chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash looked like hives on the top half of the arm; Rash on left arm; This case was reported by a physician via sales rep and described the occurrence of hives in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced hives and injection site rash. On an unknown date, the outcome of the hives and injection site rash were unknown.   The reporter considered the hives and injection site rash to be possibly related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and 24 hours later the patient returned to office with a rash.  The patient did not have any pain but after work went home and notice the rash on her left arm. Rash looked like hives on the top half of the arm. The patient not aware of any allergies. Looked like a localized reaction from vaccine. The physician thought this could be related to the vaccine based on the time after the vaccine and the location vaccine given. The reporter agreed to follow up.
Redness, increased warmth, itchiness on Lt deltoid where IM injection was placed.  Scratch throat, itchiness on bilateral arms, torso. Symptoms started 10 days after initial COVID 19 Pfizer 1st dose injection. No resolution yet.
This spontaneous report as received from a consumer refers to a 70 years old female patient. The patient's medical history included chickenpox as a child. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # not reported). It was reported that the patient had a red and swollen inflamed area for two days at the injection site. The patient did not seek medical attention. No treatment was given. The outcome of red and swollen inflamed area at the injection site was reported as recovered/resolved. The relatedness for red and swollen inflamed area at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
fever started 25OCT98;had 5min gen sz w/fever26OCT98;LP done;CT scan nl;EEg mildly abn;CSf clean;no growth on cult;devel viral exanthem that inc over next 2-3 days;10NOV98 rash rt thigh;dx simple febrile sz;
Syncope while working in garden 3/28/21, ED visit, no imaging, EKG NSR, treated with IVF attributed to dehydration Severe neck pain radiating to chest started 4/2/21, CT showed large pericardial effusion, admitted to hospital for acute pericarditis with pericardial effusion
Gave her a high dose flu but she is only 64 1/2 years old. She has had NO reaction to this vaccine.
Initial report received from a patient on 16 May 2007. A 66 year old male patient (with a medical history of allergy to sulfas, hypertension and seasonal allergies) complained of pain and swelling in the left axillary region. approximately one week after she received Adacel (lot number not reported) intramuscularly in the left deltoid on 26 March 2007. Two weeks after vaccination, she experienced generalized muscle aches, weakness and increased aching in the left axillary region. She had her blood drawn on 15 May 2007 for "CMP, CPK, sed rate and amylase". She did not have any illness at the time of vaccination. At the time of the report, the symptoms continue and she had not recovered.
Patient report that after speaking with the cdc this morning she was adv that by her being on steroids she should not have been given the vaccine...She stated that after the vaccine she gets rapid increase of heart beat
feel ill; kidney function at 20%/Minimal Change Disorder/reduced over 3 months to zero mg/Kidney back up to 53%/kidney back down to 23%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 at 11:00 as dose 3 (booster), single (Lot number: EW0173) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: QUINAPRIL; ATORVASTATIN; AMLODIPINE. Vaccination history included: BNT162b2 (Dose 2 at 11:45 AM on 24Feb2021, lot: EN6200, location: Right arm), administration date: 24Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose 1 at 11:45 AM on 31Jan2021, lot: EL9265, location: Right arm), administration date: 31Jan2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: RENAL IMPAIRMENT (medically significant) with onset 10Oct2021 at 12:00, outcome "not recovered", described as "kidney function at 20%/Minimal Change Disorder/reduced over 3 months to zero mg/Kidney back up to 53%/kidney back down to 23%"; ILLNESS (medically significant) with onset 11Oct2021, outcome "not recovered", described as "feel ill". The events "kidney function at 20%/minimal change disorder/reduced over 3 months to zero mg/kidney back up to 53%/kidney back down to 23%" and "feel ill" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy kidney: (07Dec2021) MCD, notes: Minimal Change Disorder; kidney function: (05Nov2021) kidney function at 20, notes: blood test showed kidney function at 20%; (16Mar2022) Kidney back up to 53, notes: Kidney back up to 53%; (25May2022) kidney back down to 23, notes: kidney back down to 23%; SARS-CoV-2 test: (02Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of renal impairment, illness. Clinical course included 11Oct2021 started to feel ill. went through 2 rounds of antibiotics over next 3 weeks. 05Nov2021 blood test showed kidney function at 20%. After kidney biopsy 07Dec2021 showed MCD., Minimal Change Disorder. Beginning 14Dec2021 on 60mg Prednisone - reduced over 3 months to zero mg. Also took a diuretic during this time. Kidney back up to 53% by 16Mar2022. 25May2022 labs showed kidney back down to 23%. Beginning 02Jun2022 on Prednisone 20mg + diuretic + Tacrolimus 1mg twice a day. labs to be redone 01Jul2022. The patient was treated with prednisone, tacrolimus and diuretic. The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected
01/20/22 presents to Birth Center Triage for "IOL secondary to cHTN v gHTN". PMHx of "Abnormal Pap, Hypertension"
Patient reported experiencing arm redness that started at the upper arm where the vaccine was given and spread down to the elbow. He said that it felt warm to the touch, but was not overly painful. He denied having a fever or any sort of open sores on the arm.  Pharmacist told patient to go see his doctor for follow up to monitor
Severe urticaria (areas of confluence on all areas of body with heaping of skin near knees causing discomfort)  and bronchospasm. Tachycardia that improved with hydration and treatment.
very high blood pressure; arm hurts; middle of chest hurts; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (very high blood pressure), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (middle of chest hurts) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERTENSION (very high blood pressure), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (middle of chest hurts) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, qd. At the time of the report, HYPERTENSION (very high blood pressure), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (middle of chest hurts) and HEADACHE (headache) outcome was unknown.        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.
