chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; SORE ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included no known allergies and patient does not abuse drug or have illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-JUN-2021, the subject experienced sore arm. On 26-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and sore arm. This report was non-serious.
Nausea prior to going to bed awakened by tachycardia, found to be sinus tachycardia in ED, responding to IV fluids No fever, headache, rash or hypotension
Headache, Fever,  General symptoms: Chills, fever, headaches, muscle  pains, fatigue
Reported adverse effects of tachycardia and irregular heartbeat about 72 hours after receiving vaccines. Patient states that he wacked himself in the chest 3 times and then it went away. He did not seek any medical care.
headache, left side of head bothering me; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, left side of head bothering me) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (headache, left side of head bothering me). The patient was treated with NAPROXEN SODIUM (ALEVE) in March 2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache, left side of head bothering me) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   Reporter did not allow further contact
Fine rash, thighs, chest - skin colored. Same reaction happened to mom's sister's children (cousins)
Information has been received from a registered nurse concerning a 17 year old female with no known drug reactions/allergies and severe asthma who on 15-APR-2008 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 659964/1978U) and on 22-JAN-2009, was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 661531/1311X). Concomitant therapy included ADVAIR, FLOVENT, Prednisone, Albuterol and Influenza virus vaccine (unspecified) (given on 22-JAN-2009). The registered nurse reported that the patient became pregnant after receiving the second dose of GARDASIL. She also stated the patient delivered the baby on 11-SEP-2009; however, the baby was born with hydrocephalus. The patient sought unspecified medical attention. On 01-OCT-2009, through a telephone call, the registered nurse reported that the mother and baby were being treated by the same physician. The mother was seen in the office on 22-JAN-2009 for an appointment. She was a severe asthmatic who had been on ADVAIR for years (exact therapy dates not provided) and ADVAIR was not controlling her asthmas as well as the physician would have liked. The patient was also noted to be a smoker. On 22-JAN-2009, the patient was switched to FLOVENT, Prednisone and Albuterol for asthma management. The patient was also given a flu vaccine (manufacturer not specified) and her second dose of GARDASIL. The registered nurse further noted that on that date (22-JAN-2009) the patient had a negative urine HCG test. It was estimated that the patient was actually 3 weeks, pregnant at the time of the urine pregnancy screen because she soon found out she was pregnant and her last menstrual period was estimated to have been around 02-JAN-2009. The reporter did not have the mother OB/Gyn contact information or any specific information surrounding her labor and delivery. She reported that she thought that the baby's hydrocephalus was diagnosed by ultrasound prior to his birth, but she did not have the baby's chart available at the moment to consult. She did report that the baby was 36 weeks gestation at birth on 11-SEP-2009. She did not have any more details to provide. She reported that she thinks he spent time in the hospital and thought he had a stent placed to treat the hydrocephalus. The health care professional contacted during telephone follow-up could not supply the following information: healthcare provider name and contact information for mother's OB/Gyn care or specific information about the baby. Additional information has been requested.  11/06/09 Medical records recieved for DOS range 1/22/09-10/14/09. Pt seen for asthma check 1/22/09 with vax given. ED visit for fall on ice and lower back pain mid Feb 2009. Subsequently found (+) pregnant. LMP (1/28/09). EDD 10/7/09. Return to ED 2/15/09 with abd pain and persistent back pain. UTI (+).  Several ER visits for asthma exacerbations. Prenatal consults note fetus with moderate to severe hydrocephalus and club feet seen on U/S. Amnio notes normal chromosomal, male fetus. Subsequent PCP visit for exacerbation of asthma. Poor air movement. Neb and MDI tx. Improved.  Live male infant born at 36wks. Apgars8/9 .Severe hydrocephalus.
