chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue  Sore throat  Congestion or running nose Care Coordination Progress Note    COVID 19 Navigator Initial Patient Assessment   Ordering Prescriber has completed required FDA EUA elements.    COVID-19 Positive Result Date (and on chart/file): 05/20/2021 Start of Symptoms Date:  05/17/2021  Meets Criteria:   ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age       ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease
Patient received her second dose 16 days from the first Pfizer dose, she was supposed to have 21 days in between
Pain is felt all the way down arm from the injection site; Fatigue; Shivering; Feels feverish; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019 18:00, the patient received the 1st dose of Shingrix. On 24th September 2019, immediately after receiving Shingrix, the patient experienced pain in arm, fatigue, shivering and fever. On an unknown date, the outcome of the pain in arm, fatigue, shivering and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, shivering and fever to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine left arm. The patient reported that she experienced immediate pain upon receiving the vaccine at 6:00 pm on day before reporting.   The patient said that the pain in her arm was as painful as period cramps. The pain in her arm progressively worsened throughout the night.   The pain was felt all the way down her arm from the injection site.   Less than a day after vaccination, the patient also experienced shivering, fatigue and feels feverish. The patient could barely get out of bed on day of reporting. The reporter did not consent to follow-up.
COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD & FLU) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, SARS-CoV-2 test: (Positive) patient took a home Covid test which was positive.         No concomitant medications were reported.  On Jan-2021, the patient received first dose of Moderna vaccine. On 17-Feb-2021, the patient received second dose of Moderna vaccine. On Feb-2022, the patient received third dose of Moderna vaccine.  One week after receiving the most recent dose, the patient became sick with tiredness and cold like symptoms. She called the physician who recommended Tylenol cold and flu and advised the patient to remain quarantined for 5 days.   Reporter did not allow further contact
Red rash at injection site, increased over 3 day period so far, slight itching and soreness
BLEED, SWOLLEN  AND HARD BUMP  APPEARRED   AT THE SITE OF INJECTION. NO OTHER SYMPTOMS. PATIENT WAS FINE AFTER 15 MINS SITTING ON THE BENCH EXCEPT THE SWELLING ON THE ARM.
Pain in shoulder (injection site) started the evening of the shot. Overall fatigue began. Next morning and thought the day: fatigue, muscle ache, very bad headache, joint pain, chills, some loss of appetite, and fever of 100.9 after having taken 2 tylenol that same morning.
A report was received from a healthcare professional on 13Nov01 regarding a 1 month old girl who accidentally received Fluvirin 0.5ml instead of hep B. There were no adverse events reported. No specific treatment other than supportive care was provided. There was insufficient information to determine the reporters causality assessment.
Information has been received from a nurse concerning her 16 year old daughter with no medical history or concomitant therapies who in July 2007, was vaccinated with her first dose of Gardasil.  In September 2007, the patient was vaccinated with her second dose of Gardasil.  After the second dose, the patient fainted and also had a headache.  She then developed a pseudo cerebral tumor which started to cause blindness.  She had a spinal tap and also had the fluid drained to relieve the pressure she was having.  No further information was provided.  Subsequently, the patient recovered from fainting, her headache, the pseudo cerebral tumor and blindness.  The blindness was considered to be an other important medical event.  Additional information has been requested.  02/29/2008 MR received from neurologist for OV 1/17/2008 with Dx:  Pseudotumor cerebri.  Pt presented with some loss of vision in the L eye and headache x 2 weeks with papilledema noted on fundoscopic exam.  PE WNL except papilledema.  3/27/2008 Additional records received from opthomology consults 1/18/08 and 1/30/08 and f/u neurology 2/28/08. Seen by ophth 1/18/08 with visual field changes with h/a. PE (+) for optic nerve edema. DX: Pseudotumor cerebri.  Mild blepharitis, mild refractive error L eye. Ophth consult 1/30/08 with report of improved visual acuity and no h/a. Edema still present on optic nerve exam, improved from last visit.  Neuro f/u with improvement noted in visual field and h/a.
This spontaneous report was received from a physician via company representative refers to a patient of unknown age (gender unspecified). On an unknown date, the patient was vaccinated with a dose of live ZOSTAVAX, (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient had a small outbreak of zoster. The outcome of the event was unknown. Additional information is not expected.
