chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product used 3 days post use by day. Moderna consulted, advised no next steps needed.
About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling. Still present, but not as painful. About 1 week post injection, began getting chest pains, difficulty breathing, and dizziness/lightheadedness. We to urgent care 1 week after symptoms started to appear as they got worse. EKG ran showing potential heart attach in past, but I don't think I've had one before. Was noted and told might have been due to crutches. Symptoms got worse next day so went to urgent care at different facility. Brought to ER for x-ray, blood , and EKG. Told no myocarditis, but potentially pericarditis.
This spontaneous report was received from a nurse referring to patient of unknown age and gender. The Patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored doses of VARIVAX (lot number: M002061 and expiration date 12-JAN-2018 (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient felt abnormal/like being pushed off something (outcome unknown). This follow-up submitted to notify the batch/lot number not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
When I was moving 2600 meters above sea level, I had a loss of oxygen reaching 58
Pt exp very mild sxs p/2nd dose; sxs resolved & pt received 3rd dose & exp no adverse effects;
pt recv vax & devel lt arm pain, redness & swelling 8hr p/vax;redness & swelling progressed in subsequent 48hr to entire arm & forearm;
Mild fever; Body aches; Lethargic; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the right arm on 01May2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously had walnuts and experienced allergy to nuts and also grapes and experienced fruit allergy. The patient previously had penicillin for unknown indication on unknown date and experienced penicillin allergy. The patient previously took codeine (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced drug allergy. Concomitant medications taken within two weeks of vaccination included atenolol (MANUFACTURER UNKNOWN), famotidine (PEPCID), loratadine (CLARITIN) and iron (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewo151) via an unspecified route of administration in the right arm on 10Apr2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 18:30, the patient experienced mild fever, body aches, lethargic. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events mild fever, body aches, lethargic was resolved on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Patient was  alert and verbally responsive in usual state of health on 1/11/2021 received Moderna vaccination dose 1.  Patient seemed stable until 2/6/21.  Then on 2/6/21, patient was noted with slight elevated temp of 99.2, pulse 100, spo2 94%RA at 2:15am.  By 5:20am, patient was pronounced dead.
Patient reports that she woke in the middle of the night after receiving the vaccine with very sore arm. Over the following 4 days, she reports that she had severe arm swelling (shoulder to elbow), elevated temp and severe headache. As patient already takes pain medicine and anti-inflammatory, she did not take any additional medications for these rxn(s). She did apply ice and heat to her arm.
24yo male received the 2nd dose of Moderna COVID-19 vaccine on Friday 8-13-21. Symptoms started later that evening and progressed over the weekend with headache, body aches, fatigue, chest tightness, shortness of breath and intermittent palpitations.  Denies taking any medication for symptoms.  Denies prior medical problems. TELEDOC consult on 8-18-21 and referred patient to ER for in-person evaluation.
Redness, swelling, increased warmth. itchy rash 4-5 cm left upper arm, mild induration, mildly tender, one week after vaccination.  Symptoms mildly bothersome, not affecting daily activities.
Missed menstrual period for the same month I received my 2nd dose.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female non-pregnant patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9261) via unspecified route of administration in the left arm on 05Feb2021 at 09:15 (at the age of 22 years old) as a single dose for Covid-19 immunisation. The patients medical history included chronic migraine. Concomitant medication included Norethindrone Acetate (MANUFACTURER UNKNOWN) and Ethinyl Estradiol (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL0140) via unspecified route of administration in the left arm on 15Jan2021 at 09:15 (at the age of 22 years old) as a single dose for Covid-19 immunisation and previously took aloe Vera and experienced an Allergies. Prior to vaccination, Patient had no symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since the vaccination. On unknown date in Feb2021, the patient experienced Missed menstrual period for the same month she received her 2nd dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of menstrual disorder was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
