chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 13:15 (Lot number: FH8030) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing); "Dose Number 1: Moderna/ Dose Number 2: Moderna/ Dose Number 2: Pfizer booster" (unspecified if ongoing); "If Covid Prior Vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (prev_dose_product: COVID19,, prev dose brand:Moderna,, prev dose brand unknown:False,, prev dose lot number:006M20A,, prev dose lot unknown :False,, prev dose administration date:19Feb2021,, prev dose administration time:02:30PM, prev dose dose number:1,, prev dose vaccine location:Left arm), administration date: 19Feb2021, when the patient was 74 years old, for Covid-19 immunization; Moderna (Prev dose product:COVID 19,, Prev dose brand:Moderna,, Prev dose brand unknown:False,, Prev dose lot number:0061321A,, Prev dose lot unknown:False,, Prev dose administration date=19Mar2021,, Prev dose administration time=01:45PM, Prev dose dose number:2,, Prev dose vaccine location:Left arm,), administration date: 19Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 25Nov2021 12:00, outcome "not recovered", described as "diarrhea". The event "diarrhea" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional information: No other vaccine in four weeks. Prior vaccination had covid. Covid was tested post vaccination. Nasal swab test type post vaccination.15 Minute test. Patient stated he got diarrhea soon after taking the Pfizer booster (22Nov2021) and still have it (13Mar2022). Treatment for adverse event with Anti-Diarrhea Medication & Scheduled For Colonosc  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to a 2 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M021124, expiration date 02-FEB-2018 (dose, route and site of administration were not reported) for prophylaxis. No symptoms were reported. Product quality complaint was not involved. The administered dose of VAQTA was stored in the temperature of 32 degrees Fahrenheit for 15 minutes and in the temperature of 31 degrees Fahrenheit for 15 minutes. The reporter did not know why the temperature excursions occurred. There were no previous and no further excursions. Data logger was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012916: US-009507513-1608USA012908:
Symptoms started on day #2, mild armpit pain in the injection arm. Today is day #3 (1/14/2022) and I?m experiencing severe pain in my armpit (maybe lymph node swelling). It hurts to move my arm and hold a bottle of water. This happened with my last vaccine on 8/13/2021 too.
ABDOMINAL PAIN; DIED; This spontaneous report received from a consumer via social media via a company representative concerned a 100 year old male of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was in good health prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reporter that "My father 100 years old in good health and still driving was taken and coaxed by his neighbor for the one-time J&J COVIC vaccination shot. He developed abdominal pain. Hospital one month, nursing home one month, four months later at home, dead! End of health and life." The patient died of unknown cause on an unspecified date. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abdominal pain was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220239600- covid-19 vaccine ad26.cov2.s-died, abdominal pain. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Upon awakening the morning after receiving the 2nd dose of Moderna Covid vaccine, I was slightly short of breath and my heart was racing. Heart rate sustained most all day between 120-130s, with increasing palpitations. (I was experiencing a headache and low grade fever also). This continued all day. Went to local Urgent Care, there were 28 patients ahead of me so I left. Went home and called cardiology office to ask for appt. Was told to go to the ER, that a heartrate that high and lasting over 20 minutes is an emergency and put me at rick for stroke. My husband drove me to the ER, where there was a 5 hour wait. I then left there and went to my PCP urgent care office. Was seen by NP. An ekg was done and I was told it was abnormal and to go back to the ER. My heartrate at that time had slowed down some- to the 110s. I returned to the ER and was seen soon after. Labs, EKG, and a chest xray was done. Labs and chest xray were all okay. EKG was abnormal so was monitored for a short while. Still having palpitations at that time but less frequently. Was told by the ER physician that the increased heartrate and irregular beats/incomplete beats/  palpitations were a reaction to the vaccine. This started at 0700am on August 23. I returned home from the ER at around 1100pm.
