chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 26 year old female patient. The patient's concurrent conditions and medical history were not reported. On 25-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (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 113 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.; Sender's Comments: US-009507513-1705USA014053:
02/14/23 presents to ED for "fatigue". PMHx of "chronic back pain with prior history of lumbar spinal stenosis and lumbar radiculopathy"
Presented with asymptomatic pancytopenia.  Bone marrow aplasia consistent with severe aplastic anemia
I started having pain around 12/24 when I was running. I ran on 12/31 and the next day my hip was extremely painful.  10-12 days afterward I went to see a doctor and they were concerned it was a fracture. So, they had me get an MRI and it showed a fracture of the femoral neck. I saw an orthopedist who told me to be non-weight baring for 6 weeks. The endocrinologist prescribed bisphosphonates. I will get a repeat MRI at the end of April to see if its healed.
Pain, swelling, warmth and redness around the injection site, over an area approximately 4-5 inches in diameter. Accompanied by discomfort and tightness in arm and shoulder and discomfort up into neck on the left side. Mild paresthesia in lower arm for a short period (< 1 hour). No loss of muscle power.  Treated with ibuprofen, 400mg  orally three times daily for three days, to date.  Ice packs applied to injection site once a day.  Neck discomfort resolved after two days. Today (four days after onset) symptoms and signs are lessening but some are still present. Area is still warm but pain and redness have diminished, and swelling and feeling of tightness are almost gone.
Information has been received regarding a case in litigation concerning a 12 year old female pt who had received a  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) vaccine in 1992 with no complications. On  09Jun03 the pt was vaccinated with a dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The consumer reported that this particular immunization caused a terrible reaction. The consumer reported that approximately 15 minutes after the shot was administered, the pt passed out or fainted, and had a seizure type episode. It was reported that this happened in the doctors office. The pt had a terrible fever and a headache for the remainder of that day. Upon internal review, passed out or fainted and had a seizure type episode were determined to be other important medical events (OMIC). No further information is available.
Patient states that muscle has felt badly ever since the shot was administered. The muscle is tense all the time without releasing.
The next day after vaccination, I felt nauseous and dizzy when I woke up.  I fainted and lost conciousness for a couple of minutes.  After I woke up, and rested for a bit,  I went back to bed to sleep for another 8 hrs.  I felt fine after that.
sore arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), intramuscularly (administered on the arm) on 23Feb2021 as 1st dose, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 16Mar2021 as 2nd dose, single dose both for COVID-19 immunisation. The patient's medical history was not reported. The patient has no concomitant medications. The patient experienced sore arm on 23Feb2021 and recovered on 25Feb2021, he also experienced sore arm on 16Mar2021 and recovered on 18May2021.   Information on the lot/batch number has been requested.
After a few minutes there was mild itching at injection site, after a few hours normal pain in arm from injection, during the night I woke up with neck pain and pain in opposite shoulder of injection, the following morning I had some upper back pain that progressed through the day to significant back pain (like having the flu).. the next day, Friday, I woke up with headache and body ache to the point of needing to take Ibuprofen throughout the day.. Saturday I still had a slight headache and back pain did not need to take anything.. Sunday was the first day since the injection that I felt good, no pain, no headache
This spontaneous report was received from a registered nurse and refers to a 6 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 98 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
pt recvd vax;3-4 hrs later,pt had a 5min spell of being very pale & somewhat limp & irritable;no fever,no further sxs beyond 24 hrs;
pain; redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 1st dose experienced extreme pain, redness, and swelling. This case has been linked with case US2019AMR167047, reported by the same reporter.
Within 1 minute of receiving vaccination, heart rate increase to over 145 bpm.  Blood pressure increased significantly.  Began sweating profusely.   Developed a very dry mouth and high rate of breathing.    Lasted for about 20-30 minutes and then returned to normal.
Patient became very light headed, started sweating and said felt faint. 911 was called. EMT staff evaluated and said he was ok t go home.
CHILLS; HEADACHE; NAUSEA; FATIGUE; HEART POUNDING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 04:20 on left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced heart pounding. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 14-MAR-2021, and chills, headache, nausea, and fatigue on 15-MAR-2021. This report was non-serious.
I went to bed with a sore throat. I had a headache and congested. I took a COVID test, and it was positive. My temperature was 99.7.  The doctor said I don't have to take the Paxlovid. On 28Feb23 I woke up with a bladder infection. The doctor tested me for a bladder infection, and it came back negative.  They had me go in last week for bacterial infection and it was positive.
