chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe flu symptoms; Bed rest for 4 days and could not go to work; Weak; Dizziness; Chills; Nausea; Vomiting; headache; Lowgrade fever; Body aches; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), PAIN IN EXTREMITY (Sore arm), ASTHENIA (Weak) and DIZZINESS (Dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D [VITAMIN D NOS], CURCUMIN and UBIDECARENONE (COQ 10) for an unknown indication.    On 20-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced MYALGIA (Body aches). On 27-Jan-2021, the patient experienced INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), ASTHENIA (Weak), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 01-Feb-2021, INFLUENZA (Severe flu symptoms), BED REST (Bed rest for 4 days and could not go to work), MYALGIA (Body aches), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (headache) and PYREXIA (Lowgrade fever) had resolved. On 02-Feb-2021, DIZZINESS (Dizziness) had resolved. On 04-Feb-2021, ASTHENIA (Weak) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7 F. On 28-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patient demographic details updated. Lab data added. 2 nd dose details added. Concomitant medications added.New events added. The outcome of the event (s) changed from unknown to recovered.
Swelling and pain of left supraclavicular lymph node approximately 18 hours after second dose/left axillary node temporarily swollen; Swelling and pain of left supraclavicular lymph node approximately 18 hours after second dose; Left supraclavicular node is no longer painful, but still swollen and palpable (moveable); This is a spontaneous report from a contactable other hcp (patient). A 28-year-old non-pregnant female patient received 2nd dose of bnt162b2 (lot number: EK4176), via an unspecified route of administration in the left arm on 09Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included allergies: shellfish- severe GI response (not anaphylaxis) from an unknown date and unknown if ongoing. Concomitant medication included desogestrel, ethinylestradiol (APRI), colecalciferol (D3), paracetamol (TYLENOL) and unspecified multi vitamin. The patient did not receive other vaccine in four weeks. The patient previously received 1st dose of bnt162b2 (lot number: EH9899) on 19Dec2020 11:30 AM in the left arm for COVID-19 immunization. On 10Jan2021 06:00, patient experienced swelling and pain of left supraclavicular lymph node approximately 18 hours after second dose. Also left axillary node temporarily swollen. Left supraclavicular node is no longer painful, but still swollen and palpable (moveable). Outcome of events was recovering. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Jan2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment was given for events. The patient was not diagnosed of covid prior vaccination.
Patient's face was flushed, had red hives on arms and legs and complained of back spasms.
On March 15th I had a complete physical with Dr and it was showing slight anemia for the first time ever in my life. I had to go back in 3 weeks for blood work again and was told my red blood was down but Iron was ok. I was sent to gastro for test to see if i was loosing blood. He did not find anything, but i am getting tired and really cold .  Went back in for more blood work an it was down more so she said I will give you Iron and hope that will help . I just got blood checked again and it was up a little
per staff at facility patient died 24 hours post vaccination. Please contact Director of Nursing for further details.
Initial unsolicited report received from consumer on 05 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, route and site of administration was not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination; the patient had experienced alopecia. Patient was also vaccinated with INFLUENZA VACCINE (FLU SHOT) on unspecified date in last year and experienced alopecia. Laboratory data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Fatigue, chills, body aches, headache lasted 12 hours. Treated with ibuprofen.
able to smell thing but not tell what it was; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received 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 an unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history included COVID-19 (my taste and smell went away and came back different) from Dec2020 to an unknown date. It was reported that post COVID 1 month the patient's smell started to return some and somewhat went back to normal. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced able to smell thing but not tell what it was. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
hearing loss; shingles; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around April 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, lot #, expiration date, site and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and hearing loss. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered both events to be disabling. Upon internal review, the event of hearing loss was determined to be medically significant.
Eyes were burning, felt unsettled, then sharp pains in top right rib area under breast, shortness of breath followed by severe pain under breast & back area. Chest was hurting- Continued for 15-20 min, walked, tried to use restroom, continued to hold hand on rib area. Called neighbor (nurse) to come help me. I couldn't sit, lay down, trouble getting on/off toilet. felt like bad gas - daughter took me to ER.
