chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm after first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included MELOXICAM and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-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 PAIN IN EXTREMITY (Little sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (Little sore arm after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol. Concomitant products included Blood pressure medicine, Cholesterol medicine.   This case was linked to US-MODERNATX, INC.-MOD-2021-076482 (E2B Linked Report).
16 year old got the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna Covid 19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna Covid 19 vaccine). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna Covid 19 vaccine) 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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number 019B21A) with no associated AEs reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received does not contain any significant information. On 28-Apr-2021: Follow-up received does not contain any significant information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number 019B21A) with no associated AEs reported.
Two days after receiving the vaccine, I began to have the feeling that my insides (as in my "guts" or my intestines) were on fire. I didn't have diarrhea, but the feeling was very intense and I had to go to bed. I took Pepto Bismal, hoping it would alleviate the awful feeling. It wasn't like any other stomach or intestinal upset I've ever had. It literally felt as though my insides were "on fire", inflamed. The feeling persisted for 2 days and then went away. During that time, I just ate tea and toast and hoped that I wouldn't see any blood in my stool. It was very frightening.
No adverse events noted in the immediate observation period after vaccination.  Concern is that she may have had undiagnosed and undisclosed COVID illness when she was vaccinated.   Scheduled for COVID test on 1/23/21.  Results pending.
BAD FLU-LIKE SYMPTOMS; CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced bad flu-like symptoms. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from bad flu-like symptoms, chills, and fever on MAR-2021. This report was non-serious.
Severe headache, Moderately bad body aches, Feel foggy, Joint aches, Hot, Chills, Eyes feel hot, Eye pain, Moderately bad arm pain-hard to move arm, slight sensitivity to light, Nausea, Fatigue
felt real real weak; not be able to do house and yard work; she is not going to receive the second dose; felt like a different person; felt real real weak; nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard), the first episode of ASTHENIA (felt real real weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not be able to do house and yard work), PRODUCT DOSE OMISSION ISSUE (she is not going to receive the second dose) and FEELING ABNORMAL (felt like a different person) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension, THYROID for Thyroid disorder.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced EPISTAXIS (nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard). On an unknown date, the patient experienced the first episode of ASTHENIA (felt real real weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not be able to do house and yard work), PRODUCT DOSE OMISSION ISSUE (she is not going to receive the second dose), FEELING ABNORMAL (felt like a different person) and the second episode of ASTHENIA (felt real real weak). On 07-May-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not be able to do house and yard work), FEELING ABNORMAL (felt like a different person) and the last episode of ASTHENIA (felt real real weak) had resolved, PRODUCT DOSE OMISSION ISSUE (she is not going to receive the second dose) outcome was unknown. At the time of the report, EPISTAXIS (nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported. No consent to follow up
Transverse myelitis. 9/2/14 - left arm weakness. 9/6/14 - right leg weakness. 9/8/14 - increased weakness, neck pain, poor head control.
It has been 7 days since I received the vaccination and I am still dealing with fatigue, chills, sweats, soreness on the injection site, and several lesions on my face - one or which is the size of a quarter - that are continuing to spread.
Started as sore throat.  Turned into a bad cold and then a severe sinus infection that lasted 6 weeks.  Again on April 4, 2013, the same symptoms occurred. Finally was given Augmentin which got rid of dark mucus, but I still have non-allergic rhinitis and cannot get rid of it.  I never had a sinus infection before 12/26/12.  Reflecting upon this, I strongly believe it is related to the flu vaccine administered on December 21, 2012. Please note that there was localized inflammation at the site of the injection.  This lasted about a week.
Rash on face, neck, and leg then arm. Seen in office by Dr. on 4/23, rash described as: maculopapular areas blanching on left arm diffusely, scattered on legs, abdomen, broad erythema face bilaterally, no pustules, no vesicles. Treatment of probable allergic reaction with Benadryl. Will also test for Lyme.
5/15/14 objective fever 101.2 degrees F tympanic. 5/16-5/18/14 subjective fever.
Patient recevied vaccine around 9:30 am.  During first five minutes of observation, she experienced a seizure-like event/tightening of muscles and she lost consciousness for 30-60 seconds. After waking up, she remained upset and crying. Due to the seizure-like activity, EMS was called. Fire Department arrived within 5 minutes and assessed the patient. She was advised to follow up with Emergency room and released with mother around 10 am.
