chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bivalent vaccine administered twice with 2 weeks apart between doses; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses).    No Concomitant drug information was provided by reporter.  No treatment information was provided by reporter.
pt slept up to 4hr p/vax;waken for feeding;pt rolled back eyes-was noted to be limp for few seconds was taken to ER;
It started when I woke up and my eyelids were severely swollen. Then throughout the day the swelling started to go down but then my neck began getting red. I then developed a light rash on my neck, chest, and arms. The only part that was slightly itching was my neck. I continued to take Benadryl and used cortisone cream on my neck. I woke up the next day with my eyelids being swollen again. Benadryl helped. The rash is going down and all I have left is a rash on my left wrist which developed on the 4th day after my vaccine.
Fever 101.4 F; Mild pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.4 F) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever 101.4 F). At the time of the report, PYREXIA (Fever 101.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.4 °f (High) 101.4 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Arm was very sore and achy for days and every day things became very painful to do.  Getting dressed, washing back in shower, buckling seatbelt just to name a few.   Became extremely difficult to do anything.
Patient experienced oral swelling 12 hours after her 1st dose of Pfizer. She had symptoms 2 hours after 2nd dose. Took antihistamine and felt better.
On 9/25/00, the pt developed a maculopapular vesicular rash. Rash was on abdomen, hands, oral mucosa, perineum, and legs. He also had a fever.
tested positive for COVID; voice was almost gone; voice was bad; A spontaneous report  was received from a healthcare professional concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid, voice was bad, voice was almost gone.  The patient's medical history was not provided. Concomitant medications reported were exemestane 25 mg have not taken it since Friday for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20A) via unknown route of administration in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event tested positive for covid. On 4 Feb 2021, the patient experienced the events voice was bad, voice was almost gone.  Treatment details included Tylenol, ibuprofen, they were given azithromycin and an inhaler because when they got busy they, run out of breath.  Action taken with mRNA-1273 in response to the events was not reported.  On 4 Feb 2021 the outcome of event voice was bad was resolved.  On5 Feb 2021 the outcome of event  voice was almost gone was resolved. The outcome of event tested positive for covid was unknown.
A day after my vaccination I was feeling really bad and had chills and a bad migraine. I was not able to work and had to go to the urgent care for a checkup and get a doctors' note. The advised me to do bed rest and take Tylenol which I did and after the next day I felt better.
Patient's father stated that the patient started to have flat red spot on her face, and forehead. Patient did not experience any shortness of breath. Patient's father was asked to call 911 due to the father having transportation issues. Patient's father stated that he contacted 911 and the ambulance came out and did not recommend for the patient to be taken to the hospital at that time. On the morning of 03/21/2018 patients father was contacted and an update was given that the patient had improved and he has no further concerns at this time.
5 x 9 cm right deltoid area red, warm, swollen. Denies discomfort.
tested Covid 19 positive; This is a spontaneous report from a contactable female consumer (patient) via a Pfizer-sponsored program, Covax US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EL9269) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the first dose of Pfizer COVID-19 vaccine on 09Mar2021 and supposes to receive the second dose on 30Mar2021, however, she tested positive for COVID 19. The patient stated that on 18Mar2021, she got tested for Covid and it just came back positive (on an unspecified date). She was supposed to get second dose on this 30 of this month (March), and she don't know if she is getting the next shot; she asked how she can get her second shot. The outcome of event was unknown.  Information on lot/batch number was available. Additional information has been requested.
Patient called at 12:13PM and reported swollenness to the face and neck area after receiving his first dose of the covid19 Pfizer vaccine today.  Patient was advised to go to the ER and take his vaccination card with him.
developed small hives on feet that gradually moved up both legs in patches, very itchy no pain no drainage. Also same thing around L hip + bikini line. Hives turned into small raised round bumps that scabbed over. Still itching by day 10 but getting smaller
Throat felt funny, face tingly, swollen, eyes very red and draining - tongue started to swell.  10/26/09 ED records received service date 10/22/09. Assessment: Allergic reaction. Patient presents with dyspnea and tongue swelling. Jaw pain. Eyes itchy, throat tightening, voice muffled. Face flushed, throat swelling. Uvula red and swollen. Feeling chilled.
