chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu shot at 10AM on 9/17/10 and his wife found him in bed unconscious, bleeding from the mouth at 4PM. 911 called transported to E.R. - He bit his tongue from possible seizure. Spent 3 days in the hospital.
This spontaneous report was received from a registered nurse and refers to a 6 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 63 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Larger lump with redness. Fever 2 1/2 days of 99 degrees.
covid arm: rash on arm starting 10 days after vaccine, resolving after 2-3 days
Chest pain, unknown kidney pain, AKI acute kidney injury , ringing ears. Chronic fatigue.
At the injection site a lump the size of a gold ball formed and took well over 10 days to diminish.  I had to continue to put hot compresses and it still isn't totally gone.
Swelling, itching, round rash of about 3 inches diameter and redness in the injection site
Dizziness, ache, weakness, hands swelling, feels sandy, fingers locking on right hand, runny nose, allergic to flu shot.
C/O headaches starting 2 wks after 1st vaccination. Had seizure 3 months after 3rd vaccination.
Shot was given May 5.  My menstrual cycle started May 9 and has continued for 16 days.  It is heavy and painful.  The bleeding started off very light and has continued to get heavier as the days have gone on.   I am on day 16 and still have very heavy bleeding.
Inadvertently administered 0.2 ml of adult formulation of Pfizer/BioNTech, rather than pediatric formulation of Pfizer/BioNTech. Discovered within five minutes of injection. Monitored x30 minutes. Informed mother immediately after discovery of incident. No adverse effects during the 30 minute monitoring period.
headache; body ache in back and legs; upset stomach; what she is experiencing after second dose is more severe than after first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body ache in back and legs), ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (what she is experiencing after second dose is more severe than after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache in back and legs), ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (what she is experiencing after second dose is more severe than after first dose). At the time of the report, HEADACHE (headache), MYALGIA (body ache in back and legs), ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (what she is experiencing after second dose is more severe than after first dose) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
Coughing; Fever; Went downhill fast/Feeling out of it, kind of like an out of body experience that was weird; very, very, very tired; Sore throat; Sore left arm; This is a follow up spontaneous report from a contactable consumer (patient, self-reported). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 14Feb2021 at 10:30 (age at vaccination: 61 years), as a single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure. Family Medical History included patient's father was diabetic and had cancer. Concomitant medications were not reported. The patient did not received any vaccination prior vaccinations (within 4 weeks). On 14Feb2021, the patient experienced sore left arm. She was basically fine. 6 days later on Saturday, 20Feb2021, she started having a very mild sore throat. On Monday, 21Feb2021, she was very tired. On 22Feb2021, she was very, very, very tired and went downhill fast/Feeling out of it, kind of like an out of body experience that was weird. Yesterday, 25Feb2021, she started having coughing and fever. She went to get a COVID test this morning and was still waiting for her results. The patient asked if this could be from the vaccine. She mentioned she did report through the V-safe text system for the first week. The adverse events did not require a visit to emergency room and physician office. There was a Product Complaint. Description of Product Complaint included in response to adverse events ongoing she had COVID test 26Feb2021, but results were unknown at this time, not resulted yet. The patient underwent lab test and procedure included COVID test with unknown result on 26Feb2021. Out-come of the event sore left arm was recovered on an unspecified date, went downhill fast/Feeling out of it, kind of like an out of body experience that was weird was recovering and for all other events, it was unknown.  No follow-up attempts are possible. No further information is expected.
Narrative:  Pt presented to emergency department 04/15/2021. He reports having SOB since 04/12/2021. Patient had been watching news reports and is concerned that he may have a PE. No evidence of PE found.
Patient report red bumps around Band Aid where vaccine was administered around 8:00 am on 10/7/17. Says she saw "red bumps, like a couple of blisters around" the injection site. One of the blisters popped this morning. Has not reported worsening in symptoms from 8 to 12pm
This spontaneous report was received from a nurse refers to unknown number of patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant medications were not provided. On unknown dates, these patients were inadvertently vaccinated with improperly stored PROQUAD (Merck) (lot # L034932, expiry date: 03-MAR-2017). The vaccine underwent a temperature excursion to -6 degrees Celsius for a time frame of 8 hours 58 minutes. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Severe joint pain and swelling, fatigue with inability to engage in everyday life functions without severe pain or modifications to activities.  Remained in this state until starting prednisone to reduce inflammation in joints. Prednisone therapy started 1/14/23 for 4 weeks.  Prednisone therapy has reduced both pain and inflammation with return to most activities resulting. Doctor believes RA inflammatory reaction was due to vaccine and has advised no more vaccines to be taken at this time. Doctor is monitoring health.
Left leg swollen, indurated, red upper 2/3 of thigh (itching). Right leg reddish, no induration 3cmx4cm. Able to bear weight, active and playful.
Patients second dose of Pfizer-BioNTech COVID-19 vaccine was administered 6/10/21 with booster dose given 12/1/21 which is 9 days early from 6 month mark.