Patient developed hives on his face and neck 5 minutes after administering vaccine. Patient was given Benadryl 12.5mg PO and observed for 30 minutes, Hives started to subsided about 15 mins after administering Benadryl.
This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB (strength, dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored RECOMIBVAX HB on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT STATED HE RECEIVED TWO VACCINES IN THE SAME ARM. PATIENT WAS HAVING ISSUES WITH HIS SHOULDER ON THE OTHER ARM. PATIENT STATED THAT THE PERSON THAT ADMINSTERED THE VACCINE CLEANED THE AREA THOROUGHLY AND KEPT THE IMMINUZATIONS 2 INCHES APART. PATIENT DID NOT HAVE ANY PAIN OR ADVERSE REACTIONS AT TIME OF VACCINATIONS. PATIENT WENT HOME AND AT NIGHT HAD ADVERSE REACTIONS TO THE VACCINATIONS INCLUDING: PAIN IN THE ARM WHERE THE VACCINES WERE ADMINSTERED, HAD A HARD SPOT DEVELOP IN THE ARM, PATIENT TEETH WERE "CHATTERING" ALL NIGHT, PATIENT SUFFERED FROM DIZZINESS AND CONFUSION AS WELL. PATIENT STATED THE ADVERSE SYMPTOMS HE WAS EXPERIENCING ARE GETTING BETTER BUT HE HAS NOT FULLY RECOVERED FROM THE SHOTS. PATIENT WAS ADVISED TO GO SEE A DOCTOR DUE TO THE ADVERSE REACTIONS HE WAS HAVING.
had 2 other patients who have reported metallic taste in their mouth after the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients. This is second of two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she also had 2 other patients who had reported metallic taste in their mouth after the vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug/event; different patient
Redness, swelling, unable to raise arm to 90 degrees. DO with Keflex.
bloody nose; sore arm, body muscles; trembling arms and legs; chest gunks; This is a spontaneous report from a contactable consumer. A 65-year old non-pregnant female consumer (patient) reported that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318, expiration date: unknown) via an unspecified route of administration on 04Feb2021 at 11:15 on left arm at single dose for COVID-19 Immunization. The medical history included macular degeneration, high blood pressure. Also, the patient was allergic to Levaquin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), estradol, omeprazole. On 04Feb2021, patient experienced trembling arms and legs. That night sunburned looking cheeks then woke up with tons of gunk in my chest. The next day patient experienced sore arm and body muscles. On next day, patient started feeling better but have been getting a bloody nose on and off. On sunday, the patient started feeling bad again. On, Tuesday patient slept all day even though she slept good the night before. The outcome for the events trembling arms and legs, chest gunks was not recovered whereas, sore arm, body muscles recovering and bloody nose was unknown.  No follow-up attempts are possible. No further information is expected.
I work up at 2am with my right pinky- first knuckle -  pounding in pain. Never had that happen before.  Then I realized my mouth was extremely dry. I got up, drank some water and layed back down. After about 15-20 minutes the pain subsidded and I was able to fall back to sleep.  Just weird! Odd side effect for sure. Hope the second shot is that simple too!
Rotavirus Monovalent vaccines was adminitered intramuscularly instead of orally. No adverse effects noted in clinic. Mother states child was irritable at home.
GBS hospitalized 9OCT91 eval & dx; tx plasmapheresis-responded well, but complicated by septic arthritis of rt knee;
Vertigo; Daily headaches; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, atrial fibrillation, obesity and degenerative disc disease from unspecified date. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported started on an unknown date for unknown indication. The patient was allergic to sulfur medication, apples and stone fruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021, the patient experienced vertigo and daily headaches. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with unspecified medication. On an unknown date, the patient underwent nasal swab test with unknown results. The clinical outcome of vertigo and daily headaches was not recovered.   No follow-up attempts are needed. No further information is expected.
Fever 103.5 at 5:00am on 12-29-07. Fussy 12-28 and 12-29, crying, sleepy. Give Tylenol at time of shot and every 4 hours - applied ice every hour for 15 minutes first 6 hours. Very irritable for four days.
Starting a couple hours after vaccination, I began to feel unwell, overall poorly, nothing specific.  Went to be early at 9:30 and awoke at one a.m.on February 26 with splitting headache.  Could not get back to sleep well and felt terrible all that  day with headache, nausea, and foggy thinking, not funcional after about 2:30 p.m.  Took Ibuprofen at 3 p.m., called doctor and went to ER at Medical Center.  Was seen at ER a few hours later.  Slept some in waiting room. Had sore throat, the worst splitting migraine type headache ever, and was extremely foggy headed, couldn't process thoughts, eyes had difficulty focusing, nausea.  My temperature was a little high for me, I am normally low and it was 99.  My blood pressure is usually low and it was 105/59, pulse was 82 and respiration was 16 with 96 % Oxygen Saturation. They did tests and had an ophthalmoligist give me an exam also.  They said I could go home with the same meds they were giving me in the hospital since they were working to alleviate my painful headache, 600 mg of ibuprofen, reglan and benadryl.  Before I left they gave me the potassium chloride. I am continuing my medications today, two days after my vaccine.