Rash on upper right arm and shoulder( Opposite injection Site).; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration on his left arm on 05Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included peripheral arterial disease (PAD), chronic obstructive pulmonary disease (COPD) and hypertension. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and metoprolol (MANUFACTURER UNKNOWN); all for unknown indications form unknown dates and unknown if ongoing. Patient was allergic to pseudoephedrine hydrochloride (SUDAFED). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. One week after vaccination on 12Mar2021 at 06:00, the patient experienced rash on upper right arm and shoulder (opposite the vaccination site). It started as muscle pain, which was not itchy. It was just uncomfortable muscular pain. He did not receive treatment for the events. The clinical outcomes of the rash and muscular pain were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "High cholesterol" (ongoing). There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 21Jul2023, outcome "recovering" and all described as "tested positive for Covid 19". The patient was hospitalized for vaccination failure, covid-19 (start date: 21Jul2023). The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (21Jul2023) Positive, notes: tested positive for Covid-19.  Clinical course: This report was related to a study or programme. Details. HCP Type: Cardiologist. Investigations and other products stated as No. Agent stated she was calling with a patient on the other line because he just told her that he was in the hospital because he had Covid. Physician: Full Contact Details Unknown. Caller stated he tested positive for Covid-19 on Friday evening, and he was admitted to the hospital on Friday evening. Caller stated they did an MRI this morning and if it all come back normal on the results of everything, they will discharge him the day after this report (stated as tomorrow). Caller stated he has had all 5 Pfizer Covid 19 vaccines.  Caller stated he didn't even know he had Covid until he visited his daughter and he had a cough and that was it. Caller stated one time when they took his temperature he had a fever, but it went down the next time. He had no aches or anything. Caller stated his Daughter brought his Vyndamax to the hospital so that he could take it. Therapy Start Date: Caller states he started taking it a long time ago. He stated his older daughter died in 2015 and the doctor suggested checking the family for that gene that killed his daughter and he had it, so he contacted Pfizer and he had been getting his Vyndamax and has been on it since 2016 of 2017.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Several days following administration, pt. developed unusual symptoms that she's never had before that primarily included difficulty breathing from constriction of her airways. OTC antihistamines helped somewhat but because symptoms persisted we went to the emergency room at a local Hospital. She had a battery of tests including a COVID test (which was negative) and a variety of other tests including full blood and urine panel, which did not show any particular cause. Pt was administered steroids and IV benadryl to help her breathe, which seemed to help her, and was discharged after spending about 4-6 hours in the ER.  At the ER's recommendation, Pt was examined by a pulmonologist, who concluded her lungs were healthy and had no issue. He suggested that she may be having an unusual allergic reaction to the vaccine and that she should see an allergist. Consultations with an allergist did not produce any suggestions--in our experience typical allergists are not equipped to deal with this kind of reaction.  The reaction has persisted for an extremely long period (it is still being felt now, 7 months after the vaccine), and the only thing we've found that helps manage it is taking large doses of OTC antihistamines (e.g., Claritin, Allegra, Zyrtec) on a daily basis. Even then, if pt. engages in any significant physical activity, she gets winded much more easily than in the past. Pt is disabled and largely confined to bed due to her chronic nerve disorder--any significant physical activity increases her pain levels. This sedentary lifestyle combined with the antihistamines is letting her manage the reaction.
He c/o soreness at site several hours after injection left arm.  mom noticed redness 24 hours later, increasing over the next 24 hours.  he said it was really itchy, denies cratching arm.  area of eythema 5 1/2 in wide and 4 1/2 high, on back of arm redness down to elbow.  area of 2x 2 induration within center ot eythema with 3 1 cm holes like he scratched arm.
He says he experiences nausea; Sweating; Dizziness; He can't walk straight.; He's experiencing inflammation; This is a spontaneous report received from a contactable consumer (Patient). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in May2021 as single dose for covid-19 immunisation. Medical history included autoimmune disorder. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Apr2021 as single dose for covid-19 immunisation. On an unknown date, the patient experienced nausea, sweating, dizziness, he cannot walk straight and experienced inflammation. Clinical course of the events was reported as Every morning, he says he experiences nausea, sweating, dizziness, and he can't walk straight. He's experiencing inflammation and it's not settling down. Outcome of the events nausea, sweating, dizziness and he cannot walk straight was reported as unknown and event he's experiencing inflammation was reported as not recovered at the time of this report.  Information on the lot/batch number has been requested.
I started bleeding and cramping, my period isn?t due for 2 more weeks. Headache, dizziness, insomnia, tiredness, nausea,.
A few seconds after HPV vaccine was given in right deltoid pt slumped over on left side and was unresponsive - her body was shaking, she came around after about 30 seconds - she was very pale, complained of a headache that lasted a few minutes. She was placed in supine position, given water & monitored for 30-60 minutes.
Chief Complaint: Difficulty breathing Additional Medical History:  Patient presents to the emergency department with complaint of cough and difficulty breathing that has been ongoing since 2022-01-06.  Patient was diagnosed with COVID-19 teen on that date.  His initial symptoms had been consistent with a gastroenteritis he had come complaining of epigastric pain diarrhea and vomiting he did have some slight cough at the time so he was tested and subsequently found to be positive he was not hypoxic at the time so he was discharged and instructed to get outpatient monoclonal antibody therapy as he was at risk.  Patient has developed progressive shortness of breath since presents now with difficulty breathing and palpitations nonproductive cough.  I questioned him about his advanced wishes regarding mechanical ventilation, and he does not want to be on a ventilator though he is willing to allow us to try BiPAP.