Pain in shoulder near placement of vaccine.  Pain worsened the next day and caused difficulty in range of movement of her arm.
I have had every effect listed on the paper of side affect including, difficulty of breathing, fainted, dizzy, nauseous, I have spent days in bed
I have stopped to have menstruation for over 1 year. 1 week after the vaccine, menstruation came back and lasted for 3-4 days, just like before menopause.   After the second shot on May 28th, the same thing happened again, in about 1 week.
Per MD Note on 8/22/2022: Pt. is a 12 month old female with rash. Rash described as red raised patches located on the entire body.  It started as just a couple of patches on her abdomen 2 days after she received vaccines at her well check, and since then has become quite diffuse.  The areas of redness definitely move and change, and mom has with her a series of photos showing progression.  If it does not seem itchy.  She has not had any mouth lesions.  She did vomit the day after the rash 1st appeared, but she has had normal appetite, no apparent belly pain, and no other symptoms.  She did have a temperature of 99.5 earlier today.  She has otherwise been well.
Left arm swelling and redness noted hours after vax, visit to urgent care same evening. No meds given. Swelling progressed to face and chest, no difficulty breathing noted. Fever and itching next day. Max temp 101.3 deg F, orally. Ret to clinic 3 days post vax. Arm swelling still apparent. Face and chest resolved. Diffuse redness and swelling over entire left arm.
3rd dose of GARDASIL 9 not given 6 months after first dose.; This spontaneous report was received from a pharmacist, referring to a 14 year-old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at 0.5 milliliter, intramuscularly (frequency, lot # and expiration date were not reported) for prophylaxis.  It was reported that the third dose had been administered 8 months since the first dose instead of 6 months as recommended in the prescribing information. There was no product quality complaint involved.
The patient was inadvertently administered a dose of Rotateq that had been improperly stored; No adverse effect reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.      The reporter stated that on an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R033255, expiration date on 26-JUN-2020, lot # S000961, expiration date on 19-OCT-2020, for prophylaxis, (strength, dosage, frequency and route were not provided), that had been improperly stored on 21-AUG-2019. No adverse effects were reported. It was stated that rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was under 18.5°F during 15 minutes. Also it was reported that there was a previous temperature excursion of 46.9 °F during 5 minutes. Data logger was positive.
This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was scheduled to receive VARIVAX to prevent against chickenpox and accidentally received ZOSTAVAX (dose, route of administration, lot # and expiry date were not reported). No adverse effect was reported.
This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (multiple myeloma experience accelerated lesions) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 PLASMA CELL MYELOMA (multiple myeloma experience accelerated lesions) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA (multiple myeloma experience accelerated lesions) outcome was unknown.            Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
About 6pm (day of injection) I started having chills and feeling  achey.  I had a fever of  which went to 100.7 at 3:30am.  (My normal temp is 97.4) I began taking Tylenol ES  that night and Aleev the next day. I had fever (from 98.2 to 99.9), aches and fatigue  the next two days while taking Tylenol ES  every 6 hours.   On the third day  about noon, my fever went back to normal, and has stayed that way.  My upper arm was red and  swollen and painful for the first week.  On the  4th day after the injection the redness was spreading and moving down my arm.  I called one dr. and started taking 4 Aleev a day.  By the 7.th day, I sent photos to my PCP and she had me come into the office.  She was concerned it might be infected since it was spreading down to my elbow, so she gave me  a double dose of antibiotic (500 mg of Cephalexin to take 4 times a day for 7 days).  I finished that on  1/26)  It stopped spreading and gradually the redness went away. The round (quarter sized place at the injection site ) stayed for days after and now the skin is peeling.  The site is still painful if I press on it.
As far as I know, I was sitting after dinner reading and I was aware that I could not see well out of my right out, it was very blurry and at the very same time though I had a very sharp pain in the left occipital region. So I was most worried about my eye because I know something was wrong. First thing in the morning I called my eye DR and she told me that I had a right side occlusion in my right eye. So then what she had me do was wait a couple weeks to see if it would go away spontaneously and it didn't. So I went to a retinal specialist and they gave me shots in that eye because I could still not see out of my eye. It has not completely cleared but it is much better. I also had a severe pain in my neck and brain. I went to the ER and the DR that evaluated me there didn't know what my diagnosis was at the time but he put me on some medications that he thought would help with the inflammation. So he put me on cortisone and gave me a prescription for valacyclovir, because I have a history of herpes infections all over my body. SO that was on the Sunday that I went to the ER. Then by Wednesday the pain was so severe that I went to the ER at the hospital because I was so uncomfortable and worried. At the end of five weeks it just went away. I did see a neurologist but it was over by then, he said the diagnosis was occipital issues.
