chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hemmorhage of my right retina; numbness and tingling in her fingers, knee, and feet; numbness and tingling in her fingers, knee, and feet; swelling in joints; stiffness in joints; joint pain; patient felt an achiness throughout her entire body with extreme fatigue; body aches/ patient felt an achiness throughout her entire body; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL HAEMORRHAGE (hemmorhage of my right retina), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet) and PARAESTHESIA (numbness and tingling in her fingers, knee, and feet) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NUTRIENTS NOS (SUPER GREENS), THUJA OCCIDENTALIS (THUJA) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (body aches/ patient felt an achiness throughout her entire body). On 01-May-2021, the patient experienced RETINAL HAEMORRHAGE (hemmorhage of my right retina) (seriousness criterion medically significant), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet) (seriousness criterion medically significant), PARAESTHESIA (numbness and tingling in her fingers, knee, and feet) (seriousness criterion medically significant), JOINT SWELLING (swelling in joints), JOINT STIFFNESS (stiffness in joints), ARTHRALGIA (joint pain) and FATIGUE (patient felt an achiness throughout her entire body with extreme fatigue). At the time of the report, RETINAL HAEMORRHAGE (hemmorhage of my right retina), HYPOAESTHESIA (numbness and tingling in her fingers, knee, and feet), PARAESTHESIA (numbness and tingling in her fingers, knee, and feet), JOINT SWELLING (swelling in joints), JOINT STIFFNESS (stiffness in joints), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (low grade fever), FATIGUE (patient felt an achiness throughout her entire body with extreme fatigue) and MYALGIA (body aches/ patient felt an achiness throughout her entire body) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.  Company Comment: 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.
sore throat; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.   No treatment information was provided.     Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: the follow up were received on 15-apr-2021 and contains following updated information :Patientconfirmed he had sore throat and fatigue after the vaccine, but he feels fine now. He does not want to fill the AE follow-up format and denies further follow-up.
Lyme vaccine shot 11/11/1999 and 12/8/1999 Lot #LY116A2 exp 3/17/2000 12/1/2000 lot #LY146A9 exp 11/18/2001 I was diagnosed with breast cancer 10/2000. I am not sure if the lyme vaccine had anything to do with developing breast cancer. My cancer is not genetic. I had the test done.
No additional adverse effects reported; one dose of expired and improperly stored PROQUAD was administered to a patient; one dose of expired and improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 3 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-AUG-2020, the patient was vaccinated with dose of expired and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection, subcutaneously, lot # S003868, expiration date 08-AUG-2020 (strength and dose were not reported) reconstituted in properly stored sterile diluent for prophylaxis.  On 04-AUG-2020, the dose of the vaccine was exposed to temperature excursion at -8.7 Celsius degrees (C) for 4 hours 30 minutes. The call was due to digital data logger. No additional adverse effect was reported.
Patient developed fever on 10/28-treated with OTC meds. He developed a rash on 10/29 located on trunk and face. Eye blinking occurred as well as abdominal pain. Behavioral changes all sx resolved by 11/2/09.
This spontaneous report was received from a registered nurse regarding a patient of an unknown age. Information on the patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2018, the patient was vaccinated with M-M-R II that was reconstituted with expired sterile diluent (lot# M009800, expiration date: 12-SEP-2018) (expired product administered) for prophylaxis. No adverse effects was reported (no adverse event). There was no product quality complaint. Sender's Comments: US-009507513-1901USA009968: US-009507513-1901USA009967: US-009507513-1901USA007603.
Left arm developed an itchy rash on my wrist and forearm.  About 30 minutes later my ears started itching.  About 45 minutes later my right eye was itchy.  I took two Benadryl tablets and decided to work from home.  I drove home and took a nap.  When I woke up the rash and itching were gone.
Left deltoid: swelling the size of a tennis ball, erythema, and pain.  Site measures 6.5cm by 8.5cm.  Pt was seen by her doctor.  Pt given ZYRTEC 10mg bid until improved.
a patient that received her first dose of GARDASIL 9 at the age of 12 and received the second dose one month later instead of 6 months later; No other AE; Information has been received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not provided.      On an unknown date, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) at the age of 12 and received the second dose one month later instead of 6 months later (inappropriate schedule of product administration). The reporter was inquiring if the patient now needed a third dose. No other adverse event were reported.
