chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received pediatric dose (orange cap) of covid-19 Pfizer vaccine instead of the adult (purple cap)  dose. The pediatric vaccine was also not diluted prior to administration. In addition 0.25mL was give instead of 0.3mL.  The patient had no adverse reaction or symptoms due to the dosing error.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist and RN concerning a 65 year old retired white female with no known drug allergies and degenerative joint disease of the back who in August 2003, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 6456247/1171M). It was reported that on 08/28/03, the pt complained of redness at the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. The pharmacist also reported that another pt developed shortness of breath, a flushed face, arm swelling, warmness and cellulitis after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent from Lot # 645247/1171M (WAES # 0309USA00493).  Additional information is not expected.
reports having joint pain still in R shoulder, starting following flu vaccine. has been taking IBU and icing shoulder
On day 3 there was slight swelling, tenderness and heat at injection site.  On the fourth  and subsequent days there has been a red rash. It is about 2+ inches wide and 3+inches long. Still quite red and tender to touch. Muscle underneath the injection site is still tender. It has been eight days since the injection. I also experienced some lethargy for the first two or three days.
pt recv vax 16DEC97 & 9MAR98 lab eval revealed lack of response;one additional pt was reported w/same exp p/vax;
pt recv vax 11 or 12MAY96 & 13MAY96 pt exp gen rash w/10 vesicles on face;
Extreme pain at site of the Fluzone Intradermal injection. Pain in muscle did not go away. It got worse over time and continues to get worse. Dr recommended ice and Advil which did not work. He then recommended an Orthopedic which after 4 months did not help. The Orthopedic recommended a neurologist who I am currently seeing. I have extreme pain in the bicep muscle most of the time with sharp stabbing pain in the bicep muscle when I reach backwards.
After taking a three hour nap, we woke her and she had a fever of 102.7F and was throwing up. Treated with Over the counter medication.  Two days later fever was gone but broke out in rash all over her body for two days.
Received vaccine 9/04/2010 at approximately 3:00 pm.  The following day he was doing yard work at home at the end of the day when he noted what he thought were hives on his upper arms and trunk area and some bruising on his legs.  During the night, he awoke with what he describes as a blister inside his mouth.  He ruptured this and it continued to spread and bleed throughout the night.  The following day (9/06/2010) he awoke with some ecchymosis on his face.  He also stated that when brushing his teeth that morning he noted that his buccal membrane was sloughing off as well as bleeding.  He presented to the ED where he was found to have a platelet count of 3,000 with a normal hemoglobin and white count.  He denies any bleeding from the nose, GI tract, urine.  No headaches, cough, SOB, bone pain.  Treatment:  Rho (D) immune globulin 1400 mcg IV, immune globulin gamma, dexamethasone 40 mg IV
This spontaneous report as received from a pharmacist refers to an approximately 80 years old male patient. On 07-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # H016295, Expiry date: 02-NOV-2013, 0.5 ml, intramuscular. The pharmacist reported that the patient received an expired dose of PNEUMOVAX23. No adverse effects were reported. Additional information is not expected.
This is an instance of COVID-19 breakthrough disease after which a death occurred.   The individual was vaccinated with the Pfizer product on 02/19/2021 and 03/12/2021.   They became symptomatic for COVID-19 disease on 08/11/2021 and tested positive via both antigen and PCR on the same day. They were admitted to the hospital on 08/16/2021 and experienced complications of pneumonia and renal failure. They remained hospitalized until their death on 08/19/2021.
