chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M031969 or lot # M038857. The VARIVAX was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The digital data logger was involved in recording the excursion. This is one of six reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005170: US-009507513-1708USA005168: US-009507513-1708USA001493: US-009507513-1708USA005166: US-009507513-1708USA005167:
Headache; muscle aches; soreness at vaccination sight; ringing in ears; nausea; dizziness
PATIENT HAS SWELLING AND REDNESS AROUND INJECTION SITE. THIS IS LIMITED TO THE UPPER ARM BETWEEN ELBOW AND SHOULDER AND ONLY ON THE FRONT OF THE ARM
About a week after pt received the immunization, she began to complain of her eyes "shaking back and forth" and immediately having blurred vision. She reported the shaking to be a few seconds and the blurred vision to last a min or so, sometimes longer. She reported it happening at least twice per hour, sometimes more. No other symptoms reported.
Pt. received PCV 13 4/27/10. Per mom leg was sore and child was unable to walk that evening. Starting 4/28/10 in PM mom noticed redness and swelling at injection site. Today 4x6 cm non tender erythema slightly swollen area on leg.
Fever between 99.6-100 degrees fahrenheit for 24 hours.  Weakness and mild nausea.
Patient is 10 years old, was given Dtap.  Patient should've gotten a Tdap due to age.
light red rash on left arm/Also a bright red rash on ring finger on left hand/wrapped around the finger and in centre of finger with knuckle in middle; This is a spontaneous report from a contactable other HCP. This 55-year-old female other HCP (Patient) reported that: A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EH4176), via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 15:45 (at the age of 55-year-old) as single dose for COVID-19 immunisation at Hospital. Patient was not pregnant at the time of vaccination. Medical history included Known allergies: Penicillin (rash as a child). Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included probiotics (PROBIOTICS); vitamin d NOS (VITAMIN D NOS); cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]); calcium (CALCIUM); magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EH4176), via an unspecified route of administration, administered in Arm Left on 07Jan2021at 15:45 (at the age of 55-year-old) as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination. Patient reported adverse event 3"x2" light red rash on left arm about an inch under where vaccine was administered on 27Jan2021. Rash was not raised also a bright red rash on ring finger on left hand rash not raised but wrapped around the finger completely and in centre of finger with knuckle in middle. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown dates since 31-AUG-2016, the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23 with either lot number L019835 and expiration date of 23-MAR-2017 or lot number L014458 with expiration date of 11-FEB-2017 (strength, dose and route of administration were not reported), which were stored at 67 Fahrenheit degrees for 10.5 hours. There was no previous temperature excursion. The temperature excursion was not detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
The patient complained of severe pain and stiffness. She is unable to use her arm. She applied ice but still no relief.
A physician reported that a 6 month old received 2 doses of Prevnar and was hospitalized on 6/21/01 due to coma. An unspecified culture was reportedly positive for gram diplococci. As of the date of this report, no further information was available. Additional information received from company representative on 07/07/2001, subsequent to 2nd dose of Prevnar immunization, infant developed acute otitis media and was treated with Amoxicillin and Augmentin. On 06/21/2001, the infant developed penicillin resistant pneumoccocal meningitis. the infant waw switched to vancomycin, meropenen, and rifampin for 3 weeks.
began shaking while sitting in high chair;hands were cold, lips bluish, then became limp & groggy;feels warm to mom @ 1PM & seems sluggish at 1PM;
Appendicitis; Prev dose administration date=26Mar2021, Prev dose dose number=1/ Administration date=02Apr2021, Dose number=2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200291865 (Pfizer).  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 14:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRINTELLIX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 26Mar2021, when the patient was 26 years old, for COVID-19 Immunization. The patient was reporting about Covid vaccine for AE. Facility type vaccine was reported as, other. No other vaccine was administered in four weeks. The following information was reported: APPENDICITIS (hospitalization, life threatening) with onset 03Apr2021 00:45, outcome "recovered", described as "Appendicitis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 14:00, outcome "unknown", described as "Prev dose administration date=26Mar2021, Prev dose dose number=1/ Administration date=02Apr2021, Dose number=2". The patient was hospitalized for appendicitis (hospitalization duration: 1 day(s)). The event "appendicitis" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of appendicitis. Appendicitis, resulted in the Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). AE treatment was mentioned as, Appendectomy. Patient had no covid prior vaccination and it was unknown if covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Infantile spasms started at 5pm. Watched her for about an hour before taking to Emergency Room for evaluation.
