chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included seasonal allergy, pain killer allergy, medical marijuana abuse/medical marijuana smoker, alcohol use, rheumatoid arthritis, and lymphoma, and other pre-existing medical conditions included the patient had a retoxic treatment in MAY-2020. The patient was previously treated with methotrexate for immunosuppressive drugs five days prior to the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to left deltoid for prophylactic vaccination. Concomitant medications included leflunomide (20 mg once daily) for rheumatoid arthritis.  On 25-MAR-2021, the patient's first antibody test was negative (non reactive). On 08-APR-2021, the second antibody test was also negative (non reactive). Test results suggested that the patient experienced confirmed immunological vaccination failure (coded to- therapy non-responder). The patient did not develop antibody, which he was suspecting because he read an article about it, the reason of this was that he was taking leflunomide. He did not develop any side effects after getting the vaccination and he mentioned that it was difficult to say if he experienced a side effect because he had a medical condition that could be the cause.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417253-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED; Stomach pain; Diarrhea; Muscle pain; Mobility decreased /Count not hardly move; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT MISUSE (Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED), MOBILITY DECREASED (Mobility decreased /Count not hardly move), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and MYALGIA (Muscle pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 016B21A) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for Pancreatic insufficiency.    Previously administered products included for Product used for unknown indication: AUGMENTIN. Past adverse reactions to the above products included Vomiting with AUGMENTIN. Concurrent medical conditions included Drug allergy (manifested by vomiting) and Pancreatic insufficiency.   In October 2020, the patient started PANCREATIN (CREON) (Oral) 1 dosage form. On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MOBILITY DECREASED (Mobility decreased /Count not hardly move) and MYALGIA (Muscle pain). On 26-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced INTENTIONAL PRODUCT MISUSE (Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED). In May 2021, MOBILITY DECREASED (Mobility decreased /Count not hardly move) and MYALGIA (Muscle pain) had resolved. At the time of the report, INTENTIONAL PRODUCT MISUSE (Intentional product misuse / PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED) outcome was unknown, ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and DIARRHOEA (Diarrhea) was resolving.            No concomitant medications were reported.  The patient only eat small amount of food so she would only need to take one pill in order for her not to completely run out of medication. She had not gotten her refill and only 10 capsule left and having the adverse event because she was not taking the medication as recommended.  No treatment medications were reported.  The reporter's causality for the event(s) of MISUSE/PATIENT WAS NOT TAKING CREON MEDICATION AS RECOMMENDED and COUNT NOT HARDLY MOVE was not provided. The reporter's causality for the event(s) of SEVERE DIARRHEA, STOMACH PAIN and MUSCLE PAIN with CREON(PANCREATIN) was no reasonable possibility.
PATIENT STATES 2 DAYS AFTER TDAP WAS GIVEN HE DEVELOPED ITCHINESS AND HIVES THROUGHOUT HIS WHOLE BODY.
2 wk h/o rash, fever, itchiness. Started w/itchy rash on feet, now all over body. Decreased appetite.R/tm red/bulge, oropharynx is nml, face w/diffuse macular rash. Tx:OM:Zithromax x5 days; Fever: Motrin, Rash:?able etiology.
The vaccination was given in the shoulder area. After 2 hours, I wasn't able to raise my left arm more than 5 inches. It was very painful to move my left arm and I had very little range of motion. My Doctor referred me to a shoulder specialist. He also confirmed that the vaccine was given in the shoulder. I was given stretches to do and was told to take 6 Advils a day for 2 weeks. The arm got better, but I still have pain in my left shoulder. My main concern is that sooner or later I'm gonna get the Doctor's visits bills.
No adverse reactions noted. Resident received 2 doses of the bi-valent Moderna booster.  Resident had stated had not had one.
Information has been received from a health professional concerning a 36 year old white male who on 12/17/01 at 9:45 was vaccinated SC in the left arm with a dose Of Varivax. It was reported that the patient was vaccinated SC in the left arm with a dose of MMRII on 12/05/01. Fourteen days post-vaccination with Varivax on 12/31/01, the patient developed a varicella rash with ten lesions and also experienced diarrhea, abdominal pain and nausea. Unspecified medical attention was sought. Follow-Up information received from the physician indicated that 16 days post vaccination, on 01/02/02, the patient developed multiple lesions on his trunk, arms, right shoulder, back and thigh. There were a total of 20 lesions varicella titers IgM and Ig G were checked on 01/14/02 and were negative. Subsequently, the patient recovered. No further information is available.
48 hrs after vaccine, mom reported low grade fever, vomiting, (L) arm red, swollen, hard (approximately 5 inches).
