chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left leg 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2018 (unspecified if ongoing), notes: Breast cancer survivor 2018. The patient's concomitant medications were not reported. Past drug history included: Known allergies: amaoxicillin, reaction(s): "Penicillin allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Jul2023) Positive, notes: tested positive again tonight. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2023 to 15Jul2023. Clinical course: Covid rebound- finished Paxlovid 15Jul2023, tested positive again that night, 20Jul2023 after symptoms started 19Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300256198 Same patient, different drug/event;
Mother called states that child had immunization on Wed and didn't know if child was having or not. Eyes are swollen over eyes, on yesterday one day post vax. They were puffy over and beneath the eye. States has a little cold. Child has had other injections in early childhood and no type reactions with other injections. Puffiness was not a known reaction. Recommended to see private MD for evaluation. Mother states ok will take her today.
Varicella Information has been received from a registered nurse (RN) concerning a 9 year old male who on 08-APR-1997 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (Oka/Merck) (Lot #617695/0776D). There was no illness at the time of the vaccination. The RN reported that on 01-OCT-2005, the patient developed breakthrough varicella characterized by less than 30 varicella lesions that spread to his face and neck. The patient was noted to be afebrile. On 04-Oct-2005 the patient was seen by a dermatologist, but no treatment or laboratory/diagnostic tests were required. In 2005, the patient's breakthrough varicella spontaneously resolved. Additional information is not expected.
Nausea and vomiting, extreme fatigue, soreness, achy legs and feet.
Lightheadedness, tingling in face, arms and welts. Gave 25 mg BENADRYL, 1/2 hr later, symptoms subsided, employee then got a ride home. 11/28/08
Employee received Flu shot 9-30-15 at 2210. States noticed symptoms at 1600 on 10-1-15. Went to E.D. on 10-2-15 at 0930. Symptoms include: hives, itching, swelling of face and arms and burning; as well as difficulty swallowing. Rx prednisone.
Fatigue started night of 04302021.  Could not keep eyes open, extreme fatigue 05012021.  Fever of 102.7.  Barely ate all day (around 300 calories).  Did not start feeling ok until 05022021 in the morning.
Information has been received from a physician concerning a 15 year old female with penicillin allergy and eczematous dermatitis who on 01-NOV-2006 was vaccinated with a second dose of Gardasil (lot #656049/0187U). On 01-MAY-2007, "roughly at the end of this vaccination series," the patient developed autoimmune thrombocytopenia and leukopenia. The patient was diagnosed with Evan's Syndrome. The patient was hospitalized for 5 days treated with platelets, immunoglobulin and prednisone. At the time of the report, the patient had not recovered. The reporting physician considered Evan's syndrome and leukopenia to be immediately life-threatening and disabling events. The reporting physician reported that he was not personally certain the Gardasil of the events. Additional information has been requested.
Per Pt/Employee; She reported a mild herpes like reaction on left lateral side of body. extending  from back to torso. She consulted be PCP; PA. confirming herpes rash
Severe swelling, redness, tenderness at injection site of right deltoid.  Associated left sided headache and left leg tingling sensation.
Pt recv vax on 6/8/98; on same day pt exp flu-like sx
Hospitalization for COVID-19 on dates 1/25/2023- 1/27/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Erythematous macule with few fine papular lesions left deltoid region onset same day as Tetanus vaccine given in that location.
This spontaneous case reported by a consumer, describes the occurrence of malaise (not feeling well), urine abnormality (can't hold urine) and incomplete course of vaccination (supposed to take second shot of Moderna COVID-19 vaccine today) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 16, 2021, patient experienced malaise (not feeling well) and urine abnormality (can't hold urine). On an unknown date, patient experienced incomplete course of vaccination (supposed to take second shot of Moderna COVID-19 vaccine today). At the time of the report, malaise (not feeling well) and urine abnormality (can't hold urine) outcome: unknown; and incomplete course of vaccination (supposed to take second shot of Moderna COVID-19 vaccine today) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
The initial case was received on 04 November 2010 from a healthcare professional. A 16 year old female patient received on 23 August 2010 an injection of MENACTRA (lot number not reported). On 29 October 2010, she experienced "seeing spots" and a headache. Her physician contributed it to having a "cold". She had a physical on 26 October 2010 and "all systems checked out" okay and her vision was 20/20 in both eyes. The patient had no illness at the time of the vaccination. She had no concomitant medications. Her pre-existing medical conditions included chronic back pain and headaches (she had fallen from a horse years ago). She was evaluated by an ophthalmologist on 29 October 2010 and was referred to a neurologist. No further information was provided. The patient's recovery status was unknown. Documents held by sender: None.