[Pfizer-BioNTech Covid-19 Vaccine EUA ] ? fever; chills; intense stomach pain; night sweats; leg cramps; leg/feet swelling; weakness; joint pain; light-headed; not feeling well.  --If these had lasted only a few days, I would accepted them as typical. However, stomach pain; leg muscle pain; joint pain; swelling and weakness have lasted OVER THREE WEEKS! And, still ongoing.  I have not heard of this anywhere else.
The vaccine was administered at approximately 0830. That night, before the child went to bed, he became nauseous. According to his mother, he went outside into the cooler air to cool down. He had one "session" of vomiting that consistent of vomiting multiple times. After, he felt a lot better. He went to bed. The following day, his mother kept him home from school. He felt exhausted. He also had a sore arm. His mother reported it was not red, not warm, not swollen. The child reported the pain as a 5 out of 10.
Left upper arm small puncture in deltoid, area of erythema surrounding x6cm and induration warm, Advised cool compress, Motrin PRN.
I started having PVCs a lot, they woke me up at night. My heart pounded so hard. I went to the doctor who ordered me a Holter monitor around Jan 4th. I had significant rate of PVCs and was referred me to a Cardiologist. The Cardiologist ordered an Echo. With new medication the PVCs are controlled and I no longer have them as of now. Around May 5th I got COVID-19 which started with a sore throat. I was congested. The next morning I did a COVID-19 test and it was positive. I had symptoms of a cold/flu. I recovered rapidly but I continued with a non productive cough for 2-3 months.
pain around his lower waist, by his hips; pain around his lower waist, by his hips/couldn't move his hips due to the pain; This is a spontaneous report from a contactable consumer and a Non- contactable Nurse. These two reported similar events for 2 patients. This is 2nd of 2 reports. These two reported for a male patient that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain around his lower waist, by his hips, couldn't move his hips due to the pain. Stated that she only had a sore arm. His physical therapist came that day and he was fine. On Wednesday, he could not hardly stand the pain around his lower waist, by his hips and could not move his hips due to the pain, and he just hollers when he tried to move them. Caller states that he has fought 2 injuries since Jul2020. He broke his left leg, and then broke his right leg up by where the bone connects to the hip. So, he had been in therapy. States that he was in a rest home for 3 months and he has been home for 4 months. Patient home physical therapy and a home care nurse that comes. At first they thought that the pain may have just been from the physical therapy on Wednesday, but when the in home nurse came on Thursday, she said that therapy wouldn't have done that and she thought it was a side effect of the vaccine. The nurse also said that her dad complained of the same thing after getting the vaccine. The clinical outcome of events were unknown.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244776 same reporter/drug/event, different patient
Headache and sinus related symptoms immediately following vaccination and was ongoing.   on 7.28.21 was falling, very dizzy and had tingling in his feet and legs.  Was hospitalized for 4 days and released after MRI, CT scans, COVID testing and blood work came back normal.  He was given IV fluids and medication for dizziness.    2nd Onset of symptoms ..... Extreme lower extremity weakness, falling, dizziness, diarrhea, tingling in feet approximately 1 week prior to 7/28/21.  On 7/28/21 lost feeling in both feet and L leg up to the knee, R leg lost feeling from foot to mid thigh, very unstable walking, progressive paralysis present in both lower extremities and above R knee.  Lost the ability to stand on his own or to walk.  He fell around 3 pm and was taken to  Health Center where tests were normal results.  A lumbar puncture was done and was positive for high levels of protein present in his spinal fluid and diagnosed with Guillian Barre' Syndrome.  