chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got his vaccine and was instructed to sit in the waiting/observation area for 15 minutes. At approximately 3:10pm, I heard a loud bang and peeked my head out of the pharmacy and saw that there was a young man on the floor. He fell into the endcap. I immediately ran out to the customer. Upon talking to him, he did not pass out or hit his head but did severely scratch the left side of his cheek to his neck above is collar bone.  I checked his blood pressure and it was 119/79. He initially said he felt very hot and was sweaty, then we gave the patient orange juice as he stated he hadn't had much to eat, and felt better after drinking the juice. He denied EMS and called his grandmother to come pick him up.
Combined initial reports received from physician on 24 Feb 2011 and 25 Feb 2011: This patient received FLUVIRIN (batch number 11259701) intramuscularly on an unknown date.  The patient developed arrhythmia.  No other information was reported.
Positive rapid antigen test for Covid-19; Positive rapid antigen test for Covid-19; feeling bad; Headache; cough; chest congestion; fatigue; dose 4 (booster); dose 4 (booster); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old patient received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 20May2022, outcome "unknown" and all described as "dose 4 (booster)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022, outcome "not recovered" and all described as "Positive rapid antigen test for Covid-19"; FEELING ABNORMAL (non-serious) with onset 11Jun2022, outcome "not recovered", described as "feeling bad"; HEADACHE (non-serious) with onset Jun2022, outcome "not recovered"; RESPIRATORY TRACT CONGESTION (non-serious) with onset Jun2022, outcome "not recovered", described as "chest congestion"; COUGH (non-serious) with onset Jun2022, outcome "not recovered"; FATIGUE (non-serious) with onset Jun2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Negative; (11Jun2022) Positive. Positive rapid antigen test for Covid-19 despite receiving 2nd booster shot of Pfizer vaccine on 20May2022. Mild symptoms so far included headache, cough, chest congestion and fatigue. The patient travelled last week for vacation and tested negative on 09Jun2022 (last Thursday) before leaving on 10Jun2022 (on Friday) to return home, but the patient began feeling bad on 11Jun2022 and took an at home test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A Pt  of unknown age and gender had been treated with OncoTICE for an unknown period of time. The pt experienced a fever after an OncoTICE instillation. No further information is available.
second inoculation cost me a night's sleep; Shivering; Had two shingles innoculations a month apart; This case was reported by a consumer via  interactive digital media and described the occurrence of sleeplessness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced sleeplessness, shivering and drug dose administration interval too short. On an unknown date, the outcome of the sleeplessness, shivering and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the sleeplessness and shivering to be related to Shingles vaccine.  Additional details was reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received two shingles inoculations a month apart. The patient received 2nd dose of shingles vaccine, before than the recommended interval, which led to shortening of vaccination schedule. The patient stated that vaccine cost him/her a night's sleep and patient could not stop shivering. No other information was available.
Congestion, extreme soreness (not like typical arm soreness), fatigue, sore throat, cold sores.
Information has been received from a physician concerning a 38 yr old male pt who was vaccinated with varicella virus vaccine live.  The physician reported that the pt had received two doses of varicella virus vaccine live (dates not reported), possibly not at his practice because no records were found. The physician reported  that on 12May04 the pt was tested for immunity to varicella and he tested negative (EIA 0.74 ISR). It was noted that no treatment was required for the adverse event. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Pt received a VARIVAX injection on 6/9/08 in Lt upper arm SC at 2:30 pm. Pt returned on 6/10/08 at 4 pm with a 5x7 cm indurated red warm area (urticarial lesion) past (L) arm. BENADRYL 50 mg every 6 hours PRN per MD.
Patient reported that he has developed a painful rash that could be shingles. He has been referred to his PCP for treatment.
2/22: RLE started to swell, attempted to elevate overnight but no improvement 2/23: 2+ pitting edema in RLE warm to touch 2/24: 2+ pitting edema in RLE warm to touch, painful and SOB 2/24: went to er: dopper on Right leg and CT with contrast of chest 2/24: admitted to hospital for bilateral PE and DVT in RLE
DEATHLY ILL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On SEP-2021, the patient experienced deathly ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deathly ill. This report was non-serious.