tested positive for Sars-COV-2; tested positive for Sars-COV-2; Felt terrible and hardly out of bed; Felt terrible and hardly out of bed; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 29Jan2021 08:00 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration, administered in arm on 08Jan2021 08:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Age at vaccination was 79-year-old. The patient medical history was none. Family medical history relevant to the events was none. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTEREEN/HYDROCHLOORTHIAZIDE) taken for blood pressure measurement; vitamin B12; ascorbic acid (VITAMIN C); colecalciferol (VITAMIN D 3); biotin. Prior Vaccinations (within 4 weeks) included: She got a flu shot, but she did not know the date of when she received it last. She did not remember whenever she got her shingles shot. It was two shots, that she got from Pharmacy. She thought she got the second shingles shot in Mar2021. She thought she got the first shingles shot six months before that (2020). Lot number and expiration date were unknown for both doses of the shingles shot. The patient experienced that she tested positive for Sars-COV-2 on 11Jul2021. She stated her symptoms consist of respiratory, a bad cold, chills. She felt terrible and hardly out of bed. She did not have fever. Coughing, cold. She walked three miles a day. The patient underwent lab tests and procedures which included Rapid covid test: negative on 11Jul2021, Send off covid test: positive on 11Jul2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
On 4/30/21 I experienced chest pain, began having a lot of soreness in my arms and legs that did not resolve. I went to my physician 14 days into my adverse event. My O2 levels were at 76%, I was unable to move or breathe easily, and after testing negative for COVID 19 it was determined my symptoms were a reaction to the vaccine. I was prescribed prednisone, they did my bloodwork which showed creatinine was extremely high, which resulted in my being diagnose with myositis which my doctor determined to be a rare reaction to the COVID 19 Pfizer vaccine. It took 3 weeks for the symptoms to abate. I'm in physical therapy to restore muscle strength from that adverse event.
Patient is 4 years old and but given Pfizer COVID vaccine dose for 5-11year old (10mcg dose)
Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot #, dose and route unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Vomiting X 6, fever 101 degrees, chills, severe headache, body ache lasting 12 hours.
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 16-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 05-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
SICK 3-27-22 WITH WEAKNESS AND VOMITING X1, FELL BY BEDSIDE. AMBULANCE TO THE ER.  TESTED + FOR COVID-19 BY PCR 3-27-22  ADMITTED ON 3-27-22 DISCHARGED 4-1-22
Information has been received from a nurse in a physician's office concerning a 4-5 years old male who was vaccinated with a dose of Proquad. Subsequently two days after the vaccination the patient experienced lesions. It was unknown how many lesions the patient had. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
4 year old male received booster MMR at 11:30AM 3/27/08.  Within 10 minutes he had multiple episodes of vomiting, followed by generalized erythema, urticarial hives and pruritis.  Thereafter, he developed chills.  He was given Antihistamine with no improvement followed 45 minutes later by doctor.  He improved within 1 hour.
The day after I received the vaccine, I felt weak, sweating, chills, and low grade fever. I was so weak that I had to have help walking and moving around all day Sunday. I needed help being fed. I felt dizzy. Monday I was started to feel better.   I spoke with my primary care team and they told me to call VAERS and make a report.
severe pain in her left shoulder; Arm discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of LIMB DISCOMFORT (Arm discomfort) and ARTHRALGIA (severe pain in her left shoulder) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort). On 10-Feb-2021, the patient experienced ARTHRALGIA (severe pain in her left shoulder). On 29-Jan-2021, LIMB DISCOMFORT (Arm discomfort) outcome was unknown. At the time of the report, ARTHRALGIA (severe pain in her left shoulder) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: normal (normal) normal.     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.
pt recvd vax 16APR93 & then on 17APR93 c/o tenderness, sl erythema, a white papular rash in middle of inject site & nausea; 19APR93 rash is spreading, has chills, hot flashes, seen in office; react @ site is not a case of cellulitis;
Pt fainted for approx 1-2 minutes. Afterwards vomited. C/O nausea and vertigo.
Patient returned to clinic two days post vaccination with a red, slightly swollen area to Right upper arm.  Area is circular in shape and the size of a half dollar.  Patient withdraws arm upon palpation to area.  Instructed to administer Tylenol for discomfort.
