chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received Paxlovid as treatment from 03Dec2022 to 07Dec2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient give hep B (peds) on 5-1-09 vac exp date 4-28-09
Terrible, excruciating pain in arm of injection, the entire arm but mostly lower. Terrible head and neckache. Worst pain in life besides childbirth, even worse than complete shattering of both ankle bones and heel after being hit by a car.
Right arm swelled 4 inches in each direction from injection site. Area was hot, red and painful which caused an inability to move arm at the shoulder joint.
Became red and itchy all over. Went to walk-in clinic and treated with Benadryl.
patient stated that around 12 hours after vaccine administration she developed extreme fatigue and around 48 hours after receiving vaccine she developed a headache severe enough for her to miss work. The fatigue is still present and forces patient to nap for 2 hours which is unusual for her and she still gets headaches on and off which is unusual for her.
product storage error; This spontaneous report was received from an office manager referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S018595, expiration date 17-JUN-2021, at a dose of 0.5 milliliter (ml) (route of administration and anatomical site of vaccination were not reported) and with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021824, expiration date 25-JUN-2021, at a dose of 0.5 ml (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported), both for prophylaxis.      Both vaccines were stored in a temperature of 54.0 degree Fahrenheit (°F) for 43 hours as recorded by a data logger. There was no previous temperature excursion reported.
3 days after receiving the flu vaccine developed hives on wrist, elbow, forearm and right shoulder of arm that flu vaccine was given in. Took Benadryl improved
NAUSEA mild nausea 1/7 evening resolved after 15 - 20 mins
Called 1/18 due to post vaccination symptoms. Symptomatic 1/7-1/11 but did not call earlier because employee is per diem. Had high fever up to 102, body aches, rashes all over body and vertigo. Symptoms resided by 1/18 except vertigo. Mentioned PMH but not seen neuro since 3/2020. Saw opthomologist 1/25 and dx with nerve swelling and increased ICP, recommended medication adjustment. Vertigo is still there but she feels better, when turns around fast. Will go to neuro appointment 3/3/21 for update and returned back to work with restrictions.
Nausea, vomiting, severe headache, tired, couldn't get awake, fever
I experienced minor throat swelling about an hour after my shot. I took a Benadryl. I hadn?t consumed anything before or after my shot, so I?m certain the swelling was related.   I also got a headache that started about an hour or two after receiving the vaccine. This headache persisted until around 10pm the following evening. I took ibuprofen as I was able.
PFIZER COVID VACCINE #3 GIVEN 9/28/21, LOT #FF2587; 1/27/22 pt had a hospital admission Hospital in from a facility with AMS, hepatic encephalopathy, thrombocytopenia, ascites; functional decline; 2/10/22 tested positive for COVID while in the hospital; required IV morphine for worsening dyspnea; dc'd to Hospice, where she passed away
12 hours after injection: fever, joint aches, nausea, exhaustion lasting 1 day. Injection bump forms on arm. 2 days after injection: hard knot in muscle of arm, radiates heat, and injection site is itchy.
21 weeks pregnant, due September 8, 2020. Started vomiting at 4am on 5/2/2020. Vomited about once an hour until 4pm 5/2/2020. Heart rate started racing and felt very dehydrated so went to the ER. Got IV fluids and an EKG. Nausea remained that evening but began to ease on 5/3/2020.
Dose administered beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered beyond use date). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The nurse had administered the second dose of vaccine to the patients and the dose had a threw date of 29-Apr-2021 and do not use date of 29-May-2021. The patient did not have any reaction to the dose that was administered and were therefore discharged. The nurse was unable to answer all the medical questions as the nurse no longer had access to the patient's records and the patient was gone from the facility.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Significant followup : route and site of administration, lot number and expiration date updated for dose 2 of suspect vaccine, updated patient demographics (ethnicity and ethnic group), updated facility information and an updated narrative
When they left the office, within the hour after eating lunch, the patient started to scream and cry in headache pain. He vomited 2-3x and felt nauseated and lightheaded. They called our office. The mom took the child home and he slept it off. He did not go to the emergency room or need any prescription medicines. We kept in contact with him during the day.
This spontaneous was received from a health worker for VARIVAX, a Pregnancy Registry product, regarding a 37 year old female patient. On an unknown date, the patient was vaccinated with (merck) VARIVAX and M-M-R II while she was pregnant. Concomitant medications were not reported. The last menstrual period (LMP) was reported as 10-JUL-2012 and an estimated delivery date (EDD) of 16-APR-13. Ultrasound was done. The patient sought unspecified medical attention. Follow up information has been received from a health care professional regarding a 37 year old female patient. Patient with 3 previous pregnancies and 1 full term deliveries, in the previous pregnancies did not occur a birth defect or still birth or any miscarriage..On 18-JULY-2012, the patient was vaccinated with (merck) VARIVAX. The patient was not test for varicella antibodies before vaccination with varicella zoster virus containing vaccine. Prenatal testing were performed: ultrasound (29-JAN-2013) negative, the reasons to performed this tests were gestational diabetes and fetal growth. Maternal Serum Alpha Fetoprotein was performed on 29-OCT-2013 negative. Additional information has been requested.
