chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Family stated that patient was tired and laid down instead of playing Friday night after getting the shot that morning (9/28/18). By Saturday (9/29/18) morning she started running a temperature of up to 100 and had a headache. Continued to run a fever on Sunday 9/30/18) and wasn't feeling well enough to go to school on Monday (10/1/18) morning and was taken into the local clinic with a fine red rash on her face and by the time she left the clinic had the rash from "head-to-toe". She was put on a MEDROL dose pack at the clinic which she started on Monday morning and instructed to take BENADRYL for the rash and itching. Ran a low-grade temperature on Monday in the 99 degree F area. By Monday evening after two doses of BENADRYL the rash was gone and she has been feeling fine since. Never had any respiratory issues.
Severe soreness under left arm; Soreness in the armpit; Rash on the back of the arm; Lymph nodes swelling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe soreness under left arm), AXILLARY PAIN (Soreness in the armpit), RASH (Rash on the back of the arm) and LYMPHADENOPATHY (Lymph nodes swelling) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Nov-2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe soreness under left arm), AXILLARY PAIN (Soreness in the armpit), RASH (Rash on the back of the arm) and LYMPHADENOPATHY (Lymph nodes swelling). At the time of the report, PAIN IN EXTREMITY (Severe soreness under left arm), AXILLARY PAIN (Soreness in the armpit), RASH (Rash on the back of the arm) and LYMPHADENOPATHY (Lymph nodes swelling) had not resolved.        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.   No relevant concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
High Fever (103), Headache, Coughing/Wheezing, Itchy all over, Achy, Legs hurting, Heart Pounding FAST, Highly Agitated. Went back to sleep at 5:30 am and Slept until 11am - got up with no appetite, Fever 102, Legs still hurting, tiredness.
Severe shoulder pain; complete inability to move the shoulder or any muscle in the left arm without EXTREME pain starting around 8pm (5-6 hours post injection.) Occasional numbness in pinky and ring finger. By mid morning the next day (14 hours post injection) I could move the arm but still with a good deal of pain and very limited range of motion. It is now 36 hours post injection and I cannot lift the arm to the side above 30 degrees without severe pain and I cannot reach behind me at all. I believe the nurse administered the shot into my shoulder joint, not the deltoid muscle. It was placed very high on the shoulder. I took a picture of the administration site for records at the request of medical clinic. They urged me to go to Urgent care, but I didn't want to incur the expense so I declined.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient with no known drug allergies who on 24-APR-2008 (also reported as 28-APR-2008) was vaccinated with the first 0.5 ml IM dose of GARDASIL. On 26-JUN-2008 the patient received the second 0.5 ml IM dose of GARDASIL. On 24-OCT-2008 the patient received the third 0.5 ml IM dose of GARDASIL (lot # 659439/1267U). Concomitant therapy included insulin and SYNTHROID. At the time of the third dose the patient reported she was pregnant and LMP was 06-OCT-2008. Lab diagnostics studies included ultrasound and bloodwork. Ultrasound showed that LMP was 06-AUG-2008. Estimated delivery date was 13-MAY-2009. Bloodwork for OB profile was performed with all results in normal limits. The patient sought unspecified medical attention. Follow up information has been received from a completed questionnaire by a physician. It was reported on the questionnaire that the patient with diabetes, hypothyroidism had no complication and no infections or illnesses during pregnancy. On 24-DEC-2008, 18-FEB-2009, 01-APR-2009, 15-APR-2009 and 29-APR-2009, the patient had ultrasounds which were normal. On 30-APR-2009 at 38 weeks from LMP, the patient underwent a cesarean section due to breech and had a normal female liveborn infant. There were no congenital anomalies. She was 9 lbs 2.2 oz weight, 21 inches long, apgar score was 9/9. Upon internal review, cesarean section due to breech was considered to be an other important medical event. Additional information is not expected.
Menactra 2 weeks ago, history of Eczema at 2 week mark increased in Eczema head to toe, skin dry, papular, scaly, rash, myalgia, and chills.
Thrombocytopenia - admitted to the hospital with platelets of 2, hematuria, petechial rash
This case was reported by a consumer (the subject's parent) and described the occurrence of seizure in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 7 August 2011 the subject received unspecified dose of ENGERIX B (details unknown). On an unspecified date in 2011, less than one month after vaccination with ENGERIX B, the subject experienced seizure and elevated liver enzymes. The consumer reported that the subject was born on 05 August 2011 and received ENGERIX B vaccine on 07 August 2011, and "since then" the subject had experienced seizures and elevated liver enzymes. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The consumer refused to provide any further information.