Caller reports patient received an extra dose of MMR II; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 21-SEP-2020,  the patient was vaccinated with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA)  formulation was not reported but defaulted to subcutaneous injection, 0.5 ml, Lot# S020160, expiration date 30-JUN-2021 for prophylaxis.   No additional adverse events details were available.
inflammation around lymph nodes in their neck; Neck pain; Pain spread from ear to clavicle; trouble swallowing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain), PAIN (Pain spread from ear to clavicle), DYSPHAGIA (trouble swallowing) and LYMPHADENOPATHY (inflammation around lymph nodes in their neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NECK PAIN (Neck pain), PAIN (Pain spread from ear to clavicle) and DYSPHAGIA (trouble swallowing). On 14-Feb-2021, the patient experienced LYMPHADENOPATHY (inflammation around lymph nodes in their neck). At the time of the report, NECK PAIN (Neck pain), PAIN (Pain spread from ear to clavicle), DYSPHAGIA (trouble swallowing) and LYMPHADENOPATHY (inflammation around lymph nodes in their neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Computerised tomogram: inflammation around lymph nodes in neck inflammation around lymph nodes in neck.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details were not reported.
Local reaction below injection site to (L) upper arm 4 in diameter - red, blanching, macular area, mild warmth. Experienced low grade fever day after injection & mild flu like s/s - headache/dizziness.
Event may or may not be related as patient has as stated may noted illness. Patient described N/V after shot. Not sure if related but I wanted to report it regardless as I told patient just to be safe.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient clims arm is inflammed & hurts.  I did not notice any redness or swelling but pt claimed that her arm hurt.
RED, RASH AREA, RESTRICTED ARM MOVEMENT, FELT PAIN BACK TOWARD SHOULDER BLADES, CAME IN PHARMACY TODAY (9-13-18) SAID FEELING BETTER AND HAS IMPROVED ARM MOVEMENT.
My symptoms started approximately three hours after I got my second shot. I became very dizzy and had vertigo. The side effect has been going on for weeks now today is September 29 and I?m still suffering from the side effect. The dizziness and vertigo hit me without warning often when I?m driving or  just sitting down. This is a dangerous side effect for anybody who flys  airplanes (career ended BTW) or  truck drivers those people really need to be cautious.
From the minute it took me to walk over to the chair for observation a severe throbbing headache started on the right side of my head. I have had that same persistent headache for over a month in the same location. 2 days after my shot on July 23, I noticed a pain in my right breast. It was a persistent pain as though I was hit for about a week. Then the pain has come on sporadically. Even the touch of a shirt can cause pain. I started noticing small tiny bruising underneath my right breast. At times, the pain is also a pins and needles type of feeling around my nipple. That comes and goes but I have felt it at least once daily since July 24. I have also been experiencing nerve issues on the right side of my body. My arm and leg can go numb even if I am standing. My leg has started about 2 weeks ago with the sensation as though it's cold. My leg does get cold to the touch. You can feel the difference between the left and right leg as far as temperature. Same with my arm. Moving around will not cease the effects. It is persistent and happens daily. I still get the headache in my right temporal region. They typically can last all day. The same pins and needles feeling I get on my right breast I can feel in my right leg and right arm. The injection site is still sore to the touch as well. The pain/numbing etc feeling in my arm starts right below the injection site.
Chills some time between 11p 3/11 to 4am 3/12 Neck ached on awakening 6am lasted all day Achy joints on awakening 6am lasted till 3/13 12n Shooting pains in neck and in head throughout 3/12 3/13 Rash on injection arm approx 3 in. Wide x 8 in. Long Felt quite hot to the touch but not painful or itchy 3/15 redness in rash diminished,  just warm to the touch
Got HD vaccine at 12pm yesterday and notice about 4 hours later.  Swollen, hot, and red arm.  Put ice packs and ibuprofen
Almost immediately after vaccination, patient reported dizziness ("seeing stars"), so I (pharmacist) grabbed water and had her remain seated. Upon return with water, patient reported tingling in the lips and trouble breathing so I called 911. While on the phone with the dispatcher, I grabbed an epinephrine auto-injector but I did not use it as the patient reported feeling better (tingling in lips had stopped and breathing was not as difficult), although she did mention severe sharp back pain. When EMTs arrived she reported feeling OK but before they left she seemed to decline and was having trouble breathing again and felt faint.