what are the side effects from the second shot; 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 VACCINATION COMPLICATION (what are the side effects from the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (what are the side effects from the second shot). At the time of the report, VACCINATION COMPLICATION (what are the side effects from the second shot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided
Flu Shot received at Workplace Flu Clinic and the shot was given to high in my left arm and the provider missed the muscle and injected the flu shot into my Bursa Sac.  Since then, range of motion in left arm is extremely limited and there is a lot of pain and I cannot lift or pull things and it has effected my daily acts of living  for example getting dressed and am not able to use that arm without feeling pain down my arm from the shoulder down my left arm, sleep and anything related to using my left arm is effected.   My sleep has been very disrupted and am not able to get comfortable and have to prop self up to sleep.  There has has been a lot of inflammation, pain down my left arm from the shoulder down my left arm and constant throbbing pain.  Saw a healthcare provider through work to report the incident and another provider who I saw that treated me for evaluation and did an Xray and Cortizone Shot. Since the Cortizone Shot, I have had less pain and inflammation, but there is still pain and limited range of motion in that arm.  Workplace restrictions are in place and I am not to lift anymore than 10 lbs and have been told not to reach overhead and physical therapy orders have been provided for twice weekly PT.  I will be following up with this doctor again at the end of November 2023.
test positive for the virus; test positive for the virus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date in 2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the COVID-19 vaccine a couple of weeks ago and tested positive for the virus on an unspecified date in 2021. She was asking what she should do about the second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Patient was in for her Moderna Dose 1, however was give only 0.25mg booster dose.
patient received vaccine, got up from the immunization booth and walked over to her mother, within seconds, she fainted and was on the ground. patient came to immediately. we called 911, paramedics came and patients
Father called public health on 9/15/17 to report that his daughter woke up this morning at 4:00 am, "with a fever of 101, body aches and sore arms". The father reported that TYLENOL was given and repeated 5 hours later due a fever of 100.6. Nurse questioned father regarding possible allergic reaction symptoms, father denied any wheezing, difficulty breathing or hives. Nurse instructed father if any of allergic symptoms occur to go to the ER. Nurse offered a home visit or office visit, father stated it was not necessary. Nurse encouraged increasing fluid intake, cold or warm packs to injection sites and using Ibuprofen or TYLENOL as needed. Nurse reported to the father that this form would be completed.
My COVID-19 symptoms started on 02/16/2023 with a sore throat. At nigh I had fever, achy, dizzy and I felt really bad. On 02/17/2023 I tested positive. After few hours around 04:00pm I  called my doctor and did  a telehealth. She prescribed me Paxlovid  for 5 days. I was positive for 7 days. I tested negative on 02/25/2023.
Febrile seizure (generalized) lasted 5 minutes without intervention. Temperature 103F in ER.
passed out; Head ache; nausea; chills; fever; This case was reported by a consumer and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), headache, nausea, chills and fever. On an unknown date, the outcome of the passed out, headache, nausea, chills and fever were recovered/resolved.   The reporter considered the passed out, headache, nausea, chills and fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a terrible reaction to the 1st of the second dose shingles vaccination.  The patient had head ache, passed out the next morning, nausea, chills & fever for a few days.  The reactions to the second dose were not quite as severe. For tolerance of second dose refer US2021AMR205343, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205343:same reporter
Information has been received from a physician concerning a 14 year old female who was intramuscularly vaccinated with the first 0.5ml dose of GARDASIL.   Concomitantly the patient was given Hepatitis A vaccine injection (manufacturer unknown).   A couple weeks later, the patient was admitted to the hospital for guillain-barrce syndrome on an unspecified date.  The duration of hospitalization was unknown, as well as the outcome.  The patient sought medical attention.   Additional information has been requested.  2/27/09 Received PCP medical records which included hospital & rehab hospital d/c summaries. FINAL DX: Guillain Barre syndrome; Miller Fisher variant Hospital admit 10/21-10/27/2008. Records reveal patient experienced progressive ascending bilateral LE tingling & weakness x 5 days, reduced oral intake, lump in throat, difficulty swallowing & walking, balance disturbance, speech alteration, HA & double vision.  Had been seen in PCP office & sent to hospital.  Had diarrheal illness approx 10/10.  Admitted PICU.  Neuro consult done.  Feeding tube inserted. Tx w/IVIG x 3, neurontin & pain meds.  Improved, diet advanced & transferred to inpatient rehab. where she continued to progress & d/c to home 11/15/08 w/Neuro f/u, rolling walker & outpatient PT/OT as well as homebound school.  4/13/09 Received additional hospital medical records of 10/21-27/2008.  No new information.
Pt is a resident in a SNF. He went for dose 2 of his Pfizer Covid series at 950am on 6/2. At 12:30am on 6/3 he became weak, anxious, SOB and required oxygen supplementation. He was shaking and weak and transferred to  hospital via ambulance.
RED RASH WITH SWELLING ITCHING OVER 90% OF BODY. MOST PRONOUNCED ON FEET TO KNEES. IMMEDIATELY BEGAN DAY AFTER INJECTION.
Face rash/Face swelling Lymphadenopathy Weakness Joint pain/Muscle pain Feeling unwell Fever (99) Tired/Sleeping a lot  This is day five since my second shot.  Better but not feeling well yet.  Weakness.  Swollen Lymph Node is on the left (injection arm).  Have taken Advil.
Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 168/104, notes: now have continual readings of 168/104; (20Jan2022) normal 124/78, notes: have always had normal Blood Pressure  124/78; SARS-CoV-2 test: (20Jan2022) Positive, notes: Nasal Swab; Weight: (20Jan2022) Normal, notes: I am normal weight and activity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FEVER, CHILLS, NAUSEA, VOMITING, PAIN AT INJECTION SITE, BODAY ACHE, Appendicitis.