severe headache; muscle and bones and my back; muscle and bones and my back; felt a pressure on my chest; I would take a really deep breath it would hurt when I would exhale; it was difficult to stand; exhausting couple of days; feeling ill; muscle and bones and my back; muscle and bones and my back; This is a spontaneous report from a contactable consumer (Patient).  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 at the age of 67-year-old as dose 2, single for covid-19 immunisation. Medical history included hypertension, overweight and Patient had breast cancer surgery in 2015 and she had went on the 5-year cancer pill (Unspecified Medication) for breast cancer. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation and had all of the symptoms that you list from the injection site, feeling ill, pretty high fever, shivering so bad i couldn't even type and went home to bed, all of the pain all of the muscle and bones and all of the other in the back. The patient's concomitant medications were not reported.  On 24Mar2021, patient took the vaccination and the very next day she woke up and she had severe headache and muscle and bones and my back. Patient called her physician was she also felt a pressure on chest, not like, had feeling ill rt pain or anything like that, it was just a pressure and when she take a really deep breath it would hurt when would exhale and it was difficult to stand, to make something to eat because it seemed like as when she stood and feel the pressure more than when was sitting or kind of reclined. And it was just exhausting couple of days. She didn't go back to work for another 2 days. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Mom states 1 month after injections were given on 1-31-03 had small area LLT like a hole starting.  Had next injections on 3-14-03 with no mention of area or area noticed by nurse.  Went to pvt MD end of April 03 where it was noted by MD.  Mother did not mention it before it was noted.  MD referred to Health Dept for VAERS.  At time of visit on May 5th area measured 2cm x 2cm.  With loss of pigment in area.  Discussed with our CD nurse.  Referred back to pvt. MD for continued follow-up.  Photos were taken of the area.  Mom states it has been slowly getting larger.  Let us know if you want copy of photos.
-patient developed nasal congestion, constant right sided drooling and malaise 3 hours after vaccination
pt recv vax & was later hosp w/GBS;MD suggested it may be r/t flu vax given 14NOV96;
I believe this vaccine has increased my production of RED BLOOD CELLS to require, so far, two phlebotomies within a three-month timeframe. I have a chronic condition that requires me to take chemo drug orally, Hydrea, to suppress HEMATOCRIT or red blood production. I have taken this drug for approximately 10 years with no adverse reactions. In 2020, I only required one (1) phlebotomy for the entire year to keep my hematocrit below 45.   I received my normal course of one phlebotomy per year (usually not more than three per year) on January 25, 2021, however, after receiving the Moderna Covid-19 vaccine Jan 22 2021, my hematocrit has been above 46, requiring phebotomies on April 22,2021, and again in June 2021. Highly irregular. Nothing in my life or disease has changed. This was caught because my doctor and nurse have been checking my numbers now every six weeks instead of every three months. I need to double my Hydrea and go back in 6 weeks.
diarrhea; cognitive dysfunction due to fatigue; painful lump under arm of vaccination; extreme fatigue; shivers; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 31-AUG-2023, 1 days after receiving Shingrix, the patient experienced cognitive disturbance (Verbatim: cognitive dysfunction due to fatigue), axillary lump (Verbatim: painful lump under arm of vaccination), fatigue (Verbatim: extreme fatigue), shivers (Verbatim: shivers) and fever (Verbatim: fever). On 05-SEP-2023, the patient experienced diarrhea (Verbatim: diarrhea).  On 05-SEP-2023, the outcome of the shivers and fever were resolved (duration 5 days). The outcome of the diarrhea was not resolved and the outcome of the cognitive disturbance and fatigue were resolved and the outcome of the axillary lump was resolving.   It was unknown if the reporter considered the diarrhea, cognitive disturbance, axillary lump, fatigue, shivers and fever to be related to Shingrix.     It was unknown if the company considered the diarrhea, cognitive disturbance, axillary lump, fatigue, shivers and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 The reporter reported about herself she had side effects after receiving Shingrix vaccine on August 30, 2023.  The day following her injection, she experienced fever, shivers and extreme fatigue leading to cognitive dysfunction (she left a pan on her stove which caught on fire) and she also reports a lump 2 inches in diameter appearing under the same arm of the vaccination about one half inch below the axilla, which was very painful.  The fever, shivers and some of the fatigue and the cognitive dysfunction had resolved and the lump was now smaller at about a half inch diameter.  The reporter consented to follow up.
vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug was provided.  No treatment drug was provided.   Reporter did not allow further contact
Pfizer vaccine was administered outside of source - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------- I21.4 ACUTE NON ST ELEVATION MI 6/19/2021 ACUTE NON ST ELEVATION MI I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 6/19/2021 ACUTE NON ST ELEVATION MI
Severa arm pain; Body aches; Chills at times; It hurts to walk; Extreme fatigue even to shower; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disc disease and had known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 23:00, the patient experienced severe arm pain and can't lift arm, body aches all over are at an 8 almost a 9, chills, it hurts to walk, extreme fatigue even to shower and had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe arm pain and can't lift arm, body aches, chills, it hurts to walk and extreme fatigue was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Recipient reports fever, malaise and red, hard, warm, raised lump at PPSV23 infection site and inability to raise left arm above head. Fever continued on and off for 48 hours from onset.  Recipient took TYLENOL for pain and fever and applied ice to lump for 24 hours then started applying heat. Seventy two hours after symptom onset, recipient states lump size is decreasing, able to raise arm above head and is feeling 80 - 90% better. Recipient missed 2 days of work.
pt recv vax 26FEB97 & 3-4 days p/vax pt had temp of 102 + pain over left deltoid;2 days later pain & swelling had inc as well as devel of a rash;pt adm 5MAR97 to hosp to r/o necrotizing myofascitis;final dx arthus rxn, cellulitis;
lethargic; arm is still sore and itchy; arm is still sore and itchy; Felt sick; still feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN IN EXTREMITY (arm is still sore and itchy), PRURITUS (arm is still sore and itchy), MALAISE (Felt sick) and FATIGUE (still feeling tired) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargic), PAIN IN EXTREMITY (arm is still sore and itchy), PRURITUS (arm is still sore and itchy), MALAISE (Felt sick) and FATIGUE (still feeling tired). At the time of the report, LETHARGY (lethargic), PAIN IN EXTREMITY (arm is still sore and itchy), PRURITUS (arm is still sore and itchy), MALAISE (Felt sick) and FATIGUE (still feeling tired) had not resolved. Not Provided          Concomitant medications were not provided. Treatment details were not provided.
Patient was given Pfizer 5-<12 and should have been given Pfizer 6 months-4 years. Parent informed at appointment. Patient tolerated all vaccines given. This nurse has not had any other further conversation with the parent at the time of completing this form.
Ringing in Left ear; Low nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 03Aug2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021, the patient experienced ringing in left ear and low nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ringing in left ear and low nausea was not recovered at the time of this report.
Chills, body aches, headache, loss of appetite.  2 days later developed large circle rash around injection site and also pain, large red circle under armpit on pectoral
Information has been received from a physician concerning a 15 year old female patient with a history of asthma who was vaccinated with a first dose of Gardasil. Within twenty-four hours after receiving the vaccine, the patient experienced difficulty breathing. Unspecified medical attention was sought. At the time of this report the patient had recovered. It was reported that the patient will not complete the series. No product quality complaint was involved. Additional information has been requested.
How does the second dose affects me if I get it several years later?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-Mar-2022 Reporter's comment: This case was reported via Shingirx.  The patient was asking how does the side effects of Shingles vaccine if he/she get it after several years later.  Additional Supportive Information: The case was self reported by the patient. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
stroke-like symptoms; episodes of passing out/seizure like reaction; episodes of passing out/seizure like reaction; experiencing prolonged neurological issues; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), tow doses both via an unspecified route of administration, administered in right arm on an unspecified date (at 28-year-old, not pregnant at time of vaccination) as single dose, for COVID-19 immunization. Medical history included allergies: amide, PCOS (polycystic ovarian syndrome). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin (METFORMIN) taken for PCOS, thyroid medication. On 01Aug2021 the patient was experiencing prolonged neurological issues. She had multiple episodes of passing out/seizure like reaction. Presenting at hospital with stroke-like symptoms. Nearly a week later she still had dizziness and neurological issues. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Pending additional testing. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Cerebrovascular accident, Loss of consciousness, Seizure cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.