Patient presented to get 3rd Moderna (booster dose).  Vaccine was given.  Clinic looked at later when processing and clinic reports Moderna, 1-4-21, Moderna 2-8-21, Pfizer 8-9-21.  No reported issues with vaccination.
feel tired; felt like they had the flu; lethargic; chills; achy all over, but mostly in hips; shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's; sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (felt like they had the flu) and LETHARGY (lethargic) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats) and CHILLS (chills). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like they had the flu) and LETHARGY (lethargic). On 01-Mar-2021, the patient experienced FATIGUE (feel tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 01-Mar-2021, PAIN (achy all over, but mostly in hips), TREMOR (shaking so badly that she couldn't hold a toothbrush (chills were so strong, beyond any chill she's), HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (felt like they had the flu), LETHARGY (lethargic) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (feel tired) outcome was unknown.            Concomitant Medications were not provided by the reporter.   This case was linked to MOD-2021-031587 (Patient Link).
Patient felt dizzy and fell out of chair about 10 minutes post vaccination.  BP was low but returned to normal and patient was released to home.
PC 25SEP 2 hrs p/shot pt in crib w/difficult breathing; "didn't breath for 10-15 sec"; blew in face p/20-30; Taken to ER;
Rapid heartrate, weakness, confusion, chest pain. Went to urgent care then sent to ER for EKG, bloodwork, X-ray, all came back normal.
pt recv vax;fussy all day p/ inject;constant cry 2-2 1/2 hr later;apap given;T 103;mom noticed white spots in mouth;2APR dentist dx thrush;3APR leg lump quarter size,clammy,t102.5 (ear);5APR pt not self yet
A large rash and swelling in the left arm around the injection site exactly one week later. It is itchy and warm to the touch. This may be similar to  "COVID arm". It started last night. After I worked out this morning, the rash and swelling increased.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was very worked up and nervous before receiving vaccine. Seemed to calm down after vaccine administration. Within a few minutes patient fainted. Had patient lie down with feet up. Once patient could sit up, blood pressure reading 75/42. Patient was given water and laid down/sat for about 30 minutes. Feeling better and blood pressure reading of 98/69 before leaving store.
at injection site her skin did not feel like skin; horrific pain in arm; at injection site her skin did not feel like skin, noticed swelling; chills; chronic fatigue, feeling being exhausted; headache; dizziness; eyes watering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), LACRIMATION INCREASED (eyes watering), SKIN DISORDER (at injection site her skin did not feel like skin), PAIN IN EXTREMITY (horrific pain in arm) and VACCINATION SITE SWELLING (at injection site her skin did not feel like skin, noticed swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), LACRIMATION INCREASED (eyes watering), SKIN DISORDER (at injection site her skin did not feel like skin), PAIN IN EXTREMITY (horrific pain in arm), VACCINATION SITE SWELLING (at injection site her skin did not feel like skin, noticed swelling), CHILLS (chills), FATIGUE (chronic fatigue, feeling being exhausted) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) and LACRIMATION INCREASED (eyes watering) had resolved, SKIN DISORDER (at injection site her skin did not feel like skin), PAIN IN EXTREMITY (horrific pain in arm), VACCINATION SITE SWELLING (at injection site her skin did not feel like skin, noticed swelling) and FATIGUE (chronic fatigue, feeling being exhausted) outcome was unknown and CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.
Severe migraine, then severe vertigo and nausea. Migraine was approximately 20 hours after vaccine then vertigo / nausea within 48 hours. Dizziness is so severe am unable to function - must sit or lie down. Nausea is strong, even after taking an ondansteron.
A 32 year old female patient, born on Sept 1 1973 was vaccinated with 1 ml RabAvert IM on Aug 11, 14, 18, 25 2005 and on Sept 8 2005. On Aug 11 2005 the patient also got HRIG. Patient was bitten by the family dog who was determined to be rabid. On Sept 2 2005 the patient was found to be pregnant with twins. She lost pregnancy and had dilation and curettage on Oct 5 2005. Seriousness criterion: medically significant (OMIC). Causality not related. Drug exposure during pregnancy is expected, abortion is unexpected, after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.