CLOSING OF THROAT; HIVES; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included corn allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced closing of throat. On 10-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from closing of throat, and hives on 10-APR-2021. This report was non-serious.
The patient was seen in the ED on 8/16/23 for increasing weakness over the past 2 days. She took an at-home COVID-19 test prior to coming into the ED which resulted positive. The patient additionally had a fall at home - this is what prompted her to come to the ED.  She additionally reports symptoms of sore throat, malaise/fatigue, generalized weakness, and congested cough. A COVID-19 PCR test also resulted positive in the ED. While in the ED, she was found to have atrial fibrillation with RvR - this resolved during her admission.  Ultimately, she was admitted on 8/16/23 - 8/19/23. Discharge diagnoses include COVID pneumonia, among other diagnoses.
Burning pain "deep" at injection site at time of injection.  The pain has gotten worse and is now limiting movement of shoulder.  Numbness and tingling in arm extending into hand and all fingers.
Redness and swelling that extended to the elbow at injection site which appeared today on right deltoid.
Patient developed left groin pain that radiated to his left hip- Testicles felt very tender- this happened the day after receiving the injection
Feverish, chills, weakness injection site red & hot at PNEUMOVAX site.
Arm swelled severely, hot to touch, and painful. Pt went to her doctor and received a cortisone short which cleared up her symptoms. Pt recovered and is now in good health.
pt recvd vax; pt died of SIDS w/in 30 days of vax;
Patient reported "worst taste" in her mouth.  I took her to a secluded area.  Vitals stable.  3:43pm reported chest tightness, itchy in throat, and down her right arm.  20ml children's benadryl administered PO.  Vitals 98% O2, low 80s HR.  3:46pm she had expiratory wheezing in lungs, tickle in throat.  98% O2, pulse low 80s.  At 3:53pm, pulse 83 and 98% O2.  At 4:05pm, she reported it getting more difficult to breath.  Vitals were 98% and 83 HR.  She went into tripod position at 4:05pm, pale, more difficult to speak, more difficult to catch breath.  Administered epinephrine 0.3ml IM to left arm at 4:09pm.  BP 144/92, 99%, 102 HR.  QRS showed up and she left by ambulance at 4:20pm.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: Patient says shingrix vaccine caused her to get shingles
Swelling of vaginal labia during next period, two nodules (opposite each other on outer labia) swelled to size of ~1/2 inch diameter, red in color, no visible blistering, irritated by fabric and urine no discharge or leakage from node. Disappeared in 3 to 4 days. Symptoms reappeared ~15 days later, have not formed nodules but same zone is sensitive and irritated by urine.
reports pain radiating up shoulder, no rash or redness, that started 3 days after vaccine
Information has been received from a medical assistant concerning an infant who on 04-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No treatment was required. The patient was not hospitalized. No adverse event was mentioned except that it was given to a child at an age less than indicated in the prescribing information. At the time of the report the patient's outcome was unknown. Additional information has been requested.
After vaccine, I had a sore arm. Then I got shingles which I believe the vaccine trigged. I went to my doctor and was received some prescriptions. I chose not to take the steroid due to side effects. The shingles lasted for months and all summer which was painful with burning and itching. By fall, it was mostly gone. When I get stressed or another virus, they still come on at times.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX.  Additional details were provided as follows: On 25th October 2018, the patient was hospitalized for surgery un-related to receiving the SHINGRIX vaccine. The healthcare professional did not provide the lot number or expiration date of the SHINGRIX vaccine used for the 1st dose. The reporter gave consent to follow up.
Tested NAAT positive for COVID 10/7/21 after being fully vaccinated.
High Fever, Fatigue,  Hallucinations,  Muscle Cramps in arm,  Lasted for two full days
Developed large area of erythema, warmth and associated rash on left thigh after injection. Resolved.