Pt presented with redness, pain and warmth to right upper arm surrounding site where vaccine was administered. Treated with antibiotic and Tylenol.
Patient with complaints of redness, warmth to site, mild tenderness noted, no pustule, no papule. Advised to apply cool compresses take Benadryl. Return to clinic if unresolved.
Positive COVID Test after vaccination; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID Test after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID Test after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID Test after vaccination) had resolved.        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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
Swollen lymph node armpit  (side of injection); still significant after 36 hours   Fever up to 102.3?lasted for 24 hours
6/1/15 Mom returned to office approximately ten minutes after she had left with infant. She stated that patient cried after receiving shots. He quieted in the elevator on the way to the car. In her car she lay him down to feed him and noted him to be limp and lacking muscle tone. He was still breathing and had no color change. He had no abnormal motor activity. She rushed back to the office. Our office manager noted him to be somewhat limp when appeared with him. She pulled from a patient room to examine patient. When I arrived, patient was breathing quietly. He had normal capillary refill. Oxygen saturations were obtained and were 97% RA. His heart rate was 96 and his respirations were 32. Patient awoke while and became very active while we obtained O2 Sats so we were unable to obtain a manual blood pressure. I requested mom feed patient in the office and she did so without incident. I also requested she watch him today and tomorrow at home and gave her a work note to do so. I will recheck him tomorrow and perform a neurological exam again tomorrow. I will also report this incident to the VAERS. Etiology of event not completely certain although I suspect vasovagal episode. Patient with no pause in respiration, no swelling, and no evidence of respiratory difficulty to suggest anaphylaxis. His mother did breast feed him just prior to immunizations and she did say that he spits up frequently. He many also have refluxed and choked on reflux although lack of color change makes this less likely. 6/2/215 Return visit At follow up visits his mother states that he appeared back to baseline. He was reportedly playful and interactive. His appetite was decreased the day the immunizations were given but resumed the next day. He had no fevers, no fussiness, and no irritability. On my exam, patient's neurological status was completely normal and consisten with his exam prior to his immunizations. I discussed the episode at length with his mother. His maternal grandmother reportedly told his mother that one of her sibs had had a similar incident with immunizations when she was an infant. Patient also has a sib who had breath holdin spells as an infant. Incidnet is most consistent with a vasovagal response. I suggested we give further immunizations individually and patient's mother is in agreement.
Dizziness, Myalgia, NauseaVomiting, Palpitations, swollen lymph nodes in neck, SOB
patient's grand mother came to the pharmacy on 06/04/2021 evening to inform us that her grand daughter went through a significant side effect from her 2nd dose of Moderna Covid-19 vaccine, which she received on 05/25/2021. She informed us that patient went through partial paralysis of her facial nerves and had to go to the ER, where she was told that she has suffered Bell's Palsy. She was provided treatment for the same and is still recovering from the adverse event
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2016, the patient was treated in the same hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Body aching; slight fever; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7532, Expiration date: Unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 43-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The medical history was not reported. The patient concomitant medications included Paroxetine (PAXIL), start and stop dates were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198, Expiration date: Unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 43-years-old), as 1ST DOSE, SINGLE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 02:00, the patient had experienced body aching and slight fever. The patient received treatment with TYLENOL for the reported events. The clinical outcome of the events body aching and slight fever were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow-up (29Jun2021): Amendment: This follow-up report is being submitted to amend previously reported information: country added in patient information, patient's details added, concomitant medication Paxil was recoded, allowed to contact hcp was updated as no, age and age unit was added in historical vaccine and lead and final sentence (Since provided allowed to contact as No) in narrative was updated.  No follow-up attempts are needed. No further information is expected.