Patient described bruising and swelling  below the injection site that prolonged over a month. Palpable bump present, concern of clot. Recommendation from pharmacy to be seen by PCP
1:58pm vaccine administered in left deltoid, immediately after shot patient said "I feel dizzy" then became pale, diaphoretic,  and hard to rouse.  Help called. RN's NP.   Blood pressure taken 76/35, heart rate 46 b/m. EMS notified, patient protected from falls and head held stable, nausea  and then patient vomited. Oxygen placed on pt.  Patient air way assessed and patent, no sign of anaphylaxis, patient appears to be experience an vasovagal event related to vaccine administration.  Blood glucose monitored with vitals every 3 to 5 minutes.  2:20 pm EMS arrived and patient transferred to their care.
Rash 4 days ago 9/8/11 itchy - many lesions skin trunk, back, groin. Scattered vesicles on an erythematous base - some lesions with just erythema, no vesicular base.
Elevated pulse rate between 95-128 for approximately 24 hours, no other symptoms, resolved without treatment
patient stated at her second dose that after 6 to 7 days she developed an itchy hot rash on her arm and it disappeared in 8 to 9 days.
Information has been received from a 67 year old female patient with epinephrine allergy referring to herself. Sometime in 2008 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route were unknown). On 23-JAN-2016 the patient experienced severe pain on her head. On 24-JAN-2016 a rash formed on her face, head and around her eye. The patient sought medical attention. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine expiry date was on 15-Oct-2021. No adverse effects was experienced by the patient. The Moderna vial was removed from the freezer to the refrigerator on 11-Oct-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials.   This case was linked to MOD-2021-355973 (Patient Link).
TINGLING SENSATION; SHOCKLY SENSATION; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tingling sensation, and shockly sensation. The action taken with covid-19 vaccine  was not applicable. The outcome of the tingling sensation and shockly sensation was not reported. This report was non-serious.
Possible Stroke per Medical examiner but Reported symptoms after covid vaccine 2/11 therefore being considered poss Covid vaccine related also. No hospitalization prior to death. (Symptoms reported to office 2/17) Fatigue, decreased appetite-
On 01/30/2023, I was lying in bed, and I started having heart palpitations. I didn't think too much about it because I've had palpitations in the past. However, they didn't stop. We were on our way to another state to spend part of our winter there. By 02/03/2023, it still hadn't stopped and actually felt stronger. On 02/03/2023, I went to an urgent care. They called an ambulance because my heart rate was really high. They took me to the hospital, where they said I had atrial fibrillation. They admitted me to the hospital where they did a cardiac conversion to try to stop the palpitations and get my heart back to its normal cycle. It worked for only around four hours. They kept me in the hospital and tried some drug therapy. After several days, they got serious about the treatment and gave me a cocktail of medications that I'm not sure of. Within ten minutes, my heartbeat was regular, and they released me shortly after. Ever since then, my heartbeat has been regular, and they put me on some new medications to help with that.
Old scar on right knee (2017) inflamed, sore, itchy, raised.; Old scar on right knee (2017) inflamed, sore, itchy, raised.; Old scar on right knee (2017) inflamed, sore, itchy, raised.; This is a spontaneous report from a contactable consumer. This 14-year-old female patient received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EWO185, expiry date not reported) dose 2 via unspecified route of administration, administered in left arm on 04Jun21 16:15 (at age of 14-years-old) as dose 2, single for COVID-19 Immunisation. Patient medical history include penicillin allergy and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The Patient previously received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EWO171, expiry date not reported) dose 1 via unspecified route of administration, administered in left arm on 14May21 16:00 (at age of 14-years-old) as single dose for COVID-19 Immunisation. On 05Jun21 (one day after vaccination) patient experienced Old scar on right knee (2017), inflamed, sore, itchy, raised. Patient did not receive treatment for adverse events. The Outcome of events was recovering.   Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
I had a terrible fever for about 36 hours, tachycardia, horrendous head and eye pain, congestion, really bad vertigo, and headache. My skin was also extremely dry. I decided to take an at-home COVID-19 which came back positive. It took 13 days before I got a negative test. Afterwards, I contacted my endocrinologist about my leftover symptoms. She was concerned about myocardia from rebounding COVID-19. A couple of days later, I started experiencing double vision so I went to the emergency room. They performed examinations including hand-eye coordination, pupil check, and other tests to ensure the clotting and headache wasn't extreme and that I wasn't suffering from a stroke. I opted in to stay for more hours for further monitoring. Eventually, I was discharged and was able to go home with a prescription for Ibuprofen. As of now, I still have episodes of dizziness. I have an appointment with a PCP on 03/16/2023 for further diagnosis.