Patient was bleeding a little more than normal. I watched it briefly and opted to put a second inject safe bandage of the first one. She called the next morning and said that she bled for 30 minutes while shopping in the store. When she removed the bandages there was a clot.  I suggested that she contact her PCP to make sure nothing more serious was going on. At the time of the exam there was slight bruising and she wasn't concerned unless severe bruising occured. They had her come in, and the provider felt that I did not push the needle in far enough, but I used a 1 inch needle and when I released the needle retraction mechanism I recall nothing unusual.
approx 36hrs following vax pt devel 1 lesion, @ time of rpt pt had 15 scattered vesicles on face & trunk. & fever.
Swollen throat within 1 hour; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient 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 17March2021at 23:15 (at the age of 69-years old) as a single dose for COVID-19 Immunization. Medical history included diabetes and heart condition, fruits allergy (walnuts, citrus), food allergy (gluten, tomatoes). Past drug history included allergy to aspirin, penicillin and norco. Concomitant medications included coreg (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), calcium supplement, (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) for unknown indication. Patient did not receive any other vaccine within 4 weeks prior to the COVID-19 and was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17March2021 patient experienced swollen throat within 1 hour of vaccination. Benadryl tablets were taken on an unknown date for the event. The clinical outcome of the event swollen throat was recovered. No follow-up attempts are possible; information about lot number cannot be obtained.
First dose: little spacey, lightheaded; First dose: little spacey, lightheaded; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Deltoid Left on 30Mar2021 (received at the age of 66-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included GI (gastrointestinal) bleeds and irritable bowel. Concomitant medications were not reported. Historical vaccines included Pneumonia 23 in 2020 and Influenza shot in 2020. Last year (2020), since she is now a senior citizen, when they gave her the Pneumonia 23, the tech who gave it to her, gave it too close to her shoulder bone, gave it too high, gave it 2 inches too high, it got all red and swollen and hot to touch and came across, 6 inches across towards her chest and breast, blamed it on her not putting it on the right spot. She also had the Senior Influenza shot, and that got a little red, which she never had that before either. The patient experienced little spacey, lightheaded on 30Mar2021 after receiving the first dose of bnt162b2. She stated with the first dose she was fine; she got a little spacey or lightheaded or something as soon as they put the stuff in her arm. The events began and ended 30Mar2021. The events lasted for about 5 minutes. She confirmed she recovered completely. Outcome of the event was recovered on 30Mar2021. The reporter assessed the events as serious (medically significant).; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
July 21, 2022 I tested positive for COVID-19. I had a low-grade fever, muscle and joints ache, cough, and a headache. I contact my doctor and she instructed me to come in for a kidney function. The kidney function came back as normal.
26OCT AM had sx of bladder infection but no fever; got flu shot; 3PM pain in back & breast & seen by MD for bladder infect; 28OCT pain cont so seen by MD did x-ray sx pleurisy; MD not sure if vax related; 9NOV92 pt feeling tired;
trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work.  Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem.  Information on batch/lot number has been requested.
This may NOT even be related to the JJ shot I had,  but I got Conjunctivitis  (Pink-Eye) 4 days after the shot.  Blurred vision and severe itchiness sent me to get relief  from Urgent Care
worsening asthma symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "worsening asthma symptoms".  Additional Information: It was reported that the patient mentioned that he got the booster shot in July and the reporter believes it is the monovalent booster that the patient received, but not entirely certain. The reporter wanted to know when the adult bivalent vaccine came out.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 28Feb2021 18:00 as single dose for COVID-19 immunization. Medical history included reaction to flu shot many years ago and known allergies from clams. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); lisinopril; amitriptyline hydrochloride (AMITRIPTYLIN); rosuvastatin. No COVID prior to vaccination. The patient had not been tested for COVID post vaccination. On 28Feb2021 18:15, the patient experienced within 20 minutes my throat felt tight and he had trouble swallowing, his voice sounded froggy. The patient visited the emergency room/department or urgent care for the events. Treatment medications included Epipen, Benadryl and steroids. Outcome of the events were reported as recovered with sequel.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a child patient who was vaccinated with the initial dose of MMR II and developed a rash. The only clue to the age of the child is the child is due for a second dose to enter school. The patient has sought medical attention at office and had recovered from rash (date unspecified). Follow up information has been received from a physician concerning the 6 year old male patient who was vaccinated with MMR II. Subsequently the patient experienced facial angioedema and fever of 102. The patient was taken to the emergency room and was given adrenaline and steroids. Subsequently, the patient recovered on an unspecified date. Upon internal review, facial angioedema requiring adrenaline and steroids was determined to be other important medical event. Additional information is not expected.