Sore arm with general swelling noted in deltoid and upper shoulder on post-vaccine day 0 and 1. Managed with acetaminophen and resolved by morning of post-vaccine day 2. Headache started in morning of post-vaccine day 2 and increased in intensity throughout day.  Initially managed with acetaminophen. Difficult to manage as day progressed.  In addition, dizziness and slight vertigo not dependent on position/posture manifested in moderate intensity in late afternoon.  Rested in reclined position which did not ease symptoms of headache or dizziness. Was able to sleep and woke up in morning with no symptoms.  Dizziness did manifest in mild intensity on post-vaccine day 3 off an o, not dependent on activity or position, but was manageable. No further symptoms since day 3.
Bell's Palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Bell's palsy, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It is reported that the patient was given with a steroid shot. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (strength unspecified) (lot# M010440 with expiration date: 09-DEC-2018 and lot# M020102 with expiration date: 18-MAR-2019), route unspecified. The suspect product was exposed to 50.2F for 36 minutes detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breathe/S.O.B when lying down; feeling irregular heart rhythms; chest pain; chest pressure; migraine; feeling warm; arm pain; muscle pain; shivering/chills; fatigue; swollen at injection site; pain and swollen at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7484, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 01Aug2021 at 12:00 pm (age at vaccination was 21 years) as dose 2, single for COVID-19 immunization. The patient's medical history included scoliosis. The patient did not have any known allergies. Concomitant medications or other medications the patient received in two weeks included melatonin and citrus aurantium, crataegus monogyna fruit, cymbopogon citratus, matricaria recutita flower, mentha spicata leaf, rosa x centifolia, rubus fruticosus leaf, tilia spp. flower (SLEEPYTIME HERB) (sleepytime tea) both taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0198, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jul2021 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Aug2021 at 14:45 pm, the patient experienced feeling warm, shivering/chills, migraine, chest pressure, chest pain, shortness of breathe/S.O.B when lying down, feeling irregular heart rhythms, fatigue, pain and swollen at injection site, muscle pain and arm pain. No treatment was received for the adverse events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Diarrhoea; Redness at injection site; Swelling at injection site; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site), CHILLS (Chills) and VOMITING (Vomiting) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALLOPURINOL, CLOPIDOGREL, METFORMIN, AMLODIPINE, ATORVASTATIN and MIRTAZAPINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site), CHILLS (Chills) and VOMITING (Vomiting). On 11-Mar-2021, DIARRHOEA (Diarrhoea), CHILLS (Chills) and VOMITING (Vomiting) had resolved. On 13-Mar-2021, VACCINATION SITE SWELLING (Swelling at injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-073248 (Patient Link).
Immediate nausea, vertigo, tinnitus, severe fatigue, migraine, blurred vision.  These have persisted since vaccination administration.  Vertigo and blurred vision persists, tinnitus daily but not continuous, severe fatigue, and daily migraine.
A physician's assistant reported that after receiving her first dose of Prevnar, that evening the child developed a fever of 101.8 F., irritability, and vomiting.
Intense wave of nausea; Diarrhea; Sinus headache; Body aches (concentrated in lower back, legs, and feet); Injection site soreness; Mild dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma, fibromyalgia, IBS (irritable bowel syndrome), depression and anxiety. Concomitant medications included gabapentin (NEURONTIN), sertraline hydrochloride (ZOLOFT), levocetirizine dihydrochloride (XYZAL), ethinylestradiol/norgestimate (TRI-PREVIFEM) and colecalciferol (VITAMIN D3); all for unknown indications from unknown dates and unknown if ongoing. 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. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, side effects began 14 hours after second dose, waking the patient up from sleep and the patient experienced intense wave of nausea, diarrhea, sinus headache, body aches (concentrated in lower back, legs, and feet), injection site soreness and mild dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense wave of nausea, diarrhea, sinus headache, body aches (concentrated in lower back, legs, and feet), injection site soreness and mild dizziness was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.