redness in arm, extending from deltoid to elbow, raised, hive. Fever 100.3, lightheadedness, headache, brain fog (hard to think),fatigue, chills achiness, loss of appetite and energy
Initial report received on 07/Nov/2005 from another manufacturer.  Manufacturer report #: A0580377A.  A 34-year-old male patient had received an administration (route not reported) of TETANUS TOXOID (lot number and site of administration not reported); A first dose (route not reported) of ENGERIX-B (manufacturer, GlaxoSmithKline), lot number AHBVB013BA (site not reported) and an administration (route not reported) of HAVRIX (manufacturer, GlaxoSmithKline) (lot number and site not reported) on 07/Sep/2005.  At an unspecified time later the patient experienced a metallic taste in his mouth.  The event resolved some time prior to 01/Oct/2005.  The patient subsequently received a second dose of ENGERIX B (manufacturer, GlaxoSmithKline) lot number AHBV171AA (Incorrect lot number), route and site not reported, on 01/Oct/2005.  This is sooner than the recommended interval of one month between the first and second doses of ENGERIX B.  He once again experienced a metallic taste that evolved to a rusty taste.  The event resolved prior to 01/Nov/2005.  Follow-up information received on 26/Jan/2006 from a health care provider.  The patient received an intramuscular injection of TDS ADULT (not TETANUS TOXOID as previously reported), manufacturer sanofi pasteur, lot number U1019AA.  ENGERIX B and HAVRIX were also administered intramuscularly.  Sites of administration were not reported.  The subsequent dose of ENGERIX B was administered intramuscularly on 01/Nov/2005, (not on 01/Oct/2005 as previously reported and not within four weeks of the original vaccination).  All corrections have been amended in the case.  Relevant diagnostic/laboratory tests were none.  The patient is recovered, and additional information is not expected.
Soreness; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Chills) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PAIN (Soreness) outcome was unknown and FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was eager for her second dose and stated she never wanted to go through or her family go through Covid again. Concomitant medications were not provided. Treatment information was not reported.   Reporter did not allow further contact
battle with pericarditis as a result of getting the 2nd Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURE), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant, life threatening), outcome "unknown", described as "battle with pericarditis as a result of getting the 2nd Covid vaccine". Therapeutic measures were taken as a result of pericarditis. Clinical courses: The patient had open heart surgery and barely survived.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash around the injection site and slightly above it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site and slightly above it) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site and slightly above it). At the time of the report, VACCINATION SITE RASH (Rash around the injection site and slightly above it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included supplements (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter did not follow up with HCP- she received second dose in other arm and did not have any event.
I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/11/2021 PULMONARY EMBOLISM, UNSPECIFIED.
Information has been received from a physician concerning a 44 month-old female with an allergy to amoxicillin who on 08-Aug-2003 was vaccinated with a dose of varicella virus vaccine live, "1 vial" . There was no concomitant medication. On 19-Aug-2003, the patient developed a varicella like rash throughout her body and a fever. It was noted that the patient visited the physician on 19-Aug-2003 and "no therapy administered". No prescription drug was required. It was also noted not to contact the physician. Unspecified medical attention was sought. It was noted that the patient had not recovered. No further information is expected.
Had some itchiness day of around the area and side of neck, next day the pain continued to intensify and spread more and more every day for 6 days after vaccination. Pain grew from injection site to behind the shoulder, up the neck, under the arm and down the side and down to elbow. On and off itchiness, but never redness or swelling or heat. Pain began to subside around day 7.
7/4/07 - 12:30 pm after lunch experienced stomach knots/cramps; 5 pm after dinner stomach knots again and nuasea, very hot; 8 pm vomit, nuasea, fever of 100.0-100.9, stomach knots, body aches; tried to sleep, limited food/ liquid intake until 7/6 when I felt more normal; advil as needed
Thurs noticed large localized reaction, heat, swelling larger than silver dollar, Friday symptoms then intensified, saw dr on Saturday, he prescribed antibiotic which patient started, cellulitis diagnosed.
extreme joint pain; Fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 66-years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported),via an unspecified route of administration ,at the age of 66 years old,on 10Feb2021 as Dose 1,single for an unspecified indication. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took advil [ibuprofen] for arthritis and prednisone for arthritis.The patient experienced extreme joint pain and fatigue on an unspecified date.Therapeutic measures were taken as a result of extreme joint pain.The outcome of the event was unknown.  Follow up (11Feb2021): This is a follow-up spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported for a patient (husband),The caller stated that the patient or her husband suffered from joint pain after taking 1st dose of Pfizer covid19 vaccine.The caller was asking if her husband can take anti-inflammatory medications for pain. Follow-up (11Feb2021): This is a follow-up spontaneous report received from a contactable consumer.This consumer reported for a patient (husband) that:dates for fatigue,joint pain.Reason for no lot number of Unspecified Vaccine was due to Caller unwilling to complete the report,and no lot number of Advil and prednisone was due to Suspect captured for MI query.Reporter was unwilling to share further information, hence, product details (LOT#, expiration date, NDC#, UPC#) and other details were unknown.Limited information was available over the call.  Information on the lot/batch number has been requested.