COVID-19 SOB (shortness of breath) Cough Suspected COVID-19 virus infection Care Coordination Progress Note RN (Registered Nurse)    COVID 19 MAB Infusion Navigator Initial Patient Assessment   Ordering Prescriber has completed required FDA EUA elements.    COVID-19 Positive Result Date (and on chart/file): 5/8/21   Start of Symptoms Date: 5/6/21  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   ED to Hosp-Admission Discharged  5/10/2021 - 5/18/2021 (8 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Discharge Summary Discharge Summary   BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: DO Primary Care Physician at Discharge: MD    Admission Date: 5/10/2021     Discharge Date: 5/18/2021   Discharge Diagnosis  Medical Problems     Hospital Problems        POA    * (Principal) Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Yes    Overview Signed 5/14/2021 10:50 AM      05/11/2021 Dexamethasone 05/11/2021 Remdesivir            Essential hypertension Yes         CLL (chronic lymphocytic leukemia) (CMS/HCC) Yes         OSA (obstructive sleep apnea) Yes         Persistent atrial fibrillation (CMS/HCC) Yes        DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission Patient is an 82-year-old male with past medical history significant for CLL, obstructive sleep apnea, obesity and persistent atrial fibrillation who presented to the ER on 5/10 for evaluation of progressively worsening shortness of breath after recently being diagnosed with Covid?19.  ER work-up concerning for severe sepsis with acute hypoxic respiratory failure for which he was admitted to the PCU under the hospitalist service.   Hospital Course He was treated with dexamethasone and remdesivir but remained hypoxic requiring alternating trials of high flow nasal cannula and BiPAP for which pulmonology was consulted on 5/12.  Unfortunately, he did not tolerate prone positioning.  Despite his advanced age and several risk factors, he slowly but surely progressed from a pulmonary standpoint.  He was weaned off high flow oxygen 2 days ago and deemed stable for downgrade to MedSurg with telemetry at that time.  Since then he has continued to recover well, now requiring 6 L of oxygen with activity and 4 L at all other times.  He is anxious to be discharged home and appears medically stable to do so with home health care services, remote patient monitoring and outpatient pulmonology follow-up with PAL as prior to hospitalization.  Prior to discharge, all questions were answered and patient and his son expressed understanding, appreciation and agreement with the discharge plan at this time.   Treatments: IV hydration, analgesia: acetaminophen, cardiac meds: metoprolol, furosemide and aldactone, anticoagulation: eliquis, steroids: dexamethasone, respiratory therapy: O2 and remdesivir
Patient stated that her arm was very sore (more so than other flu shots she has had in the past). She said her arm feels hard where she was given the injection and that her arm was red around the injection site and had become more red since yesterday.
Finger nail size welts/rash on both thighs and forearms. appears during night and was itchy. Applied hydrocortisone cream at night and in morning.  Took 1 Benadryl after about 14 hours after onset. Mostly disappeared by 3 PM
This spontaneous report as received from a physician, via a company representative, refers to an unspecified number of patients. The physician reported that the number of patients was "in the teens". No demographics or information on their medical history, concurrent conditions or concomitant drugs were provided. On unknown dates the patients were vaccinated with doses of ZOSTAVAX, 0.65 ml, subcutaneously (sites of administration, lot# and expiration dates not reported). On unknown dates the patients developed shingles at unspecified time post vaccination. The patient sought medical attention via contacting the physician. Reportedly the patients were not treated. The outcome of shingles was unknown. Relatedness between use of ZOSTAVAX and the adverse event was not reported. Additional information is not expected, as there was no consent to contact the reporting physician.
Rash within 20 min of vaccine administration.  Benadryl prescription rash resolved
First dose / December 19th 2019 / second dose / not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th December 2019, from batch number 5552S with expiry date 26th February 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The healthcare professional was not sure about the lot number provided. The reporter consented to follow up.
Hepatitis c 0.9 positive; Herpes or shingles on groin; Extreme fatigue; Fever; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 24Mar2021 13:30 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient experienced Hepatitis c 0.9 positive, Herpes or shingles on groin, extreme fatigue, and fever on 11Apr2021. The patient underwent lab tests and procedures which included nasal swab: negative (covid tested post vaccination) on 15Apr2021 and Hepatitis C 0.9 positive on 11Apr2021. Therapeutic measures were taken as a result of the events which included Valtrex, cough syrup, antibiotics as treatment. The patient received the second dose of BNT162B2, administered in arm right on 14Apr2021 08:00. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient reported: Afternoon of 25 Jan 08-Fatigue, thought he was starting to be sick.  Evening of 25 Jan 08-Fever of 102 degrees, chills, RT upper arm pain 8/10 and severe headache.  Took Advil.  Had trouble sleeping that night.  26 Jan 08-RT upper arm warm with pain 8/10, 27 Jan 08-RT arm pain 4/10, neck pain 8/10, RT upper arm muscle twitching. Took Motrin, 28 Jan 08-RT upper arm slightly warm with pain of 2/10.
Myalgia, Fever, noticed sore arm this AM (1/6/21) then myalgias and fever this afternoon to 101.1, now 100.6 and tingling feeling all over
within 24 hours of vaccine developed rash on face, neck, chest,sides, arms and back of knees with itching. Saw PCP and unsure about receiving 2nd dose of vaccine. Went to work on 1/13. given a prescription for benadryl to premedicate prior to 2nd dose and also prednisolone if benadryl had little or no benefit.
