chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that an 8 week old male pt received IPOL, and ACTHib both administered on 10/1/02. Routes and sites of administration were not reported. The next day, the pt experienced pyrexia. The pt was hospitalized, but no specific info was provided. The pt reportedly did recover from this event. From additional info received on 12/15/03 through telephone contact with a health care professional, it was reported that the pt was seen in the office the next day in office, where he showed a temp by ear of 99.1 deg F. The mother stated that the infant was running a temp of 100.6 axillary that morning. He was admitted to the hospital on 10/2/02. The pt's physical examination on admission revealed a temp of 100.7 deg F, pulse 168 and respiratory rate of 50. He was alert and smiling. The anterior fontanelle was flat and soft and the tympanic membranes were normal bilaterally. Oropharynx was not red and the nares were clear and supple. The pt's lungs were clear. The heart was a regular rate and rhythm without murmur. Abdomen was soft, no hepatosplenomegaly. There was no evidence of rash. The pt was not on antibiotics and was discharged on 10/3/02. The discharge summary states that the fever is secondary to the immunizations. No other info was reported. 19/Jan/2004: Administrative case closure. No further information is anticipated, this case is considered closed.
muscle soreness after the first dose/left arm muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Mar2021 (Lot number: ER8730, Expiration Date: Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Verbatim: she has had high blood pressure for about 10 years. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 29Mar2021, outcome "recovered" (2021), described as "muscle soreness after the first dose"/left arm muscle pain. Therapeutic measures were taken as a result of myalgia.  Additional Information: Patient reported that with her first COVID-19 Vaccine shot she had the same kind of left arm muscle pain for a day and a half, and the muscle pain went away on its own, the left arm muscle pain didn't go into her left shoulder. Additional Vaccines was not Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any AE(s) require a visit to Emergency Room and Physician Office.  No follow-up attempts are possible. No further information is expected.
Vesicle 8X8mm, erythema 30mm X 30mm with outside light erythema 75mm X 75mm with slight rash at edges, hard tissue and bump from site to L axilla 153mm X 150mm. Pt C/O itching all over, headache, muscle ache, fatigue, sore lymph nodes ??, night sweats. Referred to infections disorder MD.
Patient blacked out for 4-5 seconds after administration of 2nd vaccination at 8:05am. He has high anxiety to needles and held his breath during immunization despite being reminded by father and Medical Assistant to keep breathing. He was in a sitting position leaning on father when incident occurred. We called his name and he began talking to us. We laid him down for 15 min post incident and gave him water and took BP. Pt left happy and alert. Vitals were normal.
My menstrual cycle was dark and clotted- not normal for me.  I?ve heard of this reaction before so I?m  documenting it here for your side effects.
On 2/13/99, two weeks post vax, with the third dose, the pt experienced soreness, redness, and slight itching near the injection site. Shortly thereafter, an indentation appeared approximately 2.5 inches below the injection site on her upper right arm. The indentation gradually manifested as muscular atrophy. The pt was seen by a dermatologist and a biopsy was performed. The was dx with morphea scarring of the tissue and therapy with doxycycline and calcipotreine topical ointment was initiated.The MD was not certain of the cause of the incident, and was not sure if the incident was vaccine related. At the time of the report, the pt had not recovered from the experience. No further information is available.
I woke up on Wednesday and could not hear out of my left ear. I had fluid in my ear and also I was dizzy.
Night sweats and joint pain. Rash on both arms.   Tx with over the counter ibuprofen and antihistamine.   Sx lessening as of 0647 hours.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, drug reactions/allergies, past drugs and concomitant medications were unknown. On 05-MAR-2019 the patient was vaccinated with expired dose of PNEUMOVAX 23 (dose and frequency were unknown) (lot # N013541; expiry date: 23-JAN-2019) intramuscular for prophylaxis. No known adverse effects (no adverse event).
Initial report received from a healthcare professional on 26 September 2013. A 31-years-old female patient had received an intradermal first dose of FLUZONE ID (Lot number: UT4719AA) on left deltoid on 20 September 2013. The patient was pregnant at the time of vaccination. Date of last menstrual period was 19 Jun 2013 and the estimated date of delivery was reported as 26 March 2014. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g. : alcohol, tobacco or recreational drugs) was not reported. Treatment for infertility and concomitant medications were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 07 July 2014: The patient was 32-years-old at the time of pregnancy (initially reported as 31-year-old) with no relevant health issues. The patient had no family history of congenital anomaly and the patient did not receive any treatment for infertility. The patient had two previous pregnancies with no live birth with congenital abnormalities, no pre-term birth, elective abortion, spontaneous abortion prior to 20 weeks gestation and no fetal deaths. The patient did not experience any relevant non-serious adverse event. The patient's health during pregnancy and specific risk factors were not available. OB panel was done and everything from HIV to gonorrhea and chlamydia was negative. The patient had no complications during pregnancy. The patient delivered two babies with no complications of labor or delivery. The child's gender, APGAR score, delivery mode was not reported. Follow up received from healthcare professional on 28 Jul 2014: The patient received 0.5 ml dose of FLUZONE ID. The patient delivered two babies at 38 weeks of gestation with no congenital abnormality. One of the baby was male who weighed 5.5 and the female baby weighed 5.3 (units not reported).