Patient found to laying on her husband's lap. Was asked by RN if patient felt okay. Patient stated she felt dizzy. Face noted to be flush and diaphoretic. Legs elevated. EMS called. Alcohol and ammonia applied. Patient then felt nauseated. Emesis bag was given. Vital signs obtained. Patient was given water and powerade. Patient felt better after treatment .
child received first covid monovalent pfizer peds vaccine for 6 mo through 4 years on 11/22/22.  Gave covid bivalent peds pfizer as 2nd dose on 1/6/23, child should have received 2nd monovalent covid vaccine.  No adverse reactions
Red rash, hives like area itching on arms and legs, took 25mg Benadryl lasted x 3 days.
Loose stool; Really bad chills; High fever/erratic fever; Vomited twice; Strong fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0777) via an unspecified route of administration in the right arm on 23Apr2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included irregular heart beat and heart murmur. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (ADVIL) taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 00:00, night of second vaccine, the patient experienced really bad chills, high fever and vomited twice. On 24Apr2021, 1 day after the vaccination the patient had erratic fever and strong fatigue. On 25Apr2021, 2 days after the vaccination the patient experienced loose stool. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events really bad chills, high fever, vomited twice, strong fatigue and loose stool were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from a nurse on 18 March 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Tetanus Vaccine (batch number, expiration date, dose, dose number, route and site of administration were reported as unknown) on an unspecified date in 2002 at another office. Patient's ongoing illness, medical history, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On an unspecified date in 2002, post vaccination, the patient experienced considerably enlarged lymph node in neck and pain in the lymph node on the side where she received the tetanus injection. Laboratory data and corrective treatment were not reported. The patient's outcome was not reported. List of documents held by sender: none.
This spontaneous prospective pregnancy report was received from a pharmacist (who is the female patient) of unknown age regarding herself. On 04-SEP-2013, the patient who is pregnant was inadvertently exposed to ZOSTAVAX, (lot number, expiry date and route was not reported) via a needle stick on her finger as she was preparing to administer the vaccine. The LMP and EDD were not known. No adverse effects were reported. Additional information is not expected.
Dizziness, Myalgia, Arthralgia, Fever, Chills, Sweating Narrative: Reported injection site reaction after 1st dose on 12/31/20--8-12 hours after shot felt like golf ball under skin, very sore and immobilized arm for 24 hours. After the 2nd dose on 1/26/21 - awoke early morning of 1/27/21 with fever of 102.5, terrible chills, myalgias and arthralgias. Symptoms laster for 8 hours. Ibuprofen 800 mg and Tylenol alternating every 2 hours helped with fever. Still noted fevers (100-100.5) throughout the day on 1/27/21, and continued myalgias/arthralgias. Additionally reported profuse sweating and dizziness. Symptoms lasted into the day on 1/28/21. Missed 2 days of work. No known prior covid infection
Information has been received from a physician concerning a 71 year old male who on 09-DEC-2008 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (lot # 662856/1559X). Concomitant therapy included TRICOR, COUMADIN and TOPROL XL TABLETS). On 15-DEC-2008 the patient experienced a fever of 100 degres. Also the patient experienced itching, chills and redness at the injection site.  The patient sought uspecified medical attention.  Additional information has been requested.
Information has been received from a nurse practitioner concerning an 8 week old male patient, who on 18-NOV-2010 was vaccinated with a dose of ROTATEQ (Lot # not reported). The nurse stated that on 18-NOV-2010 the patient threw up and had been crying all day. The patient did not seek medical attention. It was reported that the AE had not improved at the time of the report, the patient's present status was not reported. Additional information has been requested.
DTP/HIB/OPV given 17MAY91 on 18MAY91 parent reported to MD child was hypotonic, & had unresponsive episode x 5min w/fever 102.4 on eve of 17MAY91; Child was reported happy, eating well, fever lower the AM of 18MAY91;
This spontaneous report was received from a Nurse refers to a patient of unknown demography. On 23-JAN-2014, the patient was vaccinated with first dose of GARDASIL 0.5 ml, intramuscular. On 20-MAY-2014, the patient was vaccinated with second dose of GARDASIL 0.5 ml intramuscular. No adverse effects reported. No further information was provided. This case is linked to the case 1405USA012483 (same reporter link). Additional information has been requested.
Three days after injection, I developed a hot, raised, lumpy, itchy red rash at the injection site.  The site itself was black and blue, but the rash was around and below the injection.
Fever to 102.7F  Rigors Nausea Myalgia   All began morning after second vaccine and worsened throughout day
By that evening already I was starting to ache and at night I was shaking and I was in pain. I was like that the whole night I couldn't sleep. This lasted total of 2 days and then I went back to my normal life. On 11/27/2021 I started getting leg pain in my muscles. These pains were the same pains. It reminded me of the day of the vaccination. We really don't know why this is happening.
COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit disorder, back pain, cigarette smoker, and cough, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.
Soreness, redness (4cm x 9cm erythema) Rx. Tylenol and topical ice.
Itchy rash to left side of face, arm, and leg. Timing of onset uncertain but was in days following vaccine. Patient was seen by outside physician and given a one-week course of Benadryl, after which rash resolved.