The evening after I received my vaccine I became very cold and couldn't get warm, to the point of shivering very hard, while at the same time having a fever of 102 F (about 9:30 pm).  The house was 68 F, and I bundled up with thermal underwear, fleece pajamas, a robe, and two extra blankets, but I couldn't stop feeling cold.  My body was painfully sore the rest of the night; this may have been a reaction from shivering so hard and wearing my muscles out.  Later that night, I woke up in a sweat (maybe 11:30pm) and had to strip out of my clothes down to my underwear, and I couldn't stop feeling warm.  I slept the rest of the night on top of the covers, and woke up very frequently, probably every half hour.  Each time I woke, I drank half a glass of water (about 6 oz).  The next day my fever was gone and I felt normal temperature wise, but my muscles were all very sore.  I had flu-like symptoms for about a week, a little bit less each day.  It was probably a full week later until I felt normal.
Little fever; Body pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever 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, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Little fever) and general body pain (Verbatim: Body pain). The outcome of the fever and general body pain were resolved.   The reporter considered the fever and general body pain to be related to Shingles vaccine.     The company considered the fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2023 This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine and it caused him/her little fever and body pain and the patient was already recovered and he/she prefer to felt the symptoms of the vaccine that he/she would suffer from shingles in the future. The patient reported that he/she missing the second dose in one month. The patient reported that if you're over 50 as he/she recommend, get the vaccine. The patient reported that this was a lifelong vaccine, he/she would already be protected from shingles. The patient reported that if he/she were to get it, he/she would not suffer the same as if he/she had not been vaccinated. The patient reported that for your good, protect yourself. Follow-up would not possible, as no contact details were available.
Patient was given .2ml of Pfizer 5-11year old Orange Top vial without being reconstituted with 1.3ml of saline.
This spontaneous report has been received from a nurse referring to a 13 year old female patient with no pertinent medical history or drug reactions/allergies. The nurse reported the patient received the first dose of GARDASIL (lot # H019495, exp date 26-JUN-2015), on 22-APR-2013 and the second dose of GARDASIL (lot # K008335, exp date 23-JUN-2016) on 10-SEP-2014 (inappropriate schedule of drug administration). On 01-MAR-2016 the patient was vaccinated with the third dose of GARDASIL 9 (lot # L036245, exp date 09-FEB-2018) 0.5 ml, intramuscularly in the left deltoid (interchange of vaccine products). There was no concomitant medication. The nurse reported the patient experienced numbness, which began in the left thumb, after receiving the GARDASIL 9. The nurse was notified by the patient's mother that the numbness had extended to the left arm, since the patient left the office. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the outcome of events was unknown. Additional information has been requested.
Systemic: triggered onset of asthma attack-Medium, Additional Details: probably not related but possible trigger of asthma attack. pt states she had a asthma attack 2 days ago. she states she has been having increase attacks in the last couple of weeks.
pain on her breast/"shooting pain down below her boobs pulling on the nerves and around the rib cage"; shooting pain down below her boobs pulling on the nerves and around the rib cage"/ and her ovaries shooting like jump like pain; pain on her lower and upper body; shooting pain down below my boobs pulling on the nerves and around the rib cage; shooting pain down below my boobs pulling on the nerves and around the rib cage; my ovaries shooting like jump like pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 60 (units unspecified)) received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 21Feb2021 as Dose 1, Single for COVID-19 immunization. The patient's medical history included sensitive to medicines (she tried to stay away from medicines) lower blood count of platelets (borderline). The patient's concomitant medications were not reported. The patient's past medications included flu vaccines (she had no reaction to the flu vaccines). On 21Feb2021 (Sunday) after she received the vaccine she felt like "something happened", yesterday she experienced pain on her breast and pain on her lower and upper body for a couple hours (4 hours), she described it as a "shooting pain down below her boobs pulling on the nerves and around the rib cage", and on her lower body and her ovaries shooting like jump like pain for couple of hours was that part of the vaccine. She had no fever. She queried if she could stay only with the first vaccine and be protected. She was concerned because she's "not heavy enough" and she received the same dose of the vaccine than everyone else, she's also "sensitive to medicines" she tried to stay away from medicines. She stated she would still be using mask to protect herself; she would like to know if she should use mask after receiving the vaccine. She would like to know if the vaccine was effective against the strains of the virus. She would like to know if she can receive the second vaccine in May or later. The patient underwent lab tests and procedures which included blood count platelets: lower blood count of platelets (borderline) on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Dizzy and nauseous immediately after administration. Patient sat down, put fan on her and gave water. She felt better and recovered in about 10 minutes.
Initial unsolicited report received from nurse on 28-Nov-2017. This case involves a female patient (age not reported) who was vaccinated with 0.5 ml prefilled syringe dose of FLUZONE QIV (Batch number: U589DA, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced large red rash. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. List of documents held by sender: none.