sick for 2 days After the first and second doses; chills After the first and second doses; feverish After the first and second doses; body ache After the first and second doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days After the first and second doses), CHILLS (chills After the first and second doses), PYREXIA (feverish After the first and second doses) and MYALGIA (body ache After the first and second doses) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 2 days After the first and second doses), CHILLS (chills After the first and second doses), PYREXIA (feverish After the first and second doses) and MYALGIA (body ache After the first and second doses). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick for 2 days After the first and second doses) had resolved and CHILLS (chills After the first and second doses), PYREXIA (feverish After the first and second doses) and MYALGIA (body ache After the first and second doses) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-402894, MOD-2021-402914 (Patient Link).
Client and mother lied about client's age reporting they were 12. Client was 11 so dose was given while client was ineligible.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021 at 11:08 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 30-Sep-2021 at 11:08 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Sep-2021 at 11:08 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  Reporter stated that the vaccine facility members placed the vaccines into the freezer the same day they were delivered. They only removed a vial from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.  Vaccine facility members did not have a vial stay in the refrigerator for more than a week, since all unused vials were utilized for the patients. Then only removed enough vials to provide vaccines for those scheduled for that day and provided scheduled vaccines, no walk-ins.
2JUL91 pt devel fever, swollen glands, h/a, malaise, achy joints;
When patient mom made appointment she was asked if child was over 18.  Mom said yes and that she wanted Moderna vaccine.  Mom confirmed patient was 18 through message and again said child was 18 and she preferred Moderna.  After giving the shot and checking Show me vax child's birth date is 11/28/2004 and was not 18.  Called Mom at home to explain the med error.  Explained I took responsibility for not checking a third time about child's age.  Mom said " oh I did tell you she was 18 because I didn't think it would matter." " I wanted her to have Moderna because I had Moderna. " I explained it is a med error on my part as she should have received Pfizer and would have to receive Pfizer for her 2nd dose.  Mom states, " She might just wait a while and see if Moderna is approved for 17 year olds in the next few months before taking Pfizer as she really wants Moderna.  Mom reports no adverse reaction in the child.  Explained for her to call me if any side effects occur.
Red welt itchy rash at injection site; Red welt itchy rash at injection site; Red welt itchy rash at injection site; Red welt itchy rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red welt itchy rash at injection site), VACCINATION SITE URTICARIA (Red welt itchy rash at injection site), VACCINATION SITE PRURITUS (Red welt itchy rash at injection site) and VACCINATION SITE RASH (Red welt itchy rash at injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESTRADIOL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red welt itchy rash at injection site), VACCINATION SITE URTICARIA (Red welt itchy rash at injection site), VACCINATION SITE PRURITUS (Red welt itchy rash at injection site) and VACCINATION SITE RASH (Red welt itchy rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red welt itchy rash at injection site), VACCINATION SITE URTICARIA (Red welt itchy rash at injection site), VACCINATION SITE PRURITUS (Red welt itchy rash at injection site) and VACCINATION SITE RASH (Red welt itchy rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report from a contactable pharmacist. A female patient aged 17-18 years old received TRUMENBA (lot number and expiration date not reported) via an unspecified route of administration, on an unspecified date, single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, within 1.5 hours of injection, the patient developed headache. Outcome of the event was unknown. Information on the batch number has been requested.
Deep  joint pain that travels the body requiring almost one week to resolve. Additionally, next menstrual cycle began very early, at day 14, with very notable pelvic cramping and greater bleeding/tissue excretion.
This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender who on 13-NOV-2013 was vaccinated with an expired dose of GARDASIL (lot # 668261/1397AA, Exp date 09-APR-2013) (route and dose not provided). No adverse effects were reported. Additional information has been requested.
Information has been received from a licensed practical nurse concerning 4 females (ages not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date were vaccinated with Gardasil vaccine (lot# unknown). There was no concomitant medication. The nurse reported that 4 patients received Gardasil vaccine due to a nursing error. Each patient received .25 mL dose of Gardasil given subcutaneously near the wrist on 17-OCT-2007. The person who administered the doses split a 0.5mL dose of Gardasil vaccine equally among the 4 patients. They were supposed to receive a tuberculin test. The day after administration, each patient developed an injection site reaction right above the wrist. The injection site was red, hard to the touch and painful. One of these patient was seen by the nurse and the other 3 patients called her office. Medical attention was sought. At the time of reporting the patient had not recovered. Follow-up information was received. A 25 year old white female patient who on 10-OCT-2007 was vaccinated with Gardasil vaccine (lot# 658285/1263U). On 18-OCT-2007, the patient was given a 1/4 dose of Gardasil vaccine by mistake. The patient was to receive a tuberculin test instead. On an unspecified date one week later the patient recovered. Follow-up information was received from a licensed practical nurse. The LPN reported that one vial of PPD was delivered to the office one day. On the following day one vial of Gardasil vaccine was delivered to the same office. The medical assistant who was located in the office, in error drew the medication that would be used for the PPD test from the Gardasil vial instead of the prescribed PPD vial. The LPN stated that the error was not due to product confusion. As a result of this error, the Gardasil vaccination would only be administered at another office and not in the current office to assure that this error would not occur again. The patient that received Gardasil vaccine was treated with cold/warm compresses and recovered. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; Dose 1 and 2= Moderna /Dose 3= Pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Jun2023 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Oct2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Nov2022 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jun2023 at 08:00, outcome "unknown", described as "Dose 1 and 2= Moderna /Dose 3= Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: Based on the available information and the known product safety profile, a causal relationship between the reported events interchange of vaccine products, drug effective, COVID-19 and BNT162b2, BNT162b2 omi ba.4-5 is considered possible.