He was admitted and  Plasma Exchange was started immediately the next day.  there were 5 exchanges done in 10 days.  At this point he had started to regain some feeling and movement in his right leg and foot and was admitted into the hospitals Inpatient Physical Therapy Program .  He was in intensive physical therapy and occupational therapy  for the next 8 days.  Upon discharge he was able to walk with assistance of another person using a walker and/or cane.  To this date he has not regained any feeling to his right leg, has hand tremors, severe back pain and balance issues.  He is unable to drive or work, having to resign his fulltime position as a forklift operator.  He requires assistance with all ADL including bathing, preparing meals, and transportation to and from all appointments.   He is now taking several medications to help him with the nerve pain and affects of this chronic illness.   He is a fall hazard due to his unstable gait and posture.   His right foot and leg is still paralyzed and unable to bear weight.  He is in in home physical therapy twice weekly.     Prior to taking the vaccine and developing this illness he was able to live a normal life and worked full-time 10 hr shifts at a time.    He requires periodic resting now throughout the day and is unable to earn a income.
extreme fatigue, moderate fatigue, mild fatigue; This spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), dose 1, administered on left arm on 08Mar2021 (Lot Number: EN6202) as 1st dose, single dose (at the age of 50 years old) for COVID-19 immunization. The patient's medical history included asthma. The patient's concomitant medications were not reported. On 08Mar2021 at 16:30 and 09Mar2021, the patient experienced extreme fatigue. On 10Mar2021, the patient experienced moderate fatigue. On 11Mar2021, the patient experienced mild fatigue. The patient received no treatment for the events. The patient also reported of no known allergies. The outcome of the events was recovering.     No follow up attempts are possible. No further information is expected.
Pt completed COVID-19 Moderna vaccine series 2/17/21. Lot number is not specified in the medical record. Pt was admitted to the reporting hospital on 8/30/21 with diagnosis of anemia due to chronic kidney disease. Pt was reported in the ER to have dry hacking cough with diarrhea, low grade fever without chills and shortness of breath. Symptomatic screening NP swab PCR positive for COVID on 8/30/21. Pt was discharged on 8/31, but is presently being re-admitted to the hospital 9/3/21 for low O2 stats.
This spontaneous report was received from a medical assistant regarding multiple unspecified patient with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On unspecified dates in 2016, multiple unspecified patients received improperly stored RECOMBIVAX HB injection 2.5/0.5 (lot # M022077 with expiry date: 10-MAR2019), since the previous excursion on 30-JUN-2016. No adverse effects reported. Temperature/time frame: 1.6 C for 1 hour, 47 minutes. No previous excursions. Data logger involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt arrives at 9:45am for Vaccine. Observed for 15 minutes and returns to car. Enters back into the facility at 10:10am and states, "My face feels numb. The feeling you get when numb at the dentist but in my face. I don't think that's normal." Pt states, "My face is numb, especially up by my eyes. They feel a little swollen too." Patient denies any shortness of breath, chest pain, other numbness or tingling. Pt also denies any feeling of swelling or numbness in mouth or throat. No facial drooping noted and patient able to follow commands, wrinkle nose, smile, stick tongue out. Patient A&Ox3 and able to communicate without difficulty. 10:15 Patient given 25mg IM Benadryl in RT Deltoid. 10:30 patient denies any improvement or worsening of symptoms. EMS called to further evaluate. EMS arrives at 11:00am for further work-up.
Patient contracted shingles after one dose of varicella. She has never had chicken pox. Shingles was a result of her varicella vaccine. I am a healthcare provider (FNP) and her mother.  She still acts like her left thigh hurts where the shingles occurred.
