm.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Pneumonia Vaccine approx. 9:30am. Arm extremely painful several hours later. At approx. 6:00pm began to have chills, sweats, then experienced "waves of dizziness" and "threw up". Gradually felt better.
Patient said that she was in pain the day after getting the shot in her right arm. Patient also experienced fatigue.
Rash about the size of a quarter at injection site.  Rash feels like a hard bump 2 days later (02/11/2011).