Fatigue, upset stomach, vomiting once  36 hours after vaccine, Diarrhea, stomach pain, feeling better after day four Treatment: Tylenlol, Pepto, Aleeve
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history was not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose, route, lot# and expiration date were not reported), exposed to 50.5 for 77 hours and 44 minutes. Concomitant medication was not reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
weakness of rt facial musculature going to lt side;unable to close eye properly;food particles accumulated in rt cheek; unable to close rt angle of mouth properly;hosp; recurrent Bell's palsy;r/o demyelinating disease,inflam,cerebral tumor;
Immune system is firing on a thousand different cylinders; inflammation; Diarrhea; Cough; Exhausted, all she wants to do is sleep; Zero energy; Nausea; sweating; Sore arm; Headache; Fever; Chills; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: FA7485, expiry date: not reported), via an unspecified route of administration in the left arm on 03Aug2021 17:30 (at the age of 36-years old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis, immunodeficiency, in either 2014 or 2015, she got the Flu shot and about a month later got the worst strain of the Flu a person could get, she was sick with the Flu for a month. The patient has been immune compromised since her mid-twenties. Family history included passed away from the Flu three years ago because her mother was autoimmune compromised. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Aug2021, the patient experienced sore arm, headache, fever, chills, sweating. On 04Aug2021, the patient experienced nausea, exhausted, all she wants to do is sleep, zero energy. On 05Aug2021, the patient experienced diarrhoea, cough. On an unspecified date, the patient had inflammation, immune system was firing on a thousand different cylinders. The day of the vaccine, she came home two hours later, started with sore arm, had a headache right away, managed to finally wake up today finally free of headaches, had fevers, chills, nausea, diarrhoea, not been able to hold food down, experiencing this cough that at this point, is now coughing up clear stuff. She was tested and confirmed she is COVID-19 negative. Exhausted, all wanted to do was sleep, zero energy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on Aug2021. The patient has done a virtual visit to the physician. Therapeutic measures were taken as a result of inflammation (prednisone). The outcome of the events sore arm, headache, fever was recovered. The outcome of the events chills, sweating, nausea, exhaustion, zero energy was not recovered. The outcome of the events diarrhoea, cough was recovering. The clinical outcome of the event immune system was firing, inflammation was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse concerning a 33 year old female patient with rhinitis allergic, recurrent upper respiratory tract infection, dermatitis allergic, itching and allergy to ALLEGRA "spotting" and history of cough and nasal congestion itching who on 11-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX intramuscularly. Concomitant therapy included XYZAL. EPIPEN, phentermine and "CLUX-E" (unspecified). It was reported that the patient began to experienced rapid hair loss during the same time she got the vaccine. It was reported that the hair was coming back and she was getting some new growth. It was reported that the patient saw her primary care physician and an endocrinologist. It was reported that unspecified laboratory diagnostic tests were performed. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-JUL-2018, the patient was vaccinated with a dose of improperly stored VARIVAX lot# N022979, expiration date: 23-AUG-2019 (dose, frequency and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MRK INJ). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit to 14 degrees Fahrenheit for 14 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. Upon receipt of follow-up information, it was determined that this case is now valid because (patient identifier was received). Follow-up information was received from the nurse on 24-AUG-2018. The patient demographics were received (Initials and date of birth). The reporter reported that there were no issues to the patient after receiving the VARIVAX.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
After 2 days, my injection site became very painful, hot, swollen, red and itchy.  I also had pain all around the armpit on that same arm.  I took Benadryl, hydrocortisone cream and motrin.  None did anything to help.  After 4 days I contacted my doctor who told me they see this all the time.  I had never heard of it.  No one I know who received Moderna had this reaction.  I had J&J for my 1st dose and no reaction like this.  I've also NEVER reacted to any vaccine in my life like this.
Information has been received from a 16 year old female with asthma and no drug allergies who in March 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and in June 2008, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient experienced menstrual cramping after the first and second dose of GARDASIL. Cramping was more severe after second dose. The reporter was undecided as to whether to receive final dose of GARDASIL. On an unspecified date, the patient recovered. The patient was not experiencing any menstrual cramping at the time of reporting. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Reaction occurred 9 days after injection: injection site pink and swollen; no fever, pain, other symptoms. No previous complaints  Doctor visit on 1/7
Case number PHEH2015US026886, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 40 year female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 19 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The nurse stated that, the reason for the refrigerator to be out of temperature range was unknown. There was no any further problem since the temperature excursion problem. No further information provided. No adverse event was reported following this medication errors. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
The patient reported that after 1 day of receiving the 2nd dose, he started having left thumb, left ankle and left wrist swelling. After a couple of days, the ankle was back to normal, but the left thumb and wrist continue sored and he continued with difficulties on lifting weight or moving it normally. Until today, Nov 03, he says that there are remaining symptoms. He never sought a medical opinion despite the recommendations. So, no diagnostic information or medical recommendations and treatments.