This spontaneous report a received from a female patient who was a nurse of unknown age regarding herself. The patient's medical history included shingles experienced for the first time approximately on an unknown date in 2008 (reported as 5 years ago) unrelated to ZOSTAVAX vaccination, when she was around a patient who has chickenpox. The patient developed shingles after she administering ZOSTAVAX to 3 patients. On an unknown date, she had experienced shingles twice in the past after vaccinating patients with ZOSTAVAX. She did not have names of those 2 patients. Most recently she developed rash on 22-MAR-2013, on her shoulder and neck after administration of ZOSTAVAX (lot number # H021711 and expiry date was 07-MAR-2014). She experienced tingling sensation and pain 2-3 days prior to development of the rash. The outcome of the most recently occurred shingles, rash on her shoulder, tingling sensation and pain was unknown. The two events shingles which had occurred previously was recovered on an unspecified date. Additional information has been occurred.
Pt recv vax on 8/7/98; on 8/20/98 pt exp chicken pox.
he got hit by a bus, very painful; night sweats; had joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (he got hit by a bus, very painful), NIGHT SWEATS (night sweats) and ARTHRALGIA (had joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (he got hit by a bus, very painful), NIGHT SWEATS (night sweats) and ARTHRALGIA (had joint pain). At the time of the report, PAIN (he got hit by a bus, very painful), NIGHT SWEATS (night sweats) and ARTHRALGIA (had joint pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Patient lost sense of taste stating ketchup tasted like chemicals.. On 10-Mar-2021, Pyrexia: 100°f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment included Ibuprofen and Allergy pill
Nose started to bleed heavily at 10 pm July 4. Heavy period came on suddenly at 12:30 pm July 5
horrible bruising on her legs; Elbowand shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (horrible bruising on her legs) and ARTHRALGIA (Elbowand shoulder pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (horrible bruising on her legs) and ARTHRALGIA (Elbowand shoulder pain). At the time of the report, CONTUSION (horrible bruising on her legs) and ARTHRALGIA (Elbowand shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a Certified Medical Assistant (C.M.A) concerning a 65 year old female patient with bruising on the abdomen, rash on the left posterior shoulder, hypertension, mild diverticulitis, sulfonamide allergy, drug hypersensitivity to antihistamines (unspecified) and cetirizine hydrochloride (ZYRTEC) who on 19-APR-2007 was vaccinated IM in the right arm with a dose of Pneumovax 23, lot #655668/1004F. Concomitant therapy included Lovastatin, Bupropion HCl, Clobetasol propionate cream, Clobetasol propionate topical solution, Clotrimazole, Estradiol (ESTRACE), Flunisolide, Lorazepam, Metronidazole (METROGEL), metaxalone (SKELAXIN) and atenolo/chlorthalidone (TENORETIC). On 19-APR-2007, in the afternoon or early evening (within 24 hours on injection) the patient developed redness and swelling at the injection site. The area was hot to the touch. The reaction continued to get worse during the night. The patient had swelling of the tongue and went to the emergency room. Specific details on how the patient was treated at the emergency room or what tests were done was unknown. Subsequently, the patient recovered. The assistant mentioned that other patients have received injection from the same lot with no reactions. The reporter considered swelling of the tongue to be life threatening and considered the events to be other important medical events. Additional information has been requested.
Pt gets body ache and joint pain like she is having a flare of her juvenile rheumatoid arthritis and a cough, symptoms now improving but still persistent.
(1) Ankles and lower legs and feet swelled noticibely. Painful, a little nauseating. (2) Elevation, Ice, Anti inflammatory
morning of 5/7/99 around 5AM woke w/fever;c/o h/a & stomachache;vomited 2 times;mom says was not but did not take temp was giving pink tablets thinks for pain & fever;had sz, seemed to no be breathing s did mouth to mouth;viral infect;
11/06/22 presents to ED for "extremity weakness". PMHx of "CKD3, HFpEF, HTN, COPD on 3L at home, DM (diet controlled)"
On Saturday Nov. 26, I started experiencing spiders in my eyes, its like these dark moving things in my vision, and I knew that there was something that was a problem with my vison and I reached out to the specialist, and he scheduled an appointment for to come in that day, he dialated my eyes and looked and discovered retinal tears in both of my eyes, which needed immediate care, on Monday the 28th the treated the right eye, and the next day Tuesday the 29, the treated the left eye. The left eye when being treated had more tears in it and so they had to inject a gas bubble into my left eye. So because of the gas bubble in my left eye, it required me to lay down on my right side all day and all night except when I ate, and that is because the wanted gas bubble would travel to the left side of my eye and stick to it so it did not float around.  This was for two weeks, was taking anti inflamitory in my right eye, and also antibiotics and I am still taking those drops today at least four to five hours away from each other.  It has been six weeks now since this happened and hopefully by now they are fully healed .  I do have my vision back completely and the gas bubble is gone as well as of yesterday I could no longer see it.