MODERNA ADULT DOSE WAS GIVEN TO PATIENT UNDER 18 YEARS OLD
This is a vaccination administration error.  Patient received her 2nd Covid vaccine too soon.  Her 1st dose was 5/4/21 and her 2nd dose was 5/18/21, which is 2 weeks apart.  Moderna should be give 4 weeks apart.
Employee received vaccine dose and within 10 minutes developed facial flushing, felt slightly SOB, felt lip tightness, felt like voice was hoarse, with mild lip swelling noted-- reports history of nut allergies/ATBs-- no known history of allergic reaction to a vaccine previously. Employee was brought to ED and received benadryl, epinephrine, decadron, IV fluids in ED and was discharged home.
Fever on set 36 hours post shot; headache; chills; sinus pressure; General soreness across body; Grogginess; This is a spontaneous report received from a contactable consumer (Patient) via  Reference No. A 26 year old male reported for himself that he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: ER8727; expiry date: unknown) via an unspecified route of administration in the left arm on 25-MAR-2021 at 4:00 as a single dose for COVID-19 immnunisation. The patient did not had any relevant medical history. Concomitant medications were not reported. On 27Mar2021, the patient experienced Fever on set 36 hours post shot, headache, chills, sinus pressure, general soreness across body. By 5th day, fever, chills, and soreness have subsided, all that remains is the headaches and grogginess. The patient did not have allergies to medications, food, or other products. The patient did not receive any treatment for the event. The patient did not receive any vaccine prior to vaccination. The outcome for the events headache, chills, para nasal discomfort were captured as recovering and the outcome for pyrexia and grogginess was captured as not recovered.   Follow up closed. Information of lot/batch is available.
Rash on back, close to left neck, and a little to the right; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back, close to left neck, and a little to the right) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history provided).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced RASH (Rash on back, close to left neck, and a little to the right). At the time of the report, RASH (Rash on back, close to left neck, and a little to the right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114500 (Patient Link).
Received MMR and Varivax on 1/30/09. Came to the office on 2/3/09 with a flat pinkish rash on chest and legs with a temperature of 103.8.
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 32-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 at 13:00 as dose 3 (booster), single (Lot number: EW0186) at the age of 32 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 known allergies. 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 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound, positive after negative; Positive, notes: Rebound, positive after negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient not received other medication in 2 weeks. The patient took anti-viral product Paxlovid for COVID 19 Treatment starting from 30Jul2022 to 04Aug2022.  No follow-up attempts are possible. No further information is expected.
11/17/2021 - Moderna booster 11/21/2021 - Rapid antigen test - Negative 11/23/2021 - PCR Covid test - Negative 12/02/2021 - ER visit  - Shortness of breath. Dr: maybe Covid/vaccine related? 12/07/2021 - Dr - Covid capsid antibody test negative. Still slightly elevated protein in urine. 12/12/2021 - continued low SpO2, weight loss, shortness of breath, tired 12/14/2021 - Dr - CT-angiography scheduled 1/4/2022 02/22/2022 - SpO2 up a couple percent to 95%. Poor exercise tolerance. 02/23/2022 - Dr - CT coronary arteries ok, but overread shows scarring in lungs and fibrosis. 03/01/2022 - Dr - Pulmonology consult. Orders lung CT. Scheduled for 3/16 03/26/2022 - Dr - Lung CT confirms Pulmonary Fibrosis. Blood work ordered. Pending results
Myalgia, Arthralgia, Numbness in back. "Felt like someone gave me an epideral" Narrative:
Started to get extreme fatigue. To the point where I just wanted to lay down all day. Shortness of breath. Muscle cramping and aching in joints. Still current at this point. Both arms, both legs.