Information has been received from a 68 year old female with hypertension who about 2-3 months ago, in approximately June 2008, was vaccinated with ZOSTER vaccine, 0.65 ml, subcutaneous. Concomitant therapy included PRAVACHOL, CLARITAN, and lisinopril. The caller reported that about 3 weeks after receiving ZOSTER vaccine, in approximately June 2008 she experienced itching and marks in vaginal area; and also itching on face after receiving ZOSTER vaccine, Physician prescribed "VOLTREX" for the latter events; but it had not helped according to caller. At the time of reporting, the patient had not recovered yet. Additional information has been requested.
temperature excursion; No additional AEs; This spontaneous report was received from a registered nurse and refers to a 14-year-old female. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U036586, expiration date: 21-OCT-2023, administered intramuscularly for prophylaxis (strength, exact dose and dose number was not provided) and influenza vaccine live reassort 3v (FLUMIST), lot #PH3533B, expiration date: 21-OCT-2023, administered nasally for prophylaxis (strength, exact dose, dose number, and formulation were not provided) (Product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. No adverse events were reported (No adverse event).  The reporter considered temperature excursion to be not related to suspect vaccines.
Didn't hurt where shot went in, pain localized to shoulder (front of shoulder). No bruising, redness, rash (just pain) treated with prednisone 20mg 2 qd x 5 days. Following up w/PCP.
PATIENT GOT unconscious FOR 15 SECOND , AND WE CALLED 911 , HIS BLOOD PRESSURE WAS ON THE LOW NORMAL
negative test result on his antibody test; 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 58 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization; Bnt162b2 (Dose: 2nd), for COVID-19 immunization. The following information was reported: ANTIBODY TEST NEGATIVE (non-serious), outcome "unknown", described as "negative test result on his antibody test". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient reports a negative test result on his antibody test, following full vaccination (primary series and booster dose) of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap). Patient stated: "he took an immunosuppressant [CellCept] and he did an antibody test following my full vaccination with the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap)". Patient asked "If get a negative antibody test result does that mean he was totally unprotected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Light headed, headache, severe wheezing, multiple asthma attacks, used nebulizer treatments, rescue haler did not work to alleviate asthma attacks or severe wheezing.
After receiving 2nd COVID vaccine, patient reported that she had some arm soreness and neck stiffness on the day of injection.  The following day she c/o generalized body aches and nausea with progressive pain in head and neck.
Extreme stiff neck on same side as shot in arm was given. Could not turn head at all-he had his head facing the right side upon waking and could not move it or the pain was very intense. I put heating pads on neck as well as put a soft collar around his neck so he could function. Missed two days of school. Shortly after a rash on skin on neck appeared and lasted for about two days.
This case was reported by a physician and described the occurrence of a lump on leg at injection site in a 7-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline.  Concurrent vaccinations given on 15 April 2008 included the 3rd dose of ACTHIB, Sanofi; and the 3rd dose of PREVNAR, Wyeth.  Previous vaccinations given on 29 November 2007 and 30 January 2008 included the 1st and 2nd doses of PEDIARIX, GlaxoSmithKline.  On 15 April 2008 at 10:45, the subject received 3rd dose of PEDIARIX (.5 ml, unknown, left thigh).  On 12 May 2008, 27 days after vaccination with PEDIARIX, the subject developed a 1 cm in diameter lump on her left thigh, which was the site of the PEDIARIX injection.  On 18 June 2008, the subject was seen again in the physician's office and the lump was described as being solid, cystic, purplish in color, and more superficial.  The physician stated that the lump had not improved, but had changed since the first time he saw it.  The physician reported that the subject experienced no problem following her two previous PEDIARIX doses.  At the time of reporting, the event was unresolved.  The physician considered the event was probably related to vaccination with PEDIARIX.
Fever on 12/30/2008- Temp 101 degrees- redness and induration at left upper thigh.
Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.