BREAKTHROUGH INFECTION; This spontaneous report was received from. This report concerned multiple patients of unknown ethnicity and race. The objective of this study was to describe Predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: UNKNOWN) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection. As per the reporter, " the vaccine breakthrough infections are more likely to be caused by immunity-evading variants as compared to unvaccinated infections. The predominance of immune-evading variants among breakthrough cases indicated selective pressure for immune-resistant variants locally over time in the vaccinated population concurrent with ongoing viral circulation in the community". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210855307. This case was associated with product quality complaint number: 90000191350.; Sender's Comments: V0: 20210855269 -covid-19 vaccine ad26.cov2.s- Breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Positive covid antigen test.; Positive covid antigen test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old male patient received BNT162b2 (COMIRNATY), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 22Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022 at 11:00, outcome "not recovered" and all described as "Positive covid antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: Covid test type post vaccination= Nasal Swab,. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Patient noticed this flu shot was more painful than in the past. It was more achy and it progressively got worse as time went on. She is on a second round of prednisone. Says she has pain in her arm. Numbness and Tingling as well. Dr thought there was some inflammation in the muscle.
Shortly after vaccination within 5 mins pt was sitting on floor. She stated she wanted trash can and shortly after vomited. She stated dizzy too. BP was not low, and no other SS were noted.
Swollen lymph nodes; Fatigued; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Shingrix. On 23rd April 2022, 1 days after receiving Shingrix, the patient experienced fatigue. On 26th April 2022, the patient experienced swollen lymph nodes. On 24th April 2022, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the swollen lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the fatigue and swollen lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-APR-2022 Reporter's Comments: The patient fatigued and recovered on next day. On 26th April 2022 morning, the patient had lymph nodes and were swollen and not resolved. The reporter did not give consent to follow-up.
she had diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient wanted to report the side effects she had after receiving the first and second dose of Pfizer COVID-19 vaccine. She read the prescribing information sheet but the side effect she had was not listed. Patient did not have any questions she was just calling to report the side effect. She said 2 days after receiving the first dose she had diarrhea for a day and the same thing happened after the second dose. The outcome of the event was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
For abt the first 5 days I was in a lot of pain from elbow to collarbone. It has improved slightly but still  experiencing pain in arm w limited mobility. Appears to be in the joint.  Feels similar to what I?ve been through w my left shoulder (bursitis, arthritis etc resulting in a scope/surgery)
Hives on the head, neck, torso, extremities, 2 fingers left hand and palm of the right hand, there was swelling, lips, swollen jaw, swollen crotches, it is been 4 days.
Pt called call ceneter on 5/4/21. Noted no emergency s/sx. Pt stated she got 1st covid vaccine Pfizer 4/29/2021 at VSC and then pt got tiredness, arm pit soreness through chest soreness not chest pain, left breast soreness, muscle pain, headache, dizziness(pt denies emergency s/sx) from last Friday to today. Pt said all symptoms got better today. Pt took ibuprofen and hot tea for symptoms. Pt requests to make appt with MD d/t pt's health hx and appt scheduled for 5/5/21
Developed erythema and itching on face the same day as vaccine administration- lasted for a week before patient sought treatment.  No trouble breathing or throat swelling.
Had fever and headache but the event that occurred at the indicated time was uncontrollable movements - almost as if the chills except much more exaggerated movements and higher paced. This was very scary and lasted for an hour or two
Redness, warmth, swelling, tenderness to left upper arm, approx. 15 cm x 15 cm erythema. BACTRIM DS initiated after blood culture, repeat CBC. Ice for discomfort with OTC analgesic. 10/10/16 only slight redness noted to upper left arm, no tenderness, no swelling.
Within 90 minutes after receiving 1st dose of Moderna vaccine on January 4, the patient experience a sensation of tongue swelling. She took oral benadryl and it resolved, did not recur. She did not have any hives, pruritus or shortness of breath. She did not report the reaction until presenting for her second dose on February 2. The second dose was not administered on February 2. Her primary care physician was notified about the reaction and evaluation by an allergist was recommended.
Body aches, headache, chills, nausea, low fever, fatigue, all on the day after the vaccine and all being gone by the following day.