Large cellulitis left thigh extending up into femoral area. Hot, tender, erythemic.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site discoloration and allergic reaction. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the injection site discoloration was recovering/resolving and the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site discoloration and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in the left arm approximately one week, before the date of reporting. The patient described that the SHINGRIX vaccine hurt when it was injected. He reported that within a day or so, he developed swelling and a large black and blue mark at the injection site. The swelling resolved within approximately three days. The black and blue mark was resolving. At the time of reporting, the outer edges of the mark were turning yellow and purple and the center was still black and blue although he felt everything was starting to fade. The patient's pharmacist told him that this was an allergic reaction and he should not receive the 2nd dose of SHINGRIX. The patient consented to be followed up. The patient gave permission for his physician to be contacted.
Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) on 23Feb2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriatic arthritis and hidradenitis suppurativa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included spironolactone (ALDACTONE) and women's multivitamin from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 23Feb2021 at 23:30 the patient experienced "same as generally expected," arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
itching sensation in his right hand; allergic reactions from the vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (reporter's father) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the Pfizer COVID-19 vaccine on Tuesday, 26Jan2021, and later that evening, his father experienced an adverse reaction that was described as an itching sensation in his right hand. The reporter knows that itchiness in the palms and feet are allergic reactions from the vaccine. His father had the injection on right arm. It lasted until 27Jan2021. The reporter asked if there is any reason to be concerned. Outcome of events recovered on 27Jan2021. Events assessed as non-serious.   Information on the lot/batch number has been requested.
UVEITIS/IRITIS; SORE ARM; TIRED; This spontaneous report was received from a 58-year-old, White, not Hispanic/Latino female patient. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered at approximately 10:00 on left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  After vaccination, the patient waited to 30 minutes and nothing happened. On 06-MAR-2021, the patient was tired and her arm was a little sore. On 08-MAR-2021, the patient recovered from the arm soreness and tiredness and was fine. On 22-MAR-2021, the patient woke up with blood in the left eye, her vision was deteriorating and had foggy vision. The patient visited an ophthalmologist 3 times after which she started treatment with prednisone acetate, Cyclogyl (cyclopentolate hydrochloride), and Prolensa (bromfenac sodium) (dates unspecified). Later, on 05-APR-2021, the patient went to the retinal specialist who was unsure when the patient's vision would return and thought the diagnosis was uveitis/iritis. The patient's doctor thought that the patient got the shot and then her immune system kicked and was fighting the shot or the coronavirus disease (COVID-19). The patient was tested negative for COVID-19 two times and her and her white blood cell (WBC) count was "through the roof" (result unspecified) (test dates unspecified). It was reported that the patient would be seeing a specialist regarding the diagnosis of uveitis/iritis on 25-JUN-2021 The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and tired on 08-MAR-2021, and had not recovered from uveitis/iritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210507327-covid-19 vaccine ad26.cov2.-Uveitis. This event(s) is considered unassessable. 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).
This spontaneous case report was received from medical assistant (PVX2018-1149) on 19-Apr-2017. The report describes a male consumer who "consumed expired VAXCHORA". The consumer was receiving VAXCHORA (lot number: 7000002; expiry date: Feb 2018) for cholera vaccine. It was reported that a medical assistant gave an expired pack of VAXCHORA to the consumer and the consumer took it on the same day (19-Apr-2018). The action taken with VAXCHORA with respect to the event "consumed expired VAXCHORA" was not applicable. The clinical outcome of the event "consumed expired VAXCHORA" was unknown. The causality of the event "consumed expired VAXCHORA" was considered as not applicable. Sender's Comments: The causality of the event "consumed expired VAXCHORA" was considered as not applicable.
Patient said  that she had a sunburn like spot covering the whole left deltoid starting 3-4 days after her first shot. She said there was no pain, swelling, or bumps. She said it lasted for 3 weeks and she did not take anything to help with rash.
EvER sIncE GETTING VACCINE SHE HAS HAD IRREGULAR AND HEAVIER PERIODS
MONOVALENT COVID VACCINE GIVEN AS A BOOSTER.  RECEIVED EMAIL TO DISCONTINUE USE OF MONOVALENT VACCINES AS BOOSTERS ON 09/01/2022 @ 3:42 PM.  VACCINE GIVEN AT 2:42 PM.  NO OTHER ADVERSE REACTION KNOWN.
This spontaneous report as received from a nurse refers to a 6 months 13 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Fingers and feet (both top and bottom of feet and all toes) covered in red itchy bumpy rash. Large itchy bumpy rash on front of right thigh, about 8" x 4". Headache. Tiredness. No rash at site of injection.