Pt recvd 3 doses of Engerix-B, 3rd dose given 11JUN90 & it was determined that pt did not convert to a protective surface antibody level;
tell us about the route of pneumococcal vaccine in thigh of a two and half months baby; This spontaneous report as received from a physician and refers to a two and a half month patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) in the tight, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter was wondering if the route of administration should be intramuscular or subcutaneous.
Within 2 min, Pt asked if it was normal to feel vaccine traveling down arm, "tingling feeling Rt arm down to fingers." She then states top of her head started hurting and denies having symptoms prior to vaccine, and having dizziness, blinking her eyes frequently, newly noted.    1435hrs: BP 195/92, HR69, SpO2 100 on room air, RR 17. BP continued to elevated (197/111, 211/106, 242/113) and transported to exam room and consulted provider who recommended ER.  As BP continues to elevate, H/A increases from 2/10 to 5/10, dizziness continues and blurry vision starts.  1503hrs:  BP 148/96, HR 46, SpO2 99% on 2L O2 via nasal cannula.  Pt states "I'm having medication taste in my mouth, is this normal?" She then states she is having chest pressure and EMS arrives.   1509hrs: Patient transported by EMS to local hospital ER via ambulance and she states after transfer to gurney that "my chest really doesn't feel good."
Hives on hands, toes,thighs, elbows Fogginess Weakness
It has been a month since I had the vaccine and I still have pain in the shoulder where the shot was given.  I have trouble lifting my arm up higher than my shoulder and also have pain when I lift objects with that arm. I have taken Tylenol, Naproxen, and have used both heat and cold on the affected arm.
Dizziness, vertigo. It comes out of nowhere. Lasts for ~30 seconds.
Approximately 30 minutes after the injection I felt myself get very flushed and slightly lightheaded.  This feeling lasted for about 45 minutes before resolving.  Had right shoulder pain start about 1-2 hours after the vaccine and it steadily increased to the point where it was too painful to move in certain ways that utilized that muscle.  I had to assist my right arm with my left when needing to move it in certain ways between 12-36 hours after the vaccine was received.  The pain dissipated to manageable levels after 48 hours post vaccination and resolved completely after about a week.  Also experienced significant fatigue that started 3-4 hours after the vaccination.  the first night after the vaccination I slept for 12 hours and the second night I slept for 10 hours.  I was still able to go to work which does not involve too much labor and alot of computer work.  Once home I did essentially nothing except rest on the couch or in bed.  When I woke up on the third day the fatigue was mostly gone.  It was completely resolved on the 4th day.
Pain started in evening, next morning swelling and redness about 3 1/2 inch to 4 inch circumference around injection site raised about 1/8th inch high. Injection site darker red possibly bruised, feels hot. Another raised bump about 1/4 inch raised near posterior elbow, 2 inch oval, not as red or sore.
After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Patient had severe allergies for over 30 years and never being able to spend more than a couple of hours outside without non stop sneezing.).    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After having the shots in May of this year the allergies have been reducing to where Ican now spend all day outside wit) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment information not provided.
wrong, outfeeling; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (wrong, outfeeling) and VACCINATION SITE PAIN (Sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (wrong, outfeeling) and VACCINATION SITE PAIN (Sore arm). At the time of the report, FEELING ABNORMAL (wrong, outfeeling) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.
Received An Expired Dose; Initial Report Received on 13-Mar-2023  A pharmacist reported that a 48-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was expired.   Medical history, allergies, and concomitant medications were unknown at the time of vaccination.  On 12-Mar-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 937232, expiration date 04-Mar-2023, NDC # 43528-0002-01) intramuscularly in the left deltoid. The HEPLISAV-B vaccine had expired 8 days before the injection. No adverse effects were reported by the patient.   No further information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
PT C/O HAVING A FEVER ON SATURDAY 101.5 AND FEELING TIRED,DIARRHEA AND SWELLING ON HER LEFT ARM LIKE A BUG BITE.DENIED SOB,HIVES.
FELT VERY ACHY; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced felt very achy, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 plus Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt very achy was not reported. This report was non-serious.