Flu like symptoms; Body ache; Fever; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to codeine.), Insomnia and Herpes infection. Concomitant products included VALACICLOVIR for Herpes infection, TRAZODONE for Insomnia.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 04-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.      Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: no new information
Mom is a Pediatric ER nurse. 6/7 baby started with fever and rash to face. Continued with fever, tmax 102.9 rectally, rash to face and spreading to torso. Rash bright red, large mostly flat spots. No conjunctivitis noted. Baby fussy and poor sleep 6/7-9. Baby still taking fair oral intake. Baby much improved, rash resolved, afebrile on 6/10 and 6/11. 6/12 baby started with fever and fussiness again. Tmax 102.9 again. GI upset, one episode of vomiting, 4 episodes of loose stools between 6/13-17. 6/15 started with fine, red, flat rash to entire torso. 6/16 same rash spread to face, upper arms, diaper area. 6/15 last day of fever. Rash appears minimally itchy. No rash or blisters to hands, feet or mouth observed. 6/14 observed very large lymph nodes to base of skull bilaterally. 6/17 Patient's pediatrician called to inform of possible vaccine reaction and appearing to have symptoms of rubella. Informed me that ?you can?t get measles or rubella from the vaccine.? Declined pediatrician visit due to baby taking liquids well, fevers resolved.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (route, dose, and lot # not provided). The vaccine "did" function as intended [considered meant the vaccine did not function as intended] and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a Medical Center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a pharmacist referring to 5 newborns (numbered 98, 99, 100, 101 and 102). Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time= 72 hours) that the temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 15-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
10 minutes following vaccine patient became confused, sweating, pale and dizzy, lasted 10-15 minutes and then resolved without treatment.
extreme pain, cannot drive or work, limited range of motion, shoulder pain, radiating pain from neck to fingertips
Severe debilitating headache, severe muscle pain , severe almost paralyzing body aches , chills for about 36 hours , slight nausea
Pfizer 3/10/21 and 4/7/21. Positive on 1/9/22
Case number PHEH2014US020975, is an initial spontaneous report from a health care professional received on 17 Oct 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 161208) intramuscularly on 16 Oct 2014. No adverse event was reported following this medication error.
Nauseau; Dizziness; Severe headache; Fever; Cold sweats; Bodyaches/ horrible pain; Burning urine; Fatigue; Anxiety; Off label use; Dose received : 3; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 29Sep2021 at 10:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan potassium (LOSARTIN), tamoxifen (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (B12), biotin (MANUFACTURER UNKNOWN), E and D; all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 11Feb2021 at 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 at 01:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient previously received tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Sep2021 at 03:30, the patient experienced nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine followed by fatigue and anxiety aftermath. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, dizziness, severe headache, fever, cold sweats, body aches, horrible pain, burning urine, fatigue and anxiety were resolved on an unknown date in 2021.
a child who only received one of the two dose series last year; Upon second medical examination of the case during internal review, a significant correction was performed on 11-Jul-2019 to update the case "non-case" to "valid case".  Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves child patient of unknown age who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that a child who only received one of the two dose series last year.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to missed dose.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.  Addendum: Upon second medical examination of the case during internal review, a significant correction was performed on 11-Jul-2019 to update the case "non-case" to "valid case".
On February 03, 2021 my arm started itching.  On February 04, 2021 my arm continued to itch with the appearance of three distinct circular areas of bumps (dime sized circles).  On February 05, 2021 I was awakened from my sleep due to my arm itching.  The previous distinct dime sized circles had merged into one large red papule (oval shaped 3 inches long by 2 inches wide).  I contacted Dermatology clinic for an appointment.  In the meantime I applied Hydrocortizone ointment to the area and took a benadryl tablet orally for the itching.  My doctors appointment is scheduled for 02/05/2021 at 10:30 AM.
Patient came in 12/18/18 stating she has arm soreness/stiffness that started about 7days post immunization. This pain has been consistent for 2 months with no improvement yet. No other symptoms notes by patient. Pain is localized to center up the upper arm (near the bottom of the deltoid muscle). She does not report pain near the top of the shoulder. Pt has not felt like the pain was significant enough to call the doctor yet.
Since the night of 7-7-14, experiencing fever (up to 103.5), chills, sweating excessively, nausea, headaches.
The following morning after receiving the vaccines, the patient's arm hurt and turned red for 3 days. The patient's temperature was 101F for 2 days and his whole body ached for 2 days. All symptoms were resolved after 3 days.
This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and age. On 19-FEB-2015, the patient was vaccinated with an improperly stored (Oka/Merck) VARICELLA (lot dose) dose 1, 0.5 ml, subcutaneously. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information is not expected.