As I inserted the needle of the syringe into the patient's arm, some drops (2-3) ran down her arm.  Most of the vaccine went into the deltoid muscle thereafter.  The patient was calm.  The patient was calm, responsive and show no signs of adverse reactions to the vaccine.  3/24/21
Bells palsy; His left hand side and face are not working properly; His left hand side and face are not working properly; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARAESTHESIA (Bells palsy; His left hand side and face are not working properly) in a male patient of an unknown age 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.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEMIPARAESTHESIA (Bells palsy; His left hand side and face are not working properly) (seriousness criterion medically significant) and HYPOAESTHESIA (His left hand side and face are not working properly). At the time of the report, HEMIPARAESTHESIA (Bells palsy; His left hand side and face are not working properly) and HYPOAESTHESIA (His left hand side and face are not working properly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   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. Further information has been requested; 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. Further information has been requested
My face started tingling like pins and needles. I started having slurred speech.  Facial paralysis and numbness. My face was numb and slurred speech like Bell?s palsy for 4 days. Left side of face stayed numb for 3 weeks
Mom reported light red rash noted over both arms and torso-approximately 3 hours after injection.  Prescribed Benadryl 3/4 tsp. every 6 hours per mouth-rash gone after 1.5 hours after Benadryl.
Mild tingling on upper lip lasting 24 hrs- thought it was a herpes prodrome , took valcyclovir 1000 mg x1.  This was unusual because  I don?t ever get tingling in upper lip , I only get cold sores occasionally on lower lip, so then I realized after talking with my coworkers, it was probably a vaccine reaction and I shouldn?t have taken the Valcyclovir
This case was reported by a physician and described the occurrence of muscle soreness at injection site in an adult male subject who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  In October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  In October 2007, the same day after vaccination with Flulaval, the subject experienced muscle soreness at injection site.  One day after vaccination with Flulaval, the subject experienced tiredness and achiness.  The subject experienced muscle soreness at injection site, tiredness and pain for approximately one day after the vaccination.  The subject was treated with Advil.  At the time of reporting, the events were unresolved.
Information has been received from a physician concerning a 31 month old female who on 14-NOV-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 01-MAY-2007, the patient developed a mild breakthrough of less than 50 lesions after receiving varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. Unknown patient recovery status reported. No product quality complaint reported. Additional information has been requested.
On 5/31, I just had pain in my arm. On Wednesday, I was still experiencing arm pain but also was having some body aches. My temperature was 99. something but I was feeling cold, so I stayed home to rest under a blanket all day. Thursday, I was having a headache and body aches, but nothing too severe. On Saturday morning 06/04, I started to experiencing laryngitis and began to lose my voice.  I spoke with a friend who also has experienced this after a vaccine, so I wasn't too concerned until I noticed some mucus build up. So I intended to see a doctor on 06/05, but I woke up that morning on 06/05 and my symptoms had begun to improve and this morning on 06/06 the mucus had broken up so I decided to not go to see a doctor.
Works in an ER. Got COVID vaccine - 2 days ago. + Coughing, + Rhinorrhea/ nasal congestion
Severe itch and rash throughout trunk on body and upper right collar bone area. Redness and painful itching. Occurring 4+ days. Treatment to take benadryl at night and claritin during the day
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.
Started having itchy reaction - almost 7 days after 1st vaccine. Patient observe a bump - around injection site. She also observed it was very warm at the injection site.  Husband looked at it this evening (3/18) about 8 PM - redness around the site and the bump measured about 1 inch in diameter.  We are concerned - is this worthy of a visit to an ER Room or not!! - - No clear guidance on reactions like this have been given except: - rash, bumps etc. - which could lead to an anaphylactic reaction should have occurred within 1-2 hours after the vaccination. patient noticed no reaction - she could even see the site - till today. - all other "reactions" should have disappeared within about 6 days.  So - is it serious - or just triggering another auto-immunity type reaction? We're not Doctors - you tell us !!
ears ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via RA. The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 15:00 (Lot number: EW0166) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: TINNITUS (non-serious) with onset 08May2021 09:00, outcome "not recovered", described as "ears ringing". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient woke up on 08May2021, with her ears ringing. Her husband and she thought that pollen or a shift in the barometric pressure may have caused. When it didn't go away by 5/12, she searched "why are my ears ringing for no reason" and the vaccine connection came up. The ringing has yet to go away as of 28May. Needless to say, she wants the issue reported as part of the vaccine's side effect. No covid prior vaccination. Not tested for covid post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. Follow-up attempts are completed. No further information is expected.