This spontaneous report as received from a medical assistant refers to a currently 4 year old patient. On an unknown date the patient was vaccinated with improperly stored VARIVAX (1 dose, lot# reported as N014366, expiration date 09-MAY-2019, route unknown) for prophylaxis. The sterile diluent (1 dose, lot# reported as N015631, expiration date 18-MAR-2019) did not undergo any temperature excursions. No adverse effects reported. Temperature and time frame was 15 Fahrenheit degree (F) to 46 F for 8 hours with previous temperature excursion of 15 F to 46 F for 4 hours. The call was because of a data logger.
Information has been received from a licensed practical nurse and physician concerning a 2 month old male who on 18-APR-2008 was vaccinated with his first dose of ROTATEQ (lot# 660291/1829U). Upon administration the patient coughed some of dose into the administering nurse's eye (WAES# 0804USA04714). No symptoms were reported for this patient. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting licensed practical nurse indicated that the 9 week old (15lb, 2oz., 23 in.) male who on 18-APR-2008 at 10:45 was vaccinated PO with his first dose of ROTATEQ (lot# 660291/1829U). There was no illness at the time of vaccination. Additional information has been requested.
Vomiting x3, afebrile- no previous illness, no family illness-discussed re-hydration and signs and symptoms of dehydration.
within a few hrs after receiving first dose of shingrix( previously had zostavax 3 yr prior and had local reaction only) I developed headache, nausea, tiredness, chills, had low grade fever, shivering, soreness and mild rash at site of injection, overnight had rash develop on chest and back and neck area, slightly itchy and red and flat.  s/s lasted about 36 hr, although rash persisted up to 72 hr and mild headache feeling had some stomach pains first day with nausea.  fever about 24 hr.
Redness, swelling  and pain at site of injection.  Area of redness was 4 inches and was warm to the touch
Discharge Provider: DO Primary Care Provider at Discharge: DO Admission Date: 1/29/2023 Discharge Date: 2/6/2023    HOSPITAL COURSE: Patient is an 87-year-old male with a past medical history significant for BPH s/p TURP on 1/18, chronic foley from 11/2022 until 1/24 due to urinary retention. He presented with generalized weakness and inability to care for himself at home after two falls in the previous 24 hours after going back to independent living from patient care facility; patient was at subacute rehabilitation after being discharged from his admission.  Patient had not had any infectious signs or symptoms. Work-up revealed pyuria and bilateral hydroureteronephrosis.  He was given ceftriaxone in the ED and admitted for possible UTI, urinary retention and weakness; ceftriaxone was continued and urology was consulted. Urine culture with mixed flora, so UTI was felt to be ruled out.  Foley catheter was replaced, and Urology recommending leaving in until outpatient follow-up.   He developed worsening cough and intermittent hypoxia.  Repeat chest x-ray showed atelectasis.  He then developed a fever. Ultimately, patient tested positive for COVID. He was started on remdesivir and decadron.  He did require 2 L oxygen briefly, but was able to be weaned back to room air by discharge.   He was felt to be stable for discharge home on 2/6/23.  He should follow-up with his PCP in 1 week.  He will be discharged on 2 more days of oral Decadron (5 total days) and Tessalon Perles as needed for his cough.  He will be discharged with Foley catheter in place, and will need outpatient follow-up with Dr. to discuss continued catheterization vs repeat trial of catheter removal.
Information has been received from a registered nurse concerning a 65 year old female who on 04-OCT-2006 was vaccinated IM, into the left deltoid, with a second dose of Pneumovax 23 (lot#651357/0391F). On 05-OCT-2006 the patient developed pain and tenderness with swelling and redness at the left deltoid site. The patient reported that she could not perform activities of daily living for 1 day. Unspecified medical attention was sought. Subsequently, the patient recovered completely. Pain, swelling and redness at the left deltoid site were considered to be disabling events. Additional information has been requested.