FOUR YEAR OLD PRESENTS WITH MOTHER FOR VACCINATIONS. TRANSLATOR PRESENT IN ROOM WITH NURSE. NURSE REVIEWED WITH MOTHER THE VACCINATIONS NEEDED FOR SCHOOL. MOTHER ALSO REQUESTED AN INFLUENZA VACCINE. NURSE PULLED INFLUENZA VACCINE AND ADMINISTERED. WHEN NURSE WENT TO DOCUMENT VACCINES, NURSE REALIZED THAT IT WAS AN EXTRANEOUS DOSE. CLIENT HAD RECEIVED INFLUENZA VACCINE AT ANOTHER FACILITY ON 10/10/23. MOTHER WAS INFORMED OF THE ERROR. WHEN NURSE INQUIRED ABOUT OTHER DOSE, MOTHER STATES "OH YEAH".
no other AEs reported; medical assistant reporting adminitration of ROTATEQ to a patient 13 months of age; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender.  Information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 28-MAY-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose by oral route for prophylaxis (with lot number 1742461 and expiration date 17-NOV-2021, which were verified to be valid; vaccination scheme frequency was not reported) (product administered to patient of inappropriate age). No other adverse events were reported.
Immediately after the Hep A and varicella vaccine was given, pt developed redness with slight warmth around 1/2 of upper right thigh area, extending toward the back of thigh. Approx. 3 minutes later, one urticarial lesion appeared near the varicella injection site. He had a similar reaction on the left thigh, though not as red and no lesion. Pt remained stable without resp. issues, no emesis. Mom denied known allergies. He was monitored in the clinic for approx. 30 minutes and the redness improved.
2nd dose shot was given at 10:50am on Sat. 3/6/21 , that evening my left arm started hurting, during the night it woke me up with throbbing pain. Next day Sunday,  my arm was really sore. I had chills off and on all day plus a fever of almost 100 at times. Felt a little strange, hard to explain. No energy, just the blobs. Spent a few hours in bed during the day which was Sunday. The next day Monday, I felt much better. Today 3/9/21 I am back to normal. I was not too worried because I had heard a lot of people had issues with the 2nd dose. First dose, no problems except a sore arm for a day or two.
felt bad; felt Tired; Muscle aches; Headaches; This case was reported by a physician via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness, muscle pain, headache and feeling bad. On an unknown date, the outcome of the tiredness, muscle pain and headache were recovered/resolved and the outcome of the feeling bad was unknown.   The reporter considered the tiredness, muscle pain, headache and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and felt tired, had muscle aches & had headaches consistent with the label. The patient felt bad for 2 days and then went sailing. The reporter agreed to follow up. This case linked with US2019AMR167048, reported by same reporter.
Mom states child had a mild sz (head jerked back & eyes rolled) same night immun was administered; Child seen in ER;
tested positive for covid 12/9/2021- no sx, tested as part of follow up due to known exposure- wife positive
Information has been received from a registered nurse concerning her son, a 37 year old male with penicillin allergy, hepatitis C, hypertension, seizures, possible right blocked artery, bipolar with psychosis and paranoia, piece of metal in head, elevated liver function, left torn medial meniscus, hypothyroidism and alcoholism who on 13-NOV-2009 was vaccinated with the first dose of RECOMBIVAX HB. On 13-NOV-2009 the patient also received the first dose of VAQTA (MSD). On 29-JAN-2010, the patient was vaccinated with an unspecified vaccine. Other concomitant therapy included ZOLOFT, ZYPREXA, levothyroxine Na, DEPAKOTE and aspirin. On 13-NOV-2009 the patient experienced local muscle aches, swelling, redness, heat, low grade fever and slept all day Saturday and only up for hours. The patient got up Monday at 3 PM after sleeping all day. The patient was fine until receiving RECOMBIVAX HB and VAQTA (MSD) and had "flipped out mentally and self destructive". The patient was hospitalized. There were no lab diagnostics studies performed. At the time of the report, the patient recovered from local muscle aches, swelling, redness, heat, low grade fever and sleeping for long periods but time period unspecified. At the time of the reporting, the patient still was "flipped out mentally and self destructive". Local muscle aches, swelling, redness, heat, low grade fever, sleeping long periods and "flipped out mentally and self destructive" were considered to be other important medical events due to "police intervention", to be disabling and immediately life-threatening. Additional information has been requested.
contracted COVID-19/Bad sore throat/Stuffy nose/loss of taste/Loss of smell; contracted COVID-19/Bad sore throat/Stuffy nose/loss of taste/Loss of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "contracted COVID-19/Bad sore throat/Stuffy nose/loss of taste/Loss of smell". The patient reported he/she contracted COVID-19 however because he/she received the Pfizer vaccines and booster, he/she did not die. He/she had bad sore throat for a few days, stuffy nose, loss of taste and smell. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
02/11/22 presents to ED for "lvl 2 transfer with a C2 fracture after an MVC and level trauma". PMHx of "GERD, hiatal hernia, HTN, and abdominal hernia repair".
(L) arm deltoid red/swollen x 2 days. 101 fever x 1 day. Cellulitis- BACTRIM susp 3 tsp BID.
Pt recv vax on 10/19/98; on same day pt exp LA pain; 1 mo later pt exp left hand/wrist swelling
Moderna COVID-19 Vaccine EUA  Lymphadenopathy, axillary node on injection side. Palpable and painful, approximately 3-5 cm in diameter.