HIGH PULSE RATE; CHEST MUSCLE ACHE; THROWING UP; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bactrim allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, Laboratory data included: Polymerase chain reaction (NR: not provided) Negative. On 05-APR-2021, the subject experienced high pulse rate. On 05-APR-2021, the subject experienced chest muscle ache. On 05-APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F, and Pulse rate (NR: not provided) 120 beats per minute (bpm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, high pulse rate, throwing up, and chest muscle ache. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Vaccine given to patient past 30-day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient past 30-day BUD) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient past 30-day BUD). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient past 30-day BUD) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) patients antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Reporter stated that the vaccine was given unknown amount to patient past 30-day beyond use date (BUD). Patient did not report any adverse events or symptoms.                           Treatment information was not provided by the reporter. It was reported that the analysis of the vial(s) associated with your storage excursion was completed. The vaccine administered on or after 31-Jul-2021, from lot number 037C21A likely did not maintain the activity necessary to fully protect against the SARS CoV-2 (COVID-19) virus at time of administration.   This case was linked to MOD-2021-415889 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Narrative updated regarding Analysis of the vial(s) associated with storage excursion.
Pt had hematoma after injection, pressure applied, complained of dizziness, moved to cot, complained of heart racing and heaviness in chest and felt like she was about to pass out then stated throat was closing and was very scared. Epi pen administered at 09:38am with improvement of sx. O2 NC at 15L. 130/80, 86 HR, 99% O2sat.  EMS called and took pt to ER at 09:45 am.
body aches; muscle pain; headache; fever,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), MYALGIA (muscle pain), HEADACHE (headache) and PYREXIA (fever,) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In December) and Pneumonia.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (body aches), MYALGIA (muscle pain), HEADACHE (headache) and PYREXIA (fever,). At the time of the report, PAIN (body aches), MYALGIA (muscle pain), HEADACHE (headache) and PYREXIA (fever,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Developed hives on opposite arm shortly after shot (but idiopathic hives are normal for me and it was the wrong arm so I thought nothing of it). Full body aches, especially in legs, from about 6:30pm on 3/13 to midnight of 3/14. Location of shot was warm to the touch, sore, and slightly swollen. Temp was 98.6 F.  After midnight the aches became centered on my legs and became more severe coming in waves every few seconds. Tachycardia. Muscle weakness. Nausea. Teeth began to hurt (from clenching?). Severe dizziness and vertigo starting from 7pm on 3/13 and peaking around midnight. Migraine with visual disturbances beginning at 7pm on 3/13 peaking at about 9pm and lasting at least several hours. Vertigo and migraine seemed related. Former worsened every time the pressure in my head did. Looked like the room lit up briefly every few seconds. My sense of touch felt off - textures felt different than normal and couldn?t feel my back when I touched it. Leg pain began to lessen around 4am, and fully resolved around 7am. Dizziness began to improve around 6am but persisted, albeit to a milder degree, for most of 3/14. Brain fog and sinus pressure from around 7pm 3/13 persisting through the following day. Some nausea throughout 3/14 but less severe than on 3/13. Poor temperature regulation from about 6pm 3/13 to 3pm 3/14. Symptoms became tolerable around 3:30pm on 3/14 and had mostly resolved by evening. Muscle weakness resolved by evening of 3/15. Pressure headache resolved by late morning 3/16.
This spontaneous report as received from a other health professional refers to a patients of unknown age. In October 2016, the patients were vaccinated with VARIVAX lot # M025870 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Developed Shingles - vesicles, itching on anterior mid chest and posterior mid back
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: patient came back later in the afternoon in a cheerful mood to obtain COVID-19 card, say thank you, and that he was diagnosed with vasovagal syncope.
PT WAS VACCINATED USING MODERNA ON 2/24/21 (LOT 015M20A) + 3/31/21 (LOT 047A21A). TESTED + 9/03/2021