Diagnosed with COVID-19 on 30Jun2021 after receiving the covid vaccine; Diagnosed with COVID-19 on 30Jun2021 after receiving the covid vaccine; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL8982), via an unspecified route of administration, administered in arm left on 11Feb2021 (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. Patient was not diagnosed with Covid prior vaccination. Patient was Covid tested post vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231), via an unspecified route of administration, administered in arm left on 21Jan2021 (at the age of 26-year-old) as dose 1, single for COVID-19 immunization. The patient diagnosed with COVID-19 after receiving the Covid vaccine on 30Jun2021. AE resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR test was positive, Molecular alere testing was positive (nasal swab) on 30Jun2021. The patient did not receive treatment for AE. Outcome of the events was recovering.; Sender's Comments: based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
No additional AEs; Patient has one GARDASIL vaccine - unknown valent - at an unknown age; Patient has one GARDASIL vaccine - unknown valent - at an unknown age; This spontaneous report was received from a registered nurse and refers to a 31-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was administered first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. It was reported she had Merck hpv vaccine unknown valent. The patient thought she may also received second vaccination, but she was not sure. On 06-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml administered intramuscularly, lot # 1637642, expiration date: 28-MAY-2022 (strength and anatomical location were not provided) for prophylaxis (Circumstance or information capable of leading to medication error, interchange of vaccine products).  No additional adverse event reported.
7 DAYS OF SINSTOMES,PAIN ON IJECTION SITE,SWELLING ON INJECTION SITE PAIN AND SWELLING ON RIGHT ARM PIT (GANGLIOS INFAMATION )
AFTER RECEIVING THE VACCINE, SHE FELT WOOZY AND NAUSEAS. OUR ON SITE PHYSICIAN RESPONDED . SHE WAS MONITORED, FELT BETTER AND WAS RELEASED
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A 66-year-old female patient of an unspecified race received PREVNAR 13 at single dose for immunization on unknown date via an unspecified route. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced pain in arm, the outcome of the event was unknown.
pain on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on his arm) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain on his arm). At the time of the report, PAIN IN EXTREMITY (pain on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found unresponsive in a swimming pool; This is a spontaneous report received from a contactable Physician. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest, congestive heart failure, difficult breathing and arrhythmia. Concomitant medications included metoprolol; omeprazole; propranolol; duloxetine; fosinopril; pravastatin; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); levothyroxine sodium (SYNTHROID); insulin glargine (BASAGLAR); asa and ranitidine hydrochloride (ZANTAC). The patient previously minocycline for swelling and the patient had a historical vaccine of shingrix on 11May2020. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 for covid-19 immunisation. The reporter stated that the patient was found unresponsive in a swimming pool on 18Feb2021. The patient also experienced shock, reduced central pulse volume and loss of consciousness and potential anaphylactic reaction on an unspecified date. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer_BioNtech COVID-19 Vaccine prior to the event being reported. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of the events was fatal.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: found unresponsive in a swimming pool; Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction
Called to the treatment room after patient was witnessed to have her eyes roll back in her head and lose consciousness immediately after receiving her immunizations today (first doses of HPV9/GARDASIL, Meningococcal/MCV4/MENACTRA, and Tdap). On arrival to the room patient was noted to be unresponsive in a lateral recumbent position with her eyes open, and was noted to have a tonic posture with blinking and lip smacking. She appeared to have lost bladder control. After approximately 30 seconds she was spontaneously responsive to voice and was oriented to person, place, and time with fluent speech. On questioning patient and her mother indicated she was in her usual state of health today, but patient admitted to not eating any breakfast today. Patient's mother denies recent illness, prior adverse reaction to vaccines (although she stated patient is very "scared of needles"), prior episodes of fainting, and chest pain/palpitations. No rhinoconjunctival, cutaneous, pulmonary, or GI symptoms. Patient's mother reports a recent closed head injury in January of this year associated with a loss of consciousness (CT head obtained in the ER at that time was negative).
Sudden onset vertigo.  Went to primary care physician.  Was able to replicate vertigo.  whenever I turned my head from left to right, while on back, room started spinning from left to right, top to bottom. I has also seen a neurologist a few days before, and an opthalmologist the week before, both for routine exams and they didn't see anything wrong with their exams.  My Primary Care Physician sent me to the emergency department for a CAT scan to rule out posterior stroke.  At the ED they gave me the CT scan but the radiologist said I also needed an MRA which they did.  No evidence of posterior stroke.  ED doctor discharged me with prescription for meclizine and valium.  Told me to do employ maneuvers.  If vertigo continues, consider vestibular physical therapy.
No additional AE reported; dose of expired MMRlI was administered; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender.There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 08-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) 0.5 ml, lot #: T007235, expiration date 27-FEB-2022 (expired product administered) (formulation and route of administration were not reported) for prophylaxis. No additional adverse events reported (no adverse event). No product quality complaints reported.