hives on all upper joints, right hip, and in middle of back; feeling itchy on back, arms, hands.; Injected arm very difficult to use; Aches; Tiredness; Very sore injected arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on all upper joints, right hip, and in middle of back), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches), PRURITUS (feeling itchy on back, arms, hands.) and PAIN IN EXTREMITY (Very sore injected arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore injected arm). On 26-Feb-2021, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches) and FATIGUE (Tiredness). On 06-Mar-2021, the patient experienced PRURITUS (feeling itchy on back, arms, hands.). On 07-Mar-2021, the patient experienced URTICARIA (hives on all upper joints, right hip, and in middle of back). The patient was treated with CORTISONE on 07-Mar-2021 for Hives, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Mar-2021 for Hives, at a dose of UNK dosage form. On 10-Mar-2021, URTICARIA (hives on all upper joints, right hip, and in middle of back), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches), PRURITUS (feeling itchy on back, arms, hands.), PAIN IN EXTREMITY (Very sore injected arm) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medication and antihyperlipidemic..   This case was linked to MOD-2021-103076 (Patient Link).
This spontaneous report as received from a health professional via company representative refers to a 14 month old patient. On 30-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) (lot # J007862, Exp date: 28-DEC-2014) (dose and route unspecified) and a dose of VARIVAX (Merck) (lot #, dose and route unspecified). No PQC, and no adverse effects reported. No product confusion discovered. Additional information has been requested.
Immediately after patient was given the vaccine, patient stated that he was experiencing chest pain in the middle of his chest. Patient appeared very anxious even prior to the vaccine. Vitals were obtained and were within normal limits and patient was observed for additional 15 minutes with no progression. Patient was advised to seek medical care for his chest pain. On 4/8 patient came through Walk In to be seen for body aches.
Felt nauseated; Loose stools; Itchy rash, concerned might be shingles; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (had before).   On 3rd May 2022, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. In May 2022, less than a week after receiving Shingrix, the patient experienced nausea, loose stools and itchy rash. On an unknown date, the outcome of the nausea and loose stools were recovered/resolved and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the nausea, loose stools and itchy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in her right arm and unspecified pneumonia shot in her left arm and less than a week after vaccination, for the first couple of days she felt nauseated and had loose stools and then resolved. 10 days after the immunizations she developed an itchy rash on her left lower chest that she was concerned might be shingles.  The rash had not resolved. The patient had not seen a doctor yet regarding this rash. She said she did not feel bad and did not had a fever. It was unknown if the reporter considered the nausea, loose stools and itchy rash to be related to unspecified pneumonia vaccine. The reporter consented to follow-up.
Rash onset 2/22.  Initially on back.  Rash is vesicular on left upper back, chest and left arm. Dermatomal distribution consistent with zoster.  Pt was seen by PMD at clinic and diagnosed w/zoster and given Acylovir.  Pt suspected vaccine reaction due to the fact that vaccine given in left arm and rash appears only on left side.  Counseled re:zoster and vaccine.
After the 3rd vaccine the following day  I collapse to the floor in the bathroom.  I was on the floor for 17th hours, they finally sent someone to check on me.  They got me an ambulance to hospital, they told me I was suffering from Rhabdomyolysis.  My arm was in a lot of pain after the 3rd vaccinations. I took Tylenol for the pain to be able to sleep  They gave me pain medication, due to the intense pain on my left side. I couldn't pick myself up without screaming.  The pain medication in the hospital wasn't getting rid of the pain and it went on for 3 days.  I was hospitalized for 4 days. I used over the counter pain patches, for the pain.  They were lidocaine patches, now im fine and it doesn't hurt. I had two an half weeks of occupational therapy and physical therapy in my home after i got out of the hospital. I'm scheduled to go for physical therapy in the center.  Sept Thursday 16th until late 19th I was in the hospital.
Roughly 20 hours after vaccination, my daughter complained of significant pain in her left wrist and forearm.  As of the time of this report, the pain has been continuous and she developed swelling.
Went in for my yearly lab work in 04/2022, my doctor called and stated that CBC and B-12 were abnormal. My doctor put in on B-12 1000mg a day supplement and asked to to redraw lab in 8 weeks. When I went in for the second lab draw my B-12 was elevated and CBC was still abnormal. I have another blood draw in October of this year.
Nausea and vomiting. Pt vomited small amount, approximately 100 mL, clear bile-appearing fluid. Complaining of nausea. Refusing to take medication. Refusing to eat due to acute nausea.
Pain, Hives, swelling in arm and throat, cramps in right bicep and forearm.
After receiving the vaccine a few moments later i instantly started to have this metallic taste in my mouth and that has not gone away since receiving my vaccines. I also was very fatigue the following 3 days after the vaccine. I am a very healthy person and about 2 weeks later I started to feel pain and soreness throughout my body, mostly my joints. It got to the point that I had to visit my chiropractor just to feel a little relief.