Patient reported to health department on 4/28/21, that following her 2nd covid vaccination on 3/3/21 she had a lot of bruising and soreness to her right arm that continues.  Reports her injection was given lower in her arm than her first and pointed to lower end of deltoid muscle.  Unable to determine injection location at this time.  Does have darker flesh toned area approx 1.5-2 inches long near area.  Recommended patient follow up with PCP for concerns/treatment.
On May 1,  2021 I developed acute, severe upper back pain which progressed to myelopathies in my bilateral upper extremities and lower bilateral extremities and torso from sternum down.  This was later diagnosed by MRI as inflammation from C3 to T2 vertebrae. Tx included steroids (from May 5 - October 10), pain medication, 28 days of IV antibiotics (to rule out Lyme or other infection in the spine) and ultimately with decompression/fusion of C5-C7 surgery on 9/29/21.  Other tx have included PT for strength and balance, which is ongoing as the myelopathies have not resolved at this point.  A follow up MRI is anticipate at 2-3 months post-op.  I feel this report is appropriate as providers have not yet been able to identify the cause of the extensive inflamation in my spine which began acutely 3 days post vaccination.
Child's face went gray, she fainted. I caught her and laid her on the floor. Her head tilted to the side and began jerking and her eyes rolled back in her head. It lasted about 10 seconds from fainting to the end of the seizure.
Shot site on arm began hurting a lot around 1am the next day Jan 26. I began to feel nauseous the next day at 11 am. Also had some chills. Took Advil soon after and helped alleviate the chills right away. Received Pfizer-BioNTech COVID-19 Vaccine EUA
Buzying in both ears. Done hearing test, lost of hearing in both ears. numnese in left hand, baby finger and thumb. Just talked to the Doctor and he stated that I could have metal pins insturt into my skin to find out where my troubles are.
This spontaneous report was received from a medical assistant, refers to 4 year old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 25-JUL-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M047660, exp. date: 02-DEC-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. The outcome of events was unknown. On 05-SEP-2017, a return call was received from reporting medical assistant who stated that she would check the chart and fax the patient identifiers and dates of vaccination if any patient were vaccinated with the above products during or after the temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1708USA001467.
Numbness in right thigh from  hip bone to knee cap. Still numb as of 1/21/2021.
does not fully have his taste and smell back; does not fully have his taste and smell back; first dose vaccination on 12Aug2021, tested positive on 16Aug2021 and still tested positive to COVID-19 on 30Aug2021; testing positive to COVID-19; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: unknown), dose 1 via an unspecified route of administration on 12Aug2021 as dose 1, single for COVID-19 immunization. The patient reported that second dose scheduled on 02Sep2021. The patient's medical history and concomitant medications was not reported. On 16Aug2021, the patient experienced testing positive to COVID-19 and reported that still tested positive to COVID-19 on 30Aug2021 and also reported currently, patient did not fully have his taste and smell back and completed his required isolation. On 16Aug2021 and 30 Aug2021 patient underwent lab test and procedure includes COVID-19: SARS-CoV-2 test and result reported as positive. Patient asked if could get the second dose of the Comirnaty vaccine up to 4 days after the scheduled date. The clinical outcome of all events was unknown.   Information about lot/batch number has been requested.
Narrative:  When pt at covid vaccine clinic receiving 2nd dose of covid vaccine pt report diarrhea lasting several days after he had received his 1st dose of covid vaccine. Pt did not report taking any treatment medications.
redness, warmth, itchiness at injection site in an area about the size of her hand
A few days post vax pt developed generalized muscle aches, weakness in her arms and legs, swollen hands and malaise.
On days 19,20,21 post Moderna booster, pain and joint swelling systemically but in particular in hands. Literally unable to use right hand  at all due to extreme pain and joint swelling of entire hand. Abated over the course of several days with the use of Advil. No history of any arthritis at all prior to booster. Immediately post booster, also had 3 days of systemic and severe joint pain which then resolved, only to return again about 3 weeks later as noted above.  Better now but not totally back to baseline normal.
This medically confirmed spontaneous report (initial receipt 02-Nov-2011) concerns a pregnant female patient. On 30-Oct-2011, the patient received a partial dose of AFLURIA. No adverse effect was reported. In the absence of a reported date of last menstrual period (LMP) or estimated date of delivery (EDD), CSL has approximated the EDD to be 27-Jun-2012, using the CSL receipt date of this initial report to be the date of six week gestation.
Red, swollen, Painful, warm to touch. Symptoms started one hr after administration and continued for 7 days.
17DEC93 pt let out cry; dad picked up-pt head fell back, eyes crossed & went upward-went limp & was pale-seemed to quit breathing; eyes glazed;
Pt was 15 minutes after his first vaccine when he passed out in his chair and fell to the floor.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 42 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.