I contracted COVID-19 with symptoms of fatigue, congestion, headache, diarrhea, vomiting, abdominal pain, insomnia, body aches, brain fog, and fatigue. I was prescribed PAXLOVID on 11/22/22. I was ill for 17 to 20 days before my symptoms began to resolve. I am still experiencing lingering fatigue and insomnia. I am not fully recovered yet.
Irritability, not just mild annoyance but full on wanting to punch a wall anger. I can only explain it as the same anger I feel while hypomanic. It lasted all afternoon and I was able to resolve it by going to sleep.
Pt said she ran fever and had nausea and vomiting and then developed a rash on right arm.
One day after administration of the INFLUENZA vaccine in the left anterior thigh the patient experienced swelling of the leg, a red hive like rash that covered the leg. There was no itching or tenderness. BENADRYL was given by parents and this reduced the erythema. Leg was still swollen at office visit.
09APR91 pt vax; 11APR91 exp rash on neck; Tx w/Benadryl;
Changes in menstrual cycle while taking hormonal birth control (nuvaring). Been using nuvaring for approx 1 year. My August period was 4-5 days early (post vaccine 1). My September period was a week late (post vaccine 2).
Sore arm at site of the injection, extreme nausea, loss of appetite, feeling feverish, coughing, headache, sore throat, nasal congestion, achy, fatigue, and generally not feeling well for  5 days so far.
No adverse reaction.  Patient was administered the monvalent vaccine instead of the bivalent vaccine that was ordered.  Pharmacist dispensed the wrong vaccine.
pt recv vax 8MAY96 630PM & 945PM mom went to bath pt & found rash on back & trunk into diaper area;pt was agitated trying to take similac w/iron but retained feeding;pt had similar rxn w/Hep b vax @ birth;
Bells Palsy. Symptoms began on 4/21/2021 with alteration of taste.  On 4/22/21, tingling on right side of the face began in the morning. At 2pm unable to talk, face drooping and eye tearing.  Went to ER and testing ruled out stroke. Admitted for further observation and testing. Discharged on 4/23 with Prednisone 60mg x 6 days and Valtrex x 6 days
Myalgia, Fever, Chills Narrative:  Patient with prior COVID positive diagnosis. Experienced body  aches, chills and fever up to 102 F the day after vaccination. Treated with  acetaminophen bid. Symptoms interfered with ability to work, but resolved after 1 day.
The patient was administered an improperly stored dose of  PEDVAXHIB; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 10-OCT-2019, the patient received improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # R036178, expiration date reported as 19-OCT-2021, but upon internal validation established as 09-OCT-2021, strength, dose and route were unknown) for prophylaxis. The vaccine was exposed to 46.5 degrees Fahrenheit for 15 minutes. No previous excursion was reported. The data logger was not involved. No adverse effects were reported.
This spontaneous report was received from a physician refers to a patient of unknown age who on an known date, was vaccinated with a dose of VARIVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that at unspecified time in the past after receiving VARIVAX the patient developed shingles. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient developed shingles after receiving VARIVAX (merck) was unknown for VARIVAX (Merck). Additional information has been requested.
pt arm lt swelled up & became warm to touch about 1-2hr p/vax;the pain went away in about 24hr & th4e swelling in 72hr;pt took DPH & APAP;
Caller reports no additional AE.; Caller states a dose was administered today, 3/15/2021 after the labeled expiry of 3/12/2021.; This spontaneous report was received from a registered nurse, referring to a 4-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not provided.   On 15-MAR-2021, the patient was vaccinated with an expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliter (mL), as prophylaxis (formulation, strength, vaccination scheme frequency, route of administration and anatomical site of vaccination were not provided; lot number 1660956, which has been verified to be valid, expiration date reported and validated as 12-MAR-2021). No additional adverse events were reported.
pt c/o itching @ site;lt arm became warm to touch, erythema to upper arm, swelling to the fingers;this occurred approx 5min p/vax;applied ice & administered DPH;sx subsided w/in 30min of initial episode;
Rash on arms; This is a spontaneous report from a contactable nurse (patient). A 39-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm, on 02Jan2021 at 10:30 (at the age of 39-years-old) at a single dose for COVID-19 immunisation. Medical history included hypertension and hypercholesterolemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included losartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient experienced rash on arms on 01Feb2021 at 06:00. The event was reported as non-serious. Therapeutic measures were taken as a result of the event, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of rash on arms was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.