a bad headache; chills; fatigue; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 58 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "a bad headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 at 06:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
This spontaneous report was received from a pharmacist refers to a 41 year old male patient who is non-smoker. The patient's pertinent medical history included high blood pressure (reported as well controlled). Concomitant therapies included BENICAR. On 25-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency unknown) (lot # K010522, Expiration date: 25-FEB-2016), FLUVIRIN (lot #, expiration date, dose and frequency unknown) and Tdap (lot #, expiration date, dose and frequency unknown) via intramuscular route concomitantly in the left deltoid arm for prophylaxis. On 26-SEP-2015, the patient developed soreness and swelling in the left arm. It was unknown if this was treated. On 27-SEP-2015, the patient blacked out (medically significant) while driving, crossed 2 line of traffic and hit a fence. The pharmacist stated that the patient went to an unspecified emergency room and then was hospitalized for a couple of days with dehydration and acute kidney failure (medically significant). The patient also had complaints of pain in shoulder, pain in left deltoid arm and left leg. The patient was treated with Intravenous fluids and the unspecified physicians ran unspecified tests and diagnosis was reaction to vaccinations. The outcome of the events was not recovered (reported as patient was not back to normal but doing ok, limited on what he could do at the time of report). The relatedness of the events to the suspect product was unknown. There was no product quality complaint present. The reporter considered the events acute renal failure and dehydration to be serious due to hospitalization. Upon internal review, the events acute renal failure and loss of consciousness were considered to be medically significant.
Throwing up Excess sleeping Dizziness Extreme lethargy Extreme burning sensation in lower legs (started under knee cap all the way down to ankles)
died from a rapid heartbeat after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (died from a rapid heartbeat after getting the vaccine) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (died from a rapid heartbeat after getting the vaccine) (seriousness criterion death). The reported cause of death was died from a rapid heartbeat after getting the vaccine. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: increased (High) increased.         No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: This case concerns a female patient of unknown age who had a fatal event of HEART RATE INCREASED after receiving mRNA-1273. The reported cause of death was died from a rapid heartbeat after getting the vaccine. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a female patient of unknown age who had a fatal event of HEART RATE INCREASED after receiving mRNA-1273. The reported cause of death was died from a rapid heartbeat after getting the vaccine. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: died from a rapid heartbeat after getting the vaccine
Patient received a Moderna vaccination at  Family Medicine on 12/29. Then patient received a Pfizer vaccination at fairgrounds on 1/26. Patient was monitored for 30 minutes with no adverse outcomes. Patient education provided on adverse reactions and when to seek emergency services. Reinforced CDC guidelines to not receive an additional dose of Moderna or Pfizer vaccination.
Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration on Jun2021 as unknown single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that four of my colleagues (including myself) reporter's colleagues (including reporter) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. They all were researchers and recognize the impossibility of this not being a variant. Consumer was totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. The patient underwent lab tests and procedures which included SARS-COV-2 test which was positive on 25Jun2021. The outcome of event was unknown.   Information on the lot/batch number has been requested. .
Headache & NauseaVomiting, Narrative: chils, headache, arm swelling and redness at injection site. Nausea. For one day after injection
pt recv vax 8DEC95 & 10DEC95 pt devel a rash consistent w/ varicella & approx 20DEC95 exp intermittent chest discomfort; routine lab tests, CXR, & echocardiogram that turned out to be negative were performed;
Information has been received from a registered nurse concerning a 19 year old female patient with asthma and no known allergies who on 11-DEC-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 ml intramuscularly.  Concomitant therapy included ADACEL and HAVRIX.  On 11-DEC-2008 the patient experienced left arm pain, arm pit pain, left sided chest pain and swelling of her left arm.  The patient sought medical attention at the office.  At the time of report the patient was recovering.  Additional information has been requested. Fllow up information received from the registered nurse indicated that the 19 year old female patient weighted 135 pounds and was 69 inches height. The nurse reported that the patient developed right arm hurting and swollen at the injection site (previously reported as left arm swelling), then the pain went to under arm and the right side of the chest (previously reported as left side). Additional information is not expected.
Pt developed mild erythema on left shoulder with warmth. Treated with Clindamycin 150mg #28 1 QID.
The first time I reported it to my Doctor and got Plaxovid and my symptoms lasted 5 days. By the time I finished the Plaxovid it was gone. I had tiredness, muscle aches, congestion. My symptoms were like a severe cold. On the night of sept 22nd I felt the symptoms come back, and I did a at home test and it was positive. The symptoms were about the same as before, again not horrible and not as bad but they lasted longer.
606 doses were given after expiration date; vial was stored after expiration date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vial was stored after expiration date in the refrigerator) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (vial was stored after expiration date in the refrigerator). On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vial was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      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. No temperature excursion was reported. Date place in refrigerator 18-Oct-2021. There  was no product complaint associated.   This case was linked to MOD-2022-491837 (Patient Link).
OV on 7/22/14 for c/o HA, blurring of vision, vertigo and ringing in ears x5 days. BP was 98/64. Dx with viral illness but given eye appt. Seen by optometrist on 7/24/14. Dx with (R) optic nerve elevation and swelling. Referred to neuro. ophthalmologist. OV on 7/25/14 ongoing HA, dizzy, blurred vision, improving but still present. 7/26/14 seen in ER with increased HA, blurry vision. Dx with sinusitis and likely complex migraine. Referred to neuro. 7/28/14 normal exam with neuro. ophthalmology. Also saw neuro. on 7/28/14 - no report yet. 8/5/14 OV vision better, still "not himself" per mom.
pt recvd Typhoid vax & devel a very sore arm, nausea, & flu like sx for 3 days;