Hip synovitis right more than left. Unable to bear weight for 48 hours 12/21/06 Received medical records from hospital which reveal patient admitted 12/13-12/14/06 following 2 days of right hip pain with weight bearing & also had some pain left hip.  Pain kept patient awake at night.  No illness or trauma.  Flu vax 3 days prior to symptoms.  Exam revealed right hip with pain when flexed at 90 degrees, pain with extrenal rotation beyond 60 degrees and pain increased when hip internally rotated.  No pain when flexed or at rest.  Treated w/anti inflammatory & pain meds overnight & was able to walk next day.  D/C to home to be f/u as outpatient. Final Dx: Synovitis of hip/ss
Very frequent urination. Did urnianalysis 2 times which is normal. Also did Urine culture twice which is also negative.
Was very fatigued and nauseated and became hyperglycemic.   At 3:00AM Tandem insulin pump alarmed that is was no longer working and needed to be replaced.  Called company or replacement and switched to injected insulin and old insulin pump in AM
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 24-month-old male patient who experienced seizure. The patient received a dose on 08-Jun-2010. Patient received PREVNAR therapy on 08-Jun-2010. On 09-Jun-2010, the patient experienced a seizure and was admitted to the hospital. Patient recovered on an unspecified date. No further information was provided.
pain seemed to move around her arm/ her injection site arm hurt/arm pain (of injected arm); This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. In November 2020, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient received the Shingrix shot and her injection site arm hurt. The reporter stated it hurt her more on the 2nd and 3rd day and the pain seemed to move around her arm. The pain has since resolved. The reporter stated he did not want to file a report thus no further questions were asked. (He did not specify if it was patient's first or second dose of Shingrix).
9/9/21 PMHx significant for Kyphosis, Glaucoma, who presented to the ER with shortness of breath, fever and fatigue
Pfizer-BioNTech COVID-19 Vaccine EUA: in clinic visit immediately following vaccination patient reports eyes watering, redness on face, throat swelling. Vital signs all within normal ranges. Provider noticed swelling of soft tissue around eyes and cheeks. On physical exam no hoarseness noted; lungs clear without wheezing, rhonchi, or rales. Administered diphenhydramine in clinic and advised to continue at home and referred to allergy/immunology clinic for follow-up.
5-10 minutes his vision was blurred; dizziness; For a week he had some shortness of breath; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (For a week he had some shortness of breath), VISION BLURRED (5-10 minutes his vision was blurred) and DIZZINESS (dizziness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included no adverse drug effect. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VALSARTAN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (For a week he had some shortness of breath). On an unknown date, the patient experienced VISION BLURRED (5-10 minutes his vision was blurred) and DIZZINESS (dizziness). Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Diarrhea for 5 days post vaccination no blood in stool. Fussy for 2 days.
A spontaneous report received from consumer via Regulatory Authority (VAERS) concerning a 3 year old female patient. Concomitant medications were not provided. The patient's medical history included hives. The patient's concurrent disease(s) included tachycardia and shellfish causing hives. The patient had been receiving FLUMIST (intranasal), started on 31-Jan-2014. Lot number was unknown. It was reported that the patient developed Guillain-Barre syndrome approximately 1 week after vaccination with nasal flu vaccine. She required admission to PICU and received IVIG but was recovering nicely, should make full recovery. Never required intubation but had tachycardia requiring monitoring. The patient recovered from the event of Guillain-Barre syndrome on an unspecified date. MRI brain contrast done and per report normal. LP contrast done and CSF showed WBC 1, RBC 12, glucose 57, protein 277. The reporter assessed the event of Guillain-Barre syndrome to be serious with the seriousness criteria of life threatening and hospitalization. Laboratory values and diagnostic test details are available.
Pt was given a 0.5 ml dose versus age appropriate of 0.25 ml. No reaction was documented.
After getting vaccines, plus chills, fever to 102.9 seen at ER, did blood, urine, CXR "All normal" Low grade fever since ER visit (10-10-08) ER (10-9-08) shots given (10-8-08)
Pt received Pneumovax on 7/24/19. On 7/26/19, she called, stating approx. 24 hrs later, she had a rash "bubblu-like hive" rash on arm injection had been given from elbow to wrist. Minimal rxn @ injection site. patient instructed to be evaluated & to call back. Pt never called back. PCP unsure if rxn is from vaccine or other
The patient called the pharmacy at 9:00am 7/21/2017 stating  that the arm he received the vaccine in was very swollen, very itchy and very painful. The patient was advised to contact his physician for followup and additional instructions. The physician advised the patient to take Benadryl, ice the area, and elevate the arm.
Received first dose and got covid and wants to cancel her second dose; Received first dose and got covid and wants to cancel her second dose; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration, on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing cancer. Concomitant medications were not reported. The patient received first dose and got COVID and wants to cancel her second dose. The patient also had an infusion the day before reporting and is a cancer patient. The outcome of the events was unknown.  Information on the lot/batch number has been requested.