Pt complained of severe muscle spasms in her back and difficulty walking. Pt was given a wheelchair to sit in and was continuously observed by a pharmacist on duty. After about 15 minutes pharmacist asked pt how they were feeling and they said they thought they were okay now. Pt attempted to stand and was successful. Pt stated that they thought they were fine and walked away.
little bit of rash on her legs and a tiny bit on her arms; slight burning sensation on her left breast; left shoulder pain; tired; Soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9265), via an unspecified route of administration in the left arm on 05Feb2021 at 10:00 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history included blood pressure abnormal and dermatitis from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine besilate, valsartan (EXFORGE) taken for blood pressure abnormal from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient clarified that she received the first dose of the Pfizer COVID 19 vaccine on 05Feb2021 at 10:00AM in the left arm. That day she noticed soreness in her arm. Mentioned she took two Tylenol and the soreness went away. The second day (06Feb2021) she got really tired and noticed a slight burning sensation on her left breast, also reported left shoulder pain. A week after the first dose (on 11Feb2021) she had a little bit of rash on her legs and a tiny bit on her arms, but it was not noticeable, it did not itch; and it went away. The events did not result in emergency or physician room visit. Therapeutic measures were taken as result of soreness in her arm. The clinical outcome for the events was recovered for little bit of rash on her legs and a tiny bit on her arms on an unspecified date in 2021 and soreness in her arm on 05Feb2021, slight burning sensation on her left breast and left shoulder pain on 06Feb2021 and tired on 08Feb2021.  No follow-up attempts are possible. No further information is expected.
Early in day after vaccines child's eyes were droopy, mother put child in bed, child's eyes slightly open but not responding as normal - ie no smiles when grandmother walked in after mother left room grandmother saw baby trembling for approximately 2-3 minutes.
Mother states post vax, patient woke up with a puffy face that was red and warm to touch. The mother treated this with Tylenol. Mother also states the patient's lower arms and lower legs are blotchy and warm to touch. Child is irritable and scratching face. Mother denies any new foods or previous reactions. Patient referred to Dr.
body aches; fever of 99; chills treated with Tylenol and bed rest resolved itself within 16 hours
This spontaneous report as received from a registered nurse refers to a 12 years old female patient who on 04-SEP-2012, was vaccinated IM in the upper right deltoid with the first 0.5 ml dose of GARDASIL (lot # 0555AE, exp 14-DEC-2012). No concomitant medications were reported. It was reported that the patient was vaccinated with improperly stored GARDASIL. No adverse effects were reported at this time. Additional information has been requested.
08/29/2021 I went to my pre-op for upcoming surgery. She did an EKG. Ordered an Echocardiogram.  My doctor but me on a blood thinner and a Bata blocker.
Got Cold/Flu like symptoms 3 month after shot.  Approx 2 weeks of slight fatigue and sinus issues, Prolonged cough also. 14 days does if AntiBiotics fixed issue, Infected spouse, also tested negative COVID. All better now.
No additional AE; Nurse reported AE related to improperly stored and administered PROQUAD. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/exp)--PROQUAD X002292 6/21/2024        ?    Temperature--6.93 F        ?    Time frame--1 H; This spontaneous report has been received form a health care professional (Licensed Practical Nurse (LPN)), referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 12-JUL-2023, the patient was vaccinated with 1 dose of improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection, (strength, exact dose, frequency, route of administration, and anatomical injection site were not provided; lot # X002292 was verified to be a valid lot number with a reported and validated expiration date on 21-JUL-2024) for prophylaxis (product storage error).  Administered dose of vaccine experienced temperature excursion of 6.93 degrees Fahrenheit for 1 hour 30 minutes and 0 seconds. There were previous temperature excursions of 52.01 degrees Fahrenheit for 2 hours 6 minutes and 0 seconds and 9.74 degrees Fahrenheit for 4 hours 34 minutes and 0 seconds. No additional adverse event was reported.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial was initially stored in the refrigerator on 04-Nov-2021. No temperature excursions happened.  No treatment medication was reported by reporter
pt recv vax 9SEP97 & 11SEP97 pt was unable to stand on legs, exp arthralgia & limped;presented to MD who dx transient synovitis of the lt hip;limp resolved; then recurred 1wk later;